CORE West 2023 Agenda
Wednesday, April 26th
Registration and Retreat Check-In | Stone Building | 1:00 – 2:00 PM
Welcome to CORE, Opening Remarks & Connecting the Dots | 2:00 – 2:15 PM
Laurie Halloran, CEO, Halloran Consulting Group
Session 1 | 2:15 – 3:00 PM
Merck’s 5-Point Diversity Plan to Ensure Studies Are Inclusive to All Representative Patient Populations
Natasha Risotto-Scholtes, Clinical Research Director, Oncology Early Development, Merck
Sonya Martin, Director, Site Management and Monitoring, Merck
Lorena Kanu, Clinical Research Director, Infectious Disease, Merck
Session 2 | 3:00 – 3:45 PM
Implementation of FDORA: What Does This Mean for Your Organization?
Ryan Brown, VP, Diversity Solutions, Circuit Clinical
Jocelyn Ashford, Founder, Rare Advocate
Sonya Martin, Director, Site Management and Monitoring, Merck
Moderator – Rashida Challenger, Senior Consultant, Clinical Operations, Halloran Consulting Group
Break | 3:45 – 4:15 PM
Session 3 | 4:15 – 4:45 PM
Improving Patient Experience in Clinical Trials for Enhanced Diversity and Inclusion: A Step Towards Fulfilling FDORA’s Mandate
Kyle Hogan, President, Datacubed Health
Jillian Tygh, VP, Marketing, Datacubed Health
Session 4 | 4:45 – 4:45 PM
Sponsor Perspective on Diversity & Inclusion in Oncology Clinical Trials
Katy Armstrong, Therapeutic Area Head, Oncology, Research & Early Development ClinOps, Genentech
Break | 5:15 – 6:15 PM
Cocktail Reception & Dinner | Stone Building Lawn (Outdoor) | 6:15 – 8:30 PM
Thursday, April 27th
Breakfast | Stone Building Lawn (Outdoor) | 8:00 – 8:45 AM
Day One Recap & Day Two Intro | 8:45 – 8:50 AM
Tania Zieja, President, Halloran Consulting Group
Session 5 | 8:50 – 9:30 AM
Lessons from a Grateful Patient
Rolf Benirschke, Founder & Chief Executive Officer, Legacy Health Strategies
Session 6 | 9:30 – 10:15 AM
Considerations to Elevate the Patient Voice to Enable Thoughtful Clinical Trial Design
Jacquline Blem, President, Cardiff Clinical Consulting
Jessica Scott, President, Legacy Health Strategies
Mark Milberg, Sr. Director, Clinical Outsourcing, Ultragenyx Pharmaceutical
Moderator – Kristi Clark, VP, Clinical Operations, Avidity Biosciences
Session 7 | 10:15 – 10:45 AM
Fireside Chat | Otsuka & Verily Partnership: A Journey Towards a Patient-Centered Approach to Clinical Research
Dana Cho, Chief Design Officer, Verily
Erica Lawson, Director, Applied Innovation, Otsuka Pharmaceutical Companies
Break | 10:45 – 11:15 AM
Session 8 | 11:15 – 11:45 AM
Completing the Study Delivery Puzzle: How Roche Raised Their Game with Protocol Compliance & Study-Specific Training & Patient Centricity
Malachi Bierstein, VP, Global Sales & Marketing, ScienceMedia
Mark Surles, Chief Executive Officer, ScienceMedia
Monica Eason, Operations Program Director, Genentech
Session 9 | 11:45 – 12:30 AM
Elevating Your Clinical Operations and CMC Partnership for Cell and Gene Therapy
Alpana Loomba, VP & Head of Clinical Operations, Allogene Therapeutics
LaTanya Tomlinson, VP, Development Operations, Tenaya Therapeutics
Darren Hart, SVP, Development, Graphite Bio
Moderator – Jason Milovanovic, VP, Clinical Development & Operations, Halloran Consulting Group
Lunch | Stone Building Lawn (Outdoor) | 12:30 – 1:30 PM
Session 10 | 1:30 – 2:00 PM
Phase I Case Study Whitepaper Review: Realizing the Speed, Quality, and Cost Benefits of Australia as a US Biotech
Dr. Arvinder Dhalla, VP, Clinical Development, Rani Therapeutics
Chris Hickey, EVP, Business Development, Nucleus Network
Session 11 | 2:00 – 2:30 PM
How CVS Health’s Clinical Trial Services is Innovating the Trial Process to Improve Health Equity and Trial Effectiveness in Communities Across America
Owen Garrick, CMO, Clinical Trial Services, CVS Health
Session 12 | 2:30 – 3:00 PM
Are We Ready for Artificial Intelligence in Clinical Trial Operations?
Scott Chetham, Co-Founder & CEO, Faro Health
Session 13 | 3:00 – 4:15 PM
Interactive Workshop | Comments & Feedback to FDA on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigators Draft Guidance
Jason Milovanovic, VP, Clinical Development & Operations, Halloran Consulting Group
Sheila Gwizdak, VP, Organizational & Quality Solutions, Halloran Consulting Group
Break | 4:15 – 5:15 PM
Bus Pick Up To Benziger Family Winery | 5:15 PM
1883 London Ranch Rd, Glen Ellen, CA 95442
Benziger Wine Cave Tasting & Dinner | 5:45 – 9:00 PM
Attire: Business Casual
Friday, April 28th
Breakfast | Stone Building Lawn (Outdoor) | 8:00 – 8:45 AM
Day Two Recap & Day Three Intro | 8:45 – 8:50 AM
Tania Zieja, President, Halloran Consulting Group
Interactive Workshop Recap | 8:50 – 9:00 AM
Jason Milovanovic, VP, Clinical Development & Operations, Halloran Consulting Group
Sheila Gwizdak, VP, Organizational & Quality Solutions, Halloran Consulting Group
Session 14 | 9:00 – 9:30 AM
A Paradigm Shift in Clinical Trial Intelligence
Todd Johnson, VP, Global Solutions, Lokavant
Session 15 | 9:30 – 10:15 AM
The New Blueprint for Trial Data: Operationalizing Innovation and Automation Throughout the Trial Lifecycle
Raj Indupuri, CEO, eClinical
Salam Ammus, Executive Director, Clinical Data Management, Alkermes
Break | 10:15 – 10:30 AM
Session 16 | 10:30 – 11:30 AM
Understanding How Policy May Impact Your Development Programs
Betsy Ricketts, Vice President, Policy Government and Public Affairs, Ultragenyx Pharmaceutical
Chris Cunningham, Senior Director, Federal Government Relations, California Life Sciences
Richard White, Manager of Federal Advocacy, Biocom California
Moderator – Katie McCarthy, Chief Innovation Officer, Halloran Consulting Group
Session 17 | 11:30 – 12:00 PM
Fireside Chat | Life Sciences Industry Outlook for 2023 and Beyond: How to Execute with Less
Niall O’Donnell, Managing Director, RiverVest Venture Partners
Katie McCarthy, Chief Innovation Officer, Halloran Consulting Group
Closing Remarks | 12:00 – 12:15 PM
Laurie Halloran, CEO, Halloran Consulting Group
Boxed Lunch | Stone Building Lawn (Outdoor) | 12:15 – 1:30 PM
