Novateur team members, individually or as a team, have played a key role in development of over 80 drugs and devices including the ones listed below.


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.

Clinical Development

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.
Houman David Hemmati, MD, PhD
Head Ophthalmology Development
Full bio of Houman Hemmati
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.

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 H. 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
Biostatistics Lead
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.
Rhona Shanker
Head US Device Regulatory Affairs
Full bio of Rhona Shanker
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, 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.
Paula Tomat
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.

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.

Device Development

Curtis Figley, PEng
Medical Device Development Advisor
Full bio of Curtis Figley
Curtis Figley is Novateur’s Advisor for the engineering aspects of medical device design and development. With over 30 years experience, he has helped create a variety of specialized devices for laboratory and medical applications including: endoscopic cancer imaging; automated cell cytometry; functional electrical stimulation; inhaled Nitric Oxide delivery; hand gesture capture; micro-fluidic chip loading; and PCR analysis. His work extends across early invention and product R&D efforts to formal product design projects targeting certified and approved commercial devices. He received Bachelor of Engineering (Engineering Physics) and Masters of Science (Physics) degrees from the University of Saskatchewan and is a registered Professional Engineer in Canada.  

Health Economics & Reimbursement

Brent Korte
Health Economics & Reimbursement Lead
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.
Eric Mensh
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

Steve A. Lisi, MIB
Head Global Finance & Strategy
Full bio of Steve Lisi
For the past twenty years, Steve Lisi has played an instrumental role in analysis and investment in both private and public companies ranging from $2M to $250B market cap. For the first 18 years of his career he held variety of executive investment positions at Mehta & Isaly (now split into Orbimed and Mehta Partners), SAC Capital, Millennium Partners, and most recently as a managing partner at Deerfield Management, one of the leading healthcare investment firms on Wall Street. Following Deerfield he was responsible for restructuring Flamel Technologies, where he transformed the company from a $100M enterprise value to $1B in three years. His major finance related accomplishments included a $121M equity financing, sale of a contract manufacturing facility, reducing overhead by 50%, and the establishment of a presence in Ireland to allow for future tax optimization. His investment and executive management experience covers both pharmaceuticals and medical devices. He is the Co-Founder and Chairman of the Board of Mico Innovations, a next generation novel bare metal stent company and a board member of Trio Health, a leading edge healthcare IT company. Steve holds a Master in International Business from Pepperdine University.


Jonathan Polak
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

Betsabeh Madani
Growth Strategies


Full bio of Betsabeh Madani

Focused on addressing global challenges in healthcare, environment, and education: Betsabeh Madani has built effective organizations and led a series of strategic partnerships across North America. In addition to her role as an EIR with Innovation Boulevard, Betsabeh is currently a Partner at Auxterra Inc., focused on advising and investing in scientific and impact heavy startups.

Her career highlights span strategy and operations at start-ups (Equicare Health, Boreal Genomics, Peroxyium), general management and growth strategies at larger corporations (Cerner), scientific research in academia, management consulting and organizational restructuring (Boston Consulting Group), and innovation commercialization (MITACS) with a diverse portfolio of life sciences, clean technology, advanced engineering, agriculture, and healthcare.

Betsabeh holds Honors Bachelors in Physics and in Biochemistry from UVic, a Masters in BioMechanical Engineering from UBC, and a Dartmouth’s Tuck School of Business MBA. Outside of work, she judges Engineering Innovation and Design competitions, mentors women in STEM, and advises early stage start-ups across new technology and life sciences.

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.


Ali Ardakani
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.

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.
Dana Kulhava, MEng
Project Coordinator
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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