Hamid R. Email and Phone Number
NDA/sNDA projects delivered:- Pexidartinib (Turalio): Pivotal Phase III Formulation development (Formulation patent, NDA approval 2019)- Cobimetinib (Cotellic): Pivotal Phase III QbD-based formulation development (Formulation patent, NDA 2015)- Quetiapine (Seroquel): Formulation development, tech transfer, and NDA submission- Rosuvastatin (Crestor): Authored reports, contributed to formulation and NDA submission- Key pharmaceutical expert: Multiple partnered projects (GDC-0973, PLX9486, and PLX8394)- Development of poorly soluble compounds, amorphous (SDD, HME) and lipid-based formulationsExperienced senior pharmaceutical scientist with extensive product development experience from concept to market, multiple patents, SME in API polymorph, salt screening, pre-formulation, QbD-based formulation development using dry granulation and high-shear wet-granulation.Expert in process selection, scale-up, technology transfer, validation, and CMO selection and management. Proven track record as a constructive team builder and manager with internal and external partners, USP Small Molecules Expert committee member. Excellent FDA/ICH knowledge, multiple IND, IMPD, NDA, and marketed products.
Us Pharmacopeia
View- Website:
- exelixis.com
- Employees:
- 51
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Usp Council Of Experts: Expert Volunteer (Small Molecules)Us PharmacopeiaSouth San Francisco, Ca, Us
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Senior Director, Formulations And Clinical ManufacturingExelixis Apr 2023 - PresentAlameda, California, UsLeading formulation team responsible for:- Development of FIH formulations (multiple projects) via US and international CMOs- Leading process optimization of NDA stage oncology solid oral formulations - Selection and management of multiple CMOs to deliver early/late-stage CTM supplies- Management of multiple senior formulation scientists (Principal Scientists holding Ph.D.) -
Senior DirectorCytokinetics Aug 2022 - Apr 2023South San Francisco, California, Us- Led formulation development team responsible for the development of multiple FIH formulations- Formulation process optimization of NDA stage project (CK-274, Aficamten)- Managed CMOs and delivered early and late-stage CTM supplies using internal/external resources -
Executive DirectorEscape Bio Apr 2022 - Aug 2022South San Francisco, California, Us- Departure due to company closure (pre-IPO)- Led formulation team responsible for developing FIH formulations and late-stage CTM supplies- Utilized internal resources and external GMP facilities of small and multi-national CMOs. -
Senior Director Of PharmaceuticsPlexxikon Inc. 2016 - 2022South San Francisco, California, Us- Departure due to Plexxikon closure by Daiichi-Sankyo (March 31 2022)- Led formulation development team from discovery to regulatory submissions:- Pexidartinib (Turalio): Developed commercial Formulation (Patent, authored reports, NDA 2019)- Developed multiple (BCS II, III, and IV) projects, discovery and pre-clinical to regulatory submissions- Researched, selected, and managed CMOs, and manufactured CTM supplies for multiple projects- Established the pharmaceutical development team (pre-formulation, formulation, and analytical)- Built Formulation team: Hired, developed, retained staff; built formulation development capabilities -
Director Of PharmaceuticsPlexxikon Inc. 2013 - 2016South San Francisco, California, Us
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Scientist (Manager), Small Molecule PharmaceuticsGenentech 2007 - 2013South San Francisco, California, Us- Formulated GDC-0973 (Cobimetinib), GDC-0623 (MEKi), GDC-0464 (PI3Ki), AKTi, PLKi, ...- Developed and optimized multiple QbD-based formulations (member QbD Task-force)- Technology transferred projects following scale-up, optimization and validation- Established, staffed, and managed Genentech's 1st small molecule R&D and cGMP Labs -
Senior ScientistAstrazeneca Pharmaceuticals 2000 - 2007Cambridge, Cambridgeshire, Gb- Developed, optimized, transferred formulations, and authored regulatory submissions- Formulated multiple NCEs: AZD7512, AZD6280, AZD3783, AZD0947, AZD3409, ...- Authored multiple development reports, contributed to scale-up, validation, PAI inspection- AAPS Visiting Scientist, AZ global compaction team lead, CPPR representative (Purdue University)
Hamid R. Skills
Hamid R. Education Details
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University Of CincinnatiPharmaceutics -
The Ohio State UniversityPharmacology-College Of Medicine
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Ohio Wesleyan UniversityChemistry
Frequently Asked Questions about Hamid R.
What company does Hamid R. work for?
Hamid R. works for Us Pharmacopeia
What is Hamid R.'s role at the current company?
Hamid R.'s current role is USP Council of Experts: Expert volunteer (Small Molecules).
What schools did Hamid R. attend?
Hamid R. attended University Of Cincinnati, The Ohio State University, Ohio Wesleyan University.
What skills is Hamid R. known for?
Hamid R. has skills like Research And Development, Gmp, Validation, U.s. Food And Drug Administration, Hot Melt Extrusion, Spray Dried Dispersion, Quality By Design, Quality System, Drug Delivery, Pharmaceutics, Drug Development, U.s. Pharmacopeia.
Who are Hamid R.'s colleagues?
Hamid R.'s colleagues are Xia Ma, Paula C., David Rousseau, Taegon Baik, Rick Mesler, Thao T. Tran, Lisa Politza.
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