David Leahy Email and Phone Number
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Pharmaceutical development professional with over 19 years experience and extensive project leadership accomplishments. Talent for analyzing problems and finding innovative solutions. Proven track record for global and cross-disciplinary collaboration. Industry-recognized leader in green chemistry.
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Vice President Drug Substance DevelopmentBiohavenMarblehead, Ma, Us -
Vice President Drug Substance DevelopmentBiohaven Oct 2022 - PresentNew Haven, Ct, Us• Built a streamlined drug substance organization comprised of internal and external talent that can efficiently execute all aspects of drug substance development for Biohaven’s portfolio of assets ranging from preclinical to Phase III/validation across diverse modalities including small molecules, peptides, biologics, cellular products, and ADCs (8 to 13 assets at a time). • Provided strategic direction and technical oversite for route scouting, process optimization, experimental design, data collection, and technical writing for regulatory filings ranging from INDs to NDAs as well as post approval filings.• Accelerated multiple early development programs in complex modalities by implementing aggressive CMC strategies, at risk work, and parallel activities in a fully externalized environment. -
Senior Director, Chemistry Manufacturing And ControlsBiohaven Oct 2020 - Oct 2022New Haven, Ct, Us• Led drug substance teams through successful EMA approval for rimegepant and NDA filings for zavegepant and troriluzole, completing process characterization and validation activities. • Spearheaded cost of goods and green chemistry improvement projects for commercial and development assets using state of the art technologies such as flow chemistry, catalysis, biocatalysts and surfactant chemistry. • Successfully completed drug substance diligence and tech transfer activities to enable the sale of Biohaven’s CGRP franchise (including Nurtec ODT and Zavzpret) to Pfizer for $11.6 billion. -
Associate Director, Process ChemistryTakeda Jul 2017 - Oct 2020Tokyo, Jp• One-over accountability for half of the small molecule process chemistry projects in Boston (~7 projects) including three highly accelerated programs and one NDA filing. Drove multiple scientific advances including route discovery, new reaction development, with a strong focus on process design, leading to multiple examples where API was taken off the critical path.• Supervision of group of seven scientists, most at the Ph.D. level. Committed to the professional development of project teams and direct reports, helping refine their skills, obtain promotions, grow as team leaders and managers, and identify new roles that meet their career aspirations and passion. • Spearheaded key initiative projects in automation, biocatalysis and surfactant chemistry, building internal capabilities and expertise in these areas. Initiated 4 academic collaborations to solve long-term chemistry challenges leading to multiple publications while providing concrete portfolio impact.• CMC leader for a highly complex and high priority immuno-oncology program. Led team to deliver API, drug product and finished goods to support a first-in-human study, enabling a 7 month acceleration. -
Principal ScientistBristol-Myers Squibb 2013 - 2017Lawrence Township, Nj, Us• Project leader for two high priority small molecule oncology programs, delivering preclinical supplies for five separate analogues (three separate chemotypes) at an external CMO at least one month prior to candidate nomination. Developed a new chemical route for the most complex analogue to overcome poor efficiency (key fragment improved from 1.4% yield in 8 steps to 33% yield in 5 steps).• Chemistry lead for a highly accelerated oncology program, responsible for the late-phase development and external execution of three complex regulatory starting materials. Invented a new synthetic route to circumvent a key scale-up liability, while removing numerous bottlenecks. • Project leader for a biologics/small molecule conjugate PET tracer. Developed bio-orthogonal chemistry to prepare and purify the cold PET tracer analogue needed for IND toxicology studies. Key thought leader in developing new CMC strategies utilized by subsequent PET tracer teams.• CMC leader for diabetes and fibrosis assets. Led cross-functional CMC team and Exploratory Development team through a very complex tautomer challenge. Strategically laid out and executed plans demonstrating that the tautomers posed no risk to patient safety and effectively communicated this to the FDA. Guided team to achieve key program milestone of First in Human. • Co-invented a novel, non-chromatographic approach to purification of macro-cyclic peptides.• Co-chair of the ACS Green Chemistry Institute Pharmaceutical Roundtable, responsible for implementation of strategic priorities and management of a $375k budget. • Team lead for BMS corporate sustainability 2015 and 2020 goals to integrate sustainability throughout development and commercialization.• Supervision of Ph.D. level direct reports. Committed to the professional development of project teams and direct reports, helping refine their skills, obtain promotions, and identify new roles that meet their career aspirations and passion. -
Senior Research Investigator IiBristol-Myers Squibb 2009 - 2013Lawrence Township, Nj, Us• Conceptualized a commercially viable second-generation synthesis of a CGRP antagonist utilizing three state-of-the-art stereoselective transition-metal catalyzed transformations, improving the overall yield from 9% to 40% and reducing the number of steps from 12 to 6.• Project leader for an accelerated late-stage asset, overseeing a team of ~20 chemists, engineers, and technologists responsible for 1 kg to 400 kg API deliveries, control strategies to ensure quality, and knowledge collection to support a QbD filing. -
Senior Research Investigator IBristol-Myers Squibb 2006 - 2009Lawrence Township, Nj, Us• Simultaneously led multiple projects in four disease areas, culminating in the delivery of pre-clinical and Phase I API supplies for nine clinical candidates. Directed internal teams and external CMO and CRO partnerships throughout Europe and Asia. • Established enabling synthetic routes for two extremely complex targets (11β-HSD, CGRP), dramatically accelerating FIH timing. The previous synthesis was described as ‘punishing’ by the discovery chemistry director and capable of producing only milligram quantities. • Founder of the BMS green chemistry team, responsible for promotion of green chemistry ideals. Revamped departmental work practices, established the periodic review of projects using green chemistry metrics. Improved greenness scorecard for enhanced discrimination and ease of use. -
Research Investigator IiBristol-Myers Squibb Feb 2004 - 2006Lawrence Township, Nj, Us• Designed a robust process for the Brivanib alaninate API step that overcame problematic epimerization and transamination, and was successfully validated at a manufacturing site. Established a design space through Design of Experiments to support a QbD filing. • Developed chemistry to alkylate azaindoles to generate phosphonooxymethyl prodrugs that enabled pre-clinical and Phase I supplies for three clinical candidates. General method was later used widely in discovery and development for construction of similar prodrugs.• Co-chaired the BMS Safety Alert Committee, responsible for the deployment of a site-wide labeling standard and continued improvement of departmental inspection program.
David Leahy Skills
David Leahy Education Details
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Indiana University BloomingtonOrganic Chemistry -
University Of DelawareOrganic Chemistry -
Lebanon Valley CollegeChemistry
Frequently Asked Questions about David Leahy
What company does David Leahy work for?
David Leahy works for Biohaven
What is David Leahy's role at the current company?
David Leahy's current role is Vice President Drug Substance Development.
What is David Leahy's email address?
David Leahy's email address is da****@****bms.com
What schools did David Leahy attend?
David Leahy attended Indiana University Bloomington, University Of Delaware, Lebanon Valley College.
What skills is David Leahy known for?
David Leahy has skills like Organic Chemistry, Organic Synthesis, Green Chemistry, Biotechnology, High Throughput Screening, Lifesciences, Gc Ms, Ir, Quality By Design, R&d, Catalysis, Gas Chromatography.
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