Real world drug development experience-based consulting services for biologics (e.g., antibodies, peptides, recombinant proteins, bispecifics, antibody drug conjugates (ADC), oncolytic virus, gene editing and gene delivery) viral, cell and gene therapy), small molecule pharmaceuticals, therapeutic peptides and medical devices.
- A team of virtual full drug developers (preclinical, clinical and regulatory experts)
- Actively engaged in acquisition of clinical stage biologics and small molecule drugs from pharmaceutical companies supported by funds from VC investment firms
- Early VC funding to support early proof-of-concept clinical trials
Rakesh Dixit, Ph.D., DABT
President, CEO and Founder
- 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 & Co., Inc., Johnson & Johnson, MedImmune, AstraZeneca, Seneca Pharmaceuticals (current)
- 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.
Global Biopharma Companies Consultancy-Advisory Committees-Board of Directors Experiences (May 2019-Current)
- Heidelberg Pharma (Germany)
- NBE Therapeutics (Basel, Switzerland)
- Emergence Therapeutics (Germany & France)
Advisory Board & Board of Directors
- Araris Biotech (Zurich, Switzerland)
- Sotio Pharma (Czech Republic)
- Ultrahuman (UK)
- Immunosoft (Seattle, WA)
- Palleon Pharma (Boston, MA)
- BLA-Regulatory, Gaithersburg, MD
- Amador Bio (Pleasanton, CA & Hangzhou, China))
- NextImmune (Gaithersburg, MD)
- BOL Pharma (Israel)
- QILU Pharma (Shanghai, China)
- Bliss Biopharmaceuticals (Hangzhou, China)
- LegoChem Biosciences, Daejeon, South Korea
EDUCATION & BOARD CERTIFICATION:
Dixit conducted extensive 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.