Management Team

Brian Leuthner

President and CEO

Mr. Leuthner, one of our co-founders, has served on our board of directors and has been our President and CEO since our inception in January 2009. He has more than 28 years of experience in the biotechnology and pharmaceutical marketplace, with a specific expertise in orphan products, critical care and neurocritical care. Mr. Leuthner has also worked in the hematology and oncology, infectious disease and cardiology marketplaces.  Prior to founding our company, Mr. Leuthner was the CEO of Fontus Pharmaceuticals, Inc. from 2007 to 2008, the Senior Head of Marketing for The Medicines Company (NASDAQ: MDCO) from 2005 to 2007 and the Director of Market Development for ESP Pharma, Inc. from 2003 to 2005. He also held marketing and sales positions of significant responsibility at Burroughs Wellcome and Company, Glaxo Wellcome plc and Johnson & Johnson (NYSE: JNJ). Mr. Leuthner received his B.S. and M.B.A. degrees from the University of North Carolina at Chapel Hill.

Herbert J. Faleck, D.O.

Chief Medical Officer

Dr. Faleck has been our Chief Medical Officer since August 2013. He is a pediatric neurologist trained at the Cleveland Clinic and has more than 25 years of extensive and successful experience in clinical research and development in the pharmaceutical and biotechnology industries. Prior to joining us, Dr. Faleck was with Celgene Corporation (NASDAQ: CELG) from 2000 to 2010. At Celgene, he served in several roles, most recently as the Chief Medical Officer for Celgene Cellular Therapeutics, where he led the clinical, medical and regulatory functions. He was also Celgene’s first Vice President of Clinical Research and Development. After leaving Celgene and prior to joining us in August 2013, Dr. Faleck was a freelance consultant. Previously, he held several positions at Novartis Pharmaceuticals Corporation. Dr. Faleck holds a D.O. from The University of Health Sciences College of Osteopathic Medicine.

Albert N. Marchio, II

Chief Accounting and Administrative Officer

Mr. Marchio has been our Chief Accounting and Administrative Officer since October 2016, and also served as Interim Chief Financial Officer from March 2017 to October 2017. Previously, Mr. Marchio was our Chief Accounting and Operations Officer from March 2014 to October 2016. Prior to that, he served as our Chief Financial Officer from December 2011 through March 2014. Mr. Marchio has 26 years of experience in the pharmaceutical industry. Prior to joining as our Chief Financial Officer, Mr. Marchio was a Managing Operating Partner with Three Fields Capital, a multi-strategy healthcare focused investment firm and provided consulting services to life science companies through Rockabye Valley Consulting from January 2009 to May 2013. Previously, Mr. Marchio served as the Executive Vice President, Chief Financial Officer of Informed Medical Communications from February 2008 to October 2009, and as the Vice President, Treasurer of MedPointe Pharmaceuticals from 2006 to January 2008. He began his career in life sciences as the Vice President, Treasurer of Alpharma, Inc. from 1992 to 2005. Mr. Marchio holds a B.A. in Economics from Muhlenberg College, an M.B.A. in Professional Accounting from Rutgers Graduate School of Business and a Post-M.B.A. Certificate in Taxation from Bernard Baruch College of the City University of New York.

W. Bradford Middlekauff

Senior Vice President and General Counsel

Mr. Middlekauff has been our Senior Vice President, General Counsel and Secretary since October 2015.  Mr. Middlekauff has more than 20 years of experience in the life science industry. Prior to joining Edge, Mr. Middlekauff served as Executive in Residence at Princeton University from October 2014 to October 2015. Prior to assuming his position at Princeton, Mr. Middlekauff was a freelance consultant from August 2013 to October 2014.  Previously, Mr. Middlekauff was Chief Legal Officer, General Counsel and Secretary at Kolltan Pharmaceuticals, Inc. from December 2008 to August 2013, where he also ran the business development function; Senior Vice President, General Counsel and Secretary of Medarex, Inc. from March 2000 to November 2007; and Senior Vice President, Strategic Planning of Medarex, Inc. from November 2007 to April 2008. Mr. Middlekauff was an associate with the law firm of Cooley Godward, LLP from September 1993 to June 1998, where he advised life science companies on a broad range of business and legal matters.  Mr. Middlekauff has served as Chairman of the Biotechnology Industry Organization (BIO) General Counsels’ Committee and Vice President of the Yale Law School Executive Committee and has spoken at numerous conferences on legal and business issues relating to biotechnology. Mr. Middlekauff received a bachelor’s degree from Brown University and a law degree from Yale Law School.

Andrew Saik

Chief Financial Officer

Mr. Saik has been our Chief Financial Officer since October 2017. Mr. Saik was Chief Financial Officer at Vertice Pharma, LLC From August 2015 to July 2017.  From August 2014 to April 2015 he was Chief Financial Officer at Auxilium Pharmaceuticals, Inc., where Mr. Saik led all financial and information technology activities and relationships and played a critical leadership role in executing Auxilium's diversification and growth strategy.  From February 2013 to August 2014 Mr. Saik was Senior Vice President, Finance and Treasurer at Endo Health Solutions, Inc., where he was responsible for internal and external reporting, global consolidations of M&A transactions, cash management, debt financing and risk management. During his tenure at Endo, he helped complete the acquisition of Paladin Labs. Prior to Endo, Mr. Saik served in senior financial management roles with increasing responsibility at Valeant Pharmaceuticals International from January 2001 to July 2012, including Senior Vice President, Finance. In this post, he served as the overall finance lead for the acquisition and integration of the Johnson & Johnson and Sanofi-Aventis dermatology business units in the U.S. and Canada. From October 1999 to January 2001 he was a finance manager at Nexgenix, Inc. and prior to that, from 1996 to 1999, he was a senior financial analyst at Atlantic Richfield Corporation.  He holds a Master of Business Administration from the University of Southern California and a Bachelor of Arts from the University of California, Los Angeles.

Alyssa J. S. Wyant

Senior Vice President, Regulatory Affairs

Ms. Wyant has been our Senior Vice President, Regulatory Affairs, since February 2017. Ms. Wyant has 20 years of global regulatory experience with a focus on the development, registration and successful launches of several innovative, biologic and small molecule orphan disease products. Most recently, Ms. Wyant served as Vice President, Global Regulatory Affairs at PTC from March 2015 to February 2017. While at PTC, she was responsible for the strategic planning and execution of global regulatory activities relating to several orphan disease indications and acted as regulatory agency liaison for a number of drug approval filings with the European Medicines Agency, FDA and Health Canada, among other significant regulatory responsibilities. Prior to her tenure at PTC, Ms. Wyant served as Senior Director, International Regulatory Affairs at NPS Pharmaceuticals from October 2012 to March 2015. Earlier in her career, she held multiple leadership positions in global regulatory affairs at Shire Human Genetic Therapies in the U.S. and Switzerland from January 2004 to October 2012. She also held regulatory affairs positions at Vertex Pharmaceuticals and Genetics Institute / Wyeth-Ayerst Pharmaceuticals. Ms. Wyant holds a B.S. in cell and molecular biology from the University of Washington.

Board of Directors

Brian Leuthner

President and CEO

Mr. Leuthner, one of our co-founders, has served on our board of directors and has been our President and CEO since our inception in January 2009. He has more than 28 years of experience in the biotechnology and pharmaceutical marketplace, with a specific expertise in orphan products, critical care and neurocritical care. Mr. Leuthner has also worked in the hematology and oncology, infectious disease and cardiology marketplaces.  Prior to founding our company, Mr. Leuthner was the CEO of Fontus Pharmaceuticals, Inc. from 2007 to 2008, the Senior Head of Marketing for The Medicines Company (NASDAQ: MDCO) from 2005 to 2007 and the Director of Market Development for ESP Pharma, Inc. from 2003 to 2005. He also held marketing and sales positions of significant responsibility at Burroughs Wellcome and Company, Glaxo Wellcome plc and Johnson & Johnson (NYSE: JNJ). Mr. Leuthner received his B.S. and M.B.A. degrees from the University of North Carolina at Chapel Hill.

Sol Barer, Ph.D.

Board Chairman

Dr. Barer has served on our board of directors since September 2011 and has been Chairman of our board of directors since January 2013. He is the Managing Partner of SJ Barer Consulting. Dr. Barer spent 24 years at Celgene as, among other positions, President, COO and CEO, as well as its Executive Chairman and Chairman before retiring in June 2011. Dr. Barer currently serves as Chairman of the Board of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), Lead Independent Director of the Board of ContraFect Corporation (NASDAQ: CFRX), a biotechnology company; and Chairman of the Board of Aevi Genomic Medicine, Inc. (NASDAQ: GNMX), a genomic medicine company. Dr. Barer holds a B.S. from Brooklyn College. He earned his Ph.D. in Organic Chemistry from Rutgers University.

Isaac Blech

Board Vice Chairman

Mr. Blech has served as Vice Chairman of our board of directors since January 2013.  Mr. Blech serves as a director of life sciences companies Cerecor, Inc. (NASDAQ: CERC), a CNS company, a director of ContraFect Corporation (NASDAQ: CFRX), an infectious disease company and a director of Marina Biotech (OTC: MRNA).  Mr. Blech serves as Vice Chairman of Diffusion Pharmaceuticals (NASDAQ: DFFN), a company targeting treatment to resistant cancers.  Mr. Blech also serves as Vice Chairman of 10 different privately held life sciences companies.  Mr. Blech earned a B.A. degree from Baruch College in 1975.

Rosemary A. Crane

Ms. Crane has served on the board of directors since September of 2017.  She has served as President and Chief Executive Officer of MELA Sciences, Inc. from 2013 to 2014.  Ms. Crane was Head of Commercialization and a partner at Appletree Partners from 2011 to 2013.  From 2008 to 2011, she served as President and Chief Executive Officer of Epocrates Inc.  Ms. Crane served in various senior and executive positions at Johnson & Johnson from 2002 to 2008, including as Group Chairman, OTC & Nutritional Group from 2006 to 2008, as Group Chairman Consumer, Specialty Pharmaceuticals and Nutritionals from 2004 to 2006, and as Executive Vice President of Global Marketing for the Pharmaceutical Group from 2002 to 2004.  Prior to that, she held various positions at Bristol-Myers Squibb from 1982 to 2002, including as President of U.S. Primary Care from 2000 to 2002 and as President of Global Marketing and Consumer Products from 1998 to 2000.  Ms. Crane has served on the Board of Directors of Catalent (NYSE: CTLT) since 2018 and currently as Vice Chairman of the Board of Zealand Pharma A/S (NASDAQ: ZEAL) and a member of the Board of Directors of Teva Pharmaceuticals (NYSE: TEVA) since 2015.  Ms. Crane received an M.B.A. from Kent State University and a B.A. in communications and English from the State University of New York.

James J. Loughlin

Mr. Loughlin has served on our board of directors since November of 2011. Since 2007, he has served on the board of Celgene Corporation (NASDAQ: CELG), where he is Chairman of the audit committee and a member of the compensation committee.  Mr. Loughlin retired in 2003 after 40 years at KPMG LLP, a leading professional accounting and business consulting firm. As a partner at KPMG, he served for five years as a member of the board as well as National Director of the Pharmaceuticals Practice and as Chairman of the pension and investment committee of the KPMG Board from 1995 through 2001. Mr. Loughlin is a certified public accountant and received his B.S. degree in Accounting from St. Peter’s University in 1964.

R. Loch Macdonald, M.D., Ph.D.

Dr. Macdonald, one of our co-founders, has served on our board of directors and as our Chief Scientific Officer since inception. Dr. Macdonald is a scientist, researcher and neurosurgeon and a recognized expert on brain hemorrhage, including Delayed Cerebral Ischemia (‘‘DCI’’). For the past 20 years, his research interest has focused on improving patient outcome after brain hemorrhage, with a specific focus on developing a cure for cerebral vasospasm and DCI. From 2007 to 2015, he served as Keenan Endowed Chair, Head, Division of Neurosurgery at St. Michael’s Hospital. He is currently Professor of Neurosurgery at the University of Toronto. Prior to St. Michael’s Hospital, he was Professor of Surgery and Radiation & Cellular Oncology at the University of Chicago Medical Center. Dr. Macdonald holds an M.D. from the University of British Columbia and a Ph.D. in Experimental Surgery from the University of Alberta. He completed his Neurosurgery residency at the University of Toronto.

Liam Ratcliffe, M.D., Ph.D.

Dr. Ratcliffe has served on our board of directors since June 2016. Dr. Ratcliffe is a Managing Director at New Leaf Venture Partners, and concentrates on biopharmaceutical investing. Dr. Ratcliffe joined New Leaf in September 2008. Dr. Ratcliffe was previously Senior Vice President and Development Head for Pfizer Neuroscience, as well as Worldwide Head of Clinical Research and Development. Additional positions during his 12 years at Pfizer included Vice President of Exploratory Development for the Mid West region (based in Ann Arbor, MI), and Head of Experimental Medicine at Pfizer’s Sandwich, UK Laboratories. Dr. Ratcliffe received his M.D. degree and Ph.D. degree in immunology from the University of Cape Town and his M.B.A. degree from the University of Michigan. He completed his internal medicine training and fellowship in Immunology at Groote Schuur Hospital and associated teaching hospitals in Cape Town, South Africa. Dr. Ratcliffe serves on several academic and industry advisory boards, as well as a director on the board of Deciphera Pharmacueticals (NASDAQ: DCPH), and several privately held companies.

Robert Spiegel, M.D., FACP

Dr. Spiegel has served on our board of directors since August 2013. He has been an Associate Professor at Weill Cornell Medical College since 2012 and is an Advisor to Warburg Pincus, LLC and the Israeli Biotech Fund. He served as Consultant and Chief Medical Officer of PTC Therapeutics, Inc., (“PTC”) from 2011 to 2014. Prior to joining our board of directors, Dr. Spiegel spent over 25 years at Schering-Plough Corporation, retiring in 2009 from his position as Chief Medical Officer and Senior Vice President of the Schering-Plough Research Institute. Dr. Spiegel serves as a member of the board of directors of Geron Corporation (NASDAQ: GERN), a biotechnology oncology company, where he also serves on the compensation committee. He currently serves as Chairman of Vidac Pharma and on the Board of Neximmune, private biotechnology companies.   He was previously a director of Talon Therapeutics, Inc., a biopharmaceutical oncology company, where he also served on the audit committee, and Sucampo Pharmaceuticals where he served on the compensation and nominating and governance committees and Clavis Pharma ASA, a pharmaceutical company based in Oslo, Norway.  Dr. Spiegel holds a B.A. from Yale University and an M.D. from the University of Pennsylvania. Following a residency in internal medicine, he completed a fellowship in medical oncology at the National Cancer Institute and held academic positions at the National Cancer Institute and New York University Medical Center.

Clinical and Scientific Advisors

Robert S. Langer, Ph.D.

Dr. Robert S. Langer has served as chair of Scientific Advisory Committee for Edge Therapeutics, Inc. since August 2012. He is a world-renowned scientist and entrepreneur with vast experience in the healthcare, biotechnology and pharmaceutical industries.

Since 2009, Dr. Langer has been a David H. Koch Institute Professor at the Massachusetts Institute of Technology (MIT). Prior to this position, he was an institute professor at MIT from 2005 to 2009. He has authored more than 1,200 journal articles and has had his patents licensed or sub-licensed to over 250 companies worldwide.  Dr. Langer is also one of seven individuals to have received both the 2006 United States National Medal of Science and the 2011 United States National Medal of Technology and Innovation. As a recipient of the Charles Stark Draper Prize. Dr. Langer is regarded as one of the pioneers in drug-delivery-related inventions. He was also named by Time magazine and CNN as one of the 100 most important people in America.

Dr. Langer received his Bachelors of Science degree from Cornell University and his Doctor of Science degree from the Massachusetts Institute of Technology, both in Chemical Engineering. In addition, he holds honorary degrees from 22 universities worldwide.

Daniel Hänggi, MD

Dr. Daniel Hänggi was the principal investigator of the NEWTON-2 study of EG-1962 at Edge Therapeutics, Inc. Professor Dr. Hänggi is the Chairman of Neurosurgery at the University Medical Center Mannheim, Ruprecht-Karls-University Heidelberg, Germany. Previously, he was the Vice Chairman of the Department of Neurosurgery at Heinrich Heine University in Düsseldorf, German. Prior to joining Edge Dr. Hänggi was the senior physician and head of Vascular Neurosurgery at the Neurosurgical Clinic at the University Hospital Düsseldorf as well the University Hospital in Basel, Switzerland. In 2011, the Josef Klüh Foundation presented him with the Promotion of Innovation in Science and Research Award.

Dr. Hängii received his doctorate in Human Medicine from the University of Basel.