2017 Agenda

  • 8:00 am

  • Registration and Breakfast


  • Part I: Keynotes & the Future of CROs

  • 8:45 am

  • Chair’s Welcome

    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company

  • 9:00 am

  • Opening Presentation: Industry Update: How the Clinical Collaborations Landscape is Changing and its Impact on R&D Operations

    ken-getz-2017-bw
    Ken Getz

    Director of Sponsored Research Programs, Tufts CSDD

  • 9:30 am

  • Fireside Keynote Discussion: Models for Exquisite Project Delivery with Internal and External Partners

    Join Dr Andrew Lee in a frank discussion moderated by Ken Getz, as he shares his insights, concerns and suggestions for working more effectively to strike a better balance in the delivery model for effective drug development. Discussion points include, but not limited to:

    • How do companies of different sizes find the model to get the work done?
    • How do sponsors manage a flexible portfolio; How to best navigate the ups and downs?
    • What’s needed to cover the depth and breadth of projects across the globe?
    • How do you establish partnerships?
    • What is the right model for an organization (fully internal, fully external or a hybrid?)
    • Challenges the CROs have created and their immense capabilities

    Andy_Lee_bw
    Andy Lee

    SVP, Head of Global Clinical Trial Operations, Merck

    with

    ken-getz-2017-bw
    Ken Getz

    Director of Sponsored Research Programs, Tufts CSDD

  • 10:00 am

  • Keynote: Big Trends Impacting Clinical Development

    Dr Steve Cutler shares his thoughts on big trends impacting clinical operations and gives insight into his vision on collaborating with sponsors for effective clinical development.

    Steve Cutler B&W
    Steve Cutler, PhD

    CEO, ICON

  • 10:30 am

  • Networking Break

  • 11:00 am

  • The Importance of External Collaborations and R&D Growth: Driving Innovation through Transformative Partnerships

    In R&D, it’s not realistic for one company to do everything well, which is why Takeda looks to partner with the best and brightest companies. Andy Plump, Takeda’s Chief Medical and Scientific Officer, will discuss how partnerships foster innovation in R&D and, ultimately, help advance the mission of delivering transformative medicines over the long term.

    Andrew_Plump_bw-new
    Andy Plump, MD, PhD

    Chief Medical and Scientific Officer, Takeda

    with

    TamiKLerr-bw
    Tami Klerr

    EVP, Business Development, PRA Health Sciences

  • 11:45 am

  • How Janssen is Creating Strategic Collaborations that are Driving Patient Centered Trials

    An enormous amount of attention and resources have been dedicated to understanding what patient centricity means and how to truly engage patients and put them at the center of all R&D. It takes a village. In this case study, here how leading pharmas are collaborating to achieve patient-centered trials.


    Katherine Capperella

    Global Patient Engagement Leader, Janssen Pharmaceuticals


    Bennett Levitan, MD, PhD

    Senior Director, Benefit-risk Assessment, Department of Epidemiology, Janssen R&D, LLC

  • 12:20 pm

  • Patient Centered Collaborations

    Luther Clark
    Luther Clark, MD, FACC, FACP

    Global Director, Scientific, Medical and Patient Perspective, Cardiovascular in the Office of the Chief Patient Officer, Merck

  • 12:30 pm

  • Luncheon


  • Part II: Collaborations & Technologies

  • 1:45 pm

  • What Collaboration is Needed between the Sponsor, CRO, Vendor and Site to Vastly Improve the Management of Ever-Evolving Protocol Demands?

    We know if site staff do not have access to or do not utilize the tools and technology to manage ever-evolving protocols, patient selection, safety and quality are negatively affected. Protocols continue to become more complex, yet site staff are not equipped to handle the increasing challenges. We know that sponsors, CROS, sites and technology companies need to collaborate effectively to ensure the safest patient conditions while producing the best quality data. In this panel discussion we address how this can become a reality.

    Moderated by:
    Kerri Weingard B&W
    Kerri Weingard

    COO, Verified Clinical Trials

    Panelists:
    BeVard_Deidre_bw
    Deirdre BeVard

    VP, Development Operations, Nektar Therapeutics

    Brian Craig B&W
    Brian Craig

    CEO, Pillar Clinical Research, LLC

    Monica Salamea
    Monica Salamea

    Associate Director, Clinical Trial and Data Manager, Trevena

    Gary Zammit-bw2
    Gary Zammit, PhD

    President & CEO, Clinilabs, Inc

  • 2:30 pm

  • How and Who is Mapi Collaborating with to Integrate the Voice of the Patient

    While it is now widely accepted that incorporating the patient voice is critical to the success of clinical development programs, trial operations must meet the needs of healthcare providers and the sponsor, as well. Often, advocacy and online support groups also play a role in study recruitment and retention, so their voice must be heard, as well.

    The complex interrelationships at play in our healthcare system require us to understand the viewpoints of all stakeholders. In this session, you will learn about:

    • How Mapi facilitates collaboration between sponsors, patients, caregivers, multiple clinicians, and support and advocacy groups to ensure our studies are designed to meet the needs of all involved.
    • A process for integrating the voice of the patient and caregiver with those of healthcare provider, sponsor and advocacy group
    • Examples of where multiple stakeholders provided valuable input into a clinical development program.

    Kelly Franchetti BW
    Kelly Franchetti, RN, CCRN, CEN
    VP, Global Patient Insights and Engagement, Real World Evidence, Mapi Group

  • 2:45 pm

  • Networking Break

  • 3:15 pm

  • Addressing the Elephants in the Room: What Do We Really Need to Do to Collaborate?

    Judith_Dunn_bw-new

    Judith Dunn, PhD
    VP, Global Head of Clinical Development and Head, Innovation Center, Roche Innovation Center New York

    Amir_Kalali_bw
    Amir Kalali, MD

    Head, Neuroscience Center of Excellence, QuintilesIMS

  • 4:15 pm

  • Solutions & Case Studies

    This concluding session builds on the previous session and highlights a group of companies who share a specific drug development challenge and demonstrate their solution to that challenge.

    Moderator:
    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company

    Presenters:

    Jae_Chung
    Jae Chung

    Founder and President, goBalto

    Ryan Norris
    Ryan Norris

    Chief Technology Officer, Be the Partner

    Komathi_Stem_bw
    Komathi Stem

    Founder and CEO, monARC Bionetworks

  • 5:00 pm

  • Networking Reception

2017 Agenda

  • 8:00 am

  • Registration and Breakfast


  • Part III: Collaborations & Multi Stake-holder Initiatives

  • 8:20 am

  • Chair’s Welcome

    Katherine_Vandebelt_bw
    Katherine Vandebelt
    Global Head, Clinical Innovation, Eli Lilly & Company

  • 8:25 am

  • The State of Collaboration in the Clinical Trials Enterprise

    In this presentation a veteran outsourcing industry analyst will explore the ways drug development companies and their CRO outsourcing partners are collaborating with many colleagues. He will discuss their efforts to work with hospitals, sites, and other participants in both the broad clinical research enterprise and the larger healthcare delivery ecosystem.

    Mike_Martorelli_bw
    Michael Martorelli
    Director, Fairmount Partners

  • 8:55 am

  • What Does the CRO of the Future Need to Look Like?

    In this session, we address the changing needs of sponsors and how this will impact the future of the CRO. What can the sponsor do to protect themselves and get the service they need? What do CROs think about this and how do they see themselves changing to meet the needs of sponsors? More specifically:

    • Priorities and expectations
    • Models
    • Alignments

    Moderator:
    Murray_ Abramson-bw-new
    Murray Abramson, MD

    VP, Global Clinical Operations, Biogen

    Panelists:

    lapuerta_pablo-bw
    Pablo Lapuerta, MD

    EVP and CMO, Lexicon Pharmaceuticals


    Adrian McKemey, PhD

    SVP, Consulting Services, QuintilesIMS

    Ross_Pettit-bw-new
    Ross Pettit

    SVP, Development Operations, BeiGene

    Stephanie_Petrone_bw
    Stephanie Petrone

    Executive Director, Medical Operations, Novartis

    Jim-Roach-BW
    Jim Roach, MD, FACP, FCCP
    CMO, Veristat

    Row_Bill-bw
    Bill Row

    Divisional Principal, Real World Evidence Solutions, ICON plc

  • 9:50 am

  • Optimizing Collaborations in Different Outsourcing Models

    Pharma and CRO organizations utilize a number of models to partner and deliver clinical trials. At the heart of any successful collaboration is the right design that optimizes both sponsor and provider capabilities that plans for the greatest probability of successful outcomes (medical, scientific, regulatory and commercial). We will explore how to implement the best model including a discussion of:

    1.  Asset value and accelerated development
    2. Resources – dedication and reduced risk for sponsors
    3. Quality – maximized quality without overburdening operational delivery
    4. Technology – integrated platform to act as the ‘control tower’ for transparent analytics
    5. Governance – escalation, resolution, oversight, innovation and control


    James Anthony

    Corporate VP, Strategic Account Leader, PAREXEL

  • 10:05 am

  • TransCelerate’s POV on How to Structure a Successful Collaboration

    You may know about TransCelerate’s mission, but do you know how they do it?  This session will take a deeper dive into several successful collaboration approaches across several industry stakeholders groups including Sites, Patients, CROs and Health Authorities. Laura Galuchie, Director, Merck and assigned leadership to the Oversight Committee of TransCelerate BioPharma Inc., will share best practices and insights from successful case studies.

    Laura_Galuchie_bw2
    Laura Galuchie

    Director, Clinical Research, Merck

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Keynote Presentation with Robert Califf, MD


    Robert Califf, MD, MACC

    Donald F. Fortin, MD Professor of Cardiology, Duke University School of Medicine

  • 11:30 am

  • Global Clinical Trials Leadership Panel: Collaborations Needed to Embrace Competition & New Challenges

    We know global clinical trials are becoming more complicated and more competitive. Global clinical trial leaders come together in this panel to help the audience work though the following topics:

    • Current challenges of managing global trials
    • Overcoming the challenge of getting drugs into countries, import licenses
    • The competition of global clinical trials
    • How is the trend going of local global CROs being bought by larger CROs?
    • What opportunities exist for collaborations?
    • Best practices in developing global clinical trial collaborations

    Moderator:


    Ken Getz

    Director of Sponsored Research ProgramsTufts CSDD

    Panelists:


    Mike Collins

    Head of R&D Vendor Management, Alexion Pharmaceuticals

    deborah-howe_bw2
    Deborah Howe

    Associate Director, Vendor Alliance Lead, Central Clinical Planning & Solutions, R&D, Bristol-Myers Squibb

    Veronica Ludensky B&W
    Veronica Ludensky
    Senior Manager, Clinical Outsourcing, Takeda Pharmaceuticals

    Adrian Otte B&W web
    Adrian Otte, MB, BCH, FFPM
    VP, Global Development Operations, Amgen

    Joel Rothman B&W
    Joel Rothman
    VP, Development Operations, Cytokinetics

  • 12:15 pm

  • Lunch Break


  • Part IV: Clinical Trials as a Care Option: Bring Clinical Research Closer to Patients & Patients Closer to Clinical Trials

    Venue:
    The Exchange Conference Center
    212 Northern Ave, Boston, MA 02210

  • Clinical Research as a Care Option: Making this a Reality (CRAACO)

    Arguably the greatest change we can collaborate on in bringing patients closer to clinical research is to make clinical trials a care option. Higher rates of clinical trial participation inside of a health system produces better patient outcomes, lower cost of care and happier patients. Health systems and patients get access to the latest research and pharma gets access to more patients. The entire afternoon of CTC is dedicated to working through the process in how to make this a reality and how to scale up?

  • 1:30 pm

  • Co-Chairs' Welcome

    Jeffry_James-bw-new
    Jeff James
    CEO, Wilmington Health

    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company

  • 1:40 pm

  • Keynote Speaker Panel: Bridging Healthcare to Life Science

    Moderator:
    Jennifer Byrne B&W
    Jennifer Byrne

    Founder, Greater Gift Initiative

    John McConnell B&W
    John McConnell, MD

    CEO, Wake Forest University Medical Center

    Tom Pike
    Tom Pike

    Life Science Advisor, Former CEO, Quintiles

  • 2:20 pm

  • Accountable Care Organization (ACO): Clinical Research as a Counter Measure

    Healthcare is moving quickly towards a value based system where quality, cost and experience are transparent to the patient. This value proposition will cause changes in physician and patient behavior. The connection between clinical research and population health and value is starting to become clear. This discussion will focus on how organizations are using clinical research in conjunction with their Accountable Care Organization to drive towards value.

    Moderated by:

    Jeffry_James-bw-new
    Jeff James

    CEO, Wilmington Health

    Panelists:

    Kenneth_Bilgebw2
    Kenneth Bilger

    CEO, Christie Clinic

    Robert Matthews B&W
    Robert Matthews
    President and CEO, Medisync

  • 3:05 pm

  • Refreshment & Networking Break

  • 3:35 pm

  • Value-Based Health Care Delivery: Improve Value for Patients

    Value-based health care delivery claims to improve value for patients by improving processes and reducing costs without sacrificing outcomes. With this central goal, healthcare enterprises need to measure and be accountable for patient outcomes with a given medical condition in the care cycle. The International Consortium for Health Outcomes Measurement (ICHOM), convenes groups of global experts on specific conditions together with patients to define minimum standard outcome sets and risk factors for each medical condition. These outcome standards are putting providers, payers, patients, and information technology vendors on a common path for tracking what needs to be tracked and making implementation of outcomes measurement easier and more efficient. This discussion will explore opportunities to interface research driven value based care delivery in the patient’s care cycle.

    Moderated by:
    Meredith_Alger-bw
    Meredith Alger

    Healthcare Researcher, Program Manager, Harvard Business School

    Panelists:
    Christina Akerman-bw
    Christina Åkerman, MD

    President, International Consortium of Health Outcome Measurements (ICHOM)

    Toyin Okanlawon B&W
    Toyin Okanlawon, MD

    Senior Researcher, Harvard Business School, Institute for Strategy & Competitiveness

  • 4:20 pm

  • Data Science to Drive Value for Research and Care Delivery

    Transforming the life sciences through data science is a work in progress to enable and accelerate evidence-based, data-driven decision-making. This discussion will highlight opportunities for life science organizations to create value from data science in ways that are technical and organizational in which aligns incentives and make it easier for physicians to conduct clinical research, improve data quality, and preserve patient safety. The power of integrated, data-science led analytics can boost the research and care interfaces, improve health outcomes and transform the care experience from the patient’s viewpoint.

    Moderated by:
    Craig Lipset B&W New
    Craig Lipset

    Head of Clinical Innovation, R&D, Pfizer

    Panelists:
    William_Crown-bw3
    William Crown, PhD

    Chief Science Officer, Optum Labs

    Ken Mandi-bwnew
    Kenneth Mandl, MD

    Director, Computational Health Informatics Program / Professor, Boston Children’s Hospital / Harvard Medical School

    Kyu Rhee-new-bw
    Kyu Rhee, MD

    Chief Health Officer, IBM

  • 5:05 pm

  • Co-Chairs' Closing Remarks

    Jeffry_James-bw-new
    Jeff James

    CEO, Wilmington Health

    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company