B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) Email & Phone Number

California, United States

CMC, FDA interactions, small molecules, biologics, medical devices, combination products, Early Development, IND enabling studies, IND, NDA, regulatory writing...

Columbus, Ohio, Us

• Role of IND Sponsor representative and built regulatory infrastructure. • Provided strategic regulatory leadership for development teams.• Developed and submitted regulatory dossier• Conducted regulatory research and analysis, developed and communicated recommendations regarding new/emerging regulations to the management and project teams• Late-Stage Development using combination of clinical and Animal Rule regulatory path - overcame challenges faced with Animal Rule and determination of human efficacious dose through leading Type D meeting FDA. Managed interactions and communications with FDA.• Managed regulatory affairs and quality assurance related to CMC and submission strategy.• CMC and Pharmaceutics and manufacturing process validation – strategy for PPQ and analytical validation• Ensured the company is adhering to all applicable government regulations, submission regulations and guidelines• Planning of NDA submission strategy and expedited regulatory review request.• Developed regulatory strategy for drug development tool biomarker qualification.

• Provided strategic regulatory leadership for development teams (protein therapeutic, vaccine, drugs, autoinjectors)• Provided regulatory representation and expertise on cross-functional product development teams as needed.• Led regulatory team developing opioid abuse treatment drugs (NDA approved Feb 2022).• Role of regulatory affairs and quality lead for 2 chemical defense programs• Regulatory lead for COVID-19 therapeutics (plasma and Ab products) development and EUA resulting in two currently active INDs.• Successful accomplishment includes lead role for 3 each of Pre-INDs and INDs and One NDA • Completed two phase 1 clinical trials resulting in MTD determination and advancing programs for further development • Successful completion of Bioavailability and Bioequivalence study for a small molecule NDA• Covered GCP, GLP, cGMP and other quality regulations related to INDs and an NDA.• Obtained IND - ‘Study May Proceed’ and IRB and HRPO approvals for clinical trials

• Regulatory Affairs related to DoD Medical countermeasures products (Drugs/Biologics/Devices)• Regulatory strategy and target product profile of medical products (protein therapeutic, vaccine, drugs, IVDs)• Regulatory guidance, reviews, meetings, and submissions (Type A/B/C meetings, pre-IND/IND interactions and submissions, Assay Master Files, Quality Amendments, etc).• Create and maintain regulatory timelines and track deliverables to timelines• Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program.• Review of regulatory documents supporting clinical development of biologics (blood product and vaccines), drugs, diagnostics, combination products, and master files• Audit of GMP and CMC facilities including drugs, biologics, and diagnostics.• Interface with functional areas (CMC, Nonclinical, and Clinical) to obtain information required for regulatory submissions.• Master File submission and FDA acceptance.• Preparation and conduct of Agency meetings as necessary to support regulatory filings• Knowledge of current US and Global rules, regulations, and guidance governing drugs and biologics in all phases of development.

• Provided regulatory, QA/QC, Scientific consultancy to clinical analytical laboratory• Assisted in Phase I and II metabolic clinical sample method validation and analysis

Early Preclinical Development of monoclonal antibody to treat NSCLC (lung cancer) and metabolic diseases.• Developed research strategy, business plan, regulatory, and exit strategy.• Identified funding sources and KOLs for collaboration.

San Diego, Ca, Us

Led group of pharmacologists including Ph.D.’s, CVM portfolio, Project Leadership.• Phase I/II Drug development: As a project lead and pharmacology/toxicology support lead, I contributed to two compounds reaching Phase I and one compound reaching Phase II. Wrote supporting sections or documents supporting IND.• Generated preclinical PK/PD data using hyperglycemic clamp that lead to dose prediction for Phase I study. • Prepared pharmacology data package for phase I clinical study and IND submission.• Developed new pharmacology and biomarker methods for preclinical and clinical studies

New York, New York, Us

Pharmacology Lab Head, Project Leadership, Biomarker Strategy.• Developed preclinical PK/PD methodology that was used in Phase I clinical study. Wrote pharmacology section in IND document.• Planned, managed, and collaborated six external/contract primate pharmacology studies.

Led pharmacology lab, assay development, high throughput screening (HTS), target validation.• Led and managed an early discovery project team, developed HTS and selectivity assays. • Generated preclinical validation rodent data for several early targets.

• NIH grant collaboration with Professor RA Coleman (P.I.) and independent state and University grants• Managed lipid biochemistry lab• Guest lectures on lipid biosynthetic pathways to Masters Nutrition students • Cloned and characterized genes/proteins of triglyceride and energy metabolism• Coordinated Nutrition Department Seminar Series.

Certification, Rac

Specialized Certificate In Regulatory Affairs Essentials, Glp, Gcp, Gmp, Drugs And Biologics

Specialized Certificate In Clinical Trial Administration (2012)., Nuts And Bolts Of Clinical Trials

Postdoctoral Training, Lipid Biochemistry And Cell Biology

Ph.D., Biochemistry