The traditional drug development paradigm draws the “finish line” before the payer. Regulatory approval leads directly to reimbursement by payers and patient access. Historically, payers had reluctantly accepted this paradigm and provided reimbursement with little influence on what they were receiving or whether they chose to accept it.
Today, the finish line for novel drugs in Europe is different; navigating the payer landscape can take up to two years after attaining regulatory approval. This results in many patients experiencing unacceptable delays to accessing lifesaving medicines.
It is assumed that by putting the patients’ needs first and working together, that all stakeholders can benefit in the following ways:
• Sponsor – earlier certainty of a path to market and business case, and earlier revenues through “provisional pricing”
• Regulator – earlier alignment with regulatory requirements
• Payer – earlier alignment with reimbursement requirements and opportunities to risk/cost share
• Patient – earlier access to medicines
However, executing this collaboration is difficult due to challenges in communicating across different competencies and motivations. The goals of payers differ from that of patients, sponsors, and regulators.
Join this webinar with Drs. Carl Kirkpatrick and Craig Rayner to learn how “pharmacology to payer” (P2P) can be used as a quantitative framework that bridges the disciplines of pharmacology, epidemiology, and health economics to support meaningful dialogue between industry, regulators, and payers. Their thesis holds that if this quantitative framework could stand stakeholders’ scrutiny, then its outputs would enable meaningful dialogue much earlier in the development process. The P2P framework has been applied to multiple indications in infectious diseases and is readily expandable across other diseases including dementia and multiple sclerosis. The approach may inform early target product profile (TPP) requirements for investigational drugs, procurement strategies, and strategic pricing and deployment decisions, including combination with adjacent non-therapeutic interventions.
By attending this webinar, you will learn why P2P offers an unprecedented opportunity to create impactful solutions that will help address market failures in drug development.
Craig Rayner, President of Consulting Services, Certara
Dr. Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early Development (Roche), Clinical Development (CSL-Behring), Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University).
Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities. He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University) and is broadly published in clinical pharmacology and also infectious diseases.
Carl Kirkpatrick, Professor of Pharmacy and Pharmaceutical Sciences, Monash University
Professor Carl Kirkpatrick is the Director of the Centre for Medicines Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. Since receiving his Doctor of Philosophy (Medicine) from the University of Otago (NZ) in 2002, Carl has worked at the University of Queensland and more recently Monash University. Carl has extensive knowledge in the area of PK/PD modelling and the factors that alter these processes, pre-clinical and clinical drug development, and clinical applications to optimization of therapy. He has worked on projects and produced publications across a number of therapeutic areas including diabetes, cardiovascular disease, cancer, aged/frailty, and infectious diseases (bacteria, viruses, and fungi).
Who Should Attend?
This program is intended for professionals from pharmaceutical and biotech companies involved in regulatory affairs, medical affairs, commercial strategy, health economics & outcomes research, and research & development.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.