Experience

Sionna Therapeutics
• United States
• Biotechnology
• 1 - 100 Employee
• VP DMPK

  • Mar 2023 - Present


Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Consultant for Project Out-Licensing

  • Oct 2022 - Present

  Consulting to out-license an oncology project for which I was the project leader through development candidate identification to IND enabling stage. Actively interacting and vetting interested parties, presenting program status and clinical strategy has resulted in ongoing, advance Business Development contract negotiations. Consulting to out-license an oncology project for which I was the project leader through development candidate identification to IND enabling stage. Actively interacting and vetting interested parties, presenting program status and clinical strategy has resulted in ongoing, advance Business Development contract negotiations.



FORMA Therapeutics, Inc.

• Director/Executive Director of DMPK, Clinical Pharmacology and Safety

  • Mar 2018 - Oct 2022

  Reported to Chief Medical Officer serving as strategic leader and subject matter expert in nonclinical development of novel therapeutic agents from early discovery to clinical development across pharmacology, toxicology, and pharmacokinetics, including regulatory submissions and health authority interactions. Created and led cross-functional team including PhD level PK / PD modeler, MS level DMPK project representative, PhD level toxicologist, and MS level clinical pharmacologist. Actively contributed to portfolio growth by proposing novel targets in hematology and target validation strategy/criteria. Led oncology project through Lead Optimization and into IND enabling. Show less



Ironwood Pharmaceuticals

• United States
• Biotechnology Research
• 200 - 300 Employee

• Director DMPK

  • Apr 2013 - Mar 2018

  Managed Discovery and Development DMPK Team of 18 providing project strategy and in-vitro ADME / in-vivo PK compound profiling and setting ADME / PK, PKPD criteria for development candidate nomination. Led early clinical development strategy, selection of FIH doses, generation and timely delivery of IND packages, and provided Clinical Pharmacology support through Ph1a/b to Ph3 by coordinating with consultants and inhouse clinical research. Project representative as DMP Core Team member on Early and Lead Optimization stage projects prosecuting soluble-guanylate-cyclase (sGC) stimulators for treatment of pulmonary hypertension and exploring novel indications. Show less



boehringer-ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director

  • Sep 2010 - Mar 2013

  Managed in vitro ADME Group individual and team performance for total of 5 direct reports in support of infectious disease drug discovery projects. Provided scientific and technical guidance to 4 bench scientists and 1 PhD level project representative in areas of metabolism, biotransformation, absorption, and PKPD. As part of leadership team, met regularly with all team leaders ensuring DDSG providing highest quality support for projects. Managed in vitro ADME Group individual and team performance for total of 5 direct reports in support of infectious disease drug discovery projects. Provided scientific and technical guidance to 4 bench scientists and 1 PhD level project representative in areas of metabolism, biotransformation, absorption, and PKPD. As part of leadership team, met regularly with all team leaders ensuring DDSG providing highest quality support for projects.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Scientist II

  • 2001 - 2010

  Led DMPK team of 9 in vitro ADME scientists managing performance and driving scientific innovation within group. Onboarded and mentored junior PhD scientists in biotransformation, metabolism, and project representation. Provided scientific and strategic leadership to LO projects project teams in CNS area (schizophrenia, mood disorders). As Core Team member for the GAB2/3 partial modulators project, I actively contributed ADME and PKPD strategic support to the selection and advancement of two development candidates to Phase I clinical trials. Led in vitro Metabolism Global Network and contributed to generation of strategy documents and of assay validation guidelines for CYP induction / inhibition and for drug transporter assay development. Developed new in vitro assays to measure CYP induction. Contributed to standardization and improvement of hepatocyte metabolism assays. Provided global teams with tools to develop key cell-based transporter assays.  Represented DMPK as core team member of LO projects providing scientific leadership in ADME / PKPD, driving identification and progression of high-quality candidates for development (CD). Provided support to clinical teams during Phase I and Phase II providing PKPD translational strategy and contributing to clinical trial design to test DDI and early efficacy readout. Show less



DuPont Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Research Scientist - Drug Metabolism and Biopharmaceutics

  • Aug 1996 - Nov 2001

  As a DMPK Discovery Support and Project team representative I implemented use in vitro ADME assays (metabolism, P450 and drug transporter interaction and passive permeability screens) across early discovery. Took on role of Laboratory head supervising 1 research associate and 1 research scientist. As DMPK representative to early phase I Sustiva / Efavirenz Project team I collaborated with Safety and Biotransformation scientists to contextualized metabolism based, species-specific kidney toxicity and CYP3A4 inhibition potential for drug-drug interactions enabling backup molecule strategy while still progressing Efavirenz to clinical trials. Contributed to IND and EU regulatory submission documents by compiling in vitro P450 interaction and biotransformation packages. As DMPK representative to Cardiovascular Project team - I supported discovery of Losartan, first-in-class angiotensin II convertase inhibitor, by implementing in vitro pro-drug screen in collaboration with medicinal chemistry to identify Losartan, as the alcohol pro-drug of the active but poorly permeable acid. I worked across functions to build translation of pro-drug conversion in rats and humans. Losartan progressed to market, transforming standard of care in hypertension. Compiled, retrospectively, discovery DMPK data for Losartan regulatory submissions. Show less