Strategic NonClinical Solutions LLC
Common sense solutions for drug development.
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Expertise

More than 20 years of experience working with biotechnology professionals

Expertise

 

Here at Strategic Nonclinical Solutions, we have more than 20 years of experience working with biotechnology professionals to support drug development programs in various areas, including pharmacology, bioanalytical, toxicology and pharmacokinetics. Our work is driven by common sense strategies and industry-related business advice, which are specially designed to further corporation’s pipeline actions and minimize development costs.

 


DYAX CORP. 2007  2016
Senior Vice President, Pharmacology and Preclinical Development

  • Design and implement corporate strategies for the development and registration of novel therapeutics
  • Drive internal pipeline activities in collaboration with company executives and Research functional area heads including accountability for headcount, timelines, and budget
  • Evaluate internal drug candidates/targets and provide critical input to maximize viability of Development programs
  • Direct the design and conduct of in vivo pharmacology studies and both GLP and non-GLP IND-enabling and registrational preclinical development studies
  • Management of multiple functional areas including bioanalytical, pharmacology, toxicology, and pharmacokinetics
  • Design, lead and implement Regulatory drug development strategies
  • Author and review/edit program-specific Regulatory inquiries

 


Biogen Idec (Biogen) 2002 – 2007
Senior Director, Pharmacokinetics and Drug Metabolism

  • Established Pharmacokinetics and Drug Metabolism Group and managed nonclinical and clinical activities in support of both biologic and small molecule development programs
  • Leadership of small molecule ADME screening activities to support Research-stage programs
  • Critical analysis of both nonclinical and human clinical pharmacokinetic and pharmacologic data
  • Management of budget, headcount, and program prioritization
  • Direct supervision and mentoring of scientists and project coordinators
  • Active support of business development through critical reviews of in-licensing opportunities

 


BIOGEN InC 1996 – 2002
Preclinical Development

  • Leadership of program-specific preclinical development activities including the design, implementation, and completion of IND-enabling toxicology, toxicokinetic, and pharmacokinetic studies
  • Author of regulatory submissions, including INDs, CTAs, and BLAs
  • Direct responsibility for program-specific Regulatory inquiries
  • Critical analysis of human clinical pharmacokinetic and pharmacologic data
  • Direct supervision and mentoring of scientists and project coordinators
  • Oversight of program-specific preclinical development activities including the design, implementation, and completion of IND-enabling toxicology, toxicokinetic, and pharmacokinetic studies
  • Generation of Regulatory submissions, including INDs, CTAs, and BLAs
  • Direct responsibility for program-specific Regulatory inquiries
  • Direct supervision and mentoring of scientists and project coordinators
  • Participated in program-specific preclinical development activities including the design, implementation, and completion of IND-enabling toxicology, toxicokinetic, and pharmacokinetic studies

 


Hoechst-Roussel Pharmaceuticals Inc. 1994 – 1996
Pharmaceutical and Analytical Development

  • Introduction of biopharmaceutical approach to aid in the identification of new chemical entities that were bioavailable after oral administration using both in vitro and in situ experimental models
  • Development of oral dosing strategies that maximized the bioavailability and therapeutic performance of lead compounds based on their in vitro and in vivo behavior
  • Formulation and development of both immediate- and sustained-release oral dosage forms
  • Identification and development of new technologies and processes for use in solid dosage applications

 


Warner Lambert/Parke Davis 1993 – 1994
PHARMACOKINETICS AND DRUG METABOLISm

  • Development of experiments to evaluate the potential of a novel prodrug (Fosphenytoin) as an oral therapeutic agent
  • Assessment of in vitro stability of drug candidate in various intestinal fractions to characterize the rate of conversion of the prodrug to the active form
  • Conducted in vivo studies to assess pharmacokinetics of parent and prodrug