Scientific Advisory Board Hibernaid In the News

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Stephen J. PettiStephen J. Petti
Chief Executive Officer

See expanded bio on Company Management page.

Email him at sjpetti@hibernaid.com

 

Laurence Katz, M.D.Laurence M. Katz, M.D.
Founder, Chief Scientific Officer, Chief Medical/Scientific Consultant to the CEO

See expanded bio on Company Management page.

Email him at lkatz@hibernaid.com

 

Pia Mikkelsen Lynch, M.D.Pia Mikkelsen Lynch, M.D.
Chief Medical Officer and Director of Clinical Operations

Pia Mikkelsen Lynch, MD serves as the Company's Medical/Clinical Advisor and as the Safety Officer for our studies. She was formerly Vice President of Global Clinical Affairs of Novoste Corporation, and Director of Clinical Research of Élan Pharmaceutical Research Corporation, prior to founding Lynch Consulting Group, Inc. where she is the President & Managing Director providing the industry with medical/clinical services. Dr. Lynch has 18 years of international clinical drug, device and biologics development experience. Over the course of her career serving both pharmaceutical and device companies as well as CROs she has participated in five successful NDAs/PMAs covering a wide range of therapeutic areas.

Email her at plynch@pmlmedical.com


Kathryn M. Martin, PharmDKathryn M. Martin, Pharm.D.
Director, Drug Development

Dr. Martin joined Hibernaid in July 2010 with nearly 25 years of experience in clinical trial management and regulatory affairs. She heads up the company's Regulatory Affairs effort, as well as medical writing and scientific communications. Dr. Martin holds a BS in Pharmacy from Northeastern University and a Pharm D from the University of Texas in Austin. She completed residency training in oncology pharmacy practice at the Audie Murphy VA Hospital and was among the first clinical pharmacists in the United States to become certified by the American Society of Health Systems Pharmacists. Kate has experience in a range of areas within pharmaceutical development, including medical writing, regulatory affairs, and IND/NDA/BLA development and filings. This experience includes interpreting clinical and statistical data, writing of clinical and regulatory documents, and development/execution of scientific communication plans. She has previously served as a consultant to Novartis, Amgen, Teva Pharmaceuticals, Wyeth Ayerst and Drais Pharma. She is the founder and president of Glenmere Research in Montebello NY, an independent contract firm specializing in medical writing and regulatory affairs.

Email her at kmmartin@hibernaid.com


Melissa BarronMelisa K. Barron, Ph.D.
Director, Chemistry, Manufacturing and Controls/Formulations Development

Melisa Barron joined Hibernaid in 2012 with over 20 years of industry experience as scientific contributor and management. She heads the Company's CMC and formulations areas. Dr. Barron holds a B.S. degree in Chemistry and obtained her Ph.D. in Pharmaceutical Sciences at the University of Texas at Austin specializing in preformulation and formulation techniques for drug delivery of biologics and poorly soluble small molecule therapeutics. Dr. Barron has held key development team and leadership positions at Theravance and Affinium Pharmaceuticals responsible for managing technical consultants and contract manufacturing and research organizations to support non-clinical and Phase I/II/III development of novel, small molecule antibiotics. As senior scientist at Theravance, Dr. Barron was principal to the successful NDA submission and approval for marketing and commercialization of the new drug product, VIBATIV™ (Telavancin®) for Injection in September 2009. She is the author of many research articles in peer reviewed scientific journals and has delivered several presentations at scientific conferences in the US and abroad. Most recently, Dr. Barron is owner of an independent contract consulting firm providing professional pharmaceutical development consulting services with expertise in drug delivery, manufacture of clinical trial materials and regulatory submissions.

Email her at mkbarron@hibernaid.com


Sydney GilmanSydney Gilman, Ph.D.
Director, Regulatory Affairs

Sydney Gilman joined Hibernaid in 2012. Dr. Gilman is a former FDA Chemistry reviewer who spent 6 years at FDA in various CDER Therapeutic Drug Divisions of the Center for Drug Evaluation and Research with consulting ties to both Biologics and Devices. Dr. Gilman also has an additional 20 years of experience in the pharmaceutical industry in positions ranging from Senior Scientist to Director to Vice President responsibilities. He earned his Ph.D. in Organic Chemistry from the University of Pittsburgh.

Email him at SYDGILMAN@aol.com


Samn RaffanielloSamn Raffaniello
Director, Administration and Project Services

See expanded bio on Company Management page.

Email her at samn@hibernaid.com