pharmaceutical, pharmacokinetics and bioanalytical chemistry expert resume
Resume of REG, Ph.D. Consultant

  • Pharmaceutical
  • Pharmacokinetics
  • Bioanalytical Chemistry
  • GLP Compliance

This expert has a Ph.D. in Pharmaceutical Chemistry from the University of California in San Francisco, CA.

This expert has an M.S. in Pharmaceutics and a B.S. in Pharmacy from West Virginia University in Morgantown, WV.

Pharmaceutical, Pharmacokinetics and Bioanalytical Chemistry Expert Resume

This expert specializes in pharmaceutical science and management with advanced training in pharmacokinetics, drug metabolism, bioanalytical chemistry and GLP compliance applied to drug development.

This consultant has managed internal and external resources to develop new drugs or formulations in various therapeutic areas including hormone replacement, metabolic disease, transplant rejection, anti-infective, cardiovascular, CNS, and respiratory in a highly regulated environment.

This consultant is a focused and effective collaborator within multi-disciplinary teams that successfully led to more than 10 marketed prescription drugs. This expert was the Chief Scientific Officer and co-founder of a drug development organization funded by private and venture capital to develop an in-incensed synthetic estrogen for topical use.

Other related areas of specialization include intellectual property strategic planning, authoring of invention records for consideration as drug development candidates and patents, human bioavailability studies, bioavailability and efficacy reports and invitro testing.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in pharmaceutical science and management, pharmacokinetics, drug metabolism, bioanalytical chemistry and GLP compliance, and related expertise to a wide variety of clients.


Chief Scientific Officer, Hygeia Therapeutics, Holden, MA

Managed all scientific activities of the company including development of a detailed NCE development plan for a topical product through Clinical Phase IIa. Coordinated in-licensing evaluations and led intellectual property strategic planning.


Director, Drug Metabolism, Preclinical Development Operations, Sepracor Inc. Marlborough, MA

Managed outsourcing of all preclinical DM/PK development activities using a dozen or more contract research organizations for simultaneous development of multiple drug candidates. These activities include in vitro and in vivo metabolism as well as LC/MS/MS method development and validation in support of toxicokinetic assessment. Authored preclinical DM/PK sections of INDs and NDAs. Initiated and co-authored several invention records for consideration as drug development candidates and patents.


Pharmacokineticist, Hurley Consulting Associates Ltd., Chatham NJ

Collaborated with other pharmaceutical scientists to provide pharmacokinetics and bioavailability assessment for various clients using software tools such as WinNonlin Pro, NONMEM and SAS. Wrote the Human Pharmacokinetics and Bioavailability sections of NDAs and summarized animal TK and ADME studies for INDs. Designed and wrote protocols for human bioavailability studies. Trained document managers to write document shells for scientific reports from protocols. Assisted in the evaluation of a new drug delivery technologies.


Bioanalytics Unit Head and Group Leader, Physical Methods Laboratory, Analytical Biochemistry Section of the Drug Metabolism and Pharmacokinetics Department, Sandoz Research Institute/Novartis, East Hanover and Summit NJ

Was responsible for supervising BS and MS-level technicians and post-doctoral scientists developing and applying quantitative HPLC/UV/FL, GC/FID, GC/MS and LC/MS/MS bioanalytical methods in support of GLP studies. Designed and built the first GLP-compliant bioanalytical mass spectrometry laboratory within Sandoz. Pioneered the use of networked, automated quantitative LC/MS/MS. The first Sandoz MS lab networked for flexible data reduction and electronic data file transfer. Supported drug discovery work by developing fast generic LC/MS/MS methods in a non-GLP environment to produce preliminary exposure and relative kinetics on several families of drug discovery candidates. Authored and co-authored pivotal bioavailability and efficacy reports with clinicians, statisticians, and in vitro testing personnel. Responsible for writing the pharmacokinetic and bioanalytical sections of INDs and NDAs.


Senior Scientist, Drug Disposition, Astra Pharmaceutical Products, Inc. Westboro, MA

Designed pharmacokinetic studies in man and prepared study reports. Supervised 2 technicians to develop HPLC/UV bioanalytical methods. Operated a Finnigan GC/MS for qualitative and quantitative analyses. Coordinated pharmacokinetic and appropriate bioavailability studies for drugs under development.

This expert is the author of numerous publications and presentations in areas related to and including bioorganic and medicinal chemistry, pharmacotherapy, mass spectrometry, clinical pharmacology and therapeutics, biochemical medicine, pharmaceutic

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