Media Resources
XLerator Network Webinars
"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:
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 (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.
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.
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.
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.
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.
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
Session #2: Strategies for engaging with Faculty
Session #3: Strategies for engaging companies with researchers and entrepreneurs
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.
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.
Patent 101
Click HERE to listen to the webinar.
Pitching Your Research
Click HERE to listen to the webinar.
Everything You Need to Know About Agreements
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.
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
NIH leadership welcomes attendees to the 2021 HHS Small Business Program Conference, focusing on supporting the diverse perspectives that SEED impactful innovation. Learn about the NIH's commitment to supporting product develop and the plethora of perspectives, initiatives, product development tools, and other resources that help to move innovations into the hands of the patients, clinicians, researchers and caregivers that need them.
Speaker: Matt McMahon, Director, SEED, Oice of Extramural Research, NIH
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
This session focuses on the NIH's efforts to diversify the national scientific workforce and increase diversity and inclusion in science. Presenters will discuss the issues and concerns that under-represented populations in the small business community face; present the latest data on participation and success rates; and provide an overview of NIH initiatives, Congressional mandates, and other efforts to enhance the participation of underrepresented groups in the biomedical, clinical, behavioral, and social sciences.
Speakers: • Ericka Boone, Director, Division of Loan Repayment and Acting Director, Division of Biomedical Research Workforce, NIH • Stephanie Fertig, HHS Small Business Program Lead, NIH • Charlene Le Fauve, Senior Advisor to the Chief Officer for Scientific Workforce Diversity, NIH • Eric Padmore, Senior Policy Advisor, NIH (Moderator)
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
NIH Small Business Program experts share the nuts and bolts of the NIH Small Business Programs, which includes Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. In addition, You'll hear about important policies that potential applicants and awardees need to know about. Discover how NIH invests over 1.2 billion dollars a year into U.S. health, biomedical, and life science companies and what opportunities are available for your small business.
Over $1.2 billion is available in seed funding through HHS, including NIH, and the doors are wide open for female and minority entrepreneurs and researchers to receive funding for their innovative healthcare solutions. Which of the small business programs are you eligible for and who at the NIH can help answer your question? Find out what resources are available to help you take your research innovations from concept to commercialization.
Speakers: • Rob Vinson, Small Business Program Manager, SEED, Office of Extramural Research, NIH • Stephanie Fertig, M.B.A., HHS Small Business Program Lead, SEED, Office of Extramural Research, NIH
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
Discover how the relationship between small businesses and academia can be mutually beneficial. This session covers the hows and whys of partnering with academic institutions, including MSIs and HBCUs. Presenters address both small business and academic perspectives and experiences. This session also explores the effective use of programs, like Diversity Supplements to NIH grants, that can be used to enhance your project team.
Speakers: • Kelly Drew, Chief Executive Officer, Be Cool Pharmaceutics • Johnathan M. Holifield, Senior Vice President of New Economies, Bitwise Industries • Monique Kuykendoll Quarterman, M.B.A. Executive Director of Kentucky Commercialization Ventures • Moderator: Ashim Subedee, Ph.D. Academic Innovation Team Lead, SEED, Office of Extramural Research, NIH
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
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
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
Recommended for additional information: Mock SBIR/STTR Review Meeting and Review Basics (NIA) - https://www.youtube.com/watch?v=a9N2C...
Join NIH SBIR/STTR Program Officials for a close look at what it takes for new applicants to craft a winning Phase I SBIR/STTR proposal. This session covers HHS SBIR/STTR program basics, what reviewers look for, and how to be a strong contender for funding. Peppered with real-life examples of goals achieved and mistakes made, the panel provides tips on developing a project plan, how to approach each section of your proposal, the importance of a strong team, and positioning your project for Phase II.
Speakers: • Miguel A. Contreras, Ph.D. Health Scientist Administrator, Division of Comparative Medicine, Office of Research Infrastructure Programs, NIH • Lili M. Portilla, M.P.A. Director, Office of Strategic Alliances, National Center for Advancing Translational Sciences (NCATS), NIH Moderator: • Monique Pond, Ph.D. Program Director, National Cancer Institute, NIH
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
Your company has demonstrated the feasibility of your project and has a clear plan for the Phase II. You’re ready to write and submit your Fast-Track or Direct-to-Phase II proposal -- or are you? This informative session explores key considerations for Fast-Track or Phase II proposal preparation with specific emphasis on choosing the right program and developing a strong commercialization plan. The panelists will provide suggestions for structuring and organizing your commercialization plan, and ways to articulate the value proposition and market appetite of your technology. You’ll also hear insightful tips to jumpstart your application to achieve commercial success.
Speakers: • Christie A. Canaria, Ph.D. Program Director, NCI SBIR Development Center, NIH • Luis T. Gutierrez, Jr., M.B.A. Entrepreneur in Residence, National Heart, Lung, and Blood Institute, NIH • Todd Haim, Ph.D. Chief, Office of Small Business Research, National Institute on Aging, NIH (Moderator)
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
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
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
The NIH provides small businesses more than just money. Explore the resources that we provide to new businesses through the Technical and Business Assistance (TABA) and NIH I-Corps programs. The NIH also provides award recipients with regulatory and business development consults with NIH's Entrepreneurs in Residence. There are even opportunities for companies to engage in training the next generation of entrepreneurs through the NIH Diversity Supplement program.
Speakers: Chris Sasiela, RAC Innovator Support Team Lead & Senior Regulatory Specialist, NIH (Moderator) Kwame Ulmer, Entrepreneur in Residence, NIH Robert Vinson, Small Business Program Manager, NIH Michael Weingarten, Director, National Cancer Institute SBIR Development Center, NIH
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations
The NIH provides seed funding for companies to get their innovations to market, but many companies will need more money than the small business program can provide. The time to start thinking about who is going to support your company during the next phase of development is now! In this session, panelists share best practices for interacting with investors and partners and how to optimize those relationships. Hear directly from investors and strategic partners on how to maximize your success after your small business funds end.
Speakers: • Stephen F. Flaim, FAHA Senior Special Advisor & Investor in Residence, National Heart, Lung and Blood Institute, NIH (Moderator) • Teddy Johnson, Director of Technology Development, Institute of Translational Health Sciences/WE-REACH • Lebone Moses CEO, Chisara Ventures Inc. • Eli Velasquez, Managing Partner, Investors of Color Network
Recorded Session: 2021 HHS Small Business Program Conference: Diverse Perspectives SEEDing Impactful Innovations