The Alpha-1 Project Scientific and Business Advisory Council

A Scientific and Business Advisory Council will guide the establishment of the therapeutic strategies and ensure that TAP’s investments in various drug and device therapy projects is fiscally sound.

Michaela Griggs

Michaela is a fast-tracked successful multi-national and global health-care business leader with over 20 years of experience of delivering creative marketing solutions, transforming consumer and healthcare professionals' behaviour and loyalty and driving business growth. Michaela has leveraged her clinical/scientific background to translate complex scientific information into easily-understood positioning and messaging to multiple audiences, and utilizes her classic marketing skill-set to drive scientific-based brand appeal to a broad consumer base. Michaela has consistently introduced 'best–in-class' marketing and sales communication programs resulting in competitive advantage and product differentiation in highly complex life-sciences markets, including device, consumer (OTC) and pharmaceutical (Rx).

Currently, Michaela is the Global Head of Marketing and Business Development at 3M Unitek based in Southern California. Her prior leadership roles have included VP of US Marketing for Bayer Diabetes Care where she led a team of 40+ marketing, consumer promotion, trade marketing and 70 call-centre professionals, developing and implementing the long and short-term strategic marketing, sales and financial plans for Bayer Diabetes portfolio and Vice President, Global Strategic Business Unit – Cardiovascular Aspirin Portfolio; where Michaela was the global leader for both the Rx and OTC divisions of Bayer HealthCare for Bayer ®Aspirin (low dose) with responsibility for the development and global rollout of Bayer’s Cardio Aspirin strategies, marketing programs, new products and medical & clinical activities. Prior to that Michaela has been the marketing lead for several well know brand such as Bayer® Aspirin, One-A-Day®, Flintstones®, Bactine® and the Campho-phenique®. Michaela started her career as an orthoptist for the British National Health Service (NHS)

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Albert W. Leland

Mr. Leland has held senior-level positions with many large financial institutions. Since leaving the corporate banking industry, Mr. Leland has become a highly sought after financial and business advisor to many significant family trusts.

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Kevin Robie

Mr. Robie is Vice President of Portfolio Management for Soin International and is responsible for providing strategic management, acquisition diligence, administrative support and financial services to the Soin International portfolio of businesses.

Mr. Robie began his career in 1981 with The Reynolds & Reynolds Company in Dayton, Ohio holding several senior level positions for more than 20 years. In 2001, Mr. Robie was named Vice President of Marketing for The Relizon Company, an $800 million document management and business process outsourcing provider.

Mr. Robie holds a bachelor's degree in marketing from the University of Dayton and a master's degree in business administration with a concentration in marketing and finance also from the University of Dayton.

Mr. Robie currently holds the position of President and Treasurer on the Board of Directors for two National Heritage Academy Charter Schools in Dayton, Ohio. National Heritage Academy owns and operates over 50 charter schools nationwide. Mr. Robie serves as Board Trustee for The Entrepreneurs Center, an incubator for technology enterprises.

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James D. Crapo, M.D.

James D. Crapo, M.D., is Professor of Medicine at National Jewish Health and the University of Colorado Health Sciences Center in Denver, Colorado. He served as Executive Vice President of Academic Affairs and Chair of the Department of Medicine at National Jewish from 1996 to 2004. Dr. Crapo received his M.D. from the University of Rochester. Prior to moving to National Jewish in 1996, Dr. Crapo spent over 15 years as Chief of the Pulmonary and Critical Care Medicine Division at Duke University Medical Center. Throughout his professional career he has been active in numerous professional societies, including service on the National Institutes of Health's National Heart, Lung, and Blood Institute Board of Extramural Advisors and serving as President of the American Thoracic Society. Dr. Crapo maintains a large research program focused on the role of oxidants and antioxidants in the causation and treatment of diseases. He specializes in Chronic Obstructive Pulmonary Disease (COPD), Alpha-1 Antitrypsin Deficiency, Chronic Cough, and Emphysema. Dr. Crapo is Board Certified by the American Board of Internal Medicine and the American Board of Pulmonary Diseases.

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Terence R. Flotte, M.D.

Dr. Flotte is Dean of the School of Medicine and Executive Deputy Chancellor of the University of Massachusetts Medical School (UMMS). In these roles, Dr. Flotte serves UMMS as chief academic and administrative officer of the School of Medicine, overseeing all academic activities of the basic and clinical science departments, including education and research for the School of Medicine and the Graduate School of Biomedical Sciences. Dr. Flotte joined the Medical School in May 2007 from the University of Florida (UF), where he was the Nemours Eminent Scholar and Chair of the Department of Pediatrics for the College of Medicine.

Dr. Flotte received his undergraduate degree in the biological sciences from the University of New Orleans in 1982, and his medical degree from the Louisiana State University School of Medicine in 1986. After serving his residency in pediatrics at Johns Hopkins University, he completed a pediatric pulmonary fellowship and postdoctoral training in molecular virology there in 1992.

In 1996 Dr. Flotte joined the faculty of the University of Florida and was appointed Associate Director of UF’s Powell Gene Therapy Center. In 2000 he was named Director of the Powell Center and founding Director of the newly established UF Genetics Institute, a cross-campus multidisciplinary unit encompassing gene therapy, human genetics, agricultural genetics and comparative genomics. In 2002 he stepped down from these roles to accept the position of Chair of the Department of Pediatrics.

An internationally known pioneer in human gene therapy, he is currently investigating the use of gene therapy for genetic diseases that affect children, mainly cystic fibrosis.

He is the author of more than 130 scholarly papers and his research has been funded by the National Institutes of Health, the Cystic Fibrosis Foundation and the Juvenile Diabetes Research Foundation.

He is a member of the American Society for Gene Therapy and the American Society of Microbiology, among many other professional associations.

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Bibek Gooptu BSc, MD, PhD, MRCP

Dr Gooptu trained as a physician scientist at the University of Manchester and in the MD/PhD program of the University of Cambridge, UK. He gained his PhD (MRC Research Studentship) in 1999 for work characterizing disease mechanisms on 2 diseases closely related to alpha1-antitrypsin deficiency. From 2000-2006 he worked full-time as a junior hospital doctor in General (Internal) and Respiratory Medicine. He was then awarded a Clinician Scientist Fellowship by the Wellcome Trust to continue research into alpha1-antitrypsin deficiency. He returned to the University of Cambridge as Clinical Lecturer in Metabolic Medicine in 2011. He has recently been appointed Senior Clinical Lecturer in Respiratory Medicine at King’s College London.

NNoel G. (Gerry) McElvaney, M.D., BCh, BAO, FRCPI, FRCPC

Dr. McElvaney is Chairman of and Professor of Medicine in the Respiratory Research Division of the Royal College of Surgeons in Dublin, Ireland. Dr. McElvaney received his medical education at the University College Dublin and completed his postgraduate medical education at the Mater Misericordiae Hospital and the Mater St. Laurence Hospital both in Dublin.

Dr. McElvaney's unit has a well-established track record in research into Cystic Fibrosis and their work on lung defenses has led to interactions with pharmaceutical companies interested in translational research. For example, in 1999 Beaumont Hospital was the first site worldwide for intravenous administration of transgenic alpha-1 antitrypsin to individuals with Alpha-1 Antitrypsin Deficiency. In 2003 Dr. McElvaney founded the Alpha One Foundation of Ireland and subsequently received funding from the Department of Health and Children to set up an Alpha-1 research unit to further research into the condition. He also established the first targeted detection program and registry for individuals with Alpha-1 in Europe.

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Jon F. Merz, J.D., Ph.D., MBA

Jon F. Merz is Associate Professor and Associate Chair for Faculty Affairs in the Department of Medical Ethics in the School of Medicine, Senior Fellow in the Center for Bioethics; and an Associate Scholar in the Center for Clinical Epidemiology and Biostatistics, at the University of Pennsylvania. He holds a B.S. in Nuclear Engineering from Rensselaer Polytechnic Institute, an M.B.A. from the University of North Florida, a J.D. from Duquesne University, and a Ph.D. in Engineering and Public Policy from Carnegie Mellon University. Dr. Merz has established research expertise in the areas of research ethics, biobanking and genetics research, and gene patenting. Since 2003, Dr. Merz has managed the IRB Forum, a moderated discussion forum focused on theoretical and practical research ethics oversight issues. Dr. Merz's seminal empirical work on the ethics and public policy of gene patenting has been cited in support of proposed federal legislation as well as by national policy committees in Canada, the UK, and France, as well as by the Organisation for Economic Co-operation and Development (OECD). He has provided testimony on these issues to both the Department of Health and Human Services (DHHS) Secretary's Advisory Committee on Genetic Testing as well as the US House of Representatives.

He is a member of the American Association for the Advancement of Science and the American Society for Bioethics and Humanities, and he served in 2001-2002 as an at-large member of the American Bar Association Coordinating Group on Bioethics and the Law.

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Tue H. Nguyen PhD

Dr Tue H. Nguyen is currently an independent Pharmaceutical Biotech consultant.

From 2006 to 2012 Dr Nguyen served as Vice President, Chemistry and Manufacturing, then Vice president, Research and Pre-clinical Development, at the Institute for One World Health (OWH), a non-profit pharmaceutical company in San Francisco. He was responsible for directing R&D activities at OWH focusing on expanding the Diarrhea portfolio of projects, and leading the development of CFTR inhibitor as a treatment for acute secretory diarrhea. He was also Project Team Leader of the semi-synthetic artemisinin project, developing a new production technology based on synthetic biology and photochemistry to manufacture the key ingredient in the treatment of Malaria.

Before joining OWH, he spent over twenty years at Genentech, a biotech pharmaceutical company in South San Francisco, progressing from scientist to Director of Pharmaceutical Research and Development where he was in charge of all product pre-formulation, formulation and drug delivery system development. He also served as Director, Analytical Sciences responsible for protein structure and activity characterization, as well as bio-analytical assays development for preclinical and clinical studies.

Dr Nguyen received his BS in Pharmacy from the School of Pharmacy, University of Saigon, VN, his MS in Industrial Pharmacy from St John University, New York, USA, and his PhD in Pharmaceutical Chemistry from the University of Kansas, USA. He is a Fellow of the American Association of Pharmaceutical Scientists. He was a member of the Board of Industrial Advisor for the Higuchi Bioscience Center, Kansas University, and adjunct associate professor at the Kansas University School of Pharmacy. He has also served as a member of the Pharmaceutical Development Steering Committee of PhRMA, the Pharmaceutical Manufacturer Association

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Robert A. Stockley, M.D.

Dr. Stockley is Professor of Medicine at Birmingham University and Medical Director of the Lung Resource Centre, Queen Elizabeth Hospital, Birmingham. He is Director of Research and Development for the University Hospital Birmingham NHS Foundation Trust. He is a member of the British Thoracic Society, European Respiratory Society and American Thoracic Society. He is also a section head for COPD & Allied Disorders, part of the Respiratory Disorders faculty. His area of specialty is the pathogenesis of COPD. His work has received grants from British Lung Foundation, UBH Endowment Fund and a non-commercial program grant from Bayer. He is also an Associate Editor of The Respiratory Research Journal.

Dr. Stockley has a longstanding interest in COPD with special reference to airway inflammation, proteinases and anti-proteinases, and especially the role of the neutrophils, bacteria and exacerbations. His research focuses on investigating the factors governing neutrophil differentiation, activation and recruitment as processes that determine the degree of tissue damage resulting in the establishment and progression of chronic lung disease.

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Jeffrey H. Teckman, M.D.

Dr. Teckman is Director of Gastroenterology and Hepatology at Cardinal Glennon Children's Medical Center in Saint Louis, Missouri. He has been involved in research on Alpha-1 Antitrypsin Deficiency, and other liver diseases for 15 years, and has served as a volunteer and patient educator for the American Liver Foundation and the Alpha-1 Foundation. Research in Dr. Teckman's laboratory has included insights into the mechanisms of cellular damage within the liver, as well as human therapeutic drug trials.

Dr. Teckman's work has been recognized with awards for research, patient care, and service, including the Miles and Shirley Fiterman Basic Research Award in Gastroenterology and Best Doctors in America. Dr. Teckman has served as a consultant to the pharmaceutical industry for projects on drug safety and drug development, and has been involved in patient advocacy for genetic disease anti-discrimination efforts.

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Bruce C. Trapnell, M.D.

Dr. Trapnell is Director of Cincinnati Children’s Hospital’s Cystic Fibrosis Therapeutics Development Network Center, Assistant Director of the Adult Cystic Fibrosis Care Center, Director of the Rare Lung Diseases Clinical Research Consortium, and Scientific Director of the Pulmonary Alveolar Proteinosis Foundation.

Dr. Trapnell received his M.D. from the University of Maryland in 1985, and completed a medical residency at The Ohio State University Hospitals and a fellowship in pulmonary medicine at the Clinical Center of the National Institutes of Health (NIH), where he then served as senior attending physician. Subsequently, he established the Division of Pulmonary and Virology Studies at Genetic Therapy, Inc., a subsidiary of Novartis, Pharmaceuticals, serving as Vice President before joining Cincinnati Children’s Hospital Medical Center, where he is now professor. Dr. Trapnell is also a former Scientific Director of the Alpha-1 Foundation, for which he organized and directed the grants program for eight years.

Dr. Trapnell has conducted research in the field of lung disease since his early medical training and has been continuously funded by the NIH since 2001. He has published over 90 original articles and has trained more than 16 post-doctoral fellows. Dr. Trapnell’s research interests are focused to the pathogenesis and therapy of rare lung diseases and mechanisms by which GM-CSF regulates innate immunity and lung host defense.

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Rubin M. Tuder, M.D.

Dr. Tuder is currently the Hart Family Professor of Medicine and director of the program in translational lung research at the University of Colorado Denver, School of Medicine. He received his M.D. in 1979 and completed his pathology residency at São Paulo University, School of Medicine. After completing a post-doctoral fellowship at Stanford University, he worked as both an attending pathologist and medical supervisor at University Hospital in São Paulo, Brazil. He then moved to the University of Colorado Health Sciences Center where he worked as Instructor, Assistant Professor, and Associate Professor. In 2001 he accepted a position as an Associate Professor of Medicine and Pathology, and Director of the Division of Cardiopulmonary Pathology at Johns Hopkins University. In 2003 he was promoted to the position of Professor of Pathology and Medicine and continued to lead the Department of Cardiopulmonary Pathology. In 2008 he returned to the University of Colorado Denver, School of Medicine and his current appointment.

Dr. Tuder serves as Chair of the Alpha-1 Foundation’s DNA & Tissue Bank Advisory Committee and is a member of the Medical and Scientific Advisory Committee and the Grants Advisory Committee. He is a founding member and senior fellow of the Pulmonary Vascular Research Institute. He is currently on the Editorial Board of the Journal of Cell Death and he is a member of the Respiratory Disorders Faculty of the Faculty of 1000 Medicine.

Dr. Tuder’s research has included: focus on defining the mechanisms of COPD pathogenesis, exploring the molecular, cellular, and histopathological features of Pulmonary Hypertension, studies of the pathogenesis of cigarette smoke induced emphysema and its underlying mechanisms, including the role of RTP-801 and adipocytokine, as well as his investigation in the pathogenesis of schistosomiasis-related pulmonary hypertension.

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Adam Wanner, M.D.

Dr. Adam Wanner serves as the Scientific Director of the Alpha-1 Foundation as well as a Joseph Weintraub Professor of Medicine at the University of Miami (UM) School of Medicine. Dr. Wanner is a graduate from the University of Basel School of Medicine in Switzerland. He completed his residency at the Kantonsspital in Switzerland and the Philadelphia General Hospital in Pennsylvania. Dr. Wanner also completed a pulmonary fellowship at the Mount Sinai Medical Center in Miami Beach, Florida. He began employment in the pulmonary department at the University of Miami Miller School of Medicine in 1973. He quickly climbed through the ranks at UM, serving as Chief of Pulmonary/Critical Care division, directing the Pulmonary/Critical Care Fellowships and serving as the Vice Chair of Research in the Department of Medicine. Dr. Wanner effectively balances research with teaching, patient care and service to the community. He has had over 200 original research papers published and has written over 40 book chapters and review articles. Dr. Wanner has been active on a number of editorial boards, and has served on and chaired several NIH study sections. He has chaired the Veteran's Association (VA) Merit Review Board for Pulmonary Disease and has had uninterrupted federal grant support for the past 30 years. Dr. Wanner also served as the President of the American Thoracic Society from 2001-2002.

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