2018 Agenda


  • Part I:  Clinical Collaborations: The Evolution, Current Examples to Challenge Us & Progress

  • 8:30 am

  • Registration, Coffee & Tea

  • 9:00 am

  • Co-Chair’s Opening Remarks

    The clinical trial ecosystem is constantly challenging how to best collaborate with partners for the future of drug development. Who do we collaborate with for patient-centric virtual clinical trials, and how, is just one example. How are our clinical partners evolving? And how will pharma benefit from these changes to manage big data and drive efficiencies for better clinical outcomes? The 2018 CTC event showcases clinical collaborations for the anticipated needs of 21st century drug development and address the challenges associated with them.

    Murray Abramson
    Murray Abramson, MD

    VP, Global Clinical OperationsBiogen

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research / FounderTufts CSDD / CISCRP

  • 9:15 am

  • Opening State of Industry Address: Taking Stock of the Contract Clinical Collaborations Landscape

    • Summary of current development operating conditions inviting new and hybrid contract clinical collaborations
    • Overview of notable recent activities and transactions shaping the landscape 
    • Assessment of strategic implications of unprecedented sector involvement by private equity investment
    • Identification of new entrants and models with the potential to disrupt traditional outsourcing

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research / FounderTufts CSDD / CISCRP

  • 9:55 am

  • A Collaborative Ecosystem for the 12 Month Clinical Trial

    One of the end goals in clinical trials is to decrease the development timeline, but how are we ever going to get there within our ecosystem? What does the ecosystem need to look like to achieve greater efficiencies?

    • How do the partners in my ecosystem align to decrease the drug development timeline?
    • What role do they play?
    • How are we driving the industry to think differently about pricing models?
    • How can we create a standard operating system to plug into, similar to iPhone app platforms or iOS for an iPhone, that will create a more efficient partnerships?


    Jay Kaminski

    SVP, Global Clinical R&D Operations, Celgene

  • 10:30 am

  • Morning Networking Break

  • 11:00 am

  • Transformative Partnerships: A Year Later

    In 2017, Takeda and PRA Health Sciences announced a long term transformative partnership.  How are they doing a year later? In this session, our presenters return to give us an update on progress, where the bumps in the road appeared and lessons learned to help those in clinical partnerships.


    Tami Klerr

    EVP, Global Business Development, PRA Health Sciences

    Azmi Nabulsi
    Azmi Nabulsi, MD, MPH
    Deputy Chief Medical & Scientific Officer, Head of R&D Strategic & Professional Affairs, Takeda Pharmaceuticals

  • 11:45 am

  • Data & Analytics - Better Bridge Between Pharma and CRO

    Suresh Katta
    Suresh Katta

    Founder and CEO, Saama Technologies

  • 12:15 pm

  • Luncheon & Biotech Breakout Option

    Take the first 30 minutes to get lunch and take a break. At 12:45 pm, you have the option to join the biotech breakout discussion.


  • Biotech Breakout Option: Addressing Clinical Timelines and the Unique Needs in Clinical Partnerships for Smaller Companies

    • How is biotech advancing its collaborations to utilize creative trial designs to compress the drug development timeline?
    • How much can you compress a trial timeline utilizing creative designs without compromising quality and the ability to meet objectives?
    • Examples such as biomarkers, adaptive designs and seamless trial designs  
    • Quality issues?
    • How do smaller pharmas and biotechs avoid getting lost in the shuffle of major CRO?
    • Contracting Best Practices for Successful Clinical Outcomes
    • Best practices for standardization


    Jim Roach, MD

    CMO, Pulmatrix

    Molly Rosano
    Molly Rosano

    VP, Clinical Operations, NuCana
  • 1:30 pm

  • Models of Collaboration, One Size Doesn't Fit All

    • Multiple Niche CROs vs One End-to-end CRO
    • Why have you chosen the model you’re using?
    • What is and isn’t working well in your partnership model?
    • Models that work between CRO/Pharma/NPO/other structures

    Moderator:

    Jim Roach, MD

    CMO, Pulmatrix

    Panelists:

    Yusuf Ghadiali
    Yusuf Ghadiali

    Senior Director, Global Clinical Operations, Biogen

    Clara Heering
    Clara Heering, MSc

    Capacity and Alliance Management Workstream Lead, Johnson & Johnson

    Murray Stewart
    Murray Stewart, MD

    EVP Head of R&D, Novelion Therapeutics

  • 2:15 pm

  • Collaborative Partner Case Study on CRO Oversight

    The recent FDA guidance on ICH E6 (R2) has dramatically increased the demands of sponsor monitoring of clinical outsourcing. In the session, Allergan’s Executive Director of CRO Oversight, Ann Hegarty presents a strategy on how to collaborate with your Clinical Partner to meet FDA monitoring standards. More specifically:

    • Communications
    • Establishing expectations
    • Monitoring results

    Ann Hegarty
    Ann Hegarty

    Executive Director GSMO, CRO Oversight, Allergan

    Jennifer Irwin
    Jennifer Irwin

    Senior Director, Strategic Alliance Management, Syneos Health
  • 2:45 pm

  • Afternoon Networking Break

  • 3:30 pm

  • Case Study: Pfizer's Patient Data Hub


    Munther Baara

    Senior Director, Clinical Paradigm, Pfizer, Inc

  • 4:00 pm

  • How Best to Move Forward When Your Long Term Relationship with a CRO Goes through a Merger or a Major Change

    • How to continue the relationship when your key contacts leave the company?
    • How to create a common culture of mutual understanding and better communication across the relationship
    • What are leadership best practices and how do you influence your team members?
    • How to keep the team focused on the end goal


    Mitchell Katz, PhD
    Head of Clinical Research Operations, Purdue Pharma

  • 4:30 pm

  • Group Session: Current Examples of How Industry is Collaborating with Patients throughout Different Touch Points of Product Development

    This interactive session begins with a review of a chart on End to End Patient-Centricity across the Medicines Development Lifecycle. The audience is welcome to share how they are collaborating to:

    1. Involve patients in medicines development 
    2. Reduce the burden to the patient

    Led by:

    Murray Abramson
    Murray Abramson, MD

    VP, Global Clinical OperationsBiogen

  • 5:00 pm

  • Day One Concludes

    Reception

2018 Agenda


  • Part II: Strategic Collaborations, Virtual Trials & Next Generation Monitoring

  • 8:30 am

  • Coffee & Tea

  • 9:00 am

  • Co-Chair’s Opening Remarks

    Murray Abramson
    Murray Abramson, MD

    VP, Global Clinical Operations, Biogen

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research / Founder, Tufts CSDD / CISCRP

  • 9:15 am

  • Fireside Chat: A Veterans’ View on What it Takes to Develop Strategic Collaborations

    In this frank discussion industry veterans, Drs Jeremy Chadwick and Murray Abramson, share their experience from leading clinical operations on what they feel it takes to develop strategic collaborations.

    • Process
    • How do we build deep and meaningful partnerships between sponsors and CROs?  
    • How do we match expectations between partners?
    • How do we create partnerships between sponsors and vendors as opposed to transactional relationships?
    • Measurements and lessons learned

    Murray Abramson
    Murray Abramson, MD

    VP, Global Clinical Operations, Biogen

    Jeremy Chadwick
    Jeremy Chadwick, PhD

    Group VP, Clinical Development Operations, Shire Pharmaceuticals

  • 10:00 am

  • Collaborating with Patient Associations for Modern, Efficient Clinical Trials

    EMD Serono’s approach to clinical trials requires significant levels of transparency between all of the players in the clinical development ecosystem to ensure responsible innovation in their therapeutic area. How did their partnerships with patient associations make them key strategic allies in the journey to drug approval?

    Paulo Moreira-2018
    Paulo Moreira

    VP, GCO, Head of External Innovation, EMD Serono
  • 10:30 am

  • Morning Networking Break

  • 11:00 am

  • The Value of Collaboration from Pre-Study through Study Execution

    What we can learn from a Sponsor, Site Network and CRO Cooperating for Quality Delivery:

    • Data-Driven feasibility to ensure predictable delivery timelines
    • Cooperation and flexibility to drive study start-up
    • Execution that everyone owns
    • Engaging Principal Investigators and patients to impact studies

    Kathy Kole
    Kathy Cole

    Associate Director of Feasibility, PMG Research, part of ICON’s Site & Patient Recruitment Group

    Joy Graham
    Joy Graham

    Manager of Clinical Operations, PMG Research, part of ICON’s Site & Patient Recruitment Group

    Kristin Kinlaw
    Kristin Kinlaw

    Associate Director of Communications, PMG Research, part of ICON’s Site & Patient Recruitment Group

    EB McLindon
    EB McLindon

    SVP, Site & Patient Recruitment, ICON Clinical Research Services

  • 11:20 am

  • How and Who to Collaborate with for a Virtual Clinical Trial

    We can debate the definition of a virtual clinical trial, but in this session, we consider both a portion of the trial that is virtual as well as the entire trial. Either way, how and who do we partner with to bring more of a virtual experience to reduce the burden to the patient while collecting better quality data? This session is led by some of the most experienced professionals in virtual clinical research.  Komathi Stem, formerly Strategic Innovation Leader at Genentech and now Founder and CEO of monARC is one of the first pioneers to embrace virtual trials and she is joined by a fellow pioneer, Dr Tomasz Sablinski, Founder, Transparency Life Sciences to address:

    • Different approaches and models
    • Planning process
    • Creating an internal business plan
    • Red flags
    • Internal and external challenges
    • How should it work


    Tomasz Sablinski, MD, PhD

    Founder, Transparency Life Sciences


    Komathi Stem

    Founder & CEO, monARC Bionetworks

  • 12:10 pm

  • Next Generation Collaborations to Standardize Practices through Analytics and Data

    Data is anticipated to be the main disrupter in operations in 21st century drug development.

    • How can we have a more precise and predictable path to product approval?
    • How can we combine data technology and capabilities to connect in ways that have never been seen before
    • How are we creating standardization from an old analog world? 
    • How are partnerships promoting utilization of large data sets for better execution of clinical trials?
    • What are the benefits to pharma?

    Lynn DiFinizio
    Lynn Difinizio

    Head of Clinical Programming and Technical Solutions, Alkermes

    Sarah Alwardt
    Sarah Alwardt, PhD

    VP, Health Informatics and HEOR, McKesson Specialty Health

  • 12:30 pm

  • Lunch

  • 1:30 pm

  • Case Study on Jointly Accelerating Clinical Research


    Komathi Stem, MS

    Founder & CEO, monARC Bionetworks

    Pauline Bianchi
    Pauline Bianchi, RN, BSN

    VP of R&D, Pulmonary Fibrosis Foundation
  • 2:00 pm

  • Collaborating to Achieve Diversity in Patients while Reducing the Burden to the Patient: Case Study with Science 37 and Sanofi

    Noah Craft-2018
    Noah Craft, MD, PhD

    Co-founder and CEO, Science 37

    Kimberly Hawkins
    Kim Hawkins, MPH

    CSO Project Leader Head, Sanofi Genzyme

  • 2:30 pm

  • Collaborating to Bring the Patient Voice into the Development of Clinical Trials

    • Why is it important to ask the experts?
    • Collaborating with internal study teams and working within their timelines
    • Collaborating with advocacy/patient support organizations

    Zaharoff_Beth
    Beth Zaharoff

    Director of Patient Focused Clinical Trial Engagement, TESARO​

  • 3:00 pm

  • What is the Next Generation of Risk-Based Monitoring Collaborations?

    • What difficulties can be posed by handling multiple platforms?
    • How does this relate to EMR technologies?
    • Will this actually lower costs of clinical trial programs?


    Laura Galuchie

    TransCelerate Program Lead, Merck

    Esther Huffman
    Esther Huffman

    Associate Director of Global Monitoring and Excellence, Bristol-Myers Squibb

  • 3:40 pm

  • Afternoon Tea Reception

2018 Agenda


  • Part III: How to Bring Clinical Research Closer to Patients and Patients Closer to Clinical Research

    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 can get access to more patients in need of clinical research options.

    Clinical research is typically transactional and not integrated as part of a healthcare organization’s care options. Patients almost never learn about clinical research from their physicians unless their physicians are directly engaged in a clinical trial. The value of integrating clinical research into the overall continuum of care is often lost on health care organizations and in this meeting, we address how to bridge the gap and overcome many of the obstacles. It is our goal to generate a strong pipeline of leaders that have a shared vision for the future of clinical research as a care option and support the changes needed to make this a reality.

    Advisory Board:

    Murray Abramson, MD, VP, Clinical Operations, Biogen

    Jennifer Byrne, Founder, The Greater Gift

    Marcella Debidda, PhDVP, Patient Advocacy, monARC Bionetworks

    Jeff James, CEO, Wilmington Health

    Suzanne Nutter, Sr Director, Pharmaceutical Project Management, Eli Lilly

    Katherine Vandebelt, Chief Ecosystem Officer, Reify Health, Inc

  • 8:15 am

  • Breakfast

  • 8:45 am

  • Co-Chair's Opening

    • State of the industry as it relates to clinical research as a care option
    • What does this mean as a movement and how can we create it?
    • Community examples of raising public awareness of clinical trials
    • Unlocking the potential of clinical research through awareness
    • What role do leaders in healthcare play?


    Jeff James

    CEO, Wilmington Health


    Katherine Vandebelt

    Chief Ecosystem Officer, Reify Health, Inc

  • 9:00 am

  • Why Are Clinical Trials Not Typically a Care Option?

    • What are the blockers or conflicts (laws, culture, behaviors, etc) that prevent clinical research from becoming a care option? 
    • What is the difference between a movement and an initiative – how should we think about clinical research as a care option? Benefits?
    • What are the enablers or requirements to incorporate clinical research into care options for the patient?
    • How to pave a path for possibility?
    • Update on data to support how trials can be a care option

    Murray Abramson
    Murray Abramson, MD

    VP, Clinical Operations, Biogen


    Jeff James

    CEO, Wilmington Health

  • 9:30 am

  • What are the Regulatory and Ethical Considerations if Lines are Blurring between Clinical Research vs. Clinical Care?

    • Ethically and regulatory, research and care or treatment are separate spheres. What happens when they are brought together?
    • Are there ethical barriers that need to be overcome to allow clinical research to be offered as an option as part of clinical care?
    • What are the ethical issues that surround offering a patient the opportunity to consider enrolling in a clinical trial?
    • What current efforts are underway to address these issues?


    Katherine Vandebelt

    Chief Ecosystem Officer, Reify Health, Inc


    Alison Bateman-House, PhD, MPH, MA

    Assistant Professor, Division of Medical Ethics, NYU Langone Health

  • 10:00 am

  • Patients and Patient Advocacy View on CRAACO

    • What patient advocacy thinks about clinical research being a care option
    • Influence and relationship with payors
    • How can we leverage patient advocacy’s expertise?
    • How can we educate patients on opportunities for patient engagement?
    • Value, impact, investment and time

    Moderator:

    Marcella Debidda
    Marcella Debidda, PhD

    VP, Patient Advocacy, monARC Bionetworks

    Panelists:

    Christopher Dowd
    Christopher Dowd

    Business Director of Clinical Affairs, Cystic Fibrosis Foundation

    Sarah Krug-new
    Sarah Krüg

    CEO, CANCER 101

    Albert Rizzo-bw
    Albert A Rizzo, MD, FACP, FCCP

    Senior Medical Advisor, American Lung Association and Section Chief Pulmonary, Christiana Care Health System

    Tricha Shivas
    Tricha Shivas
    Development Manager, WomenHeart

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Healthcare and Clinical Research Ecosystems Jointly Discuss how to Come Together to Give Patients the Best Possible Care Options that Include a Clinical Trial

    This session brings together representation from pharma, CRO, ACO, payers, and regulatory to jointly answer the following:

    • Who are the primary constituents in the clinical care ecosystem and how do they influence and inform each other?
    • How do we break the stigma that clinical research is too specialized as an option for patients?
    • How do we make it an easy, manageable part of patients’ daily lives?
    • Is it an offering that is made in the best interest of everybody?
    • How do we manage the importance of transparency of expectations, randomizations, outcomes of clinical research?
    • Do some of our solutions to our problems create barriers for other members of the system?
    • How do we align the objectives and perspectives of patients, sites, and industry?
    • What is the industry’s obligation? What should they be doing?

    Moderator:

    Jennifer Byrne
    Jennifer Byrne

    Founder, Greater Gift Initiative

    Panelists:

    Murray Abramson
    Murray Abramson, MD

    VP, Clinical Operations, Biogen


    Jeff James

    CEO, Wilmington Health

    John Stewart
    John Stewart, MD

    Chief of Surgery, Associate Professor of Surgery, Durham Veterans Administration Hospital, Duke University

  • 11:45 am

  • Payor View on CRAACO

    • What are the barriers from the insurance companies?
    • Self funded employee view
    • Insurance company view
    • How could large insurance companies fit this in or how it would be a challenge?

    Moderator:

    Joseph Ternullo
    Joseph Ternullo, JD, MPH

    Vice Chair, Society for Participatory Medicine

    Panelists:

    Mary Hennings
    Mary Hennings

    Mary N. Hennings, Consulting LLC

    Neil Shah
    Neil Shah, PharmD

    Specialty Pharmacist, Blue Cross Blue Shield North Carolina

  • 12:30 pm

  • Lunch

  • 1:30 pm

  • How Can We Work with Medical Practices to Offer Patients Clinical Trials as a Care Option?

    • Infrastructure and support
    • How to establish physician champions?
    • How to influence leadership support?
    • Contacting patients

    Jennifer Byrne
    Jennifer Byrne

    Founder, Greater Gift Initiative

    Judy Hung
    Judy Hung, MD

    Director Trial Innovation Unit, Division of Clinical Research, Massachusetts General Hospital


    Jeff James

    CEO, Wilmington Health

    Greg Sweatt
    Greg Sweatt

    Senior EVP Value Based Care, Co-Founder, ePatientFinder

    Kurt Waldhuetter
    Kurt Waldhuetter

    VP, Research Innovation & Business, Aurora Research Institute

  • 2:00 pm

  • How Do We Recruit and Train More Investigators?

    • How to make it easier for physicians to become investigators
    • How to get physicians involved?
    • What is the pathway?
    • How to get physician champions who are well versed in clinical research?
    • What programs are available for physicians?

    Jennifer Byrne
    Jennifer Byrne

    Founder, Greater Gift Initiative


    Jeff James

    CEO, Wilmington Health

    John Stewart
    John Stewart, MD

    Chief of Surgery, Associate Professor of Surgery, Durham Veterans Administration Hospital, Duke University

  • 2:30 pm

  • How to Move Clinical Research Into Communities That Would Truly Benefit from It

    • Educating sites to build confidence and skill sets
    • Case examples

    Jonathan Jackson
    Jonathan Jackson, PhD

    Director, CARE Research Center, Massachusetts General Hospital

    Jim Kremidas
    Jim Kremidas

    Executive Director, Association of Clinical Research Professionals

  • 3:15 pm

  • Closing Statement/Wrap-Up