2025 AGENDA

Networking and breakfast in the exhibit hall

One2One partnering in dedicated meeting space

Welcome remarks on the main stage

One2One partnering in dedicated meeting space

More information coming soon

One2One partnering in dedicated meeting space

Dr. Marty Makary
FDA Commissioner

Silvia Taylor
EVP, Chief Corporate Affairs and Advocacy Officer
Novavax

The United States is home to some of the most influential life science clusters in the world, fueling innovation, investment, and job creation. In this session,top leaders from key U.S. life science powerhouses will discuss how these clusters are shaping the future of the industry. 

Moderator: 

Patrick Plues
Senior Vice President, State Government Affairs & Affiliate Relations
BIO

Panelist:

Kelly Schulz
Chief Executive Officer
Maryland Tech Council 

Kendalle Burlin O’Connell
Chief Executive Officer and President
MassBio 

John Newby
Chief Executive Officer
Virginia Bio

One2One partnering in dedicated meeting space

Artificial Intelligence (AI) is transforming clinical research, offering unprecedented efficiency, accuracy, and cost savings. AI-driven tools are enhancing patient recruitment, protocol design, safety monitoring, and data analysis, leading to faster trial completion and improved patient outcomes. However, the adoption of AI in clinical trials presents significant regulatory, ethical, and privacy challenges, particularly concerning bias, transparency, and compliance with evolving laws such as HIPAA, GDPR, and the EU AI Act. This session would explore cutting-edge AI applications in clinical research, examining both their potential and the legal, regulatory, and ethical frameworks governing their use. Attendees will gain insights into responsible AI adoption, best practices for mitigating risks, and the evolving landscape of AI governance in drug development.

Moderator:

Alexandra Moylan
Shareholder
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Panelist:

Mike Halaiko
Shareholder
Baker, Donelson, Bearman, Caldwell & Berkowitz, PC

Tim Kulp
Chief Innovation Officer
Mind Over Machines

Subha Madhavan
Vice President & Head of AI/ML
Pfizer

Carter Mitchell
Chief Security Officer
Kemp Proteins

BioHub Maryland Introduction to Biopharma Manufacturing

This 2.5-hour session is for anyone interested in learning more about biopharmaceutical manufacturing. It will take attendees through the basics of biopharmaceutical manufacturing as well as some of the most exciting and impactful trends in the industry, such as how single-use technologies are being utilized in the sector. Whether you work in the production area, are a hiring manager, a recruitment consultant, or a vendor, this session is for you. 

Key Topics Covered: 

• A typical biomanufacturing monoclonal antibody production process
• An overview of cell and gene therapies
• An overview of the key terms used in biopharmaceutical production
• An insight into how single-use technology is utilized in the sector

More information coming soon

One2One partnering in dedicated meeting space

In this session, we will explore how incubator models, translational centers, and customers are shaping the future of cell therapy. By fostering collaborative ecosystems that unite translational research, biotechnology, and industry, we can accelerate innovation, streamline processes, and address critical manufacturing challenges.

A key focus is the role of incubators and translational centers in bridging the gap between research and commercialization. These hubs provide shared resources, infrastructure, and expertise that lower barriers to entry, enabling companies to scale efficiently while maintaining regulatory compliance. Through the integration of automated and closed-system manufacturing technologies within these ecosystems, we can enhance reproducibility, safety, and cost-effectiveness.

By fostering a network of innovation within structured ecosystems, we can accelerate the translation of research breakthroughs into clinical applications. Together, we are building a more connected, scalable, and sustainable future for cell therapy—one that improves accessibility and ultimately enhances patient outcomes.

BioHub Maryland Introduction to Biopharma Manufacturing

This 2.5-hour session is for anyone interested in learning more about biopharmaceutical manufacturing. It will take attendees through the basics of biopharmaceutical manufacturing as well as some of the most exciting and impactful trends in the industry, such as how single-use technologies are being utilized in the sector. Whether you work in the production area, are a hiring manager, a recruitment consultant, or a vendor, this session is for you. 

Key Topics Covered: 

• A typical biomanufacturing monoclonal antibody production process
• An overview of cell and gene therapies
• An overview of the key terms used in biopharmaceutical production
• An insight into how single-use technology is utilized in the sector

More information coming soon

One2One partnering in dedicated meeting space

The biomanufacturing landscape is rapidly evolving, driven by cutting-edge innovations that enhance efficiency, scalability, and cost-effectiveness. Pioneering Progress: The Future of Biomanufacturing and Therapeutics will explore emerging trends and breakthrough technologies revolutionizing biomanufacturing, from automation and AI-driven process optimization to next generation cell and gene therapies. Experts will discuss key challenges and opportunities in scaling therapies, addressing bottlenecks in production, supply chain resilience, and workforce development. Additionally, this session will highlight strategic approaches to reducing costs while maintaining quality. With regulatory frameworks continually evolving, panelists will also provide insights on navigating global compliance requirements, ensuring accelerated yet safe pathways to market. Attendees will gain actionable strategies to drive innovation, scalability, and affordability in the future of biomanufacturing.

BioHub Maryland Introduction to Biopharma Manufacturing

This 2.5-hour session is for anyone interested in learning more about biopharmaceutical manufacturing. It will take attendees through the basics of biopharmaceutical manufacturing as well as some of the most exciting and impactful trends in the industry, such as how single-use technologies are being utilized in the sector. Whether you work in the production area, are a hiring manager, a recruitment consultant, or a vendor, this session is for you. 

Key Topics Covered: 

• A typical biomanufacturing monoclonal antibody production process
• An overview of cell and gene therapies
• An overview of the key terms used in biopharmaceutical production
• An insight into how single-use technology is utilized in the sector

More information coming soon

One2One partnering in dedicated meeting space

Companies expend enormous time and energy into perfecting their storytelling approaches to investors.  It’s a good use of time: storytelling efficacy is often the reason why similarly situated companies have different valuations, trading liquidity, research coverage, acquisition multiples, and even employee retention.  But our presenter has some candid thoughts about why so much life science storytelling is ineffectual, and he’s got a succinct message for us: “You’d tell your Company’s story much differently, if you understood how investors actually perceive your company.”

Speaker: 

Adam J. Epstein, a former institutional investor and bestselling author, is going to take us inside an investment committee’s deliberation to understand what really constitutes “forensic diligence.”  You’re going to have a front row seat to understand what fund managers are assessing, why they are focused on some information more than other data, and what conclusions they are drawing before they even meet with you.  Unlike most of what you hear about how investors think and act… Adam isn’t speculating.