EMPLOYMENT 

Regeneron Pharmaceuticals, Inc.

Vice President Nonclinical and Clinical Bioanalysis

Nov 2023 - Present

Sana Biotechnology

Vice President Bioanalytical and non-Clinical Biomarkers 

Jan 2021 - Sep 2023 

Pfizer Inc. (previously Wyeth)
Last position: Senior Director   Regulated & Non-Regulated Bioanalysis, Biotherapeutics (2015 – 2020)

INDUSTRY ENGAGEMENT 

Active member of the AAPS organization with 20+ years of experience in working the various AAPS teams, including meeting programming, Biotech section leadership, Ligand Binding assay focus group leadership. Still interested in advancing global science by publishing and presenting at national and international conferences 

DETAILED EXPERIENCE

Regeneron Pharmaceuticals, Inc.

Vice President Nonclinical and Clinical Bioanalysis

Nov 2023 - Present

Leading group that is supporting vast and diverse portfolio of biotherapeutics developed by Regeneron Pharmaceuticals. Bioanalytical Sciences group works on development, qualification and validation of PK, immunogenicity and target analysis assays, bioanalytical support of toxicology and clinical studies, including Phase I through Phase III trials. Support of the diverse and complex portfolio requires high degree of collaboration within significant BAS team and with many internal departments of the company. Although majority of the bioanalysis is supported internally, expertise of the BAS team includes assay outsourcing to external CROs.  

Sana Biotechnology

Vice President Bioanalytical and non-Clinical Biomarkers 

Jan 2021 - Sep 2023 

Leading group that is actively investigating In vitro Pharmacology, Biomarker Discovery and Bioanalysis of various advance stage modalities developed at Sana Biotechnology. Supporting Discovery and later stage studies and investigations, providing strategic leadership for non-regulated and regulated. Working with internal and external collaborators

Pfizer Inc. (previously Wyeth)

Senior Director   Regulated & Non-Regulated Bioanalysis, Biotherapeutics (2015 – 2020)

Previously
Director Regulated Bioanalysis, Biotherapeutics (2008 – 2015)
Associate Director, Regulated Bioanalysis, Biotherapeutics (2004-2008)
Section Head, Regulated Bioanalysis, Biotherapeutics (2000-2004)

Through my time of working at various organizations, my responsivities included:

• Supervision of non-regulated and regulated (GLP and GCP compliant) bio-analytical (BA) laboratory supporting large molecule drug development

• Ensure quality and on time support for the entire pan-Pfizer Biotherapeutic portfolio, including all involved biotherapeutic modalities and therapeutic areas 

• Establishing the vision, mission and objectives for the regulated Biotherapeutics BA discipline

• Build and maintain positive, collegial and focused attitude in the Bioanalytical group fostering maximum value to the Pfizer R&D organization

• Provide strategic, technical, and scientific bioanalytical leadership for the Biotherapeutic Pfizer portfolio in the development, implementation and data interpretation of an integrated non-clinical and clinical plan supporting proof of concept, decision making and registration for assigned clinical programs across therapeutic areas

• Establishing immediate and forward-looking goals for the group, working with senior group members for the same 

• Aligning group goals with the Pfizer WR&D objectives and priorities 

• Chair of the internal Pfizer Immunogenicity Expert Working Group (I-EWG). The group provides feedback on immunogenicity risk and mitigation strategies for pan-Pfizer biotherapeutic portfolio assets. Responsible for goal setting, review of immunogenicity risk documents, associated bioanalysis strategies, communications with project teams 

• Oversight of the regulatory compliance status of the lab. Development and maintenance of appropriate SOPs and other training documentation.  Work with QC / QA group 

• Oversight of Part 11 instrument validation (including writing / reviewing validation plans, risk analysis assessment, life cycle support documents)

• Management of internal non-clinical GLP and clinical GCP support of ongoing studies

• Management of non-clinical CRO based activities (assay development, validation, sample analysis, assay result and report reviewing)

• Management of clinical assay transfers, including PK, ADA and NAb assays

• Liaise with the Drug Safety and Clinical Pharmacology groups 

• Prepare and manage associated budgets

• Resource management to ensure appropriate and timely support for Pfizer WRD Biotherapeutics portfolio 

• Responsible for program prioritization and resourcing for a diverse organization of scientists and programs

• Concurrent management of multiple projects for timely completion

• Oversight of various BA laboratory activities, including: 

  • LBA development, validation and study support

  • Focus on Immunogenicity and quantitative (PK) assays 

  • Assay reagent development and provisioning 

  • Timely issue of relevant assay and study reports

  • Preparation of sections for regulatory submission documents and product related filings

  • Maintains Bioanalytical group scientific excellence in Immunogenicity and PK clinical assay implementation 

  • Directing BA scientists to identify and execute technical platform innovations applied to non-clinical and clinical activities and provides rigorous assessment of technologies

Regeneron Pharmaceutical Inc. 

Scientist (1997 – 2000)

• Protein isolation, purification and identification 

• Bio-assay development

• Proteome analysis, including use of 2-D gel technology

• Identification of proteins involved in BMP signaling pathways

• Supervision of BS/MS scientists