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Take a look at our library of webinars or participate in our upcoming webinars. Mark your calendar now!

Navigating FDA

Navigating FDA:

Drug (and Biologic) Development Requirements

Device (and Diagnostic) Development Requirements

About the Event :

The basics of drug development are well known in many labs – but what happens when you have to shift from that general understanding to developing specific plans for your own project? What’s most important to think about? Where do you find information? When do you engage with FDA or a regulatory professional? During this talk you will learn how to find information to inform your specific development effort, and how to recognize when its time to call in the professionals.

Many types of medical devices, diagnostics, and digital health products must be reviewed by the FDA Center for Devices & Radiological Health (CDRH) before they hit the market. It can be daunting for innovators to determine which regulatory approach is applicable to their technology, and how to plan ahead for their interactions with FDA. In this webinar, an overview of the most common pre-market pathways will be provided, along with several key concepts. Attendees will gain a better understanding of where to start and where to find CDRH regulatory resources relevant for their own commercialization strategy.

Click HERE to learn more

Drug Repurposing Course: info on all sessions

Drug Repurposing Course (main page)

SESSION 1:

IP STRATEGIES: CLAIMING NEW METHODS OF USE AND NEW FORMULATIONS, AND LICENSING IP

Introduction to regulatory considerations for 505b2 application
Intellectual Property (IP) considerations for drug repurposing
Two mini case studies: new drug formulations vs new use

Presented by Gaby L. Longsworth, Ph.D., director, Sterne Kessler's Biotechnolgy & Chemical Practice Group, co-chair, Diversity Committee at Sterne Kessler, and LMG Life Sciences "Life Sciences Star", 2016-present.

RECORDING

SESSION 2:

COMMERCIALIZING ACADEMIC REPURPOSING DISCOVERIES: THE TECH TRANSFER AND COMPANY PERSPECTIVES

Working with the inventor/PI
Patenting and other exclusivity issues
Collaboration and negotiations
Due diligence issues
Contracting, goals and reporting
Relationship Management
Confidentiality and other disclosures issues

Presented by Raja Krishnan, commercialization manager, University of Kentucky Office of Technology Commercialization, and Bruce Bloom, chief innovation officer, Healx. Raja Krishnan will provide an introduction and conclusion.

RECORDING

SESSION 3:

FDA: 505B2 APPLICATIONS AND POSITIONING STRATEGY

DATE: Thursday, February 25, 2021

TIME: 11:00 a.m. - 12:00 p.m. ET

Regulatory considerations for drug repurposing
Mini-case studies

Presented by Ken Phelps, president and founder, Camargo.

RECORDING

SESSION 4:

FUNDING OPPORTUNITIES: A NON-PROFIT FOUNDATION

DATE: Thursday, March 11, 2021

TIME: 11:00 a.m. - 12:30 p.m. ET

Drugs that have been repurposed successfully and gotten FDA approval
Clinical trials of repurposed drugs
Case study of success story through non-profit foundation funding program

Presented by Barbara Goodman, president and CEO of Cures Within Reach, and/or Clare Thibodeaux, Ph.D., director of Scientific Affairs, Cures Within Reach, and TBD.

RECORDING

SESSION 5:

INDUSTRY EXPERT PANEL

DATE: Thursday, April 29, 2021

TIME: 11:00 a.m. - 12:30 p.m. ET

Moderator-led discussion with industry and regulatory experts on drug repurposing
Opportunity for audience to ask the experts questions

Panelists: Kristen Gullo, vice president of Development and Regulatory Affairs, US World Meds, Bruce Bloom, chief innovation officer, Healx, Douglas Balogh, director of Life Sciences, Guidehouse and TBD.

Moderator: Raja Krishnan, commercialization manager, University of Kentucky Office of Technology Commercialization.

Regulatory Pathways for Phase I SBIR Companies

Regulatory Pathways for Phase I SBIR Companies.

Click HERE to Lean More

Click HERE to listen to the webinar recording.

Click HERE for the webinar slides.

Tech Transfer 101 Series

Tech Transfer 101 is a 3-part webinar series for university administrators with a small or unestablished Technology Transfer Office (TTO) in the Southeast IDeA-Region (AR, KY, LA, MS, PR, SC, WV). The series addresses best practices for accelerating tech transfer and commercialization without a fully resourced office.

Focus:

Session #1: Bare minimum services and recommended initiatives for building a successful Tech Transfer Program

Slides_Session 1

Session #2: Strategies for engaging with Faculty

Slides_Session 2

Session #3: Strategies for engaging companies with researchers and entrepreneurs

Slides_Session 3

EnRICH Q&A Sessions

EnRICH is a human health-focused innovation harvesting and commercialization “pre-accelerator” program for faculty and student innovators at Historically Black Colleges and Universities (HBCUs). We conducted two Q7A sessions to answer your questions. You can find the recordings of these sessions here.

Session 1

Session 2

Idea to Impact: The Translation and Commercialization of
Academic Research

Join Fast Forward Medical Innovation for a series of live, á la carte WEBINARS intended to educate and connect life science researchers and academic innovators interested in the commercialization of academic research. The series will outline the significance and critical milestones of developing novel therapeutics, medical devices, diagnostics, and digital health innovations, as well as essential collaborations with industry partners to translate a research-based idea into a product of impact.