Access to advanced therapies that can fundamentally alter disease trajectories is one of the most pressing frontiers in healthcare. Among them, cell and gene therapies offer unprecedented hope for millions, especially those grappling with rare, chronic, or previously untreatable conditions.
Yet, realizing the full potential of these therapies requires more than scientific innovation—it demands cross-sector collaboration, global accessibility, and a steadfast focus on patient dignity. These themes were central to the May 2025 installment of the Bridging the Gap webinar series, hosted by Azenta Life Sciences and the Emily Whitehead Foundation.
This powerful session featured Dr. Madhu Sudan Peshwa, an internationally respected biopharmaceutical executive and CEO of MKC Biotherapeutics. With a career spanning startups, multinational corporations, and groundbreaking cellular therapies, Dr. Peshwa shared his deep knowledge and heartfelt personal insights into the promise and challenges of cell and gene therapies (CGTs).
He was joined by Adam Clark, Director of Foundation Operations at the Emily Whitehead Foundation, with moderation from Dr. Patrick Hanley, Chief and Director of the Cellular Therapy Program at Children’s National Hospital.
Building a Foundation for Patient Empowerment
Adam Clark began the session with moving updates from the Emily Whitehead Foundation, emphasizing their new commitment to direct patient support in advanced therapies. He highlighted the launch of the “Believe Bundle” program—a unique initiative that delivers care packages to patients undergoing treatment at hospitals across the country. But as Clark explained, these bundles are much more than gifts.
“They’re not cookie-cutter bundles. Each is co-curated by a member of our patient community and the hospitals themselves,” Clark noted. “These packages open a funnel of connection, linking patients with the foundation and helping to amplify patient voices.”
Clark recounted a powerful moment with Victoria Gray, a sickle cell patient and pioneer in gene therapy, who met with future patients at a hospital in Boston. Her encouragement to others preparing for treatment underscored the emotional and educational importance of peer-to-peer connections.
“To hear her coach the spirits of those two patients… it was unbelievable,” Clark shared. “It’s one thing to go through this journey. It’s another to guide someone else through it.”
The Science of Regeneration: From Molecules to Market
Dr. Peshwa took the virtual stage to guide attendees through a three-part exploration of CGTs, starting with the biology of regeneration. He explained that while some organisms can fully regenerate lost parts, human biology is constrained by complexity and inflammation.
“Regeneration is an ongoing battle between biological repair processes and inflammation,” he explained. “True healing involves preparing the environment—like cleaning up after an earthquake—before rebuilding can begin.”
Dr. Peshwa compared CGT innovation to the early days of the semiconductor industry, where manufacturing advances—not just scientific breakthroughs—enabled rapid scaling. Similarly, cell and gene therapy must overcome manufacturing complexity to become truly accessible.
“It’s not just what’s in the bag,” he emphasized, “but what happens to that product once it’s inside the patient. These are living drugs.”
Proven Therapies, Proven Challenges
Drawing from decades of experience, Dr. Peshwa shared stories from his work on pioneering therapies:
- Provenge, the first FDA-approved autologous cell therapy for prostate cancer, taught him the challenges of scaling fresh cellular products and securing reimbursement.
- Casgevy and LentiGlobin, gene therapies for sickle cell disease, showed how editing or supplementing genes can produce dramatic, life-altering effects.
- A mesenchymal stromal cell (MSC) therapy approved in India for osteoarthritis exemplified how global innovations, paired with deep biological insight, could offer effective disease-modifying therapies—at a fraction of U.S. costs.
Despite their diversity, these therapies illustrated consistent themes. “Even subtle variations in biological material or clinical handling can have a major impact,” Dr. Peshwa noted, pointing to three primary sources of variability: donor biology, manufacturing processes, and clinical administration. Each demands thoughtful engineering controls to ensure product consistency, safety, and efficacy.
To bridge the gap between therapeutic design and real-world application, Dr. Peshwa advocated for expanding the traditional Target Product Profile (TPP). His “TP4P” model introduces a more comprehensive view—one that accounts not only for the therapy’s intended biological profile, but also for the real needs of patients, providers, and payers.
“It’s not just about what the product is,” he explained, “it’s about how it performs in the healthcare system.”
Lessons from the Beautiful Game
In a light-hearted yet insightful moment, Dr. Hanley asked Dr. Peshwa to draw parallels between his passion for soccer and CGT logistics. The answer reflected Dr. Peshwa’s holistic thinking.
“Like in soccer, success requires a team,” he said. “It’s not just the goal scorers. Every pass, every strategic move builds toward success—just like every step in delivering a therapy matters”
Adam Clark added that the “fan experience” in sports can inform how we engage patients—with empathy, clarity, and inclusion. His transition from live entertainment to healthcare was guided by one simple truth: “Everything you know about the fan experience, you need to port to the patient.”
Key Takeaways from the Session
- Patient-centered innovation is essential: Therapies must be developed with patient education, access, and dignity in mind.
- Living drugs require living systems: The success of CGTs depends on what happens both during and after manufacturing.
- Global innovation matters: Effective, affordable therapies developed abroad can—and should—be brought to wider markets.
- Manufacturing needs to catch up: Biological breakthroughs alone won’t deliver access. Scalable, efficient production methods are crucial.
- Holistic planning wins: Success requires integrating scientific, commercial, and human perspectives from the outset.
As Dr. Peshwa put it, “Innovation that only helps 1% of patients isn’t doing its job.” His current mission at MKC Biotherapeutics is to bridge that gap by globalizing proven innovations, expanding manufacturing access, and ultimately bringing transformative therapies to more people, everywhere.
Stay tuned for the next Bridging the Gap webinar, where science, compassion, and innovation continue to meet at the frontier of life-changing medicine.
About the Guest
Madhusudan V. Peshwa, Ph.D.
Chief Executive Officer, Board Member, MKC Biotherapeutics, Inc
Madhusudan Peshwa is a seasoned life sciences executive, entrepreneur, and investor with a track record of guiding biopharmaceutical innovations from early concept to commercial success. With leadership roles spanning private startups to public enterprises, he has driven FDA approvals, global partnerships, and strategic licensing agreements across the U.S. and Asia. Dr. Peshwa’s expertise spans cellular therapies, biologics, and vaccines, with deep experience in process and product development, regulatory strategy, manufacturing operations, and fundraising.
He has served as CEO of MKC Biotherapeutics, held CTO roles at Tessera Therapeutics, Mana Therapeutics, and GE Healthcare, and is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE). Known for building high-performing teams and forging impactful collaborations with academia, government, and industry, Dr. Peshwa remains at the forefront of therapeutic innovation—driven by a passion for advancing science to improve global health.