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Rakesh Dixit, Ph.D., DABT
President & CEO, Bionavigen at Former Vice President, R&D, MedImmune

Profile

Current: President, & CEO, BIONAVIGEN, LLC, Gaithersburg, MD

Ex-VP, Biologics Drug Development (AstraZeneca until April 2019)

President & CEO, BIONAVIGEN, LLC, a biopharmaceutical virtual drug development company specializing in advising and consulting for all aspects of drug development, including discovery, preclinical development, CMC, translational sciences, clinical development, and regulatory filing.

Consultant and advisor to ten different biopharmaceutical companies

A member of several scientific advisory boards and corporate board of directors.

Selected by pharmaceutical peers as the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVoice in 2015

An accomplished executive, inventor, and scientist with over 30 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, MedImmune, AstraZeneca. 

A highly respected global leader known for building highly motivated safety assessment teams to advance small and large molecule biologics drug development programs and achieve company goals. 

A key opinion leader in translation sciences, safety, pharmacology, drug development with outstanding knowledge and proven experience in drug discovery, preclinical, and clinical development from IND/CTA, phase I, II, III, BLA/MAA, and approval. Strong track record in building business franchises and in building relationships with investors, media, and analysts. 

A key contributor to successful marketing approval of 10 different marketed biopharmaceuticals, including  for MedImmune (AstraZeneca Biologics): Imfinzi (anti-PD-L1 mab), Fasenra (anti-IL-5R afucsolytated mab), Brodalumab (anti-IL-17) in collaboration with Amgen, Moxetumomab (anti-CD22-PEA immunotoxin), multiple flu vaccines and for Merck: MAXALT (Anti-migraine)-1998, SINGULAIR (Anti-Asthma)-1998; CRIXIVAN (Anti-AIDS)-1998; VIOXX (COX-2 Inhibitor)- 2000, EMEND- 2003.  

Successful submissions and approvals of over 100 INDs and over 15 BLAs-NDAs.

 

EDUCATION & BOARD CERTIFICATION: Dr. Dixit conducted extensive undergraduate, graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. 

Rakesh Dixit, Ph.D., DABT's Network

Agenda Sessions

  • Challenges and Opportunities to Improving the Subcutaneous Delivery of Biologics

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