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.
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 & Quality
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.
Head US Device Regulatory Affairs
Full bio of Rhona Shanker
EU Regulatory Affairs Lead
Full bio of Beate Schmidt
CMC & Bioanalytics
CMC Small Molecule Development Lead
Full bio of Rick Rhinebarger
Blog posts by Rick Rhinebarger
Health Economics & Reimbursement
Health Economics & Reimbursement Lead
Full bio of Brent Korte
Blog posts by Brent Korte
Health Economics & Reimbursement Lead
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
Full bio of Eric Zimmerman
Eric Zimmerman recently moved back to his hometown of Austin to pursue investing and entrepreneurship. Previously, Eric was a Vice President at 6 Dimensions Capital (formerly WuXi Healthcare Ventures) in Cambridge, Massachusetts, where he split his time between early-stage biotech and late-stage medtech venture investing. He closed 5 deals during his tenure representing over $150M in combined capital raised. Before 6 Dimensions, Eric was on the investment team at Excel Venture Management, a Boston-based healthcare focused venture firm, where he focused on early-stage healthcare IT and late-stage biotech investments. Previously, Eric got his professional start at Santé Ventures. Eric received his BA from Duke University, focusing on biotechnology and business, with distinction.
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
Anne Assmus, PhD
Head of Global Business Development
Full bio of Anne Assmus
Dr. Anne Assmus has over 10 years of international experience in biotech business development and strategic consulting. Prior to joining Affimed, Dr Assmus worked as Senior Consultant at a Boston-based boutique consultancy, was Senior Manager of Business Development at Immatics Biotechnologies GmbH, Tuebingen, Germany, a peptide-MHC identification, vaccines and T-cell therapy company. Before Immatics, Dr Assmuss was Manager of Business Development at MorphoSys AG, Munich, Germany, one of the world’s leading antibody technology companies, and Marketing Analyst at Novozymes A/S, Bagsvaerd, Denmark.
Dr. Assmus holds a PhD in economics industry from the University of Passau, a Master’s degree in Biology from Heidelberg University, and a BSc in International Business from Copenhagen Business School.
Paul Brennan, MSc
Global Business Development Lead
Full bio of Paul Brennan
Mr. Brennan brings more than 25 years of experience in building and leading pharmaceutical and biotechnology companies in the United States, Europe and Canada with a strong track-record in partnering and licensing transactions.
Previous to Novateur, Mr. Brennan was Vice-President of Business Development at Aquinox (NASDAQ: AQXP), where he successfully completed the out licensing of rosiptor to Astellas in the Asia-Pacific region for $100 million in upfront and milestones. Prior to Aquinox, he was Senior Vice-President of Business Development at Arbutus Biopharma Corp (NASDAQ: ABUS) and played a central role in the merger of Tekmira (NASDAQ:TKMR) and Oncore (private) to create Arbutus which at the time of the merger was valued at over $1 billion. Prior to joining Tekmira, Paul served as CEO of Altair Therapeutics, Inc. In past roles Mr. Brennan contributed to the sale of Aspreva Pharmaceuticals Corp. to Vifor Pharma Ltd. for $915 million and the sale of AnorMED Inc. to Genzyme Corp. for $580 million. Mr. Brennan also served in senior business development and regulatory affairs roles with AstraZeneca PLC, operating in Sweden, the United Kingdom and Canada.
Head Global Development Strategy, BD & Marketing Advisory Group
Full bio of Hooshmand Sheshbaradaran
Founder & Managing Director
Full bio of Ali Ardakani
Ali Ardakani, is a technical and entrepreneurial corporate development & operations biotech executive with 20 years experience in managing life science projects and companies. His work includes research, discovery (inventor of several patents), licensing and development of oncology, respiratory, and infectious disease therapeutics and medical devices.
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
Janice Williams, BSc, PMP
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.
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