Regulatory Roadmap: Designing a Strategy for Commercial Success


Navigating the regulatory landscape is critical for biotech companies. This interactive workshop will provide expert insights on preclinical and clinical regulatory considerations, CMC, testing, manufacturing decisions and investor expectations.

Join industry leaders as they share lessons learned, key strategies for preparing for a successful IND and how to position your company for long-term success. Ā 

Whether you're an early-stage startup or advancing toward commercialization, this session will equip you with the knowledge to make informed regulatory and manufacturing decisions.

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šŸ“ 5 Laboratory Dr, Research Triangle Park, NC 27709

ā–¶ļøĀ  What to Expect:

šŸ“… 9:00 AM - 9:15 AM | Arrival & Registration
Check in, grab a coffee, and get ready for an insightful session.

šŸ—£ 9:15 AM - 10:15 AM | Early-Stage Companies (Interactive session with audience Q&A)
Experts will cover key topics for startups, including:

  • Regulatory planning to support fundraising
  • Preparing a first pre-IND briefing book
  • Key insights for a successful IND submission
  • Quality and manufacturing strategies
  • Lessons learned: ā€œI wish Iā€™d known this earlierā€
  • Manufacturing strategy: outsourcing vs. in-house
  • Slide control strategy & item specification

ā˜• 10:15 AM - 10:45 AM | Networking Break

šŸ“ˆ 10:45 AM - 11:30 AM | Regulatory Path to Your End Goal (Expert insights & Q&A)

  • Overview of the regulatory landscape
  • Strategies for commercial success
  • CMC considerations for growth
  • Partnerships & exit strategies

ā“ 11:30 AM - 12:00 PM | Wrap-Up & Open Q&A
A final opportunity to ask questions and connect with industry leaders.

Who Should Attend

Founders, operators, and leaders of startups in small molecule drugs, biologics (including cell and gene therapies), and biomanufacturing technologies.

Event Details

šŸ“… Date: April 4, 2025
šŸ“ Location: Released upon registration

Spots are limitedā€”register today!

Spots are limited, register today!

Register Today!

Seats are limitedā€”reserve your spot.

Meet Your Speakers

Jessica Blomberg, PhD

Jessica Blomberg, Ph.D., is a leading expert in CMC, regulatory strategy, and quality systems, with nearly 25 years of experience guiding biopharma, biotech, and cell and gene therapy companies through drug development and regulatory approvals. As Founder and CEO of Quality CMC Consulting, she has spent over 12 years helping companies optimize development plans, de-risk regulatory strategies, and achieve commercial success.

A longtime RTP resident and Duke University Ph.D. graduate, Dr. Blomberg has supported startups and global firms in advancing novel therapies, securing regulatory approvals, and navigating complex manufacturing challenges. Her expertise spans injectables, oral, inhalation, and topical products, contributing to multiple approvals and over $1.1 billion in biotech M&A deals in 2024.

An active industry leader, she serves on the Astronaut Scholarship Foundation board, mentors biotech entrepreneurs, and was named Triangle Business Journalā€™s 2020 Life Science Consultant of the Year.

Kelli Luginbuhl

Kelli Luginbuhl is the Co-Founder and former CSO-turned-CEO of Isolere Bio, a Duke spinout developing innovative bioprocessing reagents to accelerate advanced therapeutics with faster, higher quality, and more scalable purification.Ā Isolere was acquired in 2023 by Donaldson Company, a Minnesota-based filtration company. Kelli stayed on to lead the integration efforts and now serves as General Manager of Isolere Bio by Donaldson.Ā 

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Kelli has led the growth of the team and its transition from R&D to commercialization.Ā Ā Since the acquisition, Isolere has launched two products, both designed for the purification of viral vectors critical to cell and gene therapies. Her role has included go-to-market and regulatory strategy with product launches, as well as executing manufacturing and quality management systems through both an outsourced CDMO model and an internal buildout of production capability here in North Carolina.

Dave Ousterout, PhD

Dave Ousterout, Ph.D., is a scientist, executive, and serial entrepreneur committed to advancing North Carolinaā€™s life science startup ecosystem, focusing on patient-centric biotech ventures.

As a Co-Founder of Cape Fear BioCapital, Dave aims to transform venture financing for local biotech companies by providing essential seed funding to build investment-ready, NC-based ventures.

With a PhD from Duke University, Dave co-founded Locus Bio, which raised over $150 million and developed the first CRISPR-based antibiotic in clinical trials.

Dave also advises Kineticos Ventures and Inceptor Bio, supporting cell and gene therapy and cancer treatments.

Having spent 15 years in North Carolina, Dave is passionate about enhancing funding and support for the stateā€™s biotech innovation.