HMD Pharmaceutical Consulting LLC

Industry Experience

McNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON, Morris Plains, NJ 2006 – 2008 – Senior Director, Medical Affairs
• Managed record-setting $465MM Rx/OTC switch of Zyrtec® including FDA submissions
• Successfully defended challenges to children’s’ cough-cold products to continue marketing

PFIZER CONSUMER/WARNER-LAMBERT, Morris Plains, NJ 1998 – 2006 – Senior Director, Medical Affairs and Clinical Research
• Managed Phase II-IV clinical research group and Phase I clinical trials unit in Sweden
• As senior member of global medical department assigned increasing responsibilities including leader of upper respiratory, eye care, tobacco dependence therapeutic areas; developed robust pipeline and successful new claims
• Conducted effective clinical research in all these areas with $10MM annual budget
• Managed EU medical affairs group in UK and supported major global medical brands Nicorette, Benadryl, and Sudafed with frequent presentations to regulatory agencies, advertising review, claims development and defense, litigation support and sales training

WHITEHALL-ROBINS DIVISION OF WYETH, Madison, NJ 1996 – 1998  -Director, Clinical Research and Medical Affairs
• Represented U.S. OTC industry at WHO in Geneva and successfully defended initiative to delist ephedrine resulting in continued sales of $32MM per year
• Provided regulatory and medical support for challenging drugs e.g. inhaled epinephrine, ephedrine, brompheniramine, with active participation in CHPA to allow continued marketing.
• Medical member of team for successful Rx/OTC switch of Axid AR® (nizatadine)

HOFFMANN-LaROCHE Inc, Nutley NJ 1992 – 1996 – Associate Director, Clinical Research
• As medical monitor for pivotal Phase III clinical trials leading to successful NDA for Xenical® (orlistat), introduced innovative strategies for subject retention; supervised team of 17; medical terms glossary officer for entire global project
• Responsible for U.S. centers of international pivotal Phase III protocols for acetyl-l-carnitine for diabetic peripheral neuropathy: set new company standards for subject accrual
• Designed and supported Phase II/III international protocols for LTD4 Antagonist for asthma and rhinitis: prepared budgets; conducted pre-study site visits, investigators’ meetings and safety review
• Member of international teams to develop VIP Analog and IL-12 for asthma, and intranasal steroid for allergic rhinitis