2025 AGENDA
8:00 AM – 9:00 AM
Registration, Networking, Breakfast
Networking and breakfast in the exhibit hall
8:00 AM – 10:00 AM
One2One Partnering
Click here to learn more about One2One Partnering for life sciences attendees. Access to One2One Partnering Meeting (Included in Industry registration, $125 all others as an add-on at registration) not available for students.
9:00 AM – 9:15 AM
Kickoff to the Bio Innovation Conference
Welcome remarks on the main stage
9:15 AM – 10:00 AM
Panel: Accessing Capital in a Risk-Averse Environment
This panel will feature a conversation with investors and dealmakers on different approaches that innovators can take to pursue capital in a risk-averse environment. Attendees will hear practical advice on how best to navigate the current investment landscape in order to secure the capital needed to fuel growth and development.
Moderator:
Angus McQuilken
Business Development Associate Director, Life Sciences, Orrick
Panelists:
Tony Chan
Partner and Global Co-Chair of Life Sciences Practice, Orrick
Deborah Hemingway
Managing Partner, Ecphora Capital
Shana Lawlor
Venture Capital Investor and Founding Managing partner, Totipotent Capital
Jess Miciak
Investment Associate, ACS BrightEdge
Bibhash Mukhopadhyay
Managing Partner and Co-Founder, Sound Bioventures
10:05 AM-10:55 AM
Inside the FDA: A Fireside Chat with the Commissioner
Dr. Marty Makary
FDA Commissioner
Silvia Taylor
MTC Board Member
10:55 AM – 11:10 AM
Networking Break
11:10 AM – 4:05 PM
One2One Partnering
Click here to learn more about One2One Partnering for life sciences attendees. Access to One2One Partnering Meeting (Included in Industry registration, $125 all others as an add-on at registration) not available for students.
11:10 AM – 11:55 AM
Panel: U.S. Life Science Clusters: Driving Economic Growth and Workforce Development
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
12:00 PM -1:30 PM
Midway Momentum: Connect and Collaborate
Networking Lunch
1:30 PM – 2:15 PM
Panel: Ai implementation in Clinical Research: Risks, Benefits and Compliance Considerations
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
1:30PM – 4:05 PM
BioHub Maryland Session
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
Presenter: Cory Harrington, Biomanufacturing Training Specialist, BioHub Maryland, Powered by Maryland Tech Council
2:20 PM – 3:05 PM
Meeting the Challenges of Modern Biologics: Emerging Trends in Transient Protein Production and Protein Expression Workflows
Biologics innovation is accelerating rapidly, with increasing demand for new modalities such as antibody-drug conjugates (ADCs), bispecific antibodies, and other next-generation therapeutics. Additionally, the complexity of proteins being expressed as antigens and/or reagents for biologics development is also becoming more challenging as industry continues to focus on therapeutics targeting membrane proteins and multi-subunit complexes. All of these molecules bring unique challenges for protein expression, from achieving sufficient yield and quality to addressing stability and manufacturability concerns. At the same time, there is a growing push to automate expression workflows — enabling greater run-to-run consistency, improved laboratory efficiency, and the generation of large data sets that can support AI/ML-driven discovery.
This panel will bring together scientific and industry leaders to explore advances in protein expression that are shaping the future of biologics development. Topics will include strategies for overcoming bottlenecks in difficult-to-express proteins, the role of innovative transient expression systems in accelerating discovery, and opportunities to integrate small-scale, high-throughput automated protein expression workflows into development pipelines. Attendees will gain insights into the tools, platforms, and collaborative models that are enabling faster, more reliable, and more scalable solutions for modern biologics.
Moderator: Mark Powers, Vice President, Research & Development, Life Sciences Solutions Group, Thermo Fisher Scientific
Panelist:
- Matt Drew, Eukaryotic Production Lead Protein Expression Lab Frederick National Lab
- Jon Zmuda, Senior Director of R&D, Thermo Fisher Scientific
3:05 PM – 3:20 PM
Networking Break
3:20 PM – 4:05 PM
Panel: Reimaging the Future of Biomanufacturing for Competitive Advantage
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.
Moderator:
Jake Greenwood
VP, Project Farma
Panelists:
Brian Stamper
Executive Director and GM, Cell Therapy Operations
AstraZeneca
Craig Malzahn
EVP and CTO
REGENXBIO
David Fidler
GM and VP of Manufacturing
Bora Pharmaceuticals
3:20 PM – 4:05 PM
Roundtable Discussions
Roundtable 1:
Beyond SBIRs: Non-Dilutive Funding Strategies to Advance Your Pipeline and Bottom Line
Did you know you can receive non-dilutive support from the federal government without writing grants?! This roundtable will discuss non-dilutive support strategies apart from rolling the dice with grant submissions. Topics could include:
- Partnerships providing indirect/in-kind support – for which federal labs expend monies, expertise and capabilities on your behalf
- The wide range of company and technology development stages that can benefitRoundtable Host: Michael L. Salgaller, Ph.D., Supervisor, Technology Analysis and Marketing Unit (TAMU), Technology Transfer Center | National Cancer Institute | National Institutes of Health
- Utilizing indirect support to achieve value inflection points
- Leveraging these relationships to impact burn-rate
- Enhancing the valuation of your pipeline through licensing
Roundtable 2:
Dx and AI
Roundtable Host: Jeffrey Hung, Ph.D. CEO and Co-Founder, Accufy Diagnostics
- Dx and AI- what are the advancements and bottlenecks of multimodal diagnostics (NGS, imaging, MRI, PET scan and other blood test) and the computational and AI capabilities to integrate the tests for a holistic diagnosis?
- Dx and Tx- how are Dx serving and advancing targeted Tx for hematological tumor and solid tumor? clinical benefits and promise? bottleneck.
- Dx, LDT and regulatory framework- how can FDA and CMS keep up with the technology and AI advancement?
- Clinical adoption- How do we convincingly integrate diagnostics into workflows and reimbursement models?
- Dx and AI workforce- What strategies can attract and retain skilled diagnostics professionals?
Roundtable 3:
AI Adoption in Lab Settings
Roundtable Host: Mike Toomey, CEO of Secom Security Technologies
This roundtable will discuss observations and practical insights on the rapidly evolving topic of AI. Specifically, the host will address:
- Realtime observation, monitoring and detection of sample handling, PPE detection, safety protocols, reagent usage, security standards, temperature and building controls and more with notifications based on user settings
- The minimization of basic human error with the utilization of environment wide real time monitoring with definitions provided by the user
- Issues and challenges involving personal and data privacy
- The automation of routine procedures in a lab setting as well as the immediate flagging of anomalies in experiments
- Discovering new forms of data analysis based on individual user input
Roundtable 4:
Funding and commercialization resources for cancer technologies at the NCI Small Business Innovation Research (SBIR) development center
Roundtable Host: Linda K. Zane, Ph.D., Program Director, SBIR Development Center, National Cancer Institute
Roundtable discussion points:
- Overview of NIH-wide SBIR and STTR programs
- Current funding opportunities
- Application tips
- Resources and initiatives to support applicants and awardees
Roundtable 5:
CGT Roundtable Discussion
Roundtable Host: Scott Pattison, Ph.D. Senior Director, uBriGene Biosciences
- Cost and reimbursement- How to reduce costs and create sustainable value-driven payment models?
- Manufacturing and scaling- How to build reproducible, decentralized production?
- Supply Chain logistics-how to guarantee identity, custody, timing in delivery;
- Clinical trial design – how to optimize orphan drug clinical trials?
- Clinical adoption- How do we develop a commercialization/reimbursement model for CGT?
Roundtable 6:
Making AI Practical in Clinical Research & Drug Development
Roundtable Host: Tim Kulp, Mind Over Machines
Building on the broader insights shared during the panel discussion, this roundtable will bring the transformative potential of AI down to a more personal and operational level. This session offers an intimate setting for attendees to explore how AI can be practically implemented within their organizations, addressing real-world challenges and opportunities.
Participants will engage in candid dialogue around the practicalities of AI within your organization and the hurdles of compliance, organizational readiness, and ethical adoption. Through shared experiences and peer exchange, the conversation will focus on what it really takes to pilot, scale, and govern AI tools in the high-stakes environment of clinical research.
Whether you’re just beginning your AI journey or looking to optimize existing initiatives, this roundtable will provide a space to ask tough questions, share lessons learned, and walk away with actionable strategies tailored to your context
Roundtable 7:
Growing the Maryland Medtech Ecosystem
Roundtable Host: Martha Wang, Assistant Director, Fischell Institute for Biomedical Devices at the University of Maryland College Park
Please join us to discuss plans for regular events this year supporting Medtech in Maryland. During the roundtable discussion, we hope participants will suggest new ways to help the Maryland Medtech Ecosystem grow and expand.
Roundtable 8:
Creating Communities of Bio Innovation in the DC/MD/VA Region
Roundtable Host: Brian Darmody, Chief Strategy Officer, Association of University Research Parks
The DMV Region is now ranked in the top 3 of bio clusters in the U.S. The presence of NIH, the FDA, high quality universities. foundations and hospitals plus a vibrant private sector have led to this nationally ranked bio cluster. Learn from peers how to grow this sector through public-private-government partnerships
Roundtable 9:
Design on the Move: Leveraging Adaptive Trials to Accelerate Innovation
Roundtable Host: Hana Mekonnen, SVP of Biometrics and COO, Amarex
Adaptive trial designs are emerging as a critical enabler of speed, flexibility, and patient-centricity. This roundtable will explore how adaptive designs—when embedded within collaborative ecosystems —can streamline development, reduce risk, and enhance regulatory engagement.
Key discussion points will include:
- Benefits and limitations of adaptive designs in trials
- Regulatory expectations and pathways for Complex Innovative Trial Designs (CID)
- Operational challenges, including infrastructure, data integration, and decision-making frameworks
- The role of CROs in supporting adaptive design implementation
Participants will share real-world experiences and strategies for navigating the complexities of adaptive trials, including Bayesian approaches, interim analyses, and seamless phase transitions. Join us to explore how adaptive designs, when supported by the right ecosystem, can transform the pace and precision of therapy development.
Roundtable 10:
MTCEdge for Procurement: Smarter Buying in Life Sciences
Join this interactive roundtable to learn how MTCEdge is helping Life Sciences companies streamline purchasing, reduce costs, and access trusted suppliers. Meet with MTC and Thermo Fisher Scientific staff to explore how your team can benefit.
4:10 PM – 4:55 PM
Closing Keynote: An Institutional Investor's Candid Perspective: Storytelling to Drive Value
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.
5:00 PM – 6:00 PM