Michael Abernathy Email & Phone Number

California, United States

Thousand Oaks, Ca, Us

Responsible for leading Amgen's Global Regulatory Affairs CMC Function including: • RA CMC oversight for all stages of product development from molecular discovery through commercialization and life-cycle management.• Accountable for the global regulatory strategy, facilitation and registration of Amgen’s product portfolio including the Global RA CMC Clinical, Commercialization and Life-cycle Management (LCM) Centers - 50+ clinical programs of varying modalities (mAb, BiTE, CART, siRNA, personalized gene therapies, oncolytic viruses, small molecules) at different stages of development from discovery through clinical Phase 3 - Global marketing applications at various stages of commercialization from late stage Phase 3 through major and emerging market approval - 17 approved commercial life-cycle programs• Responsible for the oversight of the Tactical Center and Amgen's Global Module 3 Authoring Process (GM3AP) which provides authoring/reviewing tools, process efficiency and project management support to the Clinical, Commercialization and Life cycle Centers• Accountable for the management, growth and career development of Global RA CMC staff • Responsible for Global RA CMC business operations including budget, processes, external engagement/advocacy and program/project prioritization

Thousand Oaks, Ca, Us

Proactively designed Amgen’s RA CMC organizational structure based on Centers of Excellence leveraging staff expertise, skill-sets and experience to optimize resources and departments efficiencies while contributing to staff growth and development. In addition to maintaining previous department responsibilities described below as the Global RA CMC HUB Lead, my new role incudes accountability for Amgen’s development portfolio including the Clinical and Commercialization Centers of Excellence. This portfolio of programs includes 50+ clinical programs at different stages of development from discovery through early clinical phase 3 and three current global marketing applications at various stages of commercialization from late stage Phase 3 through first approval. In addition, I am responsible for the oversight of the Tactical Center of Excellence which provides tools, process and project management support to the Clinical, Commercialization and Life-cycle Centers. Responsible for the career development of half of Amgen's Global RA CMC staff.

Thousand Oaks, Ca, Us

Responsible for a Global RA CMC Organizational Unit (HUB) spanning Seattle, WA, USA to Uxbridge, England, United Kingdom including 8 to 12 direct reports including contract workers. Included the oversight for FIH, late-stage clinical and commercial products and Regulatory oversight for three of Amgen’s operating sites. Assigned the opportunity to lead Amgen's Analytics of the Future (AoF) Initiative, focused on streamlining testing of all Amgen products from FIH to approved legacy commercial products. Responsible for forming and developing a highly effective team, capable of managing over 25 initiatives, developing regulatory strategy, preparing global filings, influencing company, industry and Agency ideology in regards to testing quality product attributes. Maintain responsibility and accountability for all Amgen BioVex (MA) and Amgen Rhode Island (ARI) Site related regulatory activities, gene therapy and monoclonal antibody products and staff at Amgen's Woburn (MA) and West Greenwich facilities. Responsible for oversight and Senior Management review for Enbrel, Vectibix, talimogene laherparepvec and late stage Phase 3 products being commercialized through the ARI and AWM manufacturing facilities.

Thousand Oaks, Ca, Us

Relocated from Amgen Colorado to the East Coast to head up a Northeast RA CMC Center of Excellence. Responsible for all Amgen BioVex (MA) and Amgen Rhode Island (ARI) Site related regulatory activities at Amgen's Woburn (MA) and West Greenwich facilities. Responsible for the successful phase 3 to commerical development of viral and monoclonal anitibody biotechnology therapies as well as commercial life-cycle molecules ENBREL and Vectibix. Additionally, the Global RA CMC lead for Amgen's oncology therapy, talimogene laherparepvec (T-VEC). Submitted Amgen's first ever Gene Therapy Marketing Application to CBER's Office of Cellular, Tissue and Gene Therapies Division on April 30, 2014. Previously responsible for all regulatory activities at Amgen's multi-host facilities in Longmont and Boulder, Colorado as well as the Global RA CMC lead for Amgen's Advanced Cancer therapy XGEVA and the osteoporosis treatment Prolia.

Thousand Oaks, Ca, Us

Responsible for all Amgen Colorado Site related regulatory activities at Amgen's Longmont and Boulder multi-host facilities. Responsible for the successful phase 3 to commerical development of biotechnology therapies as Colorado remains Amgen's main commercialization and launch site. Additionally, the Global RA CMC lead for Amgen's blockbuster oncology therapy XGEVA as well as the drug substance lead for Amgen's osteoporosis treatment Prolia.

Thousand Oaks, Ca, Us

Global Regulatory CMC lead for Amgen’s most recent approved blockbuster therapeutics, Prolia® and XGEVA™. In this role I had oversight for the regulatory strategy, execution, including submission and approval, of the global marketing applications as well as the Phase 3 clinical programs.

Master'S Degree, Cell/Cellular And Molecular Biology

Bachelor'S Degree, Human Physiology

Bachelor'S Degree, Sports Medicine And Exercise Physiology