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Webinar
AI and Life Sciences: Legal, Compliance, and Operational Strategies in the Era of FDA Agentic AI Review
This webinar will provide a timely overview of the U.S. Department of Health and Human Services’ (HHS) AI strategy and examine how the FDA is implementing advanced AI tools in regulatory review. Attendees will gain practical insights into evolving legal and compliance requirements, operational best practices, and the implications of AI for sponsors and stakeholders in the life sciences sector.
Key Topics:
- HHS’s AI vision, strategic pillars, and compliance mandates
- FDA’s use of generative and agentic AI in regulatory processes
- Legal safeguards for confidentiality and transparency
- Operational readiness and best practices for AI-enabled review
- Recommendations for engaging with HHS and FDA on AI policy
Who Should Attend?
Regulatory affairs and compliance leaders; general counsel and in-house legal teams; healthcare and life sciences professionals overseeing regulatory, privacy, or policy matters; clinical research and R&D leaders involved in FDA submissions; health system compliance and IT leads; digital health, medtech, and health IT professionals; data privacy officers and data science teams supporting regulated products; AI/ML developers and vendors working in regulated industries or with FDA/HHS; and law firms, consultants, and government affairs professionals focusing on healthcare regulation.
Agenda
Prizes
- $10K in office/lab space
- $5,000 Legal Services
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- $5,000 Tax Services
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- Free Investor Readiness Bootcamp - Top 2 Winners
- $4,500 for each scholarship to the Big Tree Investor Readiness bootcamp
- $2,500 USD in-kind services
- Facilitation of a CMC strategy workshop & Up to 80 additional hours of complimentary consulting support through the end of 2026
- Admission to the Femovate portfolio plus $15k in award-winning digital product design.
- Winner will receive a slot in TechCon's Semi-finals 1 of 32) for a chance to present at TechCon in May (1 of 8) with a Grand Proze of $1M Cash funding plus substantial service credits.
- Free sign up for Pitch to Profit, All presenters can be nominated to bypass step one of the 2026 HealthTech Impact Award - HealthTechImpactAward.com
- $20k in office/lab space
- Digital Marketing and Branding Services (worth $5,000)
- $10K in office/lab space
- $10K in office/lab space
- $25k custom UX design package from the largest femtech incubator in the US
- Admission to Maroon Research Institute's Global Longevity Scientific Venture Studio for 6 months and eligible investment of $125k per venture
- $10,000+ in Strategic Go-to-Market Research
- Exploratory biostatistics package: 3 reports
- $10,000+ in Strategic Go-to-Market Engineering
- $4,500 for each scholarship to the Big Tree Investor Readiness bootcamp
- Membership to Mayo Clinic Innovation Exchange
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- Winner will receive a slot in TechCon's Quarter-finals for a chance to present at TechCon in May with a Grand Proze of $1M Cash funding plus substantial service credits.
- Regulatory kit and Regulatory strategy consulting (Medical Device only)
- $5,000 of tax services
- $5,000 Legal fees
- Two months campaign on startup program
- 3-day ticket to the upcoming 2025 RESI Conference
- Contingent Permanent Placement ($5,000 off); Retained Search services ($5,000 off)
- $5,000 of tax services
Learn from Subject Matter Experts
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Kimberly Chew
Senior Counsel and Co-Leader, Psychedelics and Emerging Therapies Practice, Husch Blackwell LLP
Kimberly Chew is senior counsel in Husch Blackwell LLP’s virtual office, The Link. Chew is a seasoned professional with a rich background in biotech research, leveraging her extensive experience to guide clients through the intricate landscape of clinical trials, FDA regulations, and academic research compliance. As the co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is particularly inspired by the potential of psychedelic therapeutics to address mental health conditions like PTSD. Her practice encompasses regulatory due diligence and intellectual property enforcement, particularly in patent infringement and validity.
Odette Hauke
Principal Consultant, Odette Alina LLC
With over 12 years of experience spanning global regulatory affairs, drug development, and clinical research, Odette brings a wealth of expertise—particularly in advancing innovative therapies for rare and underserved diseases. Her career has been shaped by a deep commitment to ensuring that novel treatments are both effective and safe, especially for vulnerable populations including children.
MC/MODERATOR
STARTUP SHOWCASE
JUDGES
Judges
Sponsors
Startup Market
Catalyst Capital Symposia
Activating Startups
This monthly forum provides a unique opportunity for participants to gain valuable insights into emerging sectors and disruptive technologies that have the potential to revolutionize human health, the environment, and society.
Through engaging discussions, informative panels, and interactive workshops, aspiring and seasoned entrepreneurs and investors can learn about essential concepts, strategies, and best practices directly from industry experts.
By engaging the venture and startup ecosystem, the symposia encourages investors to be activists and empower startups with cutting-edge technology.
INVESTOR-ACTIVIST
Investing in Startups
Join the ranks of investor-activists who not only provide financial backing but also lend their expertise, networks, and influence to nurture startups, catalyzing a collective effort towards a brighter, more innovative future.
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RESOURCES
Startups: Apply to Pitch
Pitch your startup to an audience of industry experts, colleagues, and seasoned investors to gain valuable insights and feedback, forge strategic partnerships and connections, secure vital funding for your pioneering project, and elevate your startup to the next level!
Apply to pitch at one of the upcoming symposiums.
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Connecting with Potential Customers
Sponsorship at Catalyst Capital Symposia provides a range of advantages, such as heightened brand visibility, lead generation, networking opportunities, thought leadership, and early access to emerging technologies.
To explore the ways in which your company can benefit from sponsoring our event, reach out to us for more information.
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