Pharmaceutical Product Development Specializing in Sterile Parenteral, Inhalation and Topical Drugs (1332)
Expertise
Sterile pharmaceutical product development bringing over 50 sterile products to worldwide markets.
Parenteral suspension - products commercialized based on development and issued patents.
Inhalation and topical aerosols - developed Merck's first inhalation aerosols, and other inhalation systems.
Considerable lyophilization experience bringing several products to market.
Aseptic powder filling - developed and brought major antibiotic products to market.
Quality assurance - set up QA systems for start-up company.
Assembling CMC Data for IND and NDA submittals interacting with FDA.
Design sterile facilities - pilot plants/small commercial facilities.
Experience
Independent Consultant 1999 - Present
Consultant for the pharmaceutical Industry.
Specializaton in steril producs, parenteral supensions, lyophilization, and inhalaton and topical aerosols.
Start Up Pharmaceutical Company, Monmouth Junction, NJ 2000 - 2005
Co founder of stat up company withdrug delivery by inhalation. Held many key positions: Executive Director of Development, Executive Director of Quality Assurance; presented the company's science to potential investors and Co-Chairman of the Scientific Advisory Committee.
Brought two new aseptically produced sterile formulations to IND stage in less than three years. Responsible for interfacing with outside pharmacology, toxicology, medical and regulatory.
Designed laboratories and initiated and built a seminal quality assurance department
Managed sterile product development and analytical research and development.
Participated in writing CMC Section of two IND's.
Genaera Corporation, Plymouth Meeting, PA Executive Director Manufacturing 2003 - 2004
Advised on formulation of lyophilization products.
Advised on compatible sterile packaging components and their assessment for suitability.
American Pharmaceutical Partners, Inc. (APP), Director- Pharmaceutical Sciences 1995 - 1998
A multisource parenteral product company which develops, manufactures, distributes pharmaceutical products.
Led efforts of formulation development scientists to bring multisource parenteral products into the market.
Several products were developed and submitted as ANDAs: Cefoxitin, Cefuroxime, Cefotaxime, Iopamidol Injection, Acylovir Liquid Injection, Haloperidtol Decanoate for Injection, Clonidine Injection, Dipyridamole Injection, Dacarbazine for Injection, and Oxytocin. Interacted with marketing, business development, medical information, QA, QC and manufacturing sites.
Transferred products and processes to plants. Input CMC sections of ANDAs
Applied for patents for unique processing of Acyclovir Liquid, Midazolam, and Paclitaxel Injections.
Recruited, attracted and hired 50% of the staff.
Actively trimmed the established procedures to hasten the development time line.
Participated in an advisory capacity in licensed in amphotericin liposome and new encapsulated anti-cancer product being developed by the parent company of APP.
Responded to FDA inquiries, through regulatory affairs as well as via direct contact.
Schein Pharmaceutical, Phenoix, AZ., Corporate Consultant, 1995
Familiarized staff with corrective actions to improve suspension products.
Demonstrated improved processes for marketed suspensions, and initiated development of new suspension products.
Interacted with partner company (Bayer) to scale-up a proprietary product at Steris.
Participated in troubleshooting formulation problems, and developing of injectibles lyophillized powders, and ophthalmic multisource products.
The Liposome Company, Princeton, N.J. 1987 %u2013 1995
A biotech pharmaceutical corporation specializing in lipid and liposome delivery systems of parenteral products.
As Vice President of Development, responsible for product development efforts based on unique biophysical drug delivery system involving lipid or liposome based formulations of active drug moieties.
As Executive Director, Development, responsible both pharmaceutical R&D and analytical R&D.
As Director of Development responsible for building and managing a pharmaceutical-research and development group to develop a number of sterile products from the formulation and early processing stages, into IND, manufacture and distribution.
Evaluate and purchased equipment and raw materials. Developed cGMP/GLP practices and necessary documentation.
Merck Sharp & Dohme, West Point, PA 1961- 1987
Various management and professional positions over a 26 year career.
Focus on formulate and scale to production of a number of inhalation aerosol, topical, and suppository dosage forms.
Interact and communicate widely with multi-disciplinary groups throughout the company, both domestic and abroad. Responsible for worldwide development of all sterile pharmaceutical products at Merck Travel widely for the company.
Interact with outside groups, including the FDA.
Honors & Publications
Numerous Patents and publications
Pharmacy Licensure in PA, NJ, FL and AZ
Education
Ph.D. Program - all course work completed, Temple University
M.S. Physical Pharmacy, Temple University
B.S. Pharmacy, Temple University