Pinky Doshi

Regulatory Director at Bristol-Myers Squibb (CAR T products)

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Multiple Myeloma
CAR T
Cancer Immunotherapy with Chimeric Antigen Receptor (CAR) T-Cells
Combined B-Cell and T-Cell Disorders
Work experience
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May 2013 - Present

Bristol-Myers Squibb

Regulatory Director

- Regional (US) regulatory lead on the CAR T program (bb2121) for multiple myeloma. Experience with Breakthrough therapy designation (BTD) product in cell therapy including leading BTD multidisciplinary meeting, BLA format/content meetings and other interactions with FDA for managing regulatory strategies for CAR T program. - Primary contact for FDA for the bb2121 CAR T program - Prepare company team for FDA meetings, including EOP2, BTD, pre-BLA, Phase 3 study design meetings - Represent Regulatory Affairs on various cross-functional teams, including Project teams, Safety Management meetings, study teams - Served as a regional regulatory lead on early development Oncology project for solid tumor indications and global regulatory lead on solid tumor development projects and marketed products (Note: Celgene until 2019 and now BMS)

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Sep 2012 - Feb 2013

Roche

Regulatory Program Director

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Apr 2010 - Sep 2012

Roche

Associate Director

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Sep 2006 - Apr 2010

Schering Plough

Senior Regulatory Affairs Manager & Liaison

- Global regulatory leader on project teams providing strategic direction and guidance for the development of drugs for allergic rhinitis (Phase II/III), cough (Phase I), overactive bladder (Phase I) and HIV (Phase III) indications - Key contact to FDA for Phase I-III development products working on FDA guidance meetings (Pre-IND and Type C) and maintenance of INDs - Facilitate preparation of briefing book for an EMEA Scientific Advice meeting for a development product and maintained EU CTAs for clinical trials - Lead Global Regulatory Strategy teams (GRSTs) for development and marketed products - Provide global post-marketing support such as labeling changes, NDA annual reports and Health Authority correspondences for Dermatology products

Aug 2003 - Sep 2006

Johnson & Johnson Pharmaceutical Research & Development

Regulatory Affairs Manager

- Global regulatory leader on a Phase I compound development team providing regulatory strategic plans and contributing to development of target product profiles - Regulatory lead on U.S. IND and global CTA dossier teams, providing strategic and operational guidance for submissions to worldwide Health Authorities for the CNS and Inflammation therapeutic areas - Principal liaison to U.S. and EU national health authorities for IND and CTA submissions for investigational drugs - Provide regulatory intelligence and ensure timely and clear communication of the regulatory environment and its implications to team members - Active contributor and trainer in the regulatory redesign taskforce responsible for the development of new processes

Nov 2002 - Aug 2003

Halsey Drug Company

Regulatory Affairs Associate

- Compile CMC data and write U.S. annual reports for approved ANDA products - Actively co-coordinated a CBE-30 submission required for site transfer of a marketed product - Review labels, package inserts and change controls for marketed products

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Oct 2000 - Oct 2002

Quest International

Regulatory Affairs Associate

- Provided assistance to pharmaceutical customers on the constantly changing worldwide regulatory requirements for raw materials used in the pharmaceutical industry - Served as a primary contact for regulatory issues on infectivity (BSE) and acted as a company representative developing and maintaining positive relationships with the FDA, USDA and other worldwide regulatory agencies - Developed and implemented requirements for submission of Type IV Drug Master File (DMF) and European Certificate of Suitability (CoS) for excipients - Involved with customer audits, presentations, cGMP regulations and supplier discussions for excipient manufacturing

Education

2000 - 2001

1999

BS, Cell & Structural Biology

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