Navigating FDA Strategy: What Every Biotech Startup Needs To Know

Bio-By-The-Lagoon Biotech Event

Navigating FDA Strategy – What Every Biotech Startup Needs to Know

Date: Sunday, February 22, 2026

Time: 11:30 AM – 2:30 PM

Join us for a practical, startup-focused session on how to navigate FDA strategy across Therapeutics, Diagnostics/Medical devices. This event is designed for a broad audience, from individual contributors to founders and C-suite leaders, who want a clearer roadmap for building regulatory strategy that enables speed, reduces risk, and supports long-term success.

Meet Our Expert Speakers 🎤:

• Michelle Roeding (Diagnostics/Medical Devices)

• Meredith Brown-Tuttle, RAC, FRAPS (Pharma)

• Plamena Entcheva-Dimitrov, PhD, RAC (Pharma)

What You'll Learn:

Our speakers will present on three critical topics, followed by a panel discussion:

• 🔬 AI-enabled products & tools: navigating datasets, bias, and FDA approvals

• 💡 FDA interaction strategy: Pre-Sub & early meetings - what to ask and how to de-risk

• 🗺️ Regulatory pathways 101: choosing the right route early (Dx / Device / Therapeutics)

Have questions about navigating regulations? Submit them during registration and our panel will address them live! Alternatively, questions can be emailed to biobythelagoon@gmail.com.
 

REGISTER HERE

Location

Audubon Elementary School
Multi-Purpose Room
841 Gull Ave.
Foster City, CA 94404

Parking: Parking is available directly outside the MPR and along Gull Ave. Parking is limited, so please arrive with plenty of time.

Event Day Schedule

• 11:30 AM — Lunch & Mingle
• 12:00 PM — Welcome
• 12:05 PM — Short presentations
• 12:45 PM — Q&A 
• 1:15 PM – 2:30 PM — Networking

Participants

Review the list of attendees who registered (LinkedIn profile summary & job search/opportunities).
Note: Check your profile/info and request any updates by leaving a comment in the document @biobythelagoon@gmail.com (or you can send an email).

Reading Materials

Here are materials selected by our speakers on Recent Advances in Cell Therapy and Bispecific Antibodies.

🌱 Sustainability

Please bring your beverage or a refillable container if possible. The Chamber is a green business, and your support in reducing waste is appreciated! We will have coffee, water, and iced tea available in addition to regular light lunch items.

About Us

Bio-by-the-Lagoon is a community of biotech professionals coming together to connect, learn from one another, and support each other's journeys. Whether you're innovating, conducting research, hiring talent, or exploring new opportunities, BBL offers a space to share what you're working on and grow together.

Bio-by-the-Lagoon has partnered with the Foster City Chamber Foundation and supports CORA, a non-profit organization supporting victims of intimate partner abuse.