Raghu Cavatur
West Hollywood,CA
Summary
Pharmaceutical product development and regulatory CMC professional seeking a position in Regulatory CMC. Strategic-thinking individual experienced in product development and successful regulatory outcomes. Offering engaging and pleasant personality with expertise and team working skills to enable efficient project progression.
Overview
26
26
years of professional experience
Work History
Director and Head Reg CMC
Rapt Therapeutics
03.2023 - Current
- Reg CMC representative for all small molecule development programs
- Developed strategy for ongoing projects for Phase 3 and commercial development
- Authored PIP and PSP Development plans in collaboration with CMC
- Collaborated with CMC and Clinical in development of strategy for Phase 3 clinical program and DP bridging strategy from clinical to commercial
- Provided guidance to clinical development, clinical pharmacology on mass balance studies, pediatric formulation development, discriminatory dissolution methods approaches to relative BA and BE studies related to formulation changes during development
- Developed risk based regulatory strategy for product development, drug substance and drug product commercialization
- Coordinated with CMC to provide responses to Health Authorities with successful outcomes.
Director, Reg CMC
Kronos Bio Inc.
07.2022 - 03.2023
- Reg CMC representative for all small molecule development programs
- Developed strategy and content for submission of IND Amendments, IMPDs, briefing packages for all development projects
- Represented regulatory CMC on all cross functional teams and core teams, with additional responsibility of functioning as a CMC coordinator responsible for development of CMC development strategy
- Collaborated with QA, CMC staff and consultants to ensure compliance with all regulatory requirements
- Reviewed change controls, risk assessment and filing strategy for implementation of changes in collaboration with Quality
- Submitted major IND Amendments to introduce new manufacturing sites, manufacturing process for drug substance and drug product, specification changes, analytical procedures and shelf-life extensions for development projects.
Associate Director, Reg CMC
Aeglea Bio Therapeutics Inc.
11.2021 - 07.2022
- Reg CMC representative for all enzyme replacement therapy pegylated enzyme programs
- Developed strategy and content for submission of INDs, major IMPD amendments, and responses to health authority queries
- Represented regulatory CMC on all cross functional teams and core teams
- Collaborated with QA, CMC staff and consultants to ensure compliance with all regulatory requirements
- Collaborated with regulatory and SME’s in ensuring appropriate filing package for pegzilarginase MAA
- Coordinated with external partners to ensure successful filing of MAA of pegzilarginase
- Collaborated with CMO’s in ensuring availability of regulatory submission documents on time
- Authored PACMPs as necessary and QOS for the IND and MAAs
- Reviewed change controls, risk assessment and filing strategy for implementation of changes in collaboration with Quality.
Associate Director
BioMarin, Inc.
01.2019 - 11.2021
- Lead Reg CMC representative for Development phase Oligonucleotide molecules
- Lead Reg CMC representative for development of drug substance content and submission for Vosoritide NDA/MAA (a recombinant peptide) - approved in EU, US and Japan
- Lead for providing responses to MAA/FDA during review
- Lead for content and authoring of briefing book for Pre-NDA/MAA meetings with Health Authorities (FDA/EU)
- Lead for working with Japan Reg CMC for draft of Drug Substance sections for JNDA
- Preparation of content guides for authoring of all 3.2.S and 3.2.P sections for biologics and small molecules
- Work closely with SME’s in authoring of various sections of gene therapy BLA (primarily 3.2.P.2 and 3.2.P.3) CMC related information and label claim verification in 3.2.P sections
- Review of analytical validation documents
- Regulatory CMC strategy for IND/IMPD amendments and MAA/NDA
- Reviewed change controls, risk assessment and filing strategy for implementation of changes in collaboration with Quality.
Staff Fellow
Food and Drug Administration (FDA)
04.2016 - 01.2019
- Authoritative assessment of Module 3 of e-CTD submissions for compliance with regulatory and technical guidance documents of FDA and ICH
- Author internal assessment documents and provided deficiencies to applicants.
Sr. Research Associate
Reckitt Benckiser
07.2012 - 04.2016
- Member of internal integrated Quality assessment team
- Lead formulation scientist for Mucinex OTC brand
- Development of 505b (2) modified release OTC products for Mucinex brand
- Manage formulation development and clinical trial manufacture at contract manufacturing organizations
- Project member of Matrix team of quality, regulatory and Clinical groups
- Author sections of Module 3 for regulatory filing.
Principal Scientist
Population Council
07.2011 - 06.2012
- Principal formulation scientist for development of implantable and biodegradable contraceptives
- Lead development of vaginal gels for contraception
- Author funding proposals to NIH and other funding agencies.
Principal Research Investigator
Sanofi-Aventis
07.2001 - 04.2011
- Principal formulation scientist for development of NCE’s and NME’s
- Formulation development of various NCE’s, as solid oral dosage forms
- Clinical trial manufactures for Phase I/IIA studies
- Development of other dosage forms such as inhalation, and intranasal formulations as needed
- Develop poorly soluble compounds to enhance bioavailability by amorphous solid dispersions, and Nano sizing
- Represent pharmaceutical sciences on project teams, CMC and clinical sub-teams
- Provide guidance to project management on timelines and deliverables
- Author relevant sections of regulatory documents.
Scientist II
Dura Pharmaceuticals
09.1998 - 07.2001
- Formulation scientist for development of dry powder inhalation formulations using proprietary inhaler
- Developed formulations with enhanced respirable fractions
- Developed formulations used in scintigraphy study to study aerosol deposition pattern.
Education
Ph.D. in Pharmaceutics -
College of Pharmacy, University of Minnesota
Minneapolis, MNMasters in Pharmaceutics - undefined
College of Pharmacy, Kakatiya University
Warangal, IndiaBachelors in Pharmacy - undefined
College of Pharmacy, Kakatiya University
Warangal, IndiaSkills
Development of regulatory CMC strategy, content, and submission for IND, IMPD, NDA/BLAs
Strategic and regulatory CMC leadership across all phases of development
Representing regulatory CMC on cross-functional teams and CMC coordinator for all product development
Preparation of high-quality, on-time CMC sections for regulatory submissions including for INDs, IMPDs, US NDA, MAAs and briefing packages
Deep knowledge of all applicable FDA, ICH guidelines
Experienced in regulatory CMC landscape for small and large molecules
Expertise in formulation development of various dosage forms (solid oral dosage forms, intra-nasal, inhalation)
Expertise in pre-formulation and formulation development of new chemical entities
Expertise in GMP Manufacturing experience of clinical trial batches, tech transfer and management of formulation development at contract manufacturing sites (CMO’s)
Member of cross functional matrix project teams, quality, regulatory and clinical sub-teams
Patents
- Pharmaceutical tablet containing at least two tablets - N. Ahlgren, R. Cavatur, K. Chen, M. Kaser, H. Qiu.
- Tablet formulation of a pi3Kalpha inhibitor. M. Baud, R. Cavatur, D.Parikh and P.Raju.
Awards
- Procter and Gamble Graduate research award, AAPS, 1996.
- Eli-Lilly Graduate research award in pharmaceutical technologies, AAPS 1998.
- USP Pharmacopeia Fellowship, 1995-1996.
Publications
- R.K. Cavatur, N.M. Vemuri and R. Suryanarayanan. Preformulation Studies for Tablet Formulation Development, in Pharmaceutical Dosage Forms, Vol. 2 (Eds. S. Hoag), 2008.
- N.M. Vemuri, Z. Chrzan, R. Cavatur. Use of isothermal microcalorimetry in pharmaceutical pre-formulation studies. Part I. Monitoring crystalline phase transitions as a function of temperature and humidity. JTAC, 78: 47-54 (2004)
- N.M. Vemuri, Z. Chrzan, R. Cavatur. Use of isothermal microcalorimetry in pharmaceutical pre-formulation studies. Part II. Amorphous Phase Quantification in a Predominantly Crystalline Phase. JTAC, 78: 55-62 (2004).
- R. Cavatur, N.M. Vemuri and Z. Chrzan. Use of isothermal microcalorimetry in pharmaceutical pre-formulation studies. Part III. Evaluation of excipient compatibility of a new chemical entity. JTAC, 78: 63-72 (2004).
- R.K. Cavatur, N. Murti Vemuri, A. Pyne. Z Chrzan, D. Toledo-Velasquez and R. Suryanarayanan. Crystallization behavior of mannitol in frozen solutions. Pharm. Res., 19: 894-900, 2002.
- R.K. Cavatur and R. Suryanarayanan. Characterization of phase transitions during freeze-drying by in situ X-ray powder diffractometry. Pharm. Dev. Tech., 3(4): 579-586 (1998).
- R.K. Cavatur and R. Suryanarayanan. Characterization of frozen aqueous solutions by low temperature powder X-ray diffractometry, Pharm. Res. 15: 194-199 (1998).
- N. Phadnis, R.K. Cavatur and R. Suryanarayanan. X-ray powder diffractometry of pharmaceutical dosage forms, J. of Pharm. Biomed. Anal. 15: 929-943 (1997).
Timeline
Director and Head Reg CMC
Rapt Therapeutics
03.2023 - Current
Director, Reg CMC
Kronos Bio Inc.
07.2022 - 03.2023
Associate Director, Reg CMC
Aeglea Bio Therapeutics Inc.
11.2021 - 07.2022
Associate Director
BioMarin, Inc.
01.2019 - 11.2021
Staff Fellow
Food and Drug Administration (FDA)
04.2016 - 01.2019
Sr. Research Associate
Reckitt Benckiser
07.2012 - 04.2016
Principal Scientist
Population Council
07.2011 - 06.2012
Principal Research Investigator
Sanofi-Aventis
07.2001 - 04.2011
Scientist II
Dura Pharmaceuticals
09.1998 - 07.2001
Ph.D. in Pharmaceutics -
College of Pharmacy, University of Minnesota
Masters in Pharmaceutics - undefined
College of Pharmacy, Kakatiya University
Bachelors in Pharmacy - undefined
College of Pharmacy, Kakatiya University