2024 Agenda

Scientific Session:  Latest Breakthroughs in Cell and Gene Therapy

Cell and gene therapy has been one of the biggest breakthroughs in the treatment of patients with blood cancers and genetic disorders. In the past two years, this novel class of therapies are now being explored in the treatment of a large variety of clinical indications. In the first half of the scientific session, we convened a group of panelists who will speak about their expertise in four different classes of cell and gene therapy including ex vivo engineered cells, stem cells, gene therapies and peptide based therapies. In the second half, the panelists will discuss a variety of topics to inform the audience about the upcoming scientific advances including CRISPR based approaches and hottest questions around gene editing.

MODERATOR:  Metin Kurtoglu, Chief Technology Officer, Cartesian Therapeutics

PANELISTS:
George Buchman, Research Fellow, Catalent Pharma Solutions
Ye Liu, Vice President of Gene Therapy Research, REGENXBIO
Geoff Lynn, Senior Vice President of Synthetic Immunotherapies, Barinthus
Jon Rowley, Founder and Chief Product Officer, RoosterBio, Inc.
Mindy Sadik, Director of Cell Therapy Sciences, Thermo Fisher Scientific

Expedited FDA Approval and Expanded Access Tools:  Getting Products to Patients

This panel will examine regulatory pathways for faster FDA approval and greater access to patients for investigational drugs.The discussion will provide a substantive overview of expedited approval mechanisms, including fast track, breakthrough therapy, priority review, and accelerated approval (Subpart H), as well as expanded access INDs. The panel will also feature examples from the industry on how these tools can be leveraged to increase patient access and speed FDA approval.

MODERATOR:  Justin Coen, Partner, Venable LLP

PANELISTS:
Jacqueline Corrigan-Curay, Principal, FDA’s Center for Drug Evaluation and Research (CDER)
Randall N. Hyer, Chief Executive Officer, Merlin Biotech
Melissa Robb, Senior Director Regulatory Strategy, REGENXBIO

How to Ensure Commercialization Success:  Important factors for successful ATMPs after BLA approval

Advanced Therapeutics and Medicinal Products (ATMPs) have ushered in a new era of therapeutics and medicinal products including cell and gene therapy, RNA-based vaccines to name a few.   In spite of the plethora of FDA and EMA approval of ATMPs, the commercial success of ATMPs has been elusive.  The million dollar price tag and the manufacturing and logistic challenges of the approved ATMPs hinder the products being embraced and afforded by patients at large.  In this panel, we have invited the experts in the fields of medicine, economics, regulatory science and therapeutic development to outline the factors for ATMPs post licensure commercial success.

MODERATOR:  Jeffrey Hung, Founder and CEO, DiscerNMR, Inc.

PANELISTS:
Metin Kurtoglu, Chief Technology Officer, Cartesian Therapeutics
Brian Stamper, Executive Director, Cell Therapy, AstraZeneca
Xiulian Sun, Founder and CEO, UBriGene International, Inc.
Kim Watanabe, Executive Director and the Cell and Gene Therapy Pillar Head at PPD, part of Thermo Fisher Scientific

Put AI to Work for Your Life Science Company

Our panelists will cut through all the hype surrounding Artificial Intelligence (AI), and share how their businesses actually use AI. They will share how they learned what worked, what didn’t work, and how their businesses are using AI to gain a competitive advantage in their respective markets. Come learn how your company can take the first steps to integrate AI in your life science company’s business operations.

MODERATOR:  Matt Puglisi, Co-Founder and Chief Operating Officer, Netrias

PANELISTS:
Mohammed Eslami, Co-Founder and Chief Scientist, Netrias
Christopher Knouss, Chief Data Officer, Corporate Responsibility, JP Morgan
Peter Shen, Head of Digital Health, North America at Siemens Healthineers
Eric Stahlberg, Director, Cancer Data Science Initiatives, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research

Exploring Future Frontiers in Vaccine Development:  Bridging Science and Business Perspectives

In this panel, we delve into the evolving landscape of vaccine development, focusing on innovative approaches and strategic opportunities that transcend traditional boundaries. However, it’s not just about the science. Business leaders play a crucial role in identifying, assessing, and capitalizing on these opportunities. This session brings together scientific experts and business visionaries to discuss not only the scientific advancements but also the strategic implications and business opportunities in the vaccine development space. We will explore questions such as:  

• What are the emerging trends in vaccine development that businesses should be aware of?
• How can companies leverage new technologies and regulatory shifts to stay ahead in the market?
• What are the financial and strategic considerations when transitioning from traditional to novel vaccine platforms?
• Who are the key stakeholders driving innovation in this field, and how can collaborations be fostered for mutual benefit?

How to ensure your company is fundable – legal and accounting considerations for a smooth fundraising process

Whether you are working on preparing a pitch deck or anticipating receiving a term sheet in the near future, ensuring your company has taken the appropriate legal and accounting steps is key to a successful capital raise. We have invited corporate lawyers, an accountant and an executive who has been through the legal and accounting diligence process numerous times to discuss recommended to-dos before kicking off the fundraising process.

MODERATOR:  Lila Inman, Corporate Attorney, Cooley LLP

PANELIST:
John. B Forrest IV, Associate, Cooley, LLP
Andrew Krouse, Chief Executive Officer, GenEp