Pharmaceutical Drug Development Expert Specializing in FDA and ICH Quality and Compliance

Technical Consultant #1646

Managing pharmaceutical operations, process and analytical methods development.
New pharmaceutical product formulation development, scale-up, process start-up, optimization and troubleshooting.
FDA-recognized expert in formulation development and technology transfer.
Pharmaceutical licensing, Regulatory Affairs (CMC), quality systems and staff management.

Undisclosed Company, Consultant, 2009 - Present

Consulted on pharmaceutical development, CMC and quality systems issues.
Managed complete development programs.
Wrote CMC sections of INDs and NDAs.
Implemented process optimization for formulations and resolved manufacturing issues.
Resolved quality systems issues with respect to pharmaceutical development as part of remediation of FDA 483 citations at a generic company.

Tobira Therapeutics, Princeton, NJ, Vice President, Pharmaceutical Development, 2008 - 2009

Managed manufacturing development and transfer of manufacturing technology and processes to third parties for new anti-HIV clinical stage compounds.
Wrote RFP's for API and drug product manufacturing, identifying companies for technology transfer and scale-up of both API and drug product for Phase 2b studies.
Prepared relevant documentation and timelines for synthesis, optimization and manufacturing.
Provided scientific direction to CRO's for analysis, manufacturing and packaging clinical trial materials, allowing for on-time delivery for Phase 1 and 2a clinical studies.

Barrier Therapeutics, Princeton, NJ, Vice President, CMC, 2006 - 2008

Supervised pharmaceutical development and manufacturing activities from proof of concept through regulatory filing and product support.
Participated in new technology and licensing, as well as acquisition assessments.
Wrote CMC section of NDA for oral dosage dermatological product.
Troubleshot drug manufacturing issues with contract manufacturer, ensuring on time commercial market introduction.
Evaluated, oversaw and coordinated synthesis and, or manufacture of drug substances.
Facilitated preparation of non-clinical and clinical supplies.

Organon, West Orange and Roseland, NJ, Executive Director, 1995 - 2006

Global Business Development and Pre and Early Clinical Development Laboratories

Supported life cycle management utilizing drug delivery systems for global venture, proof of concept and therapeutic area teams.
Coordinated 4 life cycle management deals introducing Organon drugs into new delivery systems.
Lead partnering and divestiture of closed loop infusion device.
Led and directed cross-functional due diligence team for licensing a new analgesia drug product.
Facilitated priority setting and decision-making process on exploratory portfolio
Wrote 2 business plans for development of new biotech compound and proprietary new drug delivery technology.
Directed drug development programs for oral contraceptives, fertility agents, intravenous anesthetics and neural muscular blocking agents.
Directed formulations development, analytical development, stability, quality systems and clinical packaging groups and achieved successful regulatory approval for 20 new drug products and 14 regulatory filings.
Oversaw the on-time availability of 1100 shipments of clinical supplies.
Implemented an international technology transfer procedure designed to reduce product development time.
Co-leader to resolve FDA warning letter issues, insuring compliance and supervised successful ISO 9001 audit and follow up audits for pharmaceutical drug development.

Hoffmann La Roche Inc., Nutley NJ, Research Leader, 1990 - 1994

Pharmaceutical Operations

Managed and administered the operation of Process and Technical Development, including new product scale-up, process development (biotech, sterile, tablet/capsule, suspension and emulsion products), process improvement, cost reduction, new process start-up and development, manufacturing process troubleshooting and product transfer to alternate manufacturing sites.
Developed FDA-recognized standard operating procedure for technology transfer and scale-up, development, facilitating pre and post approval inspections.
Identified by FDA as expert in the scale-up of encapsulated dosage forms and lectured to FDA inspectors.
Brought 25 new products to market on time and within budget.
Coordinated over 20 products in development in both Nutley and Puerto Rico, including cardiovascular, anesthetic, anti-viral, antibiotic, and dermatological compounds.
Developed strategic plan, set policy, approved major capital expenditures and established promotional guidelines, as member of Pharmaceutical Operations Management Team.

Bristol Myers Company, Princeton, NJ, Section Head, 1983 - 1990

Pre-formulated, formulated, and developed OTC and generic products.
Introduced generic products into manufacturing facilities, domestic and abroad.
Improved vitamin product line, increasing yield by 10%, utilizing statistical process control techniques.
Substituted raw material sources in Theragran M%uFFFF realizing a savings of over $500,000 annually.
Formulated and supervised the development of the first 3 vitamin products for manufacture in China.
Supervised the preparation of 16 ANDA products and prepared 14 manufacturing and technical packages required for ANDA submissions.
Designed, developed and coordinated installation and validation of instrumentation and equipment for 14 thousand sq. ft. pharmaceutical development and analytical laboratory.

Lederle Laboratories, Pearl River, NY, Research Scientist, 1979 - 1983

Formulations Research and Development

Pre-formulated, formulated, and developed new clinical leads, OTC and generic products, tablets, capsules and controlled release products.

Academic and Professional Affiliations

Publications and Patents

Speaker for Center for Professional Advancement in Process Development (Solids), Amsterdam, The Netherlands, U.S.
Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Co-Chairperson, International Symposium
U.S. and European patent - chewable tablet.