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Key Sessions

Greg Koski, PhD, MD

Where do we stand and what lies ahead? Transforming the clinical trial landscape.

Alliance for Clinical Research Excellence and Safety (ACRES)

T.J. Sharpe

Navigating the Patient Journey - A Story of Hurdles and Health

Starfish Harbor LLC

Melanie Ivarsson, PhD

Patients as Partners Case Study: What We've Learned and Where We're Going.

Shire

May 30
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7:15am - 8:30am

Registration and Morning Coffee

More
8:30am - 8:40am

Opening Remarks from the Chairperson

  • Christina Bodurow, PhD - former Senior Director, External Sourcing, Eli LIlly
More
8:40am - 9:20am

Where do we stand and what lies ahead? Transforming the clinical trial landscape.

  • Greg Koski, PhD, MD - Co-Founder, President and CEO, Alliance for Clinical Research Excellence and Safety (ACRES)
More
9:20am - 9:55am

Networking and Refreshment Break in Exhibit Hall

More
Showing of Streams
Showing of Streams
12:00pm - 1:10pm

Networking Lunch in Exhibit Hall

More
1:10pm - 1:15pm
Chairperson's Remarks

Chairperson's Remarks

  • Amanda Wright - Executive Director, Greater Gift
More
1:15pm - 1:45pm
Info

Navigating the Patient Journey - A Story of Hurdles and Health

Navigating to the best, right treatment for a cancer patient is a painfully difficult process.  Understand some of the hurdles patients face, and what the industry should do about them, while hearing one man’s story of overcoming melanoma – and the barriers he faced in getting the treatments that would ultimately save his life.

  • T.J. Sharpe - Patient, Speaker, Writer and Advocate, Starfish Harbor LLC
More
1:45pm - 2:15pm

Patients as Partners Case Study: What We've Learned and Where We're Going.

  • Melanie Ivarsson, PhD - Vice President, Clinical Programs Therapeutics Area Head, Clinical Development Operations, Shire
More
2:20pm - 3:25pm

One-to-One Appointments & Networking and Refreshment Break in Exhibit Hall

More
Showing of Streams
5:35pm - 7:35pm

Collaboration Bar and Drinks - Networking Reception

More
7:15am - 8:30am 75 mins
Registration and Morning Coffee
8:30am - 8:40am 10 mins
Opening Remarks from the Chairperson
  • Christina Bodurow, PhD - former Senior Director, External Sourcing, Eli LIlly
8:40am - 9:20am 40 mins
Where do we stand and what lies ahead? Transforming the clinical trial landscape.
  • Greg Koski, PhD, MD - Co-Founder, President and CEO, Alliance for Clinical Research Excellence and Safety (ACRES)
9:20am - 9:55am 35 mins
Networking and Refreshment Break in Exhibit Hall
9:55am - 10:00am 5 mins
Paradigm Shifts in Clinical Trials: Partnership and Collaboration
Chairperson's Remarks
  • Christina Bodurow, PhD - former Senior Director, External Sourcing, Eli LIlly
9:55am - 10:00am 5 mins
Patients as Partners: Voice of the Patient
Chairperson's Remarks
  • Donna Hamel - Director, Clinical Trials Operations, Duke Early Phase Clinical Research, Duke Clinical Research Institute
10:00am - 10:45am 45 mins
Paradigm Shifts in Clinical Trials: Partnership and Collaboration
Panel Discussion: Sponsor-CRO Collaborative Partnerships: Adding Equity and Finding the Equilibrium
  • Moderator Frank Leu - CEO & Co-Founder, Novapeutics, USA
  • Panelist Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients
  • Panelist Jay Turpen - formerly Senior Director, Clinical Project Management, Biomedicines, Eli Lilly
  • Panelist Robert Drakas, PhD - Executive Director, ShangPharma Innovation
  • Panelist Travis Caudill - Vice President, Worldwide Clinical Trials
10:00am - 10:35am 35 mins
Info
Patients as Partners: Voice of the Patient
Patient Engagement: New Frameworks and Current Management Practices
  • Stella Stergiopoulos - Senior Project Manager, Tufts Center for the Study of Drug Development, USA

There is growing consensus that patient engagement is critical to assuring that patient needs are met. With increasing interest – and investment – in patient centricity, there are corresponding efforts to develop approaches for implementing patient-centric practice and tools for assessing the effectiveness and impact on drug development. This session will:

  • provide information on industry approaches to patient centricity;
  • identify existing frameworks and models for implementing patient engagement
10:35am - 11:30am 55 mins
Patients as Partners: Voice of the Patient
Interactive Panel/Audience Discussion: Voice of Patient Protocol. It's essential, so how do we maximize it?
  • Moderator Robin Farmanfarmaian - Patient & Investor and VP, Invicta Medical
  • Panelist Rob Metz - Senior Vice President, Global Business Operations, Horizon Pharma
  • Panelist Jasmine Benger - Research Services Project Manager, Center for Information & Study on Clinical Research Participation (CISCRP)
10:45am - 11:30am 45 mins
Info
Paradigm Shifts in Clinical Trials: Partnership and Collaboration
Are You Easy to do Business With? A Panel Discussion
  • Moderator Norman Goldfarb - Chairman, MAGI
  • Panelist Lorraine Rusch, Ph.D. - President, High Point Clinical Trials Center
  • Panelist Chris Clendening - Executive Director of Global Project Management and Design, Central Lab, PPD Laboratories
  • Panelist Jay Turpen - formerly Senior Director, Clinical Project Management, Biomedicines, Eli Lilly

If you want partners to do business with you, make it easy for them. What makes a sponsor/CRO/site easy to do business with? What drives sponsor/CRO/site partners crazy? Why isn't everyone easy to do business with already? What will being easy to do business with look like in five years?

11:30am - 12:00pm 30 mins
Info
Track Presentation 1
Meeting the Challenges of Future Clinical Trials: The Power of the Network
  • Jonathan Sheffield, OBE FRCPath - Chief Executive Officer, National Institute for Health Research Clinical Research Network (NIHR)

Navigating new terrains is part of the day job for the National Institute of Health Research in the United Kingdom (UK). Discover how the world’s most integrated clinical research infrastructure is embracing the digital revolution and preparing for a future which features: adaptive clinical trials, research in non-healthcare settings, real world evidence requirements, life outside of the EU. Could this be the Brexit antidote?

11:30am - 12:00pm 30 mins
Info
Track Presentation 2
The New State of Collaborative Trial Management Technology
  • Kyle Byron - Senior Account Manager, Bio-Optronics, Inc.

Clinical trials management collaboration is evolving, and attendees will learn best practices for reducing study startup time and increasing data quality through the study lifecycle by utilizing technology like CTMS. Innovative process improvements will be discussed for site selection, budget negotiation, milestone tracking, regulatory compliance and credential management. Attendees from CROs, SMOs and Sponsors will understand how to maximize critical efficiencies and communications through detailed tracking and reporting, ultimately to enhance quality, profitability and sponsor relations.

12:00pm - 1:10pm 70 mins
Networking Lunch in Exhibit Hall
1:10pm - 1:15pm 5 mins
Chairperson's Remarks
  • Amanda Wright - Executive Director, Greater Gift
1:15pm - 1:45pm 30 mins
Info
Navigating the Patient Journey - A Story of Hurdles and Health
  • T.J. Sharpe - Patient, Speaker, Writer and Advocate, Starfish Harbor LLC

Navigating to the best, right treatment for a cancer patient is a painfully difficult process.  Understand some of the hurdles patients face, and what the industry should do about them, while hearing one man’s story of overcoming melanoma – and the barriers he faced in getting the treatments that would ultimately save his life.

1:45pm - 2:15pm 30 mins
Patients as Partners Case Study: What We've Learned and Where We're Going.
  • Melanie Ivarsson, PhD - Vice President, Clinical Programs Therapeutics Area Head, Clinical Development Operations, Shire
2:20pm - 3:25pm 65 mins
One-to-One Appointments & Networking and Refreshment Break in Exhibit Hall
3:25pm - 3:30pm 5 mins
Paradigm Shifts in Clinical Trials: Digital Transformation
Chairperson's Remarks
  • Kyle Byron - Senior Account Manager, Bio-Optronics, Inc.
3:25pm - 3:30pm 5 mins
Patients as Partners: Recruitment and Engagement
Chairperson's Remarks
  • Amanda Wright - Executive Director, Greater Gift
3:30pm - 4:15pm 45 mins
Paradigm Shifts in Clinical Trials: Digital Transformation
Panel Discussion: Moving from paper to digital: What's Working, What's Not?
  • Moderator Robin Farmanfarmaian - Patient & Investor and VP, Invicta Medical
  • Panelist Gary Thompson, MS - formerly Senior Director, Data Sciences and Solutions, Eli Lilly, currently Managing Principal, Strategic Consulting, Medidata Solutions
  • Panelist Cassandra Smith - Associate Director, Investigator & Patient Engagement, Janssen
  • Panelist Melissa Menke - Founder and CEO, Access Afya
3:30pm - 4:15pm 45 mins
Info
Patients as Partners: Recruitment and Engagement
Interactive Panel/Audience Discussion: Voice of Patient Practical: Engagement, Recruitment and Research - Build a fully Integrated Approach
  • Moderator Lani Hashimoto - Clinical Program Benchmark Manager, Trial Operations Management, Novartis
  • Panelist Daisy Daeschler - Research Partnerships Officer,, The Michael J Fox Foundation
  • Panelist Kay James - Executive Director, Cystic Fibrosis Foundation, Carolinas Raleigh Chapter
  • Panelist Tamara Owens, RN, MSN, MBA - Associate Director, Patient Recruitment, Site Operations Strategy, Boehringer Ingelheim Pharmaceuticals, Inc/.

During this panel, we'll discuss:

  • Burdens / challenges of clinical trial participation and then corresponding solutions
  • Innovations to drive research by advocates and corresponding innovations by pharma / sites to support patients in research
  • Research literacy efforts by advocates and corresponding patient literacy efforts by pharma / sites
4:15pm - 4:45pm 30 mins
Paradigm Shifts in Clinical Trials: Digital Transformation
Case Study: Blockchain Protocols for Advanced Medicine
  • Bob Stewart - CTO & Board Member and Founder & CEO, Alliance for Clinical Research Excellence and Safety (ACRES) & Exochain
4:15pm - 4:45pm 30 mins
Info
Patients as Partners: Recruitment and Engagement
Patient Partnering in Clinical Development: A UCB Case Study
  • Elizabeth Manning - Patient Engagement Strategy, UCB
  • Mitch Herndon, MPH - Associate Director, Patient Recruitment & Engagement, UCB

UCB is a global biopharmaceutical company focusing on creating value for people living with severe diseases. In the quest of achieving patient-preferred clinical studies, UCB is striving to partner with patients across the clinical study continuum. Discussion of this case study will offer successes, challenges and learnings within one of UCB’s clinical development programs.

4:45pm - 5:30pm 45 mins
Info
Paradigm Shifts in Clinical Trials: Digital Transformation
Panel: All this new tech to capture data. How can we incorporate more effectively and efficiently?
  • Moderator Loni Branon - Senior Director, Sitetrove, Pharma Intelligence
  • Panelist Jake LaPorte, PhD - Head of Digital Development, Novartis Pharmaceuticals Corporation
  • Panelist Amanda Goltz, MPA - Vice President, Digital Innovation, BTG
  • Panelist Jasmine Benger - Research Services Project Manager, Center for Information & Study on Clinical Research Participation (CISCRP)

Wearable technology and medical devices are becoming increasingly popular and will only continue to grow interest. The flexibility, ease of use, and convenience of wearables is enticing to patients, and potentially eliminates daily visits to their physician. What wearables are being used in clinical trials currently, and what are their benefits? What technologies would you like to see involved in trials? How do we drive regulatory convergence around accepting these data for label claims? These questions, and more, will be explored during this panel discussion.

4:45pm - 5:30pm 45 mins
Info
Patients as Partners: Recruitment and Engagement
The State of Real World Data: Putting Patients First, Where They Should Be
  • Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients
  • David Dworaczyk, PhD - former Head of Life and Health Sciences Strategic Development, Oracle

The industry has been fascinated with creating new terms and approaches with clinical research, but it’s no longer sustainable. We’ve basically just discovered “patients” and how key they are to the drug development arena, not just as the receiver of the treatment. The presentation will look at ways in which to enrich the quality of clinical research through targeting input by patients, with a focus as to what is “REALly” of value. We’ll also discuss the effective and efficient use of Real World Data across the drug development and commercialization continuum to create substantial value to a wide array of Healthcare and Life Science/Pharma user groups.

5:35pm - 7:35pm 120 mins
Collaboration Bar and Drinks - Networking Reception