Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Research Fellow

  • Jun 2015 - Present

  Cambridge, MA • Design and conduct all IND and NDA enabling studies (ADME, TK, PK and in vitro) at the CROs. Review all study reports and ensure that all critical studies are completed with regulatory submission quality work. • Provide metabolism data and scientific scholarship to early discovery programs to select molecules with optimal ADME properties. • Use bottom-up approach including SimCYP and Gastro plus to predict/simulate DDI potential of development candidates • Conduct critical… Show more • Design and conduct all IND and NDA enabling studies (ADME, TK, PK and in vitro) at the CROs. Review all study reports and ensure that all critical studies are completed with regulatory submission quality work. • Provide metabolism data and scientific scholarship to early discovery programs to select molecules with optimal ADME properties. • Use bottom-up approach including SimCYP and Gastro plus to predict/simulate DDI potential of development candidates • Conduct critical regulatory studies with right experiments at the right time in a cost effective way • Write/review preclinical sections of IND/IB and nonclinical drug metabolism and pharmacokinetics and clinical pharmacology modules for Common Technical Document to support regulatory NDA filings • Provide timely response to regulatory queries related to DMPK, DDI and clinical pharmacology • Provide Toxicokinetic and formulation support for development candidates • Investigate and evaluate cutting edge technologies for drug metabolism, PK and DDI and radiolabeled ADME studies in preclinical species and humans • Visit, evaluate and identify CROs for metabolite ID, radiolabeled ADME studies, in vitro metabolism, CYP /transporter inhibition/induction and clinical studies

• Senior Research fellow

  • Jun 2015 - Present

  Cambridge, Massachusetts, United States



CPPharma Consulting

• Principal Consultant

  • Apr 2015 - Jun 2015

  Nort Andover, MA Consulting for drug metabolism/pharmacokinetics/clinical pharmacology/bioanalytical from discovery (Lead optimization and selection of development candidate) to registration. Review/design of study protocols for both preclinical and clinical studies including (FIH, SAD/MAD, combo, DDI, food effects, organ impairment, radiolabeled ADME). Reviewing and interpretation of drug metabolism, clinical and PK/TK study results. Writing and reviewing regulatory documents (IND/CTA, IB, eCTD) and preparing… Show more Consulting for drug metabolism/pharmacokinetics/clinical pharmacology/bioanalytical from discovery (Lead optimization and selection of development candidate) to registration. Review/design of study protocols for both preclinical and clinical studies including (FIH, SAD/MAD, combo, DDI, food effects, organ impairment, radiolabeled ADME). Reviewing and interpretation of drug metabolism, clinical and PK/TK study results. Writing and reviewing regulatory documents (IND/CTA, IB, eCTD) and preparing responses to regulatory queries Show less



Biogenidec

• Senior Director

  • Jul 2008 - Mar 2015

  Cambridge, MA • Manage the biotransformation group within drug metabolism and preclinical safety. Help to foster an intellectual environment in which a high level of scientific and interpretative ability is expressed and applied effectively to the discovery of novel drugs • Prepare preclinical DMPK summaries for IND/IB/EOP2, response to regulatory queries  Serve on the drug metabolism department senior leadership team. Identify, interview and hire talented scientists. Coordinate evaluations of new… Show more • Manage the biotransformation group within drug metabolism and preclinical safety. Help to foster an intellectual environment in which a high level of scientific and interpretative ability is expressed and applied effectively to the discovery of novel drugs • Prepare preclinical DMPK summaries for IND/IB/EOP2, response to regulatory queries  Serve on the drug metabolism department senior leadership team. Identify, interview and hire talented scientists. Coordinate evaluations of new technologies and techniques, set budgets, and make recommendations for new equipment purchase. • Identify best practices, internally and through liaison with other scientific leaders and led best practice discussions.  Design and conduct experiments for ADME studies of drugs in laboratory animals and humans using radiolabeled and non-labeled drugs in support of Discovery and Development.  Interact with other functions regarding enabling activities, drug analysis, preclinical and clinical pharmacokinetics, safety assessment, isotope chemistry, medicinal chemistry, and contract research organizations etc.  Represent DMPK discipline on due diligence teams for in-licensing drug candidates. Write very detailed due diligence reports outlining the DMPK related issues and studies needed to mitigate these issues if we go forward to licensing Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Fellow

  • 2000 - 2008

  Groton, CT 06340 Built from scratch and managed the biotransformation group Represented drug metabolism/pharmacokinetics (DMPK) line on Project and Program teams from several therapeutic areas ( Immunology, inflammation, central nervous system, cardiovascular and metabolic diseases and oncology) Led the Global Biotransformation Group up to 40 scientists. Enhanced close interactions and provided opportunities of shared learning within and across four sites Assisted medicinal chemists to facilitate the… Show more Built from scratch and managed the biotransformation group Represented drug metabolism/pharmacokinetics (DMPK) line on Project and Program teams from several therapeutic areas ( Immunology, inflammation, central nervous system, cardiovascular and metabolic diseases and oncology) Led the Global Biotransformation Group up to 40 scientists. Enhanced close interactions and provided opportunities of shared learning within and across four sites Assisted medicinal chemists to facilitate the successful achievement of lead optimization programs and the rapid and efficient progression of drug candidates in preclinical development Designed and conducted experiments for in vitro/in vivo ADME studies of drugs in laboratory animals and humans using radiolabeled and non-labeled drugs in support of Discovery and Development. Mentored and Coached Ph.D., MS and BS Scientists of all development levels necessitating different situational leadership styles. Prepared preclinical DMPK summaries for IND/IB/EOP2, response to regulatory queries. Participated in writing CTD of six compounds for NDA/MAA submission and wrote DMPK section of IND and IB of more than fifteen candidates. Contributed to bring four products in market and five in Phase III Served as a primary expert and provided guidance and advice in biotransformation sub-disciplines of DMPK to project teamsRepresented DMPK discipline on due diligence teams for in-licensing drug candidates. Contributed to several In-licensing late phase compounds

• Associate Research Fellow

  • 1996 - 2000

  Groton, CT 06340



Pfiizer

• Senior Investigator

  • 1992 - 1995

  Groton, CT 06340



Vanderbilt University

• United States
• Higher Education
• 700 & Above Employee

• Research Instructor/Assistant/Associate Professor/Associate Director of Mass Spectrometry Center

  • 1985 - 1992

  Nashville, TN Directed research in synthetic and bioanalytical chemistry and xenobiotics metabolism. Developed highly sensitive and specific analytic methods for eicosanoids, cardiovascular and CNS drugs and their metabolites. Developed mass spectrometry techniques for the identification of metabolites Prepared stable isotope and radiolabeled compounds for metabolic studies. Developed GC/MS and HPLC methods for the quantitative analysis of both drugs and endogenous compounds. Supervised… Show more Directed research in synthetic and bioanalytical chemistry and xenobiotics metabolism. Developed highly sensitive and specific analytic methods for eicosanoids, cardiovascular and CNS drugs and their metabolites. Developed mass spectrometry techniques for the identification of metabolites Prepared stable isotope and radiolabeled compounds for metabolic studies. Developed GC/MS and HPLC methods for the quantitative analysis of both drugs and endogenous compounds. Supervised research assistants (BS and MS), post-doctoral fellows and graduate students. Show less



University of Maryland

• United States
• Higher Education
• 700 & Above Employee

• Faculty Research Associate

  • 1979 - 1985

  College Park, MD Performed research on the analysis and synthesis of biologically and membrane active molecules. Synthesized inhibitors and substrates for enzymes involved in the glycoprotein biosynthesis. Elucidated structures of radiolabeled oligosaccharides by enzymatic and chemical degradation. Supervised graduate and undergraduates