Agenda

Track 1
How Rapid Manufacturing Innovations Can Streamline Drug Development

The degree of process innovation in advanced therapies is unprecedented – how are we harnessing this innovation to solve capacity constraints, get products to patients faster, and reduce costs while managing the regulatory risks during the drug development cycle. Our panel will explore how industry can harness these innovations to solve capacity constraints, safely get products to patients faster, and reduce costs while managing regulatory risks. 

Moderator:                                                                                                              Michael Grace, Ph.D., CMC Business Unit Lead, Biologics Consulting

Panelists:
•  Tristan Marshall, Vice President, Process Development, REGENXBIO
•  Erich Blatter, Ph.D., Director, Process Science Laboratory – MSAT, GSK
•  David Anderson, Quality Site Head, Kite                                                  •  Vince Narbut, Senior Consultant, Biologics Consulting

Track 2
Bench to bedside: How to Accelerate Safe Development and Delivery of Cell and Gene Therapies to Patients in Need

As demand for cell and gene therapies rises, so does the need to develop these therapies at scale. From clinical trial design and manufacturability to patient advocacy, this panel will explore opportunities to reduce the time patients must wait to gain access to safe, effective treatments.

Moderator:
•  Brad Stewart, MTC Board Chair, Senior Vice President, Business Development, Montgomery County Economic Development Corporation

Panelists:
•  Audrey Chang, Ph.D., Executive Director, WuXiApptec
•  Jennifer Helfer, Ph.D., Senior Director, Patient Advocacy & Engagement, Viridian Therapeutics, Inc.
•  Vivien Sheehan, M.D., Ph.D., Associate Professor of Pediatrics, Emory University School of Medicine
•  Brian Stamper, Executive Director of Manufacturing Sciences, AstraZeneca

Track 1
Going Global – Navigating the International Landscape for CGTP

Navigating the regulations of cell and gene therapy products (CGTP) can be a challenge. Highlights of the international regulatory oversight and environment for CGTP will be discussed, with a specific focus on the applicable regulatory guidance’s for US, EMA, Japan, and China. The panel will also discuss unique Chemistry, Manufacturing, and Controls (CMC) challenges for CGTP and tips from a previous FDA CBER CMC reviewer, along with some recent real-life industry CMC issues related to CGTP.

Speakers:
•  Tammy McCracken, M.S., Vice President, CMC Emerging Therapies, ProPharma

•  Chenghong Wei, Ph.D., Director, CMC Regulatory Affairs, Astrazeneca

Track 2
Immunotherapies: Unleashing Promise Outside of Oncology

Immunotherapy has gained widespread attention for its promise as a cancer treatment, yet it also holds vast potential in fields beyond oncology. Immunotherapy harnesses the body’s immune system to fight diseases, and its application is being explored in a range of non-oncology medical contexts, including autoimmune diseases, infectious diseases, and allergies. Our panel will discuss opportunities for expanding immunotherapy to a range of conditions in order to change lives for even more patients.

Moderator:
•  Aubrey Watkins III, Ph.D., M.S., Senior Director, Corporate Development, Emergent Biosolutions

Panelists:
•  Patrick Hanley, Ph.D., Chief and Director, Cellular Therapy Program, Children’s National Hospital
•  Tonya Villafana, Ph.D., MPH, Global Franchise Head, Infection- Late V&I, AstraZeneca
•  Hugh Welles, Ph.D., Director of Synthetic Immunotherapy Development, Vaccitech

Track 3: Workshop
Maximizing Your Access to Capital Today and Tomorrow

Following the Covid-19 driven life science and med tech investment surge in 2021, capital markets have tightened, and valuations have decreased. Inflation, rising interest rates, and economic uncertainty have further complicated access to capital. However, life science and med tech industries are resilient, and market indicators may be pointing toward some stabilization. This panel of experts will discuss the current status of the capital markets and what to expect in the near-term future.

Moderator:
•  Martin Rosendale, Chief Executive Officer, Selnova, LLC

Panelists:
•  Matthew Miessau, Senior Associate, Epidarex Capital                                                                                •  Ken Krisko, Partner, Cooley, LLP
•  Patti Seymour, Managing Director, BPTG, BDO

Track 1
Dramatic Change – Evolution and Future of Vaccines and Immunotherapy

The field of vaccines has experienced significant advancements in recent years, and novel platforms have emerged that promise revolutionary changes in how vaccines are developed and administered. Our panel will discuss advances such as mRNA, nano scaffolding, monoclonal antibodies, and combination vaccines, and how they enable researchers to tackle complex infectious diseases more comprehensively.

Moderator:
•  Bill Enright, Chief Executive Officer, Vaccitech

Panelists:
•  Michael Anderson, M.D., Senior Advisor, Children’s National Hospital, Senior Advisor to the Assistant Secretary for Preparedness and Response (ASPR), HHS
•  Sanjay Phogat, Ph.D., Vice President, R&D, GSK.                                      • Lisa Dunkle, M.D., Vice President, Global Medical Leader, Novavax, Inc.

Track 2
Artificial Intelligence in Medicine: Applications, Implications, and Limitations

Artificial Intelligence (AI) has the potential to revolutionize therapeutic treatments, unlocking new possibilities and accelerating advancements in this cutting-edge field of medicine. This panel will explore how researchers and clinicians can harness AI to streamline various stages of the development and deployment process, potentially leading to faster and more effective therapies for patients in need.

Moderator:
• Mike Snodgrass, Senior AI Analyst, Google

Panelists:
•  Daozhan Yu, Ph.D., President and Chief Executive Officer, AAVnerGene, Inc.
•  Sanat Mohanty, Ph.D., Founder and Chief Executive Officer, Pienomial, Inc.                                                                                                                                •  Diana Pankevich, Ph.D., AI Public Policy Lead, Pfizer

Track 1
Beyond Oncology, Exploring the Next Phase of Cell and Gene Therapies

A new wave of innovations hold significant potential for expanding cell and gene therapies to areas outside of cancer. What technologies could enable this advance? What can be learned from experiences in cancer, and what hurdles remain? What are the unique challenges from a commercialization and clinical testing perspective? Join a panel of experts, clinicians, patients, and regulators for a vibrant discussion of what the future holds for this revolutionary field of medicine. 

Moderator:
•  Christopher Jewell, Ph.D., Chief Scientific Officer, Cartesian Therapeutics

Panelists:
•  Metin Kurtoglu, Ph.D., Chief Operating Officer, Cartesian Therapeutics
•  Heather Lombardi, Ph.D., Director, Office of Cellular Therapy and Human Tissue,  FDA/CEBER
•  Sarah Meeks, Ph.D., Senior Vice President, Global Business Development,  MaxCyte
•  Gregory A. Sahagian, M.D., Chief Executive Officer, The Neurology Center of Southern California                                                                                       •  Allison Foss, Executive Director, Myasthenia Gravis Association

Track 2: Workshop
Pivoting Your Life Science Facility Strategies in Challenging Economic Times – Fireside Chat

Pat Larrabee, President & CEO of Maryland-Based Facility Logix, will share insights from her 30+ year career advising organizations on their life science facility and ecosystem growth strategies. Lab and manufacturing space planning requires significant investment and lead time, and C-suite executives are often faced with navigating changing market dynamics. Pat will share lessons learned on how to improve the flexibility of your facility growth options in tight funding environments to ensure continued growth during these challenges. 

Host:
•  Matt Brady, Principal, Executive Vice President, Scheer Partners

Speaker:
•  Pat Larrabee, President & CEO, Facility Logix