RAPS’ Regulatory Convergence is now just a little more than six weeks away so it’s a good time to take a look at the conference agenda and start planning how best to spend your time in San Jose. While each session will certainly appeal to different people based on their specific work or interests, we picked out a few to highlight based on current hot topics or popular areas within regulatory affairs.
Highlighted below are some standout sessions that might help you with your Convergence plans, but bear in mind this list is by no means complete. Of the more than 100 individual sessions, featuring more than 250 speakers, there are many that will be highly informative and well worth attending. With that caveat, we present in no particular order five of the 10 sessions we identified that are likely to be popular this year. Sessions six through 10 are covered in part two.
The EU has approved biosimilars more quickly, but momentum has been gaining steam in the US. The US Food and Drug Administration (FDA) has now approved two biosimilars and advisory committees have unanimously backed two more. Still, fostering a robust market for biosimilars while maintaining proper standards remains a tricky balance. This session on Tuesday, 20 September, 3:30–4:45 pm, will examine some of the key questions, and FDA’s Leah Christl, associate director, therapeutic biologics, CDER, will be among the speakers.
2. Aligning Regulatory and Market Access: How to Establish a Drug’s Value for Different Stakeholders
The way drugs are developed and brought to market is changing rapidly. Including payers and patients earlier in the process helps ensure treatments are viable as products and valuable to the people they are intended to help. This session, to take place Tuesday, 20 September, 8:30–10:00 am, will examine the challenges of involving these stakeholders in the development process, expedited pathways and other key considerations.
3. Breakthrough Therapy Designation/Accelerated Approval/EMA’s PRIME
FDA’s breakthrough designation was established to foster innovation in the development of treatments for serious or life-threatening conditions. Last year, more than 20% of the 45 new drugs approved by the agency were breakthrough drugs, and this year, the European Medicines Agency (EMA) established a similar program, known as the PRIME (PRIority MEdicines) scheme. This session on Monday, 19 September, 10:00–11:15 am, will examine these accelerated approval programs and their strengths and weaknesses.
4. Next Generation Sequencing (NGS) Tests and the Cost of Personalized Medicine
The promise of personalized medicine hinges on reliable and accurate NGS technologies. FDA recently released two draft guidelines on NGS. This session, taking place Monday, 19 September, 10:00–11:15 am, will examine the agency’s regulatory framework, the current process for approving NGS-based oncology panels and the costs and reimbursement challenges for personalized medicine.
5. Handling Regulatory Challenges: How to Respond with Grace Under Pressure
This interactive session, Monday, 19 September, 1:30–3:00 pm, was introduced at last year’s Convergence, and it proved to be a big hit. The session is facilitated by moderator Daniela Drago, PhD, who is an assistant professor and director of the clinical and translational research and regulatory affairs program at George Washington University. Attendees will be presented with a series of challenging real-world scenarios regulatory professionals have faced and asked to determine the best solution for each. A panel of regulatory experts will then discuss their proposed solutions and the rationale behind them. If this year’s session is anything like last year’s, the room will be packed so get your seat early.
For more information or to register for the 2016 Regulatory Convergence, visit RAPS.org/Convergence.
10 Can't Miss Regulatory Convergence Sessions: 6-10