REGULATORY AFFAIRS clay

PERSONAL PROFILE

  • Seasoned, versatile physician executive and academic, board-certified in internal medicine and
    medical oncology, with 35+ years of medical, clinical, and pharma research and development experience.

EXPERTISE

Pharma Research / Development, Clinical Strategy / Plans, Trials Design / Writing / Management / Conduct (Phases 1-3), Protocols, Regulatory Interactions (NDAs, INDs, special protocol assessments), Medical Affairs, Licensing, and Sales Support. Therapeutic Areas: Oncology and internal medicine. Has 50 publications, 53 abstracts, five book chapters, and six letters to the editor. BA -Haverford College; PhD – Brandeis University; MD – University of Miami School of Medicine. Academic Posts: University of Pennsylvania, Yale School of Medicine, Upstate Medical Center, and Case Western Reserve School of Medicine.

PROFESSIONAL EXPERIENCE

President, PhaseN Consulting, LLC
Provide medical/clinical consulting services for pharma development: Senior Advisor, Oncology for Novella Clinical and Therapeutic Advisor/Medical Monitor Consultant for SynteractHCR. Directing/funding basic research to purify and characterize small molecule responsible for asymptomatic weight loss in cancer patients. As Boston Life Sciences consultant, developed plan to evaluate Troponin as anti-angiogenic: wrote data brochure, designed Phase 1 trial, wrote protocol, and arranged for potential investigators. Consultant to: Aradigm, Boston Scientific, Alza Corporation, J & J PRD-US, Forest Research Institute, Incyte Corporation, PharmaNet, MDS Pharma Services, Sopherion Therapeutics, Sapphire Therapeutics, DelCath, CarboMed, Hybridon, Purdue Frederick, and Bayer.

Senior Medical Director, Novella Clinical

Executive Medical Director, Clinipace Worldwide

Executive Medical Director, Global Head Oncology, MDS Pharma Services

Associate Director for Clinical Trials, Yale Cancer Center

Senior Director, Global Medical Affairs, Pfizer, Inc.
Interfaced between early development and medical affairs with input on new drug development. Managed investigator-initiated grants program and publications for early development compounds. Member of core team to evaluate potential licensing opportunities. Supported field reps with updates on early development efforts and slide sets for KOLs.

Senior VP, Clinical Development, Protarga, Inc.
Responsible for developing clinical strategy for the taxane analog Taxoprexin. Developed Phase 3 program and provided critical interaction with FDA for end of Phase 2 and Special Protocol Assessment.

Senior Medical Director/Global Product Team Physician, AstraZeneca Pharmaceuticals
Global Product Team Physician Gateway Team for anti-angiogenic compounds. Designed Phase 2 program and wrote protocols. Project Physician for ZD1839 (Iressa) for prostate cancer.

Director, Clinical Cancer Research, Bristol‑Myers Squibb Pharmaceutical Research Institute
Aclacinomycin – A: Designed and wrote Phase 2 trials and protocols (discontinued). Anagrelide: Designed, wrote, conducted, and analyzed Phase 2/3 program. Met with FDA to develop registration program. Drug NDA filed by licensee Robert’s Pharmaceuticals, based on BMS Data. Elsamitrucin: Designed wrote, and supervised Phase 1/3 trials. Determined weekly schedule for Phase 2 and identified single agent activity in refractory non-Hodgkin’s lymphoma. Etoposide Phosphate: Designed, wrote, and conducted Phase 1-3 clinical trials. Wrote clinical section of NDA: filed in 1994, drug approved in 1996. Part of team responsible for NDA of ddI. Member of licensing committee for new cancer drugs including docetaxel.

Cofounder, BLM Group

Ran closely-held private research and development company focusing on finding small molecules that mobilize lipids from human adipocytes. Filed first patent application and submitted SBIR to support basic research program to identify normal mammalian hormones which activate alternative regulatory pathway for adipocytes.

 

VIEW ALL EXPERTISE

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