FDA and 21st Century Entrepreneurial Regulation
Broadcast Date: 1/25/2017
Guest presenter: Peter Pitts, Former FDA Associate Commissioner and President, Center for Medicine in the Public Interest
Entrepreneurial regulation is a philosophy that allows agencies such as the FDA to be both regulator and colleague to the industry. In such an environment, regulators gain the ability to:
- Develop policies that are an incentive for innovative medicines
- Advance the assessment of healthcare technologies
- Facilitate a competitive pharmaceutical marketplace
- Identify and advance important opportunities
This webinar explores these opportunities and how pharmaceutical companies can collaborate with the FDA to build better, more equitable healthcare.
Transparency in Clinical Evidence Sources
Broadcast Date: 10/26/2016
Study transparency is key to pharmaceutical data. The ability to easily access the clinical evidence used to make reimbursement decisions could potentially save time and minimize redundancy. However, the availability of this information in a consistent and accessible format is a challenge.
This webinar examines the behavior of influential HTA agencies, matching unique clinical trial outcomes with HTA reviews to see how much information is shared. Then take part in an interactive panel discussion on the impact of unstructured data on market access and proven techniques to manage this data.
Hepatitis C: A Modern Market Access Perspective
Broadcast date: 9/28/2016
An in-depth look at current trends in the Hepatitis C market landscape. We provide a data-driven analysis of reimbursement decisions made by the Scottish Medicines Consortium (SMC)—the first agency to review all the new Hepatitis C treatments—to see what drugs are moving to market and where others have stumbled.
For health technology assessment (HTA) agencies, cancer drugs provide a special set of challenges and level of complexity in their reimbursement evaluations. Measuring surrogate endpoints, valuing high-cost combination therapies, and keeping up with innovations like immunotherapies are all nuanced examples that are especially challenging in oncology.
Do You Trust Your Market Access Data?
Broadcast date: 6/29/2016
Developing a successful market access strategy is no easy task, especially in a fast-moving global market. Often times the key to success is understanding subtle nuances and avoiding common mistakes that can derail your plan and keep you up at night. This presentation considers five common market access missteps and how to avoid them.
Designing Your Clinical Trial for the Long Haul
Broadcast date: 4/27/2016
Clinical trials have been traditionally designed with regulatory approval in mind, often overlooking key differences in goals between reimbursement (HTA) and regulatory agencies. This webinar features a discussion on best practices for using HTA data to better inform trial design including how this can save development time and help avoid negative decisions.
Can the Patient Voice Change the Conversation?
Broadcast date: 3/30/2016
Health Technology Assessment (HTA) agencies are widely promoting the public’s ability to participate in the HTA decision-making process through patient/professional group submissions. This looks like a promising opportunity for manufacturers striving to continually demonstrate the value of their innovations—but is patient voice really having an impact? This webinar takes a data-driven approach to examine the decision outcomes from four key agencies and the relationship between those decisions and patient/professional group submissions.
Not All Positive Decisions Are Equal
Broadcast date: 2/24/2016
In Market Access positive reimbursement decisions are the end goal that drive decision-making throughout the development lifecycle. But often a positive reimbursement decision is only partially positive and restricts the population that has access to the medicine. Making the assumption that every positive decision is without restriction may have repercussions on the critical decisions you make about that drug, from clinical trial design to projection of market size based on population. This webinar offers an insightful discussion that examines the nuances of positive decisions and how to interpret them.
Could Learnings from European Healthcare Markets Apply to U.S.?
Broadcast date: 1/20/2016
The United States has long faced the difficulty of drug pricing and evaluating the cost-effectiveness of drugs—especially expensive ones. This webinar examines how several European countries use health technology assessment (HTA) agencies to evaluate efficacy and/or cost-effectiveness, and explores how the U.S. might be able to replicate these methods to solve its drug valuation crisis.
Highlights from the 2015 Context Matters webinar series, including hot industry topics like "Does Cost-Effectiveness Matter?" "HTA Secrets Unlocked," and "Building a Predictive Model for Market Access."
Broadcast date: 10/28/2015
Broadcast date: 7/29/2015
Broadcast date: 5/27/2015
Building a Predictive Model for Market Access
Broadcast date: 11/19/2015
Drafting a Blueprint for
Market Access in Six Steps
Broadcast date: 9/29/2015
Does the CDF Have
a Score Threshold?
Broadcast date: 6/24/2015
Is HTA Variability
by Agency Design?
Broadcast date: 3/11/2015