Pharmaceutics Consultant Specializing in Formulation of Ophthalmic, Respiratory, Nasal, and Dermatological Products; CMC Regulatory Planning, Execution and Writing

Technical Consultant #1730

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

Credentials

Academic and Professional Affiliations

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