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

Technical Consultant #1730


Expertise

  • 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.

Experience

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

Credentials

  • 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.

Education

  • 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
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