(3BC) Event Optimizing the Role of Male Champions

Total Page:16

File Type:pdf, Size:1020Kb

(3BC) Event Optimizing the Role of Male Champions 2018 Building Better Business Connections (3BC) Event Optimizing the Role of Male Champions FRIDAY, 4 MAY 8:30 AM – 3 PM New York Genome Center 101 Avenue of the Americas New York, NY 10013 HBAnet.org Event Sponsor 2018 HBA thanks its 2018 Corporate Partners. Together we are advancing the impact and influence of women A united force for change. in the business of healthcare. INFLUENCER LEVEL Purdue Pharma L.P. Momenta Pharmaceuticals, Inc. Pfizer Inc. Quest Diagnostics Ogilvy CommonHealth Worldwide RB Practice Fusion, Inc. Core purpose To further the advancement and impact of women in the PURPLE LEVEL Sanofi PwC business of healthcare. BD UCB, Inc. Regeneron Pharmaceuticals, Inc Bristol-Myers Squibb Company UPS Relypsa, Inc. Johnson & Johnson Vertex Pharmaceuticals Incorporated Roche Diagnostics Novartis Pharmaceuticals Walgreens Boots Alliance Sandoz Corporation Mission The Healthcare Businesswomen’s Association is a Shionogi, Inc. Publicis Health, LLC TEAL LEVEL global nonprofit organization comprised of individuals Strongbridge BioPharma plc Shire Abbott Stryker Corporation and organizations from across the healthcare industry Takeda Pharmaceuticals, Inc. Accenture Syneos Health committed to: GOLD LEVEL Alcon, a Novartis Company Syneos Health (f/k/a INC Res-inVentiv) Alnylam Pharmaceuticals Sysmex America, Inc. AbbVie Inc. • achieving gender parity in leadership positions AMAG Pharmaceuticals TBWA\WorldHealth Alexion Pharmaceuticals, Inc. Astellas Pharma US, Inc. Tesaro, Inc. Allergan • facilitating career and business connections Bulletin Healthcare Teva Pharmaceutical AmerisourceBergen Corporation Calcium USA The Lockwood Group LLC • providing effective practices that enable organizations Amgen Inc. CDM New York The Scienomics Group AstraZeneca/MedImmune to realize the full potential of their female talent Concentric Health Experience VMS BioMarketing athenahealth Daiichi Sankyo, Inc. W2O Group Baxter International Inc. Doximity, Inc. West Pharmaceuticals Services Bayer The HBA accomplishes its mission through strong Dr. Reddy's Laboratories, Inc. Boehringer Ingelheim PEARL LEVEL Ferring Pharmaceuticals business networks, education, research, advocacy and Cardinal Health Fingerpaint Marketing, Inc. Advanced Clinical Celgene Corporation recognition for individuals and companies. Giant Creative Strategy Bay City Capital LLC CSL Behring Havas Health & You BTK Communications Group, LTD Eisai Inc. Health & Wellness Partners, LLC Cipla Inc. Eli Lilly and Company Relevance, Integrity, Community, Engagement Horizon Pharma plc Habergeon, LLC Core values F. Hoffmann-La Roche Ltd Inovalon Illumina Genentech, Inc. Ironwood Pharmaceuticals KMK Consulting, Inc. GlaxoSmithKline ISPOR —The Professional Society for Health LexisNexis Risk Solutions Indivior PLC Economics and Outcomes Research Mission Pharmacal Company IQVIA JUICE Pharma Worldwide North Highland Magellan Rx Management Ketchum Peloton Coaching and Consulting Mallinckrodt Pharmaceuticals Knowledgent PharmaVOICE Medidata Solutions KPMG LLP Radius Health Merck & Co., Inc. Lundbeck Taylor Strategy Partners Merck KGaA, Darmadst Germany Marina Maher Communications - Rx Mosaic Theravance Biopharma Novo Nordisk, Inc. McCann Echo Trinity Partners Ortho Clinical Diagnostics McCann Health Wendy White Consulting Performance Health McCann Torre Lazur Veracyte, Inc. 1 agenda HBA Co-chairs 8:30 AM Arrivals, coffee 11:00 AM Workshop: Champions of Change 2018 Denise Pirrotti Hummel, chief 9:00 AM HBA Welcome innovation officer, Lead Inclusively, Inc. Amy Crolius, vice president In-depth discussion and interactive stakeholder relations workshop focused on the opportunities and behaviors which create an optimal Host Welcome work environment. Session will touch Kirsty William E. Johnson & Johnson on overt and subtle (unconscious) bias in the workplace; recognizing Graham Fitzsimmons and disrupting gender related Pharm D, MS 3BC Co-Chairs Greetings impediments; becoming a champion Bill Fitzsimmons, executive vice and change agent for gender diversity. president, regulatory affairs, clinical and research quality assurance, Astellas 12:30 PM Lunch Senior Vice President, Global Policy and International Executive Vice President, Regulatory Affairs, Kirsty Graham, svp for global policy and 1:00 PM Discussion: Effective and Reciprocal Public Affairs, Pfizer Inc. Clinical and Research Quality Assurance, Astellas international public affairs, Pfizer Male-Female Mentoring and Sponsorships Kirsty Graham is Senior Vice President, Global Policy Dr. William Fitzsimmons serves as executive vice president. 9:30 AM Panel: The Profile of a Champion and International Public Affairs at Pfizer. Kirsty is responsible In this role, he is responsible for regulatory interactions for W. Brad Johnson, PhD and David Industry thought leader briefing on the for defining Pfizer’s public policy positions and advancing development and on-market products globally. He also is Smith, PhD role and importance of advocacy best government and public affairs strategies internationally. Kirsty responsible for quality assurance for compliance with Good practices. Includes a panel discussion was formerly Vice President and Corporate Affairs Lead for Clinical Practice (GCP) and Good Laboratory Practice (GLP). Engaging discussion with contemporary with senior executive role models Pfizer Essential Health where she represented the breadth of Dr. Fitzsimmons began his career at Astellas as R&D thought leaders around a new take sharing their experiences, learnings, tips global corporate affairs issues including policy, public affairs, Project Manager in 1990, responsible for the development of on mentoring and sponsoring, on effective advocacy and sponsorship of corporate responsibility and communications on the PEH Prograf® in transplantation, and has since assumed roles of an “alternative to the traditional, women. Preliminary panelists include: leadership team. Prior to joining Pfizer in November 2010, increasing responsibility in R&D, Drug Development Project hierarchical, unidirectional mentoring model….[called] reciprocal mentoring…. Kirsty spent 16 years in the New Zealand Foreign Service Management, and Business Development. Previously, Dr. Nick Colucci, chairman, Publicis Health where she worked on a wide range of economic, foreign and Fitzsimmons served in assistant professor and specialist roles partnerships in which men and women trade policy issues with responsibilities covering China, Japan at various universities, including Rush Medical College in Joe DePinto, president, Cardinal Health play complementary roles leading to and the United States. She worked as a Private Secretary to Chicago and the University of Illinois College of Pharmacy. Specialty Solutions career and personal development for the Foreign Minister from 1994 to 1996 before moving to Dr. Fitzsimmons holds a Doctor of Pharmacy degree both parties, and ultimately, greater Brian Goff, chief commercial officer, Washington for her first diplomatic assignment in the U.S, a from the Medical College of Virginia, Virginia Commonwealth gender equality in the workplace.” Alexion Pharmaceuticals, Inc. position she held until 2001. Later that year, Kirsty took leave University; a Master of Science degree in Clinical Research to work for the British Government as Deputy Spokesperson Design and Statistical Analysis from the University of Viq Pervaaz, partner/life sciences leader, 2:30 PM Wrap-up at the British Embassy in Washington. She was appointed to Michigan; and a Bachelor of Science degree in Pharmacy from Ernst & Young’s People Advisory Services Laurie P. Cooke, HBA CEO her second diplomatic assignment as New Zealand’s Deputy the University of Illinois. Dr. Fitzsimmons has also authored Ambassador to the United Nations in 2006, a position she held more than 50 peer-reviewed publications and is a member 10:30 AM Break until 2010. Kirsty has a BA in English Literature and a post of the American Society of Transplantation and a Board graduate degree in Philosophy from the University of Otago. member of the Biotechnology Industry Organization (BIO). 2 3 Joe DePinto president, Cardinal Health Specialty Solutions 2018 HBA Board of Directors panel discussion Joe DePinto has spent the past 28 years focused on bringing life-saving specialty drugs to market, helping patients with complex diseases to access advanced care, and helping to develop future leaders in the pharmaceutical industry. His experience includes operations globally for multiple biotech and pharma companies. As President of Cardinal Health Specialty Solutions, DePinto leads one of the fastest growing businesses within the Fortune 15-ranked Cardinal Health. Established just eight years ago, Specialty Solutions has grown from $5 billion in revenues in 2015 to more than $12 billion in 2017 under DePinto’s leadership. In his current role, he has directed two key acquisitions; overseen the Profile of a Champion company’s expansion into Boston and Houston, and led critical operational expansions. DePinto’s past roles have included leadership positions at top pharmaceutical companies including Johnson & Johnson and Lilly. His core leadership competencies include leading all aspects of strategy, drug development, investor relations, and commercialization with multiple global launches. He also previously served as the EVP Chief Commercial Officer at Sunesis Pharmaceuticals, EVP Global Commercial Operations Dendreon, VP Global Commercial Operations ImClone, and VP Abraxis Oncology. Joe’s academic credentials include
Recommended publications
  • 2017 Sustainability Report
    2017 SUSTAINABILITY REPORT CREATING A BETTER WORLD CONTENTS WHO WE ARE CREATING A BETTER WORLD 4 About this Report 10 Business Overview 24 Our Goals 6 Letter from our CEO 13 Our Products 29 Our Planet 8 About Medidata OUR APPROACH GRI INDEX 14 Stalkholders 30-32 GRI Index 16 Materials References: PEOPLE FIRST Priority Issue: An issue deemed material to the company through our sustainability issue prioritization process. 18 Ethics Global Reporting Initiative (GRI): The GRI Sustainability Reporting Standards are the first and 20 Our People most widely adopted global standards for sustainability reporting. 22 Diversity Matters UN Global Compact: The UNGC is a voluntary initiative based on CEO commitments to implement universal sustainability principles and to understand partnerships in support of UN Goals. Sustainable Development Goals: The SDGs are a universal call to action to end poverty, protect the planet, and ensure that all people enjoy peace and prosperity. 2 2017 MEDIDATA SUSTAINABILITY REPORT 2017 MEDIDATA SUSTAINABILITY REPORT 3 CREATING A CREATING A WHO WE ARE OUR APPROACH PEOPLE FIRST BETTER WORLD GRI INDEX WHO WE ARE OUR APPROACH PEOPLE FIRST BETTER WORLD GRI INDEX About this Report Letter from our CEO About Medidata Business Overview Our Products About this Report Letter from our CEO About Medidata Business Overview Our Products ABOUT THIS REPORT As we reflect on the last 18 years, the spirit of No information contained on our website is innovation—one that has truly paved the way intended to be included as part of, or incorporated for better solutions, higher quality treatments, by reference into, this Annual Report on Form and quicker go-to-market times—remains our 10-k.
    [Show full text]
  • Semi-Annual Market Review
    Semi-Annual Market Review HEALTH IT & HEALTH INFORMATION SERVICES JULY 2019 www.hgp.com TABLE OF CONTENTS 1 Health IT Executive Summary 3 2 Health IT Market Trends 6 3 HIT M&A (Including Buyout) 9 4 Health IT Capital Raises (Non-Buyout) 14 5 Healthcare Capital Markets 15 6 Macroeconomics 19 7 Health IT Headlines 21 8 About Healthcare Growth Partners 24 9 HGP Transaction Experience 25 10 Appendix A – M&A Highlights 28 11 Appendix B – Buyout Highlights 31 12 Appendix C – Investment Highlights 34 Copyright© 2019 Healthcare Growth Partners 2 HEALTH IT EXECUTIVE SUMMARY 1 An Accumulating Backlog of Disciplined Sellers Let’s chat about fireside chats. The term first used to describe a series of evening radio addresses given by U.S. President Franklin D. Roosevelt during the Great Depression and World War II is now investment banker speak for “soft launches” of sell-side and capital raise transactions. Every company has a price, and given a market of healthy valuations, more companies are testing the waters to find out whether they can achieve that price. That process now looks a little more informal, or how you might envision a fireside chat. Price (or valuation) discovery for a company can range from a single conversation with an individual buyer to a full-blown auction with hundreds of buyers and everything in between, including a fireside chat. Given the increasing share of informal conversations, the reality is that more companies are for sale than meets the eye. While the healthy valuations publicized and press-released are encouraging more and more companies to price shop, there is a simultaneous statistical phenomenon in perceived valuations that often goes unmentioned: survivorship bias.
    [Show full text]
  • 4Th DIA China Annual Meeting
    ײࣷනٷ ˖࿋ڇࢇӸ 35(/,0,1$5< 352*5$0 ዐࡔᅅᄱࡔा঍ୁዐ႐ ',$ ዐࡔ౎ࣷ ຺াᄱ࿿႑တၹࣷڼ ႎظዐࡔᇑ๘হüüࢇፕᇑ WK',$&KLQD$QQXDO0HHWLQJ &ROODERUDWLRQ ,QQRYDWLRQLQ&KLQD ዐࡔฉ࡛ࡔाࣷᅱዐ႐ 6KDQJKDL,QWHUQDWLRQDO&RQYHQWLRQ&HQWHU&KLQD ౎ሆනȍȍጆ༶ಢჟ ౎ሆනȍȍࣷᅱԒߢĂ༪ஃĂቛબࢅஃ࿔ՄԒ 0D\3UHFRQIHUHQFH:RUNVKRSV 0D\&RQIHUHQFH([KLELWLRQDQG3RVWHUV WWW.DIACHINA.ORG John J. HU, PhD Vice President and General Manager, United States Pharmacopeia-China Welcome to 4th DIA China Annual Meeting in Shanghai! This year’s theme, “Collaboration and Innovation in China”, speaks to the fact that future pharmaceutical innovation is about collaboration, and China is an important member of the global innovation community that will contribute to this partnership. Thanks to the outstanding hard work of the program committee and DIA-China staff, we have added exciting new events to this year’s program. We are delighted and hon- ored to have Dr. Yin Li, the commissioner of SFDA, and two distinguished international thought leaders, Dr. David Ho and Dr. Alberto Grignolo as keynote speakers. For the first time, SFDA’s Center for Drug Evaluation (CDE), has agreed to conduct a town hall meeting that will allow meeting participants have an open and direct dialog with CDE. Working with China’s SFDA, US FDA and US Department of Commerce, we have also added two new API regulatory workshops at the preconference session. In addition, we are fortunate to be able to invite Japan’s PMDA to provide a special session focus- ing on recent regulatory policy development in the world’s second largest pharmaceu- tical market. New to this year’s program are dedicated tracks on biological and vac- cine development, CRO collaborations and China’s various high-tech parks that offer government incentives for pharmaceutical R&D activities.
    [Show full text]
  • COVID-19 and Clinical Trials: the Medidata Perspective Release 7.0
    MAYJULY 18, 13, 2020 2020 COVID-19 and Clinical Trials: The Medidata Perspective Release 7.0 Copyright 2020 Medidata Solutions, Inc., a Dassault Systèmes company JULY 13, 2020 2 COVID-19 AND CLINICAL TRIALS: THE MEDIDATA PERSPECTIVE Table of Contents What’s New/What’s Significantly Updated in Release 7.0 3 Insights to Ongoing Data Capture in Clinical Trials 3 Regulatory Response 5 Impact to Medidata Customers, Patients and Trials 6 The Race for a Vaccine 7 Medidata Solutions to Assist Sponsors/Partners, Patients and Trials 10 Details on New and Adapted Medidata Solutions 11 Summary 18 Copyright 2020 Medidata Solutions, Inc., a Dassault Systèmes company JULY 13, 2020 3 COVID-19 AND CLINICAL TRIALS: THE MEDIDATA PERSPECTIVE What’s New/What’s Significantly Updated in Release 7.0 ā New: Metrics on new patients entering trials by country/region and therapeutic area by month ā Updated: Regulatory Response ā Updated:The Race for a Vaccine ā Updated: Summary table of the current vaccine clinical trials for COVID-19 ā Updated: Graphical Representation of COVID-19 Vaccination Trials ā Updated: Summary Insights to Ongoing Data Capture in Clinical Trials Medidata is continuously monitoring the global impact of COVID-19 on clinical trials. Our first data and insights impact report was released on March 23, with subsequent releases on April 3, April 17, May 4, May 18, June 15 and now July 13. At the beginning of the pandemic, we were looking at year-over-year changes to understand and grasp the magnitude of COVID-19 on the impact on clinical trials in terms of trial activity, across geographies and therapeutic areas (TAs).
    [Show full text]
  • Optimizing Clinical Trials: Concept to Conclusiontm
    2010 MEDIDATA SOLUTIONS MEDIDATA ANNUAL REPORT Optimizing Clinical Trials: Concept to ConclusionTM TWO THOUSAND 10ANNUAL REPORT At Medidata Solutions innovation is the key driver of our value. Medidataa Solutions is a leading global providerr of SaaSS clinical developmentdevelopmenen solutionsns that enhance the effiffi ciencyciee of customers’ clinical trialss from conceptncept to conclusion. Foror over 11 years, Medidata has consconsistentlys broughtught next-generationnext-gener innovationovation to the life sciescienceien industry to lower the total cost of clinical developmentevelopmen with technology that addressessses strategy and planning, resource management, study design and start-up, and study execution.cution. Tarek A. Sherif, Chairman & Chief Executive Offi cer Dear Medidata Shareholder: In our fi rst full year as a public time in our history. Our industry- company, we strengthened our leading tools are helping our clients position as the leading independent remove barriers to their productivity, SaaS (Software as a Service) vendor reduce the total cost of global in clinical development. By providing clinical development and accelerate By enabling our customers transformational clinical technology the time to bring life-enhancing drugs to optimize their clinical solutions, we generated strong top- to market. line growth, particularly from mid-size trials from concept to pharma and biotech customers and I am exceptionally proud of the way our CRO (contract research organiza- Medidata’s customer-facing teams conclusion, we are well tion) partners. We also experienced serve as trusted advisors to our dramatic bottom-line growth, with clients, emphasizing collaboration positioned to continue record earnings highlighting the and committing to their success. excellent operating leverage in our Medidata’s strong execution on our driving profi table business model.
    [Show full text]
  • Clinical Researcher
    OCTOBER 2017 12 Getting on Board with ICH GCP E6(R2) 26 New European Medical Device Regulation 32 Clinical Trial Operations: Who is Watching? The Authority in Ethical, Responsible Clinical Research Regulations and Compliance: The Climb is Worth It See page 8 for exciting news about our next issue… Association of Clinical Research Professionals (ACRP) Professionals Research of Clinical Association www.acrpnet.org 10-Week CRA & CRC Beginner Program Meet The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, Felix but haven’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC. Upon completion, Barnett will provide resume assistance so that you can position yourself for entry into this market. 2 years of service 31,526 miles traveled 3 countries of former residence Welcome to a different kind of CRO. rhoworld.com/careers BarnettInternational.com Customer Service: 800.856.2556 Meet Felix 2 years of service 31,526 miles traveled 3 countries of former residence Welcome to a different kind of CRO. rhoworld.com/careers CONTENTS October 2017 • Volume 31, Issue 5 • ISSN 2334-1882 6 Feature PEER REVIEWED GUEST EDITOR’S MESSAGE Regulations and Compliance: The Climb is Worth It Glenda Guest, CCRA, RQAP-GCP, TIACR Clinical Researcher is your platform.
    [Show full text]
  • COVID-19 and Clinical Trials: the Medidata Perspective Release 6.0
    MAYJUNE 18, 15, 2020 2020 COVID-19 and Clinical Trials: The Medidata Perspective Release 6.0 Copyright 2020 Medidata Solutions, Inc., a Dassault Systèmes company JUNE 15, 2020 2 COVID-19 AND CLINICAL TRIALS: THE MEDIDATA PERSPECTIVE Table of Contents What’s New/What’s Significantly Updated in Release 6.0 3 Insights to Ongoing Data Capture in Clinical Trials 3 Regulatory Response 5 Impact to Medidata Customers, Patients and Trials 6 The Race for a Vaccine 7 Medidata Solutions to Assist Sponsors/Partners, Patients and Trials 9 Details on New and Adapted Medidata Solutions 10 Summary 17 Copyright 2020 Medidata Solutions, Inc., a Dassault Systèmes company JUNE 15, 2020 3 COVID-19 AND CLINICAL TRIALS: THE MEDIDATA PERSPECTIVE What’s New/What’s Significantly Updated in Release 6.0 ā Updated: Metrics on new patients entering trials by country and therapeutic area (March, April and May) ā Updated: Regulatory Response ā New section: The Race for a Vaccine. ā Updated: Summary table of the current 10 vaccine clinical trials for COVID-19 ā New: Graphical Representation of COVID-19 Vaccination Trials ā Updated: Summary Insights to Ongoing Data Capture in Clinical Trials Medidata is continuously monitoring the global impact of COVID-19 on clinical trials. Our first data and insights impact report was released on March 23, with subsequent releases on April 3, April 17, May 4, May 18, and June 15. After an initial steep decline in clinical trial activity, both in terms of new patients entering clinical trials and visit rate per subject for ongoing trials, we are now starting to see a leveling off of the impact and regional fluctuations.
    [Show full text]
  • MEDIDATA SOLUTIONS (MDSO) BEST IDEAS LONG CALL January 16, 2015 DISCLAIMER
    TOM TOBIN ANDREW FREEDMAN MEDIDATA SOLUTIONS (MDSO) BEST IDEAS LONG CALL January 16, 2015 DISCLAIMER DISCLAIMER Hedgeye Risk Management is a registered investment advisor, registered with the State of Connecticut. Hedgeye Risk Management is not a broker dealer and does not provide investment advice for individuals. This research does not constitute an offer to sell, or a solicitation of an offer to buy any security. This research is presented without regard to individual investment preferences or risk parameters; it is general information and does not constitute specific investment advice. This presentation is based on information from sources believed to be reliable. Hedgeye Risk Management is not responsible for errors, inaccuracies or omissions of information. The opinions and conclusions contained in this report are those of Hedgeye Risk Management, and are intended solely for the use of Hedgeye Risk Management’s clients and subscribers. In reaching these opinions and conclusions, Hedgeye Risk Management and its employees have relied upon research conducted by Hedgeye Risk Management’s employees, which is based upon sources considered credible and reliable within the industry. Hedgeye Risk Management is not responsible for the validity or authenticity of the information upon which it has relied. TERMS OF USE This report is intended solely for the use of its recipient. Re-distribution or republication of this report and its contents are prohibited. For more details please refer to the appropriate sections of the Hedgeye Services Agreement and the Terms of Use at www.hedgeye.com HEDGEYE 2 PROCESS INVESTMENT PROCESS 1. Idea Generation - Relative and absolute performance - Valuation and sentiment - Battleground stocks and social media - Market research Fundamental 2.
    [Show full text]
  • UNITED STATES SECURITIES and EXCHANGE COMMISSION Washington, D.C
    Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________ FORM 10-K _____________________________________ ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-34387 _____________________________________ Medidata Solutions, Inc. (Exact name of registrant as specified in its charter) _____________________________________ Delaware 13-4066508 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 350 Hudson Street, 9th Floor 10014 New York, New York (Address of principal executive offices) (Zip Code) (212) 918-1800 (Registrant's telephone number, including area code) Securities registered under Section 12(b) of the Exchange Act: Title of each class Name of each exchange on which registered Common Stock, par value $0.01 per share The NASDAQ Stock Market LLC Securities registered under Section 12(g) of the Exchange Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ý Yes ¨ No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. ¨ Yes ý No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
    [Show full text]
  • Drug Development Tools for Kidney Disease
    Drug Development Tools for Kidney Disease C-Path Overview Dr. Martha Brumfield Critical Path Institute 1 DDT-KD Topics Consortium • History of C-Path, What We Do and How We Do It • What DDT-KD Consortium Can Do and What It Will Not Do • C-Path Experience with Data Sharing and Aggregation • Example in Alzheimer’s Disease • Example in Polycystic Kidney Disease • C-Path Track Record 2 DDT-KD C-Path Mission Consortium • The Critical Path Institute is a catalyst in the development of tools to advance medical innovation and regulatory science, accelerating the path to a healthier world. We achieve this by leading teams that share data, knowledge, and expertise, resulting in sound, consensus-based science. 3 DDT-KD Critical Path Initiative Consortium Independent 501(c)3 founded in 2005 “… to foster development of new evaluation tools to inform medical product development” Memorandum of Understanding created between the FDA and C-Path in 2005 4 DDT-KD C-Path: A Public Private Partnership Consortium • Act as a trusted, neutral third party • Convene scientific consortia of industry, academia, and government for sharing of data/expertise The best science The broadest experience Active consensus building Shared risk and costs • Enable iterative EMA/FDA/PMDA participation in developing new methods to assess the safety and efficacy of medical products • Official regulatory endorsement of novel methodologies and drug development tools 5 DDT-KD C-Path Core Competencies Consortium • Regulatory qualification of preclinical and clinical biomarkers for
    [Show full text]
  • Life Sciences & Health Care M&A Update: Q2 2018
    Life Sciences & Health Care Quarterly update Q2 2018 Deloitte Corporate Finance LLC | www.investmentbanking.deloitte.com Quarterly Update | Q2 2018 | Life Sciences & Health Care Explosion of real world data in healthcare(1) In This Update Real world data (RWD) refers to heath care data gathered from a variety of sources outside of controlled clinical trials. These sources can include genomic ▪ Increasing need for data, data from health apps, wearables, and other biometric devices. This data-driven analytics information is used to generate real world evidence (RWE) and support data- driven, individualized health care reports. With the rise of digital and electronic fuels 2018 health care health care data comes a need for RWD management in the pharmaceutical transactions space. Deloitte RWE benchmarking survey findings(2) Also: This year Deloitte conducted its second annual survey of pharmaceutical ▪ Selected Recent Life companies’ perspectives regarding the advances in RWD management, RWE Sciences & Health Care value creation, and RWE applications. The survey results indicate that the (LSHC) M&A visibility and importance of RWE initiatives are increasing at the executive level. The survey found that most respondents are leveraging RWD across the Transactions enterprise to not only generate evidence, but also support other research, ▪ LSHC Sector Breakdown corporate, and commercial objectives. Other key findings include: and Analysis • Increasing importance of RWE integration: Many pharmaceutical companies are now leveraging RWD holistically throughout their ▪ Selected organizations to generate evidence and support patient research. Macroeconomic and • Growing data landscape: More so than ever, respondents are using Sector Data non-traditional data sources, such as purpose-built linked data, connected wearable technology, and health apps to drive decision making.
    [Show full text]
  • Medidata Solutions Partners with Veeva Systems to Bring Integrated Etmf to the Clinical Cloud
    Medidata Solutions Partners with Veeva Systems to Bring Integrated eTMF to the Clinical Cloud Cloud Technology Integration Gives Sponsors Path to Faster Regulatory Submissions NEW YORK, N.Y. – December 6, 2012 – Veeva Systems has partnered with Medidata Solutions (NASDAQ: MDSO) to offer the life science industry’s first cloud- based end-to-end solution that integrates clinical documentation and trial development. The two companies will integrate Vault eTMF, Veeva’s electronic trial master file (eTMF) content management application, across the Medidata Clinical Cloud, offering life science companies and their global partners a complete clinical technology solution with a searchable central repository for all clinical documentation. "Within the industry, there is an emerging demand for an eTMF to more consistently manage documents within a clinical trial,” said Alan S. Louie, Ph.D., research director, IDC Health Insights. “With the industry shift away from individual applications to more comprehensive eClinical solutions, seamless integration of applications and features such as eTMF into existing eClinical platforms should help leading life science companies to more fully and transparently manage overall trial efforts and improve process efficiencies." As clinical trials become more and more complex, the need for dependable document storage combined with real-time data accessibility is vital. The partnership will meet this need, advancing technology platform offerings in clinical development by facilitating efficient management of the trial master file collection. The integrated solution also provides secure document exchange between sites and sponsors, reducing the need for separate enterprise collaboration systems and portals. The collaborative nature of the clinical research team also demands a solution that is globally accessible and meets both regulatory and security needs.
    [Show full text]