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Biographical Sketch Rakesh Dixit, Ph.D., DABT

  • Current: Cofounder, President & CSO, Regio Biosciences, Rockville, MD
  • Current: President, & CEO, BIONAVIGEN, LLC, Gaithersburg, MD
  • Ex-VP, Biologics Safety Assessment, Translational Sciences& R & D, AstraZeneca (August 2006-April 2019)
  • Cofounder, President, and CSO, Regio Biosciences (An AstraZeneca Spin-off Company), Rockville, MD, USA: 2020 to Current

Regio Biosciences is a spin-off company of AstraZeneca and is committed to developing novel therapies to reduce plaque burden in the peripheral and coronary arteries and functionally reverse cardiovascular disease by accelerating cholesterol removal and providing new hope to patients with cardiovascular disease. REG-101 is the lead Regio clinical program, licensed from AstraZeneca. Regio was founded in 2020 and is based in Rockville, MD. REG-101 is Phase 2b ready monoclonal antibody against endothelial lipase and has been shown to increase the amount of good cholesterol HDL ApoA1 protein, macrophage reverse cholesterol to improve removal of LDL from the body.

  • President & CEO, BIONAVIGEN ONCOLOGY, LLC, Gaithersburg, MD, USA

A biopharmaceutical virtual drug development company specializing in drug hunting, advising, and consulting for all aspects of drug development, including discovery, preclinical development, CMC, translational sciences, clinical development, and regulatory filing.

  • Selected by pharmaceutical peers as the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVoice in 2015
  • Received by peers the Most Prestigious Award of Long-Standing Contribution to ADCs by World ADC (Hanson-Wade), 2020
  • An accomplished executive, inventor, and scientist with over 30 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, MedImmune, and 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.
  • I am a key opinion leader in translation sciences, safety, pharmacology, and drug developmentwith outstanding knowledge and proven experience in drug discovery, the preclinical, and clinical outcome from IND/CTA, phase I, II, III, BLA/MAA, and approval. Strong track record in building business franchises and 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 graduate and post-graduate training in Pharmacology/Toxicology–Biochemistry with both Indian and USA Institutions (e.g., University of Lucknow Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is a Diplomate and Board Certified in Toxicology from the American Board of Toxicology, Inc. since 1992.
  • MBA Training for Biopharmaceutical, Harvard Business School, Boston, MA, USA

BIOPHARMACEUTICAL PROFESSIONAL EXPERIENCE (1992 -2019):

Merck & Co., Inc. (1992-2005): In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA, where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to many blockbuster drugs (13 Years).

Johnson & Johnson (2005-2006): Rakesh was also associated with Johnson and Johnson PRD, La Jolla/Alza, as a Senior Director of Toxicology (1 Year).

AstraZeneca & MedImmune (2006-2019): In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, Rakesh is responsible for guiding research and development of biological products, including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines

Publications and Worldwide Invited Presentations:

  • Rakesh has published over 80 peer-reviewed papers in renowned international journals and has given over 130 invited lectures/presentations/workshops in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology -biopharma industry.
  • Overall Expertise: Rakesh's areas of expertise are mainly pharmaceuticals and biologics drug development, including early discovery, preclinical development, safety assessment, translational medicine, regulatory filing, etc.
  • Rakesh was a pivotalcontributor to the development and approval of 10 blockbuster biopharmaceuticals to the market.
  • Rakesh is a recognized expert in preclinical drug development, safety, and pharmacology biomarkers and their applications. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology and Journal of Toxicology and Environmental Health.
  • Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in the Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and on the appointed committee for many programs managed by the prestigious US National Academy of Sciences and the US National Institutes of Health, including

Global Biopharma Companies Consultancy-Advisory Committees-Board of Directors Experiences

  1. Heidelberg Pharma (Germany)
  2. NBE Therapeutics (Basel, Switzerland)
  3. Emergence Therapeutics (Germany & France)
    1. Advisory Board & Board of Directors
  4. Araris Biotech (Zurich, Switzerland)
    1. Advisory Board
  5. Sotio Pharma (Czech Republic)
  6. Ultrahuman (UK)
  7. Immunosoft (Seattle, WA)
  8. Palleon Pharma (Boston, MA)
  9. BLA-Regulatory, Gaithersburg, MD
  10. Amador Bio (Pleasanton, CA & Hangzhou, China))
  11. NextImmune (Gaithersburg, MD)
  12. BOL Pharma (Israel)
  13. QILU Pharma (Shanghai, China)
  14. Bliss Biopharmaceuticals (Hangzhou, China)
  15. LegoChem Biosciences, Daejeon, South Korea
  16. Quellis Bio, USA
  17. Vividian Bio, USA
  18. Disc Medicine, USA
  19. Abtis, South Korea
  20. Oncusp Bio
  21. Dianthus Bio
  22. Next Cure
    1. Advisory Board
  23. Federation Bio
  24. Velavigo
  25. Hummingbird Bio
  26. NJ Bio
    1. Adviser and SAB member
  27. Redwood (Catalent) Biologics
  28. Instil Bio
  29. Integer Bio
  30. Samsung Biologics
  31. Ajinomoto
  32. Canopy Biotech
  33. Tshaka Bio
  34. ID Bio
  35. TPG
  36. Gilda
  37. Hillstar
  38. Adcynthrix
  39. Deka Bio
  40. Gen Sci
  41. Safe Pharma

ADC Related Accomplishments

  • Honored to be selected by peers for the most prestigious award of "The Long-Standing Contributions to the field of ADC" by WORLD ADC FORUM in 2020
  • Board of Director for a German-French ADC company, Emergence Therapeutics
  • Scientific Advisory Board of several global ADC companies
  • One of the top ten most invited speakers in WORD ADC Conferences
  • Successful filing of INDS of more than 10 ADC drugs
  • KOLs for at least 10 ADC companies
  • KOL for many large investors
  • 16 years of the ADC drug development, including clinical development

30

Years of Experience

10

Marketed Biopharmaceuticals

100+

INDs

15

BLAs-NDAs

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