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Chief Medical Officer Summit 360º

Date: Apr 7, 2025 - Apr 8, 2025

Location: Boston, MA

Day 1: Monday, April 07, 2025
Showing Events in 1 Track from 08:00am to 08:20am
Registration Opens
8:00AM - 8:20AM
Registration Opens
Showing Events in 1 Track from 08:20am to 08:30am
Co-Chairs Opening Remarks
8:20AM - 8:30AM
Co-Chairs Opening Remarks
Co-Chairs:
Anna Frostegård, MD, PhD, Co-Founder, Chief Scientific & Medical Officer, Annexin Pharmaceuticals
Jeff Humphrey, MD, CMO, Myris Therapeutics
Showing Events in 1 Track from 08:30am to 09:10am
Morning Keynote
8:30AM - 9:10AM
Trends in Drug Development Keynote: Challenges in Meeting Our Promise to Patients
Keynote:
Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Showing Events in 1 Track from 09:10am to 09:40am
Policy Keynote
9:10AM - 9:40AM
Policy Keynote with BIO SVP of Federal Government Affairs
Keynote:
Aiken Hackett, Senior Vice President, Federal Government Relations, Biotechnology Innovation Organization
Moderated By:
Seemi Khan, MD, MPH, MBA, CMO, Alkeus Pharmaceuticals
Showing Events in 1 Track from 09:40am to 09:55am
Interactive Networking Session
9:40AM - 9:55AM
Interactive Networking Session
Showing Events in 1 Track from 09:55am to 10:40am
Grand Opening Break & Networking
9:55AM - 10:40AM
Grand Opening Break & Networking
Showing Events in 1 Track from 10:40am to 01:00pm
Morning General Session
10:40AM - 11:10AM
Designing Clinical Trials Balancing Simplicity with Complexity
Moderated By:
Steve Zelenkofske, DO, President/Principal, SLZ Consulting
Panelists:
Bertil Lindmark, MD, PhD, CMO, Vicore Pharma
Christopher Morabito, MD, CMO, Astria Therapeutics
Judith Ng-Cashin, MD, Chief Medical Officer, Novotech
11:10AM - 11:30AM
Medical Monitoring Oversite and Real-Time Data Access
Speaker:
George J. Atiee, MD, Director, Medical Monitoring Services, Dr. Vince Clinical Research
11:30AM - 12:00PM
Utilizing AI to Streamline Clinical Development
Moderated By:
Jeff Humphrey, MD, CMO, Myris Therapeutics
Panelists:
Mohammed Asmal, MD, PhD, CMO, Prime Medicine
Scott Chetham, PhD, CEO and Co-Founder, Faro Health
Gen Li, PhD, MBA, President and Founder, Phesi, Inc.
Peter Linde, MD, FASN, Vice President, Global Medical Officer, PPD Clinical Research Business of Thermo Fisher Scientific
12:00PM - 12:15PM
Reimagining Clinical Trials: How AI and ML Drive Precision, Efficiency and Success
Speaker:
Raviv Pryluk, PhD, CEO & Co-founder, PhaseV
12:15PM - 12:45PM
Enriching Clinical Trials with Patient Reported Outcomes: Best Practices, Potential Pitfalls and New Approaches
Moderated By:
Barry Ticho, MD, PhD, CMO, Stoke Therapeutics, Inc
Panelists:
Nataliya Agafonova, MD, CMO, Longeveron Inc.
Jason Sager, MD, CMO, Accent Therapeutics, Inc.
Wessam Sonbol, CEO, Delve Health
Dawie Wessels, CMO, Signant Health
12:45PM - 1:00PM
How to Measurably Increase Operational Efficiency in Clinical Trials
Speaker:
Julie Martin, MSc, MBA, President & CEO, Scimega Research
Showing Events in 1 Track from 01:00pm to 01:55pm
Lunch
1:00PM - 1:55PM
Lunch
Showing Events in 2 Tracks from 02:00pm to 03:35pm
Track 1: Regulatory & Patient Affairs
Track Chair:
Marcella Ruddy, MD, CMO, Tectonic Therapeutic
2:00PM - 2:30PM
Enhanced Strategic FDA Collaboration: Working with CDER and CBER
Moderated By:
Peter Francis, MD, PhD, CMO & CSO, Ray Therapeutics
Panelists:
Harpreet Singh, MD, Chief Medical Officer, Precision for Medicine
Norman Sussman, MD, CMO, DURECT
2:30PM - 2:45PM
Net Treatment Benefit: A Patient-Focused Strategy with Multiple Outcomes Analyses in the Primary Endpoint and a Reduced Sample Size
Speaker:
Pascal Piedbois, MD, PhD, CMO, One2Treat
2:45PM - 3:15PM
How to Better Partner with Patient Organizations
Panelists:
Joseph Palumbo, MD, MACPsych, EVP, CMO, Head of R&D, BioVie
Peter Schmidt, PhD, President and Chief Scientific Officer, Rho
Laura Williams, MD, MPH, CMO, Ardelyx
3:15PM - 3:35PM
Navigating Regulatory and Operations Challenges Running Ex-US Trials
Speaker:
Andrea Wang-Gillam, MD, PhD, CMO, Global Head of R&D, Jacobio Pharmaceuticals
Track 2: Medical Affairs & Commercialization
Track Chair:
Patrick Burnett, MD, PhD, CMO, Arcutis Biotherapeutics
2:00PM - 2:30PM
Bringing Medical Affairs into Clinical Development
Moderated By:
Mark Bach, MD, PhD, CMO, GentiBio
Panelists:
Johan Baeck, MD, EVP, CMO, Promontory Therapeutics Inc.
Peg Crowley-Nowick, PhD, MBA, President, Medical Affairs Consulting and Head of Medical Affairs, Lumanity
Eva Gallagher, PhD, RN, ANP-BC, Vice President, Head of Global Medical Affairs, Agios Pharmaceuticals
2:30PM - 2:45PM
Unleashing Creativity in Medical Affairs
Speaker:
Quentin O’Brien, VP, Scientific Strategy, Medical Communications & Innovation, Klick Health
2:45PM - 3:15PM
Building a "Triple Threat" Medical Affairs Team
Moderated By:
John Yee, MD, MPH, Senior VP, Medical Affairs, Apnimed, Inc.
Panelists:
Theo Hillman, Associate Director, Barrington James
Vijay Kasturi, MD, CMO, CG Oncology
Oliver Rosen, MD, Chief Medical Officer, Akamis Bio
3:15PM - 3:35PM
What CMOs Need to Know about Commercialization
Speaker:
Holly Schachner, MD, CMO, 3DC, Deerfield Management
Showing Events in 1 Track from 03:35pm to 04:00pm
Afternoon Break & Networking
3:35PM - 4:00PM
Afternoon Ice Cream Break & Networking
Graciously Hosted By:
Showing Events in 2 Tracks from 04:05pm to 05:35pm
Track 1: Internal Affairs
Track Chair:
Christophe Arbet-Engels, MD, PhD, CMO, X4 Pharmaceuticals
4:05PM - 4:35PM
What CEOs Wish CMOs Knew
Moderated By:
Kartik Krishnan, MD, PhD, CEO, OncoNano Medicine
Speakers:
Donna Higgins, CEO, The Higgins Group
Daniela Iwanski, MAOM, Vice President, Executive and Board Recruiting, Govig and Associates
4:35PM - 5:05PM
Working Flexibly with Consultants and Fractional Expertise
Moderated By:
Barbara Troupin, MD, MBA, Fractional CMO, Laguna Bio & Others
Panelists:
Jay Destino, Vice President, Functional Service Provider (FSP) Solutions, BioPoint, Inc.
Steven Katz, MD, CMO and SVP, Translational Research, Shinobi Therapeutics
George Quinn, Managing Director, Interim Leadership and On-Demand Talent | Life Sciences, WittKieffer
5:05PM - 5:35PM
Building Up a CMO Team as Your Company Evolves
Moderated By:
Harold Bernstein, MD, PhD, President, R&D and CMO, Maze Therapeutics
Panelists:
Dan Bloomfield, MD, CMO, Anthos Therapeutics
Matthew Frankel, MD, CMO, Chemomab Therapeutics
Raul Lima, SVP, Strategic Clinical Operations, inSeption Group
Track 2: External Affairs
Track Chair:
Steve Kanes, MD, PhD, CMO, Centessa
4:05PM - 4:35PM
Ensuring Effective and Efficient Trials Through Clinical Operations
Moderated By:
Roger Waltzman, MD, MBA, CMO, Indaptus Therapeutics
Panelists:
Pol Boudes, MD, CMO, Rectify Pharma
Bruce Dezube, MD, SVP, Clinical Development, Xilio Therapeutics
Jin Kim, CEO & Founder, Miracle Corporation
Raul Lima, SVP, Strategic Clinical Operations, inSeption Group
4:35PM - 5:05PM
CRO-Sponsor Best Practices for Project Success
Moderated By:
Panteli Theocharous, PhD, FRCPath, Chief Therapeutics Officer and Head of Medical and Scientific Affairs, Garuda Therapeutics, Inc.
Panelists:
Giovanni Abbadessa, MD, PhD, Chief Medical Officer, ModeX Therapeutics
Greg Licholai, MD, Chief Medical and Innovation Officer, ICON
5:05PM - 5:35PM
New Models for Working with Service Providers
Moderated By:
Joanne Lager, MD, CMO, NiKang Therapeutics
Panelists:
Sara McCradden, Director, Clinical Operations, InSeption Group
Ajay Sadhwani, VP of Operations, Harbor Clinical
Abi Vainstein-Haras, MD, CMO, Sapience Therapeutics
Showing Events in 1 Track from 05:35pm to 06:35pm
Networking Reception
5:35PM - 6:35PM
Networking Reception
Graciously Hosted By:
Showing Events in 1 Track from 06:35pm to 06:40pm
Day One Ends
6:35PM - 6:40PM
Day One Ends
Showing Events in 1 Track from 08:00am to 08:20am
Registration Opens
8:00AM - 8:20AM
Registration Opens
Showing Events in 1 Track from 08:20am to 08:30am
Co-Chairs Opening Remarks
8:20AM - 8:30AM
Co-Chairs Opening Remarks
Co-Chairs:
Anna Frostegård, MD, PhD, Co-Founder, Chief Scientific & Medical Officer, Annexin Pharmaceuticals
Jeff Humphrey, MD, CMO, Myris Therapeutics
Showing Events in 1 Track from 08:30am to 09:10am
Morning Keynote
8:30AM - 9:10AM
Trends in Drug Development Keynote: Challenges in Meeting Our Promise to Patients
Keynote:
Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Showing Events in 1 Track from 09:10am to 09:40am
Policy Keynote
9:10AM - 9:40AM
Policy Keynote with BIO SVP of Federal Government Affairs
Keynote:
Aiken Hackett, Senior Vice President, Federal Government Relations, Biotechnology Innovation Organization
Moderated By:
Seemi Khan, MD, MPH, MBA, CMO, Alkeus Pharmaceuticals
Showing Events in 1 Track from 09:40am to 09:55am
Interactive Networking Session
9:40AM - 9:55AM
Interactive Networking Session
Showing Events in 1 Track from 09:55am to 10:40am
Grand Opening Break & Networking
9:55AM - 10:40AM
Grand Opening Break & Networking
Showing Events in 1 Track from 10:40am to 01:00pm
Morning General Session
10:40AM - 11:10AM
Designing Clinical Trials Balancing Simplicity with Complexity
Moderated By:
Steve Zelenkofske, DO, President/Principal, SLZ Consulting
Panelists:
Bertil Lindmark, MD, PhD, CMO, Vicore Pharma
Christopher Morabito, MD, CMO, Astria Therapeutics
Judith Ng-Cashin, MD, Chief Medical Officer, Novotech
11:10AM - 11:30AM
Medical Monitoring Oversite and Real-Time Data Access
Speaker:
George J. Atiee, MD, Director, Medical Monitoring Services, Dr. Vince Clinical Research
11:30AM - 12:00PM
Utilizing AI to Streamline Clinical Development
Moderated By:
Jeff Humphrey, MD, CMO, Myris Therapeutics
Panelists:
Mohammed Asmal, MD, PhD, CMO, Prime Medicine
Scott Chetham, PhD, CEO and Co-Founder, Faro Health
Gen Li, PhD, MBA, President and Founder, Phesi, Inc.
Peter Linde, MD, FASN, Vice President, Global Medical Officer, PPD Clinical Research Business of Thermo Fisher Scientific
12:00PM - 12:15PM
Reimagining Clinical Trials: How AI and ML Drive Precision, Efficiency and Success
Speaker:
Raviv Pryluk, PhD, CEO & Co-founder, PhaseV
12:15PM - 12:45PM
Enriching Clinical Trials with Patient Reported Outcomes: Best Practices, Potential Pitfalls and New Approaches
Moderated By:
Barry Ticho, MD, PhD, CMO, Stoke Therapeutics, Inc
Panelists:
Nataliya Agafonova, MD, CMO, Longeveron Inc.
Jason Sager, MD, CMO, Accent Therapeutics, Inc.
Wessam Sonbol, CEO, Delve Health
Dawie Wessels, CMO, Signant Health
12:45PM - 1:00PM
How to Measurably Increase Operational Efficiency in Clinical Trials
Speaker:
Julie Martin, MSc, MBA, President & CEO, Scimega Research
Showing Events in 1 Track from 01:00pm to 01:55pm
Lunch
1:00PM - 1:55PM
Lunch
Showing Events in 2 Tracks from 02:00pm to 03:35pm
Track 1: Regulatory & Patient Affairs
Track Chair:
Marcella Ruddy, MD, CMO, Tectonic Therapeutic
2:00PM - 2:30PM
Enhanced Strategic FDA Collaboration: Working with CDER and CBER
Moderated By:
Peter Francis, MD, PhD, CMO & CSO, Ray Therapeutics
Panelists:
Harpreet Singh, MD, Chief Medical Officer, Precision for Medicine
Norman Sussman, MD, CMO, DURECT
2:30PM - 2:45PM
Net Treatment Benefit: A Patient-Focused Strategy with Multiple Outcomes Analyses in the Primary Endpoint and a Reduced Sample Size
Speaker:
Pascal Piedbois, MD, PhD, CMO, One2Treat
2:45PM - 3:15PM
How to Better Partner with Patient Organizations
Panelists:
Joseph Palumbo, MD, MACPsych, EVP, CMO, Head of R&D, BioVie
Peter Schmidt, PhD, President and Chief Scientific Officer, Rho
Laura Williams, MD, MPH, CMO, Ardelyx
3:15PM - 3:35PM
Navigating Regulatory and Operations Challenges Running Ex-US Trials
Speaker:
Andrea Wang-Gillam, MD, PhD, CMO, Global Head of R&D, Jacobio Pharmaceuticals
Track 2: Medical Affairs & Commercialization
Track Chair:
Patrick Burnett, MD, PhD, CMO, Arcutis Biotherapeutics
2:00PM - 2:30PM
Bringing Medical Affairs into Clinical Development
Moderated By:
Mark Bach, MD, PhD, CMO, GentiBio
Panelists:
Johan Baeck, MD, EVP, CMO, Promontory Therapeutics Inc.
Peg Crowley-Nowick, PhD, MBA, President, Medical Affairs Consulting and Head of Medical Affairs, Lumanity
Eva Gallagher, PhD, RN, ANP-BC, Vice President, Head of Global Medical Affairs, Agios Pharmaceuticals
2:30PM - 2:45PM
Unleashing Creativity in Medical Affairs
Speaker:
Quentin O’Brien, VP, Scientific Strategy, Medical Communications & Innovation, Klick Health
2:45PM - 3:15PM
Building a "Triple Threat" Medical Affairs Team
Moderated By:
John Yee, MD, MPH, Senior VP, Medical Affairs, Apnimed, Inc.
Panelists:
Theo Hillman, Associate Director, Barrington James
Vijay Kasturi, MD, CMO, CG Oncology
Oliver Rosen, MD, Chief Medical Officer, Akamis Bio
3:15PM - 3:35PM
What CMOs Need to Know about Commercialization
Speaker:
Holly Schachner, MD, CMO, 3DC, Deerfield Management
Showing Events in 1 Track from 03:35pm to 04:00pm
Afternoon Break & Networking
3:35PM - 4:00PM
Afternoon Ice Cream Break & Networking
Graciously Hosted By:
Showing Events in 2 Tracks from 04:05pm to 05:35pm
Track 1: Internal Affairs
Track Chair:
Christophe Arbet-Engels, MD, PhD, CMO, X4 Pharmaceuticals
4:05PM - 4:35PM
What CEOs Wish CMOs Knew
Moderated By:
Kartik Krishnan, MD, PhD, CEO, OncoNano Medicine
Speakers:
Donna Higgins, CEO, The Higgins Group
Daniela Iwanski, MAOM, Vice President, Executive and Board Recruiting, Govig and Associates
4:35PM - 5:05PM
Working Flexibly with Consultants and Fractional Expertise
Moderated By:
Barbara Troupin, MD, MBA, Fractional CMO, Laguna Bio & Others
Panelists:
Jay Destino, Vice President, Functional Service Provider (FSP) Solutions, BioPoint, Inc.
Steven Katz, MD, CMO and SVP, Translational Research, Shinobi Therapeutics
George Quinn, Managing Director, Interim Leadership and On-Demand Talent | Life Sciences, WittKieffer
5:05PM - 5:35PM
Building Up a CMO Team as Your Company Evolves
Moderated By:
Harold Bernstein, MD, PhD, President, R&D and CMO, Maze Therapeutics
Panelists:
Dan Bloomfield, MD, CMO, Anthos Therapeutics
Matthew Frankel, MD, CMO, Chemomab Therapeutics
Raul Lima, SVP, Strategic Clinical Operations, inSeption Group
Track 2: External Affairs
Track Chair:
Steve Kanes, MD, PhD, CMO, Centessa
4:05PM - 4:35PM
Ensuring Effective and Efficient Trials Through Clinical Operations
Moderated By:
Roger Waltzman, MD, MBA, CMO, Indaptus Therapeutics
Panelists:
Pol Boudes, MD, CMO, Rectify Pharma
Bruce Dezube, MD, SVP, Clinical Development, Xilio Therapeutics
Jin Kim, CEO & Founder, Miracle Corporation
Raul Lima, SVP, Strategic Clinical Operations, inSeption Group
4:35PM - 5:05PM
CRO-Sponsor Best Practices for Project Success
Moderated By:
Panteli Theocharous, PhD, FRCPath, Chief Therapeutics Officer and Head of Medical and Scientific Affairs, Garuda Therapeutics, Inc.
Panelists:
Giovanni Abbadessa, MD, PhD, Chief Medical Officer, ModeX Therapeutics
Greg Licholai, MD, Chief Medical and Innovation Officer, ICON
5:05PM - 5:35PM
New Models for Working with Service Providers
Moderated By:
Joanne Lager, MD, CMO, NiKang Therapeutics
Panelists:
Sara McCradden, Director, Clinical Operations, InSeption Group
Ajay Sadhwani, VP of Operations, Harbor Clinical
Abi Vainstein-Haras, MD, CMO, Sapience Therapeutics
Showing Events in 1 Track from 05:35pm to 06:35pm
Networking Reception
5:35PM - 6:35PM
Networking Reception
Graciously Hosted By:
Showing Events in 1 Track from 06:35pm to 06:40pm
Day One Ends
6:35PM - 6:40PM
Day One Ends
Previous
Day 1
Monday, April 07, 2025

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