Andrew S. Verderame, President, PharmaLex US Regulatory
Andrew S. Verderame, MBA, RAC leads our US-based Regulatory staff providing FDA-specific guidance and consulting services. He has over 30 years of involvement in the pharmaceutical industry, including positions of increasing responsibility in pharmaceutical production management, Regulatory CMC, US Regulatory leadership, and as Global Head of Regulatory therapeutic area teams. He has led over two hundred meetings with FDA, managed multi-site regulatory teams for both large and small pharmaceutical companies, and has presented to FDA Advisory Committees with successful outcomes.
While at Bayer Healthcare he led the US Regulatory team responsible for their anti-infective portfolio, including the billion dollar Cipro franchise. He led the efforts for the approval of the first counter-bioterrorism submission (Cipro anthrax) which became the model for the FDA “Animal Rule” legislation and guidance document. An expert at building constructive FDA relationships, he was the first industry representative ever invited to speak at the internal FDA Project Manager Forum. He also held senior Regulatory affairs positions at Replidyne and EMD Serono, where he led the approval of a novel best-in-class auto-injector drug/device combination product.
Contact PharmaLex US Regulatory at:
PharmaLex US, LLC
PO Box 441
Guilford, CT 06437
Thomas Fritz, Managing Director, PharmaLex Development Services
Thomas Fritz, MSc, is Managing Director of PDS, and has over twenty-five years’ experience in bio-technology and drug development consulting. Tom has been helping companies bring outstanding products to market through focus, creativity, deliberation, and strategic planning. He has developed and managed company-wide drug development programs and has been directly responsible for the successful completion of numerous clinical trials and regulatory submissions and FDA meetings. He has deep expertise in pharmaceutical operations management, clinical and regulatory strategy, technical and operational due diligence, and operational set-up and restructuring. He also has an extensive background in both small and large molecule manufacturing and personally led the manufacturing function of a growing biopharmaceutical company.
Tom was co-founder of the biotechnology company ImaRx which was acquired by Dupont Pharmaceutical in 1998; he subsequently joined Swiftwater Group, a drug development consulting group. Controlling interest in Swiftwater was purchased by the YES Group in 2014, and YES Group merged with PharmaLex in 2015, with each merger, global reach has expanded with increased service offerings.
Contact PharmaLex Development Services at:
PharmaLex Development Services, LLC
PO Box 149
Berwyn, PA 19312