Clinical Trial Collaborations MARCH 21 - 22, 2016 BOSTON MARRIOTT CAMBRIDGE, CAMBRIDGE, MA The Forward Looking Event on Greater Collaboration between Clinical Research Care, Cost, Quality & Performance Co-chairs Keynote Speakers

Speaking Faculty

Murray Abramson, MD, MPH Robert Califf, MD, MACC Jeffrey Kasher, PhD Bernard Munos Biogen FDA Patients Can’t Wait FasterCures Solomon Babani Jennifer Levin Carter, MD, Mitchell Katz, PhD Adrian Otte, MB, BCH, FFPM Covance MPH Purdue Pharma Amgen N-of-One Inc Deirdre BeVard Tanya Russell Kirkpatrick, PhD Ross Pettit Nektar Therapeutics Mike Collins Pfizer Infinity Pharmaceuticals Alexion Pharmaceuticals Stewart Bieler Pablo Lapuerta, MD Joel Rothman SynteractHCR Judith Dunn, PhD Lexicon Pharmaceuticals Raptor Pharmaceuticals Roche Innovation Center Phil Birch, DPhil New York Veronica Ludensky Lorraine Rusch, PhD ICON plc Takeda Pharmaceuticals Altasciences Clinical Patrick Flanagan Research: Vince & David Blume Veristat Michael Martorelli Associates Edgemont Capital Partners Fairmount Partners Tracey Gashi Komathi Stem Michael Breton INC Research Adrian McKemey, PhD Genentech/Roche Shire Pharmaceuticals Quintiles Evan Gothard Reb Tayyabkhan Matthew Bush Bioclinica Global Clinical Alan Metz, MD Bristol-Myers Squibb PPD Research Quintiles Katherine Vandebelt Barry Milton Jennifer Byrne Amy Grahn Eli Lilly and Company goBalto PMG Research Horizon Pharma Jay Kaminski Jules Mitchel, PhD Celgene Target Health

Presented By

Follow us on Twitter @ConferenceForum #CTCollaborations | www.theconferenceforum.org CLINICAL TRIAL COLLABORATIONS OVERVIEW

Dear Clinical Trials Community,

The Conference Forum and CenterWatch are pleased to present together for the first time a strategic conference on identifying better solutions to drive more efficient R&D operations, especially as it applies to outsourcing, clinical research and clinical care. The conference presents insightful ideas and challenges for both R&D operations, CRO and site executives to discover new ways of collaborating.

We are delighted to have Ken Getz, Director, Sponsored Research Programs, Tufts CSDD, co-chairing the conference. Ken sets the stage by providing a historical perspective on why we are no faster on average today than in the mid-90s at moving a drug through development and approval. He opens the program with a keynote on, “How the Drug Development Landscape is Changing and the Impact on R&D Operations,” thus setting the theme for the program. The opening keynote provides attendees with an opportunity to challenge and discuss the presented data and to work through solutions with fellow peers to tie them back into implementation. We are also delighted to have Katherine Vandebelt, Global Head, Clinical Innovation, Eli Lilly and Company join Ken as co-chair. Katherine will also be moderating the session dedicated to making way for new site models.

We are honored to welcome Covance's CEO, Deborah Keller and Quintiles’ CEO, Tom Pike. Deborah will share insights on how CROs can become better partners and Tom will address global R&D operation realities and how sponsors can better leverage their CRO. Robert Califf, MD, MACC, our new FDA Commissioner will conclude our program via webcast. Take advantage of the networking. We wish you a wonderful conference experience.

Sincerely,

The Conference Forum and CenterWatch

Elizabeth Bard Valerie Bowling Business Development Manager Executive Director The Conference Forum The Conference Forum

Joan Chambers Regina D’Alesio COO Program Manager CenterWatch The Conference Forum

Bridget Murphy Jessica Rothenberg Conference Planner Marketing Director The Conference Forum The Conference Forum

Susan Salome Meredith Sands Integrated Marketing Manager Executive Director, Business Development CenterWatch The Conference Forum

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Tracey Gashi SPEAKING FACULTY Senior Director, Site & Patient Access INC Research Murray Abramson, MD, MPH VP, Global Clinical Operations Ken Getz Biogen Director of Sponsored Research Programs Tufts CSDD Solomon Babani Global VP Alliance Management Evan Gothard Covance Senior Director, Business and Network Development Bioclinica Global Clinical Research Deirdre BeVard VP, Development Operations Amy Grahn Nektar Therapeutics SVP, Clinical Development Horizon Pharma Stewart Bieler Chief Administrative Officer Jay Kaminski SynteractHCR Corporate VP, Global Clinical Research and Development Operations Phil Birch, DPhil Celgene VP Innovation Strategy, Alliance Partnerships ICON plc Jeffrey Kasher, PhD Founder David Blume Patients Can’t Wait Managing Director and Founder Edgemont Capital Partners Mitchell Katz, PhD Executive Director, Medical Research Operations Michael Breton Purdue Pharma Director, Vendor Management Shire Pharmaceuticals Deborah Keller CEO Matthew Bush Covance Senior Director, Business Development PPD Tanya Russell Kirkpatrick, PhD VP, Clinical Operations Jennifer Byrne Pfizer CEO and Chairman of the Board of Directors PMG Research Pablo Lapuerta, MD EVP and CMO Robert Califf, MD, MACC Lexicon Pharmaceuticals Commissioner of Food and Drugs FDA Veronica Ludensky Senior Manager, Clinical Outsourcing Jennifer Levin Carter, MD, MPH Takeda Pharmaceuticals President and CMO N-of-One Inc Michael Martorelli Director Mike Collins Fairmount Partners VP, Global Clinical Operations Alexion Pharmaceuticals Adrian McKemey, PhD SVP and Managing Director, Advisory Services Judith Dunn, PhD Quintiles VP, Global Head of Clinical Development Roche Innovation Center New York Alan Metz, MD SVP and Managing Director, Strategic Partnerships Patrick Flanagan Quintiles CEO Veristat

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Barry Milton Director of Client Engagement DAY ONE - MONDAY, MARCH 21, 2016 goBalto 8:00 am Jules Mitchel, PhD Registration & Continental Breakfast President Graciously Sponsored by PPD Target Health 8:40 am Bernard Munos Co-Chair’s Welcome Senior Fellow FasterCures Ken Getz Director of Sponsored Research Programs, Tufts CSDD Adrian Otte, MB, BCH, FFPM Katherine Vandebelt VP, Global Development Operations Global Head, Clinical Innovation, Eli Lilly and Company Amgen 8:45 am Ross Pettit Keynote: How the Drug Development Landscape is SVP, Development Operations Changing and the Impact on R&D Operations Infinity Pharmaceuticals Ken Getz sets the stage by bridging the R&D landscape, Tom Pike global operating realities and collaborative inefficiencies to CEO help us work through solutions for 2016 and beyond. Quintiles Ken draws on recent data from the Tufts CSDD to include how well the outsourced model has worked over the past Joel Rothman 30 years. Other topics include: VP, Development Operations Raptor Pharmaceuticals • An evolutionary overview • What has changed? Lorraine Rusch, PhD VP, Scientific Development • What has not changed? Altasciences Clinical Research: Vince & Associates • How we use vendors? Komathi Stem • How vendors have differentiated themselves? Strategic Innovation Leader • What’s next for collaborations? Genentech/Roche Ken Getz Reb Tayyabkhan Director of Sponsored Research Programs, Tufts CSDD Head of Central Clinical Services Bristol-Myers Squibb 9:30 am Joint CRO-Industry Reaction Panel Katherine Vandebelt Both CRO and Pharma executives provide reactions and Global Head, Clinical Innovation pose ideas and suggest solutions for more effective Eli Lilly and Company collaborations that drive efficient R&D operations. Moderator: Ken Getz Director of Sponsored Research Programs, Tufts CSDD Panelists: Murray Abramson, MD, MPH VP, Global Clinical Operations, Biogen Solomon Babani Global VP Alliance Management, Covance Matthew Bush Senior Director, Business Development, PPD Mike Collins VP, Global Clinical Operations, Alexion Pharmaceuticals

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Judith Dunn, PhD Patrick Flanagan Head of Translational and Clinical Research Center, Roche CEO, Veristat Mitchell Katz, PhD Mitchell Katz, PhD Executive Director, Medical Research Operations Executive Director, Medical Research Operations Purdue Pharma Purdue Pharma Adrian Otte, MB, BCH, FFPM Jules Mitchel, PhD VP, Global Development Operations, Amgen President, Target Health Lorraine Rusch, PhD VP, Scientific Development, Altasciences Clinical 12:45 pm Research: Vince & Associates Lunch Optional Breakout Luncheon Discussion: Clinical 10:15 am Outsourcing in Small and Emerging Biotechs Networking Break At 1:15 for those who want to discuss Clinical Outsourcing in Small and Emerging Biotechs, join us at the round table 10:45 am section (location will be announced). DeCentralized Trial and The Call for Greater Collaboration between Clinical Research and • How the biotech sector is changing and the impact on Clinical Care via Webcast future collaborations with CROs Komathi Stem • What are some of the key growth trends Strategic Innovation Leader, Genentech/Roche • What biotechs want from CRO partners and how to 11:15 am better leverage them Looking Ahead at the Changing Patient Population Will the CRO ever do the phase III trial for a biotech? This session addresses how an onslaught of aging, • tech-savvy Baby Boomers will affect drug development Facilitator: and clinical research. Deirdre BeVard VP, Development Operations, Nektar Therapeutics Bernard Munos Senior Fellow, FasterCures 1:45 pm Make Way for the New Site Models 12:00 pm The data discussed in this session includes: Whatever the Outsourcing Model, What’s the Best Way to Manage it? • Game changers for sites The reality with clinical outsourcing is that it’s extremely • If more trials move out of sites into academic and large people dependent. Once relationships are sourced and health systems, how will this change the site’s strategy pharma settles on governing and economics, the relationship and way of collaborating? moves down to different levels into the project teams. Roles What are some of the key infrastructure areas or and responsibilities of hand-offs become a challenge and • opportunities with sponsors and sites? often cause delays. This is where some of the biggest pressure points come from. • Just in time sites Everyone is under huge financial pressure and this tension • Rebirth of the study broker can drive negative behavior, causing flare-ups. This session • New technologies and their impact on sites addresses the POV from clinical operation heads on what they really want from their external teams and both CROs and • What is needed to support the large health systems in becoming sites for clinical trials/Just-in-time trials? sponsors discuss what can be different for 2016 and 2017. What are some of the barriers for patients and Moderator: • physicians, especially with the growing focus on Jeffrey Kasher, PhD Precision Medicine approaches, that must be overcome Founder, Patients Can’t Wait to improve patient enrollment in trials in large healthcare Panelists: systems? Murray Abramson, MD How can physicians and patients be empowered to VP, Global Clinical Operations, Biogen • better access the trials? Deirdre BeVard VP, Development Operations, Nektar Therapeutics

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Moderator: announced plans to constitute a CRO Forum in order to Katherine Vandebelt provide a formal mechanism for collaboration between Global Head, Clinical Innovation, Eli Lilly and Company TransCelerate and CROs. Panelists: This session will serve to provide additional details about Jennifer Byrne the CRO Forum framework for collaboration, what progress CEO, PMG Research has been made to date, and the benefits to the clinical Jennifer Levin Carter, MD, MPH trials industry. President and CMO, N-of-One Inc Alan Metz, MD Tracey Gashi SVP and Managing Director, Strategic Partnerships Senior Director, Site & Patient Access, INC Research Quintiles Reb Tayyabkhan 2:30 pm Head of Central Clinical Services, Bristol-Myers Squibb Bucking the Trend in Clinical Outsourcing Some pharma companies are bucking the outsourcing 4:35 pm trend and are back to building infrastructure for clinical Where is There Potential for Clinical Service Providers development and reducing their dependency on to Collaborate? outsourcing. In this session, leading organizations share their current strategy and future vision. • Is there a market for collaboration to promote patient Tanya Russell Kirkpatrick, PhD centricity? VP, Clinical Operations, Pfizer • Is there enough differentiation or unique tools that could serve the client better? 3:00 pm Networking Break • Are there things TransCelerate can’t accomplish that CROs can? 3:45 pm How to pull this off given the current paradigm? How Private Equity is Shaking Up Clinical Trials • This session will explore the rationale and business Moderators: objectives of private equity investors as they continue to Ken Getz make their presence felt across the outsourcing industry. It Director of Sponsored Research Programs, Tufts CSDD will discuss the influence these investors tend to exert on Katherine Vandebelt their portfolio companies and how they affect the ability of Global Head, Clinical Innovation, Eli Lilly and Company those firms to deliver high-quality services. The speakers will also review the most recent activity of private equity Panelists: Stewart Bieler firms, and explore the motives of the CROs (and other Chief Administrative Officer, SynteractHCR service providers) that have been seeking growth capital from those pools of money. Evan Gothard Senior Director, Business and Network Development David Blume Bioclinica Global Clinical Research Managing Director & Founder, Edgemont Capital Partners Barry Milton Michael Martorelli Director of Client Engagement, goBalto Director, Fairmount Partners Jules Mitchel, PhD 4:15 pm President, Target Health TransCelerate BioPharma: Industry Impact through Collaboration with the CRO Community 5:30 pm TransCelerate BioPharma Inc, founded in 2012 is a non- Networking Reception profit organization with a mission to collaborate across the Graciously Sponsored by Myoderm biopharmaceutical research and development community to identify, prioritize, design and facilitate the implementation of solutions to drive efficient, effective and high-quality delivery of new medicines, improving the health of people around the world. Since its inception, TransCelerate sought an avenue to interact with the CRO industry. In the Fall of 2014, ACRO

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Amy Grahn DAY TWO- TUESDAY, MARCH 22, 2016 SVP, Clinical Development, Horizon Pharma Pablo Lapuerta, MD 8:00 am EVP and CMO, Lexicon Pharmaceuticals Continental Breakfast Adrian McKemey, PhD SVP and Managing Director, Advisory Services, Quintiles 8:25 am Co-Chair’s Opening Remarks 9:15 am Leadership Keynote with Tom Pike, CEO, Quintiles Ken Getz Director of Sponsored Research Programs, Tufts CSDD Quintiles’ CEO provides insights and advice to pharma on addressing global R&D operation realities and how Katherine Vandebelt sponsors can better leverage their CRO. Global Head, Clinical Innovation, Eli Lilly and Company Tom Pike 8:30 am CEO, Quintiles Disrupting the CRO: Challenging the CRO of the Future Disrupt or be disrupted. How will the CRO be disrupted to 9:55 am support drug development of the future? In this open Keynote Session: How Do CROs Become Better dialogue, which is not about promoting specific company Partners? innovation, but rather about challenging the following: Deborah Keller CEO, Covance • We all want to innovate, but often revert to old habits: how to bridge the gap? 10:30 am • What keeps CROs up at night? Networking Break What should be the CRO model of the future? • 11:00 am • How does the CRO model change to help companies How to Get the Commercial/Business Development move a drug to market with only so many resources Model Right? Panel discussion addresses the following critical questions: • What outside companies may disrupt drug development and how do we see working with them? • How are CROs doing in engaging with partners? Who’s them? • What can CROs do better to get this right? What happens to CROs when an outside technology • Identifying a more effective CRO sales process drives the cost of monitoring down or Google develops • a data management solution? • Who is able to move the needle the most effectively to get the job done? • How the role of genomics, technology and big data play into the future of the CRO? • Who is the absolute client advocate/“Solutioners” vs sales people • Who will be equipped to support the CRO of the future? Perspectives on what CROs are programmed to tell What expertise will be needed to run CROs in the • • pharma and what should change future? • Enterprise consistency • What will the structure of future management look like? How CROs should service large pharma vs small What are CROs doing to prepare for the future of • • pharma regulatory over-site and transparency? Moderators: Moderator: Solomon Babani Jay Kaminski Global VP, Alliance Management, Covance Corporate VP, Global Clinical Research and Development Operations, Celgene Adrian McKemey, PhD SVP and Managing Director, Advisory Services, Quintiles Panelists: Solomon Babani Global VP, Alliance Management, Covance

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Panelists: Michael Breton EXECUTIVE SPONSORS Director, Vendor Management, Shire Pharmaceuticals Pablo Lapuerta, MD EVP and CMO, Lexicon Pharmaceuticals

Veronica Ludensky At Covance, our people are committed to advancing health Senior Manager, Clinical Outsourcing care and bringing new medicines to market sooner. Our Takeda Pharmaceuticals unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of Ross Pettit drug development data in the world, helps our clients SVP, Development Operations, Infinity Pharmaceuticals identify new approaches and anticipate tomorrow’s Joel Rothman challenges as they evolve. Driven by a passion for VP, Development Operations, Raptor Pharmaceuticals excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver 11:40 am on the promise of a healthier world. Together with our Optimizing Collaboration Effectiveness in Alliance clients, Covance transforms today’s health care challenges Partnerships into tomorrow’s solutions. Visit www.covance.com. • Evolving the Partnership Model from ‘Execution’ to ‘Design & Execution’ • Implementing a Joint Innovation Agenda • Developing a Shared Vision for “Patient Centricity” Speakers: ICON plc is a global provider of drug development Phil Birch, DPhil solutions and services to the pharmaceutical, VP Innovation Strategy, Alliance Partnerships, ICON plc biotechnology and medical device industries. The company Ken Getz specialises in the strategic development, management and Director of Sponsored Research Programs, Tufts CSDD analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. 12:10 pm With headquarters in Dublin, Ireland, ICON currently, FDA Address on the Vision, Goals & Challenges operates from 77 locations in 38 countries and has for 2016 via Webcast approximately 11,700 employees. Visit www.iconplc.com. This session will also include a Q&A on the FDA’s view on the outsourcing environment and what industry can do to help.

Robert Califf, MD Commissioner of Food and Drugs, FDA Quintiles (NYSE: Q) helps biopharma and other healthcare 12:45 pm companies improve their probability of success by Program Concludes connecting insights from our deep scientific, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and ACKNOWLEDGEMENT integrated healthcare services. Visit www.quintiles.com.

The Conference Forum and CenterWatch would like to thank the speaking faculty, advisors and sponsors for all their support and guidance on the launch of Clinical Trial Collaborations.

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ASSOCIATE SPONSORS Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical Altasciences Clinical Research encompasses Algorithme testing of promising medical treatments, helping life Pharma in Montreal, QC, Vince & Associates Clinical science organizations conduct their clinical trials faster, Research in Overland Park, KS, and Algorithme Pharma with less risk and with lower costs. For more information USA in Fargo, ND, thereby making it one of the largest please visit www.mdsol.com/en. early phase clinical CROs in North America. Altasciences provides early phase clinical development services to biopharmaceutical and generic companies. To learn more, visit www.altasciences.com.

Myoderm is a global leader in sourcing, distribution, and management of commercial drugs for clinical trials and biosimilar research. Our deep expertise and our obsession with ensuring efficient and effective trials are why goBalto is the industry leader in cloud-based study startup pharmaceutical and biotech companies, CROs, and clinical software for the global life sciences industry, deployed in packagers around the world rely on us for their supply over half of top 20 Pharma and top 10 CROs. Our needs. For more information visit www.myoderm.com. customers include: Novartis, Genentech Roche, ICON, INC Research and Covance. Visit www.gobalto.com.

INC Research is a leading, global full-service clinical N-of-One interprets molecular diagnostic tests in oncology, research organization (CRO) providing the full range of linking each patients’ results to therapeutic strategies Phase I to IV clinical development services. As a including the most relevant clinical trials. N-of-One has therapeutically focused CRO, with a Trusted Process® interpreted tens of thousands of patient cases for delivery methodology, developing the medicines people diagnostic and hospital labs globally. N-of-One leverages need is something we take personally. For more information, our industry- leading team of scientists and oncologists, visit www.incresearch.com. state-of-the-art technology and propriety database. Visit www.n-of-one.com for more information.

Mapi is the leading patient-centered research company PPD is a leading global contract research organization serving academia, life science researchers, and the providing comprehensive, integrated drug development, pharmaceutical industry for 40 years. Mapi’s commitment laboratory and lifecycle management services. Our clients to patient-focused research is demonstrated not only by and partners include pharmaceutical, biotechnology, our expertise and nearly four decades of service but also medical device, academic and government organizations. through our direct contribution back to the industry. With offices in 46 countries and more than 14,500 Visit www.mapigroup.com for more information. professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. Visit www.ppdi.com.

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EXHIBITORS

PRA Health Sciences’ Strategic Solutions division maintains a sole focus on delivering practical, customized Ancillare provides end-to-end, global clinical trial ancillary outsourcing solutions that seamlessly enhance our clients’ supply chain management to pharmaceutical, infrastructure. Our unique Embedded Solutions™ model biotechnology and CRO companies. We supply everything provides people, processes, systems and expertise to for the clinical trial including consumable materials and efficiently develop internal product portfolios, enhance equipment. Ancillare provides full protocol supply planning quality and improve efficiency, while sponsors maintain and distribution services from purchase through strategic control. For more information, visit www.prahs.com. reclamation and final disposition. Visit www.ancillare.com.

SynteractHCR is a full-service, international contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our Caligor Rx is a global specialty pharmaceuticals services longstanding expertise serving small, emerging to mid-size business focused primarily on sourcing and supplying companies, we provide customized Phase I through IV drugs for worldwide clinical trials. Caligor is dedicated to services collaboratively and cost effectively. Operating in 15 serving the pharmaceutical and life science industries as countries, SynteractHCR delivers trials internationally, offering well as patients with specialty needs. Visit caligorrx.com. expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular, and respiratory, among other indications. For more information, please visit www.SynteractHCR.com.

Our mission at Cytel is to improve success rates in the development of drugs, biologics and medical devices. We do this by improving clinical trials through innovative application of statistical science, operations research and data handling techniques. Leaders in adaptive trial design and implementation, the top 25 biopharma companies rely Target Health Inc, a privately held New York City based full on our technology in their clinical studies. For more service e*CRO with staff dedicated to all aspects of information, visit www.cytel.com. Regulatory Affairs, Chemistry, Manufacturing and Controls, Clinical Research, Biostatistics, Data Management and Strategic Planning. Target Health is committed to bridging Internet-based technology with drug and device development. Visit www.targethealth.com.

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company specializes in areas such as analgesia, CNS, rare disease, oncology, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals. For more information, visit premier-research.com.

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MEDIA PARTNERS

Quotient Clinical brings innovation to early phase drug development programs through the integration of formulation development, real-time GMP manufacturing and clinical testing. Our Enabled-First-In-Human® programs are proven to reduce time to Proof-of-Concept, minimize upfront investment costs and simplify supply chains. The programs are applicable to all molecules (small and large), all formulation types (from simple to complex) and all routes of dose administration. Find out more at www.quotientclinical.com/FIH.

Veristat is a full-service clinical research organization (CRO) with over 20 years of experience supporting pharmaceutical, biotechnology and medical device companies throughout the clinical trial and regulatory approval process to bring novel therapies to market. We offer a consultative approach, providing you the personalized expertise and scientific knowledge to design and execute your clinical trials. Visit www.veristat.com.

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