This webinar discusses how early stage planning taking into account commercial production, logistics, reimbursement, and health inequities can lead to successful approvals and market adoption.
A viable cell therapy business model and reimbursement plan needs to begin ‘with the end in mind', more so than in traditional small molecule development. Much higher upfront capital expenditure, the unique needs of diverse patient populations, and potential logistical and reimbursement challenges may be barriers that manufacturers face in launching novel, targeted therapies. In niche markets as well as broader therapeutic areas that cell and gene therapies are now targeting, getting the product to the patient both seamlessly and efficiently is crucial. So innovative approaches that incorporate the needs of specific patient populations, payers, and providers need to be explored during clinical development.
This innovation needs to occur across the entire spectrum, from the referral, evaluation and approval of therapy, right through to administration and monitoring. Some core principles will not change, such as reimbursement strategies will primarily be driven by payer type, site of care, coverage factors (e.g., level of unmet need, cost offsets, strength of clinical data, etc.) and product cost. However manufacturing is an area where new thinking, such as decentralized approaches to manufacturing, could increase the likelihood of viable cells being available to a greater number of patients. And this could potentially be a first step in democratizing the cost of expensive cell therapies to make them more accessible to patients from all socio-economic backgrounds.
Key Topics Include:
- Understand challenges associated with commercializing cell therapies, recent advancements, and where the greatest barriers remain.
- Gain a better understanding of who currently has access to cell and gene therapies.
- Learn how manufacturers can promote equity and ensure access.
Presenters
Amanda O'Hora
Amanda O’Hora, is Senior Vice President of Reimbursement & Market Access at Magnolia Market Access. She has more than 25 years’ experience conceptualizing and implementing a broad range of commercialization activities for manufacturers of drugs, biologicals, cell and gene therapies, devices, diagnostics, and digital therapeutics. In addition to life science manufacturers, she also supports trade associations, health plans, and health systems.
Her areas of expertise include reimbursement (coding, coverage, and payment), manufacturer patient support services, health policy, and market access for payers, providers and patients. She is adept at integrating data analytics, market insights, and personal experience into developing strategies, putting them into action and enhancing them in response to market changes. She is a nationally recognized speaker on reimbursement, patient support services and market access, having presented at numerous conferences, the Centers for Medicare and Medicaid Services (CMS), state Medicaid offices, health systems, national sales meetings, and other events.
Prior to joining Magnolia, Amanda consulted for more than 20 years with life sciences companies on market access, reimbursement, health policy, and patient support services engagements. She also advised manufacturers on the design and development of their patient support services programs and managed the day-to-day operations of multiple outsourced patient services programs.
Amanda received her Bachelor of Arts in History from the Florida State University.
Ajay Keshava
Ajay Keshava is Senior Vice President of Commercialization Strategy at Magnolia Market Access. Ajay has over 20 years of experience both in industry and management consulting, in which he has covered all aspects of cross-functional development, approval and launch of drug, device and combination products, business development and acquisitions, interactions with regulators, as well as organizational design and scale up for both pharma and device companies.
Prior to joining Magnolia, Ajay worked at United Therapeutics, a manufacturer of specialty drugs for orphan lung diseases. During his tenure, he built the corporation’s program management function that assisted with key commercial acquisitions, and structured, facilitated, and oversaw the development and commercialization of oral, inhaled, and parenteral therapies. Ajay held a significant leadership position in the development, approval, and launch of the first dry powder inhaled treatment for pulmonary arterial hypertension. He also led the development and release of the company’s first digital therapy agnostic app focused on pulmonary hypertension and built the initial strategy for United Therapeutics’ connected device program.
Before working in industry, Ajay spent a number of years in pharmaceutical consulting, initially in operational excellence, with projects that focused on decreasing cycle time, improving throughput, and gaining efficiencies. His focus later shifted to process and organizational design in pharmacovigilance, regulatory, quality and compliance organizations for both small, mid-sized, and large pharma and biotech organizations.
Ajay received his Bachelor of Chemical Engineering and Master of Biomedical Engineering from the University of New South Wales in Sydney, Australia, and a Master of Public Affairs from Columbia University in New York.
Pamela Landsman-Blumberg
Pamela Landsman-Blumberg is an industry recognized subject matter expert in real world data (RWD) evaluation and real world evidence (RWE) generation. Her work product has improved the evidence- and value-based decision making of payers, providers, and policymakers. Pam currently advises industry and trade associations on all aspects of fit-for-purpose RWD, RWE, and HEOR strategy.
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