Dr. Jennifer Cross is an immunologist with nearly 10 years of experience in preclinical drug discovery and development. Most recently, Jennifer worked for Aquinox Pharmaceuticals, helping to drive the discovery and development of novel compounds in the areas of inflammation, pain and oncology through IND-enabling studies. She also has experience with supporting early phase clinical studies, contributing to both IND and NDA regulatory submissions and is an author on 18 peer-reviewed scientific publications.

Dr. Houman David Hemmati 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.

Lloyd Mackenzie is a biopharmaceutical Research and Development executive with over 25 years of experience and expertise in drug development, lead candidate identification, biochemistry, medicinal chemistry, chemistry, manufacturing and control (CMC), quality assurance and clinical development and operations. He has provided strategic leadership, oversight, planning and execution across all aspects of drug development from discovery through to late-stage, global, clinical trials, across multiple therapeutic areas including oncology, inflammatory diseases and pain. Mr. Mackenzie is an author on four patents and 16 scientific publications. He currently holds the position of Chief Operating Officer at NervGen Pharma with prior executive-level positions at Notable Labs and Aquinox Pharmaceuticals.

Dr. Agnes Nemet is a medical consultant with over 21 years of clinical research experience within the Pharmaceutical, Medical Device and Biotech industry, including medical/scientific writing, medical monitoring, pharmacovigilance and management of national and international clinical trials in multiple therapeutic areas. Dr. Nemet started her career in the Pharmaceutical Industry at Solvay Pharma Inc., where she held Medical Information, Clinical Specialist and Project Manager functions. After that, Dr. Nemet was Medical Director at Vasogen Inc. where she was responsible for medical monitoring and safety oversight of Phase I to III programs, including management of the Pharmacovigilance department, preparation of medical safety and clinical study reports, oversight of large adjudication programs and support of DSMB activities. Dr. Nemet holds a Medical Degree from the University of Belgrade, Serbia (formerly Yugoslavia).

Dr. Angela 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.

Dr. Patrick Tam is an expert Nonclinical Development Scientist with over 20 years of industrial experience and a track record of successful completion of preclinical, IND and NDA projects. Patrick has expertise across all aspects of early phase drug development including PK/ADME, pharmacology, toxicology, bioanalytical method development and validation, clinical pharmacology and in Phase 1-2 clinical program development and operations. He has extensive knowledge in the design and management of Phase 1 clinical studies including drug-drug interaction, ethnic bridging, bioavailability and metabolism/excretion/mass balance and has authored the nonclinical sections of regulatory filings. Most recently, Patrick held the position of Senior Director at Aquinox Pharmaceuticals with prior positions as Director, Nonclinical Development at Forbes Medi-Tech and Senior Scientist, Preclinical at Inex Pharmaceuticals and has contributed to 17 peer-reviewed publications.

Dr. Marlene Haffner 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.

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

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.

Dr. Rick Rhinebarger 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

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 several contract firms in the US and Europe and played a role in the approval of 12 products, including Bloxiverz®, Bydureon®, Panretin®, Symlin®, Targretin® and Topotecan®. She was directly responsible for the launch of several 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.

All blog posts by Gina Stetsko

505(b)(2) Regulatory Submissions Require Flexibility, Creativity and Resilience

Entrepreneurial Pharma: Confronting the Adage, “Experience Is Something You Get Just After You Need It.”

Forgoing Retirement: Why I Became an Advisor at Novateur Ventures

Quality Assurance: An Important Contributor to Value Creation

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.

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.

All blog posts by Anne Assmus

With BioEurope Around the Corner: Are Your Meeting Requests Getting Rejected or Never Answered?

Yvonne Joseph is an experienced Business Development and Investment professional providing search and evaluation services on the buy and sell-side for digital health and therapeutics. Her nursing background provides transferable skills in sourcing appropriate opportunities for clients across the areas of oncology and immunology and in the management of value-enhancing activities. Yvonne is currently the Managing Director at CIMYM Biosciences Ltd., but she has also provided Business Development search and evaluation activities for Sierra Oncology and provided strategic, operational oversight of investment portfolios at Astra Investments Ltd.

Dr. David Kennard has over three decades within the pharmaceutical industry. His Business Development experience spans both the buy and sell-side and is under-pinned by a comprehensive understanding of research, development and commercial requirements in developed and emerging markets, including regulatory and clinical development of small molecules, biologicals, devices and diagnostics. Dr. Kennard is currently an industry advisor for the Follicular Lymphoma Foundation and was most recently an advisor for re-structuring and implementing change within the Commercial Partnerships Division and leading the Opportunity Sourcing and Translation group within Cancer Research UK. His prior experience also includes Senior Advisor, Corporate Development at Gilead Sciences, leading the search and evaluation of product opportunities and candidate selection for Gilead’s core therapeutic areas of HIV/HBV, oncology, cardiopulmonary and liver disease. Through his career, Dr. Kennard has led or participated in over 17 successful transactions.

Dr. Hooshmand 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

Importance of Women’s Leadership in Life Sciences

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.