Media Resources

XLerator Network Webinars

Omnibus vs. Targeted Solicitations

XLerateHealth partnered with the National Institutes of Health and hosted a webinar regarding the differences between applying through investigator-initiated "omnibus" notices of funding opportunity (where an applicant proposes a research topic of their choosing) and “targeted” SBIR/STTR offerings (where some NIH institutes or centers seek solutions to specific ailments or topics, e.g., Alzheimer's). 

The panel included NIH representatives from the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute, the National Institute on Aging (NIA), and the National Institute of Neurological Disorders and Stroke (NINDS)

Click here to view the webinar.

Funding Biomedical Innovations for Non Academic Innovators

XLerateHealth partnered with the National Institutes of Health and hosted a 2-hour webinar regarding how non-academic biomedical entrepreneurs can jump-start their business and develop their technology through NIH SBIR/STTR grant funding.  

The NIH shared how they support Biomedical Innovators through their entrepreneurial-focused programs and resources.  Program officers from 13 NIH Institutes discussed the funding opportunities (and nuances) relative to their particular institution.  Additionally, attendees learned about other non-dilutive funding opportunities and commercialization resources for NIH applicants and awardees.

Both academic and non-academic innovators joined the session, which was followed by a productive Q&A between the presenters and participants.

Click here to view the webinar.

XLerat-ing IDeAS - SBIR/STTR Conference

"XLerat-ing IDeAS" XLerator Network partnered with NIH, West Virginia University, Marshall University, and TechConnectWV to host a 2-day SBIR/STTR Conference to cover questions, tips, and advice on applying for NIH and NSF Funding. 

Click here to view the program and recordings.

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.

REGISTER 

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

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.  

UK OTC Series

Patent 101

Click HERE  to listen to  the webinar.

Pitching Your Research

Click  HERE to listen to the webinar.

How Does OTC Market Technology? 

Click HERE to listen to the webinar.

Pitching Your Research 

Click HERE to listen to the webinar.

KYNETIC Series

Translational Training for Life Science Innovators

The Translational Training Series for Life Science Innovators was developed to help train innovators regarding the unique commercialization aspects in the healthcare industry. For the first time, these videos are being delivered virtually!

There is a  library of videos to help you as you consider strategies to translate technologies out of your lab and into the marketplace.

NIH Webinars

Demyth-defying Review Submission to Score

What happens after submission? Join us as we highlight the journey of your application from submission through peer review, with key steps and important factors to note along the way. Learn how the Center for Scientific Review manages bias and conflict of interest in the review process and get your important review questions answered. This session also discusses the importance of diversity in the composition of review panels and shares details on how you can become a reviewer of SBIR or STTR applications. Speakers: • Stephanie Fertig, M.B.A. HHS Small Business Program Lead, SEED, Office of Extramural Research, NIH (Moderator) • Elia Kwee Ortenberg, Ph.D. Scientific Review Officer, Center for Scientific Review, NIH • David E. Pollio, M.S.W., Ph.D. Scientific Review Officer, Risk, Prevention and Health Behavior Integrated Review Group, NIH • Vonda Smith, Ph.D. Assistant Director, Division of Receipt and Referral at the Center for Scientific Review, NIH.

Recommended for additional information: Mock SBIR/STTR Review Meeting and Review Basics (NIA) - https://www.youtube.com/watch?v=a9N2C...

Persistence is Key: Resources for Resubmission

Unfortunately, not every application receives a great review score and persistence is the key to obtaining funding. Thankfully, the NIH allows you to address reviewer concerns and resubmit your revised application for further consideration. The panelists will walk through how to interpret reviewer comments and when to engage program staff in the post-review process. Even experienced applicants have to resubmit - learn how to use all the available tools to your advantage! Sample summary statements mentioned in session can be found at: https://www.nia.nih.gov/sites/default... https://www.nia.nih.gov/sites/default...

Speakers: • Stephanie Fertig, HHS Small Business Program Lead, NIH • Eric W. Padmore, Senior Policy Advisor, NIH (Moderator) • Nishadi Rajapakse, Program Director, National Institute on Minority Health and Health Disparities, NIH • Allen B. Richon, Scientific Review Office, NIH.