David Leahy

David Leahy Email and Phone Number

Vice President Drug Substance Development @ Biohaven
Marblehead, MA, US
David Leahy's Location
Marblehead, Massachusetts, United States, United States
David Leahy's Contact Details

David Leahy personal email

n/a
About David Leahy

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.

David Leahy's Current Company Details
Biohaven

Biohaven

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Vice President Drug Substance Development
Marblehead, MA, US
David Leahy Work Experience Details
  • Biohaven
    Vice President Drug Substance Development
    Biohaven
    Marblehead, Ma, Us
  • Biohaven
    Vice President Drug Substance Development
    Biohaven Oct 2022 - Present
    New 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.
  • Biohaven
    Senior Director, Chemistry Manufacturing And Controls
    Biohaven Oct 2020 - Oct 2022
    New 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.
  • Takeda
    Associate Director, Process Chemistry
    Takeda Jul 2017 - Oct 2020
    Tokyo, 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.
  • Bristol-Myers Squibb
    Principal Scientist
    Bristol-Myers Squibb 2013 - 2017
    Lawrence 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.
  • Bristol-Myers Squibb
    Senior Research Investigator Ii
    Bristol-Myers Squibb 2009 - 2013
    Lawrence 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.
  • Bristol-Myers Squibb
    Senior Research Investigator I
    Bristol-Myers Squibb 2006 - 2009
    Lawrence 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.
  • Bristol-Myers Squibb
    Research Investigator Ii
    Bristol-Myers Squibb Feb 2004 - 2006
    Lawrence 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

Organic Chemistry Organic Synthesis Green Chemistry Biotechnology High Throughput Screening Lifesciences Gc Ms Ir Quality By Design R&d Catalysis Gas Chromatography Formulation Sop Biochemistry Drug Discovery Drug Development Hplc Leadership Chemistry Management Medicinal Chemistry Chromatography Drug Design Nmr Lc Ms Cmc Development Cross Functional Team Leadership Analytical Chemistry Technology Transfer Life Sciences Nuclear Magnetic Resonance

David Leahy Education Details

  • Indiana University Bloomington
    Indiana University Bloomington
    Organic Chemistry
  • University Of Delaware
    University Of Delaware
    Organic Chemistry
  • Lebanon Valley College
    Lebanon Valley College
    Chemistry

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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