Investigator Training Resources
Webinars
Combo Drug & Device Strategies: Pathways to Market
Join us for Combo Drug & Device Strategies: Pathways to Market , a dynamic innovation event bringing together leaders from across the healthcare and life sciences ecosystem to explore the unique challenges and opportunities in developing and commercializing combination drug-device products.
The event will feature a panel discussion with strategic industry experts and regulatory leaders who will share insights into the evolving pathways to market for combination products, including regulatory strategy, clinical validation, reimbursement considerations, and partnering opportunities.
Preparing for Regulatory Filings: Specific Information Needed for the Chemistry, Manufacturing, and Controls (CMC) Section and CMC Q&A
Join our webinar, Preparing for Regulatory Filings: Specific Information Needed for the Chemistry, Manufacturing, and Controls (CMC) Section, where Dr. Carmella Moody will guide you through the essential data and documentation required for successful regulatory submissions. This session will cover key CMC elements, including drug substance and product characterization, manufacturing processes, analytical methods, and stability data. Don’t miss this opportunity to streamline your filing process and enhance your submission strategy.
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Dental implants replace missing teeth in at least 100 million people, yet over one million implants fail every year due to peri-implantitis, a bacterially induced inflammatory disease. Our ability to treat peri-implantitis is hampered by a lack of information on host-microbiome interactions that underlie the disease. Molecular biology and machine modeling have shown that microbial dysbiosis in the peri-implant sulcus disrupts key host-bacterial interactions, leading to chronic non-healing wound programming. This webinar is free of charge and gives you 1.5 hour of CPD or 1.5 ADA CERP Credits!
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| Human Factors Engineering in Medical Device Design |
Tuesday, January 21, 2025
10:00 AM PST | 01:00 PM EST
This 90-minute webinar will delve into the fundamental aspects of HFE, emphasizing its pivotal role in enhancing safety, efficiency, and overall user experience within the medical device landscape.
CEO Perspectives on Launching & Growing Biotech Start-Ups Webinar
NCI SBIR Program Director William Bozza and Director of Investor Relations Brittany Connors will interview Lu Alleruzzo, the CEO, co-founder, and board member of Immunophotonics, a biotech company in its clinical stage.
Attend this Peer Learning and Networking (PLAN) webinar on Tuesday, November 19, 2024, at 2:00 p.m. ET as Mr. Alleruzzo will share lessons learned and experiences launching the company early in his career, maintaining a runway, setting milestones, attracting investor support, and establishing his company’s strategic vision.
For more information, contact NCI SBIR program director William Bozza (william.bozza@nih.gov).
Register Here.
NIH’s Seed Fund: Submitting Successfully to the Small Business Program Webinar
America’s Seed Fund, also known as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program, offers small business entrepreneurs in the life sciences more than $1.4 billion in non-dilutive funding to support small business research and development.
Attend this webinar on Wednesday, November 13, at 1:00 p.m. ET to learn about open funding opportunities, common application errors, and how to avoid them.
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Decoding raw material quality and regulatory standards in cell and gene therapy |
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Wednesday, October 30, 2024 |
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Join us on Wednesday 30 October 2024 to hear from hear from regulatory affairs specialists Claire Wartel and Julie Hibbert in this webinar, ‘Decoding raw material quality and regulatory standards in cell and gene therapy‘. Explore common misconceptions when selecting critical raw materials, understand the regulatory landscape and how its ongoing changes affect your process and learn the key requirements for raw materials that will ensure a therapy’s success. |
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FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
This activity is intended to provide an overview on resources and programs that FDA has developed across CBER, CDER, and CDRH that can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. The webinar aims to educate early-stage companies (small businesses) new to the regulatory landscape at the FDA.
Attend this webinar on Wednesday, September 4, 2024, 11:00 a.m. ET to learn how entrepreneurs new to the FDA regulatory world that could benefit from support in better understanding when to contact the Agency during preclinical development. There will be a Q&A session at the end of each session.
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WEBINAR: GMP manufacturing of quality ancillary reagents for cell and gene therapy |
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Tuesday 27 August 2024 |
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Tune in on Tuesday 27 August 2024 to hear from speakers, Robert Schmidt and Jessie Ni (both BioLegend; CA, USA), as they discuss a risk-based strategy for managing ancillary materials in the manufacturing of cell and gene therapy products. Gain a deeper understanding of the available guidelines for ancillary materials suppliers and identify the critical qualities of cytokines, growth factors, antibodies and culture media for cell and gene therapies. GMP manufacturing of ancillary reagents |
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Artificial intelligence is permeating dentistry, as it has the rest of medicine, to improve dental care and patient outcomes. Advances in genomics, the microbiome and precision medicine are impacting all facets of healthcare, including dentistry. In this webinar William Giannobile will highlight advances in the better diagnosing and customizing therapies through patient stratification to improve outcomes. As artificial intelligence becomes more integrated into healthcare, periodontology and implant dentistry can leverage these technologies to advance oral health. You are invited to the next webinar of the National Osteology Group Italia, which will be held in English with Italian translation. The webinar will be on 20 June 2024 at 13:00 CEST. |
If you’re a research scientist interested in gaining entrepreneurial and leadership experience, check out the recently released Small Business Transition Grant for New Entrepreneurs. This funding opportunity aims to support career development and R&D under a new entrepreneur’s direction.
Attend this informational webinar on Tuesday, June 11, at 3:00 p.m. ET to learn more about this funding opportunity and how to apply.
The art of the exit: How to build patient-centric companies & deliver superior returns consistently from the Think Oral Health Podcast
Webinars from CareQuest Institute for Oral Health
Regional NSF i-Corps – Great Lakes Region
Summer 2022 University of Michigan I-Corps | July 11 @ 9:00 am – August 22 @ 11:00 am EDT
Fall 2022 Medical Jumpstart I-Corps Course | September 23 @ 9:00 am – November 18 @ 11:00 am EDT
Fall 2022 STEM Jumpstart I-Corps Course | September 23 @ 12:00 pm – November 18 @ 2:00 pm EDT
Bench to BARDA Panels
Panel 1: Spin Your Technology out of the Lab
Panel 2: Build Your Technology into a Product
Panel 3: Supporting startup growth via acceleration programs
Panel 4: How can early-state companies work with BARDA?
Panel 5: Partnering with BARDA via the Broad Agency Announcement
Panel 6: Scale your Company via Strategic Partnerships & Venture Financing
Virtual SBIR/STTR Intensive Workshop – June 15 -16, 2021
Workshop is produced by the Center for Biotechnology at Stony Brook University in partnership with Columbia Technology Ventures. Register here: https://www.eventbrite.com/e/sbirsttr-proposal-prep-workshop-june-2021-tickets-152360433157
Diversity in STEM Panel: Hosted by the Innovation Hub and Women Accelerators on March 10, 2021
Virtual Osteology Symposium USA
April 24-25, 2020
FDA Webinar – Dental Devices Premarket Submissions – October 2, 2019
Practicum Sessions from the 2019 Semi-Annual Meeting
Clinical Trial Essentials for Dental, Oral and Craniofacial Regenerative Technologies
Preclinical Development to Enable Clinical Studies: What Does FDA Require?
Practicum Sessions from the 2018 Annual Stakeholders Summit
Market Trends: Pucks, Skaters and Time
Commercialization of Life Science Technologies: A 3-Part Webinar Series
Part 1: Milestones & Timelines for Therapeutic Development
Part 2: Milestones & Timelines for Medical Device & Diagnostics
Part 3: Milestones & Timelines for Digital Health Technologies
Intellectual Property
Regulatory
MedTechCrossroads – Live Call-in Webinar: Fridays 2pm- 3pm Eastern. Each week we discuss the latest from FDA and connect as a community moving med tech development projects forward.
Idea to IDE: A Medical Device in the Making
Dental Devices Premarket Submissions
Commercialization
Startup Fundraising 101 (from University of Michigan’s Celebrate Invention 2020)
Communicating the Value of Your Innovation
Unique Considerations and the Clinical Utility of Medical Devices and Diagnostic Technologies
Key Considerations for the Pre-clinical Development of Therapeutic Innovations
FDA Regulation of Medical Devices and Software/Apps
Validating Your Value Proposition
Reimbursement: Hospital Adoption and Insurance Claims
Reimbursement: Health Plan Coverage
Commercialization Milestones – Devices & Diagnostics
Commercialization Milestones – Therapeutics
Pitch: Introduction, Market Potential, Stage, Next Steps, Keep in Mind
Life Science Venture Trends for 2017
Fast Forward Medical Innovation – Commercialization Education