.

CONTACT

Address: Berwyn, PA *****

Phone: 781-***-****

Email: ad08b4@r.postjobfree.com (preferred)

WEBSITE PROFILES

https://www.linkedin.com/in/farokhdotiwala/

MEDICAL / SCIENTIFIC

COMMUNICATION SKILLS

Authored, edited, and reviewed:

Scientific publications

Scientific manuscripts, grants, figures, and

tables for peer review.

Addressing reviewer/editor concerns, until

acceptance without supervision.

Excellent at making scientific, investor, and

marketing posters from scratch.

Medical/clinical

Standard operating procedures, pharmacy

manuals, investigator brochures, and

scientific/clinical reports.

Regulatory

IND, pre-IND, EAP, and ODD applications for

gene therapy and protein biologic programs.

Intellectual property

Claims and disclosure documents.

Subject matter expert

Due diligence and market intelligence in the

fields of immunology, microbiology,

infectious diseases, vaccines, cancer, gene

therapy, molecular and cell biology

Presentations and posters

Scientific conferences, investor meets,

marketing, meeting presentations for board

of directors, grant agencies, market

intelligence, and regulatory affairs.

Computer proficiency

Office suite, SharePoint, Outlook, GraphPad,

FlowJo, Adobe Acrobat, BioRender, Starting

Point, RIM Veeva.

PROFESSIONAL SUMMARY

Results-driven, detail-oriented, and determined scientist with 20 years’ experience in research and publishing in immunology, cancer, infectious diseases, microbiology and molecular & cell biology.

• Trained as a physician (MBBS) and research scientist (PhD). Research experience in anti-cancer drug testing and development, antibody and small molecule generation and testing, host- pathogen interaction, and immune response.

• Set up the scientific-IP publications and documentation team at Ocugen, supporting 6 programs.

• Introduced 2 new pipeline products in collaboration with the discovery group and broadened an existing pipeline into neurological area.

• Written and edited non-clinical and clinical documents (IND/pre-IND, ODD, EMA, CSR, SOPs) with leadership, basic accountability, strategic assistance, and planning support at the product level.

• Managed cross-functional teams with external CROs for pre-clinical, DMPK, and toxicity studies.

• Mentored 2 direct reports, reviewed and maintained document timelines and provided oversight and quality assurance for outsourced documents and other deliverables.

• Excellent conflict resolution, collaborative and influencing skills when working with cross- functional document, clinical, discovery teams.

Core Competencies include:

Scientific Medical / Clinical Regulatory

Data and review manuscripts

(start to publication)

Analysis and interpretation of

clinical trial data

Investigational new drug (IND) /

Pre-IND applications

Grant writing and reviewer

responses

Investigator brochures,

Standard operating procedures

Orphan drug designation (ODD)

applications

Data analysis, illustration and

maintaining reference libraries.

Pharmacy manuals, protocols

and amendments.

Expanded access protocols

(EAP)

Due diligence and market

intelligence

SME in immunology, cancer,

infectious diseases.

Responses to FDA queries

IP claims and disclosures Clinical Study Reports (CSRs) Working on RAPS certification

Presentations and posters Informed Consent Forms KEY ACCOMPLISHMENTS

• Led publishing for 3 pipeline products, facilitating successful phase 1/2 trials.

• Established the scientific-IP publications and documentation team at Ocugen, supporting 6 programs.

• Introduced 2 new pipeline products through collaboration with the discovery group.

• Authored numerous scientific publications, posters, SOPs, investigator brochures, and IP applications.

• Received grants and awards for research projects focused on antimicrobial resistance and immune responses.

WORK HISTORY

Associate Director – Scientific Publications and IP 02/2022 - Present Ocugen Inc Malvern, PA

• Created, adapted, and prioritized GSC product plans aligned with the scientific platform and informed through insights and feedback from cross-functional internal/external stakeholders.

• Implemented GSC plans that include but are not limited to scientific response documents, disease and product-related slide decks, global congress materials, and digital/web-based scientific content in the field of retinal disorders, gene therapy, biologics and vaccines.

• Reviewed GSC materials (Scientific, Regulatory, and IP-related) to ensure they are relevant, scientifically accurate, and consistent with company values and standards.

• Authored 6 high impact scientific reviews (3 published – 3 under review), 7 scientific posters, 5 marketing/investor posters, 15 SOPs, 2 investigator’s brochures, 3 ODD, and 3 IP applications.

• Led product-related initiatives with a direct impact on the product strategy, and provided innovative solutions to complex problems through, an understanding of infectious /non- infectious diseases, gene therapies, retinal disorders, and vaccines.

• Scientific intelligence in product knowledge, disease prevention and management, emerging therapies, vaccines, and the competitive landscape. FAROKH JAL DOTIWALA M.B.B.S., Ph.D.

SCIENTIFIC EXPERTISE

Immunology: Antigen-antibody generation,

immunohistochemistry, ELISA, immune cell

isolation, apoptosis assays, host-pathogen

immune interaction assays, flow cytometry

characterization.

Microbiology

Culture, manipulation and isolation of viral,

bacterial, fungal, and protozoan pathogens,

microscopy, aseptic procedures, antibiotic

testing, and in-vitro /vivo models of

infection.

Molecular and Cell Biology

Nucleic acid and protein purification, cloning

(PCR and vector creation), transformation,

protein expression (bacterial and

mammalian cells), in-vivo transcription, cell

culture (bacteria, fungal, protozoan,

mammalian), isolation of different cellular

compartments.

Protein characterization and function

UV/Vis Spectrometry, electrophoresis (SDS

and native), enzyme activity assays, protein

interaction assays (Western/dot blots, IP),

protein refolding assays

Animal work

Mouse breeding, maintenance of colonies

and genotyping, mouse models of infection,

drug toxicity testing, all routes of

administration, dissection, and organ

processing.

General scientific

Critical thinking, adaptability,

troubleshooting, project management,

collaboration and relationship building,

conflict resolution, training and

development, self-motivation, detail-

oriented, good communication and

presentation skills.

Assistant Professor Vaccine and Immunotherapy Center 03/2017 - 09/2021 The Wistar Institute Philadelphia, PA

• Established a research program on antimicrobial resistance and immune responses to pathogens.

• Collaborated with 4 faculty members on different research projects. Evaluated and supervised 2 post-doctoral fellows in research activities and performance.

• Assisted professors and administrators with continuous development, review, planning, and outcomes evaluation to measure vaccine and immunotherapy program performance.

• Reviewed program materials and coordinated updates for Institutional Biosafety and Institutional Animal Care and Use committees to keep department materials relevant and accurate.

• The NIH R01 grant awardee for "Role of African-centric TP53 variant in higher H. pylori prevalence in African Americans."

• Awarded the W. W. Smith Charitable Trust and the Mathers Foundation Grant for "Studying Microptosis to Combat Antimicrobial Resistance in Bacteria."

• The CURE grant recipient from the Pennsylvania DOH for "Strategies to combat antibiotic resistance."

Instructor and Post-doctoral Fellow 10/2012 - 03/2017 Harvard Medical School and Boston Children’s Hospital Boston, MA

• Conducted research on 4 guided projects in immunology and microbiology. Wrote and published peer-reviewed articles concerning findings and highlighted possible applications for findings.

• Participated in discussions, seminars, and lectures at institutional and other invited seminars.

• Collaborated with and supervised 2 post-docs, 2 graduates, and 5 undergraduate students to gather research and publish findings.

• Developed unique research into pathogen killing by killer immune cells and delivery of cytotoxic proteins into intracellular pathogens.

EDUCATION

Post-doctoral Fellow - Microbiology and Immunology 2009 - 2017 The Lieberman Lab - Harvard Medical School Boston, MA

• NRSA Research Fellowship Transfusion medicine -- NIH 2015

• Glaxo Smith Kline Cancer Fellowship – GSK 2012

Ph.D. - Molecular and Cell Biology 2003 - 2009

The Jim Haber Lab - Brandeis University Waltham, MA M.B.B.S.: General Medicine and Surgery 1998 - 2003 Grant Medical College and Sir J.J. Hospital Mumbai, India PUBLICATIONS

Publications: 23 Citations: 2267 h-index: 18 i10-index: 20 https://www.ncbi.nlm.nih.gov/myncbi/farokh.dotiwala.1/bibliography/public/ PATENTS

• Multicistronic vaccine and methods for producing and using the same – U.S. Provisional Patent number 63/447,734

• IspH inhibitors, and methods of making and using same - WO2021021933A1 AFFILIATIONS

Member:

• Regulatory Affairs Professional Society

• Genetics Society of America

• American Association for the Advancement of Science

• American Association of Immunologists

• American Society of Microbiology

Reviewer for:

• Elife

• MDPI

• Frontiers

• Frontiers in Immunology

.

Contact this candidate