About David Askin, CMC Leader

DXA Consulting LLC d/b/a David Askin Consulting is led by David Askin, PhD. David is a hands-on innovator and scientific leader in CMC drug development with over 30 years Biotech/Pharma experience. The great majority of David’s experience was gained at Genentech and Merck developing a total of 7 registered small molecule/antibody drug conjugate products: KADCYLA® (antibody drug conjugate ado-trastuzumab emtansine) for metastatic breast cancer; ERIVEDGE ® (hedgehog inhibitor vismodegib) for advanced BCC ; COTELLIC® (MEK Inhibitor cobimetinib in combo with Zelboraf®) for advanced melanoma; ISENTRESS® (HIV Integrase inhibitor raltegravir) for HIV infection; ZOCOR® (widely-prescribed “super-statin” class inhibitor simvastatin) for hypercholesterolemia; CRIXIVAN® (HIV protease inhibitor indinavir) for HIV infection and JANUVIA® (DPP-4 inhibitor sitagliptin) for diabetes.

In addition to functional leadership experience, David has also been a CMC technical team leader for an early stage oncology candidate at Genentech, as well as leading the process validation of a pivotal clinical stage ADC in Biotech. David has innate and acquired experience in all aspects of CMC drug development, including discovering and directing small molecule and linker-drug process chemistry, pharmaceutical/drug product development, analytical research and quality control, quality assurance, regulatory compliance, and supply chain management. He has over 30 US patents/applications, close to 50 peer-reviewed publications as well as numerous invited presentations at elite universities and scientific meetings.

David Askin, PhD

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