David Askin Email and Phone Number

Currently focussed on client process validation for commercial manufacturing of a linker-toxin/antibody drug conjugate in pivotal studies for small cell lung cancer. Very familiar with process characterization protocols/reports, validation protocols/reports, critical parameters, validation strategies. website: www.davidaskinconsulting.comemail: dave.askin@davidaskinconsulting.com

Responsible for a group of internal FTE’s and all external CMC collaborations to deliver small molecule pipeline. CMC leadership oversight of API synthesis/scale-up, analytics, formulation development & quality assurance. Extensive input into identification of new CMO collaborations and associated contracts. Significant input into evolving company IT strategy & electronic notebook suite. At immediate prior opportunity, led all aspects of externally-sourced CMC development. Set up key CMO collaborations for synthesis/supply, pre-formulation and analysis of lead drug candidates for preclinical development.

This position called for comprehensive discovery, development & control of enabling chemistry processes in support of late-stage research (discovery) to highly efficient, highly controlled processes in support of mid-late clinical development. Although highly technical, my role also required leadership skills of up to 24 FTE at the Sr. Scientist, Scientist and Associate Researcher levels, as well as Scientific Managers and external contractors. I recruited 16 team members and gradually grew the department as we expanded to the current capacity. Primary Roles: - Facilitated chemical processes for pilot toxicology studies, GLP toxicology studies, clinical GMP API supplies for first in human phase I, phase II studies and ultimately phase III/commercialization. - Executed in-house delivery of API supply for GLP toxicology studies and clinical manufacturing of phase I supplies from Genentech’s non-GMP and GMP clinical manufacturing facilities (hundreds of grams up to multikilograms). Special Appointments: - Standing member of Small Molecule Review Committee and Early Stage Technical Development Committee as functional leader of Small Molecule Process Chemistry Department. - Core member of Genentech Appointments and Promotions Review Committee. Key Achievements - Technical Development (CMC) Team Leader for an early development oncology candidate; achieved highly accelerated milestones for IND filing (10 months) and FPI (13 months) - Co-authored the CMC section of the first BLA/NDA for KADCYLA TM (ado-trastuzumab emtansine), Genentech’s first approved Antibody Drug Conjugate for patients with advanced HER2 positive breast cancer (approved February 2013) - Provided strategic oversight for the CMC sections of the NDA for the BCC oncolytic ERIVEDGE TM (vismodigib), Genentech’s first approved small molecule (approved January 2012) - Completed final design of new in-house high-potent API manufacturing facility at Genentech - Earned Key Contributor Award in 2011.

Through strong performance and development innovations, I progressed to the highest-ranking scientific role in our department of Process Research. I exercised broad influence and scientific oversight into our Merck product pipeline, and directed process chemistry development for a host of marketed compounds. Key Achievements: - Directed the overall process chemistry development of ISENTRESS® (raltegravir), Merck’s first-in-class Integrase inhibitor for HIV infection - Executed overall process chemistry development for the HIV protease inhibitor CRIXIVAN® (indinavir) - Developed and implemented the novel manufacturing process for ZOCOR® (simvastatin), one of the world’s most widely prescribed drugs, attaining total sales for Merck & Co in excess of $50B USD while treating millions of patients - Spearheaded development of the first pilot-scale synthesis of the initial lead/close-in analog of JANUVIA® (sitagliptin) which enabled the program’s highly accelerated development timeline - Critical member of Merck team that completed first total synthesis of the 23-membered macrolide immunosuppressant FK-506 - Key Innovator Award, Merck Research Labs 1994- Other Positions Held: Senior Investigator Senior Research Fellow Research Fellow Senior Research Chemist.