December 11-12, 2018
Westin Washington DC,
Washington, D.C.
Marshal in the Next Era of US Regulatory Policy as it Intersects with Breakthrough Scientific Innovation
Connect with FDA, CMS and CDRH for Regulatory Updates, Policies and Initiatives Impacting BioPharma and Medical Devices
Join this timely in-person event for invaluable insights into exciting developments in biosimilars, RTT, drug pricing, and more.
Shake Hands With FDA & CMS
NEW HALF-DAY WORKSHOP! Innovations in the Science of Patient Input
Presented by FasterCures, a Center of the Milken Institute
Stakeholders across R&D have a significant interest in collecting data directly from patients to understand their unmet medical needs, perspectives on meaningful outcomes, and preferences when making medical decisions as well as to understand how medical products behave in the real world.
- Hear directly from patients and patient organizations about innovations on patient-generated data and what value these will bring to patients.
- Learn how real-world evidence can be derived from patient-generated data and influence decision-making by regulators, payers, and the research community.
- Identify opportunities for innovations from within the medical device industry to collect and use patient-generated data in decision-making.
Exclusive Panel! The Future of the US Biosimilars Marketplace
CMS has recently announced a change to the Biosimilar Coding for Reimbursements policy that will not only set the stage for a more dynamic, competitive biosimilars market, but increase awareness and adoption of biosimilars as a whole. Patients will ultimately benefit with system-wide cost-savings and increased options available them. Join us to examine the 2017 developments surrounding biosimilars in the US like the Supreme Court decision in June and questions like:
- What are the key mistakes that biosimilar developers are making repeatedly?
- What are some cost effective approaches for the development of new biosimilars?
- What impact will the recent CMS reversal on biosimilar reimbursements play to US Biosimilars Market and Adoption?
Get latest information on CDER, biosimilars, and PROs directly from decision-makers
At this year's event, hear CDER deliver a new drug update for 2018. We’ll also examine the state of biosimilars in the US, and how these medicines may impact the cost curve across healthcare. A full range of topics to be discussed include:
Know What's Coming Down the Pipeline
Hear directly from CDER on goals, trends, and new drug development for 2017 and beyond.
Biosimilars Implication
Understand the economics and impacts of biosimilars on healthcare through global case studies.
The Evolving Role of PROs
Understand the implication of a more vocal patient role in drug development and feedback through a panel of patient advocacy groups and industry and FDA leaders.
Hear the latest developments in the drugs program and formulary guidance directly from decision-makers
FDA/CMS Speaker Q&A's
We asked our speakers to share their expertise on recent developments in federal drug regulations, industry changes, and the resulting impact on their work.
I would like to thank the whole event team for putting together this conference. Conferences are made by its participants and the group assembled here today is so diverse and truly experienced.
Mark McClellan, MD/PhD
Former FDA Commissioner and CMS Administrator
Summit provided a rare opportunity for a broad group of life science companies and regulators to interact in a frank, yet cooperative manner. Great opportunity to learn from peers and our FDA / CMS customer.
David McNinch
Sr. Director of Marketing
Affymax
Nobody does it better!!! Best healthcare business policy conference of the year.
John Kamp
Executive Director
Coalition for Healthcare Communication