Osteoporosis Drug Development Moving Forward Public Workshop

Transcription

1 Osteoporosis Drug Development Moving Forward Public Workshop November 4, 2015 Discussion Panel Members and Speakers Robert Adler, MD Chief, Endocrinology and Metabolism McGuire Veterans Affairs Medical Center Richmond, Virginia Shashi Amur, PhD Scientific Lead, Biomarker Qualification Douglas Bauer, MD Professor, General Internal Medicine University of California San Francisco School of Medicine San Franscisco, California Samantha Bell Regulatory Project Manager, Division of Bone, Reproductive and Urologic Products Dennis Black, PhD Professor, Epidemiology and Biostatistics University of California San Francisco School of Medicine San Franscisco, California Henry Bone, MD Internist, Michingan Bone and Mineral Clinic Detroit, Michigan Kumpal Madrasi, PhD ORISE fellow, Office of Pharmacology Michael McClung, MD Director, Oregon Osteoporosis Center Portland, Oregon Joan McGowan, PhD Director, Division of Musculoskeletal Disease National Institute of Arthritis, Musculoskeletal and Skin Disease National institutes of Health Bethesda, Maryland Bruce Mitlak, MD Distinguished Fellow Eli Lilly and Compnay Indianapolis, Indiana Thomas Permutt, PhD Director, Division of Biostatistics II Harold Rosen, MD Assistant Professor of Medicine Beth Isreal Deaconess, Harvard Medical School Boston, Massachusetts

2 Discussion Panel Members and Speakers Lorraine Fitzpatrick, MD Chief Medical Officer Radius Health, Inc. Waltham, Massachusetts Jeffry Florian, Ph.D. Pharmacometrics Team Leader Office of Clinical Pharmacology Robert Gagel, MD Professor, Division of Internal Medicine University of Texas MD Anderson Cancer Center Houston, Texas Andreas Grauer, MD Executive Medical Director, Global Development Leader Amgen Hylton Joffe, MD, MMSc Director, Division of Bone, Reproductive and Urologic Products Theresa Kehoe, MD Medical Officer, Team Leader, Division of Bone, Reproductive and Urologic Products Sundeep Khosla, MD Professor of Medicine and Physiology Mayo Clinic College of Medicine Rochester, Minnesota Arthur Santora, MD, PhD Scientific Associate Vice President Clinical Research, Diabetes & Endocrinology Merck Research Laboratories Rahway, New Jersey Stephan Schmidt, PhD Assistant Professor, Pharmaceutics University of Florida College of Pharmacy Gainesville, Florida Deborah Sellmeyer, MD Johns Hopkins Bayview Medical Center Baltimore, Maryland Elizabeth Shane, MD Professor of Medicine Columbia University College of Physicians and Surgeons New York, New York Mahboob Sobhan, PhD Team Leader, Division of Biostatistics III John Stinson, MD Medical Officer, Division of Bone, Reproductive and Urologic Products Stephen Voss, MD Medical Officer, Division of Bone, Reproductive and Urologic Products

3 Discussion Panel Members and Speakers Myong-Jin Kim, PhD Pharmacology Team Leader Division of Clinical Pharmacology III Benjamin Leder, MD Massachusetts General Hospital, Harvard Medical School Boston, Massachusetts Nelson Watts, MD Director, Mercy Health Osteoporosis and Bone Health Services Cincinnati, Ohio Thomas Weber, MD Duke University Medical Center Durham, North Carolina Li Li, PhD Pharmacologist Division of Clinical Pharmacology III

4 Disclosure Information for Panel Members: FDA is committed to ensuring transparency, balance, and objectivity at this workshop. Potential conflicts of interest or other financial relationships with the manufacturers of commercial products or products under development for osteoporosis are listed below for each participant. Panel member Robert Adler, MD Shashi Amur, PhD Douglas Bauer, MD Samantha Bell Commercial entity and Relationship number Amgen 5; Current Osteoporosis Reports 7; National Bone Health Alliance 6 Dennis Black, PhD Alexion 2; Amgen 5; Lilly 5; Radius Pharma 5 Henry Bone, MD Amgen 2, 5, 8; Merck 2, 5; Mission 5 Lorraine Fitzpatrick, MD Radius Health 3 Jeffry Florian, PhD Robert Gagel, MD Astra Zeneca 2; MD Anderson Cancer Center 3; National Bone Health Alliance 6; National Osteoporosis Foundation 6; Paget Foundation 6 Andreas Grauer, MD Amgen 3 Hylton Joffe, MD Theresa Kehoe, MD Sundeep Khosla, MD ActiveLife 9, Bone Therapeutics 9 Myong-Jin Kim, PhD Benjamin Leder, MD Amgen 2, 5; Lilly 2, 5; Merck 2,5 Li Li, PhD Kumpal Madrasi, PhD Michael McClung, MD Amgen 5; Lilly 5; Merck 5 Joan McGowan, PhD Bruce Mitlak, MD Lilly 1, 3

5 Thomas Permutt, PhD Harold Rosen, MD Arthur Santora, MD, PhD Merck 1, 3 Stephan Schmidt, PhD Deborah Sellmeyer, MD Amgen 9 Elizabeth Shane, MD Amgen 2; Lilly 2; Merck 2 Mahboob Sobhan, PhD John Stinson, MD Stephen Voss, MD Nelson Watts, MD Abbvie 5; Amgen 5,8; Janssen 5; Merck 5; Radius 5; Sanofi 5; Shire 5 Thomas Weber, MD U.C.B. Biosciences 5 Relationship: 1) Stock options or bond holdings in a for-profit corporation; 2) Research grants; 3) Employment (full or part-time); 4) Ownership or partnership; 5) Consulting fees or other remuneration; 6) Non-remuneration positions of influence (officer, board member, trustee, public spokesperson); 7) Receipt of royalties; 8) Speakers bureau; 9) Other