Inflection Point

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April 9, 2018 In this issue

Industry Briefs…2

A CenterWatch Publication Three Questions…6 Sue Vestri, CFO, Greenphire

Drug & Device Pipeline News…7 Seventeen drugs and devices have Woodcock Outlines Changes Needed to entered a new trial phase this week. Connect Clinical Research and Healthcare Trial Results…8 By Suz Redfearn clinical research and healthcare, or the CenterWatch reports on results for four drugs. he clinical research enterprise is “at entire enterprise is going to fall down.” best the sickliest link” in the chain To illustrate how little research is getting Research Center Spotlight…9 T between patients, the healthcare sys- translated into new directives for healthcare Research center profiles. tem, and science that can and should bring providers, Woodcock explained that only cures and better therapies, according to about 15 percent of professional guidelines Janet Woodcock, director of the FDA’s Center for healthcare providers in the U.S. are for Drug Evaluation and Research (CDER). based on evidence from evaluation of trials “We have a sicker population, we have or actual data; the rest are based on expert expensive new interventions and we have opinion. Innovations abound, she said, but wonderful new science that is begging to we still lack the means to evaluate their get translated and evaluated,” said Wood- impact, and that is a shortcoming of the cock in her keynote address at the recent clinical research space. Bridging Clinical Research and Clinical “We keep trying things and chang- Health Care conference. “All these forces ing things, but we aren’t ever really sure are coming together and converging on the whether we’ve gone in the right direction or clinical research enterprise. We must bridge see Woodcock on page 4 » Industry Approaching Inflection Point in Consolidation Towards Large Health Systems By Conor Hale as a hobby, or as a way to get closer to the he clinical research business is approach- cutting edge of medicine. Today it’s seen as ing an inflection point similar to the a mission-critical source of revenue, driven Tshifts seen over the past 25 to 30 years, in large part by patient demand for new only now the trends are toward consolidation treatment options, he said. in larger health systems and their affiliates Industry moved away from academia that can take a more patient-centric approach, because it is overly bureaucratic, with high according to Ken Getz, director of sponsored re- fixed costs, and lacking the speed and ef- search programs at the Tufts University Center ficiency being developed in the community- for the Study of Drug Development. based investigator and contract research “So many of the conditions that existed settings. 25 years ago are analogous to where we are Now, the trend is toward health systems now,” Getz said last week at the Bridging that are making strategic investments in Clinical Research and Clinical Health Care clinical research infrastructure, looking to conference in National Harbor, Md. expand their service areas and gain a com- Historically, academia and clinical petitive advantage amid intense revenue practices viewed participation in research see Inflection Point on page 5 »

FDA Outlines Considerations and serve as a focus for discussion among indicated that having a clear understanding for Enrolling Pregnant Women sponsors, manufacturers, institutional re- of FDA’s thinking can help inform a sponsor’s in Clinical Trials view boards and the academic community. internal decision-making about their drug de- The FDA published a new draft guidance on The draft guidance is available here: www. velopment programs, particularly early in the the scientific and ethical considerations for fdanews.com/04-06-18-PregnantWomen- product development,” the agency said. The including pregnant women in clinical trials, Guidance.pdf. FDA’s proposed plan is available here: https:// telling sponsors that data are needed to www.fda.gov/downloads/ForIndustry/User- inform safe and effective treatment during Gottlieb Outlines Plan for In- Fees/PrescriptionDrugUserFee/UCM602885. pregnancy, and that it is appropriate to enroll corporating Patient Experience pdf. pregnant women in certain situations. The Data in Regulatory Decisions agency said it considers it ethically justifiable FDA Commissioner Scott Gottlieb announced Project Data Sphere Names to include pregnant women in clinical trials a formal initiative for incorporating patient GSK Alum Bill Louv as President when adequate nonclinical studies have perspectives into the agency’s risk-benefit Bill Louv, former VP at GlaxoSmithKline, was been completed, and when the trial holds the analysis framework used in regulatory named president of Project Data Sphere, prospect of direct benefit to the women and/ decision-making. The proposal, outlining an independent, not-for-profit cancer data or the fetus that cannot be obtained by any steps under PDUFA VI from fiscal 2018 to 2022, sharing initiative of the CEO Roundtable on other means. In the postmarket setting, an includes new guidance by June 2020 articulat- Cancer’s Life Sciences Consortium. Project established safety database in nonpregnant ing how patient experience data gathered by Data Sphere, launched in 2014, is a free women should be available, and inclusion sponsors can be used to support approvals. digital library and cancer research platform, should be allowed when efficacy cannot be “The FDA recognizes a need to learn about the warehousing patient-level data from cancer extrapolated or safety cannot be assessed clinical context more comprehensively and clinical trials linked to more than 120,000 through other study methods. directly from the perspective of the patients participants. More than 1,700 registered For women that become pregnant dur- who live with the disease and their caregiv- users download the data for research use ing the course of a clinical trial, unblind- ers,” Gottlieb said, including information on in tumor types such as bladder, breast, ing should occur so that counseling may the severity of the disease, patient-centered colorectal, gastric, kidney, lung, melanoma, be offered based on whether the fetus endpoints and the degree of unmet medical pancreatic and prostate. Louv served as was exposed to the investigational drug, need. The agency is planning several efforts senior VP of core business services at GSK placebo or control, the FDA said. The risks to systematically incorporate patient experi- from 2010 to 2015, and has over 30 years of and benefits of continuing can also be ences into the framework — such as hosting experience in the pharmaceutical industry, reviewed; those who choose to continue patient-focused drug development public working in statistics, epidemiology and should undergo a second informed con- meetings; encouraging external, stakeholder- information technology. sent process. Sponsors should also gather led meetings; and providing more channels for reproductive and developmental toxicology patients, caregivers and advocates to provide FDA Proposed Fiscal 2019 data in nonclinical models, and consider the meaningful input into drug development and Spending Including Steps to gestational timing of exposure. “Historically, regulatory decision-making. In addition, the Foster Drug Development pregnant women have been an understud- agency plans to build a repository of risk-bene- The FDA published its justification for the ied population, and there have been barriers fit frame-work examples to serve as references Trump administration’s fiscal 2019 budget to obtaining data from pregnant women for its reviewers. “Industry stakeholders have see Inflection Point on page 3 » in clinical trials, including concerns about protecting women and their fetuses from research-related risks,” the FDA said. Current- CWWeekly (ISSN 1528-5731) © 2018 CenterWatch. All rights reserved. No part of this publication may be distributed or ly, collection of safety data on drugs used Susan Salomé Integrated Marketing Manager reproduced in any form or by any means without the during pregnancy is largely gathered after Tracy Lawton Drug Intelligence express written consent of the publisher. Permission Renee Breau Production requests can be obtained via fax at (617) 948-5101 or approval. The agency said it hopes the draft emailed to [email protected]. guidance will advance scientific research CenterWatch Main and Editorial Offices 10 Winthrop Square, Fifth Floor, Boston, MA 02210 Advertising packages and reprints are available. in pregnant women, within the framework [email protected] / [email protected] Email [email protected] or call (617) 948-5100. of human subject protection regulations,

Industry Briefs (continued from page 2) request, explaining what the agency would fees, for a total budget of $5.8 billion. The that broader patient population,” the FDA said, do with the funding, and listing its priori- 346-page FDA budget justification is avail- stating continued efforts to encourage greater ties to boost pharmaceutical research and able here: https://www.fda.gov/downloads/ diversity in clinical trial populations, such as development, among other regulatory AboutFDA/ReportsManualsForms/Reports/ requirements that sponsors provide analyses initiatives. An increase of $400 million for BudgetReports/UCM603315.pdf. of difference demographics and subgroups. medical product innovations would advance Discussion topics will include: the risks and competition among drugmakers to lower FDA Holding Public Meeting benefits of trial participation; potential regula- drug development costs and foster innova- on Inclusion, Exclusion Criteria tory, geographic and socioeconomic barriers; tion and investment in developing treat- The FDA is hosting a public meeting April and the rationale for eligibility criteria, as ments for unmet medical needs, according 16 in Washington, D.C., to evaluate inclusion well as the impact of exclusion criteria on the to the FDA. The agency would also direct and exclusion criteria in clinical trials, under a enrollment of infants, children, pregnant and $58 million to promote domestic manufac- cooperative agreement with Duke University, lactating women, the elderly, individuals with turing with the goal of accelerating targeted with the goal of gathering information to advanced disease and individuals with comor- therapies and enhancing the quality of assist in the development of formal agency bid conditions. In addition, the FDA would products, as well as devote $21 million to guidance on the subject. The meeting was like to hear about alternative trial designs that modernize the FDA’s offices and laboratories prescribed by the PDUFA reauthorization bill may increase enrollment of more diverse pa- nationwide. The administration unveiled its passed last year. “Certain eligibility criteria in tient populations, how changes to eligibility budget request in mid-February, calling for clinical trials can exclude patient subgroups, criteria may impact the complexity and length a 13 percent increase in budget authority for resulting in the enrollment of study popula- of clinical trials and opportunities for using the FDA and $190 million in additional user tions that may not be fully representative of data from expanded access trials.

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Woodcock (continued from page 1) actually taken a step backward,” Woodcock real doctor visits, real patient visits, or said. “For new pharmaceuticals, despite the patient’s lives,” Woodcock said. “Currently I think almost all billions of dollars spent developing them, 3. The data collected must be robust by we often lack important information when the incentives, financially or design or intent, not by quality control, they come on the market about how they’re otherwise, in this whole vast she said, adding that data produced going to perform in the real world. And we healthcare ecosystem are aligned only to satisfy quality control require- don’t really have a good way of evaluating ments alienates the whole enterprise how they’re performing in the real world.” against collaborative learning.” from the actual flow of data. The best The crux of the problem, she said, is case scenario: a world in which we verify that the goals sought by each sector of the —Janet Woodcock, director, FDA’s Center key elements in integrated fashion into healthcare and clinical research arenas have for Drug Evaluation and Research the health record so that we can rely far more to do with other priorities — such upon those elements, and in a way that as financial gain, tenure, business goals — enterprise, and now that must be sustained. no one needs to repeat input efforts, than they do the kind of collaborative learn- “The enterprise is like a hundred and fifty said Woodcock. But we’re not there yet. ing that will bring new cures. baby birds — it has to be fed,” said Wood- 4. Currently, consent documents are long “Currently I think almost all the incen- cock, mentioning laboratories, thousands of and unwieldy. Patients don’t understand tives, financially or otherwise, in this whole post docs, securing of grants and research them. Most don’t read them. Said Wood- vast healthcare ecosystem are aligned centers all across the U.S. “I don’t think you cock, we need to figure out how to do against collaborative learning,” she said. can look to NIH and say they are going to consent and randomization seamlessly Woodcock listed the stakeholders that fund this enterprise and bring about these within a digital environment so that interact with patients and study subjects, transformations. They have other incentives, potential subjects are not turned off to explaining where they err. other pressures on them,” said Woodcock. research right out of the gate. “It’s a nut For academic clinical researchers, she Given all these badly misaligned pres- that will have to be cracked in order to said, the focus is often primarily on tenure, sures on the industry’s key stakeholders, do more efficient learning in healthcare,” obtaining grant support and productivity Woodcock offered her thoughts on how to she said. in the clinic. And insurers and payers, while proceed in building “a nice, sturdy bridge 5. We need rapid knowledge terms, they could benefit from increased knowl- instead of this very flimsy and teetering said Woodcock. She pointed to pilot edge from clinical research about what bridge.” programs, taking small steps, garnering works best, do not focus on learning. “It’s not 1. Put the patient and the treating practi- quick feedback and quick confirmation their business,” said Woodcock. “It’s not how tioner in the center of the efforts. “That’s on whether one is on the right path or their incentives are aligned.” what this enterprise is supposed to be not, then communicating that to all Healthcare providers, meantime, work about: people who need treatment,” said stakeholders. in a fee-for-service environment that is an- Woodcock. Said Woodcock, “People are really eager tithetical to research, adding, though, that She added that ignoring community for answers; They don’t just want to wait ten she expects large healthcare networks to physicians and not sharing study results years to hear: do this. But right now, what eventually emerge as entry points for bridg- with them is part of the problem, and must do we tell them? ‘Here’s what we found in ing research into healthcare more rapidly. stop. “Their marginalization has lead to the this study but more research is needed.’ How The medical product industry, she said, is fact that most people are not referred into does that help a practitioner or patient? We now mired in increased research complexity clinical research in any way because their need to say, ‘This is what we know now, and coupled with an overarching desire to create healthcare practitioners are marginalized if you participate, in one year we’ll know new revenue streams, and these get in the from this enterprise and don’t want any- more and we can feed that back to you and way of maintaining a pure focus on learn- thing to do with it,” she said. to your doctors, and we will build on that ing and quickly sharing new information 2. Information collection on patients in so the knowledge we gained from you will gleaned from research. trials should be well integrated into their count. It will make a difference.’” So NIH then? Well, no. NIH, said Wood- overall healthcare. “The clinical research If those in clinical research can do that, cock, has spent the last 40 to 50 years from the trials are often in a different the rapid knowledge feedback loop will building up the basic biomedical research universe that doesn’t hinge on real life, start sustaining itself, she said.

Inflection Point (continued from page 1) pressures and declining margins. In addi- And contrary to popular belief, provid- tion, many smaller and specialty practices “A high percentage of physicians ers are generally comfortable talking about are being absorbed and integrated into tell us that they do refer patients clinical research with their patients, he larger corporate structures. — but the number they refer, added. Many are familiar with it from profes- When viewed alongside the constant need sional society meetings, or through their as a percentage of the total to recruit more patients from wider geograph- own medical or nursing training. However, ic areas, with catchment being automated number they see in a given year, is the challenges lie in referrals. through electronic medical records and other remarkably low.” “A high percentage of physicians tell databases, it’s easy to see these factors push- us that they do refer patients — but the ing a convergence between research and care —Ken Getz, director of sponsored research number they refer, as a percentage of the delivery within the clinic, he said. programs at the Tufts CSDD total number they see in a given year, is “The infrastructure now, heavily support- remarkably low,” he said. Physicians often ed by rich data and robust analytics, is the the advancements aren’t spread through the don’t know where to find the information to engine behind the patient-centric environ- industry. help them make a referral with confidence, ment that puts the health care provider, as Meanwhile, the vast majority of clinical tri- and don’t have the time to fully process that well as the larger health systems, at the core als are led by smaller companies outside the information once they have it. of this new shift and the opportunities that top 50 pharmaceutical and biotech giants. To bridge the gap, industry should take exist,” Getz said. And, because many may not have experi- new approaches to informing physicians of And with the increasing complexity of ence managing clinical trials on their own, their options, said Craig Lipset, head of clini- clinical trials and growing focus on rare more are engaging CROs for support. These cal innovation at Pfizer. diseases, it will become more difficult to find companies have shown to be more willing “Over half of physicians are in a health experienced physicians, as well as relevant to innovate and challenge the traditional system,” Lipset said. “And we still engage patient populations, across a fragmented practices implemented at the larger, more them as solo practitioners.” landscape. That will drive the need to better established pharma companies, Getz said. Companies should look for existing prin- use data to pinpoint study resources, and “There’s some important news there,” he cipal investigators in already planned studies leverage affiliate relationships with specialty added. “This may become a valuable driver that are part of health systems, which may providers. for us as we look to move more research offer connections to thousands of researchers In addition, there are currently about into the larger health system and healthcare under a single medical group, he said. And 35,000 unique investigators working on at setting.” leveraging their health IT infrastructure can as- least one clinical trial, according to the FDA, Patients are also pushing for clinical sist in patient identification or even electroni- with most only conducting a single study, care and clinical research to be seamlessly cally sourcing data in parallel with the study. with high churn rates. integrated. “How many times do you see where This fragmentation brings its own prob- “We continue to gather a lot of data that patients exist with no way to reach them?” lems — with many of the solutions being not only underscores the tremendous trust he asked, adding that health systems al- siloed themselves. Fixes are usually tailored to patients place in their healthcare provider, ready have permission to reach out to those specific, individual issues as companies try to but their desire to first learn about a clinical patients. “You don’t have to wait for a bridge close out studies as quickly as possible, and trial as part of their routine care,” Getz said. to get built.”

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Sue Vestri, Greenphire it is important that the finance team be involved More and more finance teams at both CROs and in these decisions so that the outputs continue to Sponsors are identifying the areas of invoicing, CWWeekly presents this feature as a spotlight on support their function and the systems deliver the site inquiries, reconciliation and reporting as issues faced by executives in clinical research. This ROI needed for optimization value. Automating critical resource drains that are prime for optimi- week we hear from Sue Vestri, CFO of Greenphire. one manual process may deliver an advantage zation and automation. for one team but create a host of inefficiencies for How has the finance team’s role evolved another. Implementing a solution that is proven What role does process automation have Q over the years and why is it important to to enhance end-to-end workflows is key. Q in improving the workforce and how ensure that the finance team plays an integrated can you determine which processes should be role in the clinical trial process? What impact does the finance team have automated? Q on trial timelines and performance? Regardless of industry, the role of the Optimizing the finance role starts with A finance department continues to evolve into Strong, trusting, collaborative partner- A understanding and constantly examining a dynamic cross-functional component of the or- A ships are the cornerstone to success in any areas that can be automated or outsourced. ganization. Where it was once seen as the “bean business, and clinical research is no exception. Manual, error-prone processes that limit an em- counters” in the back office, the ployee’s growth and ability to be finance team is now a critical more strategic and analytical are resource for data, insights and “It is critical to look at automation, rather the ideal processes to automate. performance metrics. The than outsourcing opportunities, as the It is critical to look at automation, finance team of today, and that level of data that can be derived from the rather than outsourcing oppor- of the future, will be required to software available today is substantial.” tunities, as the level of data that be more analytical and strategic Sue Vestri, CFO, Greenphire can be derived from the software than ever before. available today is substantial. Within the clinical research When processes are automated, industry, the finance team is a key partner to the Studies continue to show that delayed, inac- speed improves, and finance teams become Operations team, particularly around investigator curate site payments have numerous negative more empowered and reliable to their clinical grant payments. The finance team is expected impacts on a site’s performance and ability to operations teams. to be responsive and the source of real-time deliver quality data. When a finance team can If processes are simply outsourced without information around the status of payments and support monthly payments to their investiga- an automated advantage, there may be short invoices. The team’s ability to execute payments tor sites with full visibility into the details and term efficiencies gained, but the long-term cost in a timely manner is essential to support site status of the payment, this burden is completely is not scalable and quality issues will likely arise. performance and satisfaction. removed, and site performance is positively Partnering with best-in-class providers that are Additionally, high performing finance teams impacted. committed to quality with a scalable solution need to be more involved with trial timelines to The finance team can optimize site payment designed to meet the evolving needs of clinical accurately and effectively support budgeting and processes by collaborating with clinical opera- research will deliver both short-term efficiencies forecasting for the business. As the clinical trial tions teams to identify the points of manual and long-term strategic business advantages industry continues to automate various processes, efforts that can be eliminated and optimized. across finance and clinical operations.

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Company Drug/Device Medical Condition Status Sponsor Contact Wize Pharma, Inc. LO2A moderate to severe Phase II trials initiated wizepharma.com Conjunctivochalasis (CCH) enrolling 62 subjects Synlogic SYNB1020 hyperammonemia in patients Phase Ib/IIa trials initiated synlogictx.com with cirrhosis Amylyx AMX0035 Amyotrophic lateral Phase II open-label extension amylyx.com Pharmaceuticals, sclerosis (ALS) initiated enrolling 132 patients Inc. in the U.S. Rigel fostamatinib IgA nephropathy (IgAN) Phase II topline results rigel.com Pharmaceuticals announced evaluating subjects in the U.S., Asia and Europe Kazia Therapeutics GDC-0084 glioblastoma multiforme (GBM) Phase II trials initiated kaziatherapeutics.com Limited Eli Lilly and Cyramza hepatocellular carcinoma (HCC) Phase III positive topline results lilly.com Company (ramucirumab) announced evaluating 292 patients across 20 countries in North America, Asia, Europe and Latin America Allergan, Inc. and cariprazine bipolar I depression Phase III positive topline results allergan.com Gedeon Richter Ltd. announced evaluating 493 richter.hu subjects GenSight Biologics GS010 Leber Hereditary Optic Phase III topline results gensight-biologics.com (rAAV2/2-ND4) Neuropathy (LHON) announced evaluating 37 subjects Wize Pharma, Inc. LO2A dry-eye syndrome (DES) in patients Phase IV trials initiated wizepharma.com with Sjögren's syndrome enrolling 60 subjects TARIS Biomedical TAR-200 (GemRIS) organ-confined or locally- Fast Track Designation tarisbiomedical.com advanced Muscle Invasive granted Bladder Cancer Tetra Discovery BPN14770 Fragile X Syndrome Orphan Drug Designation tetradiscovery.com Partners granted PharmAbcine Inc. TTAC-0001 Glioblastoma Multiforme (GBM) Orphan Drug Designation pharmabcine.com granted Scholar Rock SRK-015 spinal muscular atrophy (SMA) Orphan Drug Designation scholarrock.com granted AstraZeneca moxetumomab hairy cell leukemia (HCL) Priority Review granted astrazeneca-us.com pasudotox Dr. Reddy’s DFN-02 migraine NDA filed with the FDA drreddys.com Laboratories Ltd. AstraZeneca BYDUREON type 2 diabetes with inadequate FDA approval granted astrazeneca-us.com Pharmaceuticals LP glycemic control Amgen Blincyto B-cell precursor acute FDA approval granted amgen.com (blinatumomab) lymphoblastic leukemia (ALL)

Allergan and Richter Announce SYNB1020. This randomized, double-blind, and had a high alpha-fetoprotein (AFP-High), Positive Topline Results for placebo-controlled study is designed to evalu- defined as an AFP of ≥ 400 ng/mL. REACH-2 is Bipolar I Depression Trial ate the safety and tolerability of SYNB1020, the first positive Phase III HCC trial in a biomark- Allergan and Gideon Richter announced posi- as well as its ability to lower blood-ammonia er-selected patient population. The REACH-2 tive topline results for RGH-MD-53, a Phase levels in patients with cirrhosis and elevated study has confirmed the hypothesis generated III study of cariprazine for the treatment blood ammonia. This Phase Ib/IIa study had by the REACH trial results, which showed that of adults with major depressive episodes two parts. In Part I of the trial, an initial sentinel a pre-specified subgroup of advanced HCC associated with bipolar I disorder (bipolar I open-label cohort of subjects with cirrhosis patients who were AFP-High derived a survival depression). RGH-MD-53 and RGH-MD-54 and a Model for End-Stage Liver Disease benefit from treatment with CYRAMZA follow- were identical Phase III, randomized, double- (MELD) score <12 received orally administered ing first-line treatment with sorafenib. blind, placebo-controlled, parallel-group, SYNB1020 (5 x 1011 CFU TID) for six days. multicenter, fixed-dose clinical trials in adult Part 2 of the trial comprised a randomized, Wize Pharma Enrolls First patients with bipolar I depression. A total of double-blinded, placebo-controlled study in Patient in Study for Treatment 584 patients were randomized to evaluate patients with cirrhosis and hyperammonemia. of Dry Eye Syndrome the efficacy, safety and tolerability of caripra- Eligible subjects were admitted to an inpatient Wize Pharma announced that it enrolled the zine 0.75 mg, 1.5 mg and 3 mg compared to facility for a run-in diet and 24-hour ammonia first patient in its Phase IV clinical trial in Israel placebo in the treatment of outpatients with profile, and those with an elevated ammonia for LO2A in the symptomatic treatment of dry bipolar I depression. Patients underwent a level proceeded with randomization and eye syndrome (DES) in patients with Sjögren’s no-drug screening period of approximately received either placebo or orally administered syndrome. This randomized, double-masked 7-14 days, followed by 8 weeks of double- SYNB1020 (5 x 1011 CFU TID) for six days. study will evaluate LO2A versus Alcon’s Systane blind treatment and a one-week, no inves- Ultra UD, an over-the-counter lubricant eye tigational product safety follow-up period. Lilly Announced CYRAMZA Met drop product used to relieve dry and irritated Cariprazine was generally well tolerated in Overall Survival Endpoint eyes. Approximately 60 patients with Sjögren’s the trial. The overall incidence of patients Eli Lilly announced top-line results from its syndrome who are experiencing DES are who experienced adverse events was 51 Phase III REACH-2 study of CYRAMZA® (ramu- being randomized in a 1:1 ratio to one of two percent for the cariprazine 1.5 and 3 mg dose cirumab) as a single agent in the second-line treatment groups, LO2A or Systane® Ultra UD. groups, and 46 percent for the placebo group. treatment of people with hepatocellular carci- Drops will be administered topically to the The majority of adverse events were mild to noma (HCC), also known as liver cancer. The trial eye over a three month period. The primary moderate and led to discontinuation in ap- met its primary endpoint of overall survival (OS) endpoint of the study is the change in corneal/ proximately 5 percent of cariprazine-treated as well as the secondary endpoint of progres- conjunctival staining score using the National patients versus three percent of placebo- sion-free survival (PFS). REACH-2 is a global, Eye Institute (NEI) Industry Grading System treated patients. randomized, double-blind, placebo-controlled after 3 months of study treatment. Secondary Phase III study of CYRAMZA and best supportive endpoints include corneal/conjunctival stain- Synlogic Doses First Patient care (BSC) compared to placebo and BSC in he- ing score after one month of treatment and in Phase Ib/IIa Trial patocellular carcinoma (HCC) patients who were change in Ocular Surface Disease Index (OSDI) Synlogic announced that the first patient intolerant to, or that had disease progression score after one and three months of treatment. was dosed in its Phase Ib/IIa clinical trial of while on or following treatment with, sorafenib

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Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies. To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100 or [email protected].

Advanced Medical Concepts PSC Einstein Clinical Cidra, Puerto Rico Phillipsburg, NJ (787) 739-3376 (704) 315-1796 [email protected] [email protected]

Advanced Medical Concepts PSC is a medical center, in practice for Einstein Clinical is a stand-alone, fully equipped research center. This over 25 years, dedicated to direct outpatient care and clinical trials. location provides a diverse patient population and is located within a We also administer an alliance of centers that also perform direct heavily populated medical community of many sub-specialties with a outpatient care as well as clinical trials. concentration on Neurological and Psychological disorders. ALAS Science Clinical Research Florida Premier Research Institute Las Vegas, NV Winter Park, FL (702) 951-1375 (407) 740-8078 [email protected] [email protected]

Alas Science Clinical Research, conducts clinical trials in diabetes and Florida Premier Research Institute, LLC, and Florida Pulmonary Research other health-related conditions (Cardiovascular, metabolic disorders, Institute, LLC, are state-of-the-art, multi-specialty facilities conducting neuropathies, obesity and medical devices). The organization has been Phase I-IV pharmaceutical research. conducting clinical trials since September 2004. AMAC Research Institute FXM Research Miramar / Francisco Flores, M.D. North Dartmouth, MA Miramar, FL (508) 717-8205 (954) 430-1097 [email protected] [email protected]

AMAC Research Institute is a dedicated research site that provides FXM Research is a privately owned and operated Clinical Research Site state-of-the-art facilities including a sleep lab, which offers inpatient that conducts Phase II, III and IV clinical research trials specializing in capabilities. Dermatology and Aesthetics/Cosmetics.

Aventiv Research Grossmont Center for Clinical Research Columbus, OH La Mesa, CA (614) 501-6164 (619) 589-4100 [email protected] [email protected]

Aventiv Research, formerly Columbus Clinical Research, was founded by Grossmont Center for Clinical Research Dr. Samir Arora, a proven leader with more than 13 years of clinical research is a dedicated research facility specializing in women’s healthcare. experience. They are an independent, multi-therapeutic outpatient clinical research center with three locations specializing in Phase I-IV clinical trials. Beacon Clinical Research Insearch Quincy, MA Tampa, FL (774) 462-6610 (727) 544-4842 [email protected] [email protected]

Beacon Clinical Research (BCR) is a full-time independent clinical Insearch is a clinical business development company that offers research facility. BCR is a multi-specialty site specializing in Phase II-IV personalized service, at no charge, to Pharma and CROs looking for clinical trials. BCR was started in 2000 and has conducted over appropriate PIs/sites for their trials. Insearch represents only the highest 500 studies to date for a wide range of clients. quality Principal Investigators and Clinical Research Organizations.