Abraxane® Actos™ AeroNOx® Aldactone® Amyvid™ Anti-Brumm® Argatroban® Aromasin® Arthrotec® Avandia® Benoral® Blincyto® Bloxiverz® Broncho-Vaxom® Bydureon® Byetta® Camptosar® Cardiolite® Celebrex® Cellcept® Copegus® CroFab® Cymbalta® Cytotec® DC Bead® Demulen® DigiFab® Effient® Egrifta® EkoSonic Endovascular System® Ellence® Emcyt® Eraxis® Erbitux® Ferinject® Folotyn® Fortral® Fosrenol® Fuzeon® Herceptin® Hexopal® Humalog® Humalog® KwikPen® Humalog® Mix50/50™ Humatrope® Humira® Humulin®N Humulin®L Lente® Humulin®U Ultralente® Inspra® Kytril® LC Bead® MabThera® Maltofer® Marqibo® Maxaquin® Monocomponent insulin® Mozobil® Negram® NeoRecormon® Neurontin® Novolin Human Insulin® Novolin Pen I® and II® Panretin® Paxil/Seroxat® Pegasys® Photofrin® Plavix® Prozac® Sutent® Symlin® (vials) SymlinPen® Tarceva® Targretin® (capsules and topical gel) Telaprevir® TheraSphere® Topotecan® Tracleer® Valchlor® Valcyte® Varithena® Velcade® Velphoro® Venofer® Vidaza® Viracept® Visudyne® Voraxaze® Xagrid® Xeljanz® Zaditor® Zavesca® Zenapax® Zinecard®
All branded medications are trademarks or registered trademarks of their respective owners.
Head of Clinical Development
Full bio of Eddie Chong
Head Ophthalmology Development
Full bio of Houman Hemmati
Dr. Hemmati is a Board-Certified ophthalmologist, and is also presently Adjunct Assistant Clinical Professor of Ophthalmology at USC Keck School of Medicine, where he serves as Attending Physician at LA County USC Medical Center. Previously, Dr. Hemmati served as Assistant Professor of Ophthalmology at the University of Vermont School of Medicine, and was a clinical/scientific consultant to Stemnion, Access BridgeGap Ventures, Boston Consulting Group, Griffen Rose, and DJF ePlanet Ventures, and co-founded Avicenna Pharmaceuticals, focused on cancer stem cell-targeted therapeutics.
In his scientific career, Dr. Hemmati has co-discovered fetal blood-forming stem cells with Dr. Irv Weissman at Stanford, discovered cancer stem cells in the brain at Caltech, and invented a hydrogel for sustained-release topical drug delivery to the eye with Dr. Robert Langer at MIT.
Dr. Hemmati earned an B.S. in Biological Sciences at Stanford, an M.D. from UCLA, a Ph.D. in Biology from Caltech, and completed an Internal Medicine internship at Stanford Hospital, an ophthalmology residency at the Wilmer Eye Institute at Johns Hopkins Hospital, a postdoctoral fellowship in Chemical Engineering and Drug Delivery at MIT, and a clinical fellowship in Cornea and Refractive Surgery at the Massachusetts Eye & Ear Infirmary, Harvard Medical School. Dr. Hemmati has received numerous awards and honors including The Alcon Research Scholar Award, and the Everhart Presidential Distinguished Lectureship from Caltech.
Clinical Development Scientist
Full bio of Victoria Levesque
Mary H. Macdonald, PhD
Medical & Regulatory Author and Analyst
Full bio of Mary Macdonald
Senior Oncology Development Advisor
Full bio of Angela Ogden
Clinical Operations Lead
Full bio of Chemise Overton
Chemise Overton is a veteran clinical operations professional with 16 years of experience leading and monitoring clinical trials globally. Working in phases 1 through 4, she has led international teams and clinical trials in 6 continents for both biotech and pharmaceutical companies. One of her most noteworthy successes includes her consultancy work at Vifor Pharma (VTX:GALN), where her role in global trial management supported worldwide approvals of a nephrology drug. Previously she worked as a Director and Associate Director of Clinical Operations at Amicus Therapeutics, and prior to Amicus she was a Senior Manager of Global Clinical Operations at Vifor Pharma. In addition to trial management, Chemise can offer a variety of services for clinical trials including budget forecasting/management, audit and inspection support, training, process development, and she can serve as a US Agent for foreign establishments. She has held clinical monitoring positions at Sanofi, Ingenix and PPD. Chemise holds Bachelor of Science degree in Biology with a minor in Chemistry, obtained from the University of North Carolina at Chapel Hill.
Full bio of Matt Truman
Matt Truman is an experienced pharmaceutical biostatistician with over 20 years of global experience. He has been involved with the development of more than 10 drugs, is fluent in the Statistical Analysis System (SAS) programming language and has worked on designing and analyzing clinical trials and managing production of outputs and statistical sections of clinical trial reports for global companies such as Roche, GSK and Covance. He holds an MSc degree in Medical Statistics and Information Technology from the University of Leicester in the United Kingdom.
Regulatory and Quality
Thomas W. Stephens, PhD
Head Regulatory Affairs
Full bio of Thomas Stephens
Senior Orphan Drug Regulatory Advisor
Full bio of Marlene Haffner
Marlene Haffner, MD, MPH, was the Director of the Office of Orphan Products Development at the FDA for more than 20 years. During her tenure in that program, it became THE orphan products program in the world. In addition to assisting in the development of more than 300 products in the US, Dr. Haffner is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond. Her extensive speaking and writing brought the term “orphan products” to the mind of many in the pharmaceutical world.
Dr. Haffner graduated from the George Washington University School of Medicine and did further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine, in New York City. She received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore.
Following her tenure at FDA and prior to forming Haffner Associates, Dr. Haffner served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world.
Carol H. Stephens, PhD
Drug and Diagnostic Development Lead
Full bio of Carol Stephens
Head US Device Regulatory Affairs
Full bio of Rhona Shanker
EU Regulatory Affairs Lead
Full bio of Beate Schmidt
Quality Assurance/Regulatory Affairs Lead
Full bio of Paula Tomat
CMC and Bioanalytics
Head Product Development & Manufacturing
Full bio of Gina Stetsko
Dr. Stetsko began her career in Product and Process Development in large Pharma at Sandoz and Sterling Winthrop. At start-up companies, she served as Senior Director of Product Development at Ligand Pharmaceuticals, then Vice President of Product Development and Preclinical, Vice President of Operations and Vice President of Research Strategic Planning at Amylin Pharmaceuticals. She subsequently was Chief Scientific Officer at Eagle Pharmaceuticals and later Vice President of Research and Development at Flamel Pharmaceuticals, living in Lyon, France.
Dr. Stetsko has built and managed teams to collaborate with numerous contract firms in the US and Europe and played a role in the approval of 12 products, including Bloxiverz®, Byetta®, Bydureon®, Panretin®, Symlin®, Targretin® and Topotecan®.
She was directly responsible for the launch of seven of these products with virtual supply chains, including two drug devices. In addition, she managed a four-way alliance for the construction and staffing of a unique sterile, explosion-proof manufacturing facility for injectable Bydureon® microspheres, while VP of Operations at Amylin.
Dr. Stetsko holds a PhD in Pharmaceutics from Purdue University.
Blog posts by Gina Stetsko
CMC Small Molecule Development Lead
Full bio of Rick Rhinebarger
Blog posts by Rick Rhinebarger
Medical Device Development Advisor
Full bio of Curtis Figley
Health Economics & Reimbursement
Health Economics & Reimbursement Lead (Canada)
Full bio of Brent Korte
Blog posts by Brent Korte
Health Economics & Reimbursement Lead (US)
Full bio of Eric Mensh
Eric Mensh has over 20 years of experience in reimbursement of medicine and devices. He has successfully launched and promoted over 30 products ranging from orphan to blockbuster and from medical devices to biotechnology products. Eric has spent most of his career developing and implementing strategies to launch, expand and/or protect payer access and reimbursement with all types of payers for both multi-national pharmaceutical and biotechnology companies. He also has extensive experience with infused, injected, and specialty pharmaceutical products across multiple indications. Eric was Executive VP and co-owner of a Managed Markets consulting firm. He has also served as a VP of Managed Markets at McCann Healthcare and as Corporate Vice President at Option Care, where he focused on adapting specialty pharmacy operations to meet the needs of the rapidly growing number of infused and injected biologics. Eric also played a critical role at Centocor (J&J) as Director of a national team of managed care account managers and, prior to that, in payer marketing and as a National Account Manager.
Global Financing, IPO & Corporate Restructuring
Head Global Finance & Strategy
Full bio of Steve Lisi
Head Global Sales
Full bio of Jonathan Polak
Jonathan Polak has over 10 years of medical sales & marketing experience. Jonathan has dedicated a part of his professional experience to pioneering computational psychiatry and developing electronics to capture ecological measures of patient health in a real-life setting.
Prior to joining Novateur, Jonathan worked at Blackthorn Therapeutics, a neuropsychiatry drug discovery company, where he developed surrogate endpoints. Jonathan was a founder and Chief Executive of 1Datapoint Diagnostics, a startup medical software company in Cambridge, Massachusetts, using data analytics to improve the standard of care in neuropsychiatric illness. Before that, Jonathan worked as an Investment Banker in Colborne Capital in Toronto, Ontario; as VP Business Development of Intelescope Solutions Ltd. in Modi’in, Israel and São Paulo Area, Brazil; and also as aTrader in Fulcrum Capital – Distressed Debt Hedge Fund in Austin, Texas.
Jonathan holds a Bachelor’s degree in Applied Science & Electrical Engineering and a Master of Business Administration degree from the University of Toronto.
Global Marketing & Business Development
Head Global Business Strategy & Orphan Drug Markets
Full bio of Ray Federico
Head Global Development Strategy, BD & Marketing Advisory Group
Full bio of Hooshmand Sheshbaradaran
Founder & Managing Director
Full bio of Ali Ardakani
He is the Co-Founder & Managing Director of Novateur Ventures, a premier global advisory group with over 100 senior life science advisors, and the current Senior Vice President Device & Business Development for AIT Therapeutics, a publicly traded company. He is also sits on multiple boards including LifeSciences BC (Vice Chair) and Altum Pharmaceuticals (Executive Board Member) and is Entrepreneur in Residence at Innovation Boulevard. He is the Co-Founder and COO of Niiki Pharma, which was acquired in 2013 by Intezyne Technologies, of which he became the Vice President as well as the Co-Founder & CEO of Lexi Pharma, which was acquired in 2018 by Altum Pharmaceuticals.
To date, he has taken several projects from concept to FDA approval (two 510ks) for medical devices in addition to several FDA IND approvals. He has also worked on commercialization and pharma partnerships and several global mergers and acquisitions.
Blog posts by Ali Ardakani
Head of Operations
Full bio of Janice Williams
Blog posts by Janice Williams
Full bio of Dana Kulhava
Prior to working for Novateur, Dana has lived and worked in the USA and Bulgaria. She worked at a major construction and materials supplier company and she has more than 3 years of professional experience working in a laboratory. As a chemist by education, Dana has knowledge in a range of chemical techniques, procedures and assessments. Dana received Master’s Degree in Polymer Materials Science and Engineering from the University of Chemistry and Technology in Prague, Czech Republic.