Speakers

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Ahmet Tutuncu
Executive Vice President, Clinical & Regulatory
Respivant

Dr. Tutuncu has more than 25 years of experience in academic/medical practice and the pharmaceutical industry. Prior to Respivant, Dr. Tutuncu was most recently a co-founder and the CMO of Patara Pharma. Prior to Patara, he was co-founder and CMO of Elevation Pharmaceuticals, responsible for the execution of multiple Phase 2 clinical trials for a new therapy to treat severe COPD. Prior to Elevation, Dr. Tutuncu was VP of Medical Affairs at Verus Pharma where he was responsible for all clinical development activities targeted at asthma, anaphylaxis and other atopic conditions. Prior to joining Verus, Dr. Tutuncu was Director of Corporate Medical Affairs at SkyePharma where he led the clinical development of pulmonary programs including budesonide, formoterol and FlutiForm®. Previously, Dr. Tutuncu held positions of increasing responsibility in clinical development and drug safety at Alliance Pharmaceuticals. He received his PhD in Respiratory Pathophysiology from Erasmus University Rotterdam and his MD from the University of Istanbul where he was also an attending physician and faculty member specializing in intensive care medicine.

Andrei Gudkov
Professor of Oncology
Roswell Park Comprehensive Cancer Center

Andrei V. Gudkov, PhD, DSci, a pre-eminent cancer researcher was appointed Senior Vice President, Research Technology and Innovation; Chair of the Department of Cell Stress Biology, and a member of the senior leadership team for National Cancer Institute (NCI) Cancer Center Support Grant at Roswell Park Comprehensive Cancer Center in 2007. He is responsible for building on the basic and translational research strengths of the Cell Stress Biology program in DNA damage and repair, photodynamic therapy, thermal and hypoxic stress and immune modulation. As Senior Vice President, he will assist the President & CEO in developing and implementing strategic plans for new scientific programs and enhance collaborations in research programs with regional and national academic centers as well as with industry. Dr. Gudkov comes to Roswell Park from the Lerner Research Institute, Cleveland Clinic Foundation where he served as chair of the Department of Molecular Genetics and professor of biochemistry at Case Western University. He earned his doctoral degree in Experimental Oncology at the Cancer Research Center, USSR and a Doctorate of Science (D.Sci) in Molecular Biology at the Moscow State University, USSR. He has authored or co-authored 135 scientific articles and holds 27 patents.

Bernt van den Blink
Senior Medical Director
Promedior

Bernt joined Promedior in March 2016 as Medical Director. He serves as the company’s global medical lead for the on-going clinical development of PRM-151 in Idiopathic Pulmonary Fibrosis (IPF) and Myelofibrosis. Prior to joining Promedior, Bernt was a faculty member in the Department of Pulmonary Medicine at the Erasmus University Medical Center (Rotterdam, The Netherlands) for eight years. Board-certified in Pulmonology, Bernt has expertise in rare lung diseases, including interstitial lung diseases and lung transplantation. At Erasmus, he led the Inflammation and Remodeling research group focusing on translational work in interstitial lung diseases, including IPF. In addition to conducting preclinical research, he was an active clinical trial investigator.   Bernt obtained both his MD and PhD (Immunology) degrees at the University of Amsterdam, where he was also a Fellow in Internal Medicine and Pulmonology. He is the author of more than 40 peer-reviewed articles and an active member in several international lung societies.

Cory Hogaboam
Professor of Medicine
Cedars-Sinai Medical Center

Dan Rose
Steering Committee
Clinical Trials Transformative Initiative

Dr. Rose was born and raised in Denver, Colorado.  He received his BA from Wesleyan University in Middletown CT and his MD from the University of Colorado Health Sciences Center in Denver Colorado. He did a residency in General Surgery and fellowship in Cardiothoracic Surgery at New York University Hospitals. He also did research in myocardial preservation and tissue valve degeneration at the NHLBI.  Dr. Rose was a practicing cardiothoracic surgeon for over 30 years and was chief of Cardiothoracic Surgery at St. Vincent’s Medical Center in Bridgeport CT.  Along with his father and uncle, he cofounded the Pulmonary Fibrosis Foundation in 2000. He was a member of the Board of Directors until 2017 and was Chairman of the Board from 2002-2013.  He also served as President and CEO from 2009-2015.  He is presently on the Clinical Trials Transformative Initiative Steering Committee.  He has been actively involved in patient advocacy and engagement and in the use of mobile devices in clinical trials.

Elias Kouchakji
Senior Vice President, Clinical Development,
Drug Safety & Pharmacovigilance
FibroGen

Dr. Kouchakji, Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, joined FibroGen in 2014, bringing more than 25 years of experience in product development, drug safety, and clinical practice. Previously, he served as Executive Medical Director, Safety, at Amgen, Inc., supporting the development and commercialization of Aranesp®, among other programs. Prior, Dr. Kouchakji was the Global Head Pharmacovigilance and Risk Management at Elan Pharmaceuticals, Inc. (now Perrigo Company plc), Head of U.S. Safety at Hoffmann-La Roche (Roche), and Director, Drug Safety and Pharmacovigilance at Serono (now EMD Serono). Prior to his transition to industry, Dr. Kouchakji was a practicing physician with specialization in surgery, having earned his M.D. at Damascus University.

Day Two

Thursday August 29 2019

4:00 pm | Directional Approach in Clinical Trials

Eric Lefebvre
Chief Medical Officer
Pliant Therapeutics

As Pliant’s chief medical officer, Éric Lefebvre, M.D. is responsible for leading the company’s clinical development strategy and clinical operations for its portfolio of product candidates. Prior to joining Pliant, Dr. Lefebvre was head of clinical research and development for non-alcoholic steatohepatitis (NASH) at Allergan, where he advanced cenicriviroc for the treatment of patients with NASH into Phase 3 trials. Previously, he was chief medical officer at Tobira Therapeutics, whose focus was the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV, prior to the company being acquired by Allergan in 2016. Dr. Lefebvre also led global clinical development, global medical affairs and commercialization of novel treatments for HIV and hepatitis C at Janssen Pharmaceuticals for 10 years prior to starting his pharmaceutical career at GSK Canada. This was preceded by 15 years of providing primary care and conducting clinical research in HIV and hepatitis at Clinique Medicale L’Actuel in Montreal, Canada. Dr. Lefebvre earned a B.S. from Edouard-Montpetit College and an M.D. from the University of Montreal.

Day Two

Thursday August 29 2019

3:30 pm | PLN-74809, an Oral Dual Inhibitor of Integrins αVβ6 & αVβ1, for the Treatment of Idiopathic Pulmonary Fibrosis

Fernando Martinez
Chief, Division of Pulmonary & Critical Care Medicine
Weill Cornell Medicine

Dr. Martinez attended the University of Florida in Gainesville for both his bachelor’s and medical degrees. He went on to complete post-doctoral training at Beth Israel Deaconess Medical Center in Boston, and a clinical and research fellowship at the Boston University Pulmonary Center before moving to the University of Michigan, where he spent the next 23 years of his career.

During that time, he worked in the Division of Pulmonary and Critical Care Medicine at the University of Michigan Medical Center and the University of Michigan Health System, most recently as a professor and associate chief for clinical research. He received a Master’s of Science degree in biostatistics and clinical study design from the University of Michigan School of Public Health. In 2014, he moved to New York to join Weill Cornell Medicine as a professor in the Division of Pulmonary and Critical Care Medicine and the executive vice chairman of the Weill Department of Medicine before taking on this new role.

Dr. Martinez is involved in multiple National Institute of Health consortia, as well as National Heart, Lung and Blood Institute and Department of Defense efforts to bring pulmonary findings from the lab to patients. He has been awarded active and ongoing NIH and DoD grants to design and test tools to identify patients at an increased risk of developing COPD; testing new therapeutic approaches in COPD and pulmonary fibrosis; and identifying biological pathways of fibrosis and emphysema. At Weill Cornell Medicine, he leads a multicenter, NIH-sponsored clinical trial that explores the modification of the lung microbial community to improve survival in patients with idiopathic pulmonary fibrosis. He has won numerous awards for his clinical and investigative efforts throughout his career, and has been included on the Best Doctors in America list since 2002.

Dr. Martinez is a member of numerous societies, including the American Thoracic Society, the European Respiratory Society and the American College of Chest Physicians, and also sits on a number of editorial boards, including those for the American Journal of Respiratory and Critical Care Medicine, Journal of COPD and Thorax.

He has received grant support for his mentorship activities for 30 years, including a K24 mid-career mentoring grant. He is current chair of the National Heart, Lung and Blood Institute’s career development study section called the MPOR, for Mentored Patient Oriented Research.

Day One

Wednesday August 28 2019

8:00 am | What Are the Clinical Issues & Developments in the Last 12 Months of IPF Drug Development?

7:50 am | Chair’s Opening Remarks

Day Two

Thursday August 29 2019

4:30 pm | Chair’s Closing Remarks

8:30 am | Design of IPF Clinical Trials in the Era of Approved Therapies:

Ganesh Raghu
Director, Interstitial Lung Disease/ Sarcoid, Pulmonary Fibrosis Program
University of Washington

Ganesh Raghu, M.D., is a board certified physician at UW Medical Center, medical director of the UW Medicine Lung Transplant Program, director of the UW Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program, the UW’s Endowed Professor Supporting Patients with Interstitial Lung Disease in Honor of Ganesh Raghu, a UW professor of Pulmonary, Critical Care and Sleep Medicine and an adjunct professor of Laboratory Medicine.  Dr. Raghu believes in actively partnering with his patients to provide the best possible outcomes.  Dr. Raghu earned his medical degree from Mysore Medical College in India. He is board certified in both Internal Medicine and Critical Care. He is interested in basic science research on the pathogenesis of pulmonary fibrosis, including human lung fibroblast heterogeneity and genetic susceptibility to pulmonary fibrosis.

Day One

Wednesday August 28 2019

3:15 pm | Clarifying Guidelines for Diagnosis of IPF

Day Two

Thursday August 29 2019

8:30 am | Design of IPF Clinical Trials in the Era of Approved Therapies:

Hans Brightbill
Scientific Manager, Translational Immunology
Genentech

Hans Brightbill earned an undergraduate degree from the University of California, Irvine, a PhD degree in Microbiology and Immunology from UCLA, and conducted postdoctoral studies in Immunology at the University of California, Berkeley. Dr. Brightbill joined Genentech in 2006. After a number of years in Immunology Discovery Research developing large and small molecule therapeutics for inflammatory and autoimmune disease targets, Hans recently joined the department of Translational Immunology at Genentech, where his lab focusses on preclinical disease model and therapeutic development in fibrotic diseases.

Harry Karmouty- Quintana
Assistant Professor, Department of Biochemistry and Molecular Biology
UTHealth - McGovern Medical School

Dr. Harry Karmouty-Quintana received his PhD in Pulmonary Pharmacology from King’s College London (UK) where he pioneered the use of Magnetic Resonance Imaging (MRI) as a tool to non-invasively image experimental lung disease. His PhD was a joint venture between King’s College London and Novartis Pharmaceuticals. His is currently an Assistant Professor at the McGovern Medical School at The University of Texas Health Science Center Houston. He has expertise in experimental models of lung fibrosis and has used lung function and imaging to characterize the bleomycin model of lung fibrosis.

Jane Connor
Associate Director
AstraZeneca

Joe Arron
Senior Scientist & Senior Director – Immunology Discovery
Genentech

Joseph Arron earned an undergraduate degree from Princeton University, completed a combined MD-PhD degree at Cornell University Medical College and the Rockefeller University, and conducted postdoctoral studies at Stanford University School of Medicine. Dr. Arron joined Genentech in 2006, where his laboratory has discovered molecular bases for heterogeneity in asthma and pulmonary fibrosis, enabling target and biomarker discovery for novel investigational molecular therapies and resulting in more than 50 peer-reviewed publications. In addition to supervising translational research in his laboratory, he is Senior Director of Immunology Discovery, a department of 12 laboratories responsible for target discovery and preclinical therapeutic development in inflammatory, autoimmune, fibrotic, and ophthalmic diseases.

John O’Neil
Chief Scientific Officer
XYLYX

Dr O’Neill is a research Assistant Professor of Cell Biology in the College of Medicine at State University of New York Downstate Medical Center, and an Adjunct Associate Research Scientist in biomedical Engineering at Columbia University.   His work is focused on cell and tissue engineering, the innovation and development of therapeutic extracellular matrix biomaterials, and novel extracorporeal organ support systems for organ regeneration and in transplantation.   He received his PhB in Biomedical Engineering from Columbia University and BS in Physics from the University of California at Santa Barbara.

Karl Kossen
Senior Vice President of Translational Science
Indalo Therapeutics

Dr. Kossen has 15 years of experience in pharmaceutical research, including drug discovery, drug development, and the characterization of disease biology. Dr. Kossen was previously Vice President of Disease Biology at InterMune, where he focused on the detailed profiling of antifibrotic drugs and biomarkers of fibrotic disease. He also facilitated external collaborations to further elucidate the pathobiology of idiopathic pulmonary fibrosis. Following the acquisition of InterMune by Roche in 2014, Dr. Kossen co-founded Blade Therapeutics and served as Senior Vice President of Biology. His efforts at Blade helped advance the therapeutic discovery pipeline and enable a $45 million capital raise. Dr. Kossen received his B.S. in Chemistry and Cell & Molecular Biology from the University of Michigan and his Ph.D. in Biochemistry from the University of Colorado.

Kevin Flaherty
Division of Pulmonary & Critical Care Medicine
University of Michigan

Dr. Kevin R. Flaherty is a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine at the University of Michigan in Ann Arbor, Michigan.  Dr. Flaherty is the director of the Interstitial Lung Disease program, serves as Vice-Chair of the Medical School Institutional Review Board for Human Subjects Research and is the steering committee chair for the pulmonary fibrosis foundation’s Care Center Network and Patient Registry.  His clinical and research interests center around the diagnosis, monitoring, and care of patients with interstitial lung diseases.  He is an active participant on grants and clinical trials related to the study and treatment of patients with idiopathic interstitial pneumonias, particularly idiopathic pulmonary fibrosis

Komathi Stem
Founder & Chief Executive Officer
monARC Bionetworks

Komathi Stem, MS is passionate about transforming drug development by rethinking the way clinical trials are designed and executed. As an entrepreneurial systems thinker, she is focused on sparking an ecosystem change that accelerates research through greater collaboration across the healthcare ecosystem. She is currently the Founder and CEO of monARC Bionetworks, a healthcare data collection and analytics company focused on helping patients share their health and digital data to accelerate research and participate in clinical trials anywhere, anytime. She has 24 years of pharmaceutical and biotech industry experience as a senior global leader at Genentech, AstraZeneca and Eli Lilly, where she built and led multi-functional global departments. As a Global Innovation Leader for Genentech, she has tested and transferred into the business, patient centric solutions for accelerating clinical research and reducing costs. Several of these solutions have sparked new startups focused on accelerating recruitment in clinical trials by leveraging mobile technologies. Komathi is a biomedical engineer with diverse pharma/biotech leadership experience ranging from global clinical operations, strategic innovation, portfolio management, medical affairs and sales/marketing. She has extensive experience in multiple therapeutic areas including: Oncology, Neuroscience, Endocrine, Immunology, Cardiology, Respiratory, Infectious Disease, Gastroenterology and Rare Diseases.

Majd Mouded
Medical Director, Clinical Development
Biogen

Majd is currently is the medical lead for the BG00011 program at Biogen.   He received his Bachelor degree and Medical Degree from the Tufts University BA/MD program and completed his medical residency at the Johns Hopkins Hospital with a subsequent fellowship in Pulmonary and critical care at the combined Harvard program. Prior to re-joining Biogen, he worked as an Assistant Professor of Medicine at the University of Pittsburgh Medical Centers, Chief of pulmonary at Harvard Vanguard Medical Associates and as Medical Director at biotech in Boston where he focused on diseases associated with protein misfolding such as cystic fibrosis and alpha-1 antitrypsin deficiency.

Day Two

Thursday August 29 2019

8:30 am | Design of IPF Clinical Trials in the Era of Approved Therapies:

Marc Ramis- Castelltort
Co-Founder & Chief Executive Officer
Senolytic Therapeutics

Marc co-founded Senolytic Therapeutics and serves as a CEO. He is an experienced pharmaceutical and biotechnology executive. He brings a combination of scientific experience, gained through his academic career, and a proven track record of successfully translating technologies into pharmaceutical products. Marc is also an advisor for Life Biosciences Inc. in Europe helping to scout novel aging-associated ventures. Dr. Ramis-Castelltort’s experience spans academia and the business world. He has had an impressive and wide-ranging career, from co-founding and leading pharmaceutical, academic, and venture capital firms, such as Senolytic Therapeutics, Cebiotex, TBI and Chasing Science, to working with premiere research institutions such as Cancer Research UK, Oxford University Innovation and IRB Barcelona The companies he’s built and advised have created drug-delivery nano-systems for cancer, brokered corporate-academic partnerships, and more. Dr. Ramis-Castelltort’s academic degrees include a Ph.D. in Biochemistry from the University of Oxford, a Harvard Business School PLD Program, a M.S. in Chemical Engineering and a B.S. in Chemistry from IQS in Barcelona.

Mary Salvatore
Associate Professor – Thoracic Radiology
Mount Sinai Medical Center

Mary Salvatore is an Assistant Professor of Radiology at Mount Sinai and has an MBA in Healthcare Administration

Day One

Wednesday August 28 2019

3:45 pm | The Intersection of Lung Cancer & Fibrosis – as Told Through Imaging

Mehran Moghaddam
Chief Executive Officer
OROX BioSciences

Mehran F. Moghaddam, PhD, MBA, obtained his doctorate in medicinal chemistry at Oregon State University-School of Pharmacy and completed his postdoctoral training in lipid metabolism at University of California-Davis. He received his executive MBA training at University of Southern California, Marshall School of Business.   Among other things, Dr. Moghaddam’s doctorate and post-doctorate research experience included extensive studies on arachidonic acid pathway and involvement of sEH in metabolism of epoxy-eicosanoids, which resulted in patents and several publications including one in Nature Medicine. Since 1995, he has been involved in discovery and development in DuPont, Pfizer, and Celgene organizations studying small and large molecules. In Celgene, Dr. Moghaddam was involved in nomination and progression of 19 small-molecules and 1 antibody into development. He played a role in discovery of Revlimid®, Pomalyst® and Otezla®; approved therapies for multiple myeloma and psoriatic arthritis. He was also involved in the discovery of CC-90001 which has entered clinical trial for idiopathic pulmonary fibrosis. Recently, he formed a start-up biotechnology company, OROX BioSciences, Inc., dedicated to discovery and development of drugs for unmet medical needs in fibrosis and oncology. He is an author/coauthor on nearly 50 peer-reviewed publications and several patents, some of which reflect his experience with sEH.

Peter Schafer
Executive Director, Translational Development
Celgene

Peter Schafer is currently Executive Director of Translational Development for Inflammation & Immunology at Celgene Corporation based in Summit, New Jersey, were he has worked for 20 years. His research is focussed on the clinical development of products for the treatment of rheumatological, dermatological, gastrointestinal and fibrotic diseases. He was part of the drug discovery and development team responsible for bringing the phosphodiesterase-4 inhibitor apremilast (Otezla) into the clinic, and has contributed to its global regulatory approvals for psoriatic arthritis and psoriasis. Peter has been co-leading the PROLIFIC prognostic lung fibrosis consortium since 2018.

Day One

Wednesday August 28 2019

8:30 am | The Prognostic Lung Fibrosis Consortium (PROLIFIC)

Rick Jack
President, Chief Operations Officer & Chief Scientific Officer
Promedior

Rick has been President and COO of Promedior since 2015. He joined the company in 2014 as CSO. Prior to Promedior, he was VP, R&D at Mitsubishi-Tanabe Pharma USA and was a scientific cofounder of Triad Therapeutics.  His expertise is in innate immunity and inflammatory diseases developed both at Harvard Medical School and in his career in industry.  He received his Ph.D. in immunology at the University of Connecticut Health Center and was a research fellow in immunoparasitology at the International Laboratory for Research on Animal Diseases in Nairobi, Kenya.

Robert Kaner
Associate Professor of Clinical Medicine
Weill Cornell

Dr. Kaner is Associate Attending Physician at the NewYork-Presbyterian Weill Cornell Medical Center and Associate Professor of Clinical Medicine and Genetic Medicine at Weill Cornell Medicine. Dr. Kaner is the Principal Investigator of the Weill Cornell Medicine site of the National Institute of Health (NIH)-sponsored Idiopathic Pulmonary Fibrosis Clinical Research Network, one of 11 in the US and the only center in the Northeast/Mid-Atlantic region of the country. He is the project leader of an NIH-sponsored study of the molecular basis of accelerated emphysema development in HIV-1 positive smokers, which is part of a Specialized Center of Clinically Oriented Research for chronic obstructive pulmonary disease (COPD) directed by Dr. R. Crystal. He has served as principal investigator of NIH-sponsored basic research in mechanisms of vascular permeability in the lung and interactions of human alveolar macrophages with HIV-1. He has participated in multi-center research studies in severe sepsis and nosocomial pneumonia.

Day Two

Thursday August 29 2019

8:30 am | Design of IPF Clinical Trials in the Era of Approved Therapies:

Rusty Montgomery
Director – Research
Miragen Therapeutics

Rusty Montgomery is currently Director of Research at miRagen Therapeutics. He received his Ph.D. from UT Southwestern in the lab of Eric Olson.  Following a post doc in Eric’s lab, he joined miRagen Therapeutics to translate miRNA discoveries in cardiovascular  and fibrotic disease into novel therapeutics.

Sonya Zabludoff
Senior Director
Nitto Denko

Stavros Garantziotis
Medical Director, Clinical Research Unit
National Institute of Environmental Health Sciences

Stavros Garantziotis’ interests focus on gene-environment interactions in the pathogenesis of lung disease, particularly pulmonary fibrosis and lung transplantation. A particular focus is in the role that extracellular matrix plays in the tissue response to injury and repair.

Sunhwa Kim
Principal Scientist
Merck

Toby Maher
Professor of Interstitial Lung Disease
Imperial College London

Toby Maher is British Lung Foundation Chair in Respiratory Research and National Institute for Health Research (NIHR) Clinician Scientist. He is Professor of Interstitial Lung Disease and heads up the Fibrosis Research Group at the National Heart and Lung Institute, Imperial College, London. He is also an honorary Consultant Respiratory Physician on the Interstitial Lung Disease Unit, Royal Brompton Hospital and is Director of the NIHR Respiratory CRF and Director of Respiratory Research at Royal Brompton Hospital.

Day One

Wednesday August 28 2019

4:15 pm | Using Systemic Biomarkers in the Context of Clinical Trials to Give Mechanistic Understanding

Wolfgang Jarolimek
Head of Drug Discovery
Pharmaxis

Yves Wyckmans
Senior Director, Corporate Business Development & Strategic Planning at Actelion
Janssen Pharmaceuticals