What does AI actually look like in practice when it meets the complexity of medical product development? Who is holding the wheel and where is it all headed? In this rapid-fire session, 7 speakers bring 7 real-world stories in 60 minutes - honest, on-the-ground experiences straight from the people living it. Where does AI deliver? What are its limits? And how are teams navigating the intersection of automation and regulatory expectation? These are questions shaping the industry right now. Attendees will leave with a sharper picture of where AI in regulatory is heading, and concrete examples of tools making a real difference. Join and boost your confidence in the AI arena!
What does AI actually look like in practice when it meets the complexity of medical product development? Who is holding the wheel and where is it all headed? In this rapid-fire session, 7 speakers bring 7 real-world stories in 60 minutes — honest, on-the-ground experiences straight from the people living it. Where does AI deliver? What are its limits? And how are teams navigating the intersection of automation and regulatory expectation? These are questions shaping the industry right now. Attendees will leave with a sharper picture of where AI in regulatory is heading, and concrete examples of tools making a real difference. Join and boost your confidence in the AI arena!
By attending this event, participants will be able to:
MBC BioLabs
1030 Brittan Ave
San Carlos, CA 94070
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].









CEO and Co-Founder, Weave
Brandon is CEO and Co-Founder of Weave Bio, where he leads the company’s vision and growth, helping biotech and pharma teams streamline regulatory work with AI-powered technology. With more than a decade of experience spanning bioinformatics, product strategy, software development, and life sciences, Brandon has built and led teams that bring innovative technologies from concept to commercialization. He holds a Master’s degree in Bioinformatics from the University of California, Santa Cruz, and a Bachelor of Science in Biology from the University of New Mexico.
VP, Regulatory Affairs & Quality, iHealth Labs
Yang Wang brings over 15 years of experience in medical device regulatory affairs, quality systems, and global market access, with expertise spanning in vitro diagnostics (IVD), digital health, connected medical devices, and quality management systems. She currently serves as Vice President of Regulatory Affairs and Quality Assurance at iHealth Labs, where she leads regulatory strategy, quality systems, compliance, and post-market activities across global markets.
Yang has extensive experience navigating complex regulatory pathways for medical devices across the U.S., China, and international markets, including FDA submissions, global registrations, quality system implementation, and regulatory strategy for innovative technologies. Her expertise includes FDA regulatory compliance, QMSR/ISO 13485 alignment, MDSAP, risk management, post-market surveillance, complaint handling, and regulatory intelligence.
Prior to joining iHealth Labs, Yang held leadership roles across regulatory affairs, quality assurance, and laboratory operations, including oversight of accredited testing laboratories and cross-functional product compliance programs. She also began her regulatory career through experience supporting medical device evaluations in China’s regulatory review system. More recently, Yang has focused on the evolving intersection of artificial intelligence and medical device regulation, including AI-enabled medical devices, regulatory frameworks for digital health, and the practical implementation of AI within regulated quality systems. She has a particular interest in the rapidly evolving AI regulatory landscape in China and its implications for global medical device innovation, compliance, and market access.

Founder and CEO, Lexim AI
Mr. Pat Bhatt is the Founder and CEO of Lexim AI, a Silicon Valley-based regulatory automation company. Lexim was founded on the principles of helping Life Sciences companies quickly find standards, data, and information while automating rote tasks that accelerate time to market and increase productivity. Lexim offers a full suite of products from regulatory intelligence, data insights, design and quality control, risk analysis, verification and validation, labeling, submissions, and post-market analysis—all in one platform.
Pat holds three master's degrees: one in business, one in computer science, and one in mechanical engineering with a specialization in robotics and AI. Pat has brought dozens of new products to market, published several articles and papers, and holds 15 patents
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patbhatt

Director of Scientific Operations, MBC Biolabs
Rachel Hatano is a scientist and operations leader dedicated to fostering innovation in biotech. With a Ph.D. in Bioengineering from UC Merced, she has experience in cardiovascular tissue engineering and bioassay development. Before joining MBC BioLabs as Director of Scientific Operations, Rachel was the first scientist then Chief of Staff at Deciduous Therapeutics, where she played a key role in building research strategy, culture, and operations. Passionate about enabling a diverse range of biotech startups, entrepreneurs, and scientists, she is excited to contribute to MBC BioLabs’ mission of accelerating groundbreaking discoveries.
COO, Athagoras
Andrea Biasiucci is COO of Athagoras, a tech-enabled service provision life science platform, where he oversees business units spanning Regulatory Affairs, Market Access, and Real World Evidence. He also serves as CEO of Confinis, a Swiss medtech regulatory consulting firm.
A biomedical and electronic engineer by training, Andrea earned his PhD at EPFL Lausanne in brain-machine interfaces. During his doctorate he co-founded Intento, a neurostimulation system for post-stroke rehabilitation, which he later sold to MindMaze in 2018. He joined Confinis in 2017, rising from consultant to CEO by 2023 and leading its sale to Athagoras in 2025, which brought him into his current platform role.
Italian by origin and based in Switzerland since 2009, Andrea brings an entrepreneurial sensibility to private equity-backed healthcare services.

B2B SaaS Revenue Leader, Startup & Scale-Up, Founder & Investor, Kivo
Kevin is a seasoned Go‑to‑Market executive with 25 years of Marketing and Sales leadership experience, known for building and scaling high‑performing teams across emerging technology sectors. His marketing background spans Product, Corporate, and Demand Generation Marketing, leading global initiatives across industries and geographies.
He has spent much of his career supporting growth‑stage companies in dynamic markets including eCommerce, Enterprise SaaS, Social Media/Web 2.0, IoT, and Martech. Kevin also brings significant M&A experience, serving as a key contributor to diligence, acquisition, and post‑integration efforts across three successful transactions.
A frequent event speaker, podcast guest, and article contributor, Kevin remains an avid technologist at heart—beginning his career as a UNIX and database programmer in 1996 and carrying that technical curiosity into every leadership role since.

Chief of Staff, Artos
Mihikaa Jain leads Product Strategy and Customer Success at Artos, a Y Combinator–backed AI company focused on regulatory document authoring for life sciences. She brings a rare blend of product leadership, regulatory domain knowledge, and commercial strategy to the intersection of AI and healthcare.
At Artos, Mihikaa plays a pivotal role in bridging the gap between technical and non-technical teams. She works closely with regulatory affairs professionals to understand real-world user needs and translates those into actionable product requirements—shaping the company’s roadmap and ensuring engineering efforts are aligned with business priorities.
Mihikaa began her career at Bain & Company, where she advised Fortune 500 companies and SaaS startups on product roadmap design, pricing and packaging, and M&A integration. She later joined Mekonos, a cell and gene therapy platform company, where she closed its first commercial deal and built partnerships with leading biopharma organizations.
Mihikaa holds a Master’s in Translational Medicine from UC Berkeley and UCSF and a Bachelor’s in Biological Sciences and Bioengineering from IIT Kanpur. She is an active member of the RAPS SF community, where she has helped organize local events and contributed to ongoing discussions on AI adoption in regulatory workflows.

CEO & Co-founder, NyquistAI
Michelle Wu is the founder and CEO of NyquistAI. She has over a decade of experience in pharmaceuticals, medical technology, and digital innovation. She has been recognized as the Top 100 Women in AI in 2025, featured by Forbes, and given talks on AI in life science in various conferences. She is a book chapter author for AI in Healthcare by MIT Press.
Before founding NyquistAI, she was the youngest global strategy manager at Novartis AG, where she worked on the very first and so far the only asset swap deal in the history of the pharmaceutical industry among Novartis, Eli Lilly, and GSK, which led her to realize the universal pain point of manual and cumbersome data research and potential pitfalls if it is not done right. This experience inspired her to build NyquistAI. Prior to Novartis, she worked for the life science practice for BCG and served big innovative pharmaceutical and Medtech companies on their global strategy, product development strategy, and emerging market strategies. She received her MBA from Stanford University and BA from Peking University.