Let’s talk: Moving CGTx clinical development forward in 2023

Clinical trials are foundational in developing innovative life-saving treatments and cures for patients. But for developers, the considerations for clinical trial success are vast and complex. This webinar will convene advanced therapy experts from leading life-science organizations to discuss the current state, and future of clinical development for cell and gene therapies.

Key Learning Objectives:
  • Improving efficiency and quality of clinical research (technology, modeling, simulation)
  • Patient access and clinical trial diversity
  • Identifying and overcoming key challenges for a successful study execution
  • Key considerations for evaluating partners (CROs, vendors, etc.)
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Dawn Buchanan

Dawn Buchanan

VP Clinical Operations, AffyImmune

Dawn is a seasoned Clinical Operations leader, with over 25 years of industry experience. Her career has held a focus in early development oncology at both large and small pharma. Prior to joining AffyImmune, Dawn led the entire early development Cell Therapy portfolio for clinical trials at BMS. Her tenure at BMS/Celgene includes 5 years in Cell Therapy in both Clinical Operations and Cell Therapy Manufacturing roles which has provided beneficial synergies in her work at AffyImmune.

Kinnari Patel

Kinnari Patel

President & COO, Rocket Pharmaceuticals, Inc.

Kinnari Patel is President & Chief Operating Officer for Rocket Pharma. She oversees the regulatory, clinical execution, global program teams, alliance management, CMC, quality and development organizations. She has fifteen years of rare disease Research & Development experience including in Regulatory Science, Pharmacovigilance, Policy, and Quality Compliance gained at leading pharmaceutical companies including AstraZeneca, Bristol-Myers Squibb, Novartis, Hoffmann La-Roche, and Pfizer. She has led both small molecule and biologic development programs from Phase I through Phase IV across multiple therapeutic areas including immuno-oncology, oncology, respiratory, virology, transplantation, and metabolism. Most notably, Kinnari has worked on Opdivo (nivolumab) from Phase I through BLA filing for metastatic melanoma, RCC and NSCLC, submitted and gained approval of Myalept (metreleptin) for ultra-rare lipodystrophy disease, and submitted Valcyte® (valganciclovir hydrochloride) NDA for prevention of cytomegalovirus disease in pediatric kidney and heart transplant patients.

Kinnari received dual degrees of B.S. in Biology and a Doctorate of Pharmacy from the USciences in Philadelphia, PA. She also completed a two-year Post-Doctoral Regulatory Affairs Fellowship through Rutgers University. Additionally, she received her Executive MBA from NYU Stern School of Business with a specialization in Corporate Finance, Leadership, and Strategy. Most recently, she graduated from the C-Suite Harvard Business School Advanced Management Program.

In her spare time, Kinnari has a passion for mentoring, teaching, and volunteering for non-profit organizations.

Ramona Repaczki-Jones

Ramona Repaczki-Jones

Executive Director, Treatment Center Operations, Iovance Biotherapeutics

Ramona Repaczki-Jones serves as the Executive Director, Treatment Center Operations, of Iovance Biotherapeutics, where she is focused on accelerating and scaling the transition of cell therapy products from clinical to the commercial setting.

In her role, Ramona bridges the gaps of traditional clinical trials with expertise in logistics and operations necessary for cell therapy. Her impact on a treatment center minimizes disruption while leveraging a collaborative approach to supporting innovative cell and gene portfolios. She brings over 15 years of experience in cell and gene therapy, treatment center operations, quality, chain of identity, and chain of custody (COI/COC). Her experience spans academic cell therapy programs, non-profits, and industry settings.

She has led the development of academic service lines to onboard commercial therapies and was part of a cell therapy standards-setting organization. Ramona’s work has supported various publications in the Biology of Blood and Marrow Transplantation, presentations at national and international conferences, and innovative commercial chain of identity/chain of custody [COI/COC] systems.

Suma Krishnan

Suma Krishnan

President, Research & Development, Krystal Biotech, Inc.

Suma Krishnan is the President and Founder of Krystal Biotech (NASDAQ: KRYS). She has over 25 years of drug development experience. At Krystal, she has spearheaded a topical gene therapy in the treatment of dystrophic epidermolysis bullosa from concept to development to regulatory filing of the biological application. Prior to Krystal, she worked on multiple gene therapy programs from discovery to the clinic as Head of Therapeutics at Intrexon Corporation (NYSE:XON). Previously, she led the discovery, development, and approval of Vyvanse™ (blockbuster drug to treat ADHD) as SVP, of Product Development at New River Pharmaceuticals. Prior to that, Suma advanced approval of Adderall XR® and Fosrenol® at Shire. She began her career as a discovery scientist for Janssen Pharmaceuticals, Inc. Suma has multiple publications and issued US and global patents. She received her Master of Science in Organic Chemistry from Villanova University, an M.B.A. from the Institute of Management and Research, and an undergraduate degree in Organic Chemistry from Ferguson University.

Teresa Pokladowski

Teresa Pokladowski

Regional VP, Clinical Business Solutions, North America, Precision for Medicine

Respected business development strategist, building successful clinical programs for clients in Massachusetts. Innovator of fresh approaches to biomarker planning, translational solutions, and clinical study design. Experienced in executing phase 1-4 clinical trials, specialty lab services, companion and in vitro diagnostic strategies, and biomarker data management.

Teresa is a subject matter expert with Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market.