Bucks Consulting, Millbrae, CA, Dec 2010 to present
Position: Founder
I founded Bucks Consulting to provide others guidance in their development of topical (dermatological) products. Services include consultation regarding: compound feasibility for topical product development, potential formulation strategies and clinical indications in addition to non-clinical and clinical strategies for product approval as either a cosmetic, OTC or prescription.
Valeant Pharmaceuticals, North America, (Dow Pharmaceutical Sciences, Petaluma, CA) Sept 2001 to Oct 2010
Position: Director – Skin Biology / Drug Transport Department
As founder and head of the Skin Biology / Drug Transport Department, I was responsible for this department consisting of the drug transport laboratory and personnel utilized for the in vitro and in vivo evaluation of new topical formulations associated with internal (Dow) product development and with client products under contract. I functioned as the resident expert in skin biology to help guide topical product development efforts. In addition to leading Product Development Teams, I worked closely with our Clinical Department in the design and interpretation of human studies. I was instrumental in training our Clinical Associates in protocol development and writing ICH clinical reports. I supported our Regulatory Department by developing non-clinical & clinical regulatory approval strategies and review of our FDA filings associated with the approval of prescription dermatological products. I was instrumental in Client project feasibility assessments and strategy decisions, as well as the development of intellectual property.
Bertek Pharmaceuticals Inc. (Penederm, Inc.) Foster City, CA, 1997 to 2001
Position: Associate Director - Head of the Drug Transport Department
As Head of the Drug Transport Group, I collaborated with the Formulations Group in developing and evaluating new topical formulations for dermatological disease targets. Using drug delivery profiles from established as well as novelin vitro and in vivo skin penetration models, our goal was to optimize drug delivery to achieve desired efficacy and tolerability. Our Group supported 10 product development teams and as a representative to these teams I provided skin biology expertise as well as formulation development guidance. I supervised 2 - 4 scientists and managed a departmental budget of $400,000.
As a Project Team Leader, I lead the product development strategy and provided project management for a new product concept for treating actinic keratosis. Milestones achieved included the development and selection of an appropriate formulation, selection of the commercial container/closure, negotiation of the preclinical program with FDA, negotiation of clinical endpoints with FDA and a successful IND filing. Working closely with Regulatory and Clinical Groups on this project, I authored the Briefing Book for the pre-IND meeting with FDA, participated in the Pre-IND meeting, as well wrote the Investigator's Brochure and the Previous Human Experience section and the Human Pharmacokinetics section of the IND. I reviewed and edited the CMC and Nonclinical Pharmacology and Toxicology sections. Other key responsibilities as Team Leader had included coordination with the physician inventors and lead clinical investigators as well as development of project time-lines and budgets.
As a resource and support to the Clinical Group, I served as the clinical project manager for Phase I/II studies: pharmacokinetic, dermal safety and pharmacodynamic vasoconstriction studies.
In support of the Marketing Group, I served as a scientific representative to the Promotional Review Roundtable Committee where my responsibilities were to assure scientific accuracy and provide advice on medical relevance of Marketing's scientific presentations, educational programs and promotional pieces. I was regularly requested to make technical presentations to managed care groups, formularies and key physicians and to provide technical and scientific training to sales representatives.
Penederm, Inc., Foster City, CA, 1991 to 1997
Position: Group Leader - Head of the Drug Transport Department
Head of the Drug Transport Department (responsibilities defined above). Project Team Leader of Core Technologies where we evaluated utility, patent status, regulatory (FDA) approval status and developed programs to support regulatory approval of skin deposition aids. In association with the Clinical, Toxicology and Regulatory Groups I wrote in vivo human, animal, and in vitro percutaneous absorption study summaries to support the safety of Penederm’s proprietary delivery compound, PP-2, in an approved NDA. In collaboration with the Formulations Group we developed the Avita Cream formulation of tretinoin approved by the FDA for the topical treatment of acne. As a member of the Licensing Project Team I evaluated the feasibility of potential topical drug product opportunities. These activities resulted in the licensing of a permethrin product, Acticin, at the pre-ANDA stage to be marketed as a branded product.
Pharmetrix Corporation, Menlo Park, CA, 1990 to 1991
Position: Senior Research Scientist and Group Leader - Skin Biology
Headed a drug transport research group to develop and evaluate topical drug delivery from new transdermal delivery systems (patches).