Oct 10th, 2024 - Maryland Tech Council Bio Innovation Conference

Join us at the MTC Bio Innovation Conference, October 10, 2024!

The Bio Innovation Conference will connect top life sciences professionals in the region with leading global brands, venture capitalists and promising startups. Created by life sciences professionals for life sciences professionals, this forum offers an exciting and unique opportunity to reach industry leaders and decision makers across the industry and demonstrate to colleagues and clients how your products or services can lead the way to a healthier tomorrow.

Presented by the Maryland Tech Council, the Bio Innovation Conference is driving the future of life sciences in Maryland.

More information here: MTC Bio Innovation Conference

2024 Conference Agenda: 

7:30AM: Registration Open | Exhibit Hall Open | Breakfast and Networking

7:30AM – 9:30AM: BIO One-on-One Partnering Meetings

• Kelly Schulz, Chief Executive Officer, Maryland Tech Council
• Brad Stewart, Chairman, Maryland Tech Council, Principal, National Life Sciences Leader, BDO
• Steven Walker, Chair, Maryland Life Sciences, Division of the Maryland Tech Council

8:40AM – 8:45AM: Transition Period

8:45AM – 9:45AM: Session A

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

• 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

• Jacqueline Corrigan-Curay, Principal, FDA’s Center for Drug Evaluation and Research (CDER)
• Melissa Robb, Senior Director Regulatory Strategy, REGENXBIO

9:45AM – 10:00AM: Transition Period

10:00AM – 11:00 AM: Keynote Fireside Chat
Dr. Hilary Marston, Chief Medical Officer, Food and Drug Administration (FDA)
Kelly Schulz, Chief Executive Officer, Maryland Tech Council

11:00AM – 11:15AM: Transition Period

11:15AM – 12:15PM: Session B

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.

• 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

• 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

11:30AM – 4:00PM: BIO One-on-One Partnering Meetings

12:15PM – 1:30PM: Networking Lunch

1:30PM – 2:30PM: Session C

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?

MODERATOR: Steven Walker, Chair, Maryland Life Sciences

• Ouzama Henry, Vice President, Clinical Development, Dynavax
• Chijioke Bennett, Executive Director, Clinical Development, Novavax
• Jess Manning, Global Head Clinical Franchise, Next Generation Influenza Vaccines, Global Clinical Development, Sanofi

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

• John. B Forrest IV, Associate, Cooley, LLP
• Andrew Krouse, President and CEO, Slate Bio, Inc.
• Chun Yeh, Principal, BDO

2:30PM – 2:45PM: Transition Period

2:45PM – 3:45PM: Session D

FDA/CBER Review:  Latest trends, pitfalls, and successes of Innovative Therapies: Recent approvals in innovative therapies, including Cell and Gene Therapy (CGT) products, combination products, and RNA-based treatments have spurred continued enthusiasm for clinical development with the FDA/CBER seeing an increase in IND submissions in the past few years. The panel will speak to the latest trends, pitfalls, and successes in clinical development within these dynamic fields. Recent FDA focus on CMC issues, such as analytical comparability and impact of CMC issues and timing related to initiating pivotal clinical trials will be discussed. Overview of recent FDA guidance on comparability and upcoming guidances the FDA is planning to help sponsors navigate these issues will be highlighted.

MODERATOR: Tammy McCracken, Sr., Director Regulatory Affairs CMS, REGENXBIO, Inc.

• Doug Brough, Senior Vice President and Head of Research, Precigen
• Marina A. Dobrovolskaia, Director of Operations, Head of Immunology Section, Nanotechnology Characterization Laboratory
• Sadik Kassim, CSO/CTO, Danaher Genomic Medicines

Non-Dilutive Funding and Valuable Resources:  Strategies for Growth Without Giving Up Equity: In today’s competitive business landscape, securing funding is a critical step for growth and innovation. However, not all funding options require sacrificing equity. Non-dilutive funding offers a pathway to secure financial support without giving up ownership stakes in your company. This session is tailored for companies and entrepreneurs interested in exploring non-dilutive funding options that can fuel their growth and innovation projects. Join our professionals as they delve into the intricacies of non-dilutive funding, covering a range of opportunities from grants to government contracts and more. Whether you’re in the early stages of your startup or aiming to accelerate growth, this session will provide you with the insights and strategies to effectively leverage non-dilutive funding.

MODERATOR:  Brad Stewart, Chairman, Maryland Tech Council, Principal, National Life Sciences Leader, BDO

• Jeremiah Kelly, Partner, Venable LLP
• Vladimir Popov, Chief Innovation Officer, Center for Innovation and Strategic Partnerships, Frederick National Laboratory for Cancer Research
• Rachel Rath, BARDA Alliance Director leading BLUE KNIGHT, Interim Head,Johnson & Johnson Innovation, JLABS
• Michael Salgaller, Supervisor, Technology Analysis and Marketing Unit, National Institutes of Health

4:00PM – 5:00PM: Closing Keynote

5:00PM – 6:00PM: Cocktail Reception