A Local Senior Research

Jatinder Singh, Ph.D., UK Registered Toxicologist

Senior Research Fellow, Preclinical Safety Assessment, Vertex Pharmaceuticals, MA

*** *** *********** ****, *******, MA 01778

***********@*****.*** Phone: 860-***-**** Nationality: US

https://www.linkedin.com/in/jatinder-singh-phd-ert-b9066ab

Summary:

-Seasoned drug developer, team player, nonclinical safety discipline leader, manager and mentor with 25 years of experience in nonclinical safety assessment of drugs at diverse companies (Pfizer, Genentech, AZ, Retrophin, Ariad, Blueprint, Forma, Vertex).

-At Vertex: project toxicologist for AATD and Improved conditioning ADC programs, mentor of colleagues, participant in process improvement initiatives (e.g. improved authorship of regulatory document and gap analysis at project milestones); Occupational safety liaison with EHS.

-10 INDs; Contributed to 6 NDAs: Vascepa (lipid lowering; Amarin), JNDA and MAA for Ponatinib (leukemia; Ariad); NDA for Brigatinib (lung cancer; Ariad). IND for Mobocertinib (lung cancer; Ariad/Takeda), NDA and MAA for Avapritinib (GI cancer; Blueprint); NDA for Olutasidenib (leukemia; Forma).

-Doctoral / postdoctoral training in molecular/environmental toxicology & oncology

-Certified EU Registered Toxicologist.

-Toxicology study director of in-house GLP, non-GLP, and mechanistic studies at Pfizer.

-Authored toxicology and integrated nonclinical sections of regulatory submissions (IND, NDA, IB, CTA); health authority interactions and query responses.

-Proficient in discovery toxicology (target safety, LO, de-risking safety issues) and development (safety strategies for nonclinical studies to support clinical development and regulatory submissions - IND, CTA, NDA.

-Independent toxicology functional leader (supporting entire discovery and development portfolio in small companies); or part of larger nonclinical safety teams.

-Small molecule experience in Cardiovascular, Metabolism, Immunology, Oncology, rare pediatric diseases. Some experience in other modalities: peptides, nanoparticles, RNA).

-Functional leadership: manager & mentor; departmental budgets, CRO selection and qualification; outsourcing studies to CROs, study monitoring, compliance, processes.

-Contributed to additional business needs e.g. representing Pfizer drug safety to CROs and regulatory leadership in India and China; building of vivarium at Blueprint Medicines; improving operational efficiency of outsourcing at Forma.

-Scientific leadership: Published papers and epigenetic safety review article and book chapter in medical epigenetics text book (2021), presented seminars at tox meetings. Therapeutic area safety lead for neurosciences and metabolic diseases at Genentech, safety lead for AZ Waltham Oncology Portfolio team, member of Predictive Safety Testing Consortium, chair & speaker on “new considerations in carcinogenicity testing” at 2013 APT meeting, presented discovery safety strategy at 2014 APT meeting.

-Business development experience- due diligence for assets from discovery to NDA; BD liaison with CBO at Ariad.

-Business training: Harvard business school semester course, "management principles in biopharmaceutical industry”; Wharton business school leadership and management certificate program of 4 courses. BLUEQ emotional intelligence course.

Employment history:

Vertex Pharmaceuticals

Senior Toxicology Research Fellow, Preclinical Safety Assessment Dec 2022 – present

-Project toxicologist for AATD program enabling nonclinical safety assessment of discovery and development compounds; safety issue resolution; strategic planning (e.g. carcinogenicity and pediatric safety strategies)

-Project toxicologist for Improved conditioning ADC program, designing and implementing the safety assessment strategy, coordinating safety assessment across toxicology and pharmacology studies, collaborating with Research, CMC, Clinical, and regulatory functions, preparing for the pre-IND meeting.

-PSA liaison with EHSS to streamline occupational safety process; co-authored guidance document to help colleagues who contribute to the occupational safety process; conducted training sessions within PSA.

-Participated in process improvement initiatives e,g, improved authorship of regulatory documents and gap analysis at project milestones, streamlining the nonclinical overview document

-Mentor to 2 colleagues outside PCS organization; continuing into the second year.

Forma Therapeutics

Senior Director, Head, Nonclinical Safety & Nonclinical Operations 2020 –2022

-Conducted nonclinical safety studies, authored nonclinical safety sections of NDA to support registration and approval of Olutasidenib for leukemia.

-Conducting nonclinical studies to support NDA for FT-4202 for sickle cell disease, and clinical trials of FT-7051 for prostrate cancer.

-Providing toxicology & drug development expertise for 4 discovery programs.

-Built toxicology function with strategic hiring, establishing vendor & consultant relationships

-Manager of nonclinical operations staff at Forma.

-Contributing to company-wide cultural engagement through a dedicated culture team

-Mentoring staff for career progress and effective teamwork. Mentoring new employees in the FormaFriends program; mentoring summer intern pharmacist at Forma.

-Conducted due diligence activities – in and out licensing. Mentored toxicologists from Rigel for transfer of FT-7051 and with Novo for transfer of FT-4202.

Blueprint Medicine

Senior Director, Non-clinical Safety 2017-2020

-Conducted nonclinical safety studies to support registration of Avapritinib for Gastrointestinal stromal tumors and non-oncology indications - advanced and indolent systemic mastocytosis.

-Authored nonclinical tox sections and the nonclinical overview for Avapritinib NDA & MAA.

-Nonclinical Safety lead for portfolio of immune oncology projects in collaboration with Roche and for internal projects (e.g. BLU-554 in Phase 2 for liver cancer and Discovery projects).

-Nonclinical safety lead for IND stage project (backup to Avapritinib)

-Conducted IND enabling studies, authored nonclinical safety section and compiled the nonclinical overview; conducting IND enabling studies for EGFR inhibitor

-Co-authored publication on discovery of BLU-945 (J. Med Chem publication July 2022).

-Effective collaboration with CRO and consultant partners.

-Overseeing systematic target safety assessment for new targets.

-Member of team that conceptualized and operationalized the in-house vivarium

-Member of animal care and usage (IACUC) governance team.

-Streamlined the interface between nonclinical safety and CMC (re: impurity safety assessment, occupational safety document such as safety data sheets)

-Mentored staff in diverse roles.

ARIAD Pharmaceuticals

Director and Head, Nonclinical Safety 2015-2017

-Led the nonclinical safety discipline to support Ariad’s entire Oncology portfolio encompassing regulatory, discovery and mechanistic toxicology areas.

-Wrote nonclinical safety sections for regulatory filings of Ponatinib for chronic myeloid leukemia (Japanese NDA; approved), Brigatinib for lung cancer (NDA & MAA approved), and AP32788 (TAK788) for lung cancer (approved as Mobocertinib).

-Presented poster on nonclinical safety of Ponatinib at 2016 Society of Toxicology meeting.

- Business development liaison, engaged external partners; worked with Chief Business Officer.

- Mentored staff in diverse roles.

Retrophin Inc.

Director and Head, Nonclinical Safety 2014 – 2015

-Provided nonclinical safety oversight for Retrophin’s entire rare disease portfolio encompassing regulatory, discovery and mechanistic toxicology areas.

-Conducted NDA-enabling nonclinical safety studies for Sparsentan for Focal Segmental Glomerulosclerosis (currently in Phase 3).

-Conducted IND-enabling nonclinical safety studies for RE-024 for Pantothenate kinase-associated neurodegeneration (IND approved, currently in Phase 3).

-Participated in Due Diligence to bring in undervalued drug assets

-Mentored staff in diverse roles.

AstraZeneca (AZ)

Principal Scientist (Associate Director Level) 2013-2014

-Drug Safety lead for Waltham Oncology portfolio.

-Project toxicologist for Oncology and Infection projects.

-AZ representative in the inter-industry Preclinical Safety Testing Consortium.

-Mentored staff in diverse roles.

Genentech

Senior Scientist (Associate Director), Safety Assessment 2011 – 2013

-Member of Small Molecule & Investigative Tox Leadership team.

-Therapeutic area lead for metabolic disease and neurosciences.

-Project toxicologist for Oncology and Immunology projects.

-Conducted IND enabling studies, prepared IND for small molecule anticancer agent.

-Led epigenetic safety strategies, collaborated with Constellation Pharmaceuticals.

-Mentored staff in diverse roles.

Amarin Pharmaceuticals, Inc., Amarin Pharmaceuticals, Inc.

Consultant toxicologist 2011 (3 months) Contributed to authoring nonclinical safety sections of NDA for Vascepa (approved).

Pfizer

Senior Principal Scientist - Drug Safety Team Leader 1999-2011

-Project toxicologist for CV / metabolic disease programs from Discovery to Phase 3.

-Study Director for GLP toxicology studies; study monitor for outsourced studies.

-Staff manager, supervised up to 6 junior and senior technicians.

-Process improvement lead, lead for Pfizer’s outreach for nonclinical activities in Asia.

-Mentored technical staff and incoming toxicologists and clinicians.

-Received Pfizer Global R&D award for streamlining the interface to enhance communication and efficiency of drug usage between the CMC and Toxicology groups.

Education:

-1996-1999 – NIEHS National Research Service Postdoctoral Grant, Department of Pharmacology, George Washington University Medical Center, Washington, DC.

-1991-1996 – PhD, Env. Oncology, Inst. Env. Medicine, New York Uni Med Center, NY.

-1989-1991 – M.S., Medical Biochem., Post Grad. Institute of Med. Res, Chandigarh, India.

-1987-1989 - B.S., Bio. Sciences, Punjabi Univ., Patiala, India. (School education in Kenya).

Recent publications during industry employment (with sponsoring employer):

Knowledge & Awareness of Emerging Cancer Therapies and their Regulations among Budding Scientists in India: A Survey, P. Sharma, V. Jhawat*, J. Singh, R. Dutt. Published 03 Jan, 2024. Current Cancer Therapy reviews.ISSN: 1573-394 DOI: 10.2174/0115733947268695231116100736

Understanding Challenges Associated with Approval of Anticancer Products to Facilitate Regulatory Approvals: A Cross-sectional Study. P. Sharma, V. Jhawat*, J. Singh, R. Dutt. Published 08 Jan, 2024. Current Cancer Therapy reviews.ISSN: 1573-3947. DOI: 10.2174/0115733947273426231128054645.

M.S. Eno, …J. Singh,..et al. (2022) Discovery of BLU-945, EGFR inhibitor for treatment-resistant EGFR+ T790M driven lung cancer. J. Med Chem. https://doi.org/10.1021/acs.jmedchem.2c00704. (Blueprint)

J. Tajbakhsh and J. Singh. Toxicology and Epigenetics (Chapter 25). In: Medical Epigenetics. T. Tollefsbol, editor. Elsevier 2021 (Forma)

Poster - nonclinical safety profile of ponatinib at the 2016 SOT meeting (Ariad)

J. Singh. Review: Epigenetic toxicity: a confluence of pharmacology, genotoxicology and toxicology. Integr Pharm Toxicol Gentoxicol, 2015 Vol. 1(1): 2-4. (Retrophin)

T. Zabka, J.Singh, et al. Retinal toxicity with inhibition of NAMPT. TOX SCI (2015). 144(1): 163–172 (Genentech)

J. Tarrant, .. J. Singh, T, et al. In Vitro Model of NAMPTi mediated Thrombocytopenia; Mitigation by Nicotinic Acid. Tox. Methods Mech (2015). 25(3): 201-11 (Genentech)

D. Misner, .. J. Singh. et al. Cardiotoxicity of NAMPT inhibitors in rodents and rat and human-derived cells lines. Cardiovasc Toxicol (2017). 17:307–318 (Genentech)

S. Gustavson, … J. Singh, et al. Effects of a GLP-1 Mimetic on Blood Pressure in Patients with Type 2 Diabetes Mellitus. (2011). Diabetes, Obesity, Metab, 13: 1056-1058. (Pfizer)

O. Francone, .., J. Singh et al. A critical role for PPAR in cardiac degeneration in rodents. (2006). Am. J. Pathol 169: 750-759. (Pfizer)

Recent presentations:

Co-organized 2013 American Pharmaceutical Tox. (APT) meeting at Genentech; chair and presenter of symposium on new considerations in carcinogenicity risk assessment.

Co-organized 2014 APT meeting at Medimmune, presented novel toxicology paradigms.

Epigenetic safety considerations at 2013 Tox Forum, Aspen, CO (July 2013).

Epigenetic safety strategies at 2014 World Pharma Congress, Boston, MA (June 2014).

Safety assessment of epigenetic drugs, 2014 EpiCongress, Boston MA (July 2014).

“The Scientist” Webinar on Epigenetic Safety considerations (May 2014).

Presentation: Nonclinical Safety assessment: a bridge, not a bottleneck; at the Nonclinical Operations summit, Nov 14, 2016, Boston.

Recent Training Courses Completed:

Wharton School of Business, University of Pennsylvania, Certificate program in executive leadership and management (4 separate courses) - 2021

Harvard Business School Fall 2016 management in the biopharmaceutical industry.

Diverse courses / webinars from SOT and other institutes for nonclinical safety expertise.

Supervisory, interpersonal and management skills courses for leadership growth.

DMPK (DDI, transporters) courses

Publications during Ph.D. and postdoctoral training:

(1) Snow, E., Singh, J., Koenig, K., and Solomon, J. (1994) Propylene oxide mutagenesis at template cytosine residues Environmental and Molecular Mutagenenesis. 23: 274280.

(2) Singh, J., Su, L., and Snow, E. (1996) Replication across O6mG by human DNA polymerase beta. Journal of Biological Chemistry. 271: 283-***-****.

(3) Klein, C., Su, L., Singh, J., and Snow, E. (1997) Characterization of gpt deletion mutations in transgenic Chinese Hamster cell lines. Environ. and Molecular Mutagenenesis 30: 418428.

(4) Singh, J. and Snow, E. (1998) Effect of chromium(III) on the fidelity of human DNA polymerase beta. Biochemistry 37: 93719378.

(5) Singh, J., Bridgewater, L., and Patierno, S. (1998) Differential sensitivity of Crmediated DNAinterstrand crosslinks and DNAprotein crosslinks to disruption by alkali and EDTA. Toxicological Sciences 45: 7276.

(6) Singh, J., McLean, J., Pritchard, D., Montaser, A., and Patierno, S. (1998) Sensitive quantitation of chromiumDNA adducts by inductivelycoupled plasma mass spectrometry with a direct injection nebulizer. Toxicological Sciences 46: 260265

(7) Singh, J., Pritchard, D., Carlisle, D., and Patierno, S. (1998) Chromiuminduced genotoxicity and apoptosis: relationship to chromium carcinogenesis (review). Oncology Reports 5: 13071318.

(8) Singh, J., Pritchard, D., Carlisle, D., and Patierno, S. (1999) Internalization of carcinogenic lead chromate particles by human lung epithelial cells: formation of intracellular lead inclusion bodies and induction of apoptosis. Toxicology and Applied Pharmacology 161: 240-248.

(9) Carlisle, D., Pritchard, D., Singh, J., and Patierno, S. (2000) Apoptosis and growth arrest in human lung fibroblasts exposed to chromium(VI): Effects of ascorbate and tocopherol. Toxicological Sciences 55: 60-68

(10) McLean, J., Acon, B., Singh, J., and Patierno, S. (2000) The determination of Cr in human lung fibroblast cells using direct injection high efficiency nebulizer with inductivelycoupled plasma mass spectrometry. Applied Spectroscopy 54(5): 659-663.

(11) Carlisle, D., Pritchard, D., Singh, J.and Patierno, S. (2000) Chromium(VI)-induced apoptosis in normal human lung fibroblasts is p53-dependent. Molecular Carcinogenesis. 28:111-118.

(12) Pritchard, D., Singh, J., Carlisle, D., and Patierno, S. (2000) Cyclosporin A inhibits chromium(VI)-induced apoptosis and mitochondrial cytochrome C release and restores clonogenic survival in CHO cells. Carcinogenesis 21:2027-2033.

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