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Session 1: Introduction - Translating New Ideas Into Clinical Practice

Date and Time: November 6, 2020 Time: 7:00 am – 8:30 am

Statement of Need: Medical practitioners frequently identify clinical needs, new product ideas, and enhanced methodologies for improving diagnosis, treatment, and patient care. Physicians, surgeons, nurses, engineers, and others can benefit from learning about steps involved in translating their ideas and discoveries into clinical practice. Experienced industry and academic leaders will provide information on the development process, intellectual property, licensing and start-up options, and regulatory pathways.

Target Audience: Physicians, surgeons, nurses, engineers, and others interested in learning about the multiple factors necessary in translating an idea from concept to community.

Course Description: This course introduces the multiple factors involved in translating new solutions for unmet needs into clinical practice reality. The session provides an overview of the process of innovation from need identification and solution concept creation, developmental steps, and regulatory influences for commercialization of a finished medical product. VCU medical, academic, and support staff and will receive introductions to VCU resources for innovation and development assistance. This course provides a summary for potential future expansion into a series of sessions focusing on key topic areas.

Educational Objectives: Attendees will gain an understanding of the product development, essential steps in the patent process, funding and commercialization, and medical regulatory and reimbursement elements in order to move their ideas into clinical practice.

Continuing Education Credit: VCU Health designates this live activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.  

Topics

Schedule

7:05 a.m. Welcome & Intro Srirama Rao, Ph.D.
7:10 a.m. Clinical Needs -> Innovation -> Clinical Practice L. Franklin Bost, MBA
7:25 a.m.I.P. - Invention Disclosures & Patent ProcessMichael Mancini, Ph.D. 
7:40 a.m.Faculty Start-ups, FundingNicole Monk, MBA 
7:55 a.m.RegulatoryThomas Miller, Esq. 
8:15 a.m.Questions & AnswersF. Gerard Moeller, M.D. 
8:30 a.m.Thank you and follow-upLisa Ballance, MA

Speakers and Bios

P. Srirama‌ ‌Rao, Ph.D. [View Image]

P. Srirama Rao, Ph.D.

Vice President for Research and Innovation at VCU

P. Srirama‌ ‌Rao, Ph.D.,‌ ‌serves‌ ‌as‌ ‌Vice‌ ‌President‌ ‌for‌ ‌Research‌ ‌and‌ ‌Innovation‌ ‌at‌ ‌Virginia‌ ‌Commonwealth‌ ‌University.‌ ‌He‌ ‌is‌ ‌responsible‌ ‌for‌ ‌the‌ ‌overall‌ ‌strategy,‌ ‌compliance,‌ ‌growth‌ ‌and‌ ‌expansion‌ ‌of‌ ‌the‌ ‌university’s‌ ‌research‌ ‌enterprise.‌ ‌As‌ ‌the‌ ‌institutional‌ ‌official,‌ ‌he‌ ‌leads‌ ‌the‌ ‌Office‌ ‌of‌ ‌the‌ ‌Vice‌ ‌President‌ ‌for‌ ‌Research‌ ‌and‌ ‌Innovation‌ ‌in‌ ‌all‌ ‌of‌ ‌its‌ ‌efforts,‌ ‌and‌ ‌ensures‌ ‌the‌ ‌optimal‌ ‌operational‌ ‌efficiency‌ ‌of‌ ‌the‌ ‌divisions‌ ‌of:‌ ‌Clinical‌ ‌Research,‌ ‌Sponsored‌ ‌Programs,‌ ‌Research‌ ‌Compliance,‌ ‌Research‌ ‌Development,‌ ‌Research‌ ‌Integrity‌ ‌and‌ ‌Ethics,‌ ‌Communications‌ ‌and‌ ‌Outreach,‌ ‌Finance‌ ‌and‌ ‌Operations,‌ ‌Information‌ ‌Systems,‌ ‌and‌ ‌Technology,‌ ‌Commercialization‌ ‌and‌ ‌Economic‌ ‌Development.‌ ‌As‌ ‌VPRI,‌ ‌Dr.‌ ‌S.‌ ‌Rao‌ ‌oversees‌ ‌VCU’s‌ ‌research‌ ‌institutes‌ ‌and‌ ‌centers,‌ ‌core‌ ‌laboratories,‌ ‌and‌ ‌institutional‌ ‌committees‌ ‌including‌ ‌the‌ ‌Institutional‌ ‌Animal‌ ‌Care‌ ‌and‌ ‌Use‌ ‌Committee‌ ‌(IACUC)‌ ‌and‌ ‌the‌ ‌Institutional‌ ‌Review‌ ‌Board‌ ‌(IRB).‌ He‌ ‌earned‌ ‌his‌ ‌Ph.D.‌ ‌in‌ ‌allergy‌ ‌and‌ ‌immunology‌ ‌in‌ ‌1989‌ ‌from‌ ‌the‌ ‌Indian‌ ‌Institute‌ ‌of‌ ‌Science‌ ‌in‌ ‌Bangalore,‌ ‌after‌ ‌which‌ ‌he‌ ‌conducted‌ ‌post-doctoral‌ ‌studies‌ ‌at‌ ‌Pharmacia-Experimental‌ ‌Medicine‌ ‌in‌ ‌La‌ ‌Jolla,‌ ‌Calif.‌ ‌He‌ ‌has‌ ‌focused‌ ‌his‌ ‌research‌ ‌on‌ ‌the‌ ‌pathogenesis‌ ‌of‌ ‌allergic‌ ‌inflammation‌ ‌including‌ ‌asthma‌ ‌and‌ ‌has‌ ‌published‌ ‌nearly‌ ‌90‌ ‌peer‌ ‌reviewed‌ ‌manuscripts‌ ‌as‌ ‌well‌ ‌as‌ ‌several‌ ‌reviews‌ ‌and‌ ‌book‌ ‌chapters. He ‌holds‌ ‌a‌ ‌tenured‌ ‌appointment‌ ‌as‌ ‌professor‌ ‌of‌ ‌microbiology‌ ‌and‌ ‌immunology‌ ‌in‌ ‌the‌ ‌VCU‌ ‌School‌ ‌of‌ ‌Medicine.‌ ‌Dr.‌ ‌‌Rao‌ ‌also‌ ‌holds‌ ‌multiple‌ ‌domestic‌ ‌and‌ ‌international‌ ‌patents,‌ ‌is‌ ‌a‌ ‌co-founder‌ ‌of‌ ‌two‌ ‌companies,‌ ‌and‌ ‌is‌ ‌a‌ ‌senior‌ ‌member‌ ‌of‌ ‌National‌ ‌Academy‌ ‌of‌ ‌Inventors.‌


L. Franklin Bost, MBA, IDSA [View Image]

L. Franklin Bost, MBA, IDSA

Professor and Co-Director VCU Institute for Engineering and Medicine

Bost is a Professor in the VCU College of Engineering and Co-Director of the VCU Institute for Engineering and Medicine. With twelve years academic experience, he has taught over 60 biomedical engineering design, and medical regulatory courses. While at Georgia Tech, he developed and was Executive Director of the Master of Biomedical Innovation and Development (MBID) program. Bost’s interests focus on the intersection of patient needs, medical practitioners, engineering design, and business development for new solutions to advance patient care.

Prior to academic, Bost had a 30+ year industry career focused on medical device development and commercialization of products in nursing services, clinical chemistry, hemodialysis, orthopedics, and biomaterial products for craniofacial trauma and reconstruction. He has lead U.S. and international growth in medical devices, OEM products, and craniofacial reconstruction businesses. Bost has a bachelor’s degree in Product Design from North Carolina State University, Master of Business Administration from the University of North Carolina and he completed the Executive Program at the Amos Tuck Business School at Dartmouth College.

He is a member of the Industrial Designers Society of America (IDSA), a Fellow in the American Institute of Medical and Biological Engineering (FAIMBE), and member of the VCU chapter of the National Institute of Inventors (NAI).


Michael Mancini, Ph.D. [View Image]

Michael Mancini, Ph.D.

Innovation Gateway

Michael Mancini, Ph.D., is the business development manager for Innovation Gateway, the full-service technology transfer office serving VCU. In this role, Dr. Mancini manages a portfolio of high-value medical technologies, primarily platform technologies, that require deep scientific and engineering knowledge and comprehensive business development experience to reach market. Prior to joining VCU, Dr. Mancini was a co-founder and the head of research and development for Spectropath, Inc. (Atlanta, GA), a medical device company spun out of Georgia Tech and Emory University, formed to commercialize an image-guided cancer surgery platform of which he is a co-inventor. Dr. Mancini received his B.S. in biomedical engineering (with distinction) from the University of Rochester, and completed his Ph.D. in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University under the supervision of Shuming Nie. The focus of his doctoral research was on optical instrumentation and nanomaterials, including considerations of toxicology, for biomedical imaging. He is an author of several well-cited scientific publications and a named inventor on two issued U.S. patents.


Nicole Monk, MBA [View Image]

Nicole Monk, MBA

VCU Ventures

Ms. Monk serves as the Director of VCU Ventures at Virginia Commonwealth University. Prior to her role at VCU, Ms. Monk served 2 years as Vice President of Marketing and Business Development for a U.S. based private equity firm, Virginia Life Science Investments. In this role, Ms. Monk evaluated a diverse range of technologies for potential investment and played an active role inside portfolio companies to ensure maximization of shareholder value. Ms. Monk has also served as Vice President of Virginia Biosciences Commercialization Center, a firm focused on developing commercialization strategies for later stage medical device companies. During her 5 years with the VBCC, she worked with multiple later-stage medical device companies leading or monitoring the development and implementation of commercialization strategies. These activities included strategic marketing, development of reimbursement and regulatory strategies, ongoing monitoring of product development, leading initial product sales and organization of distribution networks. Prior to her work with VLSI and VBCC, Ms. Monk spent 6 years with the Virginia Bio·Technology Research Park. During this time she served as Director of Marketing in the BioPark’s incubator facility which houses over 30 early-stage life science companies. Ms. Colomb received a BS in Biochemistry from the State University of New York at Fredonia and her MBA from Virginia Commonwealth University.


Thomas (“Tommy”) Miller, Esq [View Image]

Thomas (“Tommy”) Miller, Esq

Senior Counsel, Nixon Law Group

Thomas (“Tommy”) Miller, Esq., is Senior Counsel and Life Science Practice Lead at Nixon Law Group and is licensed in Virginia, Washington, D.C., and Maryland. Tommy has almost exclusively served the healthcare life science industries during his career, representing healthcare providers and suppliers, health tech companies, pharmaceutical companies, and biotech clients. His deep knowledge of issues impacting these highly regulated businesses allows him to provide practical business and legal advice in the areas of licensure and certification, payment and reimbursement, commercial transactions, legal and regulatory compliance, fraud and abuse, and patient privacy.

In law school, Tommy was a Law Clerk at the Centers for Medicare and Medicaid Services (CMS), Office of Hearings. There, he assisted with the adjudication of administrative appeals related to Part C and D drug plan application denials. After graduating from law school, Tommy spent a brief time as a creditor’s rights and Bankruptcy attorney and later joined a Richmond-based health law firm where he represented large and small healthcare clients, including physician practices, health systems, long-term care providers, and community hospitals.

Tommy has counseled pharma and device companies on key initiatives in the development and commercialization of new and existing drug and device products. During his time in-house, Tommy advised on a broad range of matters including managed care and market access, drug marketing and advertising, specialty distribution, patient and consumer privacy, patient safety, and best compliance practices in the areas of physician engagement, aggregate spend (Sunshine Act), and third-party educational programs and grants.

Tommy has also spent time assisting a Top 25 pharmaceutical client to maintain smooth operations through a significant merger. With that client, Tommy provided general transactional advice and worked primarily on managed care strategy and contracting, including drafting and negotiating innovative value-based rebate agreements with some of the country’s largest insurance payers and pharmacy benefit managers.

Tommy graduated cum laude from both the University of Baltimore School of Law and Virginia Polytechnic Institute and State University. He is a member of the Virginia State Bar and has co-authored, published, and presented on a variety of topics. Tommy serves the Virginia State Bar, Health Law Section, as a member of the Board of Governors. He lives with his family in the Richmond metro area and is a member of the Richmond Symphony Chorus.

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VCU College of Engineering
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Email: IEM@vcu.edu
Phone: (804) 828-0349
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Last Modified: 01/25/2021
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