Advanced Strategic Planning for Life Science, Medtech StartupsFebruary 15, 2022 | 7:00 pm - 8:30 pm ET | Free Webinar
Advanced Strategic Planning for Life Science & Medtech Startups
Vicki Anastasi, Medical Device Executive & Strategic Advisor; Jo Ellen Slurzberg, VP Global Health Policy and Reimbursement, JR Associates; Christopher L. Waller, Ph. D., Vice President and Chief Scientist EPAM Systems, Inc.; Jeff Antos, Vice President, Regulatory Sciences at ProPharma Group
Launching a new entrepreneurial venture is hard work, requiring inspiration, initiative, and lots of perspiration. In a life sciences startup, as if finding Co-Founders, financing, facilities, business partners, and carrying out complex scientific research weren’t enough, there are stringent regulatory compliance and reimbursement issues that need to be met. Any product or service that provides treatment or diagnostics for humans will need regulatory approval, a decidedly non-trivial exercise. Importantly, at least in the United States, regulatory approval has no bearing on whether third-party payers (e.g., healthcare insurance) will pay the cost for patients. Whether a life science entrepreneur plans to go to market alone, or with product development partners, success requires an understanding of the process and an execution strategy that addresses appropriate R&D quality, with rigorous, validated data handling and analytics capabilities to provide critically important information to regulators and reimbursement specialists.
Tonight’s panelists will offer up insights to help life science entrepreneurs to plan for success.
February 15, 2022
(all times are USA Eastern Standard time)
Vicki AnastasiMedical Device Executive & Strategic Advisor
Vicki Anastasi has over 30 years of experience in the medical device industry, with over 20 years specifically focused on global medical device and diagnostic strategic consulting. She has held senior management roles for medical device and therapeutic companies focused in orthopedics, cardiovascular/metabolic disease and combination products. In diagnostics, she held senior positions at companies involved in the development of infectious disease and genetic-based products including companion diagnostics and precision medicine.
Her most recent role was as SVP Clinical, Regulatory and Quality at Farcast Biosciences formerly Mitra Biotech, a cancer diagnostic research company focused on fast track drug discovery using a human tumor histoculture platform. Previously she was at CRO where she served as Global Head for ICON’s Medical Device and Diagnostics Research business unit.
Vicki guides pharmaceutical, biotechnology and medical device companies in developing and implementing roadmaps for demonstrating drug and device value, safety and effectiveness by leading innovative approaches including RWE initiatives, Ph IIIb/IV, pilot/pivotal studies and HEOR evaluations across the globe to optimize market access.
Vicki is actively involved in industry groups, where she regularly speaks and participates in focused panels and discussions.
Jo Ellen SlurzbergVP Global Health Policy and Reimbursement, JR Associates.
Jo Ellen Slurzberg leverages decades of reimbursement and health policy experience as VP for JR Associates, a boutique life sciences reimbursement and market access consultancy. She is an industry veteran having served in senior reimbursement management roles at multiple companies, securing coverage, coding and payment for a spectrum of innovative biomedical, pharmaceutical and medical device technologies used in the U.S. and abroad. Her perspective comes from extensive experience driving reimbursement for small startup companies and established global conglomerates.
Jo Ellen is a speaker on health policy trends and reimbursement‐related business issues and has written numerous reimbursement‐ related articles, is a contributing author and collaborator on Harvard Business School Notes with Professor Regina Herzlinger for whom she is a research associate. She serves as a mentor to Harvard Business School/Harvard School of Public Health, and as an advisor to the Harvard Innovation Lab (I‐Lab), and other translational medicine programs. Jo Ellen has participated in the Global Educators Network for Health Innovation Education (GENiE), a consortium of health innovation business school leaders from around the world. She is an active member of the Medical Device Manufacturers Association (MDMA), previously serving on its board and chairing a Reimbursement Task Force.
Christoper L. Waller, Ph. D.Vice President and Chief Scientist EPAM Systems, Inc.
Dr. Waller is currently Vice President and Chief Scientist of the Life Sciences business unit at EPAM Systems, Inc. where his focus is on using data and analytics to transform pharmaceutical research and development.
Dr. Waller received his Ph.D. in Medicinal Chemistry and Natural Products from the University of North Carolina in Chapel Hill in 1992. Following graduation, Dr. Waller accepted a post-doctoral fellowship under the direction of Dr. Garland Marshall at Washington University in St. Louis where he focused his efforts on the design HIV protease inhibitors. In 1993, Dr. Waller accepted a position with the U.S. EPA in which he was responsible for the development of structure-activity relationship and pharmacokinetic models as a research chemist and leader of a team of analytical, computational, and synthetic organic chemists, toxicologists, and biomedical engineers. From 1996-1999, Dr. Waller served as a Research Manager at OSI Pharmaceuticals. In this role, he managed a group of computational chemists, scientific application developers, and robotics engineers. In early 1999, Dr. Waller joined Eli Lilly- Sphinx Laboratories as a computational chemist and Head of Cheminformatics in the Discovery Chemistry group. Between 2001 and 2012, Dr. Waller held a number of positions in the research and informatics divisions at Pfizer, Inc. From 2012-2017, Dr. Waller held a number of positions at Merck & Co. initially as Head of Cheminformatics and culminating in the role of Executive Director of Predictive Modeling Platforms and Data Science.
Dr. Waller is on faculty at Northeastern University where he lectures on leadership and analytics, holds an Adjunct Professor position at the University of North Carolina at Chapel Hill, is an Advisory Board member and benefactor of the Hurt Hub at Davidson College, a center dedicated to data science and innovation, and is a founding Board Member of the Pistoia Alliance, a not-for-profit organization focusing on pre-competitive collaborations in pharmaceutical research information technology.
Matthew WeinbergPresident, Regulatory Sciences at ProPharma Group
Matthew Weinberg is responsible for the global Regulatory Sciences group at ProPharma Group. As the world’s leading pharma and med device consultancy, we offer our clients the ability to move through the regulatory hurdles they face when developing new products and maintaining their market status once approved. With our reliance and decades of history of providing excellence, we have assisted in the approval of hundreds of new drugs, biologics and medical devices.
In addition, Mr. Weinberg plays an active role in the community as Chair Emeritus of Building Steps, a Baltimore-based nonprofit that helps minority and underprivileged high school students pursue careers in the fields of science and technology. Building STEPS was founded by Matthew Weinberg as an internship program in 1995. In its early years, Building STEPS had no more than 20 students in its cohorts. Today, the organization serves more than 130 Baltimore city public high school juniors and seniors, as well as 250 college students and alumni each year. Mr. Weinberg is also involved in the Jewish Community of Washington DC.
Moderator & Organizers
Kristin King, MBA.Boston Harbor Angel Investor; VP, Corporate Development, Defibtech
Kristin is an accomplished MedTech executive, serial intrapreneur, investor and strategic advisor to startups developing biotech solutions. With over 20 years spanning technical, marketing, and proud member of Boston Harbor Angels, she offers multi-discipline expertise transforming technologies from early concept to successful global divisions at leading Medical Device companies and startups.
Roger FrechettePrincipal and Founder of NEPAssociates, LLC
Roger is a life sciences consultant/advisor, helping clients by leveraging an extensive global network and multi-disciplinary insights derived from >20 years of experience in the business of life sciences, calibrated with an extensive science background. His career has encompassed success as a business executive, project/alliance manager and entrepreneur, and as a scientist, including leadership of discovery/preclinical development teams resulting in two FDA approved therapeutics. Roger has been a volunteer with Boston ENET since 2014, in addition to supporting start-ups as a mentor with MassBio, and other Greater Boston Area entrepreneur support groups. He also a mentor with 12Ronnies, a global early-stage startup mentorship organization.
Advanced Strategic Planning for Life Science, Medtech Startups
February 15, 7 – 8:30pm EST
This event is FREE, however, registration is required.
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