DUE TO GEORGIA TECH'S CAMPUS CLOSURE IN RESPONSE TO THE PANDEMIC, THIS EVENT WILL BE RESCHEDULED AT A LATER DATE

Together, Georgia Tech's Children's Healthcare of Atlanta Pediatric Technology Center (PTC), the Institute for Electronics and Nanotechnology (IEN), the Petit Institute for Bioengineering and Bioscience (IBB), and VentureLab are hosting this 1 1/2 day bootcamp to educate and motivate faculty and students across multiple IRIs and colleges to pursue biomedical translational and commercialization work. In addition, the bootcamp will help Georgia Tech bio entrepreneurs build their networks.

Open to all in Georgia Tech's bio community. 

$20 registration fee, all attendees

AGENDA

TUESDAY, MAY 12, 2020

9:00 a.m. – FDA Regulatory Session – What Researchers Need to Know - Medical Devices and Combination Devices
This session will offer best practices when conducting trials using FDA approved and unapproved devices. It will give an overview of the marketing process for medical devices, the IDE application process, and the obligations of the sponsor-investigator once the IDE application is filed with the FDA. Case studies will be presented to enhance learning and stimulate audience participation. This session will address the following questions:

• What is a medical device?
• What is FDA’s approach to regulating the commercialization of medical devices?
• What is the 510(k) pathway?
• How does FDA regulate mobile apps?
• What are the benefits of a pre-submission meeting with the FDA?
• What is an abbreviated IDE and when is this applicable?
• What is the difference between an abbreviated IDE and a “full” IDE and when is the “full” IDE applicable?
• What information needs to be included in an IDE?
• How do I submit my IDE application to the FDA?
• What are the reporting requirements once my IDE is approved?

Session Facilitator:
David Jensen, Ph.D., R.A.C., Duke University
David Jensen, Ph.D., R.A.C., is a Regulatory Associate, Senior in the office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. He uses his 15+ years of experience in US FDA-regulated medical product development to advise Duke Faculty and project teams, primarily at the Duke Clinical Research Institute (DCRI), on regulatory strategy development, FDA meetings, regulatory submissions, product manufacturing, and preclinical testing. He assists project teams with the development, coordination, and implementation of complex regulatory projects involving drugs, biologics, devices (including Software as a Medical Device), and dietary supplements. Jensen is also a patent-holding cell & molecular biologist with broad experience in drug discovery and development and with significant scientific knowledge in a variety of therapeutic areas. Prior to Duke, Jensen held regulatory positions at a major CRO and at a biotechnology company (focused on nanotechnology) and he was a project leader for oncology, osteoarthritis, and virology programs at a major pharmaceutical company. Jensen has an undergraduate degree in Chemistry from California State University at Fullerton, a master’s degree in Medicinal Chemistry from Duquesne University, and a doctoral degree in Pharmacology from the University of Virginia. He also holds the US regulatory affairs certification (RAC) from the Regulatory Affairs Professional Society. 

12:00 p.m. – Networking Lunch

1:30 p.m. – Therapeutics – What Researchers Need to Know
This session will offer best practices when conducting trials using FDA approved and unapproved drugs or substances (including biologics). It will give an overview of the IND application process and the regulatory obligations of the sponsor-investigator once an IND is filed with the FDA. Case scenarios will be presented to enhance learning and stimulate audience participation. This session will address the following questions:

• What is an investigational drug?
• Do I need an IND for my investigation?
• What are some examples of trials requiring an IND and examples of studies that are IND exempt?
• When do I need an IND for an investigation using dietary supplements?
• When should I consider having a Pre-IND meeting with the FDA?
• What information needs to be included in my IND application?
• What happens after I submit my IND application to the FDA?
• What are the reporting requirements once my IND is effective?
• How and when should I report serious adverse events (SAEs) once I have an IND?
• What accelerated pathways are available for therapies?

Session Facilitator:
Rachel Johnson, Ph.D., R.A.C., Duke University
Rachel Johnson, Ph.D., R.A.C.Johnson is a Regulatory Affairs Scientist in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine.  In this role, Johnson is responsible for providing support and guidance to investigators and regulatory study coordinators regarding the regulatory requirements relevant to their research study activities. She performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. Johnson is also involved in the implementation of operational initiatives within ORAQ. Johnson received her undergraduate degree in biochemistry from Clemson University.  She conducted her graduate research at Duke University, where she earned her PhD in Molecular Cancer Biology. During her graduate training, Johnson was the recipient of a James B. Duke Fellowship, a Ruth L. Kirschstein-NRSA Predoctoral Fellowship, and a Robert J. Fitzgerald Scholar Award.  After her graduate studies, Johnson spent two years as a Regulatory Coordinator at the Preston Robert Tisch Brain Tumor Center at Duke University. Johnson holds the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.

4:30 p.m. – Networking Reception, Petit Biotech Building Atrium


WEDNESDAY, MAY 13, 2020

8:00 a.m. – Keynote Presentation – How to Move Technology into Clinical Trials
Daria Mochly-Rosen, Ph.D., George D. Smith Professor in Translational Medicine, Stanford University

Daria Mochly-Rosen, Ph.D., is a chemist turned drug developer with clinical trials experience. Mochly-Rosen founded Stanford’s SPARK program to provide a cost-effective model to generate diagnostic and drug proof of concept using out-of-the-box academic approaches combined with industry standards. Product proposals are reviewed annually by an expert panel of faculty and industry advisors. The panel reviews new, unlicensed disclosures made to the University Office of Technology Licensing as well as proposals submitted from across the university. SPARK Scholars are funded for an average of two years and participate in weekly seminars with industry and academic experts. In addition, Mochly-Rosen runs a multi-disciplinary research lab that includes chemists, biochemists, biologists, and physician scientists. She has a Ph.D. from Weizmann Institute, Israel in Chemical Immunology and a B.S. from Tel Aviv University, Israel in Life Sciences.

9:00 a.m. – Health Information Technology Regulatory and Deep Technology Commercialization
This session will offer best practices for thinking about and assisting in drafting patents, answering office actions, and focusing on IP so that it is ready for venture capital investors. Case studies from other academic inventors will be presented to enhance learning and stimulate audience participation.

Session Facilitators: 
John Sears, J.D., Ph.D., CLP - Director of Intellectual Property, Anzu Partners LLC
Sears is an experienced patent attorney and licensing professional, educator, and chemist. John founded the law firm, Innovators Legal which specializes in working with early-stage technology companies and investors on areas of intellectual property (IP) protection and diligence. He also serves as the Director of IP at the venture capital firm Anzu Partners, where he leads the firm’s IP diligence efforts and assists portfolio companies in all areas of intellectual property strategy. John is Adjunct Faculty at Wake Forest University School of Law, where he develops and teaches courses at the intersection of IP and business.

Richard Timmer, Ph.D. - Patent Agent, Thomas Horstemeyer
Timmer specializes in the areas of chemistry, biotechnology, and medical devices. He has over 25 years of experience in the chemical and life sciences industries, which includes more than 15 years of experience with patent preparation and prosecution of patent applications with three national law firms and the management of patent portfolios within biotechnology start-ups and multinational pharmaceutical companies. Timmer has drafted well-over 100 patent applications involving medicinal and polymer chemistry inventions, and nearly as many life sciences inventions involving expression vectors, recombinant proteins, transgenic plants, medical devices, diagnostic methods, and health IT.

12:00 p.m. – Closing Remarks