INNOVATIVE COMPANIES Celebrating INNOVATION From animators to 3D tissue bioprocessing to innovator incubators to lab testing companies to clinical trial innovators to communication disrupters, these companies are changing the healthcare landscape.

pening at major nonprofit institutions, such as to each patient’s genetic analysis to help them • • • the Multiple Myeloma Research Foundation’s learn how patients respond to therapies. in no va tion CoMMpass Study, launched in 2011 as the Another example of cross collaboration is the action or process of innovating. first of its kind in myeloma. The collaboration the National Institutes of Health’s Brain Re- includes world-class researchers in more than search through Advancing Innovative Neuro- • a new method, idea, product, etc. 90 institutions. A “dream team” of cancer technologies (BRAIN) Initiative, which is part specialists is helping researchers gain access of a Presidential focus aimed at revolutionizing hen this special issue was con- ceived, the idea was to shine a W light on the innovators and in- novations that are changing the life-sciences Innovative Leaders industry. We issued a call to action to our readers to identify the companies that are Now in its fifth year, IDEA Pharma’s (ideapharma. first hepatitis C combination pill, Harvoni; the changing the paradigm and the products, com) Productive Innovation Index (PII) celebrates continued return on investment for Stribild; tools, technologies, processes, etc. that are the top 30 pharmaceutical companies most ef- achieving FDA approval and breakthrough making a difference in the lives of patients. fective at developing and commercializing new designation for Zybelig, and obtaining CDC We were overwhelmed by the responses; at medicines — bringing innovationsPharmaVOICE to market backing for Truvada. This saw the company the same time we are very much aware that the successfully. The index can be summarized by the knock Novartis down to rank third. companies and products featured in this issue question: if you gave the same molecule to two Despite its move, Novartis has remained only scratch the surface of the innovations that different companiesof in early phase, which would in the top three in recognition for the contin- are taking place everyday in every sector of make the best of it? ued growth from its core assets Afinitor, Ta- healthcare. Based on an objective, rolling analysis of signa, Zortress, and Gilenya, and contributions For example, just last month Johnson each company’s performance, between 2009 and from its industry-leading late-stage pipeline. & Johnson Innovation LLC announced the 2014, Johnson & Johnson (J&J) has continued Supporting this were a number of key approv- opening of JLABS @South San Francisco, a to demonstrate its leadership in pharmaceuti- als in 2014, including Zykadia for metastatic 30,000-square foot incubator that can ac- cal product commercialization. They remain ce- lung cancer, Xolair for hives, and Cosentyx commodate up to 50 startups from across mented in first place for the third year running, for psoriasis to name a few. Bexsero also had the healthcare spectrum including biotech, despite a significant shift in companies moving a good year with a breakthrough designa- pharmaceutical, medical device, consumer, into the top 10. tion, winning Prix Galien and FDA approval. and digital health. The first resident startups With eight of its drugs hitting double-digit What pegged Novartis back was the refusal have been selected, including the winners of growth across five disease franchises, J&J’s world- for serelaxin in heart failure, and pulling the the Johnson & Johnson Innovation, JLABS wide pharmaceutical sales increased by 14.9%, Tasigna EMA application for Philadelphia chro- Quick Fire Challenge, which was designed to with the star performer being its hepatitis C mosome positive-CML. recognize the most promising new, early-stage combination drug Olysio/Sovriad, reaching over Other companies that made significant innovation companies and award them with $2 billion in sales in 12 months. This growth was moves into the top 10 were Biogen, Amgen, the use of a bench and access to the JLABS @ bolstered further with successful launches for and Celgene – the latter was the second big- SSF community. Invokana, Imbruvica, and Zytiga, which helped to gest climber into the upper echelons, moving J&J is not the only major pharma company strengthen its position in the ranking alongside from 16th to take 8th place, for successfully that is fielding incubator type facilities to new approvals for Invega Sustenna and Rezolsta. expanding its reach from oncology and hav- encourage openCompliments collaboration. Bayer has also Notably, the biggest climber — moving up ing an immediate impact in the immunology invested in an incubator, the CoLaborator in from 18th to take second place — is Gilead Sci- arena. San Francisco, to offer biotechs the lab space, ences for its standout performance in launching The PII looks beyond revenue figures and shared facilities, and resources necessary for blockbuster drug Sovaldi, pulling in $10 billion raw approval rates and assesses companies discovery. Merck established the California in revenue in just one year, one of the industry’s based on a range of factors, including speed Institute for Biomedical Research (Calibr) and most successful launches ever. Cited as one to to market, attrition rate across phases — in

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Pfizer initiated The Pfizer Incubator and The watch in last year’s Index, Gilead’s undeniable particular Phase III, reimbursement rates, regu- Centers for Therapeutic Innovation (CTI). rise was also reinforced by the launch of the latory approvals, and analyst rankings. Additionally, open collaboration is hap-

12 April 2015  PharmaVOICE INNOVATIVE COMPANIES

our understanding of the human brain. By “innovation is work,” business executives are deliver the needed level of innovation. It seems accelerating the development and application focusing less on informal processes that pro- as though new thinking to elevate value and of innovative technologies, researchers will be duce incremental improvements to internal launch dramatic growth opportunities is in able to produce a revolutionary new dynamic operations and more on formal innovation the DNA of the enterprise, with every single picture of the brain that, for the first time, approaches that generate “breakthrough” and employee committed to innovation. shows how individual cells and complex neural “radical” innovation. Insigniam executives offer several best circuits interact in both time and space. Long In PWC’s latest innovation study, 69% practices to create an innovative culture, in- desired by researchers seeking new ways to of 1,757 senior executives contend having a cluding: inoculate against the corporate im- treat, cure, and even prevent brain disorders, well-defined innovation process is important mune system; less corporate gravity; corrected this picture will fill major gaps in our current to establishing a culture of innovation. This corporate myopia; greater innovation thrust; knowledge and provide unprecedented oppor- rigor is necessary to improve the chances of creativity, capability, and capacity; and effec- tunities for exploring exactly how the brain innovation success. To make headline-worthy tive execution. enables the human body to record, process, innovations happen, a significant percentage There is no doubt that big data in all its utilize, store, and retrieve vast quantities of of companies are looking to new innovation petrabytes is significantly driving innovations information, all at the speed of thought. models such as open innovation (collabora- across every sector. Companies such as GE and We know that innovation is happening in tion with outside partners), design thinking Siemens are breaking barriers and moving the big pharma companies, at startup biotechs, at (looking at the need from an anthropologist’s needle in significant ways. And we can’t forget med/device companies, in hospital systems, perspective), corporate venturing (investing to note IBM and Watson, the supercomputer and in every type of company that supports the in startups), and incubators (small groups of that is using big data analytics to address vast life-sciences industry. intrapreneurs that use rapid prototyping). healthcare’s hierarchy. Nontraditional healthcare companies such The consulting company Insigniam contends Over the past 15 years, PharmaVOICE has as and Microsoft are collaborating that innovations can be small or large, from incre- been excited to share the insights of innovators with brand-name pharma companies. Univer- mental step-changes to outright breakthroughs. and provide visibility to the innovations that sities are partnering with emerging startups. We agree, as evidenced by the innovations fea- are changing the industry. And, in the past Healthcare advertising agencies are teaming tured in this issue. Some are outright audacious two years we have dedicated a special depart- up with software developers. Clinical service in their vision, while others provide incremental, ment each month — Innovator’s Corner — to providers of all types are taking to the cloud. yet vital, changes to the system. spotlight companies that are changing the There seems to be no limit to the lengths for- Executives at Insigniam add that success- status quo. (See Letter from Editor). So, we are ward-thinking leaders are willing to take their ful organizations have the dependable ability particularly proud to celebrate more than 100 companies. to inspire creativity and harness small and companies and products in this special issue. According to a recent PwC report, business large innovations across the enterprisePharmaVOICE and, We look forward to hearing from you executives are banking on bold innovation to then, move them to market with speed. In a about new areas of research and development meet aggressive growth targets, so they are recent Insigniam survey of several hundred and innovations that we can celebrate through- taking innovation more seriously than ever executives, 87% of respondents say innovation out the year and in next April’s special issue. before. is of the utmost importanceof for success. Yet (Please visit PharmaVOICE.com in May for In the spirit of Peter Drucker who said, only 15% feel their organization is prepared to more details.)

Companies

AmerisourceBergen Exco InTouch Medidata Quintiles amerisourcebergen.com excointouch.com mdsol.com quintiles.com Aprecia Flagship Ventures Merge eClinical Reltio aprecia.com flagshipventures.com merge.com reltio.com Atlantis Healthcare GE Healthcare MicroMass Communications RTI International atlantishealthcare.com/us gehealthcare.com micromass.com rti.org BioMarin Pharmaceutical Google Microsoft Skipta biomarin.com calicolabs.com microsoft.com skipta.com Cerner HealthCarePoint Ogilvy CommonHealth SomaLogic cerner.com healthcarepoint.com Worldwide somalogic.com Clinical Ink HealthXL ochww.com Theranos clinicalink.com healthxl.org Organovo Inc. theranos.com Cognizant HemoShear organovo.com Unum Therapeutics Cognizant.comCompliments hemoshear.com Parexel unumrx.com Create NYC ICON parexel.com Viscira Createnyc.com iconplc.com PHT viscira.com ElMindA IMS Health phtcorp.com elminda.com imshealth.com Project Data Sphere Everyday Health Klick Health projectdatasphere.org (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] everydayhealth.com klick.com

PharmaVOICE  April 2015 13 COMPANIES Google TRANSFORMING DATA INTO HEALTH From to a Pill to Cure Cancer

the miniaturization of electronics complement Novartis’ deep pharmaceuticals and medical device expertise. Novartis aims to enhance the ways in which diseases are mapped within the body and can be ultimately prevented. Under the agreement, Google [X] and Alcon will collaborate to develop a smart lens oogle is making its presence known that has the potential to address ocular con- in the healthcare sector in a big way ditions. The smart lens technology involves G with no signs of slowing down any- non-invasive sensors, microchips, and other time soon. Perennially listed on Most Innova- miniaturized electronics that are embedded tive and Most Admired lists, reports state that within contact lenses. more than one-third of Google’s venture capi- The goal is to help diabetic patients man- tal in 2014 went to healthcare and life-sciences age their disease by providing a continuous, companies, a 9% increase from the previous minimally invasive measurement of the body’s two years. glucose levels via a smart contact lens, which Google Co-founder Even before the launch of Google Glass in is designed to measure tear fluid in the eye and 2013 — which is undergoing revisions and connects wirelessly with a mobile device. The Google wants to use the latest technology in updates to enhance its usability — Google device is also intended for people living with miniaturization of electronics to improve people’s created Google [X], a life-sciences division presbyopia who can no longerPharmaVOICE read without quality of life. dedicated to creating moonshots of healthcare glasses. innovations, a term coined by Astro Teller. is another Google-backed research According to recent reports, Google is in- and development company whose mission is Levinson was named by President Obama as vesting in several direct areas of healthcare and to harness advancedof technologies to increase one of eight recipients of the National Medal tangential areas, such as its self-driving cars, to the understanding of the biology that con- of Technology and Innovation and he was deliver on its moonshot goals. trols lifespan. The company’s goal is to use also named one of the 10 recipients of the For example, Google Genomics provides an that knowledge to devise interventions that National Medal of Science. API to store, process, explore, and share DNA enable people to lead longer and healthier In 2014, Google extended its partnership sequence reads, reference-based alignments, lives. Calico’s leadership has an impressive pharma portfolio by entering into a novel and variant calls, using Google’s cloud infra- pedigree. The company is being led by R&D collaboration with AbbVie intended structure. The idea is to collect and compare Founder and CEO Arthur Levinson, Ph.D., to help the two companies discover, develop, millions of genomes to help propel medical former chairman and CEO of Genentech, and bring to market new therapies for patients research. According to reports, the cost to and Hal Barron, M.D., former executive VP with age-related diseases, including for neuro- keep a copy of a genome with Google is just and chief medical officer of Genentech. Dr. degeneration and cancer. $25 per year. The agreement paves the way for Calico Another project Google is working on is Google’s smart lens technology has the to establish a world-class research and devel- the Nanoparticle Platform, an effort to build potential to read blood-sugar levels, which opment facility in the San Francisco Bay area. a cancer-detecting pill. The idea is that this would be a revolution for diabetics. Furthermore, Calico entered into an agree- pill will contain magnetic nanoparticles that ment with UT Southwestern Medical Center can latch onto certain cancer-related molecules and 2M Companies to advance research and in the bloodstream and that a wearable device drug development for neurodegenerative dis- could then use magnetic properties to recog- orders caused by the aging and death of nerve nize when this happens.Compliments cells. Google [X] has also entered into an agree- Most recently, The Broad Institute of MIT ment with Novartis’ eye care division Alcon and Harvard have entered into a partnership to in-license its “smart lens” technology for all with Calico around the biology and genetics ocular medical uses. The agreement between of aging and early-stage drug discovery. The Google and Alcon represents an important partnership will support several efforts at The

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] step for Novartis, across all of its divisions, Broad to advance the understanding of age-re- to leverage technology to manage human dis- lated diseases and to propel the translation of eases and conditions. Google’s key advances in these findings into new therapeutics.

14 April 2015 ● PharmaVOICE Pharma Sales Support. comTM

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Watch the video at Call us at Email Ashley Rycroft at www.PharmaCommunicationsSystems.comCompliments1-800-267-5409 [email protected] (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]

PharmaCommunications, PharmaSalesSupport.com and OASIS are trademarks of PharmaCommunications Holdings Inc. with PharmaCommunications Systems Inc. as licensee. © 2015, PharmaCommunications Systems Inc. COMPANIES AmerisourceBergen HEALTH SYSTEMS SOLUTIONS Getting Critical Medications to Patients

In September 2014, ASD Healthcare, a

division of AmerisourceBergen, realized a sig- nificant milestone — exceeding 400 billion AmerisourceBergen scans on its patented, radio frequency identi- fication (RFID) inventory solution, Cubixx. President and CEO merisourceBergen, one of the largest This translates to about 150 million scans read Steve Collis global pharmaceutical sourcing and and reported each day. ThinkLive is one way we demonstrate our distribution services companies, is The milestone reflects the success of an in- partnership approach. The annual summit offers A manufacturers a unique forum to collaborate with helping both healthcare providers and pharma novative marriage between RFID technology and biotech manufacturers improve patient and inventory management control for health- our leadership team. access to products and enhance patient care. care providers and patients. RFID tags use The company’s services range from drug dis- wireless capabilities to read and report unique, ception, awareness, and changes in market tribution and niche premium logistics to product identifiers automatically. By harness- conditions. The information is then compiled reimbursement and pharmaceutical consulting ing the RFID technology, ASD Healthcare and provided back to the manufacturer so it services. created an alternative to traditional time-con- can gain insight from the provider’s perspec- Understanding that the evolving health- suming and costly inventory management. tive and identify future trends based on this care landscape presents unique opportunities The Cubixx solution streamlines logistics feedback. and challenges for health systems, including management, including inventory certainty, To continue to foster innovation across higher patient volumes, cost constraints, safety regulatory compliance, and life-saving prod- its divisions and with its client base, Amer- requirements, and other critical issues, Amer- ucts for hospitals, physicians, and patients. isourceBergen hosts an annual manufacturer isourceBergen has responded with a number AmerisourceBergen alsoPharmaVOICE provides innova- summit ThinkLive, which provides global of innovative tools and processes to address a tive solutions for the manufacturer side of the pharmaceutical, biotech, medical device, and number of stakeholders in three key sectors of business to maximize product success at every diagnostics manufacturers a unique forum healthcare: pharmacies, providers, and manu- stage of the product life cycle, from clinical to collaborate with company executives and facturers. trial logistics andof launch strategy to distribu- hear from experts on key industry trends. The The company recently introduced a num- tion, provider education, patient access, reim- annual summit provides an opportunity for ber of solutions to address hospital pharmacy bursement support, and more. manufacturers to obtain industry insights on issues, including Pharmacy Unit Dose Plus, For example, Xcenda, AmerisourceBer- key issues, including improving product ac- an extension of the existing Unit Dose line gen’s full-service consultancy, developed a cess, supply chain efficiencies, and enhanced of individually packaged medicine that cre- virtual tumor case application as an alternative patient care. ates efficiency among hospital staff and helps to live challenging case sessions. Through this pharmacy professionals focus on patient care; application, Xcenda can present physicians TARxGET Reporting, a Web-based analysis with an online case scenario of a particular Through its state-of-the-art supply chain and forecasting tool that enables hospitals and patient. They answer questions based on per- technology and Lean Six Sigma-compliant health systems to best manage inventory and business processes, pharmacy and patients control costs while maximizing the impact of benefit from one of the safest, most secure, and efficient distribution systems in healthcare. medications on improved patient outcomes; and RxWorks Pro, a hospital pharmacy soft- ware platform that automates workflow and inventory management functions. Within the provider space, Amerisource- Bergen is the largest distributor of specialty pharmaceuticals to physician practices, the largest distributorCompliments of specialty pharmaceuticals to hospitals, the largest distributor of bio- pharmaceuticals, and the largest distributor of blood plasma, nephrology, vaccine, and biological injectable products. In 2014, the company began shipping

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] about 96,000,000 units of medication daily from what’s been called a next-generation pharmaceutical distribution center in Ohio.

16 April 2015  PharmaVOICE COMPANIES GE Healthcare TRANSFORMATIVE TECHNOLOGIES Meeting the Demands of Global Healthcare

what they see, making it an essential tool in providing personalized care from disease de- tection through treatment assessment. With the highest National Electrical Manufactur- ing Association (NEMA) sensitivity and the largest axial field-of-view in the industry, E Healthcare is providing transfor- Discovery IQ can image with both half the mational medical technologies and PET dose and half the scan time. Discovery G services that are shaping a new age of IQ offers smaller lesion detection with GE’s patient care to meet the demand for increased new Q.Clear next-generation PET recon- access, enhanced quality, and more affordable struction technology. Q.Clear provides up to healthcare around the world. From medical two times improvement in PET quantitation John Flannery President imaging, software and IT, patient monitor- accuracy (SUVmean) and up to two times ing and diagnostics to drug discovery, bio- improvement in image quality (SNR). Deliv- and CEO of GE Healthcare pharmaceutical manufacturing technologies, ering consistent quantitative SUV measure- GE Healthcare is a $17 billion segment of General and performance improvement solutions, GE ments enables fast and efficient reading for Electric Company and the first GE business with Healthcare is helping medical professionals greater confidence in evaluating a patient’s headquarters outside of the United States. deliver great healthcare to their patients. response to cancer treatment. challenge was established to help address this In March 2015, GE Healthcare announced GE Healthcare has a vast network of growing global problem. a strategic collaboration between its digital subsidiaries intent on improving healthcare The open innovation challenge, which pathology joint venture, Omnyx, and its in- around the world. One of thesePharmaVOICE companies, will stimulate interaction between academics, dustry-leading diagnostic laboratory services GE Healthcare Life Sciences, recently ex- industry, and charities, was launched in May company, Clarient Diagnostic Services to panded its relationship with Stevenage Bio- 2014 by SBC, Manchester Integrating Med- address the estimated 70% increase in cancer science Catalyst (SBC), the UK’s first open icine, and Innovative Technology (MIMIT) diagnosis predicted to occur over the next innovation bioscienceof campus, by supporting and six leading Academic Health Science two decades and an estimated 1.41 million SBC’s open innovation challenge in neurode- Centre Technology Transfer Organizations. misdiagnoses of cancer. generative disease. Proposals from academic teams for research Clarient will integrate the Omnyx pro- The link-up, which reflects GE Health- in two fields — biomarkers for diagnosis prietary software platform into its current care’s drive to advance research in the diag- and patient stratification, and inflammation/ laboratory. By combining the advanced mo- nosis of neurological disorders, builds on its neurodegeneration — will be reviewed by a lecular analysis of Clarient with Omnyx’s presence at SBC, where the company opened panel of industry, public sector, and research software, the pathology community will have a Technology Laboratory in October 2013. charity experts. Selected projects will be an- a data-rich pool of imaging enhancing the Hundreds of millions of people worldwide nounced in 2015. collaboration, gaining insights for more indi- are affected by neurodegenerative disorders vidualized cancer therapy. such as epilepsy, Parkinson’s and Alzhei- Molecular imaging centers in India make early While digital pathology is a solution mer’s disease, and SBC’s open innovation cancer detection more accessible and affordable. growing in popularity, the field continues to face challenges with greater volumes of cancer testing and a shortage in the workforce to process them. Clarient and Omnyx are work- ing together to help advance the industry, focusing on developing new solutions, analyt- ics, and infrastructure that help pathologists more easily and accuratelyCompliments diagnose patients and offer more individualized therapeutic treatment plans. Another recent innovation is GE Health- care’s Discovery IQ platform, a new PET/ CT system, which is increasingly sensitive to

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] detecting small forms of disease and built to provide consistent SUV (standardized uptake value) measurements so physicians can trust

PharmaVOICE  April 2015 17 COMPANIES Medidata TRANSFORMING CLINICAL TRIALS

Cloud-Based Solutions and lab scientist Glen de Vries formed Medi- data after they recognized the need to improve the clinical trial process. Today, the founders continue to lead the company, and their entre- preneurial spirit and passion for innovation is widely recognized and embodied by employ- ame on. These two small words pack ees, who are encouraged to take risks and push a big punch at Medidata. Embraced the boundaries of what cloud technology can G by the company’s executive team, do to make the science of drug development and often incorporated into companywide better. emails, town hall meetings, and water cooler For example, the company’s electronic pa- conversations, game on embodies the drive tient-reported outcome (ePRO) tool Medidata behind Medidata’s mission of transforming Patient Cloud can track patient compliance clinical development through innovative tech- and allow for adjustments, which enables faster nology and analytics. and easier login and a better user experience. Sitting at the of technology Design thinking is extremely important and the life sciences, Medidata is transform- and at the heart of innovation as the industry ing clinical development with its innovative moves toward a more patient-centric clinical Medidata President and applications and data-driven analytics. The research model. Medidata is in the early days company’s mission is to help customers bring of evaluating a number of different wearable Co-founder Glen de Vries Medidata has built a cloud-based infrastructure that better treatments to waiting patients around devices with the goal of identifying the best enables life-sciences companies to explore the use the world. The company believes by serving one for use in clinical trials — in terms of ease of mHealth technologies in clinical research. one and only one very large and important of use for patients and dataPharmaVOICE quality, security, industry, it can stay at the forefront of the privacy, and compliance for sponsors. data in real time — data that identify digital life-sciences sector and be relentless in its As wearable devices and connected bio- biomarkers and reveal one of the foundational quest to leverage technology to improve the sensors become more sophisticated and easier aspects of a clinical study: whether the patient efficiency of clients’ clinical trials. to use, there is strongof potential for them in is getting better. Fifteen years ago, businessman Tarek Sherif clinical trials to gather better data on patients’ Medidata is committed to fostering an response to therapy and progression of disease. innovative, agile company culture through Medidata’s industry-leading cloud platform of Medidata is responding to this paradigm shift professional development opportunities and innovative technology and data analytics is by piloting mHealth studies that use wearable resources. The company regularly conducts transforming clinical development. devices to collect extensive, objective patient hackathons and offers company-sponsored in- novation time. Medidata put these programs in place to encourage teams to come together and experiment with new concepts, research new approaches, and test methodologies. In 2014, the company’s mobile app prototype won the Patient Engagement App Challenge at the 23rd Annual Partnerships in Clinical Trials Conference. The app was recognized for its potential to positively transform the clinical trial experience for study participants — a concept that emerged during a series of creative brainstorming sessions. The company also launched the Medidata Compliments Patent Program in late 2013, an employee recognition program offering monetary awards for innovative ideas that help the company obtain patent rights. Medidata’s focus on employee innovation and investing in its people are among the

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] reasons why the company was recently named one of 2015’s Best Companies to Work for in New York State.

18 April 2015 ● PharmaVOICE PharmaVOICE Pioneering mHealthof in Clinical Trials

At Medidata, we believe that mHealth technologies can provide a much richer picture of patients’ health in the real world. Data from sensors, wearables and apps lead to better insights, improved patient experiences and more efficient trials. But correctly using that data in clinical trials is a new challenge.

That’s why Medidata is bringing the scientific discipline of clinical R&D to mHealth. We’re spearheading pioneering mHealth trials and techniques to help our customers gather, analyze and make more informed decisions through this rich new data. Compliments To learn more about Medidata’s innovative mHealth initiatives and how we can help transform your research programs, visit www.mdsol.com/mHealth. (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] [email protected] | mdsol.com | +1 866 515 6044 COMPANIES ICON SPARKS EMPLOYEE ENGAGEMENT New Global Innovation Hub Advances Clinical Development

nel to derive better insights from the data. The new jobs include roles in IT, data analytics, clinical science, project management, among others. Another example of how the company has created an environment that fosters innovative thinking and encourages new ideas from across the organization in both informal discussions CON, a global provider of outsourced and formal channels is its “Ideas Management development services to the pharmaceu- Solution.” Managed by the ICON Innovation I tical, biotechnology, and medical device Team and branded SPARK, the platform en- ICON CEO Ciaran Murray industries, is demonstrating its commitment ables all ICON employees to have their voice As innovation plays an increasingly important role to innovation through a significant investment heard in overcoming particular challenges to in improving the outcomes of clinical trials, ICON is in a new facility and an employee-engagement find new ways to ways to better deliver quality reinforcing our commitment to that goal by locating process designed to foster cross collaboration data, speed up clinical development, lower cost our global innovation hub in Ireland, one of the and ideation. to drug and device developers,PharmaVOICE and, improve leading R&D and innovation centers in the world. Guided by an overall management philos- patient safety. ophy that recognizes that it does critical work ICON employees are encouraged and chal- sustainable graduate base. Clinical research for customers that has a significant impact lenged to submit ideas to maximize the power and development generates large amounts of on patients’ lives around the world, ICON of the crowd and ofthe knowledge, experience, data, and the partnership between ICON and launched in January 2015 a new global inno- and insight each person can bring to the table. UCD is designed to deliver additional insight vation hub creating 200 new jobs in Ireland. The SPARK platform also gives employees to these data, which will be of significant value The hub is designed to foster the development an opportunity to comment and rate the ideas to pharmaceutical companies and medical of new technologies and clinical trial processes of colleagues. This, combined with business firms and offer the opportunity to increase the that will enable faster access to large volumes review against strategic and organizational efficiency of clinical trials. of clinical data and allow clinical trial person- goals, provides a perspective of which ideas are ICON also funds research scholarships best to move forward and potentially into the focused on big data projects. The emphasis is proof-of-concept stage. on the practical application of technical ap- This process of continual employee-led proaches to solving problems in business, and innovation has generated several new products on developing methods for managing decision and services for the life-sciences industry. One making. of these is the company’s ADDPLAN DF This focus on data analytics and informat- system, developed with five major pharma ics has led to the development of a new tool companies. to address the relatively poor success rates of Another innovation is the cloud-based CNS trials and the difficulty in measuring Firecrest’s eConsent program. Despite in- clinical endpoints for CNS drugs. The goal is tensive and costly monitoring, 9% of FDA to identify sites that warrant closer scrutiny by findings are due to errors in the consenting a site monitor. Complimentsprocess — the third most common cause of ICON’s commitment to innovation and FDA findings. The solution helps to eliminate creating clinical excellence has been recog- errors while providing a real-time view of trial nized over the years by several high-profile compliance that is 21 CFR part 11 compliant. industry awards, including the Vaccine Indus- ICON also funds The Chair in Busi- try Excellence (ViE) Awards for Best Clinical ness Analytics at University College Dublin Research Organization 2014, and the Institute ICON’s medical device and diagnostic (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] research group provides dedicated (UCD). The Chair in Business Analytics is for International Research and Partnerships resources throughout the lifecycle. leading the development of a long-term teach- in Clinical Trials’ Partnership Pioneers of the ing and research capability that will create a Year award along with Pfizer in 2013.

20 April 2015  PharmaVOICE If only changing patient behavior were this easy.

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Experts in Human Health Behavior WeAreSpecialists.com

15MMC002-MKT-Jrnl-Ad-Phrm_Vce-0415-M.indd 1 3/11/15 5:18 PM COMPANIES Reltio PIONEERS NEW DIGITAL PLATFORM Cloud-Based Data Management

sponsible for the overall direction and man- agement of Reltio, and the co-author of the patent that revolutionized master data man- agement (MDM) through a global business identifier. He founded the company upon the belief that organizations need reliable, relevant eltio’s moniker “be right faster” drives access to information at their fingertips. Mr. everything the company does. As a Sood and his leadership team are inspired by start-up and rapidly growing com- the desire to disrupt the multi-billion software R pany, management is prepared to make deci- market through the use of big data technolo- sions quickly with reliable data. gies, master data management discipline, and Reltio CEO Manish Sood Manish Sood, CEO and cloud computing. Additionally, they believed Consumer-driven applications such as Facebook founder, is re- that there was a gap in what IT delivered and and LinkedIn are setting the expectations for what business needs. IT spends money on data technology to be easy to use and information should management and business is frustrated with be at a person’s fingertips. IT’s time-to-value, purchases ad-hoc business intelligence products. Among the company’s cutting-edge tech- Reltio helps companies turn their data into nologies is the Reltio Cloud, which the com- information and knowledge assets in the most pany reports is the only platform to deliver efficient way, shattering the traditional notion enterprise data-driven applications with reli- that IT must combine multiplePharmaVOICE technologies able master data, relevant big data insights, to manage different types of data, and that and intelligent recommended actions. Reltio business users must purchase stand-alone tools Cloud is a modern data management platform to do their own analysis. that is a fully contained master data manage- Consumer-drivenof applications such as ment offering that has been proven to be 10 Facebook and LinkedIn are setting expecta- times more cost-effective and five times faster tions that technology should be easy to use and to deploy than legacy MDM offerings. This information should be at a person’s fingertips. is a disruption to the $1 billion plus MDM Managers at Reltio have put that same ease of software market. use and insight in the form of data-driven ap- Reltio manages all data types including plications for sales, marketing, and compliance multi-domain master data, transaction and teams so they can better predict, collaborate, interaction data, third party, public and social and respond to opportunities in real time. data. By combining operational and analytical silos, teams can continuously collaborate to improve the reliability of information, receive The cloud has leveled the playing field, giving both large and small companies the ability to recommendations relevant to their goals, and manipulate data at scale. take immediate action, all within the same application. Reltio believes the days of separate MDM systems feeding disparate analytical reporting tools for discovery, and operational applica- tions for data capture are numbered. Today reliable data, relevant insights and recom- Compliments mended actions can be combined into one single application, in the cloud, to deliver both analytical intelligence and operational execu- tion. These enterprise data-driven applications are being touted as the future of software, and a part of a consumerization of IT trend that is

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] helping sales, marketing, product brand, and compliance teams be more productive and successful every day.

22 April 2015  PharmaVOICE COMPANIES SomaLogic A REVOLUTION IN LIFE-SCIENCES AND MEDICINE Making Proteomics Accessible

he ability to identify and measure individual proteins across the depth T and breadth of the proteome (or pro- teomes) will transform biological research and even medicine. SomaLogic’s goal is to develop SomaLogic Chairman and and market breakthrough new protein bio- Founder Larry Gold, Ph.D. marker-based pharmaceutical research tools SomaLogic technology overcomes the limitations of that lead to new diagnostics and therapeutics. The crystal structure of a SOMAmer-proteinPharmaVOICE other proteomics approaches, allowing researchers SomaLogic was founded by Dr. Larry Gold pair reveals the unique binding properties of to measure broadly across the proteome. in 2000 based on the belief that a high quality SOMAmer reagents compared with traditional aptamers (base modifications are in purple). of life — wellness — is largely a matter of This new generation ofof powerful protein- “actionable” measurement, and that the mea- binding reagents is at the core of SomaLogic’s this visionary test the “Wellness Chip,” and surement that matters most is the complex and SOMAscan assay, the biomarker discovery they are working to make it possible within ever-changing array of proteins that circulate engine that drives the company’s efforts. the next decade. through our bodies in ways personalized to SomaLogic’s technology overcomes the each of us. limitations of other proteomics approaches The company believes that the ability ested in incorporating modified DNA bases such as mass spectrometry and antibody-based to monitor an individual’s health over time into the aptamer pools. A great deal of trial analyses, allowing researchers to measure by measuring changes in his or her protein and error was undertaken, resulting in the broadly across and deeply into the proteome, makeup is nothing less than a revolution in multiple modification “libraries” that exist across a large range of concentrations and healthcare. The earliest possible detection of today. protein types. disease, the evaluation of nutritional and fit- From that initial concept to present day, The company is about to launch a test that ness states, and the measurement of the effects the company has developed specific SOMAmer can tell with very high specificity and sensitiv- of external interventions such as drugs and reagents to more than 5,000 proteins, a num- ity if an individual is at risk for a second heart supplements, together will empower individ- ber that continues to grow. attack or other cardiovascular event. uals to monitor and maintain their state of The company’s second breakthrough was Currently, every person who has had a health and wellness and thus improve their the realization, established through experi- cardiovascular event is treated aggressively. If quality of life. mental use, that individual SOMAmers could there was the ability to identify that smaller SomaLogic has spent the last 10 years de- be pooled together to do large-scale protein group of individuals who requires the aggres- veloping and validating its proteomic technol- measurement/biomarker discovery in many sive intervention (and the larger group that ogy platform Slow Off-rateCompliments Modified Aptamer different types of biological samples, using does not), this could make a substantial differ- (SOMAmer). SOMAmer is being used today very small volumes. The resulting technology ence in many lives. to develop new diagnostic tests, discover new is the SOMAscan assay. To date, the company The company is also working with the Bill drugs and accelerate their translation to clini- has analyzed more than 60,000 clinical sam- and Melinda Gates Foundation to develop a cal practice, and reveal new understandings of ples across many different diseases. field-friendly test for latent and active tuber- basic human biology and disease. The company’s leaders envision a day when culosis, based on the unique properties of SO-

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] In the course of experimenting with differ- all measurements can be brought together in MAmer reagents. Significant progress has been ent types of “add-ons” to traditional aptamers, a single inexpensive and easy test — perhaps made, and the Gates Foundation renewed (and a group of SomaLogic chemists became inter- even one that can be done at home. They call upped) the funding this past year.

PharmaVOICE  April 2015 23 COMPANIES MicroMass LOOKING TO CHANGE BEHAVIOR

Evidence-Based Techniques for a New Standard of Care

based on proven intervention components and delivery principles. Last year MicroMass developed a new team within the creative department called the xecutives at MicroMass Communica- Behavioral Content Architecture group. This tions have a vision: create a new stan- team of content strategists is applying evi- E dard in healthcare through the ap- dence-based change strategies to multi-chan- plication of behavior change strategies. This nel, skill-building programs. They are also cer- vision is rooted in the company’s application tified health coaches and apply the principles of applying behavioral science to pharmaceuti- of health coaching to develop more engaging cal marketing that it started 20 years ago and and effective program content. continues to refine. The company’s “innovation Another new program offering creates pa- lab,” which operates under the Health Behav- tient-provider dialogue programs, which are ior Group uses a rapid-fire, product-focused relevant across chronic conditions. This pro- model to generate ideas and test real-word gram incorporates evidence-based strategies, feasibility to respond to changing marketplace such as shared decision making and motiva- needs. tional interviewing and includes provider dia- MicroMass President Another key principle that impacts how logue training and point-of-care tools to stim- Alyson Connor MicroMass designs solutions is the partner- ulate open conversations aboutPharmaVOICE treatments. MicroMass makes sure that all employees are ships it has with patient advocacy organiza- In addition to the Innovation Lab, Micro- trained in applying evidence-based behavior tions, health systems, and public health schools Mass facilitates employee innovation by mak- change to its offerings. within universities that serve as an extension of ing sure all employees — not just behaviorists its innovation lab. The agency chooses of — are trained in applying evidence-based partners that are also focused on inno- behavior change techniques. The agency vating to improve patient outcomes. brings in outside, non-industry experts This direct contact with stakeholders at at least once a year to expand the way the point of care ensures agency leaders employees think about applying these have their pulse on the real-world needs techniques, for example motivational in- of patients and providers. terviewing, cognitive behavioral tech- To fully engage customers and niques, and health coaching. understanding and deliver on their The agency also developed an in- needs, the company employs a three- ternal platform called Sparkology, for step method, which it calls Engage, all individuals to have the opportunity that maximizes how multi-disciplinary to develop innovative solutions for the teams pull through the behavioral in- marketplace without the budget or reg- sights and strategies into an end solu- ulatory parameters faced in client work. tion. Step one is “driver analysis;” be- Quarterly, employees are placed on haviorists and strategists prioritize key Sparkology teams and provided a health- drivers of customer engagement and care-related challenge to solve. They are craft a custom behavior change model. asked to step outside their roles as project Step two is “change mapping;” managers, account service, strategists, behaviorists, strategists,Compliments and creative etc., and collaborate to come up with an teams identify evidence-based change innovative product to meet the assigned strategies and formulate an engagement plan challenge. MicroMass leaders believe that solu- that provides a foundation for meeting behav- MicroMass’s mobile app, Time2Focus, tions that go beyond information delivery can ioral and commercial objectives. Step three is incorporates evidence-based techniques, disrupt the marketplace and build provider “solution architecture;” this is a comprehensive such as problem solving and goal setting, and patient capabilities to change and im- and leverages gamification principles to (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] action plan, outlining the tactical experience prove quality metrics that take pharma success drive lasting patient engagement. needed to engage customers and build lasting measures to a new standard that are valued by skills for better outcomes. The action plan is many different stakeholders.

24 April 2015  PharmaVOICE Crank Up Your Brand’s PulseCX.com Customer Experience (CX)

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PharmaVOICE of

“You guys get it. You really understand what we want and need.”

Those were feelings shared by patients with a rare disorder whose engagement with our client’s brand created a unique customer experience (CX) that made them feel like stars of the show. By understanding their customer journey, we created true patient and physician connections and engaged them at just the right moments with authentic communications to change behavior and drive brand adoption.

Discover how PulseCX can leverage the customer Complimentsexperience (CX) to boost success for your brand. (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]

Contact David Zaritsky at [email protected] or 215.699.9200, and visit PulseCX.com today. COMPANIES IMS Health INCUBATING EMPLOYEE CONTRIBUTIONS Bringing Innovative Ideas to the Fore

range from systems that improve the access, IMS Health CEO accuracy, and security of data, to technology for better managing clinical trials, to method- Ari Bousbib ologies that help life-sciences companies pri- IMS Health’s Recognition Program acknowledges oritize provider networks and develop regional employees’ efforts to improve the access, accuracy, and local strategies. For example, a patent for and security of data in technologies for the life- MS Health applies cutting-edge analytics a cohort feature for a trial design process ema- sciences industry. and proprietary application suites hosted nated from the Recognition Program. I on the IMS One intelligent cloud to The use of cohort-design trials by pharma- and to solve the problem in the shortest possi- connect more than 10 petabytes of complex ceutical and biotech companies is on the rise. ble timeframe. healthcare data on diseases, treatments, costs, In fact, for one of the company’s customers, a The product module was developed to and outcomes to enable clients to run their top five pharmaceutical company, 30% of tri- alleviate intense difficulties reported by clients operations more efficiently. IMS Health draws als use a cohort design. Over the past few years in planning, tracking, and predicting the on information from 100,000 suppliers and on more than half of the top 10 pharma compa- outcomes of cohort trials in real-time. The insights from more than 55 billion healthcare nies requested that IMS Health build features automation allows for modeling scenarios and transactions processed annually to provide allowing for the managementPharmaVOICE of these trials. predicting outcomes using algorithms that access to real-world evidence data that can This was a complex problem to solve and take actuals into consideration, which is im- be integrated into software applications, giv- there were many other priorities on the road- possible to perform in this fashion in Excel or ing users answers to complex questions the map. The breakthrough moment came when with any other competitive product currently pharma industry confronts today. IMS Health one client detailedof its pain of using different on the market for this type of trial design. continually invests in technology, employees, systems and Excel spreadsheets to manage Another industry innovation developed innovation, and continuous improvement. cohort trials. by IMS Health is the suite of SiteOptimizer “We develop with clients for clients” is This was a trigger to prioritize the module products. The IMS Health CTOS Optimizer how IMS Health describes the products launched in 2006 were culture of the organization. the first in the market to address The company believes the best enrollment challenges by provid- technological and procedural ing actionable insights, resulting innovations can be compared in a direct reduction in the dura- with a playground with the tion of, and expenses for, clinical most up-to-date toys and trials. Patient lives are improved structures. However, the play- by faster delivery of drugs to ground is a sad sight if there market. are no kids playing on it or Another new IMS Health if the structures are not well product is the Mobile Sales solu- suited for kids. IMS Health tion, which is reportedly the first takes a client-centric approach mobile sales and marketing ef- to understanding client needs, fectiveness solution that allows and in collaboration with cli- life-sciences companies to opti- ents builds innovativeCompliments solu- mize and execute brand strategies tions that solve their business at local levels. problems in a human-centric The patent-pending “Next way following design-thinking Best Customer” helps prioritize principles. customers based on brand strat- In 2014, about 40 inven- egy, local dynamics and multiple IMS One powers suites of commercial, clinical, (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] tion ideas were submitted to the Recognition payer and provider applications designed to data sources, including targeted prescriber Program by IMS Health employees, and 23 work together. behavior, payer influence, territory sales and were approved for patent filings. Innovations proximity.

26 April 2015  PharmaVOICE COMPANIES Klick Health A DECODED COMPANY it brings to the market. Klick Labs is run by a A Company Culture Built on Disrupting the Status Quo dedicated team of healthcare experts who are passionate about creating solutions and experi- ences for patients, HCPs, and the industry. Klick’s dedication to disrupting the sta- tus quo is captured in the New York Time’s bestselling book The Decoded Company, in which Leerom Segal, CEO and co-founder, lick Health, as they say, is different and his colleagues outline the six principles from the ground up. Formed 17 years they’ve used to decode work and unlock the K ago, the independent digital health maximum potential of their talent and share agency is fueled by, in their words, data geeks success stories from other organizations that who appreciate fine art and MBAs who have have embraced this approach. The Decoded minored in molecular biology, all of which add Company is an actionable blueprint for any up to a unique blend of business consultancy, company that wants the best from its people, creative agency, and technology shop under and isn’t afraid of radical approaches to get it. one roof. Mr. Segal, a multiple PharmaVOICE 100 Innovation is at the heart of what Klick honoree, has also been named Entrepreneur of does; agency leaders believe the best way to the Year by the Business Development Bank predict the future is to invent it. Laser-fo- of Canada, won the Young Entrepreneur of the cused on creating solutions that engage and Year award from EY, and was named to Profit educate healthcare providers about life-saving Magazine’s Hall of Fame as the youngest CEO treatments, Klick helps inform and empower ever to lead a nonprofit company. Co-authors patients to manage their health and play a PharmaVOICEinclude Aaron Goldstein, co-founder of Klick central role in their own care. Every solution who is also a senior certified project manage- hinges on Klick’s in-house expertise across the ment professional; Jay Goldman, managing digital universe — strategy, creative, analytics, director of Sensei Labs; and Rahaf Harfoush, instructional design, user experience, relation- of who is the author of several books, including ship marketing, social, and mobile. Yes We Did and was a contributor to the best- Before creating the Sensei Lab, which helps selling Wikinomics and Grown Up Digital. align organizations’ belief systems and oper- This book takes the Klick Health culture ating systems so they can execute and evolve engine, centered around its intranet, Genome, faster, Klick aligned its internal processes, and shows how using big data insight activi- first by eliminating email and then creating ties on a company’s workforce can work just as the Genome, which supports everything that well as it does for customers. happens in the agency. Genome was recently Klick’s data-driven, people-centric ap- recognized as one of the top 10 intranets in proach to business management, has earned it the world. Klick also instituted an employee multiple awards over the years. In 2015, the concierge service that regularly orders work- agency was named a Canada’s Best Managed late dinners and runs errands for Klicksters, Company for the seventh consecutive year. as agency employees call themselves, to make Program sponsors are Deloitte, CIBC, Na- their lives easier. The service also manages the tional Post, Queen’s School of Business, and company’s on-site health and wellness center MacKay CEO Forums. (offering free daily yoga and fitness classes) Klick Health also has been recognized for and convenient dry cleaning service, as well as having the Talent Acquisition Department handling customized tasks for employees, as of the Year for a small company by ERE, a required. The companyCompliments is dedicated to bring- leading authority for human resources and ing out the best in its people and fosters a sense recruiting professionals. of camaraderie in everything it does, including Klick Co-founder In particular, ERE pointed to Klick’s Camp Muskoka, where the entire company innovative experiential recruiting campaigns bunks together at a camp in the Muskokas for and CEO and the fact that the company has dedicated a weekend. Leerom Segal Culture & Engagement team advocates, who (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Klick reinvests tremendous amounts of re- Klick is obsessed with building a culture that guide job candidates through the interview sources back into R&D, which comes to life attracts and engages leading minds and is process and help ensure a positive candidate through Klick Labs and the applied innovations passionate about health and doing meaningful work. experience.

PharmaVOICE  April 2015 27 COMPANIES Everyday Health PERSONALIZED CONSUMER HEALTH INFORMATION Allowing Consumers and Physicians to Stay Informed

tion to the right user. The company’s portfolio approach with properties such as MedPage Everyday Health CEO and Today, Dr. Sanjay Gupta, Mayo Clinic, and Co-founder What to Expect is supported by a multi-chan- nel delivery system that provides information Benjamin Wolin via the web, mobile devices, video or through The company’s commitment to providing a social media. The company’s commitment to personalized experience for each consumer starts providing a personalized experience for each with up to 5,000 pieces of information. tarting with only three people working consumer who relies on the site starts with around a kitchen table in Brooklyn to up to 5,000 pieces of information that can be lytics, as Everyday Health can customize the S today’s 500-plus person company that tracked. Securing data from surveys, diet/fit- information and news they are receiving in successfully managed an IPO in 2014, Every- ness journal entries, quizzes, and media activ- their particular specialty. With two-thirds of day Health has transitioned from an online ity allows the company to develop personalized all practicing physicians in the U.S. using the publisher to a digital health marketing solu- action plans to empower and inspire people to portfolio, the company can deliver breaking tions company. get and stay healthy. Supporting content such medical news as well as insights and informa- The company’s portfolio consists of about as recipes, condition articles,PharmaVOICE expert videos, and tion from the more than 130 medical confer- 25 health and wellness properties, each fo- message boards ensures continued engagement ences around the world. cusing on a particular area of the health and and is promoted via personalized newsletters. With the ability to collect and analyze wellness spectrum. The content and tools span Physicians also benefit from data and ana- data from its audience, Everyday Health can topics, including critical health of bring value to its advertisers. Re- conditions, pregnancy and parent- al-time data and analytics allow ing, medical news and conferences, the company to deliver qualified and diet and fitness. users to the appropriate market- Everyday Health has a database ing programs within the portfolio of more than 65 million registered and to effectively measure and un- users, which allows the company derstand what users are engaging to identify and respond to cus- with. The company can then look tomer needs while using the most at how the users are impacted. advanced technology to provide The company has an internal an optimal content experience for research capability that includes all who interact with the site. The a 50-plus person team boasting company’s approach to product seven patents and four Ph.D.s. The development and editorial con- company also works with Cornell tent stems from the recognition University and the University of that consumers are searching for Notre Dame and has strategic al- relevant and credible health infor- liances with leading research com- mation, and that healthcare profes- panies including IMS Health and sionals and caretakers need quick Nielsen Catalina Solutions. access to constantlyCompliments evolving re- The company strives to cre- search and information. The com- ate a culture that encourages and pany has invested heavily in its rewards imagination. Employees product and technology teams to ensure that Everyday Health’s goal is to engage audiences develop innovative ideas that can benefit thou- the roadmaps and designs are nimble and in- with premium health and wellness properties sands of people and translate into marketable novative enough to deliver on what users need. and then use its data and analytics expertise to business opportunities. For example, members deliver highly personalized user experiences (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Predictive risk algorithms supplement and efficient and effective marketing and of the data sciences team entered into a com- self-reported disease information so that Ev- engagement solutions. petition resulting in the development of the eryday Health can deliver the right informa- Flu Map.

28 April 2015  PharmaVOICE ContactCenter-Ad9x11-032515_Layout 1 3/25/15 1:23 PM Page 1

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   Compliments                         (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]                                           COMPANIES RTI International NEW MODEL FOR COLLABORATION Actionable Insights

Peanut Allergen Test Strip, an On Demand Solar Thermal Energy Generator, TBIRD, Traumatic Brain Injury Rapid Diagnostic, and the RTI Social Frame, a customizable, research-driven approach to analyzing social RTI’s President and CEO media data. E. Wayne Holden RTI also sponsors an internal annual Inno- RTI sponsors an internal Innovation Showcase vation Showcase that highlights the creativity that highlights the creativity of its staff members, TI International, an independent, and most promising research of its staff mem- and an innovation fund was established to support nonprofit institute that provides re- bers and encourages collaboration across the breakthrough ideas. R search, development, and technical institute. Winners of the Innovation Awards services, has created a new model for collabora- are nominated by their research groups and better understand clinical trials and what tive problem solving and idea generation. RTI selected by a committee of RTI Fellows. they involve. The tool provides information is one of the world’s leading research institutes, Beginning in 2012, a Creative Disruptors required by institutional reviews boards to dedicated to improving the human condition group has sponsored annual Ideathons, sim- obtain informed consent in an engaging way. by turning knowledge into practice. ilar to hackathons, that thenPharmaVOICE selects projects Currently, the tool is tailored to individu- The organization’s Innovation Lab works to receive seed funding and participate in a als with developmental disabilities (fragile X with industry partners in interactive, partici- more formal Idea Incubator. A 2014 survey of syndrome). In the formative stage of the proj- patory, team-based working sessions to foster employees identified barriers and facilitators ect, RTI explored how individuals with fragile an idea laboratory. The labs support cross-pol- to increasing participationof in innovative activ- X syndrome are using technology and how lination by convening individuals with a di- ities. A new Innovation Fund was established it can be devised to meet their health-related versity of perspectives to consider barriers to to support potentially breakthrough ideas decision making needs. This data heavily in- innovation and opportunities for new product that can lead to new approaches, services, and fluenced the content and interactive elements. application and development. Participants in- products. Internal research and development For example, users shared that they enjoy clude representatives from companies who by funding is also available to support small em- interactive sorting activities on tablets. There- design offer distinct vantage points within ployee-initiated projects. fore, RTI created a sorting component to the and across firms — university thought leaders, One of RTI Inter- tool to help people think through the potential entrepreneurs, ethnographers, national’s recent initia- risks and benefits of participating in a clinical designers, RTI researchers, and tives is to develop trial. The organization has completed content others. an interactive, elec- development and is exporting the graphical Innovation Advisors tronic decision tool assets intended for a mobile browser. work with business cli- to help patients RTI International’s staff of more than ents to provide insights, 3,700 provides research and technical services analysis, and connections to identify to governments and businesses in more growth opportunities, commercialize than 75 countries in the areas of health emerging technologies, and and pharmaceuticals, education transform communities. and training, surveys and statis- The Innovation Labs ex- tics, advanced technology, interna- plore which solutionsCompliments might tional development, economic and provide lasting impact and social policy, energy and the envi- seek to solve complex prob- ronment, and laboratory testing and chemical lems that require integrated analysis. solutions. Framed by consideration of trends, Some of RTI’s 2014 achievements ranged industry drivers, and futurist thinking, RTI from improving sanitation in developing coun- The RTI Innovation Lab is a new model for (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Innovation Labs also help surface precompeti- collaborative problem solving and idea tries to measuring and assessing healthcare and tive and longer-term opportunities. generation. education around the world, to further devel- Some recent lab innovations include a oping clean energy technology.

30 April 2015  PharmaVOICE PRA_Full Page_PharmaVoice_Apr2015.pdf 1 3/16/15 10:03 AM

THE FUTURE OF CLINICAL DEVELOPMENT IS OURS FOR THE MAKING.

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ComplimentsCOMPREHENSIVE PHASE I-IV BIOPHARMACEUTICAL DRUG DEVELOPMENT At PRA Health Sciences, providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward and develop life-saving and life-improving drugs. We help change people’s lives (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] for the better every day. It’s who we are. Innovating to help people is at the heart of our process, but it’s even more than that. It’s also our privilege.

www.prahs.com COMPANIES Cognizant BUSINESS ACCELERATOR Bringing Employee Ideas to the Forefront

employee ideation. The company sponsors internal entrepreneurs, providing people, cap- ital, and support to create industry-specific solutions. In addition to employee-led initiatives, many of the company’s solutions are jointly Cognizant CEO ngrained in Cognizant’s DNA is a owned and managed by its clients and some belief that those who challenge the with its alliance partners. At present, there Francisco D’Souza way they work today will lead the way are more than 1,500 concepts being currently Our Emerging Business Accelerator helps identify E trends and ideas, including the most promising ones tomorrow. With a passion to make a differ- worked upon by Cognizant. across new technologies, delivery models, and ence and to encourage breakthrough thinking, Cognizant consciously emphasizes on shar- markets. Cognizant has institutionalized an in-house ing its learning and experience with the global platform called Thought Exchange, which community, to enrich the future trends. For encourages QA professionals to share newer example, Cognizant’s QE&A summits help the World’s Most Admired Companies list for the ideas. These ideas are then owned and shaped company’s experts interface with the market seventh year in a row. The company has also to solutions by centers of excellence (CoEs). helping to understand trends and challenges been named to Information Week’s Elite 40. This is one source for Cognizant’s innovative faced by clients in the quality space. An example of Cognizant’s commitment solutions, including ADPART, a model-based To keep its talent pipeline primed, Cog- to the industry is demonstrated by its phil- test design product that interlinks business nizant, which is a provider of information anthropic endeavors, including 34 grants process with testing; fastest, a cloud-based technology, consulting, and business process awarded to after-school, in-school, and sum- on-demand software testing service that en- outsourcing services, has pioneeredPharmaVOICE the concept mer programs at 54 sites across the U.S. ables pharmaceutical companies to test their of defining career paths for testing profession- through its Making the Future education ini- applications online and swiftly scale to meet als by creating unique role-based career frame- tiative. Designed to inspire interest in STEM the volatile requirements without having to works for its associates with its Cognizant (science, technology, engineering and math) invest in tools, infrastructure, or workforce; as Career Architectureof program. The company education among students from grade school well as numerous solution accelerators. has established clear career tracks for its testing through high school, the initiative supports Cognizant also boasts an Emerging Busi- professionals for progression on their domains, hands-on learning opportunities that promote ness Accelerator (EBA), which pushes the technical expertise, project management, prod- creativity, problem-solving, collaboration, and frontiers of innovation and to make sure the uct management, and consulting roles. self-expression. The 2015 grants will provide solutions keep challenging what’s possible. Cognizant’s forward-thinking approach more than 5,000 young learners with access to The EBA is organized into three areas: digital to innovation, people management, use of 250,000 hours of making activities focused on technologies, an innovation ecosystem, and corporate assets, quality of product/services, STEM topics, including electronics, robotics, business accelerator. The business accelerator among other attributes has been recognized computer programming, digital fabrication, is another example of how Cognizant supports by Fortune magazine, which named it to its 3D printing, and wearable technology.

Fastest is Cognizant’s cloud-based, on- demand, end-to-end software testing service.

Compliments (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]

32 April 2015  PharmaVOICE (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]

Compliments

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COMPANIES Exco InTouch EMPOWERING PATIENTS Creating Connections Through Technology

evolve, and therefore the team plays an im- portant role in identifying the best solutions to support patient populations and client requirements. The company has created an environment where “no idea is a bad idea” and many of these ideas have significantly advanced its business Exco InTouch CEO and rom its outset, Exco InTouch has en- capabilities. deavored to break the mold of tradi- One example is the development of the Founder Tim Davis We are trying to help individuals — patients is too tional clinical technology deployment, company’s mDNA technology, a diagnostic F generic a term for me — get better, or cope better and later healthcare services, by designing and data handling tool, which was a concept with their condition, this is my motivation. services around the needs of the patient and developed by a single software developer who integrating or developing the technology re- recognized the need to understand how and for health services in many countries around

quired to deliver on this goal. where patients were accessing its services to the world. C Over the past 10 years the opportunities optimize the way content is delivered to each The desire to change the way patients to use different digital technologies have in- patient. The technology facilitates a BYOD experience care does not reside in the clinical M

creased enormously. Initially, the company (bring your own device) approach by inter- research industry alone. In recent years the Y was formed to provide engagement services to rogating the devices in use (mobile phones, need to relieve pressure on healthcare payers clinical trial patients, using SMS text messages tablets, and computers), and checking spec- has become increasingly significant and Exco CM

to patient’s own mobile phones to remind ifications against predefinedPharmaVOICE criteria. Using InTouch saw the potential its platform offered MY and motivate them to comply with trial pro- this information, mDNA creates a key that is to change the way patients receive healthcare tocols. Now, there are new opportunities to used through the system to identify a patient and the value of improving outcomes through CY

engage with patients in different ways, using and his or her data, linking a device to an in- this approach to health payers. Therefore, it CMY smartphones, tablets, and even Internet TVs dividual and ensuringof that data submitted are adapted the platform to provide support to or games consoles to deliver services into their attributable to the original registered device. help patients with long-term conditions (and K daily lives, be it for relatively short periods of Since its original development, the technology their caregivers) manage their care.

time in defined clinical trials or over extended has now been expanded to conduct essential In 2013, through its partnership with Ltd. All rights reserved. is an Equal Opportunity Employer. International Chiltern ©2014 Chiltern timeframes as part of real-world healthcare data analysis and segregation to enable pro- AstraZeneca, Exco InTouch developed the programs. tection of personally identifiable information ground-breaking Me&MyCOPD program. Exco InTouch uses design thinking to (PII) required for the use of digital technology The program gives the enrolled patients the help develop new solutions opportunity to access personalized coaching by looking across existing and real-time information about their disease technological solutions to and treatment via their mobile phones or identify those that may other Web-enabled devices, and to use dig- add value, such as the lat- ital technology to securely collect, transmit, est app design concepts, and review their own clinical data. As a re- consumer technologies, sult, the program ultimately leads to patients IT’S LIKE IT WAS MADE FOR YOU. medical device advances, being able to better control their condition and even games consoles to and healthcare professionals to make more You have a carefully thought-out vision for how to build on your unique IP, and create something seek the best solution for informed decisions and tailor care pathways. of lasting value. It’s time someone actually paid attention. That’s why we start by understanding each population. This translates into improving patient welfare your needs and learning about your unique situation. And then draw on a vast skill set to craft Exco InTouch’s aim and outcomes and quality of life by reducing a customized engagement perfectly matched to your goals from start to finish. Sound good? is to provide servicesCompliments that the number of unplanned hospital admissions Let’s talk about what really matters: you. make a genuine and pos- and the frequency and severity of exacerbations itive difference to out- and decreasing the overall cost of treatment. comes, whether this is Exco InTouch has been recognized as an in the broader healthcare honoree in the 2014 Global Digital Health LET’S space or within the clini- This infographic from Exco InTouch shows the impact that disease 100 from The Journal of mHealth. Companies TALK (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] cal development environ- management solutions have on driving medication adherence and selected to the list fulfill criteria that mark US: +1 910 338 4760 ment. To achieve this, its improving health outcomes. them out as innovators in the field of mobile UK: +44 (0) 1753 512 000 platform must continually and digital health. www.chiltern.com Designed Around You

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IT’S LIKE IT WAS MADE FOR YOU. You have a carefully thought-out vision for how to build on your unique IP, and create something of lasting value. It’s time someone actually paid attention. That’s why we start by understanding your needs and learning about your unique situation. And then draw on a vast skill set to craft a customized engagement perfectly matched to your goals from start to finish. Sound good? Let’s talkCompliments about what really matters: you.

LET’S TALK (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] US: +1 910 338 4760 UK: +44 (0) 1753 512 000 www.chiltern.com Designed Around You COMPANIES Ogilvy CommonHealth Worldwide CHANGING BEHAVIOR Opening Minds to Better Health Decisions

To encourage an intrapreneurial approach to developing results for clients, Ogilvy Com- monHealth applies the principles of design thinking to generate strategic and tactical s the health behavior change experts solutions. For example, its proprietary brain- of Ogilvy, Ogilvy CommonHealth storming process, RedStorming, is a struc- A Worldwide is focused on gaining and tured approach focused on innovative idea acting upon customer insights that lead to generation that is inspired by a challenge de- deep understanding, which in turn leads to the rived from deep customer insights. The goal is ability to create experiences that educate, mo- to deliver practical and creative solutions that Ogilvy CommonHealth tivate, and inspire. One of agency’s core princi- integrate the capabilities of technology and the Worldwide President and ples, called the Big Idea, begins with a simple real-world needs of various target audiences. statement and challenge: “We believe the The agency also applies design thinking to its CEO Matt Giegerich world would be a better place if...” Through- development of creative ideas by first defining The company’s solutions-oriented approach puts out the organization, employees believe that the business challenge, then engaging several clients’ needs at the center and draws from the full the world would be a better place if they could creative teams to ideate, experiment, and range of contemporary healthcare ­communications — all with digital innovation at the core. bring out the inner greatness in brands, orga- evolve solutions that result in a brand experi- nizations, and their people. The agency’s goal ence that leverages the full benefits technology is to build brands that drive behavior change has to offer. what goes on beyond the visit. Following the to improve health outcomes worldwide. One example of the agency’sPharmaVOICE ideation pro- office visit, patients are interviewed to gain Ogilvy CommonHealth Worldwide is cess is Element Access, which is a first-in-class insight into what they understood from the a community of experts in health behavior innovation for pharmaceutical manufacturers. visit, what they took away overall, and what change who are dedicated to creating inspiring The product was derived from a problem-solv- they plan to do moving forward regarding solutions and delivering programs to address ing exercise for a ofsingle client around a port- treatment. At the end of the day, the physician healthcare challenges by putting people at folio-specific challenge, which led to a break- is also interviewed about the visit to gain his the heart of what they do. The agency offers through for the whole industry. or perspective. All components are transcribed a specialized suite of healthcare-specific mar- The problem required the agency to design and the data are analyzed using sociolinguistic keting services within the brand-building en- and integrate a pull-through solution built techniques, comparing and contrasting where vironment of the Ogilvy global network. This into the salesforce’s iPad-based detail aid. patients and their healthcare professionals are potent combination manifests itself in fully in- The team built a dynamic data display that aligned and where there are gaps in communi- tegrated, digital-at-the-core, multidisciplinary aggregates client data feeds into one simple cation. Patient dialogue tools are often created campaigns measured by both their pervasive formulary display that shows physicians the following this research, but the opportunities creativity and their effectiveness. top plans they see in their practice, along with are endless as far as what can come from a Ogilvy CommonHealth Worldwide’s abil- those plans’ tier status, share of business, and study like this. ity to generate insights is the cornerstone in average co-pay. It is a reimbursement detail Among the agency’s other innovations are its development of behavior-change initiatives enabling a sales rep to message simply, easily, Day-in-the-Life Patient Ethnography, a pro- across all audiences: peer-to-peer, key opinion and more importantly locally. Element Access cess to gain insights by observing patients and leader to practitioner, patient/caregiver and is helping thousands of sales representatives their loved ones performing daily activities, physician, nurse, NP/PA, pharmacist, C-suite, and reimbursement teams around the country as well as making treatment decisions; On- group practices, and third-party payers. The to be more effective in their client interactions. line Ethnography, a social listening insights agency has developed proprietary research Another agency innovation — Managing report that provides a deep understanding of methodologies in computational linguistics, the Dialogue — stems from the agency’s social media trends and ethnographic insights; and in the videoCompliments capture of real-time in-office award-winning analytics team and behavioral eKOL Identification, which leverages patient clinical dialogue, analyzed by on-staff Ph.D. insights group. Managing the Dialogue In-of- and professional targeted platforms and social linguists. In addition, one of its latest inno- fice Linguistic Research is a methodology that media monitoring resources to identify prev- vations is a comprehensive social listening allows companies to be the fly on the wall in alent posters, general demographics, channel capability, including online access to a health- physicians’ office at the moment of truth when statistics, and volume and topic trends; and care professional cohort that can be leveraged HCPs talk with their patients. The process Ogilvy TargetIQ, an analysis tool, introduced

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] to establish baseline knowledge or behavior, allows for the capture of all closed-door in- in 2014, that solves the audience targeting real-life clinical practice, and a wide range of teractions with patients and their healthcare challenge for HCP and professional cam- behavior-change insight research parameters. providers, by having a researcher on site to see paigns.

36 April 2015 ● PharmaVOICE COMPANIES ElMindA TRANSFORMING NEUROSCIENCE Visualizing the Brain, Revolutionizing Treatment

ElMindA’s BNA technology is based on In August 2014, ElMindA announced that noninvasive recordings of multi-channel EEG BNA was cleared by the FDA for the analysis event-related potentials (ERPs), and a mul- of brain functional network activity, initially tidimensional analysis of such recordings by indicated for 14 to 24 year olds. advanced algorithms. The BNA algorithms ElMindA research showed, for the first lMindA, creator of the Brain Network use sets of signal processing and pattern rec- time, the ability of BNA to map pain pathways Activation (BNA) technology, is being ognition techniques to seek and map activated in the brain and objectively and sensitively dif- E lauded for its innovative approach to neural pathways to assess ferentiate between a drug neuroscience and management of brain dis- cognitive function. By ElMindA’s BNA platform provides a effect and a placebo effect orders. The company was included on Fast projecting the individual non-invasive tool for the visualization on the brain — previously Company’s annual list of the World’s Most In- data points into clusters, and quantification of BNAs of specific only possible by subjective novative Companies that ranks companies that BNA reveals 3D images brain functionalities. measures. are radically changing an industry, consumer that represent high-reso- ElMindA’s innovative habits, and assumptions. lution functional neural approach and supporting ElMindA was founded in 2006, with the pathways. These can aid data have led to part- vision of revolutionizing the management of clinicians with profiling nerships with top phar- brain disorders and injuries, by transform- brain functionality and as- maceutical companies ing state-of-the-art neuroscience into bed-side sist with changes in disease and leading neurological clinical practice, opening a new window into a progression and response to and psychiatric institutes brain’s functionality. therapeutic interventions. PharmaVOICEaround the world. Flagship Ventures of CREATING INNOVATIVE COMPANIES Recognizing Entrepreneurialism can solve global problems and transform large R&D approach to innovation by providing markets in human health, creating sets of op- corporations with early exposure to break- portunities that are effectively untouched, in through innovations and technologies with essence true white spaces. The Flagship team the potential to contribute to a company’s lagship Ventures is an organization ded- works together to invent or identify break- innovation pipeline. Flagship’s strategic col- icated to realizing entrepreneurial inno- through technologies that address significant laboration with Merck Research Labs, formed F vation — innovating, inventing, iter- unmet medical needs. The company uses a in 2012, is an example of how it is fostering ating, founding, and nurturing to build great Darwinian process for innovation to explore life-sciences innovation at its formative stages. companies with novel technologies that can ideas, apply extreme selection pressure, form The Flagship team is comprised of scien- solve big problems and add significant value. venture hypotheses, and move the most prom- tists, engineers, doctors, inventors, and execu- Flagship creates highly disruptive compa- ising ideas to the investment stage to become tives, all of whom have business, management, nies that have the potential to solve some of start-ups, resulting in companies that are and leadership capabilities, fostering diverse the world’s biggest Complimentshealthcare challenges and poised to make significant positive impacts on thought processes while developing new ideas. is shaping the future of breakthrough health- the lives of patients. Throughout the phases The company sees the value in working care discovery by developing fundamentally of the process — exploration, proto-company, with innovative people, and each year runs a transformative and sustainable innovations in startup — the Flagship team consistently fellowship program for graduate students to therapeutics and health technologies. brings discipline and an investment mindset, further expand the company’s thought-leader Through Flagship’s VentureLabs unit, an which has resulted in the creation of more than base. Students work with the Flagship team

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] institutional platform for accelerated inno- 25 companies, including Moderna Therapeu- over a 12-week period, exploring new ideas vation and parallel entrepreneurship — the tics, Seres Health, and T2 Biosystems. and testing venture hypotheses that may lead company determines how new technologies Flagship is also disrupting the traditional to the creation of companies.

PharmaVOICE  April 2015 37 COMPANIES Atlantis Healthcare HEALTH PSYCHOLOGY Changing Patient Behavior for Better Health Outcomes

Healthcare, examined how psychological mod- eling can be used to support patients in using their treatments as prescribed. The COM-B model, first published in 2011, proposes that edication nonadherence represents an individual’s behavior is influenced by many almost $300 billion in avoidable factors, all of which can be grouped into three M healthcare expenditures in the components: motivation, capability, and op- United States, according to New England portunity. The model was developed with spe- Healthcare Institute research. Atlantis Health- cific interventions to address each component. care, which was founded in 1993 by a team Dr. Jackson and her co-authors were the first grounded in traditional loyalty marketing, is to apply the COM-B framework specifically to using its understanding of consumer behavior examine behaviors that drive nonadherence. to create a new business model relevant to Traditionally, interventions have been Atlantis Healthcare works with world leading healthcare, specifically, how to talk to patients based on two limited approaches: one-size-fits- health psychologists to develop evidence- to influence their behaviors using health psy- all and reminder-based programs. The latter based approaches to understanding the chology based on a strategic and validated assumes the main drivers of nonadherence are predictors of adherence, and the most effective techniques for behavior change. approach from academia. that people have insufficient information or In a May 2014 paper — Applying COM-B they simply forget to take their treatments. to medication adherence, A suggested frame- According to Atlantis Healthcare’s team of Atlantis Healthcare’s programs deliver a work for research and interventions — pub- health psychology experts, this is a huge personalized experience targeted at each pa- lished in The European Health Psychologist, over-simplification. Addressing nonadherence tient’s particular issues, which allows the com- Dr. Christina Jackson, Ph.D., lead author and requires a focus on the patient,PharmaVOICE which goes pany’s experts to deliver the right message to senior health psychology specialist at Atlantis beyond providing reminders and prizes. the right person at the right time. of Create NYC A NEW AGENCY MODEL Creating a Hub of Efficiency rectly incentivized to deliver quality work on time and within budget. The account team is reate NYC is structured to provide a single-point of contact an advertis- support to each client, making communica- C ing agency tion streamlined, consistent, and accountable. that does more with To date, more than 95% of all Create NYC less. The agency has projects have been delivered at the contracted a unique on-demand flat-fee rate and all clients including those Create NYC Founder model and flat-fee from its first projects, continue to rely on Cre- approach. Focused ate NYC for on-demand support. Natalie McDonald on efficiency, the agency taps into its Creator Create NYC is disrupting the marketplace Hub, a hand-selectedCompliments database of more than by providing the healthcare industry with a Create NYC employs an on-demand agency model to 100 experienced creative talents of all disci- new agency option that can meet the chal- service the healthcare industry with a specific focus plines in the business, for each project. These lenges of today’s changing industry. on post-launch brands. seasoned professionals are available on demand In February 2015, Natalie McDonald, businesses, mentor, or actively support other and work for a flat fee. This caliber of talent president and founding creator, won the 2015 women and girls involved in entrepreneurship, structured without extra layers of manage- Enterprising Woman of the Year Award from and stand out as leaders in their communities.

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] ment encourages leadership and innovation Enterprising Women magazine. The award Many of the honorees also serve as leaders of at the right levels. To support innovation and recognizes women business owners who have the key organizations that support the growth the efficiency model, all staff members are di- demonstrated that they have fast-growth of women’s entrepreneurship.

38 April 2015 ● PharmaVOICE PharmaVOICE of

ALL HUSTLE. NO BUSTLE.

The only constant in the healthcare industry today is the need to do more with less. That’s why Create NYC was designed with ef ciency at its core. With our innovative,Compliments on-demand model and  at-fee approach, we deliver quality promotional materials in less time with smaller budgets, ensuring that the brands we support meet their aggressive goals. Are you ready for more hustle and less bustle? (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] All it takes to get started is just one project. Contact us today at my [email protected] www.createnyc.com COMPANIES HealthXL CREATING MOONSHOTS Catalyzing Collaborations The company is building an ecosystem for is hosting such events in Dublin, Boston, entrepreneurs in healthcare by involving all and Munich. At these events, the company stakeholders. brings together providers, insurers, pharma, To understand customer needs HealthXL patients, innovative high-growth companies works with its clients as partners. The work is and other key stakeholders to review together based on the problems that clients are aware the best opportunities for digital health. ased on a company culture of collabo- of, are actively looking for a way to solve, and Among HealthXL’s partners are Bupa, Cleve- ration, HealthXL is a global clearing are willing to resource to get those problems land Clinic, Becton Dickinson, IBM, ICON, B house for innovation in healthcare. solved for them. ResMed, Janssen Healthcare Innovation, Linde The company is focused on catalyzing a collab- The model is unique; the company’s part- Healthcare, Novartis, Partners HealthCare, orative environment between leading brands ners actually vote for the problems they are Silicon Valley Bank, EY, SoftServe, and Her- in healthcare and the most exciting tech interested in solving. The shortlisted compa- mitage Medical Clinic. companies to improve the lives of millions of nies are then invited to a community call, they HealthXL’s business model and the way it people. Together with its partners, HealthXL pitch what they do, and HealthXL’s partners works are unique, therefore there are no rules establishes audacious goals, which it calls and advisors — all top healthcare leaders and to be followed and that makes it very innova- moonshots, to work toward within healthcare. innovators — vote for the entrepreneurs. The tion friendly for all employees. The company Then the company searches for innovators in ones who receive the most votes are invited to experiments with different approaches and digital health that it and its partners can work invite-only quarterly events, called HealthXL techniques and picks the ones that give the with to achieve those moonshots. Global Gatherings. This year the company best results.

fluence on human cell survival, tissue metab- olism, and behavior. Accurate hemodynamic HemoShear PharmaVOICEand biological transport conditions, multiple primary human cell types, and physiological or disease relevant tissue culture conditions are FROM MICE TO MENof essential to recreating human disease biology. Combined, these elements restore human Developing Transformational Tissue Systems biology and disease conditions, enabling un- derstanding of disease mechanisms, differen- tiation of compound candidates, and selection have poor treatment alternatives. HemoShear of candidates that have superior efficacy and scientists work side-by-side with its industry safety profiles. partners, sharing expertise, leveraging each The science upon which HemoShear is ver the past several decades, the phar- other’s strengths, assets and experience, and founded was born in the laboratories at the maceutical industry has cured many tackling tough issues and speeding safer, more University of Virginia. From HemoShear’s O diseases in mice. But mice and people effective drugs to patients. earliest beginnings, its co-founders actively are not the same. Traditional, industry-ac- Real breakthroughs in drug discovery are engaged with the pharmaceutical and biotech- cepted methods have led to unsustainably high possible when disease mechanisms are under- nology communities, speaking with hundreds failure rates and costly failures, while patients stood and drugs are developed with systems of industry scientists and executives to gain wait for affordable new therapies. that accurately replicate human disease. The understanding of their greatest challenges and HemoShear’s transformational tissue sys- biotechnology company is recreating human unmet needs. tems and disease models are game changers for diseases in the laboratory. The company’s drug James Powers, CEO, was named to the the pharma industry. By understanding the discovery work feeds its own pipeline as well PharmaVOICE 100 based in part on his lead- pathophysiology of human disease and trans- as collaborations with pharma partners. ership of the company and how he encourages lating this understanding into better target HemoShear’s scientific expertise, biores- new ideas and independent experimentation. identification andCompliments drug candidate selection, pository, world-class computational biology The company’s “Chrome Cone” award is pre- HemoShear is shattering the current, and old, team, and translational tissue systems enable sented annually to the staff member who paradigm that leads to clinical failure. the company to go deeper into the biology, embodies HemoShear’s innovative spirit. This Getting back to the basics of human uncover meaningful targets, elucidate mecha- person is translational, creative, innovative, disease biology demands a new way to con- nisms, and predict human drug responses in a passionate, team-oriented, thoughtful, perse- duct drug R&D. HemoShear is implementing manner not possible before. vering, focused, successful, ethical, tolerant,

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] innovative business models to share in the HemoShear’s translational tissue systems trustworthy, and respectful. Together, these successes of its partners, as well as conduct incorporate primary human tissue and phys- attributes allow the company to achieve scien- its own drug discovery in rare disease, which iological conditions that have a profound in- tific excellence.

40 April 2015 ● PharmaVOICE COMPANIES Project Data Sphere INCREASING TRANSPARENCY A Collaborative Resource for Trial Success (projectdatasphere.org) to share, integrate, and peer-reviewed analyze data sets from Phase III cancer trials. publications The nonprofit organization’s platform serves are in the pro- as a resource for researchers from all walks of cess of being The Project Data Sphere life and provides an easy-to-use interface and prepared/sub- database allows researchers analytic software to aid in data preparation and mitted; and to share, integrate, and analyze analysis as well as exploration and reporting. all of the pi- patient-level, comparator arm, In addition, the platform includes an infra- oneering da- Phase III cancer data. n an environment where researchers have structure for researchers across organizations ta-providing historically been very protective of their to work together using social media-like tools organizations have renewed and redoubled I data and development costs to find new for collaboration. their commitment by providing additional and better therapies are increasingly high, Since its launch in April 2014, there is data, and four new data providers are in the the Project Data Sphere is taking significant evidence that the platform has helped to move process of sharing their initial data sets now. steps toward using broader data transparency forward the concept of data sharing to improve The organization has been designed to be to increase research innovation for the good of research and ultimately, patient outcomes, in- flexible and adaptable and innovation often patients. As more organizations subscribe to cluding more than 10,500 patient lives repre- comes from personal experience and relation- this approach of driving increased innovation sented in the database and additional new data ships in the industry. With a strong network through increased collaboration, the question sets are already slated for upload over the next of collaboration across all sectors, despite its of providing clinical trial data will become several weeks; almost 300 users, representing small size, the synergy created by the wide “why not?” instead of “why?” 22 countries, have become authorized users; collaboration provides the opportunity to fos- Project Data Sphere provides a single, research findings from platformPharmaVOICE data have al- ter innovation such as the “Prostate Cancer free-of-charge, easy-to-use, online platform ready been publicly presented and additional, DREAM Challenge.” of Skipta SOCIALIZING MEDICAL COMMUNITIES A Network for Healthcare Professionals

kipta’s growing fessions enter the conversation, using their network of more unique perspectives on patient care. S than 30 specialized The Skipta network was built on a plat- online medical commu- form that allows for constant evolution and nities for verified health- innovation, allowing communities to evolve care professionals enable based on the activity of their members and vibrant clinical collaboration within private partners. Each community uses advanced, and secure platforms per physician specialty, secure social networking technology specifi- healthcare profession, or disease state. cally designed for enhancing the collaboration Skipta is reportedlyCompliments the only social net- between healthcare professionals. working platform that has created specialized For example, Neurologist Connect was Neurologist Connect is the hub for verified online medical communities for healthcare developed as the first and only professional neurologists to communicate and collaborate. professionals that enable collaborations on the networking platform for neurologists. For topics most relevant to them. participating life-science companies, it offers Skipta’s network welcomes verified pro- unique access to high-value, difficult-to-reach rently boasts a growing membership base of

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] fessionals, including physicians, pharmacists, customer segments and sets them apart by almost 40% of all neurologists in the United nurse practitioners, and other healthcare pro- contributing to a proprietary channel that en- States, with every neurologist visiting, on av- fessions, ensuring that a wide range of pro- gages the neurologist community, which cur- erage, at least once per month.

PharmaVOICE ● April 2015 41 COMPANIES Theranos A SINGLE DROP WITH HUGE IMPACT The Future of Lab Testing valuation based on an inexpensive, comprehen- sive blood test using a simple pinprick. At age Theranos can perform lab tests 31, she owns more than half of the company, on samples as small as 1/1,000 the size of a typical blood draw. making her America’s youngest female self- made billionaire. heranos is working to shape the future Theranos offers a full spectrum of lab tests sure the body’s information at of lab testing. Now, for the first time, certified in its CLIA laboratory that cover a the needed frequencies, doctors T its high-complexity CLIA-certified full range from blood, urine, and other samples can see small changes in test laboratory can perform tests quickly and ac- from just a small few drops. This eliminates results as they emerge over curately on samples as small as a single drop. the need for larger needles and numerous vials time. In doing so, Theranos is Elizabeth Holmes, CEO, founded Ther- of blood required for many diagnostic lab tests. working to help patients and anos in 2003 after leaving Stanford to build Theranos’ minimally invasive sample col- doctors track chronic conditions a company around her patents and vision for lection serves patients such as those receiv- and provide insights into the early healthcare. The mission is to make actionable ing oncologic, pediatric, and other in-patient detection of a broad range of medical condi- information accessible to everywhere in the treatment requiring frequent blood draws. tions. world at the time it matters most. Theranos Theranos tests are also priced at 50% of Medi- Its Theranos Wellness Centers are designed is working to enable early detection and inter- care reimbursement rates or less. to make the experience as easy and comfortable vention of disease. Theranos’ patented technology can analyze as possible. Patients can make an appointment Theranos, and Ms. Holmes, are being rec- samples as small as 1/1,000 the size of the or walk in at their leisure with their doctor’s ognized by Inc., Fast Company, and others as typical blood draw. order form. Everything is designed with pa- true disrupters. The company has a $9 billion Since the company makesPharmaVOICE it easy to mea- tient’s wellness in mind. Organovo of 3D BIOPRINTING HUMAN TISSUES Changing the Shape of Medical Practice Organovo’s near-term applications are to develop functional 3D human tissues for drug discovery and toxicology testing. The technol- ogy is able to create, without the use of scaf- rganovo is credited with developing folding, 3D anatomically correct tissues with the world’s first commercial 3D bi- integrated microvasculature. This structural O oprinting technology platform. The organization of the multiple cell types typical goal is to build living human tissues that are to tissue composition results in tissue-level proven to function like native tissues. With responses and physiologic processes found in reproducible 3D tissues that accurately repre- native biology. sent human biology, the company is enabling Today, the company is working, both in- ground-breaking therapies. ternally and with select partners, to fulfill the The flexibility of Organovo’s bioprinting technology Organovo believesCompliments that engineered tissues vision of building human tissues for surgical allows the company to target many different tissues. will someday be a routine source of therapy for therapy and transplantation. The flexibility patients with damaged or diseased tissue for of its tissue engineering technology, and its $100 million plus revenue potential in the fu- direct therapeutic use to augment or replace proven application across a wide variety of ture of a total addressable market of more than damaged or degenerating organs. More than cells, allows the company to target many dif- $1 billion. The company is planning a launch 114,300 people are waiting for an organ trans- ferent tissues. of 3D bioprinted kidney tissues in 2016.

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] plant. Last year, fewer than 5,000 transplants Company leaders believe that as Organovo Organovo’s NovoGen MMX Bioprinter took place. About 18 people die each day penetrates the toxicology market, its ex- was named one of the Best Inventions of 2010 waiting for an organ. Vive3D Human Liver Tissue and service has a by TIME Magazine.

42 April 2015 ● PharmaVOICE COMPANIES Unum Therapeutics THE GOAL: ONE CURE

A Single Cell Therapy Antibody-Coupled T-cell Receptor (ACTR) technology: starting a clinical trial in lym- phoma patients only three months after its first financing. The Phase I clinical trial is evaluating ATTCK20, the combination of Unum Therapeutics ACTR T-cells with Genentech’s Rituxan, one he vision for the leadership at Unum of the earliest monoclonal antibodies to be Scientific Founder Therapeutics is to develop a single cell approved by the FDA to treat non-Hodgkin’s Dario Campana, Ph.D., M.D. T therapy — unum = one — that can lymphoma. Researchers will test this concept At the National University of Singapore (NUS), Dr. augment the activity of multiple antibodies to at a variety of dose levels in patients with Campana developed the ACTR technology that forms treat many different cancers. The company’s B-cell malignancies who haven’t responded to the basis for Unum. disruptive approach is to use a novel synthetic Rituxan or who have relapsed after treatment. gene to direct a patient’s T-cells to kill tumor The company is starting with a molecular solving big problems — curing, not treating, cells in combination with tumor-targeting form of the therapy that can be very quickly cancer — where Unum can have a real impact antibodies. Through its proprietary T-cell made and put into patients. Results from this for patients. They understand the need for new technology, Unum believes it can transform trial support the next iteration: using a virus to solutions for patients and that means taking cancer treatment through the discovery, de- modify patient cells. Further testing will drive calculated risks to innovate and bring new velopment, and commercialization of novel the next cycle: a genome-engineered cell that approaches to bear. antibody-coupled cellular immunotherapies. can be manufactured at large scale. Informa- Considered by analysts as an up-and-comer, Unum, which was formed in late 2014, is tion from each cycle drives the next. Unum was named by Nature Biotech as one of moving very quickly to validate is proprietary The company’s leadership PharmaVOICEis focused on 2014’s Best Startups. PHT of THE EPRO PIONEER Blended Instruction Reduces Errors

ing system” using handheld devices to transmit data to a central server. Almost 20 years later, the company introduced Rater Training, which reduces rater errors and standardizes scale ad- ministration. The product is recommended by global regulators and endorsed by ISPOR. This blended instruction features customized PHT Corp. President and ith the founding of PHT, Dr. Ste- instruction on each instrument’s design and CEO Phillip Lee phen Raymond launched the elec- scales, with training specific to the instrument’s Since joining the team in 2003, I have watched PHT W tronic patient reported outcome electronic implementation. It is delivered in develop into an industry leader, providing the most (ePRO) industry, offering pharmaceutical person, on-line, in groups or private settings for innovative technologies to collect patient-driven pharmaceutical companies clinical trial tech- multi-protocol programs, with sponsor-specific eData for the purpose of clinical research services. nology and patient-drivenCompliments eData systems to certifications available. collect high-quality data directly from pa- All PHT solutions are based on customer of patient safety and efficacy endpoint data tients and clinicians. demand and primary market data. In the case collection services. The transaction combines PHT has perpetually innovated new tech- of Rater Training, PHT clinical scientists PHT’s flexible eCOA platform and world-class nologies to give clinical researchers the tools leveraged several design techniques to opti- customer service with the clinical trial tech- to develop new therapies, treat disease, and mize the current solution, which was flat and nology and service offerings of ERT, creating

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] improve patients’ quality of life. ineffective. an innovative and comprehensive solution for Back in 1995, PHT fielded the first LogPad In February, PHT announced that it was patient end-point collection and data analytics studies and filed a patent for a “health monitor- merging with ERT, a global solution provider for global clinical trials.

PharmaVOICE ● April 2015 43 COMPANIES Merge eClinical DESIGN INSPIRED, DESIGN FOCUSED Driving Site Efficiencies

up-front investment. The SaaS model allows CROs, sponsors, and AROs of all sizes to tap into EDC esign is not just what it looks like and technology that is afford- feels like. Design is how it works.” able and intuitive. D — Steve Jobs Throughout the or- Merge eClinical embraces and has staked ganization, a single its market position on this philosophy. That passion fuels their col- and the fact that every study — no matter how lective work: to help large or small — deserves the benefits offered clients manage studies by information technology to improve safety, with more control, con- quality, and study outcomes. venience, and confidence To this end, the company has incorporated than ever before to improve the human condi- Clinical trial data can be accessed anywhere, human principles into the development of tion, one study and one patient at a time. anytime, through the cloud-based system. its flagship platform, eClinicalOS (eCOS). The eCOS platform is reported to be the The eCOS platform is a cloud-based system only commercially available endpoint and every day. To date, more than 50,000 clinical that offers all of the EDC and study support adjudication module, which gives everyone research professionals have used the eCOS plat- capabilities companies large and small need. in the process — sites, coordinators, and ad- form at 80-plus countries worldwide. More It has a pay-as-you-go payment structure, judicators — online access to every important than 2 million patient records are contained which allows researchers to pay only for what study document. AccordingPharmaVOICE to the company, with eCOS, and studies have been conducted they use with no long-term commitment or at least one new study using eCOS launches in every major therapeutic area. of Aprecia MAKING PRINTED PILLS A REALITY 3D Technology Advances Product Formulations using its proprietary ZipDose technology, a formulation platform that enables medicine printing (3DP) technology. Powder-liquid to swiftly disperse in the patient’s mouth 3DP is a novel technology that forms objects with a sip of water or other liquid. ZipDose layer by layer and was originally developed products enable people to take their medica- at the Massachusetts Institute of Technology tions with greater ease, potentially increasing (MIT) in the late 1980s as a rapid-prototyp- adherence and improving symptom manage- ing technique. While 3DP technology rights ment. ablets and pills can be difficult for are currently licensed for a diverse range Aprecia plans to introduce new ZipDose some patients to swallow. Helping of industrial fields, pharmaceutical rights to products in the coming years, focusing first T these patients improve adherence is MIT’s 3DP process are exclusively licensed to on the CNS therapeutic area, where there is a the mission of Aprecia,Compliments a specialty pharmaceu- Aprecia. This process stitches together mul- need for medicines that are easier to take. tical company that has the rare opportunity tiple layers of powdered medication using an Aprecia’s leadership team is very involved to be the first at something and redefine a aqueous fluid to produce a porous, water-sol- in the actual research and actively entrenched market: enhancing customers’ experience with uble matrix that rapidly disperses with a sip in the pharmaceutical and healthcare com- highly prescribed, high-dose medications. of water. munities. Their focus is not only the standard Aprecia Pharmaceuticals was founded in The company’s technology is helping to “we want to improve lives,” but they want to

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] 2003 with the goal of achieving commercial bring easy-to-swallow medications to the do it in a way that brings options to those in production rates for unique pharmaceutical market. In October 2014, the company filed need of different, unique approaches to their dosage forms via advanced three-dimensional an NDA with the FDA for its first product treatment plans.

44 April 2015 ● PharmaVOICE Visit us at DIA EuroMeeting, Paris Booth #3.D16

Have Trials Take Flight Visit eClinicalOS.com to get started

PharmaVOICE of

Integrated Features eClinicalOS is a cloud-based IT solution that integrates everything you need for EDC and study support in clinical trials.

Fast, Easy Implementation It can be configured precisely to your workflow and is easy to learn and use, getting you up and running in days.

Scalable Commitment The choice of features and costs is flexible, so you can implement Compliments what you need and only pay for what you use. (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected]

eClinicalOS is a solution of Merge Healthcare Incorporated. © 2015 All rights reserved. 866.387.4257 | eClinicalOS.com COMPANIES Clinical Ink AN ESOURCE PIONEER Tackling One of the Biggest Hurdles to eClinical Trials: Paper

that would make clinical research faster, bet- Doug Pierce, President and ter, safer, and less expensive: the result was SureSource, which created a new market for Co-founder, Clinical Ink Our goal was to replace the paper source forms eSource when it launched in 2011 as a solution with electronic versions, which would be specifically designed to help streamline clini- completed using tablets. We had to develop both cal development by eliminating paper source the application and the market in which it would be documentation. used. ong before the iPad, Clinical Ink’s Clinical Ink combines its design thinking co-founders — Tommy Littlejohn, process with lean start-up techniques that In September 2014, the company launched L M.D., and Doug Pierce — envisioned ensure continuous innovation by guiding the the SureSource Data Transformation Toolset, a tablet-based software application that would evolution of SureSource, which the company which automates manual data mapping and look and feel like a paper document to the site bills as the industry’s first purpose-built eS- transposition processes, delivering submis- user, but would capture, validate, and share ource solution, via iterative product releases sion-ready data faster and minimizing overall data electronically with sponsors. and updates that incorporate new customer clinical development costs and timelines. Clinical Ink was founded in late 2007 on needs. For example, the company recently de- Clinical Ink was recognized by Gartner as the belief that the clinical research business veloped a more expansive range of SureSource a Cool Vendor for having significant disrup- model could be revolutionized by eliminating technology/services to capture as much data tive potential. The company also was honored the last remaining hurdle to truly electronic electronically at the point of care as possible by Frost & Sullivan in September 2014 with clinical trials: the paper source. The vision — everything from study start-up activities to North American eClinical Solutions Award was for a truly paperless clinical trial platform device integrations to studyPharmaVOICE submissions. for Entrepreneurial Company of the Year. HealthCarePoint of MAKING THE RIGHT CONNECTIONS A Global Network of More than 700,000 Healthcare and Clinical Research Professionals

they could create better lines of communica- The initial version of BlueCloud has been tion, have true collaboration, and exchange used in dozens of global clinical trials. These constructive ideas. trials are being managed directly by sponsors Operating under the guiding principle and CROs, saving the industry millions of that true collaboration can only be achieved dollars. f you think trying to break through com- by creating innovation, transparency, and trust The network now includes 700,000 health- pany silos is challenging, imagine trying between organizations HealthCarePoint has care and clinical research professionals, dozens I to overcome silos between industries. created a global network of collaborators from of national and international entities, includ- That was the daunting task that HealthCare- every sector of the healthcare and clinical re- ing 34 pharmaceutical, biotech, medical de- Point set out to accomplish when it began to search industries. vice, and other company sponsors; 14 clinical create a system to breach the silos between One of outcomes of this collaboration research organizations (CROs); and thousands healthcare and clinicalCompliments research. is BlueCloud, which launched in February of healthcare provider organizations. More than 13 years ago, global leaders from 2015, almost 13 years after its initial concep- Additionally, HealthCarePoint plans to government, not-for-profit organizations, reg- tion. BlueCloud is a collaborative network of donate this technology to national and inter- ulators, for-profit institutions, sponsors, and healthcare and clinical research professionals national not-for-profit organizations, govern- healthcare providers came together in recog- with the tools and networking technologies to ment entities, universities, investigator sites, nition that the healthcare and clinical research empower members to manage everyday opera- ethical review committees, institutional re-

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] industries were completely segregated. tional, managerial, compliance, and standards view boards, hospitals and physicians’ offices Executives at HealthCarePoint knew that processes by connecting healthcare and clinical to enhance collaboration among all stakehold- if they could connect industry stakeholders, research stakeholders. ers in healthcare.

46 April 2015 ● PharmaVOICE COMPANIES Parexel THE JOURNEY AND MISSION

Simplifying the Process harmonization allows its teams across the world ing talent needs of the clinical development to serve clients effectively as one. Through in- job market. Since 2001, the Parexel Academy, novative thinking and solutions, Parexel helps located in the United States, Europe, and Asia, biopharmaceutical companies at every step of has designed and implemented a wide range of their drug development journey. And, a collab- programs for learners outside of the company. orative culture at the company, which includes Intrapreneurialism is encouraged and reg- being a true partner to clients, helps accelerate ularly seen at the company. One such example development cycles and reduce costs. is the team that developed Perceptive My- arexel International, a global biophar- Parexel’s learning and training programs Trials, a platform that enables access to EDC, maceutical services organization, helps encompass four primary learning domains, in- randomization and trial supply management P clients prevent and cure disease by sup- cluding: company culture and strategy; func- (RTSM), clinical trial management, medical porting drug development efforts; it has tional competencies; leadership development; imaging, and ePRO programs to manage trial helped bring 95% of the 200 top-selling drugs and professional development. The company’s data more efficiently and effectively. Originally, to market. Currently, Parexel conducts clinical standardized instructional design model ensures the Parexel team developed the platform as an trials in more than 100 countries and supports training programs address the complexities of internal tool. After realizing that the technolo- 1,700-plus clinical projects in 20 therapeutic global clinical trial requirements, with each gy’s capabilities could also benefit clients, the areas. program featuring a unique set of performance company integrated the technology into its Drug development today is more than a metrics to measure operational and training ef- eClinical suite. process; it’s a journey. Parexel is committed to fectiveness across the learning disciplines. Drawing upon its marketplace longevity, helping make this journey smarter and more In addition to training employees, the Parexel continues to innovate by introducing efficient. company is committed to developing the fu- new technologies to streamline the drug devel- Guided by the principles of integration, ture, global biopharmaceutical workforce with opment process while offering the latest exper- innovation, and partnership, Parexel’s global courses specifically tailored to PharmaVOICEmeet the grow- tise on clinical needs across the globe. Viscira of CREATING INTERACTIVE SOLUTIONS New Media Communications participated in IDEO design thinking pro- — discover, design, develop, deploy, debrief grams. There is constant cross-pollination of — the company creates innovative software ideas and innovation at Viscira on client pro- applications and compelling digital content to grams and internally. drive and optimize brand engagement across Viscira is serious about innovation; about multiple channels, including online, mobile, 10% of the company’s gross revenue every year convention, and sales rep interactions. goes toward R&D investments that support Viscira’s “digital-first” focused approach innovation and new product development. In- reinforces a key focus on technology R&D, novation also comes directly from its employ- where its teams continually research and in- ees. The company sets up creative forums such vestigate the latest cutting-edge technologies as “First Fridays” collective brainstorm, where iscira is creating disruption in its that can make an impact within healthcare leaders have set up an open forum to review marketplaceCompliments by challenging tradi- and life sciences. inspirational work from anywhere on the first V tional approaches to creating digital With regard to new technology introduc- Friday of every month. The company also has solutions, new media communication solu- tion and adoption, Viscira has been recognized programs like the 5-Second Motion Challenge, tions, and interactive software applications. A by numerous pharma organizations for its best where the company’s 3D animation, visual key focus for the company is technology R&D. practice standards pertaining to technology effects (VFX), and UI / UX design teams are The company has developed specific industry deployment. challenged to create short five-second video

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] plugins for animation software firms that Viscira’s visual designers and interaction clips based on a chosen creative theme. All of better support pharma and life-science needs. designers have been specifically trained in the these types of programs help to foster an envi- Using its “5D” phased-delivery framework design thinking methods as well as having ronment of employee innovation.

PharmaVOICE ● April 2015 47 COMPANIES Microsoft DRIVING INNOVATION From the Cloud to Gaming Consoles Microsoft Kinect Sensor is enabling touchless interactions in surgical settings. These Microsoft Research Connections research- interactions allow images to be viewed, ers are collaborating with Molplex, a small controlled, and manipulated without physical drug discovery company, and Newcastle Uni- contact. versity to help scientists around the world de- icrosoft, the software giant, is using liver new medicines more quickly and at lower its big data computation abilities cost. This partnership has helped Molplex The company’s innovative approaches to M and expertise in the cloud, to de- develop Clouds Against Disease, an offering of healthcare extend to its Kinect for Win- velop innovative computing technologies and high-quality drug discovery services based on dows-based system, which enables surgeons advance research in human health issues. From a new molecular discovery platform that draws to navigate through and manipulate X-rays heath IT to experimental diagnostics, Mic- its power from Windows Azure. and scans during operations with a wave of the rosoft’s Health and Wellbeing collaboration Other projects include medical imaging hand. It’s a prime example of the burgeoning projects apply advanced computing technol- at Microsoft Research and SenseCam. Mic- field of natural user interface (NUI). ogies, such as data analysis, imaging, sensor rosoft Research is addressing the increased Other researchers are exploring ways to use networks, and visualization to provide insight dependence on medical imaging for patient Kinect for Windows to evaluate the damage into disease and human healthcare. diagnosis and treatment. Microsoft Research is caused by strokes and to create and monitor The Microsoft Biology Initiative (MBI) working with top research institutes to make game-based rehabilitation exercises, many of is a Microsoft Research effort to bring new available data and tools and advance automatic which can be performed by stroke patients in technology and tools to bioinformatics and bi- analysis of medical scans. their own homes. ology research. This initiative is comprised of SenseCam is a wearable camera with a Still other research is looking at how Ki- two primary components: .NET Bio (formerly wide-angle lens that takes photos periodically nect can assist in diagnosing disorders of the Microsoft Biology Foundation [MBF]) and the without user intervention. PharmaVOICEThis simple device brain and nervous system, including Alzhei- Microsoft Biology Tools (MBT). turns out to have many valuable applications. mer’s and multiple sclerosis. of Quintiles TRANSFORMING TRIAL EXECUTION Taking an Integrated Approach the design process. The company’s world-class management, which can lead to as much as a team includes knowledge experts in drug 25% cost reduction over traditional trial exe- development and strategic partnering, ther- cution approaches. apeutic specialists and data analysts, as well In 2015, the biopharmaceutical services as a global network of clinical trial delivery, company was named to Fortune magazine’s regulatory, and commercial experts. World’s Most Admired Companies list. Quintiles, which provides biopharmaceuti- Quintiles ranked third overall in Fortune’s cal development and commercial outsourcing Healthcare: Pharmacy and Other Services services, helped develop or commercialize all category with the top ranking for the rep- of 2013’s top-100 best-selling drugs on the utation attribute of global competitiveness market (2014 statistics pending). and second within the segment for its people uintiles, which was started 33 years The company’s technology and design management. ago in Complimentsa trailer at the University of data for dynamic scenario modeling uses the During 2014, Quintiles also was recog- Q North Carolina at Chapel Hill by Quintiles Infosario design and its data sources nized as the Best Contract Research Organiza- biostatistics professors Dr. Dennis and libraries to provide agile decision-making, tion (CRO) in the UK SCRIP awards, named Gillings, and Gary Koch, Ph.D., now con- sophisticated data visualizations, and dynamic Asia CRO of the Year by Frost & Sullivan, ducts business in about 100 countries. “what-if” scenario modeling. voted Best CRO in Asia in the BioPharma Quintiles’ integrated approach brings to- The company’s combination of services Asia Industry Awards, and was named Best

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] gether the right people, a structured design enables faster, more informed decisions, big Contract Sales Organization (CSO) in the process, robust technology, and data for better, picture insights, improved patient safety, in- PharmaField awards in addition to being more confident decision-making throughout creased study quality, and more efficient trial named to the Fortune 500 for the first time.

48 April 2015 ● PharmaVOICE COMPANIES Cerner CONNECTING PEOPLE AND SYSTEMS Leading the Way Through EHR its foundation of intelligent solutions for the healthcare industry connecting people and sys- tems at more than 18,000 facilities worldwide, and its wide range of technologies and services support the clinical, financial, and operational needs of organizations of every size. Using design-based thinking, Cerner of- aving won numerous awards for its fers strategies that empower organizations to own technologies, including being know, manage, and engage their populations. H named to Forbes’ most innovative Its applications are developed with physicians and most admired companies, Cerner takes in mind so they can focus on people, not tech- pride in the awards being accumulated by its nology. Neal Patterson, Cerner clients, including honors for quality, infor- In March 2015, Cerner’s Millennium was mation management, and innovative use of recognized as a Leader in the Gartner Magic Chairman, CEO and ­ technology. Quadrant for Enterprise EHR Systems report. Co-founder Since its inception, Cerner has innovated at With the February 2015 acquisition of Sie- Cerner remains focused on key development areas the intersection of healthcare and information mens Health Services, Cerner and the former including population health, physician experience, technology. The company’s mission remains to Siemens business unit have a combined annual open platforms, revenue cycle and mobility. contribute to the improvement of healthcare R&D investment of more than $650 million. delivery and the health of communities. The cumulative resources are expected to speed health IT solutions, enabling clients to control The company is continuously building on delivery of the company’s nextPharmaVOICE generation of costs and improve healthcare outcomes. BioMarin of FOCUSED ON RARE DISEASE Five Approved Products and a Strong Pipeline Devoted to First-in-Class Therapies the first and only FDA-approved medication for PKU to reduce blood Phe levels in patients BioMarin CEO Jean-Jacques with hyperphenylalaninemia (HPA) due to Bienaimé tetrahydrobiopterin (BH4-) responsive PKU; Under Jean-Jacques Bienaimé’s leadership, the market ith five products on the market Aldurazyme (laronidase), developed through capitalization of BioMarin went from around $450 million and a fully integrated multina- a 50/50 joint venture with Genzyme, is an in May 2005 to about $9 billion in April 2014. W tional organization in place, Bio- enzyme replacement therapy for the treat- Marin, which was founded in 1997 based on ment of mucopolysaccharidosis I (MPS I), an velopment the company has the largest pipe- its proprietary enzyme technology, is provid- inherited, often life-threatening lysosomal dis- line of any biotech company focusing on rare ing innovative therapeutics to patients with order caused by a deficiency of the lysosomal and ultra-rare disorders, and with more than serious unmet medical needs. enzyme, alpha-L-iduronidase; and Firdapse, 6,000 rare disorders in the world there’s plenty The company’s approved products include: currently approved in the EU, is the first and of opportunity to discover new products. Vimizim (elosulfaseCompliments alfa) for Morquio A, a only approved drug for the symptomatic treat- In addition to developing products to meet rare inherited disease that affects major organ ment of Lambert-Eaton Myasthenic Syndrome the needs of specialty patient populations, systems; Naglazyme (galsulfase), an enzyme in adults, a rare autoimmune disease with the the company provides individualized patient replacement therapy for the treatment of mu- primary symptoms of muscle weakness. support services, connecting those in need copolysaccharidosis VI (MPS VI), an inherited BioMarin’s pipeline reflects its dedication with case managers who assist with access to life-threatening lysosomal storage disorder to developing first-in-class or best-in-class treatment, insurance coverage, and reimburse-

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] caused by a deficiency of the lysosomal enzyme therapies for patients with rare genetic dis- ment support. N-acetylgalactosamine 4-sulfatase; Kuvan (de- eases. According to Jean-Jacques Bienaimé, BioMarin was recently named to Forbes’ veloped in partnership with Merck Serono), CEO, with eight new molecular entities in de- list of Most Innovative companies.

PharmaVOICE ● April 2015 49 COMPANIES TO WATCH

Aarhus University Hospital focuses strategically on innovation as an important part of a joint effort COMPANIES to promote and develop activities within research, TO WATCH organisation, management and technology. These companies are making waves and putting foward inter- esting concepts worthy of notice.

Companies to Watch

23andMe InnoCentive 23andme.com innocentive.com Aarhus University MC10 au.dk mc10inc.com ADM Diagnostics Perfint Healthcare admdx.com perfinthealthcare.com Illumina Yumanity illumina.com yumanity.com Finding an Antibody Needle Genentech, by licensing access to genetic in- In The Cancer Haystack formation contained in its database. In a bold 10 Artificial Antibodies That May move, it recently set up its own pharmaceuti- Prevent Cancer Tumor Growth cal arm to identify new drugPharmaVOICE targets for both common and rare diseases. The company hired A research team at Aarhus University has de- Richard Scheller, a former Genentech execu- veloped 10 new antibodies that can possibly be tive, to become its chief scientist and lead the used in the battle against cancer. The antibod- company’s R&D ofefforts. Launched in 2006, ies work by inhibiting the body’s blood vessel Human Genetics the company hit a speed bump with the FDA formation close to the tumor, which is thereby in late 2013, when the agency called on the cut off from oxygen and nutrient supply. Key to Discovering company to stop selling its DTC genetic tests. The researchers isolated their antibodies New Treatments Just a little more than a year later, however, the from a library consisting of billions of different FDA approved 23andMe’s genetic test under a antibodies, and they subsequently analyzed Genetic Testing Goes regulatory classification for novel devices for the ability of the individual antibodies to in- Beyond Consumers Bloom Syndrome. The submission was evalu- hibit blood vessel formation. This sounds like ated through the de novo regulatory pathway. incredibly extensive laboratory work, and it 23andMe wants patients to have access to their This year, researchers working with 23andMe would have been far from possible just a few genetic make up if they want it. And it wants completed the first ever genome-wide associa- years ago. However, they used a biological to provide access to that information to life-sci- tion study of rosacea, a common and incurable technology for this purpose that they devel- ences companies for use in drug development. skin disorder. The study is the first to identify oped and published in Nature Protocols three No problem there, as around 80% of 23and- genetic factors for this condition. years ago. It helps them to identify and extract Me’s 875,000 customers have agreed that the the antibodies with specific binding properties company can use their health data for medical regarding the surface proteins in blood vessel research. Since 2007, more than 500,000 peo- cells. ple have purchased the tool kit, spit in a tube, In the coming years, researchers will work and shipped it off to wait for their results to on gaining a more in-depth understanding of appear on a website.Compliments These customers can learn the 10 antibodies. Aarhus University research- what their DNA reveals about non-medical ers are among the world’s leading specialists traits such as hair texture and ancestry, as well in developing artificial antibodies for cancer as whether they carry DNA variants associated treatment and, in recent years, they have with increased risks for diseases including type worked on compositions of genes for a collec- 2 diabetes and Alzheimer’s. tion of several billion new types of antibodies.

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] In the past, the Google-sponsored company Updated February 19, 2015, 23andMe provides The University stresses that the results are pre- has collaborated with medical researchers and ancestry-related genetic reports and uninterpreted liminary. Aarhus is Denmark’s second oldest pharmaceutical companies, such as Pfizer and raw genetic data only. and largest university.

50 April 2015  PharmaVOICE COMPANIES TO WATCH

ule for other projects or planning the next solved better, faster, and at a lower cost than experiment. Most NGS library prep requires ever before. a whole day of planning around critical wash InnoCentive’ methodology is called Chal- and incubation steps. Now, with the tap of lenge Driven Innovation, a framework that a touchscreen, samples are concentrated into accelerates traditional outcomes by leveraging Taking the Wait Out of nanoliter volumes and merged with droplets open innovation and crowdsourcing along Genetic Research containing the components for executing each with defined methodology, process, and tools sequential enzymatic reaction with exquisite to help organizations develop and implement Streamlining Next-Generation precision. actionable solutions to their key problems, Sequencing Experiments Illumina has a broad portfolio of lead- opportunities, and challenges. ing-edge sequencing and array-based solutions Unlocking the potential of millions of peo- Illumina is a developer, manufacturer, and that address a range of genomic complexity ple to work productively on pressing problems marketer of life-science tools and integrated and throughputs, enabling researchers to select is the power of Challenge Driven Innovation. systems for large-scale analysis of genetic vari- the best solution for their scientific challenge. The company’s global network of millions of ation and function. These systems are enabling problem solvers, proven challenge methodol- studies that were not even imaginable just a ogy, and cloud-based innovation management few years ago, and moving the world closer platform combine to transform the economics to the realization of personalized medicine. of innovation through rapid solution delivery Illumina’s most recent development is its and the development of sustainable open inno- NeoPrep digital microfluidics platform for vation programs. Leading organizations such automated preparation of sequencing libraries. Discovery Through Open as AARP Foundation, Booz Allen Hamilton, Digital microfluidics uses electrical voltage to Innovation, Crowdsourcing Cleveland Clinic, Lilly, Nature Publishing manipulate nanoliter volume droplets through Group, Procter & Gamble, Scientific Ameri- standard library prep chemistry, to ultimately Finding Solutions Faster can, Syngenta, Thomson Reuters, and several transform sheared DNA or total RNA into government agencies in the U.S. and Europe ready-to-sequence libraries. This revolutionary By unleashing human creativity, passion, and have partnered with InnoCentive to rapidly technology enables 16 libraries to be prepared diversity, and untethering the search for solu- generate innovative new ideas and solve prob- in parallel, with only 30 minutes of initial tions from an individual, department, or com- lems faster, more cost effectively, and with less hands-on time, freeing up a researcher’s sched- pany, amazing things happen.PharmaVOICE Problems are risk than ever before. Clinical Operations in Oncologyof Trials West Coast will be returning for its 2nd annual conference in Burlingame, CA, 15th-16th April 2015 This exclusively tailored event promises to deliver suggestions and solutions on how companies can diff erentiate themselves from competitors, optimise their oncology trials and achieve operational excellence. The programme will host an array of topics, some of which include:

 Redefi ning boundaries of patient confi dentiality in a connected world to ensure trial integrity and compliance  Developing regional strategies in a global recruitment programme to enable full patient enrolment and deadline success  Developing a site activation process to ensure timely regulatory approval in any market  Developing alternative questioning models during vendor selection to ensure a seamless partnership through the duration of a trial

Key 2015 speakers include:  Sascha Ellers, Director,Compliments Clinical Operations, Veracyte Inc  Denise Coffi n, Clinical Trial Manager, BSN, MPA,  Joel Rothman, Vice President, Development Operations, Dendreon Corporation Jazz Pharmaceuticals  Ellen Ashley, Associate Director, Clinical Operations,  Jess Rabourn, Managing Director, ALS Emergency Treatment Fund Onyx Pharmaceuticals (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Secure your place today by quoting reference code MK-SRAD Book now by visiting www.arena-international.com/oncologywestcoast

CTOW0415_HP External Advert.indd 1 29/01/2015 10:02 COMPANIES TO WATCH

Bringing Wearable Technology Transforming Drug Discovery to Disease Management Addressing Changing the Course of Neurodegenerative Diseases Creating Solutions for Patients with Interventional Oncology Neurological Disorders Cancer Surgery in 3D MC10 has created transparent stamp sized “tattoos” equipped with tiny electronics that Today, physicians plan interventional pro- enable continual patient monitoring. cedures by combining 2D images with their MC10’s Biostamp platform for patient-fo- understanding of human anatomy. Physicians cused disease management solutions is a novel, are then expected to manually advance one or conformal sensing platform that will combine more instruments to reach the target, with- with UCB’s pharmaceutical products to help out causing damage to vital structures, while patients with neurological disorders. accounting for organ and patient movement. MC10 develops stretchable, electronic It is, therefore, not surprising that these pro- sensing systems that bend, flex, and twist cedures are limited to the most skilled and Biotech startup Yumanity Therapeutics to match the properties of the human body. experienced physicians. was launched to develop new therapies for MC10’s Biostamp platform offers a unique, However, radiologists around the world neurodegenerative diseases caused by protein patient-friendly solution for disease monitor- are now using Perfint’s Robotic solutions for misfolding. ing and management. This passive monitor- image guided interventional procedures such ing of patient health data will not only help as biopsy, drug delivery, ablation, drainage, According to a write up by Matthew Herper in patients but also doctors to provide more fine needle aspiration, and varied pain care Forbes, Yumanity Founder Tony Coles could personalized care. Additionally, it could help procedures for both cancerous and non-can- have had any job he wanted in the drug indus- to accelerate neuroscience clinical research and cerous pain. PharmaVOICEtry. After selling his company Onyx Pharma- provide insight into the real-world impact of Perfint’s most recent product Maxio, is set ceuticals for $10.4 billion in October 2013, therapies. to change the world of interventional oncol- the industry anticipated he would invest in MC10 reshapes electronics into body-inte- ogy. Maxio will allow clinicians to visually another biotech. Instead, Mr. Coles is taking a grated form factors that extend human capabil- plan, execute, andof validate ablation procedures different road, and started up Yumanity Ther- ities by making high-performance electronics on a single system, and all in 3D. apeutics to research how misfolded proteins virtually invisible, conformal, and wearable. Maxio has been designed to make complex, in the brain cause Alzheimer’s, Lou Gehrig’s Their products address issues across the areas multi-probe ablations simpler, which will help disease, and Parkinson’s disease by using yeast. of consumer health, medical devices, industrial to make these life-saving procedures available Yumanity’s new approach to neurodegen- and defense, and digital health. to more cancer sufferers than ever before. erative disease drug discovery and develop- For example, MC10 develops a new class Now, Maxio assists physicians to visualize ment concentrates on correcting the cellular of catheters embedded with ultra-low profile, and plan an entire procedure, such as tumor pathologies driven by misfolded proteins, the nanometer-thin sensors. It has also designed ablation, in 3D. Multiple VOI, multiple in- altered biology or phenotypes. Less than a year activity and physiological monitoring devices, struments, and placement sequencing can all old, the company’s proprietary platforms have such a sports gear and baby monitoring. It be planned before advancing a single instru- already identified one potential new target for hopes to one day use its technology to prevent ment. treating Parkinson’s disease, and Yumanity brain seizures. Once the surgical plan is confirmed, the is actively advancing its new chemical lead Maxio stereotactic arm, combined with in- series for this condition, as well as identifying tra-operative registration, assists physicians additional compounds for Alzheimer’s disease to carefully advance one or more instruments and ALS. accurately to reach the target. Yumanity’s unique approach overcomes Maxio’s post-operative image registration the fundamental limitations of the most com- helps physicians verify and extend the treat- monly used strategies in drug discovery today, Complimentsment if needed. Maxio’s reporting tool then which have repeatedly failed to deliver effec- helps generate required reports. tive therapies for these diseases. Perfint Healthcare has won the Depart- Yumanity’s integrated platforms enable ment of Biotechnology’s Biotech Product and the company to move back and forth between Process Development and Commercialisation yeast cells and human patient neurons in a award, noting that the company is a world highly iterative and parallel fashion, continu-

(c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] Wearable health tech promises to save lives, leader in planning and targeting solutions for ally building on lessons learned with multiple so startups such as MC10 are working to create image-guided interventional procedures with protein pathologies to accelerate the discovery something patients will never forget to put on. emphasis on oncology and pain care. of novel therapies.

52 April 2015  PharmaVOICE HOW CAN Fighting Alzheimer’s A CONTAINER Disease INCREASE REIMBURSEMENT? Algorithm Helps Quickly Identify Appropriate Trial Participants

Dawn Matthews, CEO of ADM Diagnostics, a global centralized CNS imaging core lab and diagnostic services provider, was invited to the White House to attend the BRAIN (Brain Research Through MAILBACK Advancing Innovative Technologies) initiative event to celebrate the PROGRAM progress being made by the federal government, universities and re- search foundations, the private sector, and others to advance the goals of the organization. ADM Diagnostics (ADMdx) is using propietary advances in brain image analysis technology to enable the early, accurate diagnosis of Alzheimer’s and other forms of dementia. Alzheimer’s disease drug development has experienced dismal results. From 2002 to 2012, 245 drugs were tested in clinical trials with 244 failing. Part of the reason, according to ADMdx, is failure to identify early, correctly diagnosis, and scale the correct patient population. Two large-scale Phase III trials reported 35% of enrolled subjects did not even have AD. The methods for choosing patients for clinical trials being used currently are biased cognitive assessment testing, and are not effective enough to quickly advance a trial, according to the company.ADMdx developed a proprietary pattern-recognition based algorithm that is applied to glucose metabolism (FDG PET) scans of subjects from DATA the ADNI data set. The algorithm quantifies the degree to which INTELLIGENCE a patient is expressing a “signature” pattern of neurodegeneration PharmaVOICE associated with the progression of Alzheimer’s disease, as an AD Pro- gression Score in cognitively normal subjects, the score was predictive of cognitive worsening and the time to progression. ADMdx also provides neuroimaging studies and data analysis of emphasizing central nervous system disorders. It has developed optimized approaches to the collection, quality control, and analysis of image data to maximize the reliability and interpretability of results. The breakthrough technology for pharmaceutical companies should improve the overall safety and efficacy in CNS, particularly Alzheimer’s disease, drug development. This innovation will allow drug developers to diagnosis and enroll the correct patient population, find patients earlier in the disease stage that are treatable, improve safety by not misdiagnosing patients, and lower costs by powering the HAPPY studies correctly, all toward developing a drug to modify or cure Alz- heimer’s disease. By even delaying the onset of AD by three or more PATIENTS years, studies report billions in saving in healthcare costs. But the true measure of success will be that fewer individuals will not suffer this incredibly awful mind-robbing disease. Compliments FIND OUT HOW. (c) PharmaLinx LLC. Rights do not include promotional use. For distribution or printing rights, contact [email protected] By applying a proprietary algorithm, ADMdx’s software can assist drug companies acquire better data quality for CNS diseases.