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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 - 8:10am

Registration and Morning Coffee

8:10am - 8:15am
Opening Remarks from the Chairperson

Opening Remarks from the Chairperson

8:15am - 8:45am

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
8:45am - 9:15am

What's on the horizon for new tech and innovation development and approval requirements?


   

more
9:20am - 9:55am

Networking and Refreshment Break in Exhibit Hall

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

Networking Lunch in Exhibit Hall

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

Chairperson's Remarks

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

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

Showing of Streams
5:45pm - 7:45pm

Collaboration Bar and Drinks - Networking Reception

7:15am - 8:10am 55 mins
Registration and Morning Coffee
8:10am - 8:15am 5 mins
Opening Remarks from the Chairperson
8:15am - 8:45am 30 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)
more
8:45am - 9:15am 30 mins
What's on the horizon for new tech and innovation development and approval requirements?
more


   

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
more
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
more
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 Earl Seltzer - Director, Global Feasibility-Site and Patient Access, Syneos Health
more
10:00am - 10:35am 35 mins
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
more

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)
more
10:45am - 11:30am 45 mins
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
more

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

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
more
1:15pm - 1:45pm 30 mins
Navigating the Patient Journey - A Story of Hurdles and Health
  • T.J. Sharpe - Patient, Speaker, Writer and Advocate, Starfish Harbor LLC
more

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
more
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.
more
3:25pm - 3:30pm 5 mins
Patients as Partners: Recruitment and Engagement
Chairperson's Remarks
  • Amanda Wright - Executive Director, Greater Gift
more
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?
  • Panelist Gary Thompson, MS - formerly Senior Director, Data Sciences and Solutions, Eli Lilly, currently Managing Principal, Strategic Consulting, Medidata Solutions
  • Panelist Eva Yuen - Global Clinical Trial Leader, Genentech
  • Panelist Cassandra Smith - Associate Director, Investigator & Patient Engagement, Janssen
  • Panelist Melissa Menke - Founder and CEO, Access Afya
more
3:30pm - 4:15pm 45 mins
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/.
more
4:15pm - 4:45pm 30 mins
Patients as Partners: Recruitment and Engagement
How Lilly is Using Social Media to Attract More People to Research
  • Elizabeth Mascherino - Advisor, Clinical Innovation, Eli Lilly
more

Clinical trials are necessary to advance medicine, yet less than 5% of the population participates. Traditional patient engagement methods are stale and in need of an overhaul. Simply placing clip art recruitment materials on social media sites is not enough. In a recent US survey, 50% of individuals reported not being aware of clinical trials, yet >90% had a favorable opinion. This represents a real opportunity for the industry to educate and empower individuals to learn more and explore clinical trial opportunities in novel ways. Lilly has a digital persona dedicated to making clinical trials more engaging and accessible. Through this persona, we are working to: • Position Lilly as a trusted source of information about clinical research • Cultivate a relationship with the public that over the long term nurtures people towards higher levels of understanding, commitment and participation • And ultimately, increase enrollment rates in Lilly clinical trials. This presentation will explore how @LillyTrials is leveraging Tweetchats, Hashtag campaigns, Paid Video campaigns and other social media tactics to attract, engage and activate a largely untapped audience.

4:45pm - 5:30pm 45 mins
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 - Director, Sitetrove/Chinatrove, 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)
more
4:45pm - 5:30pm 45 mins
Patients as Partners: Recruitment and Engagement
Real world data: what is it and how do we use biomarkers?
  • Nancy Meyerson-Hess - Associate Partner, admedicum Business for Patients
  • David Dworaczyk, PhD - former Head of Life and Health Sciences Strategic Development, Oracle
more
5:45pm - 7:45pm 120 mins
Collaboration Bar and Drinks - Networking Reception