2021 Interactive Breakout Discussions

Concurrent breakout discussion groups are interactive, guided discussions hosted by a set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

ALL TIMES EST

TUESDAY, MARCH 2

BREAKOUT DISCUSSION GROUPS

4:05-4:40 PM TABLE: Strategies for Patient-Centric Trial Design and Digital Patient Engagement
Co-Moderators:
Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer
Jane Hart, Vice President, Global Clinical Affairs, 3M Health Care
Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics
Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie
Jeffrey Siracuse, MD, MBA, Associate Professor, Surgery, Boston University
Speaker TBDGreenphire
Alicia Staley, Senior Director, Patient Engagement, Medidata
Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca
Speaker TBDLongboat
Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen
Melissa Nezos, Vice President, Clinical Operations, Firma
Michael McLaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.
Khaled Mowad, JD, Associate, Moses & Singer LLP
Speaker TBD, Praxis

4:05-4:40 PM TABLE: Building and Implementing a Data-Driven Site Selection Approach
Co-Moderators:
Jane Jacob, PhD, Vice President, Research & Clinical Affairs, Synergy Disc Replacement, Inc.
Vera Pomerantseva, Senior Central Monitoring Lead, Central & Risk Based Monitoring, Bristol-Myers Squibb Co.
Kelly White, Director Clinical Research, Global Trial Optimization Oncology, Merck
Appian Corp, Speaker TBD
Phesi, Speaker TBD
Jade Dennis, Advisor, Design Hub, Eli Lilly and Company
Eddie Dukes, Product Designer, Clinical Trial Operations, GlaxoSmithKline
Jeff Kingsley, Founder & CEO, IACT Health
Gian Prakash, Associate Director, Data Engineering, Information Research, AbbVie Inc.

4:05-4:40 PM TABLE: From Digital Endpoints to Digital Trials to Digital Healthcare and Back
Co-Moderators:
Vanja Vlajnic, Senior Manager, Statistics and Data Insights, Bayer Pharmaceuticals
Michelle Crouthamel, PhD, Director Digital Health & Innovation, Digital Health Innovation, AbbVie
Speaker TBDmdgroup
Angie Botto-Van Bemden, PhD, Director, Osteoarthritis, Arthritis Foundation
Laurie Halloran, President & CEO, Halloran Consulting Group Inc.
Peter Verwilst, MD, Research Physician, The Janssen Pharmaceutical Companies of Johnson & Johnson
Nikala Kwech, eCOA Operations Lead, Data Sciences, AbbVie
Speaker TBDExostar

4:05-4:40 PM TABLE: Technologies and Partnerships to Streamline Sample/Biomarker Management in Clinical Trials
Co-Moderators:
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co.
Speaker TBD, Medix
Brenda Yanak, Vice President, Global Biospecimen & Imaging Management, Bristol-Myers Squibb Co.
Karina Bienfait, PhD, Executive Director, Specimen Infrastructure & Informed Consent, Global Biospecimen & Imaging Management, Bristol-Myers Squibb
Mary Zuniga, Consultant, Translational Science Immunology, Eli Lilly & Co.
Lynn Wetherwax, R&D Strategy and Operations, Amgen Inc.

WEDNESDAY, MARCH 3

BREAKOUT DISCUSSION GROUPS

10:00-10:30 AM Budgeting and Contracting in the Era of COVID-19: New Technologies, Novel Outsourcing Strategies
Co-Moderators:
Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine
Richard O'Hara, Director, Clinical Business Operations, Endo Pharmaceuticals
Rehbar Tayyabkhan, Head, R&D Sourcing & Procurement, Merck Research Labs
Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics

10:30-10:55 AM TABLE: Advancing RBQM: Tools, Strategies and Lessons Learned from COVID-19
Co-Moderators:
Sarah Bednarski, MS, Director, Strategic Monitoring Analytics, Clinical Operations, Sunovion Pharmaceuticals
Darren Weston, Vice President, Integrated Data Analytics & Reporting (IDAR), JanssenJennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation
Steve Young, CSO, CluePoints
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co.
Mary Arnould, Director, Program Management/RBM Lead, Clinical Science Operations, Astellas US
Vani Nilakantan, PhD, Vice President, Research, Allina Health System
Keith Dorricott, Ambassador, Metrics Champion Consortium
Joseph Yoder, Clinical Data Analyst, Data & Statistical Sciences, AbbVie
Teri Takle-Flach, Director, Clinical Operations, Boston Scientific Corp.
Todd Johnson, MPH, MBA, Principal Consultant, Organizational Solutions, Halloran Consulting Group

10:30-10:55 AM TABLE: Navigating China's Regulatory, Drug Development and Clinical Partnering Landscape
Co-Moderators:
Jane Fang, MD, MS, CEO & Founder, Polaris Strategic Partners, Inc.
Walt Cao, PhD, Founder, Redbud Pharma; ex-FDA Senior Reviewer for Oncology Drug
Sean Zhao, PhD, HeadUS Patient Safety, US Medical Affairs, AstraZeneca Pharmaceuticals Inc.
Henry Wu, PhD, CEO, CR Medicon
Ari Feldman, Vice President, Global Compliance & Strategy, Medidata
Khaled Mowad, JD, Associate, Moses & Singer LLP

12:00-12:30 PM TABLE: Decentralized and Hybrid Trials: COVID-19 as an Accelerator
Co-Moderators:
Jane Jacob, PhD, Vice President, Research & Clinical Affairs, Synergy Disc Replacement, Inc.
Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc. (2nd choice: AI)
Laura Whitmore, Head, Clinical Operations, Cerevel Therapeutics LLC
Hassan Kadhim, Director & Head, Clinical Trial Business Capabilities, Bristol-Myers Squibb Co.
Speaker TBDSureClinical
Angie Botto-Van Bemden, PhD, Director, Osteoarthritis, Arthritis Foundation
Mary Arnould, Director, Program Management/RBM Lead, Clinical Science Operations, Astellas US, LLC
Speaker TBD, Longboat
Matthew Moyer, Director Clinical Supply Technology, Global Clinical Supply, Merck & Co.
Vani Nilakantan, PhD, Vice President, Research, Allina Health System
Anthony Costello, Senior Vice President, mHealth
David Fauvart, Associate Director, Janssen Clinical Innovation, Johnson & Johnson Pharmaceutical R&D
Speaker TBD, Appian Corp
Laurie Halloran, President & CEO, Halloran Consulting Group Inc.
Michele Teufel, Patient & Site Engagement Lead, Development Operations, AstraZeneca
Nikala Kwech, eCOA Operations Lead, Data Sciences, AbbVie Inc.
Speaker TBD, PRA Health Sciences
Speaker TBD, Praxis

12:00-12:30 PM TABLE: AI and Advanced Analytics to The Rescue: Latest Applications in Clinical Trials
Co-Moderators:
Vera Pomerantseva, Senior Central Monitoring Lead, Central & Risk Based Monitoring, Bristol-Myers Squibb Co.
Vanja Vlajnic, Senior Manager, Statistics and Data Insights, Bayer Pharmaceuticals
mdgroup, Speaker TBD
Steve Young, CSO, CluePoints
Kelly White, Director Clinical Research, Global Trial Optimization Oncology, Merck
Phesi, Speaker TBD
Peter Verwilst, MD, Research Physician, The Janssen Pharmaceutical Companies of Johnson & Johnson
Jade Dennis, Advisor, Design Hub, Eli Lilly and Company
Kafayat Babajide, MBA, Associate Director, Patient Portals, Janssen Research & Development, LLC
Jeff Kingsley, Founder & CEO, IACT Health
Gian Prakash, Associate Director, Data Engineering, Information Research, AbbVie Inc.
Joseph Yoder, Clinical Data Analyst, Data & Statistical Sciences, AbbVie, Inc.
Oriol Serra Ortiz, Head, Site Intelligence & Site Selection, Study Optimization Global Product Development, Pfizer
Todd Johnson, MPH, MBA, Principal Consultant, Organizational Solutions, Halloran Consulting Group

2:45-3:30 PM TABLE: Clinical Supply Chain – Supporting Trial Continuity during a Pandemic and More?
Co-Moderators:
Matthew Moyer, Director Clinical Supply Technology, Global Clinical Supply, Merck & Co.
Speaker TBDMedix

2:15-2:55 PM TABLE: MDR/IVDR Compliance and Data Considerations for Medical Device Trials
Co-Moderators:
Jane Hart, Vice President, Global Clinical Affairs, 3M Health Care
Jeffrey Siracuse, MD, MBA, Associate Professor, Surgery, Boston University
Kimberly Thomas-Pollei, Director Clinical Evidence and Risk Management, Rhythm Management Division, Boston Scientific
Chris Cain, Vice President, Clinical & Regulatory Affairs, Conformal Medical
Andreas Stange, PhD, Vice President, Medical & Health Services, TÜV SÜD

THURSDAY, MARCH 4

BREAKOUT DISCUSSION GROUPS

10:10-10:30 AM Measuring Success: Outsourcing Models, Vendor Quality Metrics, and Balancing Resources
Co-Moderators:
Keith Dorricott, Ambassador, Metrics Champion Consortium
Piet Theisohn, Vice President, Resource Management, Clinical Operations, R&D Clinical Operations, Bayer AG - Pharma
Subrata Bose, PhD, Global Head Clinical Trials Analytics & Insights, Bayer
Vani Nilakantan, PhD, Vice President, Research, Allina Health System
Steve Crow, Associate Director, Performance & Training, Clinical Operations, GW Pharmaceuticals
Michael Mclaughlin, Associate Director, Clinical Operations, Dermavant Sciences Inc.