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 BREAKOUT: 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
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
Christina Fawcett, Senior Director, Decentralized Clinical Trials Operations, PRA Health Sciences

4:05-4:40 PM BREAKOUT: 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.
Evi Cohen, Vice President, Global Life Sciences and Healthcare, Appian

4:05-4:40 PM BREAKOUT: 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
Tom Johnson, Senior Director, Life Sciences/Health IT Business Solutions, Exostar
Matt Johnson, ‎Vice President, Wearables & Digital Biomarkers, ERT

4:05-4:40 PM BREAKOUT: Technologies and Partnerships to Streamline Sample/Biomarker Management in Clinical Trials
Co-Moderators:
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co.
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.

4:05-4:40 PM BREAKOUT: Implementing New ICH Recommendations: TransCelerate Amendment Metadata Initiative
Co-Moderators:
Mitzi Allred, PhD, Director, Clinical Operations & Head, Clinical Content Standards, Merck
Hena Ashar, PhD, Medical Writing Manager Business Lead, Sanofi
Sharon McErlean, Clinical Development & Analytics Associate Director, Clinical Process Solutions, Novartis

WEDNESDAY, MARCH 3

BREAKOUT DISCUSSION GROUPS

10:00-10:30 AM BREAKOUT: 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 BREAKOUT: 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), Janssen                                                    Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation
Steve Young, CSO, CluePoints
Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co.
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
Beenu Kapoor, VP, IT Trial Management & Digital Trial Management Suite (DTMS) Lead
Jonathan Rowe, Associate Principal, ZS Associates

10:20-10:40 AM BREAKOUT: 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 BREAKOUT: 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 TBD, SureClinical
Angie Botto-Van Bemden, PhD, Director, Osteoarthritis, Arthritis Foundation
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, President, Patient Cloud, Medidata
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.
Isaac Rodriguez-Chavez, Senior Vice President, Scientific and Clinical Affairs, Digital Health, PRA Health Sciences
Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC
EB McLindon, Senior VP, Site, Patient and Decentralised Solutions, ICON plc
Chris Varner, Associate Director, Virtual Trial Solutions, IQVIA 

12:00-12:30 PM BREAKOUT: 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
Bhargava Reddy, PhD, Director, Advanced Insights, Janssen

2:45-3:30 PM BREAKOUT: Clinical Supply Chain – Supporting Trial Continuity during a Pandemic and More?
Co-Moderators:
Matthew Moyer, Director Clinical Supply Technology, Global Clinical Supply, Merck & Co. 
Jeremy Faulks, Director of Specialty Pharmacy & Pharmacy Procurement, Pharmacy Operations, Thrifty White Pharmacy
Zuanel Diaz, PhD, Director, Biospecimen Repository & Protocol Support Lab, Baptist Health South Florida
Alex Colgan, LedgerDomain
Thomas McDonald, Associate Director, Strategic Biospecimen, Bristol Myers Squibb 

2:15-2:55 PM BREAKOUT: 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

THURSDAY, MARCH 4

BREAKOUT DISCUSSION GROUPS

10:10-10:30 AM BREAKOUT: 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.