The ClearPath Vaccines Team | ClearPath Development Company

Donna Ambrosino, MD

More than 30 years developing vaccines and biologics for infectious diseases

CEO of MassBiologics where she invented and developed monoclonal antibodies for C. Difficile, Rabies, and HCV (Zinplava and Rabishield now licensed products)
Previously was Associate Professor at Harvard Medical School and Professor of Pediatrics at UMass Medical School
Author of over 90 publications and multiple patents
Advisory Committees/Study Sections : WHO, NIH

Chuck Finn, PhD

More than 30 years of product development and regulatory experience covering a wide range of product types and therapeutic indications. Experience includes FDA – CBER, biopharma and CRO industry

RRD International, Co-Founder, Chairman and CEO, oversees RRD’s development partnerships, managed development teams in Symphony Capital partnership; established ClearPath vaccine development partnership with Astellas Pharma
Quintiles, SVP/head of therapeutic business units comprising infectious diseases/immunology/allergy/respiratory/ dermatology, and medical device business units for the US
Genetics Institute, Director of Regulatory Affairs, responsible for several clinical stage regulatory programs
Miles/Bayer, Associate Director of Regulatory Affairs, responsible for anti-infective regulatory programs
Praxis Biologics/Lederle, Sr. Scientist, Director Regulatory Affairs, Praxis developed first Haemophilus b conjugate vaccine for infants (acquired by Lederle for $238M)
Staff Fellow, FDA, CBER, Division of Bacterial Products (Vaccines)

Mark Leney, PhD

Over 10 years of experience in the development, manufacturing, testing and clinical trials of both investigational and commercial vaccine and biologic products

PhD from the University of Cambridge (Mathematical and Evolutionary Biology & Anthropology)
Has been responsible for managing Validation, Clinical Data Management, Quality Control, Regulatory Affairs and Quality Assurance functions
Previously, was an Assistant Professor of Medicine at the University of Massachusetts Medical School, Adjunct Professor of Forensic Biology at Chaminade University of Honolulu, and Faculty at the University of Oxford

Nnamdi Nwachukwu, MSc, MS, RAC

More than 15 years of global experience in regulatory strategy, CMC, operations, clinical risk management, and market access strategies for biologics, vaccines, immunotherapies, and digital technologies.

Currently Vice President, Regulatory and Quality Operations at RRD International
experience in more than 20 countries managing regulatory programs, building quality systems, sustainable pharmaceutical manufacturing operations, providing oversight for clinical trials, and managing cross-functional teams to meet program objectives
Mr. Nwachukwu holds a Master of Science in Regulatory Affairs from Northeastern University, a Master of Science in Evidence-based Medicine from the University of Oxford, and a Master of Healthcare Delivery Science from the Tuck School of Business at Dartmouth College. He holds the RAC certification and is a Fellow of Royal Society of Public Health of England

Neil Sandler, MBA

Over 30 years of investment and finance experience including > $1B in biopharma development

Symphony Capital co-founder and Partner
Behrman Capital, Partner. Head of Healthcare
Robertson Stephens, Partner, Head of Healthcare
PaineWebber Development Corp., Managing Director; Director of product development investments including those with approved products for Amgen, Sanofi/Genzyme, and J&J/Centocor
Managed over 125 financings and M&A’s exceeding $13B

George Siber, MD

More than 35 years developing vaccines and therapeutic programs for infectious diseases

Director of Massachusetts Public Health Biologic Laboratories which developed precursor to Synagis (>$1B sales)
EVP/CSO Wyeth which developed Prevnar (now >$6B sales), Meningitec, Rotashield and FluMist
Previously was Associate Professor at Harvard Medical School
Recipient of 2016 Sabin Gold Medal Award
Advisory Committees: WHO, NIH, Gates Foundation

D Nigel Thomas, PhD

More than 25 years of experience in global clinical development with focus on operational excellence.

Senior Vice President, Development Operations at RRD International
Conducted first P3 RSV vaccine trial for protection of infants via Maternal Immunization, P3 RSV trial in Older Adults
Conducted trials in influenza and emerging diseases (Ebola and Zika)
Previously Vice President, Clinical Operations at Novavax, Inc. where he was responsible for building the company’s clinical operations infrastructure to support P1 through P3 global clinical vaccine trial strategies
PhD from University of Reading, UK (Biochemistry and Physiology)

Larissa N. Zemo

Ms. Zemo has more than 20 years of experience in drug development services, including various program management and leadership positions.

Currently Director of Program Management and Planning at RRD International, LLC. where responsible for developing and implementing long-term strategies for program management across the company, including RRD and ClearPath Vaccines
Previously Senior Project Manager at Dynport Vaccine Company leading and coordinating multi‐million dollar, complex, biopharmaceutical development candidates for the Government
Ms. Zemo received a BS in Biology from the University of Maryland and Project Management Professional Certification from the Project Management Institute