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Session 6: Disrupting the Approach to Developing Advanced Modalities

4:00 PM – 4:45 PM | West Red Level, Suite 81

Disrupting the Approach to Developing Advanced Modalities

To fully realize the potential of advanced modalities, our industry needs to take an innovative, collaborative, and strategic approach to development. Key decisions impacting a technology’s journey often occur in the early days of research. Broadening the horizon during research & development will result in higher quality, de-risked, and more impactful products. Patients are waiting for therapeutics that promise cures to debilitating diseases. It is important that we elevate the discussion on how we can collectively disrupt the approach to developing these next generation therapeutics. During this discussion, we will present case studies and testimonials through a panel discussion involving diverse perspectives from:

1. a startup biotechnology company (Julie Morse, Satellite Biosciences)
2. a service provider (CDMO) (Thermo Fisher Scientific, Patheon)
3. and tool(s) providers (Eppendorf Bioprocess Solutions)

We will provide a new way of thinking about the scientific and business approach to meeting the demands and challenges of novel therapeutics, including cell and gene therapies. Our goal is to discuss:

1. Understand the business and technical motivations for adopting process development and analytics earlier in the technology’s lifecycle
2. Complex IP (and difficult manufacturing)
3. High COGS
4. The funding environment driving the need for later stage assets
5. Preparing for technology transfer or your own GMP capabilities
6. Changing regulatory landscape
7. How to support your teams in making the leap from R&D to process development
8. Mindset and collaboration: educating scientists on the bigger picture and breaking down silos
9. Providing the laboratory infrastructure and tools
10. Establishing scalable information systems
11. How to leverage partnerships and the local Massachusetts ecosystem to advance technology

Speakers:

T.J. Chancellor, PhD, Sr. Manager, Technical Program Design, Viral Vector & Advanced Therapies Services, Thermo Fisher
Jorge Luis Escobar Ivirico, Manager Application and Customer Solutions, Eppendorf
Julie Morse, Vice President of Technical Operations, Satellite Bio
Lyndsey Rissin, Director of Science Strategy & Partnerships, LabCentral, Inc.

Biographies:

T.J. Chancellor, PhD, Sr. Manager, Technical Program Design, Viral Vector & Advanced Therapies Services, Thermo Fisher

T.J. Chancellor is a bioprocess development and manufacturing expert with over 11 years of experience in biologics and gene therapy. In his current role as Sr. Manager within the Technical Program Design group, he provides strategic support and technical knowledge to empower clients with pathways to fulfill their clinical and commercial objectives. In previous roles within process development and manufacturing he successfully led cross-functional teams in the design, scale-up, and tech transfer of multiple gene therapy programs. He holds a B.S. in chemical engineering from the University of Oklahoma and was awarded a PhD in chemical engineering from the University of Florida.

Jorge Luis Escobar Ivirico, Manager Application and Customer Solutions, Eppendorf

Jorge L. Escobar Ivirico is Manager Application and Customer Solutions at Eppendorf, Inc., based in Enfield, Connecticut, USA. In his previous role as Product Manager for Bioprocess Solutions, he worked closely with customers to understand their needs, address workflow gaps, and deliver tailored technical support in collaboration with sales and application teams. He also provided Voice of the Customer (VOC) insights to shape strategic solutions and drive innovation in advanced therapy workflows. Since joining Eppendorf in 2019, he has contributed to applied research focused on the efficient expansion of adherent and non-adherent cells (e.g., stem cells, adult primary cells) using cell culture bioreactors. He earned his Ph.D. in Biomedical Engineering from the Polytechnic University of Valencia (UPV) in 2008 and developed extensive expertise in cell therapy and regenerative medicine through research appointments at the Center for Biomaterials and Tissue Engineering (UPV, Valencia, Spain), the Institute of Biomaterial Sciences – Helmholtz-Zentrum Geesthacht (Berlin, Germany), and the Institute for Regenerative Engineering at the University of Connecticut Health (USA). In 2017, he was appointed Assistant Research Professor in the Department of Chemical and Biomolecular Engineering at the University of Connecticut.

Julie Morse, Vice President of Technical Operations, Satellite Bio

Julie Morse has over a decade of experience in cell and gene therapy, ranging from early-stage development to BLA-enabling activities. Julie currently leads technical operations at Satellite Bio, focusing on delivering tissue therapeutics to patients with liver disease. Before Satellite, Julie held various CMC-related positions at CRISPR Therapeutics, Semma Therapeutics (now Vertex), and Ocata Therapeutics (now Astellas).

Lyndsey Rissin, Director of Science Strategy & Partnerships, LabCentral, Inc.

Lyndsey Rissin is a technical leader with 15 years of experience supporting life science startup companies. Coming from a chemical engineering background, she pursued her Masters in Engineering Management to transition from the bench to operations and business development. She now convenes key stakeholders from academia/research, industry (startup to big pharma/biotech), equipment tools and reagent providers, and CROs/CDMOs to enable innovation and inform LabCentral’s science strategy. Her goal is to empower scientific breakthroughs by providing access to best-in-class resources and thought leadership.