Emerging therapeutic and pharmaceutical companies—whether developing innovative drugs, biologics, cell and gene therapies, digital health–integrated products, or other novel modalities—face a uniquely complex regulatory landscape. Limited resources, accelerated timelines, and evolving global expectations demand a strategic, proactive approach to regulatory planning. This panel brings together seasoned regulatory leaders, innovators, and industry strategists to explore how early‑stage companies can build the right foundations for long‑term success.
Through real‑world case studies and candid discussion, panelists will unpack the essential elements of regulatory excellence: designing smart development pathways, leveraging expedited programs, building scalable governance systems, navigating global convergence, and communicating science with clarity and credibility. Attendees will walk away with practical frameworks they can apply immediately—whether preparing for their first FDA meeting, planning pivotal studies, or scaling toward commercialization.
Registration Fees & Deadlines
Member $15 | Nonmember $25 | Student Member:$0 | Student nonmember: $15 (With Promo Code)
*Please reach out to a RAPS San Francisco Chapter Leader to request a Student Promo Code.
Learning Objectives
- Understand how to design strategic, phase appropriate regulatory pathways
Participants will learn to anticipate data needs, identify risks early, and align development plans with evolving global regulatory expectations—ensuring the selection of appropriate regulatory pathways and enabling smarter, more efficient decision‑making from preclinical through pivotal studies.
- Learn how to effectively leverage expedited programs and early agency engagement
Attendees will gain practical insight into when and how to pursue designations such as Fast Track, Breakthrough Therapy, RMAT, and PRIME, and how to prepare for high impact regulatory interactions, including first in human and pre IND/Scientific Advice meetings.
- Acquire frameworks for building scalable governance, documentation, and communication systems
Participants will explore real world models for establishing right sized regulatory operations, cross functional alignment, and science forward communication practices that support growth, due diligence readiness, and successful commercialization.
Agenda
5:00-5:30 pm Check-in/Networking
5:30-5:45 pm RAPS-SF Welcome & Introduction
5:45-6:00 pm Bakar Bio Labs Welcome
6:00-6:15 pm Sponsor presentation
6:15-7:15 pm Panel discussion
7:20-8:00 pm Tour of the facility
8:00-8:30 pm Networking & Wrap up
*Appetizers and beverages will be provided.
Panelist
Lynne Krummen, Ph.D.
Executive Vice President, Product Development, LARK Biotech Consulting, LLC
Lynne Krummen, Ph.D., LARK Biotech Consulting, LLC, is currently an independent consultant in the areas of biotechnology Product Development, CMC Regulatory and Technical Development. From 2018 through May 2024, she has served at various roles at Vir Biotechnology, including its Executive Vice President, Product Development and Senior Vice President of Regulatory since October 2023. She joined Vir in 2018. During her time at Vir, she has focused on ensuring the timely progress of our critical clinical pipeline programs, including the accelerated Emergency Authorization of sotrovimab for treating individuals at high risk of severe complications from COVID- 19.
Before joining Vir, Dr. Krummen held a variety of leadership positions of increasing responsibility at Genentech, Inc., most recently as Vice President of Technical Development from 2016-2018. Prior to that, she was Vice President and Roche Global Head of Biologics, Regulatory Chemistry, Manufacturing and Controls (CMC). Before that, she held various leadership positions at Genentech, Inc. in Product Development, CMC Regulatory, Process Development Operations and Cell Culture Development.
Dr. Krummen received her Ph.D. in Endocrinology from the University of Cincinnati College of Medicine.
Reem Mahrat
Founder and CEO, EazeBio
Reem Mahrat is a visionary serial entrepreneur and a respected leader in clinical research, biotechnology, and precision diagnostics. With a foundation in chemical engineering, she has spent over two decades launching and scaling ventures at the intersection of chemistry, biology, and artificial intelligence—propelling major advancements in next-generation diagnostics and personalized medicine.
Reem has made significant contributions to antibody development for both therapeutic and diagnostic applications, expertly guiding candidates from preclinical discovery through clinical development. Her unique blend of scientific rigor and business acumen empowers her to drive innovation and success across the biopharmaceutical landscape.
Her career is defined by transformative leadership roles. Reem has served as an advisor at Daybreak Labs and founded, led, and exited several breakthrough companies—including RamanID and Calico Bio Labs. She also co-founded Verano Bioscience and currently leads research innovation at Precision Biopharma. She is the Founder and CEO of EazeBio, a precision wellness company focused on early detection of metabolic and autoimmune stress, and reclaiming agency in women’s health. Reem also serves as Entrepreneur-in-Residence (EIR), lending her expertise to support innovation-driven biotech ventures.
A passionate advocate for precision medicine, Reem is an active member of leading research and advocacy organizations including AACR, ASCO, SITC, and HBA, and serves as a chapter leader for Together Women Rise, supporting global women’s empowerment. Reem’s mission is deeply personal. As someone living with an autoimmune condition, she openly shares her health journey to break stigma, create connection, and inspire others navigating similar challenges. “Sharing my story helps create a sense of community, educates others on the realities of living with autoimmunity, and offers comfort to those feeling isolated or misunderstood. Through this sharing, I find empowerment and connection.”
Her leadership blends scientific innovation with radical empathy, setting a new standard for biotech founders—one where personal experience fuels purpose, and data meets compassion.
Barbara Troupin
Fractional Chief Medical and Strategy Officer
Barbara Troupin is a fractional Chief Medical Officer working for several early-stage biotech, therapeutics and digital health companies. She works to guide teams on portfolio strategy, clinical development, regulatory planning and engagement, fundraising, and company growth. She also sits as an Independent Director on the Board of Equillium Bio (NASDAQ: EQ), and ProSciento, a private-equity backed CRO. Over her 20+ years as a life science executive, her roles have spanned Clinical, Medical, Regulatory, Operations and Strategy functional areas, working in both private and public companies. She holds an MD from the University of Pennsylvania and an MBA from the Wharton School of Business. She is broadly curious; an avid connector and values relationships where mutual learning and growth occur.
Kevin Tate
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.
Jenny Chaplin
Fractional Chief Medical and Strategy Officer
Jenny Chaplin is an accomplished, results-driven, and versatile drug development professional, with a strong track record of organizational excellence and translating strategy into execution. She has delivered multiple projects on target, managed challenging global alliances, and successfully taken on diverse functional leadership roles, including Program Management, HR, and Clinical Operations. Jenny’s experience spans large pharma to smaller, early-stage biotech and she is adept at wearing multiple hats and navigating dynamic environments. She is currently the Principal of Saffyre Consulting. Most recently,she was Vice President, Strategic Operations, at Bellicum Pharmaceuticals, where she built up Program Management as a function. She previously held project management roles at Pfizer and Vical, Inc. after transitioning from an early career in research.
Tuan Nguyen
Chief Financial Officer, Arbutus Biopharma Corporation
As the Chief Financial Officer, Tuan leads the financial operations and strategy of a biopharmaceutical company that develops innovative therapies for unmet medical needs. Tuan has over 20 years of experience in finance, business development, and investment consulting, with a focus on the life sciences sector.
Tuan have a proven track record of partnering finance with business objectives to drive continuous revenue, profit, and market-share growth. Tuan has a keen ability to assess complex transactions, perform financial and data modeling, and conduct valuation and economic analysis. Tuan holds a top 20 MBA with dual concentrations in Finance and Organization & Management, and is fluent in Vietnamese. Tuan is passionate about creating value for patients, shareholders, and stakeholders through strategic financial planning and execution.
Location
Bakar Bio Labs
2630 Bancroft Way
Berkeley, CA 94704
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.