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

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Page 1: Clinical Trial Collaborations-web - theconferenceforum.org · 3/21/2016  · CLINICAL TRIAL COLLABORATIONS AGENDA 6 Moderator: Katherine Vandebelt Global Head, Clinical Innovation,

Keynote Speakers

Murray Abramson, MD, MPH Biogen

Solomon BabaniCovance

Deirdre BeVardNektar Therapeutics

Stewart Bieler SynteractHCR

Phil Birch, DPhil ICON plc

David BlumeEdgemont Capital Partners

Michael BretonShire Pharmaceuticals

Matthew BushPPD

Jennifer ByrnePMG Research

Robert Califf, MD, MACC FDA

Jennifer Levin Carter, MD, MPH N-of-One Inc

Mike CollinsAlexion Pharmaceuticals

Judith Dunn, PhD Roche Innovation Center New York

Patrick FlanaganVeristat

Tracey GashiINC Research

Evan GothardBioclinica Global Clinical Research

Amy GrahnHorizon Pharma

Jay KaminskiCelgene

Jeffrey Kasher, PhDPatients Can’t Wait

Mitchell Katz, PhDPurdue Pharma

Tanya Russell Kirkpatrick, PhDPfizer

Pablo Lapuerta, MD Lexicon Pharmaceuticals

Veronica LudenskyTakeda Pharmaceuticals

Michael MartorelliFairmount Partners

Adrian McKemey, PhD Quintiles

Alan Metz, MD Quintiles

Barry MiltongoBalto

Jules Mitchel, PhDTarget Health

Bernard MunosFasterCures

Adrian Otte, MB, BCH, FFPMAmgen

Ross PettitInfinity Pharmaceuticals

Joel RothmanRaptor Pharmaceuticals

Lorraine Rusch, PhD Altasciences Clinical Research: Vince & Associates

Komathi Stem Genentech/Roche

Reb TayyabkhanBristol-Myers Squibb

Katherine VandebeltEli Lilly and Company

Presented By

Follow us on Twitter @ConferenceForum #CTCollaborations | www.theconferenceforum.org

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

Speaking Faculty

Co-chairs

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CLINICAL TRIAL COLLABORATIONS OVERVIEW

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Elizabeth BardBusiness Development ManagerThe Conference Forum

Valerie BowlingExecutive DirectorThe Conference Forum

Joan Chambers COOCenterWatch

Regina D’Alesio Program ManagerThe Conference Forum

Bridget Murphy Conference PlannerThe Conference Forum

Jessica RothenbergMarketing DirectorThe Conference Forum

Susan Salome Integrated Marketing ManagerCenterWatch

Meredith SandsExecutive Director, Business DevelopmentThe Conference Forum

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

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SPEAKING FACULTY CLINICAL TRIAL COLLABORATIONS

SPEAKING FACULTY

Murray Abramson, MD, MPH VP, Global Clinical OperationsBiogen

Solomon BabaniGlobal VP Alliance ManagementCovance

Deirdre BeVardVP, Development OperationsNektar Therapeutics

Stewart Bieler Chief Administrative OfficerSynteractHCR

Phil Birch, DPhil VP Innovation Strategy, Alliance PartnershipsICON plc

David BlumeManaging Director and FounderEdgemont Capital Partners

Michael BretonDirector, Vendor ManagementShire Pharmaceuticals

Matthew Bush Senior Director, Business Development PPD

Jennifer ByrneCEO and Chairman of the Board of Directors PMG Research

Robert Califf, MD, MACCCommissioner of Food and DrugsFDA

Jennifer Levin Carter, MD, MPHPresident and CMON-of-One Inc

Mike CollinsVP, Global Clinical OperationsAlexion Pharmaceuticals

Judith Dunn, PhD VP, Global Head of Clinical DevelopmentRoche Innovation Center New York

Patrick FlanaganCEOVeristat

Tracey GashiSenior Director, Site & Patient AccessINC Research

Ken GetzDirector of Sponsored Research ProgramsTufts CSDD

Evan GothardSenior Director, Business and Network DevelopmentBioclinica Global Clinical Research

Amy GrahnSVP, Clinical DevelopmentHorizon Pharma

Jay KaminskiCorporate VP,Global Clinical Research and Development OperationsCelgene

Jeffrey Kasher, PhDFounderPatients Can’t Wait

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma

Deborah KellerCEOCovance

Tanya Russell Kirkpatrick, PhDVP, Clinical OperationsPfizer

Pablo Lapuerta, MDEVP and CMOLexicon Pharmaceuticals

Veronica LudenskySenior Manager, Clinical OutsourcingTakeda Pharmaceuticals

Michael MartorelliDirectorFairmount Partners

Adrian McKemey, PhDSVP and Managing Director, Advisory ServicesQuintiles

Alan Metz, MDSVP and Managing Director, Strategic Partnerships Quintiles

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CLINICAL TRIAL COLLABORATIONS AGENDA

Barry Milton Director of Client EngagementgoBalto

Jules Mitchel, PhDPresidentTarget Health

Bernard MunosSenior FellowFasterCures

Adrian Otte, MB, BCH, FFPMVP, Global Development OperationsAmgen

Ross PettitSVP, Development OperationsInfinity Pharmaceuticals

Tom PikeCEOQuintiles

Joel RothmanVP, Development OperationsRaptor Pharmaceuticals

Lorraine Rusch, PhD VP, Scientific DevelopmentAltasciences Clinical Research: Vince & Associates

Komathi Stem Strategic Innovation LeaderGenentech/Roche

Reb TayyabkhanHead of Central Clinical ServicesBristol-Myers Squibb

Katherine VandebeltGlobal Head, Clinical InnovationEli Lilly and Company

DAY ONE - MONDAY, MARCH 21, 2016

8:00 am Registration & Continental Breakfast Graciously Sponsored by PPD

8:40 am Co-Chair’s Welcome

Ken Getz Director of Sponsored Research Programs, Tufts CSDD

Katherine VandebeltGlobal Head, Clinical Innovation, Eli Lilly and Company

8:45 am Keynote: How the Drug Development Landscape is Changing and the Impact on R&D Operations Ken Getz sets the stage by bridging the R&D landscape, global operating realities and collaborative inefficiencies to help us work through solutions for 2016 and beyond. Ken draws on recent data from the Tufts CSDD to include how well the outsourced model has worked over the past 30 years. Other topics include:

• An evolutionary overview

• What has changed?

• What has not changed?

• How we use vendors?

• How vendors have differentiated themselves?

• What’s next for collaborations?

Ken Getz Director of Sponsored Research Programs, Tufts CSDD

9:30 amJoint CRO-Industry Reaction Panel Both CRO and Pharma executives provide reactions and pose ideas and suggest solutions for more effective collaborations that drive efficient R&D operations.

Moderator: Ken Getz Director of Sponsored Research Programs, Tufts CSDD

Panelists: Murray Abramson, MD, MPHVP, Global Clinical Operations, Biogen

Solomon BabaniGlobal VP Alliance Management, Covance

Matthew BushSenior Director, Business Development, PPD

Mike CollinsVP, Global Clinical Operations, Alexion Pharmaceuticals

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AGENDA CLINICAL TRIAL COLLABORATIONS

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Judith Dunn, PhDHead of Translational and Clinical Research Center, Roche

Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma

Adrian Otte, MB, BCH, FFPMVP, Global Development Operations, Amgen

Lorraine Rusch, PhD VP, Scientific Development, Altasciences Clinical Research: Vince & Associates

10:15 am Networking Break

10:45 am DeCentralized Trial and The Call for Greater Collaboration between Clinical Research and Clinical Care via Webcast

Komathi Stem Strategic Innovation Leader, Genentech/Roche

11:15 am Looking Ahead at the Changing Patient Population This session addresses how an onslaught of aging, tech-savvy Baby Boomers will affect drug development and clinical research.

Bernard MunosSenior Fellow, FasterCures

12:00 pm Whatever the Outsourcing Model, What’s the Best Way to Manage it? The reality with clinical outsourcing is that it’s extremely people dependent. Once relationships are sourced and pharma settles on governing and economics, the relationship moves down to different levels into the project teams. Roles and responsibilities of hand-offs become a challenge and often cause delays. This is where some of the biggest pressure points come from.

Everyone is under huge financial pressure and this tension can drive negative behavior, causing flare-ups. This session addresses the POV from clinical operation heads on what they really want from their external teams and both CROs and sponsors discuss what can be different for 2016 and 2017.

Moderator: Jeffrey Kasher, PhDFounder, Patients Can’t Wait

Panelists: Murray Abramson, MD VP, Global Clinical Operations, Biogen

Deirdre BeVard VP, Development Operations, Nektar Therapeutics

Patrick FlanaganCEO, Veristat

Mitchell Katz, PhD Executive Director, Medical Research OperationsPurdue Pharma

Jules Mitchel, PhD President, Target Health

12:45 pm Lunch

Optional Breakout Luncheon Discussion: Clinical Outsourcing in Small and Emerging Biotechs At 1:15 for those who want to discuss Clinical Outsourcing in Small and Emerging Biotechs, join us at the round table section (location will be announced).

• How the biotech sector is changing and the impact on future collaborations with CROs

• What are some of the key growth trends

• What biotechs want from CRO partners and how to better leverage them

• Will the CRO ever do the phase III trial for a biotech?

Facilitator: Deirdre BeVard VP, Development Operations, Nektar Therapeutics

1:45 pmMake Way for the New Site Models The data discussed in this session includes:

•Game changers for sites

• If more trials move out of sites into academic and large health systems, how will this change the site’s strategy and way of collaborating?

•What are some of the key infrastructure areas or opportunities with sponsors and sites?

• Just in time sites

• Rebirth of the study broker

• New technologies and their impact on sites

•What is needed to support the large health systems in becoming sites for clinical trials/Just-in-time trials?

•What are some of the barriers for patients and physicians, especially with the growing focus on Precision Medicine approaches, that must be overcome to improve patient enrollment in trials in large healthcare systems?

• How can physicians and patients be empowered to better access the trials?

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CLINICAL TRIAL COLLABORATIONS AGENDA

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Moderator:Katherine VandebeltGlobal Head, Clinical Innovation, Eli Lilly and Company

Panelists: Jennifer Byrne CEO, PMG Research

Jennifer Levin Carter, MD, MPHPresident and CMO, N-of-One Inc

Tracey GashiSenior Director, Site & Patient Access, INC Research

2:30 pm Bucking the Trend in Clinical Outsourcing Some pharma companies are bucking the outsourcing trend and are back to building infrastructure for clinical development and reducing their dependency on outsourcing. In this session, leading organizations share their current strategy and future vision.

Tanya Russell Kirkpatrick, PhD VP, Clinical Operations, Pfizer

3:00 pm Networking Break

3:45 pm How Private Equity is Shaking Up Clinical Trials This session will explore the rationale and business objectives of private equity investors as they continue to make their presence felt across the outsourcing industry. It will discuss the influence these investors tend to exert on their portfolio companies and how they affect the ability of those firms to deliver high-quality services. The speakers will also review the most recent activity of private equity firms, and explore the motives of the CROs (and other service providers) that have been seeking growth capital from those pools of money.

David Blume Managing Director & Founder, Edgemont Capital Partners

Michael Martorelli Director, Fairmount Partners

4:15 pm TransCelerate BioPharma: Industry Impact through Collaboration with the CRO Community TransCelerate BioPharma Inc, founded in 2012 is a non-profit organization with a mission to collaborate across the 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

announced plans to constitute a CRO Forum in order to provide a formal mechanism for collaboration between TransCelerate and CROs.

This session will serve to provide additional details about the CRO Forum framework for collaboration, what progress has been made to date, and the benefits to the clinical trials industry.

Alan Metz, MDSVP and Managing Director, Strategic Partnerships Quintiles

Reb Tayyabkhan Head of Central Clinical Services, Bristol-Myers Squibb

4:35 pm Where is There Potential for Clinical Service Providers to Collaborate?

• Is there a market for collaboration to promote patient centricity?

• Is there enough differentiation or unique tools that could serve the client better?

• Are there things TransCelerate can’t accomplish that CROs can?

• How to pull this off given the current paradigm?

Moderators: Ken Getz Director of Sponsored Research Programs, Tufts CSDD

Katherine VandebeltGlobal Head, Clinical Innovation, Eli Lilly and Company

Panelists: Stewart Bieler Chief Administrative Officer, SynteractHCR

Evan GothardSenior Director, Business and Network DevelopmentBioclinica Global Clinical Research

Barry Milton Director of Client Engagement, goBalto

Jules Mitchel, PhD President, Target Health

5:30 pm Networking Reception Graciously Sponsored by Myoderm

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AGENDA CLINICAL TRIAL COLLABORATIONS

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DAY TWO- TUESDAY, MARCH 22, 2016

8:00 am Continental Breakfast

8:25 am Co-Chair’s Opening Remarks

Ken Getz Director of Sponsored Research Programs, Tufts CSDD

Katherine VandebeltGlobal Head, Clinical Innovation, Eli Lilly and Company

8:30 am Disrupting the CRO: Challenging the CRO of the Future Disrupt or be disrupted. How will the CRO be disrupted to support drug development of the future? In this open dialogue, which is not about promoting specific company innovation, but rather about challenging the following:

• We all want to innovate, but often revert to old habits: how to bridge the gap?

• What keeps CROs up at night?

• What should be the CRO model of the future?

• How does the CRO model change to help companies move a drug to market with only so many resources

• What outside companies may disrupt drug development and how do we see working with them? Who’s them?

• What happens to CROs when an outside technology drives the cost of monitoring down or Google develops a data management solution?

• How the role of genomics, technology and big data play into the future of the CRO?

• Who will be equipped to support the CRO of the future?

• What expertise will be needed to run CROs in the future?

• What will the structure of future management look like?

• What are CROs doing to prepare for the future of regulatory over-site and transparency?

Moderator: Jay Kaminski Corporate VP, Global Clinical Research and Development Operations, Celgene

Panelists: Solomon BabaniGlobal VP, Alliance Management, Covance

Amy Grahn SVP, Clinical Development, Horizon Pharma

Pablo Lapuerta, MDEVP and CMO, Lexicon Pharmaceuticals

Adrian McKemey, PhD SVP and Managing Director, Advisory Services, Quintiles

9:15 am Leadership Keynote with Tom Pike, CEO, Quintiles Quintiles’ CEO provides insights and advice to pharma on addressing global R&D operation realities and how sponsors can better leverage their CRO.

Tom Pike CEO, Quintiles

9:55 am Keynote Session: How Do CROs Become Better Partners?

Deborah KellerCEO, Covance

10:30 am Networking Break

11:00 am How to Get the Commercial/Business Development Model Right? Panel discussion addresses the following critical questions:

• How are CROs doing in engaging with partners?

•What can CROs do better to get this right?

• Identifying a more effective CRO sales process

•Who is able to move the needle the most effectively to get the job done?

•Who is the absolute client advocate/“Solutioners” vs sales people

• Perspectives on what CROs are programmed to tell pharma and what should change

• Enterprise consistency

• How CROs should service large pharma vs small pharma

Moderators: Solomon BabaniGlobal VP, Alliance Management, Covance

Adrian McKemey, PhDSVP and Managing Director, Advisory Services, Quintiles

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CLINICAL TRIAL COLLABORATIONS AGENDA / SPONSORS

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Panelists: Michael Breton Director, Vendor Management, Shire Pharmaceuticals

Pablo Lapuerta, MDEVP and CMO, Lexicon Pharmaceuticals

Veronica Ludensky Senior Manager, Clinical OutsourcingTakeda Pharmaceuticals

Ross PettitSVP, Development Operations, Infinity Pharmaceuticals

Joel Rothman VP, Development Operations, Raptor Pharmaceuticals

11:40 am Optimizing Collaboration Effectiveness in Alliance Partnerships

• Evolving the Partnership Model from ‘Execution’ to ‘Design & Execution’

• Implementing a Joint Innovation Agenda

• Developing a Shared Vision for “Patient Centricity”

Speakers: Phil Birch, DPhil VP Innovation Strategy, Alliance Partnerships, ICON plc

Ken GetzDirector of Sponsored Research Programs, Tufts CSDD

12:10 pm FDA Address on the Vision, Goals & Challenges for 2016 via Webcast 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

12:45 pmProgram Concludes

ACKNOWLEDGEMENT 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.

EXECUTIVE SPONSORS

At Covance, our people are committed to advancing health care and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver on the promise of a healthier world. Together with our clients, Covance transforms today’s health care challenges into tomorrow’s solutions. Visit www.covance.com.

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 77 locations in 38 countries and has approximately 11,700 employees. Visit www.iconplc.com.

Quintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by 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 integrated healthcare services. Visit www.quintiles.com.

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SPONSORS CLINICAL TRIAL COLLABORATIONS

ASSOCIATE SPONSORS

Altasciences Clinical Research encompasses Algorithme Pharma in Montreal, QC, Vince & Associates Clinical Research in Overland Park, KS, and Algorithme Pharma USA in Fargo, ND, thereby making it one of the largest 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.

goBalto is the industry leader in cloud-based study startup software for the global life sciences industry, deployed in over half of top 20 Pharma and top 10 CROs. Our customers include: Novartis, Genentech Roche, ICON, INC Research and Covance. Visit www.gobalto.com.

INC Research is a leading, global full-service clinical research organization (CRO) providing the full range of Phase I to IV clinical development services. As a therapeutically focused CRO, with a Trusted Process® delivery methodology, developing the medicines people need is something we take personally. For more information, visit www.incresearch.com.

Mapi is the leading patient-centered research company serving academia, life science researchers, and the pharmaceutical industry for 40 years. Mapi’s commitment to patient-focused research is demonstrated not only by our expertise and nearly four decades of service but also through our direct contribution back to the industry. Visit www.mapigroup.com for more information.

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 testing of promising medical treatments, helping life science organizations conduct their clinical trials faster, with less risk and with lower costs. For more information please visit www.mdsol.com/en.

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 pharmaceutical and biotech companies, CROs, and clinical packagers around the world rely on us for their supply needs. For more information visit www.myoderm.com.

N-of-One interprets molecular diagnostic tests in oncology, linking each patients’ results to therapeutic strategies including the most relevant clinical trials. N-of-One has interpreted tens of thousands of patient cases for diagnostic and hospital labs globally. N-of-One leverages our industry- leading team of scientists and oncologists, state-of-the-art technology and propriety database. Visit www.n-of-one.com for more information.

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 14,500 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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CLINICAL TRIAL COLLABORATIONS SPONSORS

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PRA Health Sciences’ Strategic Solutions division maintains a sole focus on delivering practical, customized outsourcing solutions that seamlessly enhance our clients’ infrastructure. Our unique Embedded Solutions™ model provides people, processes, systems and expertise to efficiently develop internal product portfolios, enhance quality and improve efficiency, while sponsors maintain strategic control. For more information, visit www.prahs.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 longstanding expertise serving small, emerging to mid-size companies, we provide customized Phase I through IV services collaboratively and cost effectively. Operating in 15 countries, SynteractHCR delivers trials internationally, offering 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.

Target Health Inc, a privately held New York City based full service e*CRO with staff dedicated to all aspects of 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.

EXHIBITORS

Ancillare provides end-to-end, global clinical trial ancillary supply chain management to pharmaceutical, biotechnology and CRO companies. We supply everything for the clinical trial including consumable materials and equipment. Ancillare provides full protocol supply planning and distribution services from purchase through reclamation and final disposition. Visit www.ancillare.com.

Caligor Rx is a global specialty pharmaceuticals services business focused primarily on sourcing and supplying drugs for worldwide clinical trials. Caligor is dedicated to serving the pharmaceutical and life science industries as well as patients with specialty needs. Visit caligorrx.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 on our technology in their clinical studies. For more information, visit www.cytel.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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EXHIBITORS / PARTNERS CLINICAL TRIAL COLLABORATIONS

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.

MEDIA PARTNERS

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