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As a Senior Regulatory Affairs Advisor/Director and Head of Regulatory Affairs at Battelle, I lead a team of regulatory professionals with RAC-US and RAC-Global credentials, providing strategic guidance and oversight for the development of medical products, including drugs, biologics, and diagnostics. I have more than 25 years of experience in the pharmaceutical industry, spanning from drug discovery to product approval, with a focus on medical countermeasure products for infectious diseases, opioid abuse, and nerve agents.My core competencies include developing and executing regulatory strategies, preparing and submitting regulatory dossiers, conducting regulatory research and analysis, managing interactions and communications with FDA and other regulatory agencies, and building regulatory infrastructure and processes. I have successfully obtained one NDA approval, three active INDs, and two EUAs for COVID-19 therapeutics, and have led or supported multiple pre-IND and IND submissions, Phase 1/2 clinical trials, and Animal Rule studies. My mission is to advance the development and delivery of safe and effective medical solutions that address unmet medical needs.
Bhat Regulatory Affairs Consultancy
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Bhat Regulatory Affairs ConsultancyCalifornia, United States
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Regulatory Affairs ConsultantBhat Regulatory Affairs Consultancy Aug 2023 - PresentCMC, FDA interactions, small molecules, biologics, medical devices, combination products, Early Development, IND enabling studies, IND, NDA, regulatory writing...
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Senior Regulatory Affairs Advisor/Head-Regulatory AffairsBattelle Jan 2022 - Jul 2023Columbus, 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. -
Senior Regulatory Affairs Manager And Quality AssuranceDod And Hii-Tsd Mar 2018 - Feb 2022• 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
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Senior Manager Regulatory Affairs And QualityDod And Noblis Esi Mar 2015 - Feb 2018• 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.
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Consultant, Qa/Qc, Clinical Analytical Research, MetabolomicsClinmet (Clinical Metabolomics Inc.) 2014 - 2015• Provided regulatory, QA/QC, Scientific consultancy to clinical analytical laboratory• Assisted in Phase I and II metabolic clinical sample method validation and analysis
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ConsultantImmunosol Biosciences 2014 - 2015Early 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.
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Group Leader/Senior Research Investigator, Cardiovascular And Metabolism PharmacologyNovartis, San Diego 2007 - 2014San Diego, Ca, UsLed 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 -
Senior Principal ScientistPfizer 2003 - 2007New York, New York, UsPharmacology 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. -
Principal Scientist/Senior ScientistPfizer Inc., (Formerly Monsanto/Pharmacia) 1997 - 2003Led 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.
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Research Assistant ProfessorUniversity Of North Carolina, Department Of Nutrition, 1991 - 1996• 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.
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) Skills
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) Education Details
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RapsRac -
University Of California - San DiegoDrugs And Biologics
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University Of California, San DiegoNuts And Bolts Of Clinical Trials
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University Of Florida College Of MedicineLipid Biochemistry And Cell Biology
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University Of MysoreBiochemistry
Frequently Asked Questions about B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)
What company does B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) work for?
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) works for Bhat Regulatory Affairs Consultancy
What is B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)'s role at the current company?
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)'s current role is Consultant, Bhat Regulatory Affairs/Pharma Consultancy | RAC-Global, RAC-US.
What is B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)'s email address?
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What is B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)'s direct phone number?
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global)'s direct phone number is +185862*****
What schools did B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) attend?
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) attended Raps, University Of California - San Diego, University Of California, San Diego, University Of Florida College Of Medicine, University Of Mysore.
What skills is B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) known for?
B. Ganesh Bhat, Phd, Rac (Us), Rac (Global) has skills like Drug Discovery, Diabetes, Drugs And Biologics, Obesity, Energy Metabolism, Metabolism, Atherosclerosis, Cardiovascular, Lipid And Lipoprotein Metabolism, Animal Models, In Vivo Pharmacology, Preclinical And Clinical.
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