Advisory Board Member 

Dr Albert L. Kraus

Albert is a seasoned expert in regulatory sciences and global medicine development. He brings a wealth of experience in the fields of oncology, rare diseases, dermatology, and immunology, as well as extensive knowledge in FDA advisory committee mandates and other pivotal health authority meetings.

Serving as one of the two regulated industry representative members of the Oncology Drug Advisory Committee (ODAC) for the FDA.

An expert in the strategy and organizational design of R&D entities, both in big pharma and biotech. His ability to navigate complex challenges and identify opportunities provides invaluable guidance to clients.

As a managing partner at GDS Partners LLC, Albert leverages his knowledge and expertise to support both U.S. and global-based clients.

Key Areas Of Expertise
  • Registrational drug development, specialising in clinical development (both early & late)
  • Extensive experience in Oncology, Rare Diseases, Dermatology, and Immunology
  • Active involvement in FDA Advisory Committees
  • Expertise in supporting biotech C-suite: fundraising, risk assessment, stakeholder engagement including health authorities, the medical community, investors, patient groups, and boards
Before NDA

Albert assisted the FDA as one of the two Industry Representative members on the Oncologic Drug Advisory Committee (2019-2023 term).  

He was a Global Regulatory Portfolio Lead for Oncology at Pfizer from 2011 to 2023, where he helped build oncology at Pfizer, including as Global Regulatory Franchise Lead for IBRANCE.

Prior to his time at Pfizer, Albert held Vice President, executive leadership roles at various small Biotech firms, including Onyx, Proteolix, and Kosan Biosciences.

He held multiple roles at Bristol Myers Squibb (BMS) in the US and Europe, ultimately leading global oncology Regulatory Science as Group Director.  His BMS contributions included leadership in the seminal melanoma development of ipilimumab (YERVOY), the first modern immuno-oncology medicine.

Albert began his career at Procter and Gamble, and earned his B.A. from Hamilton College, followed by an MS and PhD from the University of Michigan.

Recent Publications

Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men.   Clin Pharmacol Ther 2022 Jan;111(1):302-309.
Albert L. Kraus, Michelle Yu-Kite, Jack Mardekian, Matthew J. Cotter, Sindy Kim, Jaclyn Decembrino, Tamara Snow, Kenneth R. Carson, Jillian Motyl Rockland, Anala Gossai, Keith Wilner, Diane D. Wang, Cynthia Huang Bartlett, Norihiko Oharu, Patrick Schnell, Todd VanArsdale, Dongrui R. Lu, Jennifer M. Tursi

Applying the concepts of Good Clinical Practice in Real World Evidence.   Drug Information Association 2020 Annual Meeting presentation and Panel discussion.   Real World Data Perspectives Oncology Experience: Importance of Data Quality.  Albert L Kraus, PhD

Postmarket real-world data perspectives: Oncology registration use cases.  FDA-AACR Real-World Evidence Workshop. July 19, 2019.    Albert L. Kraus, PhD



Dr Albert L. Kraus



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