Summary
Overview
Work History
Education
Affiliations
Posters and Publications
Timeline
Generic

Barbra Weiss

Freehold,NJ

Summary

Regulatory Liaison with 13 years years of experience in Oncology in International Markets, and total over 25 years in scientific/pharmaceutical industry with strong background in fostering communication and building relationships. Skilled in team collaboration and adept at navigating changing needs to achieve results. Expertise in conflict resolution, project management, and strategic planning. Reliable, adaptable, and focused on driving success through effective partnerships and clear communication.


Overview

26
26
years of professional experience

Work History

Sr. Principal Scientist, Regulatory Liaison

Merck
05.2021 - Current
  • Manages a team (7 reports) of Regulatory Scientists/Liaisons overseeing pharmaceutical product development and marketing authorization activities for Oncologic agents in the international “Most of World” markets.
  • Provides strategic leadership to direct and indirect reports on product registration plans/sequences; attends Regulatory Agency/Competent Authority meetings for product development or registration purposes; reviews Regulatory documentation such as background packages, requests for information, product dossier content and structure.
  • Oversight with scope of responsibility into cross program safety related space for Oncologic agents, primarily for MOW space but involvement into various annual reports and RTQs as well.
  • Oversees within the scope of responsibilities and acquisition activities of partnerships for new molecular entity development and registration, with high focus into Eisai, AZ, ORION, Moderna partnerships.
  • Actively works on product development and registration applications for head and neck and broad scope of Keytruda indications, oversight of safety related updates and activities across Keytruda program, and other product lifecycle activities.
  • RAI LEAD Workstream support on partnership Collaborations and AI Company driven project initiatives

Principal Scientist, Regulatory Liaison

Merck
10.2017 - 05.2021
  • Manages a team (9 reports) of Regulatory Scientists/Liaisons overseeing pharmaceutical product development and marketing authorization activities for Oncologic agents in the international “Most of World” markets.
  • Provides strategic leadership to direct and indirect reports on product registration plans/sequences; attends Regulatory Agency/Competent Authority meetings for product development or registration purposes; reviews Regulatory documentation such as background packages, requests for information, product dossier content and structure.
  • Oversight with scope of responsibility into cross program safety related space for Oncologic agents, primarily for MOW space but involvement into various annual reports and RTQs as well.
  • Oversees within the scope of responsibilities and acquisition activities of partnerships for new molecular entity development and registration, with high focus into Eisai and AZ partnerships.
  • Actively works on product development and registration applications for head and neck and broad scope of Keytruda indications, oversight of safety related updates and activities across Keytruda program, and other product lifecycle activities.

Associate Principal Scientist, Regulatory Liaison

Merck
10.2015 - 10.2017
  • Individual Contributor overseeing pharmaceutical product development, marketing authorization, and other product lifecycle activities for Oncology (Keytruda) products mostly in the international “Most of World” markets.

Senior Scientist, Regulatory Liaison

Merck
11.2012 - 10.2015
  • Individual Contributor overseeing pharmaceutical product development, marketing authorization, and other product lifecycle activities for Bone (Fosamax), dermatological (various), and Oncology (Keytruda) products mostly in the international “Most of World” markets.

Staff Biochemist / Research Biochemist / Senior Scientist (Associate Research Immunochemist)

Merck
11.2005 - 11.2012
  • Responsible for development, validation, and sample analysis of Pharmacodynamic biomarkers to support early clinical development and clinical trial phase I, II, and III across various therapeutic areas of Merck’s broad pipeline.

Development Scientist II

PBL Biomedical Laboratories, Inc.
07.2002 - 11.2005
  • Responsible for the development and validation of Human Interferon ELISA kits.

Product Support Associate

Zeus Scientific, Inc.
09.1999 - 07.2002
  • Responsible for the development, validation, and Quality control of Human Autoimmune and Infectious Disease ELISA and AtheNA Multilyte Test Systems.

Education

BS - Medical Technology

Monmouth University
West Long Branch, NJ
08.1999

Certificate - Clinical Internship Medical Technology

Monmouth Medical Center
Long Branch, NJ
08.1999

Affiliations

  • National Certification Agency- Certified Laboratory Scientist (Aug 1999)
  • American Society of Clinical Pathologists-Certified Medical Technologist (Aug 1999)

Posters and Publications

  • WEISS, B.N., TANEN, M.R., SAMATAR, A., STRACK, P.R., LATERZA, O.F., WEINER, R. Fit for purpose validation of Phosphorylated Extracellular Signal-Regulated Kinase (perk) Assay in ex-vivo PMA Stimulated Human Whole Blood and Hair Follicles. American Association Of Pharmaceutical Scientists 2011 Annual Meeting And Exposition (AAPS), Washington DC, 10/23/11 - 10/27/11
  • CHAPPELL, D.L.* , MCAVOY, T.A., WEISS, B.N., LATERZA, O.F. Fit-for-purpose validation of an lc/ms/ms plasma renin activity assay. American Association Of Pharmaceutical Scientists 2011 Annual Meeting And Exposition (AAPS), Washington DC, 10/23/11-10/27/11
  • LATERZA, O., TANEN, M., NATASHA, T., PICA-MENDEZ, A., WEISS, B., CHAPPELL, D., KURTZ, M., HAILMAN, E., WAGNER, J., TANAKA, W. Analytical Validation of Multiplexed Immunoassays for the Quantitaion of Biomarkers in Atherosclerotic Plaques. Merck Target Through 2b Symposium. 2008.
  • TANEN, M.R., WEISS, B.N., PICA-MENDEZ, A.M., LOUGHNEY, J.W., CHAPPELL, D.L., LAZAR, G., NATASHA, T., KURTZ, M.M., HAILMAN, E.P., TANAKA, W.K., LATERZA,O.F.* Validation of multiplexed immunoassays for the analysis of putative markers of coronary artery disease (cad) in atherosclerotic plaque. American Association For Clinical Chemistry Annual Meeting (AACC), Washington DC, 7/27/08 - 7/31/08
  • LAZAR, G.., LATERZA, O., TANEN, M., LOUGHNEY, J., NATASHA, T., PICA-MENDEZ, A., WEISS, B., CHAPPELL, D., KURTZ, M., HAILMAN, E., WAGNER, J., DALLOB, A., TANAKA, W. Analytical validation of multiplexed immunoassays for the quantitation of biomarkers in atherosclerotic plaques.Merck Technology Symposium. Long Branch, NJ. May 2008.
  • TANEN, M., CHAPPELL, D., WEISS, B., PLUMP, A., TANAKA, W., LATERZA, O. Mesoscale Discovery Multiplex Assay for Use in Clinical Biomarker Development. Merck Technology Symposium. Long Branch, NJ. May 2006.
  • KOPNITSKY, M.J., LANGER, B.. Use of SeraSub as a Serum Diluent in the Manufacturing of ELISA Controls. AACC Conference, July 2001
  • "Dipeptidyl Peptidase-4 Inhibitors Administered in Combination with Metformin result in an Additive Increase in the Plasma Concentration of Active GLP-1" EM Migoya, R. Bergeron, JL Miller, M Tanen, D. Hilliard, B Weiss, P Larson, M Guterierez, G. Jiang, F Liu, KA Pryor, J Yao, L Zhu, JJ Hoist, C Deacon, G Herman, N Thornberry, J Amatruda, D Williams-herman, JA Wagner, and R SinhaRoy. Clinical Pharmacology & Therapeutics. (2010) 88 6, 801-808.
  • “Development and validation of an ultra-sensitive method for the measurement of plasma renin activity in human plasma via LC–MS/MS” Derek L Chappell, Thomas McAvoy, Barbra Weiss, Russell Weiner, Omar F Laterza. Bioanalysis, December 2012, Vol. 4, No. 23, Pages 2843-2850.

Timeline

Sr. Principal Scientist, Regulatory Liaison

Merck
05.2021 - Current

Principal Scientist, Regulatory Liaison

Merck
10.2017 - 05.2021

Associate Principal Scientist, Regulatory Liaison

Merck
10.2015 - 10.2017

Senior Scientist, Regulatory Liaison

Merck
11.2012 - 10.2015

Staff Biochemist / Research Biochemist / Senior Scientist (Associate Research Immunochemist)

Merck
11.2005 - 11.2012

Development Scientist II

PBL Biomedical Laboratories, Inc.
07.2002 - 11.2005

Product Support Associate

Zeus Scientific, Inc.
09.1999 - 07.2002

Certificate - Clinical Internship Medical Technology

Monmouth Medical Center

BS - Medical Technology

Monmouth University
Barbra Weiss