Peter A. McCroskery, M.D., M.S.

Transcription

1 1 Peter A. McCroskery, M.D., M.S. Career History: January present Biogen, Senior Medical Director, SABR Responsible for the Overall Safety Strategy for Global filing of Daclizumab and Responses to Health Authorities. Safety Lead for the successful submission and recent FDA and EMA approvals of Zinbryta, an anti- CD25 monoclonal antibody with indication in Relapsing Multiple sclerosis. o Lead Safety discussions with FDA and on labeling and REMS o Lead REMS strategy planning, execution and operational implementation of safety reporting for REMS o Lead strategy for postmarketing commitments, including a prospective observational study, Pregnancy registry, breast cancer epidemiology study and nettled cohort study for biomarkers o Lead for Safety adjudication committees for events of special interest Leadership of Avonex and Plegridy safety programs, including labeling updates, responses to Health authorities, and Pregnancy registries. September January 2015 Daiichi- Sankyo, Senior Medical Director Therapeutic Area Head - Oncology Directed a global cross- functional team responsible for the safety profiles of 16 oncology molecules in development, from Phase 1 to Phase 3. o The Safety Lead for two molecules in Phase 3, managed interactions with external DMC and adjudication committees as well as internal safety Teams o Represent Safety on multifunction due diligence team in evaluating the acquisition of new compounds or companies o Participate in strategic planning for SPA submissions and interactions with FDA and EMA Lead and coordinated a global team response to FDA safety query on malignancies reported for a marketed cardiovascular product Contribute to Safety Process improvement, including the development of global SOPs for single Investigator Brochure, Initiated Safety Review team meetings for all molecules in Phase 2 and 3 of clinical development for pro- active pharmacovigilance focusing on potential safety signals and events of particular regulatory interest. Contributed to the acquisition and customization of signal detection software for evaluating both adverse events and abnormal laboratory results reported in molecules in development and also approved products

2 Amgen Global Safety Medical Director March 2009 to September Global Safety Lead for the Inflammation Team, including Enbrel Member of the core team in the strategic response to a FDA requested REMS for Enbrel for histoplasmosis and authored ACR abstract on Identifying Cases of Disseminated histoplasmosis Lead the team response to FDA class labeling for malignancy and leukemia with TNF inhibitors and authored a manuscript describing rates of malignancy in pediatric population, confirming the rates of malignancy seen as comparable to the expected rates for the general population and a manuscript describing the rates of lymphoma in etanercept treated patients across all long term etanercept observational trials o Member of the core team to ensure quality in manufacturing of Enbrel in multiple sites, including a business partner o Member of the core team in the strategic response to biologic biosimilars o Member of the core team in the development of biomarkers for screening biologic candidates o Participated in FDA sponsored symposia on registries for pediatric rheumatology patients o Permanent safety representative to the OTIS pregnancy steering committee meeting and regulatory initiatives of ensuring safe use in special populations including pregnant women o Authored the health hazard evaluation for a specific manufacturing issue at an Amgen manufacturing site, involved with the product quality safety issues and product recall. Developed processes for future evaluation of product quality related adverse events reported with specific lots of Enbrel as well as for other products. Safety representative for due diligence in potential acquisitions of companies or products Core member of the team creating e- learning modules for safety processes, including CSR templates, RMP and ICF templates, March 2007 to March Global Safety lead for denosumab (Prolia) Managed the safety profile of denosumab in 16,000 subjects in 28 clinical trials for the postmenopausal osteoporosis indication and was involved with filing of core documents, including the integrated summary of safety, original risk management plan (RMP), pediatric investigational plan (PIP) Developed a post- marketing observational safety study with claims based comparator submitted to the FDA as part of the Risk mitigation strategy of the RMP

3 3 Prepared for FDA advisory committee to assess the safety and efficacy of denosumab in the postmenopausal osteoporosis and oncology indications October 2005 to November Aranesp Oncology, Epogen (marketed product) October 2005 to March Sensipar Teams, AMG 223 (marketed product). Primary author of the integrated summary of safety successful filing for a new indication for Sensipar in the treatment of primary hyperparathyroidism in the EU, although there were no additional new subjects or trials since 2004 when the submission was not approved. Participated in the FDA discussions on increased risk of cardiovascular an thrombo- embolic adverse events with Aranesp and Epogen and other erythropoetin stimulating agents (ESAs) at higher target hemoglobin and REMS related activities Participated in the preparation for FDA advisory committee on ESAs. GSO for several molecules in development Ph1 and Rheumatology Private Practice Stamford, Connecticut Chief of Rheumatology Stamford Hospital Rheumatology Group Practice South Miami, Fl Education: College: Degree: Graduate School: Degree: Medical School: Degree: Bowdoin College Brunswick, ME B.A. (Highest Honors in Biology) Cornell University Department of Biochemistry M.S. Dartmouth Medical School Hanover, NH M.D. Graduate Training: Internship: Massachusetts General Hospital J. Residency: Massachusetts General Hospital

4 4 S. Residency: Massachusetts General Hospital Post Graduate Medical Training: Rheumatology Fellowship Massachusetts General Hospital Academic Appointments: Clinical and Research Fellow in Medicine Harvard Medical School in Medicine Assistant Clinical Professor in Medicine Columbia University College of Physicians and Surgeons New York, New York Board Certification: 1980 Internal Medicine American Board of Internal Medicine 1986 Rheumatology American Board of Internal Medicine Licensure: Grants: Massachusetts, Florida and Connecticut (none active) National Science Foundation Grant Arthritis Foundation Postdoctoral Fellowship Grant Awards: 1973 Kappa Delta Award Academy of Orthopedic Surgeons Publications: 1. McCroskery PA, Woods S, and Harris ED Jr. Gelatin: A Poor Substrate for Mammalian Collagenase, Science 1973, 182: Harris ED Jr. and McCroskery PA. Influence of Temperature and Fibril Stability on Degradation of Cartilage Collagen by Rheumatoid Synovial Collagenase. New Engl. J.Med. 1974, 290, 1-6

5 5 3. Gross J, Harper E, Harris ED Jr., Highberger JH, McCroskery P, Corbett C, and Kang A. Animal Collagenases. Specificity of Action and Structures of Subsrate Cleavage Site. Biochem Biophys. Res. Commun. 1974, 61, McCroskery, PA, Richards, JF, and Harris, ED Jr. Purification and Characterization of Collagenase Extracted from Rabbit Tumors. Biochem J, 1975, 152, Miller EJ, Harris ED Jr., Chung E, Finch JE, McCroskery PA, and Butler WT. Cleavage of Type II and III Collagens with Mammalian Collagenase. Site of Cleavage and Primary Structure at the NH2- terminal Portion of the Smaller Fragment Released from both Collagens. Biochemistry 1976, 15, Mills JA and McCroskery PA. Periarteritis Nodosa. Hypersensitivity angiitis and Related Syndromes: Clinical and Pathological Aspects. Rheumatology Vol 1. The Kidney and Rheumatic Disease, ed. Bacon P and Hadler N. Butterworth International Medical Reviews, Stephenson ML, Krane SM, Amento EP, McCroskery PA, Byne M. Immune Interferon Inhibits Collagenase Synthesis by Rheumatoid Synovial Cells Associated with Decreased Levels of the Procollagenase mrnas. FEBS Letters 1985, Jan 21, 180 (1), McCroskery PA, Arai S, Amento EP, Krane SM. Stimulation of Pro- Collagenase Synthesis in Human Rheumatoid Synovial Fibroblasts by Mononuclear Cell Factor/ Interleukin 1, FEBS Letters 1985, Oct 21, 191 (1), McCroskery, PA et al., Identifying Clinical Features of Disseminated Histoplasmosis in Patients Receiving TNF Inhibitors, ACR abstract McCroskery, PA et al. Summary of Worldwide Pediatric Malignancies Reported after Exposure to Etanercept, EULAR abstract McCroskery, PA et al., Summary of Pediatric Malignancies Reported after Exposure to Etanercept, J. Pediatric Rheumatology 2010, rheum.com/content/8/1/ McCroskery, PA et al. Pooled Analysis of Observational Studies on Lymphoma Incidence Among Rheumatoid Arthritis (RA) Patients Initiating Etanercept Therapy, American College of Rheumatology abstract # 194, Gibofsky A et al., Rheumatoid arthritis Disease Modifying Anti- Rheumatic Drug

6 6 Intervention and Utilization study. J Rheumatology 2010, Oct 15 (epub) 13. McCroskery, PA et al., Pooled Analysis of Observational Studies on Lymphoma Incidence Among Rheumatoid Arthritis Patients Initiating Etanercept Therapy. 14. Xue F et al., Analysis of patient exposure for Enbrel using insurance claims database, Pharmacoepidemiology and Drug Safety. Conference: 26th International Conference on Pharmacoepidemiology and Therapeutic Risk Management Brighton United Kingdom. Conference Start: Conference End: Conference Publication: (var.pagings). 19 (pp S176- S177), Date of Publication: August Cutaneous Adverse Events in the Randomized, Double- Blind, Active- Comparator DECIDE Study of Daclizumab HYP Versus Intramuscular Interferon beta- 1a in Relapsing Remitting Multiple Sclerosis. Krueger JG, Kircik L, Hougeir F, Friedman A, You X, Lucas N, Greenberg S, Sweetser M, Castro- Borrero W, McCroskery P, Elkins J 16. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Gold R, Stefoski D, Selmaj K, Havrdova H, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P 17. Safety and tolerability profile of daclizumab high- yield process in patients with relapsing- remitting multiple sclerosis: an integrated analysis of clinical studies. Gavin Giovannoni, Ludwig Kappos, Ralf Gold, Bhupendra O Khatri, Krzysztof Selmaj, Kimberly Umans, Steven J Greenberg, Marianne Sweetser, Jacob Elkins, and Peter McCroskery Society Memberships: American College of Rheumatology, Founding Fellow