Cornell University

As part of the university's commitment to economic development and outreach, CTL hosts a variety of events to create connections between the Cornell campuses, industry members, entrepreneurs, and investors.

Event Information



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Location



On June 12, 2013, CCTEC and Aptiv Solutions held a Diagnostics Development Boot Camp™ at Weill Cornell Medical College. Attendees learned the keys to developing a successful in vitro diagnostic (IVD) product. The program offered information and practical advice for early stage entrepreneurs, and included presentations and discussion by IVD industry leaders, investors, regulatory, clinical trial, and reimbursement experts. Topics addressed traditional screening and diagnostic tests, as well as companion diagnostics that are delivering on the promise of personalized medicine.



For more information, contact Laura Cima Salter at LC12@cornell.edu.



Agenda


Start To Topic/Speaker(s)
8:30 am 9:00 am Registration
9:00 am 9:10 am Welcome
Vicki Anastasi, Senior Vice President, Medical Devices, Aptiv Solutions
9:10 am 9:55 am Keynote: Dx Industry Overview
Andrew Fish, Director, AdvamedDx
9:55 am 10:40 am IP/Patent Issues
Dr. Xiaochun Zhu, Partner, Scully Scott Murphy & Presser
10:40 am 10:55 am Break
10:55 am 11:40 am Understanding the Regulatory Landscape
Gail Radcliffe, Affiliate Regulatory Consultant, Aptiv Solutions
11:40 am 12:25 pm Designing Your Diagnostic Product
Christian Haller and Brian Scrivens, MPR Associates
12:25 pm 1:25 pm Lunch and Learn: A Physician Entrepreneur's Perspective
Jenny Freeman, Respiratory Motion
1:25 pm 2:10 pm Identifying Funding Sources
Jonathan Wyler, Principal, SV Life Sciences
2:10 pm 2:55 pm Designing and Conducting IVD Trials
Phil Dehayza, Director of Medical Affairs, Aptiv Solutions
2:55 pm 3:40 pm Reimbursement for IVDs
Charles Mathews, Vice President, Boston Healthcare Associates
3:40 pm 3:55 pm Break
3:55 pm 4:40 pm Case Studies: Morphotek and Prolias Technologies
Elizabeth Somers, Associate Director of Diagnostics Development, Morphotek
Dr. Thomas Fahey, Scientific Advisory Board Member, Prolias Technologies
4:40 pm 5:00 pm Final Q/A and Wrap Up
Gene Resnick, MD, CMO, Aptiv Solutions
5:00 pm 6:30 pm Networking Reception


Sponsors

Lunch

Clark+Elbing


LeClairRyan

Breakfast


Clinical & Translational Science Center



Speakers

Vicki Anasatasi, Senior Vice President, Medical Devices, Aptiv Solutions

Vicki Anastasi, Senior Vice President, Medical Devices, Aptiv Solutions

Vicki provides business development leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over twenty years of experience in the medical device industry, with over fifteen years specifically focused on device regulation. Prior to joining the company in 2007, Vicki served as director of regulatory affairs at TissueLink, Inc., (Salient Surgical / Medtronic Advanced Energy) where she was responsible for developing and implementing a U.S. and EU regulatory strategy for medical devices in the electro-surgery market. At Vista Medical Technologies, Inc., an emerging device manufacturer, she served as regulatory affairs manager, responsible for regulatory activities supporting the company’s 3-D visualization and information systems to enable minimally invasive surgical solutions in cardiothoracic, head, neck and spine, general surgical and other microsurgical procedures. She is also experienced with IVDs and held senior positions at ATC Diagnostics, Inc. and bioMerieux Vitek, Inc., where she was responsible for regulatory activities related to infectious disease and genetic-based products. Vicki holds a B.S. in medical technology from the University of Connecticut.

Gene Resnick, MD, Executive Vice President & Chief Medical Officer, Aptiv Solutions

Gene Resnick, MD, Executive Vice President & Chief Medical Officer, Aptiv Solutions

Dr. Resnick is the Chief Medical Officer at Aptiv Solutions and oversees the medical affairs, including safety/pharmacovigilance, medical writing group and translational sciences group.

Dr. Resnick is a board-certified oncologist with over 30 years of experience in cancer drug-development. He founded the oncology-focused CRO, Millennnix Inc., and later served as Chief Medical Officer at Averion International, now Aptiv Solutions. He previously held the position of Vice President, Clinical Research - Oncology at the Schering-Plough Research Institute (1992-1997) where he was responsible for all domestic and international Phase I - III clinical research projects in oncology, including development of 12 small molecules, biologics, cytokines and gene therapy products. He participated in multiple IND/NDA filings, and led the multi-disciplinary oncology product licensing and collaboration development. Prior to that, he was Vice President, Medical Affairs at In Vivo, Inc. (1989-1992), where he was instrumental in expanding post-marketing program activities to include pivotal Phase I-III clinical trials in several therapeutic areas. He acted as liaison to pharmaceutical/biotech sponsors’ clinical, scientific, and medical-marketing staff, and provided expert, FDA-compliant medical monitor function.

Dr. Resnick is Board-Certified in Medical Oncology and Internal Medicine, and is a member of ASCO, DIA, AACR and ACP. He received his BS (1970) from Cornell University, and his MD (1974) from Weill Cornell Medical College; he currently serves on the Cornell University Board of Trustees.

Andrew Fish, Executive Director, AdvaMedDx

Andrew Fish, Executive Director, AdvaMedDx

Andrew Fish is Executive Director of AdvaMedDx, the U.S. trade association representing leading manufacturers of medical diagnostic tests. AdvaMedDx operates as a division of AdvaMed, the medical device manufacturers association, where Mr. Fish holds the title of Senior Executive Vice President. Mr. Fish has extensive government relations, legal, regulatory, and policy background in food, drug, health, and agriculture issues. Prior to joining AdvaMedDx in 2010, Mr. Fish was Senior Vice President of Legal and Government Affairs, General Counsel, and Secretary for the Consumer Healthcare Products Association (CHPA), representing manufacturers of non-prescription medicines.

Mr. Fish also worked for the American Cancer Society as Senior Director of Federal Government Relations. Earlier in his career, he served in the Senate-confirmed post of Assistant Secretary of Agriculture for Congressional and Intergovernmental Affairs, after twice working for the U.S. Senate Agriculture Committee, first as a professional staff member and later as deputy chief counsel. Mr. Fish's work in private practice focused on biotech regulation, as well as on a wide range of food, drug and agriculture issues.

Mr. Fish is a graduate of Yale University and Stanford Law School.

Dr. Xiaochun Zhu, Partner, Scully Scott Murphy and Presser

Dr. Xiaochun Zhu, Partner, Scully Scott Murphy & Presser

Dr. Xiaochun Zhu is a patent attorney of the life science group at the intellectual property boutique firm, Scully Scott Murphy & Presser, P.C. Dr. Xiaochun Zhu received her undergraduate study at Tsinghua University (major in Bioscience) and received her Ph.D. in Biochemistry from Brandeis University in 1996. She was a postdoctoral fellow at Dana Farber Cancer Institute, Harvard Medical School from 1996-1997, and joined Scully Scott Murphy & Presser in 1997. She obtained her J. D., magna cum laude, from St. John's University School of Law in 2002, and was admitted to New York State Bar, and the Eastern and Southern Federal District Courts in New York. Dr. Zhu is also registered to practice before the U.S. Patent & Trademark Office. Dr. Zhu's technical expertise is in the areas of biotechnology and pharmaceuticals. She practices in all aspects of patent procurement in the U.S., and also performs in various aspects of the PCT practice, as well as assists in prosecution of patent applications outside of the U.S. Additionally, Dr. Zhu is experienced in opinion work, including patent validity and infringement opinions, and freedom-to-operate opinions, and counsels a range of clients from large corporations to start-up companies and universities. Dr. Zhu became the first woman partner of Scully Scott Murphy & Presser in January 2006, and was featured among New York Women Leaders in the Law in New York Magazine in 2008.

Gail E. Radcliffe, Ph.D., Affiliate Consultant, Aptiv Solutions

Gail E. Radcliffe, Ph.D., Affiliate Consultant, Aptiv Solutions

Gail E. Radcliffe, Ph.D. assists biotech, medical device and diagnostics companies with technical assessment, marketing and clinical/regulatory issues. She has extensive experience with IVD and CLIA regulations and has helped guide biotech and pharma companies (companion diagnostics) through the changing landscape of FDA and European regulatory requirements. Dr. Radcliffe obtained a Ph.D. in Molecular Biology from Brown University in 1986 and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. In the early 90's, while at GENE-TRAK, she developed molecular diagnostic assays for infectious disease organisms including, HIV, CMV, MTB and Chlamydia. She was also responsible for instituting the clinical affairs group. She then joined Cytyc Corporation and worked in both technical and business development roles. Dr. Radcliffe holds several patents. She is on the board of the Massachusetts Biomedical Initiatives and acts as an advisor to VC firms and to several venture backed biotech companies.

Christian L Haller, Vice President, MPR Product Development

Christian L Haller, Vice President, MPR Product Development

Christian Haller is a trusted advisor and strategist for business executives throughout the medical technology industry. Mr. Haller works with executives at start-ups and Fortune 500 companies to conceive, finance, develop, manufacture and market first of a kind products and new technologies. Mr. Haller is also a serial internal entrepreneur at MPR, where he has successfully built three new business units. Since 2002, he has been the Vice President of the Product Development division, where he directs all operations in North America, Asia, Europe and Israel.

Building upon MPR's 46 year history of medical technology design and engineering, MPR Product Development is now the largest independent third party design and engineering company for medical devices.

Brian Scrivens, Director, Business Consulting, MPR Product Development

Brian Scrivens, Director, Business Consulting, MPR Product Development

Brian Scrivens serves as MPR's Director of Product Consulting. He has over 20 years experience as a project engineer specializing in product development and manufacturing of medical diagnostic systems. Mr. Scrivens has experience in disposable device design, testing and manufacturing, in addition to development of clinical hematology and chemistry instrumentation. He has managed multi-level software development projects, as well as engineering and maintenance functions for fully-automated disposables manufacturing facilities.

Prior to joining MPR, Mr. Scrivens was employed by Advisory Associates, consulting with medical device companies and acquirers on corporate valuations and acquisition and licensing issues. Additionally, Mr. Scrivens spent three years at Beckman Coulter and 11 years at Becton Dickinson, working in design and manufacturing of diagnostic instruments and consumables. While at Becton Dickinson, Mr. Scrivens was mechanical engineering lead for development of the BD ProbeTec® molecular diagnostics system and also managed engineering and maintenance functions during expansion and start-up for disposable diagnostic device automated manufacturing in GMP/ISO environment for BD Phoenix®.

 

Dr.  Jenny Freeman, President and CEO, Respiratory Motion, Inc.

Dr. Jenny Freeman, President and CEO, Respiratory Motion, Inc.

Dr. Freeman has over 25 years of broad hands-on experience in medicine, research and entrepreneurship, including clinical and academic cardiothoracic surgery, biomedical research of sub-cellular processes and medical device innovation. Respiratory Motion, is a Boston area medical device company that has developed and is commercializing the first broadly applicable respiratory volume monitor to improve patient safety, especially in the postoperative period or when opioid pain management is required. Previous entrepreneurial efforts included the development a novel UV spectroscopy system and the development and commercialization of an innovative hyperspectral imaging technology to visualize and quantitate tissue perfusion. She was also the co-founder of Cheirologic Partners, Inc., a Wall Street research analysis and consulting firm and has run several surgical practices. She received her BA from Yale University, MD in Molecular Biochemistry and Biophysics. She attended medical school and trained in General Surgery at NYU/Bellevue. She received additional training at the University of California at San Francisco at the CardioVascular Research Institute and Boston Children's Hospital. She conducted basic research as a Post-Doctoral Fellow at the University of Washington and undertook Cardiothoracic and Pediatric Cardiovascular Fellowships at the University of Alabama at Birmingham with John Kirklin and Children's Hospital of Philadelphia with Bill Norwood. She practiced cardiovascular surgery in both academia and private practice before turning attention to the advancement of innovative medical products.

Jonathan Wyler, Principal, SV Life Sciences

Jonathan Wyler, Principal, SV Life Sciences

Jonathan Wyler joined SV Life Sciences in 2008 and is focused on medical device investments. Jon serves on the board of directors of Cibiem and Halscion, and is an active board observer or has been closely involved with the following SVLS portfolio companies: Altura Medical, MindFrame, NovaLign Orthopaedics (acquired), Ocular Therapeutix, Sadra Medical (acquired), TransEnterix and ValenTx. Jon also works with incubators Coridea, Intersect Partners, and The Innovation Factory on new company formation.

Prior to joining SVLS, Jon led the business and clinical development initiative in gynecology and laparoscopy applications at OmniGuide, Inc., a maker of flexible fibers for surgical lasers. Previously, Jon worked as a Program Manager at Abbott Laboratories' diabetes care division, leading large cross-functional product development teams in the design and commercialization of blood glucose monitoring systems. He worked at TheraSense, Inc. prior to its $1.2B acquisition by Abbott, where he developed the FreeStyle Navigator® continuous glucose monitoring system. Jon started his career at Bridge Design, a full-service product design firm, where he consulted to start-up medical device companies to conceive and develop a broad range of novel medical products.

Jon earned an MBA from the Harvard Business School and an MS in Engineering from Stanford University. He has a BS in Mechanical Engineering and an AB in Studio Art, also both from Stanford. Jon is licensed as a Professional Engineer, and is named as an inventor on two dozen pending and issued patents.

Phil Dehazya, Ph.D., Program Director, Oncology, Aptiv Solutions

Phil Dehazya, Ph.D., Program Director, Oncology, Aptiv Solutions

Phil Dehazya is currently the Program Director for the Oncology Business Unit at Aptiv Solutions. He promotes the understanding of biomarkers and advanced techniques and helps to advance the use of adaptive clinical trial methodology.

Phil did his post-doctoral work in tumor virology at UC Berkeley and in DNA repair and chemical carcinogenesis at the Fels Research Institute in Philadelphia. Subsequent work at pharmaceutical and biotech companies encompassed infectious diseases, growth factor biochemistry, vaccine platforms, monoclonal antibody epitope mapping, the use of biomaterials for drug delivery and gene therapy and drug development.

Charles Mathews, Vice President, Boston Healthcare

Charles Mathews, Vice President, Boston Healthcare

Mr. Mathews has worked on a variety of reimbursement projects identifying public and private payer coverage channels, coding options, and pricing and payment possibilities for drugs, diagnostics, and medical devices. His specific area of expertise is in diagnostics, with a focus on value-based pricing for laboratory tests and molecular diagnostics, as well as with global companion diagnostic launch strategies. His experience includes work with both test and platform developers and laboratories, drug/diagnostic combinations, and pharmaceutical product launches.

Mr. Mathews' prior experience includes working on health policy as a legislative aide on Capitol Hill. He has also worked for the government affairs office of Genentech and has participated in a National Institutes of Health sponsored clinical trial which focused on genetic testing for Alzheimer's disease. Mr. Mathews has a master's degree in public policy from Duke University and completed his undergraduate work at Colgate University.

Elizabeth Somers, Associate Director of Diagnostics Development, Morphotek, Inc.

Elizabeth Somers, Associate Director of Diagnostics Development, Morphotek, Inc.

Elizabeth Somers is Associate Director of Diagnostics Development at Morphotek®, Inc., a subsidiary of Eisai Inc., which is a biopharmaceutical company focused on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. Elizabeth has taken a lead role in the development of the Diagnostic Development Department within Morphotek and is responsible for the clinical development, manufacturing, validation, and regulatory approval, partnership management and commercialization of companion diagnostic products for the company. Elizabeth has a strong business orientation with an entrepreneurial background based on former positions held at Fujirebio Diagnostics and Centocor as Director of Business Development, Director of Clinical Development, Global marketing and Manufacturing and as Associate Director Life Science Licensing at University of Pennsylvania managing Intellectual property and commercialization of early stage technologies. Elizabeth was responsible for the in-licensing of a number of antibodies for assay development, developed the commercialization strategy and led the clinical market development program and clinical trial for regulatory submission for a number of assays on the market.

 

Dr. Thomas Fahey, Professor, Weill Cornell Medical College and Scientific Advisory Board Member, Prolias Technologies

Dr. Thomas Fahey, Professor, Weill Cornell Medical College and Scientific Advisory Board Member, Prolias Technologies

Dr. Fahey is the chief of endocrine surgery and Professor of Surgery at Weill Cornell Medical College. He is an Attending Surgeon at New York Presbyterian-Weill Cornell Medical Center. Dr. Fahey is an internationally recognized expert in the diagnosis and treatment of endocrine tumors.