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.
Eddie Chong, MB ChB, MRCP
Head of Clinical Development
Full bio of Eddie Chong
Dr. Chong is a senior executive pharmaceutical physician with over 20 years drug development experience across several therapeutic areas (cardiovascular, oncology, nephrology, endocrinology, rheumatology and immunology) and NDA/MAA submissions. Prior to Novateur, Dr. Chong was Vice President, Global Head of Clinical Research and Biometrics in Vifor Pharma (VTX:GALN), where he successfully led a global clinical development team to worldwide approvals of a nephrology drug. Previous to Vifor, Dr. Chong held executive positions at Aspreva Pharmaceuticals (acquired by Galenica/Vifor Pharma in 2007 for ~ $1 B), Inex Pharmaceuticals Corp. and Knoll Ltd. (acquired by Abbott in 2001 for ~$7 B). Dr. Chong’s experience covers the full spectrum of drug development activities, from extensive interaction with FDA, EMA and other regulatory authorities to successful partnership negotiations with American and Japanese companies.
Victoria Levesque, PhD
Clinical Development Scientist
Full bio of Victoria Levesque
Dr. Levesque has 13 years of experience in clinical development, working in a broad range of therapeutic areas including cardiology, virology, neurology and nephrology. Previous to joining Novateur, Dr. Levesque was an Associate Director in Global Clinical Research at Vifor Pharma (VTX:GALN) and an Associate Director in Data Sciences and Reporting at Aspreva Pharmaceuticals (acquired by Vifor in 2007 for ~$1 B). Prior to Aspreva, she was a Clinical Project Manager at Syreon Corporation, a global CRO. Her expertise is in late-stage clinical trial design and implementation, with an emphasis on quality data collection, analysis, interpretation and razor sharp key messaging, essential elements for a smooth path to regulatory approval.
Mary Macdonald, PhD
Medical & Regulatory Author and Analyst
Full bio of Mary Macdonald
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.
Angela Ogden, MD
Senior Oncology Development Advisor
Full bio of Angela Ogden
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 A. Overton, BS
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.
Matt I. Truman, MSc
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
Dr. Thomas Stephens has more than 25 years of experience in pharmaceutical development and he contributed to multiple INDs and CTAs in the USA, Europe, Australia, South Africa, India and Mexico. Dr. Stephens has several years of experience in Lilly global regulatory affairs as Chief Operating Officer and Senior Regulatory Scientist within USA regulatory affairs in therapeutic areas of diabetes, obesity and endocrine therapeutics, including pulmonary insulin, growth hormone, basal insulin, leptin and beta3 adrenergic receptor agonist. Dr. Stephens previously worked as Clinical Research Advisor / Asset Manager and Chief Regulatory Officer of the Chorus Division and he has managed seventeen Phase I-II development programs in a range of therapeutic areas (migraine treatment and prevention, chronic pain, depression, cognition, anti-thrombotics, postmenopausal symptoms, type 2 diabetes, osteoporosis, osteoarthritis, rheumatoid arthritis, transplant rejection and obesity). Dr. Stephens was responsible for developing initial global regulatory capability through contract resources and development of a global internet-based network for coordinating development. The Chorus Group is an autonomous division of Eli Lilly and Company; Dr. Stephens with two other founders developed business processes, defined and developed roles and SOPs for Chorus. Dr. Stephens also spent several years in pre-clinical through Phase II project management (therapeutic areas including cancer, cognition, antiviral, anti-thrombotic, lupus, rheumatoid arthritis, and sepsis) in the LRL Project Management group. He has also led discovery research programs in diabetes and obesity therapeutics including research on leptin, thiazolidinediones and amylin. Prior to work in drug and device development, Dr. Stephens was a supervisor of research and quality assurance for an in-vitro diagnostics company as well as general manager for another. Dr. Stephens received his PhD degree in Biochemistry with minor in Biomathematics from Indiana University School of Medicine and he has RAC (US) professional certification.
Marlene Haffner, MD, MPH
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
Dr. Carol Stephens has 28 years of experience in drug development and support with focus on regulatory planning, negotiation, execution, and compliance. She has worked on 6 successful new NDAs and BLAs and 4 supplements for new indications as well as INDs. Dr. Stephens worked for 25 years at Eli Lilly and Company where she focused on CNS, cardiovascular, endocrine, and oncology drugs, in vitro diagnostics, and drug-device combinations. In Regulatory Affairs at Lilly, she supported products from early clinical phases through submission, approval and market growth. Her experience includes regulatory strategies for obtaining product approvals and negotiations with regulatory authorities backed up by her expertise in US and international regulations, guidances, and agency precedents. Dr. Stephens has broad experience in using desired physician’s prescribing label claims as driver of the development process. In addition to roles within Regulatory Affairs, Dr. Stephens has served as a manager of clinical trials, alliance manager of partnerships with US and international biotechs, and project manager of drug and device development. Dr. Stephens received her PhD in Communications from the University of Wisconsin, and she has a number of publications in the pharmaceutical industry.
Virginia Anastassova, RAC
Regulatory Affairs Advisor
Full bio of Virginia Anastassova
Virginia Anastassova contributes 16 years of working experience to clients with in-depth knowledge of drug regulations in the US, Canada, EU, Japan and Australia. Prior to Novateur, she was Manager of Regulatory Affairs at Vifor Pharma (VTX:GALN), Sorin Group (a global med-tech company), Anormed (acquired by Genzyme for $580 M). She has extensive experience preparing NDA, MAA, IND, and CTA submissions and supplements, and interacting with Regulatory Agencies including preparation and participation in competent authorities meetings.
Beate Schmidt, MSc, MDRA, RAC (US, EU)
EU Regulatory Affairs Lead
Full bio of Beate Schmidt
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.
Quality Assurance/Regulatory Affairs Lead
Full bio of Paula Tomat
Paula Tomat has over 16 years of experience in quality assurance and regulatory affairs in the medical device/drug development industry. She was responsible for multiple US FDA 510(k) submissions and for Health Canada medical device licenses for two novel medical devices. Prior to joining the biotech industry, Ms. Tomat was a Respiratory Therapy Supervisor responsible for respiratory therapy support of clinical trials. Ms. Tomat graduated from the Respiratory Therapist program and obtained a Project Management Certificate from the Northern Alberta Institute of Technology in Edmonton.
CMC and Bioanalytics
Gina G. Stetsko, PhD
Head Product Development & Manufacturing
Full bio of Gina Stetsko
Dr. Gina Stetsko is a senior pharmaceutical development and manufacturing executive with over 33 years experience including 23 years in the start-up pharmaceutical field.
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
Rick Rhinebarger, PhD
CMC Small Molecule Development Lead
Full bio of Rick Rhinebarger
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.
Blog posts by Rick Rhinebarger
Curtis Figley, PEng
Medical Device Development Advisor
Full bio of Curtis Figley
Health Economics & Reimbursement
Health Economics & Reimbursement Lead (Canada)
Full bio of Brent Korte
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.
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
Steve A. Lisi, MIB
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
Ray Federico, BS, MS, MIM
Head Global Business Strategy & Orphan Drug Markets
Full bio of Ray Federico
Ray Federico has over 15 years of biotech and pharmaceutical experience specializing in the orphan disease area. He has extensive experience in pharmaceutical business development and strategy, orphan drug development, medical affairs, commercialization and growth. Ray also has comprehensive experience with niche new product launches, medical marketing, forecasting and pricing. Prior to joining Novateur, Ray was involved in business development at Aurinia Pharmaceuticals and MSI Methylation Sciences, Inc. He also held senior positions at Actelion Pharmaceuticals and Aspreva Pharmaceuticals (acquired by Vifor Pharma). He has launched three orphan drugs with global sales of over one-billion and has been involved in global licensing deals.
Hooshmand Sheshbaradaran, PhD
Head Global Development Strategy, BD & Marketing Advisory Group
Full bio of Hooshmand Sheshbaradaran
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.
Founder & Managing Director
Full bio of Ali Ardakani
For the past 18 years, Ali Ardakani has been pivotal in start-up and development of several biotech companies, drugs and medical devices, for which he has raised millions of dollars in private and grant financing. Most recently, he co-founded virtual biotech Niiki Pharma Inc in NYC, where he acquired two first-in-class oncology drugs from Europe and took them through US IND, UK CTA and Phase 1 and 2 clinical trials within 3 years. Prior to Niiki Pharma, he was the director of corporate development at iCell Therapeutics, a drug delivery platform company. Prior to iCell he led operations of PulmoNOx Medical Inc, a medical device company responsible for 510(k) approval of two novel medical devices. At the same time, he was VP of Operations of EquATec, a virtual med-tech veterinary company developing novel therapies for the equine, where he led global operations and trials in Canada, US and Hong Kong. He also managed the global alliance of EquATec with a large pharma partner.
Blog posts by Ali Ardakani
Janice Williams, BSc, PMP
Head of Operations
Full bio of Janice Williams
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.
Blog posts by Janice Williams
Dana Kulhava, MEng
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.