Albert L. Kraus, Phd Email and Phone Number
Dr Kraus is currently the Managing Partner at GDS Partners LLC, a firm specializing in Global Medicine R&D and business support from molecule identification through end Life Cycle. Dr Kraus is also a member of the Advisory Board at the NDA Group and a Yale University Entrepreneur in Residence. He has recently completed a 4-year term advising the US Food and Drug Administration as one of the two regulated industry representative members on the Oncologic Drugs Advisory Committee. Prior to that Albert served in several roles at Pfizer, including the IBRANCE Global Regulatory Franchise Leader, member of the Therapeutic Review Committee providing governance for all Oncology Therapeutics in Early Development, Chair of the Enterprise Wide Regulatory Portfolio Review Committee that provided C-suite leadership input and risk assessments for all Pfizer medicines for all Therapeutic areas, and member of the CT R&D leadership team (Pfizers largest R&D site worldwide). While at Pfizer Albert helped build the oncology therapeutic area from an acquired $1B business with few medicines to a $12+B business with over 25 medicines. Prior to joining Pfizer in early 2011, Albert was a Vice President and Executive Management Team member leading Regulatory Affairs, Pharmacovigilance, Quality Assurance, and/or Clinical Development at Onyx, Proteolix and Kosan Biosciences (San Francisco Bay area Biotech Companies). Prior to that Albert held positions of increasing responsibility at Bristol-Myers Squibb (including 4 years in a European role based in Belgium) culminating as a Group Director leading Worldwide Oncology Regulatory Affairs and FDA liaison activities. While at BMS, Albert was instrumental in the Medarex/ BMS collaboration that culminated in the advent of modern immuno-oncology medicines, including BMS’s ipilimumab and nivolumab (both Medarex acquisitions). Albert began his industry career at Procter & Gamble and while there held positions of increasing responsibility in the pharmacology, toxicology, clinical safety, and regulatory areas. Albert has worked primarily in Oncology, Metabolic, Immunology, Rare Disease, and Dermatology therapeutic areas and participated in the development of numerous small molecules and biologicals from research through end of life cycle stages. Albert received a BA from Hamilton College, with concentrations in Biology and Economics, and earned a PhD in biochemical toxicology/ cellular chemistry from the University of Michigan.
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Entrepreneur In ResidenceYale UniversityGuilford, Ct, Us -
Entrepreneur In ResidenceYale University Aug 2023 - PresentNew Haven, Ct, Us -
Managing PartnerGds Partners Llc Mar 2023 - PresentBiotech C-Suite AdvisorMedicine Development StrategyClinical DevelopmentFDA/ Global Regulatory NegotiationTranslating Science to BusinessScientific Strategy Advisory BoardsAngel Investment
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Advisory Board MemberNda Group Ab Jul 2023 - Jun 2024Upplands Väsby, Sweden, Se -
Industry Representative To The Us Fda Oncologic Drugs Advisory Committee (Odac)Fda Oct 2019 - Apr 2024Silver Spring, Md, UsRepresents Regulated Industry "at the table" with FDA Oncology Advisory Committee MembersActive Company engagement and assistance -
Oncology Global Regulatory Strategy Portfolio LeadPfizer Jan 2011 - Mar 2023New York, New York, UsMember of Leadership Team for Pfizer CT R&D sitesChair - Enterprise Wide Regulatory Portfolio Review Committee (All Therapeutic Areas) Member: Therapeutic Review Committee - Decision-making Governance for all Oncology Medicines Clinical Registration Strategy DevelopmentUS FDA Liason/ Global Health Authority Negotiation -
Vice President: Medicine DevelopmentOnyx Pharmaceuticals (Acquired Proteolix)(Acquired By Amgen) Nov 2009 - Jan 2011Strategic DevelopmentClincial Development Regulatory Strategy External Stakeholder Strategy and Implementation
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Vice President: Regulatory Affairs And Quality AssuranceProteolix (Acquired By Onyx Pharmaceutricals) Aug 2008 - Nov 2009Ssf, Ca, UsExecutive Management TeamLT member contributing to BOD meetingsStrategic DevelopmentClinical Development External Stakeholder Strategies and ImplementationActive in Business Development -
Director/ Board MemberKosan Bioscience Europe Ltd Apr 2006 - Oct 2008
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Vice President: Drug Development, Pharmacovigilance And Regulatory AffairsKosan Biosciences (Acquired By Bms) Jan 2006 - Aug 2008UsHead Regulatory, Drug Safety and PharmacovigilanceMember, Executive Management TeamLeader in Drug DevelopmentLT member contributing to BOD meetingsActive in Business Development -
Group Director: Global Regulatory Strategy And Us Fda LiasonBristol Myers Squibb 1997 - 2006Lawrence Township, Nj, UsHead Worldwide Oncology Registration Strategy Head US FDA oncology Liason groupMember - Oncology R&D and Franchise Leadership teamsIn-licensingClincial Development 4 Years EU base (Belgium) -
Section Head, Toxicology, Human Safety And Regulatory AffairsProcter & Gamble 1985 - 1997Cincinnati, Ohio, UsVarious positions of increasing people and project responsibility in multiple geographies.Global responsibilities for Toxicology, Pharmacovigilance, Regulatory Affairs, OTC Medicines, Dermatologicals
Albert L. Kraus, Phd Education Details
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University Of MichiganBiochemical Toxicology/ Cellular Chemistry -
Hamilton CollegeEconomics
Frequently Asked Questions about Albert L. Kraus, Phd
What company does Albert L. Kraus, Phd work for?
Albert L. Kraus, Phd works for Yale University
What is Albert L. Kraus, Phd's role at the current company?
Albert L. Kraus, Phd's current role is Entrepreneur in Residence.
What schools did Albert L. Kraus, Phd attend?
Albert L. Kraus, Phd attended University Of Michigan, Hamilton College.
Who are Albert L. Kraus, Phd's colleagues?
Albert L. Kraus, Phd's colleagues are Mitch Kundel, Sirah Beal, Hua Xu, Kira Biener, Tatiana Allan, Jennifer Pope, Bill Severino.
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