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2018 Agenda


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

  • 8:30 am

  • Breakfast & Registration

  • 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, 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

  • 10:00 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

  • Driving Innovation Through 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, MD
    Deputy Chief Medical & Scientific Officer, Head of R&D Strategic & Professional Affairs, Takeda Pharmaceuticals

  • 11:10 am

  • Morning Networking Break

  • 11:40 am

  • Co-Collaborating with Startups: How to Prepare for What can be a 3D Puzzle?

    Partnering with a startup can be challenging for many reasons, but their innovative take on traditional practices can prove disruptive and beneficial to the clinical development process. How do you mitigate the risk of collaborating with a startup while continuing to push the boundaries of clinical operations? In this case study, Bayer reflects on co-collaborations with start-ups to:

    • Creating a mutually beneficial pathway together
    • Be prepared for additional partners and how to integrate them in the collaboration
    • More effectively achieving deliverables


    Joseph Kim

    Senior Advisor Clinical Innovation, Eli Lilly & Company


    Michelle Shogren

    Portfolio and Operations Innovation Manager, Bayer

  • 12:30 pm

  • Luncheon


  • Biotech Breakout Option over Lunch on 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

    Led by:

    Kellie Kennon
    Director Clinical Operations, Axsome Therapeutics


    Jim Roach, MD

    CMO, Pulmatrix

  • 1:45 pm

  • Panel: 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

    Yusuf Ghadiali
    Senior Director, Global Clinical Operations, Biogen

    Kellie Kennon
    Director Clinical Operations, Axsome Therapeutics


    Jim Roach, MD

    CMO, Pulmatrix

    Murray Stewart, MD
    EVP Head of R&D, Novelion Therapeutics

  • 2:30 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
    Executive Director GSMO, CRO Oversight, Allergan

  • 3:15 pm

  • Afternoon Networking Break

  • 3:45 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

    Led by:


    Mitchell Katz, PhD

    Head of Medical Research & Drug Safety Operations, Purdue Pharma

  • 4:15 pm

  • Group Session

    Led by:


    Murray Abramson, MD

    VP, Global Clinical OperationsBiogen

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research / FounderTufts CSDD / CISCRP

     

  • 5:00 pm

  • Day One Concludes

    Reception

2018 Agenda


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

  • 8:30 am

  • Breakfast

  • 8:45 am

  • Co-Chair’s Opening Remarks


    Murray Abramson, MD

    VP, Global Clinical Operations, Biogen

    Getz_Ken-2018
    Ken Getz

    Director of Sponsored Research / Founder, Tufts CSDD / CISCRP

  • 9:00 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, MD

    VP, Global Clinical Operations, Biogen

    Jeremy Chadwick, PhD
    Group VP, Clinical Development Operations, Shire Pharmaceuticals

  • 9:45 am

  • Collaborating with Regulators and Patient Associations for Modern Efficient Late Stage Clinical Trials

    EMD Serono’s high-risk approach to a late-stage clinical trial required 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 and regulatory agencies make them key strategic allies in the journey to drug approval?

    EMD Serono

  • 10:15 am

  • Morning Networking Break

  • 11:15 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

  • 12:00 pm

  • Lunch

  • 1:15 pm

  • Case Study on Jointly Accelerating Clinical Research


    Komathi Stem

    Founder & CEO, monARC Bionetworks

    Pulmonary Fibrosis Foundation

  • 1:45 pm

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

    Alissa Kugler
    VP, Strategic Alliance Management, Science 37
  • 2:15 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?

    Jennifer Burgess
    Executive Director of Communications and Engagement, TransCelerate BioPharma Inc


    Laura Galuchie

    TransCelerate Program Lead, Merck

  • 3:00 pm

  • Audience Exercise

  • 4:00 pm

  • Day Two Concludes

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, PhD, VP, Patient Engagement, Science 37

    Jeff James, CEO, Wilmington Health

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

    Katherine Vandebelt, Chief Ecosystem Officer, Reify Health, Inc

  • 8:30 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, MD

    VP, Clinical Operations, Biogen


    Jeff James

    CEO, Wilmington Health


    Katherine Vandebelt

    Chief Ecosystem Officer, Reify Health, Inc

  • 9:30 am

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

    Led by:


    Jeff James

    CEO, Wilmington Health


    Katherine Vandebelt

    Chief Ecosystem Officer, Reify Health, Inc


    Alison Bateman-House, MD

    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

    Marcella Debidda, PhD
    VP, Patient Engagement, Science 37

    Christopher Dowd
    Business Director of Clinical Affairs, Cystic Fibrosis Foundation

    with representation from:

    American Lung Association

    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?


    Murray Abramson, MD

    VP, Clinical Operations, Biogen


    Jeff James

    CEO, Wilmington Health

    Suzanne Nutter
    Sr Director, Pharmaceutical Project Management, Eli Lilly  

    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?

    Invited:

    Brad Wilson
    former CEO, Blue Cross and Blue Shield of North Carolina

    Craig Samitt, MD
    CMO, Anthem Bluecross

  • 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

    Founder, Greater Gift Initiative


    Jeff James

    CEO, Wilmington Health

    Kurt Waldhuetter
    VP Research Innovation & Business, Aurora Research Institute

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

  • 2:00 pm

  • How can Telehealth Address Challenges in Clinical Care?

    Telehealth studies have the ability to address multiple challenges facing clinical research that are creating barriers to them being a care option. This panel features all of the stakeholders from a heart health study that utilizes the technology already in your pocket to create results for both patients and researchers. This session addresses:

    • Geographic barriers to patients
    • Reducing the cost of clinical care
    • Methods to increase patient retention
    • Challenges of centralized patient evaluation

    Jeff Kosowky, MD
    SVP Corporate Development, American Well

    Amnon Gavish
    SVP Business Operations, American Well

    Invited:

    Stanford Health Care

    Apple Health

  • 2:30 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

    Founder, Greater Gift Initiative


    Jeff James

    CEO, Wilmington Health

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


  • 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, PhD
    Director CARE Research Center, Massachusetts General Hospital

    Jim Kremidas
    Executive Director, Associations of Clinical Research Professionals

  • 3:45 pm

  • Closing Statement/Wrap-Up