- Strategic CMC development and planning of ophthalmic, respiratory, and nasal products.
- Formulation development of ophthalmic, respiratory, nasal, and dermatological products.
- Manufacturing process development, technology transfer, and scale-up of ophthalmic, respiratory, and nasal products.
- Extractables and leachables testing planning and execution for ophthalmic, respiratory, and nasal products.
- CMC regulatory writer: Pharmaceutical development and stability reports; CMC sections for IND, ANDA, NDA, IMPD/CTX, and MAA as well as pre-IND and other regulatory meetings.
- Expert witness for ophthalmic and respiratory CMC.
- Contract laboratory and contract manufacturer identification and management.
- CMC due diligence for in-license candidates.
- API and excipient identification, sourcing, and qualification.
Undisclosed Company, President, 2006 - Present
- Provide consulting services in strategic CMC, pharmaceutical, and preclinical development plans and timelines.
- Formulation development of ophthalmic, dermatological, respiratory, and nasal drug products.
- Stability assessment program design, execution, and reporting; CRO/CMO identification, qualification, and management.
- API and excipient sourcing and evaluation; regulatory CMC planning.
- Manufacture of clinical trial materials; and manufacturing process development and technology transfer.
- Prepare reports for regulatory filings from IND to NDA.
- Write and edit CMC sections for INDs, IMPDs, and FDA meeting packages.
- Write and edit pharmaceutical development reports.
- Participate in interactions and meetings with regulatory agencies.
- Conduct due diligence in CMC area of various dosage forms.
- Serve as expert witness for CMC of ophthalmic and respiratory products.
Dey, LP, Napa, CA; Senior Director, Pharmaceutical Development, 2003 - 2006
- Led department responsible for formulation development, clinical trial materials supply, preclinical development, pilot operations, manufacturing process development, and technology transfer functions.
- Identified CROs for preclinical, clinical packaging and distribution, and contract manufacturing activities.
- Wrote CMC and preclinical documentation in support of 1 NDA, 2 ANDAs, 2 INDs, 2 sNDAs, 1 Canadian NDS, 1 IMPD, & 1 EU MAA.
- Participated in several FDA meetings (pre-IND and end of Phase II).
- Prepared preclinical and CMC recommendations for in-license opportunities (more than 10 candidates annually).
Santen, Inc., Napa, CA, 1994 - 2003
- Serving several positions: Director-Vice President, Pharmaceutical Development; Principal Director, Pharmaceutics and Technology.
- Led department responsible for formulation development, analytical chemistry, clinical materials supply, stability assessment, and preclinical function.
- Identified contractors to source manufacture of API and drug products, prepare clinical trial kits, conduct analytical and stability studies, and perform preclinical studies.
- Worked with peers at headquarters in Japan and European subsidiary to develop formulation and preclinical development strategies and execute technology transfer.
- Wrote, edited, and approved CMC and preclinical documentation for regulatory submissions. Interacted with FDA both in person, written, and telephone communications.
- Prepared and/or directed preparation of CMC sections of 5 INDs, 1 CTX, 3 approved NDAs, 1 NDS, 2 MAAs, and 2 sNDAs.
- Prepared recommendations following CMC review of in-license candidates.
- Guided process validation for API and drug products; participated in PAIs for API and drug product.
CoCensys, Inc., Irvine, CA; Director, Pharmaceutical Sciences, 1993 - 1994
- Guided preformulation, formulation development, stability assessment, clinical materials supply, and research QC functions in early stage development of neurosteroid and glystatin compounds.
- Initiated formulation development of 2 compounds (1 oral, 1 parenteral) in multiple presentations.
- Developed and managed relationships with consultants and contract analytical and manufacturing facilities for development projects.
- Wrote CMC sections for 2 INDs.
Allergan/Herbert Laboratories, Irvine, CA, 1982 - 1993
Manager - Director of Product Development, 1989 - 1993
- Guided formulation development, analytical chemistry, stability assessment, and research QC functions for skin care division.
- Developed formulations to meet global requirements including parenterals, solid (immediate and extended release), and topicals.
- Scaled up several products from laboratory through pilot to commercial scale manufacture; guided site transfer of three products from U.S. to Europe.
- Interacted with other discovery and development departments, manufacturing, business development and marketing.
- Interacted with FDA verbally and in person to gain registration approval.
- Responsible for preparation of CMC sections of 11 INDs, NDAs and NDSs and a CTX.
- Evaluate, recommend, and suggest products for potential acquisition.
- Developed and managed relationships with several third party contractors
Scientist-Section Manager, Pharmaceutics, 1982 - 1988
- Brought two significant ophthalmic projects to registration status in Europe and U.S.
- Developed oral formulation, with 2 1/2-fold enhanced bioavailability in animal model.
- Formulated stable, elegant ocular solution product of 2 physically incompatible antimicrobials and developed a lyophilization cycle for its manufacture.
Procyte Corporation, Redmond, WA; Director, Pharmaceutical Development, 1988-1989
- Designed formulation and analytical chemistry laboratory.
- Shared responsibility with one other person for preparation and filing of successful IND on lead compound.
- Contributed to contract negotiations on joint venture with a major pharmaceutical company.
Creighton University, Omaha, NE, School of Pharmacy, Associate Professor, 1980 - 1982
- Taught basic pharmaceutics, pharmaceutical technology, pharmacokinetics, and therapeutics courses.
- Developed self-instructional and videotape educational materials.
University of Illinois, Medical Center, Chicago, IL, Assistant Professor, 1974 -1980
Honors & Publications
- Registered Pharmacist, California and Illinois.
Academic and Professional Affiliations
- American Association of Pharmaceutical Scientists
- Parenteral Drug Association
Publications and Patents
- Author of numerous peered reviewed articles, educational text, and presentations.
- Two U.S. patents.
- MBA University of California, Irvine, CA
- Ph.D. Pharmaceutical Science, Oregon State University, Corvallis, OR
- M.S Pharmacy, University of Illinois, Medical Center, Chicago, IL
- B.S. Pharmacy, University of Illinois, Medical Center, Chicago, IL
- B.A. General Science (Chemistry and Biology), University of Rochester, Rochester, NY