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Healthcare Innovation Catalysts
生物技术研究
Rockville，Maryland 852 位关注者
Catalyzing healthcare venture innovation by strategically engaging with the government.
关于我们
Regulatory, quality, and market access experts. Boutique service. 25+ interdisciplinary experts & specialists from the FDA, military health, academia, and industry with centuries of experience supporting client needs across the medical product lifecycle.
- 网站
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https://hicatalysts.com/
Healthcare Innovation Catalysts的外部链接
- 所属行业
- 生物技术研究
- 规模
- 11-50 人
- 总部
- Rockville，Maryland
- 类型
- 私人持股
地点
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主要
获取路线
US，Maryland，Rockville
Healthcare Innovation Catalysts员工
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Linda Young
Chair of the Partnership at Catalysts for Innovation, LLC
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JoAnn Pfeiffer, DrSC
Healthcare Innovation Catalysts
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Heather Howell
Vice President | Operations | Regulatory Training | MedTech | Pharma Biotech | Patient Safety | Market Access | Crisis Managment
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Dr. Mathew T. Thomas
MTT Consulting LLC. Former FDA India Office Country Director, FDA Senior Advisor and GCP Expert
动态
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This is a fantastic opportunity for clinical investigators, health care professionals, and others involved in clinical research! FDA CDER Small Business and Industry Assistance (SBIA)
??Now OPEN!! SBIA’s Annual FDA Clinical Investigator Training Course (CITC) - December 10 -12, 2024. Register early!! ??https://lnkd.in/eX7b83PY
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Healthcare Innovation Catalysts转发了
Coming on Wednesday! I hope you'll join us for this interactive session exploring when to interact, how to prepare, and how to optimize your FDA engagement for long-term success! Please join me and my esteemed former FDA colleagues,?Phil Desjardins?and?Steve Silverman, as we share insights gained during our time with the agency.? ? WHAT:?Know Your Regulator- How to Effectively Engage FDA WHEN: Wednesday, October 23, 2024, 2:00-3:00PM ET WHO:?Former FDA Panelists ??Deb Autor | CEO of Healthcare?Innovation Catalysts ??Philip R. Desjardins | Partner at Arnold & Porter ??Steve Silverman | President at The Silverman Group
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A beautiful day on the FDA White Oak Campus!
What a great day tailgating at FDA representing the FDA Alumni Association. The message is out -- we always welcome current FDA employees as members! Thanks to Robert Califf, Michael Rogers, MS, Vijay Walia, and Steve Silverman for the picture!
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Knowing how to effectively engage with your regulator is critical to long term success when operating in a regulated industry. On Wednesday, October 23, HIC CEO Deb Autor and her former FDA colleagues Philip Desjardins and Steve Silverman will discuss how they manage this delicate process with their clients. We hope you can join this interesting discussion! Register here ?? https://bit.ly/4eASEwX
Join us Wednesday, October 23, for an interactive webinar featuring former FDA leaders Philip Desjardins, Steve Silverman, and Deb Autor. This roundtable discussion—moderated by Bobby McMillin—will provide insights on effective FDA engagement, such as when it is appropriate to engage, finding the right engagement point, and the benefits of effective engagement. These insights will help participants move from unpredictable (and sometimes difficult) FDA exchanges to productive, long-term interaction. A live Q&A session will follow the panel. Register here ?? https://bit.ly/4eASEwX #FDA #Regulatory
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FDA's new clinical trial guidances help pave the way to decentralized trials, adaptive designs, use of real world evidence, and other clinical trial innovations. HIC is here to help!
Excellent panel conversation right now at Wilson Sonsini Goodrich & Rosati’s inaugural #Biotech Summit. Thank you Deb Autor for your insightful comments on the value of resilient, #decentralizedclinicaltrials, and noting the recent, supportive guidance from the FDA.
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?? Healthcare Innovation Catalysts in action at the Wilson Sonsini Biotech Summit! ?? Today, Healthcare Innovation Catalysts CEO, Deb Autor, shared insights as part of a distinguished panel at Wilson Sonsini's Biotech Summit in Boston. The panel discussion brought together some of the most influential voices in biotech to discuss the future of the industry covering innovative funding strategies, collaborative partnerships, and AI's transformative role in healthcare. Proud to be at the forefront of biotech innovation! ?? #biotechsummit #wilsonsonsini #innovation #FDA #healthcare #artificialintelligence
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Healthcare Innovation Catalysts转发了
Join us Wednesday, October 23, for an interactive webinar featuring former FDA leaders Philip Desjardins, Steve Silverman, and Deb Autor. This roundtable discussion—moderated by Bobby McMillin—will provide insights on effective FDA engagement, such as when it is appropriate to engage, finding the right engagement point, and the benefits of effective engagement. These insights will help participants move from unpredictable (and sometimes difficult) FDA exchanges to productive, long-term interaction. A live Q&A session will follow the panel. Register here ?? https://bit.ly/4eASEwX #FDA #Regulatory
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Healthcare Innovation Catalysts转发了
?? Check out Healthcare Innovation Catalysts' insights on the newly issued FDA guidance- Electronic Systems, Electronic Records, and Electronic Signatures. #innovation #fda #21CFRPart11 #clinicaltrials #digitalhealth #esignature
This week FDA issued final guidance on the use of?electronic systems in clinical investigations. The easy-to-read Q&A answers critical questions about system validation, the applicability of Part 11 to real-world data sources and OUS investigations, the use of digital health technologies to collect clinical data, and more. ? Are you notifying sponsors of changes in clinical trial personnel so they can quickly revoke system access? ? Did you know FDA may inspect IT providers who assume responsibility for clinical trial data management? ? Do you have an alternative data entry method in case the electronic system can't be accessed? ? Did you know FDA does not consider a signature drawn with a finger or stylus to be an electronic signature? These questions and more are answered in this helpful guidance. Check it out!
Electronic Systems, Electronic Records, and Electronic Signatures
fda.gov
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? The countdown is on for Wilson Sonsini’s Inaugural Biotech Summit in Boston, October 9-10! ? HIC's CEO and Principal Regulatory Advisor, Deb Autor, will share insights on FDA hot topics and regulatory trends alongside fellow industry leaders. Why attend? ?? Connect with influential and knowledgeable leaders at the intersection of biotech, venture capital, and policy. ? Learn about regulatory trends, antitrust issues, and strategic collaborations that drive innovation in medical therapies. ?? Engage in topics that will highlight ways to leverage AI in healthcare. You don't want to miss this event! #BiotechSummit #FDA #Biotech #Boston #WilsonSonsini #Innovation #MedTech #PharmaBiotech #Regulatory
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