Summary
Overview
Work History
Education
Skills
Accomplishments
Affiliations
PUBLICATIONS AND PRESENTATIONS
Languages
Timeline
Generic

Morse Faria

Mechanicsville,VA

Summary

Passionate pharmaceutical scientist dedicated to advancing drug therapies, with over 15 years of experience in pharmaceutical R&D, supporting preclinical and clinical drug development. Extensive expertise in:

Chemically synthesized small molecules, protein-based biotherapeutic drugs, and herbal drugs.

PK/PD principles and drug formulation.

Bioanalysis of biotherapeutics and biomarkers to support drug discovery and development.

Hybrid Immunoaffinity-LC-MS/MS Bioanalysis.

Bioanalysis of monoclonal antibodies, antibody-drug conjugates (ADCs), fusion proteins, bispecific biotherapeutics, Probody mAb, T-cell engager biotherapeutics, pegylated Fabs, ocular biotherapeutics, and mRNA drugs.

Overview

19
19
years of professional experience

Work History

Staff Fellow

Food And Drug Administration
Silver Spring, MD
01.2024 - Current
  • Serve as a Clinical Pharmacology Reviewer within the Division of Neuropsychiatry Pharmacology, in the Office of Clinical Pharmacology.
  • Lead the review of IND, NDA, and BLA submissions for neurological indications, including migraines, Alzheimer’s disease, chemotherapy-induced peripheral neuropathy, and rare neurological disorders.
  • Provide expert regulatory guidance and consultation to sponsors throughout the drug development process, including pre-IND, IND, End of Phase 2, pre-NDA/BLA, NDA/BLA, and post-marketing phases.
  • Offer strategic insights on regulatory statutes, policies, and guidance to facilitate the progression of therapeutic candidates in alignment with FDA requirements.

Staff Scientist

ThermoFisher Sceintific
West PALM Beach, FL
09.2022 - 01.2025
  • Serve as a field-based application scientist to support chromatography consumable products
  • Act as a scientific liaison between the commercial team and customers (bioanalytical laboratories).
  • Serve as a subject matter expert in chromatography sample preparation techniques.
  • Develop new application notes to support bioanalysis of proteins and oligonucleotides

Notable contributions at Thermo Fisher Scientific:

  • Executed more than 15 Lunch and learn seminars to research scientist
  • Developed in-house micro-learning series to expand product knowledge of sales account managers
  • Initiated business opportunities of greater than $10 million/year through presentation to lab managers

Senior Research Scientist

ThermoFisher Scientific, PPD
Richmond, VA
04.2019 - 09.2023
  • Oversee complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques and multiple detection techniques
  • Provide technical and regulatory consulting to internal groups and clients about their programs.
  • Provide technical guidance and mentorship to senior staff members in performing laboratory activities
  • Routinely act as the technical project leader for multiple projects, interact with clients to provide technical project updates, review and evaluate data, and write reports
  • Serve as a principal investigator to multiple projects for the development and validation of hybrid LC-MS/MS method for bioanalysis of large molecule biotherapeutics (monoclonal antibodies/antibody-drug conjugates/bispecific antibodies/Fab biotherapeutics)

Notable contributions in this role:

  • Served as an acting manager overseeing four R&D scientist and five clients
  • Designed the development and validation of LC-MS/MS method for gene therapy biomarker, to monitor the profiles of mutated knockout protein and the newly synthesized replacement protein
  • Developed a method for PK assessment, for preclinical and clinical use, of a 'protease-activated prodrug T cell engagement platform biotherapeutic' using the hybrid LC-MS/MS platform.
  • Managed the development and validation of an ocular biotherapeutic using the hybrid-LC-MS/MS platform for clinical and preclinical use with detection limits in the low picograms/mL.

Research Scientist

ThermoFisher Scientific (PPD)
Richmond City, VA
04.2016 - 03.2019
  • Conducted and provided technical guidance on scientific method development and validation projects and/or other specialty technologies studies
  • Designed and executed method development/validation studies independently and interpreted and reviewed analytical data for self and others
  • Assisted others in performing routine maintenance and performed troubleshooting on multiple instruments and multiple detection techniques, methods and procedures
  • Routinely acted as the technical project leader for multiple projects provide updates, reviewed and evaluated data, and wrote reports
  • Served as a principal investigator to multiple projects for development and validation of hybrid LC-MS/MS method for bioanalysis of large molecule biotherapeutics (monoclonal antibodies/antibody-drug conjugates/bispecific antibodies/Fab biotherapeutics)

Notable contributions in this role:

  • Developed a method for Pegylated pentameric protein biotherapeutic protein for preclinical PK assay
  • Developed a novel dual immunocapture hybrid LC-MS/MS method utilizing two immunoaffinity enrichments to improve selectivity in order to achieve low pg/ml detection limits of a Fab protein biotherapeutic for a clinical PK assay
  • Development of LC-MS/MS method for a personalized cancer vaccine for clinical applications
  • Developed several methods for PK assessment, for preclinical and clinical use, of multiple antibody-drug conjugates using the hybrid-LC-MS/MS platform
  • Designed and co-ordinated the ‘PPD Chromatographic Services Department Learning Series’ to encourage continuous training and peer-to-peer resource sharing.

Associate Research Scientist

ThermoFisher Scientific (PPD)
Richmond City, VA
11.2014 - 04.2016
  • Key responsibilities included ducting bioanalytical method and technology research and development projects to include the development and implementation of new assay methods, enhancement of existing methods, and transfer of client-provide methods under general supervision
  • Additional responsibilities included troubleshooting analytical instruments and method performance
  • Served as a principal investigator to multiple projects for development and validation of hybrid LC-MS/MS method for bioanalysis of large molecule biotherapeutics (monoclonal antibodies/antibody-drug conjugates/bispecific antibodies/Fab biotherapeutics)

Notable contributions in this role:

  • Developed and validated methods for measurement of several monoclonal antibodies and antibody-drug conjuates using the generic hybrid LC-MS/MS method platform for preclinical applications
  • Developed and validated a multiplex LC-MS/MS Assays for clinical bioanalysis of an antibody-drug conjugate of tubulysin analogue attached via cleavable linker to a biparatopic humanized antibody against HER-2.

Intern

ThermoFisher Scientific (PPD)
Richmond City, VA
07.2013 - 11.2014

Notable contributions in this role:

  • Developed a novel immunoaffinity- microflow LC-MS/MS method for measurement of osteopontin, a cancer biomarker protein, from human plasma
  • Investigated the use of stable isotope peptides as internal standards for LBA-LC-MS/MS assays.

Graduate Research Assistant

Virginia Commonwealth Univeristy
Richmond, VA
08.2010 - 06.2013
  • Aided in conducting coursework and lab-work in the PharmD Program in the School of Pharmacy.
  • Assisted in conducting regulated bioanalysis in Bioanalytical Core Laboratory at VCU School of Pharmacy

Notable contributions in this role:

  • Developed and validated a bioanalytical LC-MS/MS method for measurement of cancer biomarker protein – serum thymidine kinase from human serum by monitoring its activity.

Lecturer

Mumabi University, VES College of Pharmacy
Mumbai, India
07.2008 - 07.2010
  • Key responsibilities included delivering lectures to pharmacy undergraduate students in General chemistry, Biochemistry and Pharmaceutical Analysis
  • Managed and conducted biochemistry and pharmaceutical analysis laboratory sessions
  • VES College of Pharmacy annual magazine (Pharmaequinox)
  • Cultural and sports faculty in-charge.

Research Associate

Wockhardt Private Limited
Mumbai, India
04.2006 - 06.2008
  • Key responsibilities included development and validation of bioanalytical LC-MS/MS methods of drugs/metabolites to support clinical studies in the Clinical Pharmacokinetics and Biopharmaceutics Department
  • Regulated bioanalysis of pharmacokinetic samples in accordance with US FDA guidelines
  • Assisted principal investigators in compilation of bioanalytical reports
  • Notable contribution in this role:
  • Developed and validated bioanalytical methods for more than 14 pharmaceutical drugs to support bioequivalence studies.

Education

Ph.D. - Pharmaceutical Sciences

Virginia Commonwealth University
Richmond, VA
11-2014

Master of Science - Pharmacy

Mumbai University
Mumbai, India
02-2007

Bachelor of Science - Pharmaceutical Sciences

Goa University
Goa, India
04-2003

Skills

Analytical Techniques: LC-MS/MS, HPLC, Immunoassay,SPE, SLE, LLE, Protein Precipitation

Regulatory Compliance: USFDA GLP requirements, method validation & transfer

Method Development & Validation:Bioanalytical assays, biomarker quantification, stability testing

Software & Tools: MS Office, LIMS, Phoenix WinNonlin, Skyline, SharePoint

Cross-Functional Collaboration:R&D, QC, regulatory affairs, scientific advisory

Training & Leadership: Scientist mentoring, team management, stakeholder communication

Accomplishments

· Student Research Award, AAPS, 2014

· Charles T. Rector & Thomas W. Rorrer, Jr. Dean's Award, VCU School of Pharmacy, 2014

· John Wood Excellence in Pharmaceutics Award, VCU School of Pharmacy, 2014

· Rho Chi Honor Society Induction, Lambda Chapter, 2014

· Alpha Epsilon Lambda Honor Society Induction, Lambda Chapter, 2013

· Pre-Doctoral Fellowship ($25,000), PPD, 2013-14

· Graduate Symposium Award, AAPS, 2013

· Altria Regulatory Science Fellowship ($50,000), VCU School of Pharmacy2013-2014

· University Service Award, VCU, 2012

· National Merit Scholarship, 1Goverment of India, 1997-2003

Affiliations

· Graduate Advisory Board Member, Virginia Commonwealth University (VCU)School of Pharmacy, VA, USA

· Graduate Affiliate Faculty, Department of Pharmaceutics, VCU, VA, USA

· Graduate Advisory Committee Member, Ph.D. Student VCU Department of Pharmaceutics (2018-2022)

· Advisory Board Member, VES College of Pharmacy, Mumbai University, India

· Chair (2021-22)/Vice-Chair (2020-21), Outsourcing Community, American Association of Pharmaceutical Scientist (AAPS), USA

· Associate Editor, Journal of Applied Bioanalysis

· Guest Editor Special Issue ‘Bioanalysis of novel Biotherapeutic Modalities’ in Journal of Applied Bioanalysis, 2019

· Reviewer in multiple journals including Journal of Chromatography B, Journal of Pharmaceutical and Biomedical Analysis, Bioanalysis, Analytical and Bioanalytical Chemistry and Chemistry Central Journal (Since 2014) &· Abstract Reviewer, AAPS

PUBLICATIONS AND PRESENTATIONS

Book Chapters:

· Morse Faria, Varun Ramani, Seema Kumar. “An Introduction to Bioanalysis of Antibody-drug conjugates”. Introduction to bioanalysis of biopharmaceuticals (book chapter submitted to Elsevier as part of AAPS Book Series), 2022

· Ramakrishna Boyanapalli, Inderpal Singh and Morse Faria. “Peptides and Oligonucleotide-based Therapy – Bioanalytical Challenges and Practical Solutions”. Introduction to bioanalysis of biopharmaceuticals (book chapter submitted to Elsevier as part of AAPS Book Series), 2022

· Morse Faria, and Matthew S. Halquist. "Internal Standards for Absolute Quantification of Large Molecules (Proteins) from Biological Matrices by LC-MS/MS." In Calibration and Validation of Analytical Methods-A Sampling of Current Approaches. IntechOpen, 2018.

Publications:

· Yue Huang, Christopher J. Del Nagro, Kemal Balic, William R. Mylott Jr., Omnia A. Ismaiel, Eric Ma, Morse Faria, Aaron M. Wheeler, Moucun Yuan, Michael P. Waldron, Marlking G. Peay, Diego F. Cortes, Lorin Roskos, Meina Liang, Anton I. Rosenbaum "Multifaceted bioanalytical methods for the comprehensive pharmacokinetic and catabolic assessment of MEDI3726, an anti-prostate-specific membrane antigen pyrrolobenzodiazepine antibody–drug conjugate." Analytical chemistry 92.16 (2020): 11135-11144.

· Morse Faria, Omnia A. Ismaiel, James Waltrip, Tom Mariannino, Moucun Yuan, William Mylott, Vikram Roongta, Jim X. Shen, Pathanjali Kadiya. “LC-MS/MS Method for the Quantitative Determination of Tanespimycin and its Active Metabolite in Human Plasma: Method Validation and Overcoming an Insidious APCI Source Phenomenon”. Journal of Applied Bioanalysis, 2020, 6(3), 145-163.

· Morse Faria. "Addressing Bioanalytical Needs of Antibody-Based Biotherapeutics by LC-MS." Journal of Applied Bioanalysis 6, no. 1 (2020): 7-11.

· Luna Liu, Yanqiu Liu, Lu Dai, Cinzia Stella, Morse Faria, Junlong Shao, Jamie L Hicks, Diego F Cortes, William R Mylott Jr, Eric Wakshull, Surinder Kaur & Keyang Xu. "Immunoaffinity LC–MS/MS to quantify a PEGylated anti-Factor D Fab biotherapeutic in cynomolgus monkey serum." Bioanalysis, 11, no. 23 (2019): 2161-2173.

· Morse Faria, Marlking Peay, Brandon Lam, Eric Ma, Moucun Yuan, Michael Waldron, William R. Mylott, Meina Liang, and Anton I. Rosenbaum. "Multiplex LC-MS/MS Assays for Clinical Bioanalysis of MEDI4276, an Antibody-Drug Conjugate of Tubulysin Analogue Attached via Cleavable Linker to a Biparatopic Humanized Antibody against HER-2." Antibodies 8, no. 1 (2019): 11.

· Morse Faria, Matthew S. Halquist, Moucun Yuan, William Mylott, Rand G. Jenkins, and H. Thomas Karnes. "Comparison of a stable isotope labeled (SIL) peptide and an extended SIL peptide as internal standards to track digestion variability of an unstable signature peptide during quantification of a cancer biomarker, human osteopontin, from plasma using capillary microflow LC–MS/MS." Journal of Chromatography B 1001 (2015): 156-168.

· Morse Faria, Matthew S. Halquist, Moucun Yuan, William Mylott, Rand G. Jenkins, and H. Thomas Karnes. "An extended stable isotope labeled signature peptide internal standard for tracking immunocapture of human plasma osteopontin for LC-MS/MS quantification." Biomed. Chromatogr. 2015; 29: 1780–1782

· Morse Faria, Matthew S. Halquist, Erick Kindt, Wenlin Li, H. Thomas Karnes, and Peter J. O’Brien. "Liquid chromatography–tandem mass spectrometry method for quantification of thymidine kinase activity in human serum by monitoring the conversion of 3′-deoxy-3′-fluorothymidine to 3′-deoxy-3′-fluorothymidine monophosphate." Journal of Chromatography B 907 (2012): 13-20.

· Ojas Agrawal, Rutali Brahme, Morse Faria, Supriya Shidhaye. “Nanotechnology in cancer: A clinical review”, Journal of Applied Pharmaceutical Science,2011, 01(03), 25-29

· Poornima Hamrapurkar and Morse Faria. “HPLC fingerprinting of fenugreek seeds using trigonelline as a biomarker”, Indian Drugs, 2008, 45(12), 940-943

Oral Presentations:

· Faria, M., Meeting Bioanalytical Challenges of Protein-Drug Conjugates with Improved Efficiency using Multiplexed Hybrid LBA-LC-MS/MS Assays, 2018 PharmSci 360, Washington D.C., USA

· Faria, M., Cortes, D. Challenges and opportunities in bioanalysis of antibody-drug conjugates (ADCs) using LC-MS/MS, Bioanalytical Research Special Interest Group (BAR-SIG) Meeting, June 2014, US Food and Drug Administration, Maryland, USA

· Faria, M., Evaluation of an extended stable isotope labeled peptide as an internal standard for tracking immunocapture and digestion variability in the quantitative estimation of human osteopontin using microflow LC-MS/MS, November 2014, Richmond Chromatography Discussion Group, Richmond, VA

· Faria, M.; Halquist, M.S; Yuan, M.; Mylott, W. R.; Jenkins, R.; Karnes, H.T., Evaluation of an Extended Stable Isotope Labeled (SIL) Signature Peptide as an Internal Standard for Tracking Immunocapture and Digestion Variability for Human Osteopontin Quantification Using Microflow LC-MS/MS from Plasma, AAPS Graduate Student Research Awards in Analysis and Pharmaceutical Quality, AAPS Annual Meeting and Exposition 2014, San Diego, USA

· Faria, M.; Halquist, M.S; Yuan, M.; Mylott, W. R.; Jenkins, R.; Karnes, H.T., Development and validation of a LC-MS/MS method for quantification of human osteopontin, a cancer biomarker protein, from plasma., Virginia Academy of Science (VAS) Annual Meeting, 2014

· Faria, M., Quantitative mass spectrometric evaluation of human osteopontin, an inflammation biomarker protein using a biologically relevant tryptic signature peptide, AAPS APQ Graduate Student Symposium, AAPS Annual Meeting and Exposition 2013, San Antonio, USA

Poster Presentations:

· Faria, M., Ismaiel, O., Waltrip, J., Mariannino, T., Yuan, M., Mylott Jr., W., Roongta, V., Shen, J., Kadiyala, P., Development and Validation of a LC-MS/MS Method for Simultaneous Measurement of Tanespimycin and Its Active Metabolite (17-AG) in Human Plasma., PharmSci 360, San Antonio, Texas, November 2019

· Ma, E., Yuan, M., Lam, B., Peay, M., Faria, M., Waldron, M., Mylott Jr., W.R., Liang, M., Rosenbaum, A., Multiplex LBA-LC-MS/MS Assay for Quantification of Total Antibody and Conjugated Payload (Total ADC) from Antibody-Drug Conjugate in Human Plasma, 66th ASMS Conference, San Diego, CA, June 2018

· Peay, M., Yuan, M., Lam, B., Peay, M., Faria, M., Waldron, M., Mylott Jr., W.R., Liang, M., Rosenbaum, A., LC-MS/MS Assay for the Quantification of the Total ADC from MEDI1498 (De-acetylated MEDI4276) in Human Plasma, 66th ASMS Conference, San Diego, CA, June 2018

· Faria, M. , Lam, B., Peay, M., Ma, E., Yuan, M., Waldron, M., Mylott Jr., W.R., Liang, M., Rosenbaum, A., Multiplex LBA-LC-MS/MS Assay for Quantification of Total Antibody and Conjugated Payload (Total ADC) from Antibody-Drug Conjugate in Human Plasma, 12th WRIB Conference, Philadelphia, PA, April 2018

· Yuan, M., Lam, B., Peay, M., Ma, E., Faria, M., Waldron, M., Mylott Jr., W.R., Liang, M., Rosenbaum, A., Simultaneous Quantification of Unconjugated Tubulysin Payload (AZ9185) and its De-acetylated Metabolite (AZ7308) in Human Plasma by LC-MS/MS, 12th WRIB Conference, Philadelphia, PA, April 2018

· Yuan, M.; Faria, M.; Shen, J.; Zhao, S.; Ma, E.; Dompkowski, E.; Waldron, M.; Hidy, B.; Mylott Jr., W.; Jenkins, R., Applying Rapid Trypsin Digestion for Targeted Protein Quantitation in Rat Plasma by Liquid Chromatography/Tandem Mass Spectrometry, ASMS, San Antonio, 2016

· Faria, M.; Halquist, M.S; Yuan, M.; Mylott, W. R.; Jenkins, R.; Karnes, H.T., Evaluation of an extended stable isotope labeled (SIL) signature peptide as an internal standard for tracking immunocapture and digestion variability for human osteopontin quantification using microflow LC-MS/MS from plasma, AAPS Annual Meeting and Exposition 2014, San Diego, USA.

· Faria, M.; Halquist, M.S; Yuan, M.; Mylott, W. R.; Jenkins, R.; Karnes, H.T., Quantification of human osteopontin, a cancer biomarker protein, from plasma by immunoaffinity and microflow LC-MS/MS, National Biotechnology Conference 2014, San Diego, USA

· Faria, M.; Halquist, M.S; Karnes, H.T., Quantitative Mass Spectrometric Evaluation of Human Osteopontin, an Inflammation Biomarker Protein Using a Biologically Relevant Tryptic Signature Peptide, AAPS Annual Meeting and Exposition 2013, San Antonio, USA

· Faria, M.; Halquist, M.S.; Kindt, E.; Li, W.; Karnes, H.T.; O'Brien, P.J., Development and Validation of an LC-MS/MS Method for Determining Thymidine Kinase 1 (TK1) , AAPS Annual Meeting and Exposition 2012, Chicago, USA

· Li, W.; Kang, X.; Kindt, K.E.; Zhang, C.; Spilker, M.; Berlinski, P.J.; Eisenbraun, M.; Yan, Z.; Elliott, M.; Arbuckle, J.A.; Faria, M.; Karnes, H.T.; O'Brien, P.J., A simplified approach to measuring thymidine kinase activity in cells, tumors, and blood as a biomarker of tumor proliferative potential,  AACR 103rd Annual Meeting 2012, Chicago, USA

· Faria, M.; Singh, N.; Tomar, A.; Hamrapurkar, P.D.; Naik, S.R., Quantitation of Pitavastatin in Human Plasma by HPLC using fluorescence detection’, Analytical Research Forum 2005, Plymouth, UK.

· Faria., M; Pai, K.; Hamrapurkar, P.D.; Naik, S.R.; Single Dose Bioavailability studies of glucosamine sulphate gel in healthy human volunteers, 56th Indian Pharmaceutical Congress 2004, Kolkotta, India

Languages

English
Native/ Bilingual
French
Limited
Hindi
Native/ Bilingual
Konkani
Native/ Bilingual

Timeline

Staff Fellow

Food And Drug Administration
01.2024 - Current

Staff Scientist

ThermoFisher Sceintific
09.2022 - 01.2025

Senior Research Scientist

ThermoFisher Scientific, PPD
04.2019 - 09.2023

Research Scientist

ThermoFisher Scientific (PPD)
04.2016 - 03.2019

Associate Research Scientist

ThermoFisher Scientific (PPD)
11.2014 - 04.2016

Intern

ThermoFisher Scientific (PPD)
07.2013 - 11.2014

Graduate Research Assistant

Virginia Commonwealth Univeristy
08.2010 - 06.2013

Lecturer

Mumabi University, VES College of Pharmacy
07.2008 - 07.2010

Research Associate

Wockhardt Private Limited
04.2006 - 06.2008

Ph.D. - Pharmaceutical Sciences

Virginia Commonwealth University

Master of Science - Pharmacy

Mumbai University

Bachelor of Science - Pharmaceutical Sciences

Goa University
Morse Faria