Chris Colwell | VP, International Government & Regulatory Affairs
US Pharmacopeia

CHRIS COLWELL is Vice President, International Government & Regulatory Affairs at the United States Pharmacopeia (USP). He leads a team responsible for developing USP’s position international public policy and regulatory affairs issues related to its mission to improve global health through public standards. Chris’ prior experiences span technical and policy work across pharmaceuticals and medical devices in government, private sector and NGO sectors. He has worked at the US FDA, Merck & Co., Inc (known as MSD outside of the U.S. and Canada), Becton Dickinson (BD) and the Biotechnology Innovation Organization (BIO). Chris received his Masters in Public Policy from Georgetown University and a B.S. in Chemical Engineering from the Pennsylvania State University.

Appearances:

Pre-Congress Workshops - Monday 30th March @ 10:30

GLOBAL HEALTH WORKSHOP

GLOBAL HEALTH

Room 209AB

Identifying innovative and collaborative solutions throughout the development pathway to advance Global Health vaccine candidates beyond historical roadblocks. Understanding the factors which influence access and equity in low resource settings.

10:30am Chair’s opening remarks & presentation:

Vaccine Equity—A Historical Perspective and Future Imperatives

Dr Seth Berkley, Senior Advisor, Pandemic Center at Brown University

11am Using a partnership model for peer-to-peer learning and planning to optimize vaccine impact: A case study from Hexavalent Vaccine Implementation in Africa

Dr Kate Hopkins, Senior Director of Research, Vaccine Acceptance & Delivery, Sabin Vaccine Institute

11.20am Maternal Immunization Readiness Assessment in Kenya: A Situational Analysis for RSV and GBS Vaccine IntroductionJulie Nyanchama, Kenya Medical Research Institute (KEMRI)

11:40am From Capacity to Capability: How LMIC CDMOs Are Becoming Strategic Growth Engines

ALN Reddy, Sr Vice President, Strategic Business Development, Biological E

12:00pm Enhancing Adjuvant Availability: An Open-Access Model for Global Health

Dr Gerben Marsman, Head of Alliance Management, Vaccine Formulation Institute

12:20pm Innovative Adjuvants for Global Health

Peter Tygesen, Business Development Director, SPI PharmaJuhienah Khalaf, Director of Chemistry, InImmune

12:40pm Adjuvants at Scale: Sustaining Global Demand *Title TBC

Damien Hiley, Partner & Managing Director, Desert King

GH Vaccine Development Updates:

2:00pm Development Updates for NTD VaccinesDr Maria Elena Bottazzi, Co-Director of Texas Children's Hospital Center for Vaccine Development, Baylor College of Medicine

2:20pm Early development of a blood-stage, whole parasite vaccine for malaria

Dr Michael Good, Principal Research Leader, Head, Laboratory of Vaccines for the Developing World, Griffith University

2:40pm New Tuberculosis Vaccines – update and latest developments

Prof Richard White, Prof of Infectious Disease Epidemiology, LSHTM; Co-chair, Collaboration for TB Vaccine Discovery EMTD Research Community; WHO TB Vaccine Technical Advisory Group

3:00pm Fireside chat: The 96% Solution: Transforming the Fight Against Malaria Through Unprecedented Maternal and Infant Protection

· The Global Crisis: Addressing the critical need for next-generation malaria vaccines due to increasing cases and the limitations of current solutions.

· Breakthrough Data: Unveiling the "dream come true" results showing 96% protection against clinical malaria in infants born to mothers vaccinated pre-conception.

· Maternal Immunity: Examining the implications of long-lasting, transferred maternal immunity as a game-changer for infant survival.

· Policy and Elimination: Discussion on how this high, durable efficacy impacts global health policy, funding, scalability, and the path to malaria elimination.

Moderator: Dr Stephen Hoffman, Chief Executive and Scientific Officer, Sanaria

Dr Patrick E. Duffy, Chief, Laboratory of Malaria Immunology and Vaccinology, NIAID, NIH, Bethesda, MD USA

Ambassador John Simon, Managing Partner, Total Impact Capital, Bethesda, MD, USA

3:45pm -4:45pm Panel: How Vaccine Access Differs Across Countries—and What to Do About It

· Examine how systems shape vaccine access from development to delivery.

· Contrast vaccine pathways in high- vs. low- and middle-income countries.

· Highlight barriers like trial investment gaps and delayed approvals.

· Share strategies from global experts to improve equitable access.

Moderator: Anna Larson, Advisor, Epstein Becker & Green

Rebecca Martin, President, Global Immunization, Sabin Vaccine Institute

Larry Kerr, DVP, Global Health & Multilateral Affairs, PhRMA

Chris Colwell, VP, International Government & Regulatory Affairs, USP