Houman David Hemmati, MD, PhD is a knowledgeable ophthalmology expert bringing many years of ophthalmology development experience to Novateur clients. Until recently he was the Vice President of Medical and Clinical Development for New Therapies at clinical-stage biotechnology company Capricor Therapeutics, developing the Exosome program. Previous to Capricor he served as Director, Clinical Development at Allergan, as Clinical Scientist in the Ophthalmology Therapeutic Area on several Phase 1, 2, and 3 studies related to anterior segment indications, including overseeing the Restatis-X®’ global program.

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.

Dr. Macdonald has been a medical and regulatory author and analyst for 9 years working with several global pharmaceutical companies on filings in the US, Canada, Australia, Brazil, China, Israel, Korea, Saudi Arabia, Singapore, Switzerland and Turkey. Using her extensive knowledge of the standards for content and format required by health authorities, she has produced a wide spectrum of clinical and regulatory documents (e.g. CCDS, CSR, investigator’s brochures, briefing documents [FDA/EMA], CTD Module 2 for NDA/MAA, supplements to MAs, HA response documents [FDA, MHRA, EMA, Swissmedic], prescribing information) across multiple therapeutic areas (e.g. autoimmune disease, cardiology, oncology, women’s health, gastroenterology, iron deficiency, nephrology and infectious disease). Prior to entering the pharmaceutical industry, Dr. Macdonald was a post-doctoral research fellow at the Division of Infectious and Immunological Diseases, Department of Paediatrics, at the University of British Columbia.

Dr. Ogden has an extensive background in oncology drug development, from early clinical development through approval and post marketing life cycle management in both US and global settings. Prior to joining Novateur, she was the Head of Clinical Development at BTG and Chief Medical Officer at Niiki Pharma. Prior to Niiki Pharma, she was the Vice President of Medical Affairs at Allos Therapeutics and Abraxis BioScience (acquired by Celgene in 2010 for $2.9 B). Before Abraxis, she was the Global Medical Strategy Leader at Johnson & Johnson. She has been integral to the development and approval of multiple oncology treatments worth billions in sales. Dr. Ogden also held Senior Global Clinical Director positions at Bristol Myers Squibb and Pharmacia (now Pfizer). Previous to joining the pharmaceutical industry, Dr. Ogden held senior academic positions at Emory University School of Medicine and Baylor College of Medicine.

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.

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.

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.

Rhona Shanker is the Head of US Device Regulatory Affairs at Novateur. She is a regulatory affairs expert and a former FDA/CDRH/ODE expert regulatory reviewer with an extensive experience in the medical device industry, more than 35 years, where she reviewed over 3,500 applications. Rhona’s professional experience is focused on developing strategies for complying with FDA pre- and post-market regulatory requirements, including: developing regulatory strategies for pre-market submissions, planning IDE, 510(k), PMA, HUD, HDE, and CE projects; preparing 510(k), IDE, PMA, Design Dossiers, and Clinical Evaluation Reports for submission and more. Previously, Rhona held a position of the Expert Regulatory Review Scientist for heart assist devices at the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), in the Office of Device Evaluation (ODE), Division of Cardiovascular and Respiratory Devices, (DCRD/DCD). Prior to that, she also worked in the positions of Senior Reviewer and Consumer Safety Officer at the FDA. Rhona has been an invited speaker at multiple medical and regulatory affairs affiliated conferences, expositions and webinars. She graduated from Emory University with a degree in Biology and has co-authored several professional publications.

Beate Schmidt brings a truly unique and global experience set to the position of Novateur’s Regulatory Affairs Lead for Europe. Her 17 years of experience in the pharmaceutical/biotech industry includes a position as Scientific Administrator at Rheumatology, Respiratory, Gastroenterology and Immunology (RGI) and Anti-infective Section of the EMA (London) overseeing a wide variety of applications submitted to the agency, from initial marketing authorizations to life-cycle procedures (variations, renewals etc.). She has lived and worked in Germany, Canada, the US and UK. Prior to EMA she was Director of Regulatory Affairs at Micromet (acquired by Amgen for $1.2 B) as well as Associate Director, Global Regulatory Affairs at Aspreva (acquired by Vifor for ~$1 B).  Since 2012, she is an independent regulatory consultant based in Munich (Germany). She has prepared scientific advice procedures and regulatory submissions from development and initial marketing authorization to post-authorization procedures.

All blog posts by Beate Schmidt

5 Key Facts About EMA

Dr. Rhinerbarger is a senior executive pharmaceutical manufacturing expert with over 40 years of experience working with biotech and large pharma in lifecycle support, including chemical and formulation process R&D, analytical and process validation, and material characterization. He has been involved in filing over 30 INDs and has worked in the drug chemistry and formulation of 11 approved drugs across multiple disease areas. His expertise is in application of the analytical sciences, with emphasis on chemical process R&D for New Chemical Entities, including applications of separation techniques, spectroscopic and physical methods of analysis to understand chemical processes.  For the past 8 years he has been an independent consultant advising life sciences companies on CMC matters, interaction with FDA and audits. Prior to that he was the Director of the Analytical Division of Cardinal Health, Senior Director of Global Chemical Process R&D at G. D. Searle (Monsanto), Pharmacia and Pfizer.

All blog posts by Rick Rhinebarger

Reference Standard – An Essential Investment to Expedite Development Milestones

Brent Korte has 25 years of pharmaceutical experience in reimbursement strategy, market access and sales. He has also managed the national market access team with responsibility for public, private and federal plans in all jurisdictions across Canada. He was responsible for strategy and action plan development as well as community/advocacy relations building strong relationships with regional and national coalition partners. As part of the strategy and action plan development, Brent led the development of the policy agenda in partnership with the leadership team presenting the overall agenda, messages, etc. to the leadership team and appropriate business partner leaders. Specific policy issues identified and led included pCPA, National Pharmacare, Subsequent Entry Biologics, lifecycle management, substance abuse and diversion and orphan drug strategy and real world evidence (RWE) development. Brent’s last 22 years have been working with Janssen Pharmaceutical Companies of Johnson and Johnson. He leads the Reimbursement Strategy Unit for Canada at Novateur Ventures.

All blog posts by Brent Korte

Expanding in a Restricting World: Value Added Medicine

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.

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.

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.

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.

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.

Dr. Sheshbaradaran advises Novateur clients on global business development and market positioning of oncology and infectious disease products. He has over 20 years of experience in the pharmaceutical and biotechnology sectors in drug development, marketing, business development, financing, and executive operations.Previously, he has held senior global marketing and business development executive positions in several leading pharmaceutical companies including Global Director of Oncology Business Development at Roche and Global Director of Oncology, New Products Marketing, at Pharmacia/Pfizer. He also has extensive small biotech experience, including holding positions such as Chief Business Officer at PsiOxus Therapeutics Ltd; Head of the US subsidiary of Zeneus Pharma Ltd., (acquired by Cephalon, Inc., in 2007); and co-founder and CEO of Niiki Pharma Inc (acquired by Intezyne Technologies in 2013). Dr. Sheshbaradaran has been involved in development of several anti-cancer drugs including Camptosar, Ellence, Emcyt, Sutent and Vidaza. During his business career in the pharmaceutical industry he has participated and closed on M&As, global licensing deals and numerous regional and university deals.

All blog posts by Hooshmand Sheshbaradaran

How to Decipher Large Pharma’s Dating Game?

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.

All blog posts by Ali Ardakani

Think Globally, Work Virtually: The Future of Biotech Success

Building Blocks of Biotech Success

How to Navigate a Period of Market Instability in Biotech Financing?

Happy Holidays

Two Must Know Themes in Biotech for 2016

The Serendipity of Drug Development

How Would the Biotech Landscape Change After the Election?

Conquering the South Pole and Lessons for Biotechs

How Trump Presidency and BREXIT Are Creating the Perfect Storm for Reversing Canada’s Brain Drain

Companion Diagnostics: A Guide to Cure?

Why Did We Go Fishing with Roche Venture Fund?

More Than Engaging with Government – Let’s Work Together

Diagnostics: The Good, the Bad & the Ugly

Winding Down 2017 With Tremendous Gratitude

Off to a Fabulous Start for 2018

Go Luke! Luke Timmerman Is Hiking to the Top of Mt. Everest for Cancer Research

Rewarding Summer for Novateur and Its Clients and Portfolio Investment Companies

Janice Williams is Novateur’s Program Manager and Head of Operations. She is a certified Project Management Professional with 15 years of industry experience and a record of success in building, supporting and leading multinational virtual teams through complex, multifaceted projects. Prior to Novateur, she was the Global Program Manager for the flagship product of Vifor Pharma (VTX:GALN), and Alliance Manager for Vifor/Aspreva’s lucrative Roche partnership. Also while at Vifor, she managed four new product marketing authorization applications (including FDA and EMA) that ultimately led to four approvals, with a team located in seven countries across four continents. Previously, she held positions at PRA International and CroMedica (acquired by PRA) managing CRA resources and contributing to business development efforts.

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Virtually Seamless: Best Practices for Working in a Global Environment

Dana received Master’s Degree in Polymer Materials Science and Engineering from the University of Chemistry and Technology in Prague, Czech Republic. Prior to working for Novateur, Dana has lived and worked in the USA and Bulgaria.