Dr. Robert B. Stein MD, PhD
Dr. Robert B. Stein MD, PhD

Dr. Robert B. Stein MD, PhD

Therapeutic Area
Autoimmune Haematology Oncology
Key Indicator Area
Biologic Development Drug Discovery Preclinical Development Translational Medicine
Expertise Areas
Industry Executive Payer Advisor Regulatory Advisor Scientific Advisor

About Robert Stein

Current role and clinical setting

Dr. Robert B. Stein is Principal at RBS Biotech Consulting, PLLC (since August 2008), providing creative and collaborative problem solving at the interface of pharmaceutical science, medicine, and business, with over 40 years of experience in leadership across large pharmaceutical companies and biotech. He is Venture Partner at Samsara BioCapital (since January 2018), based in Palo Alto, CA. He serves as Senior R&D Advisor and Founder at MiNK Therapeutics (since January 2022), Senior Advisor R&D at Agenus (since April 2017), Board Member and CMO at Protagenic Therapeutics (since January 2016), Board Member at PolyPid Ltd. (since March 2020), Board Member at Immunogenesis (since January 2019), Board Member and Chief Medical Advisor at Isosceles Pharmaceuticals (since June 2018), Scientific Advisory Board Member at Autobahn Labs (since June 2020), and BioPharma Advisory Committee Member at Washington University Saint Louis School of Medicine (since October 2020). He serves as Scientific Advisor to IAG, Image Analysis Group, with expertise in preclinical development, translational medicine, oncology, and immuno-oncology. He is also a Scientific Advisory Board Member at the Drug Development Institute of the James Comprehensive Cancer Center at Ohio State University (since January 2013).

Therapeutic focus and research methodology

Dr. Stein has over 40 years of drug discovery and development experience spanning molecular and cellular biology, biochemistry, enzymology, animal pharmacology, virology, drug metabolism, and safety assessment, as well as extensive experience in translational medicine and early clinical development. He has led groups of over 1,000 scientists and physicians for over 15 years, supervising work across all major therapeutic areas. His therapeutic areas of depth include inflammation, transplant, CNS, virology, genito-urinary diseases, oncology, immuno-oncology, regenerative medicine, and neuroscience.

 

His current research advisory focus includes immuno-oncology programs encompassing checkpoint modulatory antibodies, personalized neo-epitope-directed cancer vaccines, TCR discovery and optimization, and AlloNK and NK cell therapy through MiNK Therapeutics. His consulting work at IAG is focused on helping biopharma partners shape clinical development strategy, discovery and optimization technology platforms, and portfolio in oncology and immuno-oncology programs. He has led Roche’s Translational Medicine capabilities, served on the Global Early Development Committee, Global Biologics Steering Committee, and the Joint Roche-Genentech Steering Committee.

Clinical trial experience

Dr. Stein has been a lead contributor in the discovery and registration of eight marketed drugs across his career: Sustiva® (efavirenz, HIV), Fablyn® and Viviant® (SERMs), Panretin®, TargRetin® gel and capsules (retinoids), Promacta® (eltrombopag, thrombopoietin mimetic), and Eliquis® (apixaban, anticoagulant). His contributions to Cozaar (losartan) and Gardasil (HPV vaccine) are also noted from his period at Merck.

 

At Agenus he led the development of their R&D organization and the advancement of four checkpoint modulatory antibodies and a personalized neo-epitope-directed cancer vaccine to Phase 1 trials, and led the generation of a best-in-class TCR discovery and optimization effort. During his senior advisory period at Agenus, the organization advanced 13 monoclonal antibodies into the clinic and formed significant partnerships with Incyte, Merck, UCB, and Gilead.

External recognition and standing

Dr. Stein is Board Certified in Anatomic and Clinical Pathology. He is a member of Alpha Omega Alpha (medical honor society), Sigma Tau, Sigma Xi (scientific research honor society), and Phi Beta Kappa. He has been a lead contributor to eight marketed pharmaceutical products. He has led R&D organizations of over 1,000 scientists and physicians. He serves on multiple private and public company boards including PolyPid Ltd. (public), Protagenic Therapeutics (public, PTIX), and previously Taro Pharmaceutical Industries. He has served on the Autobahn Labs Scientific Advisory Board (a joint venture of Samsara BioCapital, Evotec, and KCK Ltd.).

Background and training

Dr. Stein graduated as valedictorian and National Merit Scholar from Kokomo High School (1966 to 1968). He obtained his B.S. with honors in Biology and Chemistry (double major) from Indiana University Bloomington, graduating Phi Beta Kappa (1968 to 1972). He received his MD and PhD in Physiology and Pharmacology from Duke University Medical and Graduate Schools (1972 to 1979), graduating as a member of Alpha Omega Alpha and Sigma Tau, and completed his internship, residency, and board certification in Anatomic and Clinical Pathology at Duke University Medical Center (1979 to 1982). He spent the early part of his career at Merck Sharp and Dohme Research Laboratories (1981 to 1990) as Executive Director and Head of Pharmacology, contributing to Cozaar, Sustiva, and Gardasil. He was subsequently recruited as the first Head of R&D for Ligand Pharmaceuticals (1990 to 1996), followed by EVP Research and Pre-Clinical Development at DuPont-Merck Pharmaceuticals (1996 to 2001), President R&D and CSO at Incyte (2001 to 2003), President of Roche Palo Alto (2003 to 2007), CEO of KineMed (2007 to 2009), and President R&D at Agenus (2014 to 2017).

Appointments and advisory roles

Hospital / Clinical / Organization

Senior R&D Advisor and Founder MiNK Therapeutics (since January 2022)
Senior Advisor, R&D Agenus (since April 2017)
Scientific Advisor IAG, Image Analysis Group

Society leadership & boards

Venture Partner Samsara BioCapital (since January 2018)
Scientific Advisory Board Member Autobahn Labs (since June 2020)
Board Member and CMO Protagenic Therapeutics (PTIX, since January 2016)

Education and training

Year Qualification / Role Institution
2022 – present
Senior R&D Advisor and Founder
MiNK Therapeutics
2019 – 2023
EVP Research and Development; President, Regenerative Medicine and Biologics Innovation
MiMedx, Marietta, GA
2017 – present
Senior Advisor, R&D
Agenus
2014 – 2017
CSO and EVP R&D; President R&D
Agenus
2008 – present
Principal
RBS Biotech Consulting, PLLC, New York / Woodstock, GA
2007 – 2009
CEO
KineMed, Inc.
2003 – 2007
President
Roche Palo Alto LLC
2001 – 2003
President R&D and CSO
Incyte Pharmaceuticals
1996 – 2001
EVP, Research and Pre-Clinical Development
DuPont-Merck Pharmaceuticals
1990 – 1996
CSO and SVP Research (first Head of R&D)
Ligand Pharmaceuticals
1981 – 1990
Executive Director and Head of Pharmacology
Merck Sharp and Dohme Research Laboratories
1979 – 1982
Intern and Resident; Board Certification — Anatomic and Clinical Pathology
Duke University Medical Center
1972 – 1979
MD and PhD — Physiology and Pharmacology
Duke University Medical and Graduate Schools
1968 – 1972
B.S. (Honors) — Biology and Chemistry (Phi Beta Kappa)
Indiana University Bloomington

External resources and links

Professional profiles & society links
Office Location RBS Biotech Consulting, PLLC New York, NY and Woodstock, GA USA
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