DILEEP BHAGWAT, Ph.D., MBA
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`912 Twisted Oak Place,
`Wilmington, NC 28405 Email: DileepB@AOL.com Home Phone: (910)679-8649 Cell: 914-364-0327
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`EXECUTIVE PROFILE
`Entrepreneurial, results oriented pharmaceutical consultant with extensive global Regulatory, CMC, Quality & Clinical experience and
`excellent project management skills. 20+ years of core CMC - Pharmaceutical Product Development management experience
`(Solid/liquid oral, Topicals, injectables, MDI etc.) in multiple therapeutic areas (Oncology, Dermatology, GI, CNS, cardiovascular). Specific
`capabilities and experience are detailed below.
`Global Regulatory
`- Led multi-functional teams in defining the EU Regulatory strategy to MAA filing (including eCTD, centralized procedure) and MAA
`review process management to MAA opinion and final label negotiations. Strategy, management of Post-Approval changes
`- Full responsibility in last three positions for all CMC documentation for regulatory submissions (IND, NDA, ANDA, MAA, NDS)
`- Present and defended CMC data packages and company position to FDA, EMA, Health Canada.
`CMC - Pharmaceutical Development Management
`- Led Rx and OTC global Product Development, Technology Transfer, contract R&D, contract manufacturing, Scale up and
`commercialization teams. Pre-formulation; analytical/formulation development; IQ, OQ, PQ; analytical method validation; ICH stability
`studies; RM, in-process, finished product specifications; Cleaning validation; process validation; MBR
`- Holder of 16 US issued patents plus many international patents
`Quality Assurance – Full responsibility for Quality at last three positions: GMP audits of API/Drug Product manufacturing facilities in the
`US and Europe. Pre-FDA /EMA audit diligence and preparation of sites for audits.
`Clinical Study Management: Including all aspects of two large (200 and 500 patient) randomized blinded studies in pain.
`Project Management: Led multi-functional project teams establishing strict goals, timelines and budgets. CROs, CMOs, licensee and KOL
`relations, University R&D liaison. Business development due diligence. Retained and managed consultants – Regulatory, Quality, CMC,
`Clinical, Toxicologists, Statisticians and Legal.
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`WORK EXPERIENCE
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`WPDC, LLC
`CEO and Sr. Consultant (examples of work experience)
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` MARCH 2013 TO PRESENT
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`Sr. Regulatory consultant - To leading Japanese Pharmaceutical company on multiple projects.
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` April 2016 to present
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`Sr. Regulatory consultant - To leading French Pharmaceutical company. Updating CTD CMC sections to July to December 2015
`Company templates and incorporated prior Annual Report information for biological products. Authored
`Annual Reports. Supervise team of authors. Worked with Regulatory software/data bases (e.g. Documentum)
`Sr. Regulatory consultant – To Pharma Company based in Israel, Responsible for all CMC Sections of NDA. July’14 to May 2015
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` NDA filed June 2015
`Sr. Regulatory consultant – To top 10 global Pharmaceutical Company, in Basel, Switzerland November 2013 to July 2014
`Worked in Basel, Switzerland on authoring CMC sections and review/edits of Drug Substance and Drug Product CTD CMC Sections.
`Development had QBD elements. Pharmaceutical Development and Regulatory skills to develop strategy and finalize Development
`reports for NDA/MAA after direct interface and visit with small Development Company in Jerusalem, Israel.
`Sr. Regulatory consultant – To Fortune 100 Company in the US
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` August 2013 to November 2013
`Consulting assignment for global CMC (API) Regulatory and Quality matters. Assessed the impact of potential API manufacturing site
`change on global regulatory filings for API and Drug Products manufactured with API by customers. Comprehensive report with
`recommendations generated for management.
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` Ongoing since July 2011 (as requested)
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`Sr. CMC consultant – To small development stage companies
`Formulation Development/optimization strategy and ICH stability studies. IND and scale up.
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` 2004 to DECEMBER 15, 2012
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`EPICEPT CORP., TARRYTOWN, NEW YORK
`Sr. Vice President, Pharmaceutical Development
`Member of EpiCept’s management team, reporting to the CEO. Responsible for all aspects of drug product development (Phase I –
`III) and GMP manufacturing/commercialization/supply chain of pain and oncology compounds in the EpiCept pipeline. Responsible for
`QA and global Regulatory CMC submissions for NDA, NDS and MAA.
` Product development of oncology (including NCEs) and pain Rx products
` Developed and scaled up to manufacturing scale a topical pain Rx cream formulation. Responsible for all CMC issues (API and
`Drug Product) for NDA and MAA (successful End of Phase 2 meetings with FDA and EMA) recently completed.
` Developed challenging NCE injectable formulation for IND and early Phase 1 – 2 studies.
` Led a multi-functional project team in the regulatory filing (on time and within budget) of an eCTD MAA in Europe via the
`Centralized procedure of EpiCept’s lead compound (Ceplene – first-in class drug for remission maintenance in Acute Myeloid
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`DILEEP BHAGWAT, Ph.D., MBA
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`912 Twisted Oak Place,
`Wilmington, NC 28405 Email: DileepB@AOL.com Home Phone: (910)679-8649 Cell: 914-364-0327
`Leukemia). Managed Regulatory, Clinical, Statistical, Toxicological and CMC consultants and organized KOL meeting in Europe
`for this application. Responsible for all CMC filings
`o Responsible for all API and Drug Product GMP manufacturing (Scale up, validation) and commercial packaging to
`successful commercial launch on time.
` Led a team to generate stability data on a recombinant DNA (biological) Rx product. Data was filed and after much negotiation
`(EMA CMC, Quality and Clinical) was accepted by the EMA resulting in a much needed EMA approved changed to the package
`insert.
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` 1999 – 2004
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`BRADLEY PHARMACEUTICALS, FAIRFIELD, NEW JERSEY
`Chief Scientific Officer
`Responsible for all scientific activities at the company reporting to the President and CEO. Responsible for Product development,
`Operations Dept. (manufacturing and supply chain), setting up and managing a Clinical program, Regulatory and Quality Assurance and
`compliance. Developed and launched a number of OTC/Rx products resulting in company sales increasing over 300% during the 5 year
`period. Worked with Marketing on promotional material oversight (DDMAC) and with Sales on Sales Training. Conducted US and
`International seminars for physicians presenting scientific data on company products.
`Responsible for Bradley’s Operations Dept. and for all manufacturing and compliance of Rx and OTC products. Included
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`selection and qualification of contract manufacturers and supply chain internationally. Scale up of development projects
`to commercial scale. Regulatory filings. Quality Assurance.
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`1994 – 1999
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`PENWEST PHARMACEUTICALS CO., PATTERSON, NEW YORK
`Vice President, Scientific Development and Regulatory Affairs
`Hired by TIMERx Technologies as Vice President, Pharmaceutical R & D, reporting to the President, to organize and modernize (cGMP
`compliance) the R & D efforts of PENWEST’s emerging Oral Controlled Release business. Organized, staffed, trained and managed
`Pharmaceutical Development, Pharmaceutical Analysis and QA / QC Depts. Introduced the cGMP mind-set taking drug development
`into clinical studies. Hired / trained many Ph.D. (Director / Manager level), scientists / technicians in these Depts. Responsible for the
`installation and validation (IQ, OQ, PQ) of an in-house Clinical Manufacturing facility (in compliance with cGMPs and a new Quality
`system). Subsequently, Regulatory Affairs responsibility was added. Worked with a Sr. Management R & D Team when the TIMERx and
`Mendell (excipient) businesses were combined under Penwest Pharmaceuticals Co.
`Sr. R & D Team member in developing a Once a Day Oral TIMERx Nifedipine XL (ANDA) product (antihypertensive)
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`bioequivalent to Procardia XL using TIMERx Technology. Responsible for working with the Licensee in getting TIMERx
`technology (a new technology) through the FDA review process. ANDA was approved.
`Led a multi -disciplinary team in the Technology Transfer of TIMERx Nifedipine XL to European licensee. Worked with
`licensee on regulatory requirements (Biostudies, Clinical studies, stability and submission information on TIMERx
`Technology). Product filed (MAA) and approved in record time.
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` Developed the Regulatory strategy with Licensee of TIMERx’s first European Oral Controlled Release Once a Day
`incontinence drug MAA filing. Product was approved with no comments by the agency on TIMERx Technology (a new
`Technology to the Agency).
`Led a multi-disciplinary team for PENWEST’s largest Joint Venture Oral Controlled Release Analgesic development project.
`Led project with Sr. VP R & D of partner company in completing Phase I studies, filing an IND and moving the project into
`Phase II / III on time and in budget. Jointly evaluated and selected a CRO company to develop a Clinical Development Plan
`and undertake clinical studies. Presented project updates to Joint Alliance Committee (Sr. Management of both
`companies).
` Developed novel Oral Controlled Release antidiabetic product using the TIMERx Technology. Two US patent issued.
`Formulation was licensed after the first pilot biostudy because it gave the desired 24 hour profile.
`Prior positions at:
`PURDUE FREDERICK RESEARCH CENTER, YONKERS, NEW YORK
`Excellent all round hands on Laboratory experience in pharmaceutical analytical, formulation development research and
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`manufacturing. Progressed from Summer Intern with successive promotions and increased responsibility to Assistant Director,
`Pharmaceutical Development
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`EDUCATION Ph.D. (Industrial Pharmacy) St. John’s University, New York; MBA (International Business) - Pace University, New York
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`HONORS AND PROFESSIONAL AFFILIATIONS :
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`Rho Chi Pharmaceutical Honor Society
`Drug Information Association (DIA)
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`American Association of Pharmaceutical Scientists (AAPS)
`American Pain Society (APS)
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`PERSONAL US citizen
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