Resources and Background Materials

We have compiled background materials and helpful resources on some of the topics and policies that will be discussed during the 2019 Patient & Health Advocacy Summit for your reference. Please feel free to use these materials before, during, and after the event. We hope you find this information helpful!

BIO 2019 Patient and Health Advocacy Summit Session Slides

• International Reference Pricing and the Impact on Patient Access and Future Innovation
• Keynote: 2020 Election: Impact on Patient Access
• Wednesday Session Slides ALL
• Value Assessment Frameworks
• Thursday Session Slides ALL

Practices and Principles: Navigating the FDA

• CDER Patient-Focused Drug Development
• The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative
• FDA Patient Affairs Staff
• FDA Patient Listening Sessions
• FDA-led Patient-Focused Drug Development (PFDD) Public Meetings

Closing the Gap: Partnering to Invest in Areas of Unmet Need

• The State of Innovation in Highly Prevalent Chronic Diseases:
  • Volume I: Depression Therapeutics
  • Volume II: Pain and Addiction Therapeutics
  • Volume IV: Alzheimer’s Disease Therapeutics
  • Volume III: Type 2 Diabetes and Obesity Therapeutics

2020 Election: Impact on Patient Access

International Reference Pricing and the Impact on Patient Access and Future Innovation
An Overview of Drug Pricing Proposals in Congress and the Administration

• BIO Issue Brief: International Reference Pricing
• BIO Issue Brief: Drug Importation
• BIO Infographic: The Partnership of Publicly Research & Private Innovation
• BIO Infographic: Biopharmaceutical Sector, A Driver of Innovation
• BIOtechNOW: The Challenges and Risks of Adopting Foreign Price Controls
• BIOtechNOW: Experts Weigh In on the Dangers of Importing Foreign Price Controls
• BIOtechNOW: Despite Administration’s “Sky-High Rhetoric,” Importing Foreign Price Controls Will Harm Innovation and Patient Access
• Pittsburgh Post-Gazette: Scientists can beat Alzheimer's
• STAT News: Pharma leaders: support the social contract on drug prices
• STAT News: Patients will be the losers as Pelosi’s plan to control drug prices nearly strikes out
• Boston Globe: Biopharmaceutical companies aren’t free-riding on government research
• Morning Consult: For Oncologists, Trump’s Medicare Part B Plan Makes Treating Cancer Harder
• STAT NEWS: Personalized treatments may be threatened by drug cost-containment proposals
• Bloomberg: House Drug Bill Would Save $345 Billion, Reshape Pharma Industry
• STAT News: CBO estimate on Pelosi drug bill misses its long-term impact on health
• USC Schaeffer Center White Paper: Global Burden of Medical Innovation

The Art of Storytelling

Value Assessment Frameworks
National Health Council Value Initiative Actions

• Value Model Rubric
  • Rubric
  • Manuscript - Value to Whom? The Patient Voice in the Value Discussion
• Value Framework Get Ready
  • Checklist
• NHC Educational Program: Health Econ 101

Online series, currently comprised of seven modules, introduces the basics of health economics and value assessment. Each module takes between 10-15 minutes to complete. 

• Patient-Driven Values in Healthcare Evaluation (PAVE) Center
• NHC Value Work Group
• NHC Report – Overcoming Barriers to Amplify Patient Voice

Principles for Interactions with Patient Advocacy Organization and Industry

• BIO Guiding Principles for Interaction with Patient Advocacy Organizations
• National Health Council Corporate Relations Standard 
• National Health Council Standards of Excellence
• PhRMA Principles on Interactions with Patient Organizations
• International Alliance of Patients’ Organizations Consensus Framework for Ethical Collaboration between Patients’ Organizations, Healthcare Professionals and the Pharmaceutical Industry

This year at the BIO Patient & Health Advocacy Summit we will feature 12 roundtable discussions. This is an opportunity to network with peers from the healthcare community, the roundtable discussions will bring together Summit attendees from different stakeholder organizations, as well as the biotechnology industry, for robust discussions led by roundtable hosts.

Roundtable discussions will be held from 12:00 PM - 1:30 PM in the Salon Rooms and Gallery Ballroom on Thursday, October 25.

Newborn Screening
Hosted by: Biogen

Think you need a dedicated DC team in order to make lasting policy change? Join this discussion to discuss successes, challenges and best practices for smaller patient advocacy groups to engage in public policy. This discussion will focus on:

• How to focus your policy requests for the biggest impact 
• The power of partnerships and broadening your supporters 
• How to engage beyond Capitol Hill: regulations and state policy efforts

Discussion Leader: Carolyn Jones, Director, Public Policy and Government Affairs

 

Access to Care in Medicare Part B
Hosted by: Bristol-Myers Squibb

The Trump Administration has proposed a robust agenda to address prescription drug prices and patient out of pocket costs, including changes to Medicare Part B.  HHS is beginning to roll out policies like step therapy and competitive bidding with the aim of promoting competition, but how will these proposals impact patient access to medicines?  Join Bristol-Myers Squibb for a discussion of recent changes to Part B and the future landscape for patients.

Discussion Leader: Kelsey Lang, Director, Federal Policy & Government Affairs

 

Lilly Advocacy Dialogues: Listening Tour – What are Your Priorities?
Hosted by: Lilly       

During this interactive conversation, Lilly Advocacy leadership wants to hear from YOU! What are your organization's key policy priorities as we hit the home stretch of the 115th Congress?                                                     

Discussion Leader: Michele Oshman, Director, Lilly Federal Advocacy

 

Advancing Inclusive Research
Hosted by: Genentech

Disparities in clinical research can compromise the promise of precision medicine.  At Genentech/Roche, we believe data representative of real world patient populations is required to optimize clinical outcomes, accelerate scientific discovery, and support the promise of personalized healthcare for all patients.  This interactive session will examine the role unconscious bias plays in exacerbating disparities in clinical research and why Genentech/Roche is Advancing Inclusive Research in response.  Join us as we explore how, together, we can Advance Inclusive Research and catalyze the promise of personalized healthcare for all patients. 

Discussion Leader: Gerren Wilson, PharmD, Associate Director, Alliance and Advocacy Relations

 

Protected Classes in Medicare Part D – Potential Changes on the Horizon? 
Hosted by: Gilead Sciences

Discussion Leader: Cookab Hashemi, Director, Federal Government Affairs & Advocacy, Gilead Sciences, Inc. 

With potential changes to the six protected classes (epilepsy, mental illness, cancer, HIV-AIDS and organ transplants) in Medicare Part D on the horizon, we would welcome an opportunity to discuss how these proposals will impact the patient advocacy communities in the near future.  Join the Gilead Sciences team and others in discussing the proposals in the President’s blueprint and RFI issued by the Department of Health and Human Services (HHS).  

Identifying Best Practices in Industry Patient Services: Listening to Advocacy Insights
Hosted by: Servier

Recent legal and public scrutiny on industry patient services programs highlights the importance of developing these programs with the utmost integrity. This session will be implemented to hear from advocates about what makes a successful industry housed patient services program, including discussion on Co-pay and Patient Asisstance efforts and how to bridge the patient services efforts from industry to the valuable services provided by advocacy partners.

Discussion Leader: Wendy Poage, MHA, Head of U.S. Patient Advocacy and Patient Services

 

Transformative Therapies – Ensuring Patient Access through Reimbursement
Hosted by: BIO

New, innovative treatments – “Transformative Therapies” – provide a significant, durable benefit and value for patient health outcomes, delivery of care, and overall healthcare spending. These innovative drugs and biologicals have the potential to transform the treatment of serious and rare diseases, but reimbursement pathways must be updated to reflect the past pace of innovation. Join us as we discuss ensuring robust reimbursement across sites of care and ensuring timely patient access to these new treatment options.

Discussion Leader: Mallory O’Connor, Director, Healthcare Policy & Federal Programs

 

State Efforts to Lower Prescription Drug Costs and Control Access to New Therapies
Hosted by: BIO

States have always played a central role in determining patient access to prescription medications, but as new transformative therapies come on the market, they are becoming more aggressive in scrutinizing the cost, value and access to these important therapies. This roundtable will focus on the 2019 state legislative and policy landscape, in particular what states are likely to do with respect to prescription drug pricing legislation, Medicaid waivers and/or plan amendments, and manufacturer co-Pay assistance programs.

Discussion Leader: Patrick Plues, Vice President, State Government Affairs

 

Value in the Eye of Which Beholder? 
Hosted by: BIO

Payors are increasingly turning to value assessment frameworks to measure the “value” of new innovations and medical breakthroughs. These tools can employ complex data and calculations, but as with everything, the devil is in the details. The frameworks payors choose and how they use them in coverage decisions will play an increasingly significant role in patients’ ability to access their medicines. Our discussion will focus on emerging trends in the use of value frameworks and what patients can do to ensure value is measured accurately. 

Discussion Leader: Alex Keeton, Director, Policy Research and Analytics

 

Incorporating the Patient Voice in Drug Development
Hosted by: BIO

Recent legislation has created new directives and opportunities to better incorporate patients’ experiences and perspectives into the drug development and regulatory process, and much progress has been made. The FDA has now released their first draft guidance on Collecting Comprehensive and Representative Input as well as two discussion guides and held a public meeting to inform the next few guidance documents on patient-focused drug development. This discussion will focus on the draft guidance, discussion guides, and recent public meeting and a sharing of thoughts on the progress of this important initiative. Table participants will also be able to discuss data that are currently being collected and used by others, and general questions around patient-focused drug development. Come interact with your colleagues to learn more about what others are doing in the patient-focused drug development space.

Discussion Leader: Danielle Friend, PhD, Director, Science and Regulatory Affairs

 

Personalized Medicine: “Is This Therapy Going to Work for Me?”
Hosted by: BIO

A customizable healthcare model where medical decisions, practices, and/or products are tailored to the individual patient based on an individual’s genetic profile is no longer a fantasy. This discussion will focus on issues surrounding genetic testing such as access, privacy, targeted therapies, and whether patients should get tested.

Discussion Leader: Phi D. Vu, JD, Director, Diagnostics and Personalized Medicine Policy

 

Cell and Gene Therapy and Genome Editing
Hosted by: BIO

We have entered a new era of genomic medicine, which makes possible the use of cell and gene therapy products as well as gene editing technologies to treat and cure diseases. This session will discuss the scientific differences between these technologies, their potential and current use in the clinic, and the current regulatory framework in the US, including FDA’s draft framework on Gene Therapy products.

Discussion Leader: Sesquile Ramon, PhD, Director, Science and Regulatory Affairs

 

*Updated October 18, 2018. Subject to change.

This event brings together patient advocacy organizations, academia, regulators, biotechnology industry, and other stakeholders for two days of robust programming to discuss timely policy issues and share best practices. The Summit also provides invaluable networking opportunities to advance partnership among stakeholders in the healthcare ecosystem. Last year, the Summit convened over 350 attendees from more than 200 different organizations.

Registration is now closed for the 2019 Patient Summit.

If you have any questions or need to cancel your registration, please contact bioalliancedevelopment@bio.org.

Lunch Roundtable Discussions
12:30 PM - 1:30 PM
Grand Ballroom

A new opportunity to network with peers from the healthcare community, the roundtable discussions will bring together Summit attendees from different stakeholder organizations, as well as the biotechnology industry, for robust discussions led by roundtable hosts.

Best Practices in Creating Patient Centric Clinical Trials
Hosted by: Shire
Table 2

A discussion to explore successes, challenges and best practices in advancing rare disease R&D by integrating patients’ points of view during the discovery and development lifecycle including: 

• Patient, caregiver and advocacy group input into clinical trial design and processes
• Patient & patient advocacy group engagement with the FDA
• Accelerating clinical trial recruitment
• Patient registry creation and management to support patient reported outcome & natural history data collection

Discussion Leader:

Melanie Ivarsson, Director of Clinical Programs for Global Research and Development

 

Lilly Advocacy Dialogues: Listening Tour – What are Your Priorities?
Hosted by: Eli Lilly and Company                                                                
Table 1                                                                              

During this interactive conversation, Lilly Advocacy leadership wants to hear from YOU!  What are your organization’s key policy priorities both in the short term and over the long haul?  What are your concerns, and ideas as to how to address them.

Discussion Leaders:

Michele M. Oshman, Director, Federal Advocacy and Alliance Development

Tom Wallace, Senior Director, Global Advocacy and Professional Relations

 

The Future of Value 101:  Value Based Contracting
Hosted by: Bristol-Myers Squibb                                          
Table 6

Patients will be better served in a health care system based on value, but what does that mean? Join Bristol-Myers Squibb and their US Health Policy Lead, Stefanie Wiegand, for a 101 introductory discussion on value and how we can move towards value based contracting for healthcare services and products.

Discussion Leader:

Stefanie Wiegand, US Health Policy Lead

 

Personalized Medicine: “Is This Therapy Going to Work for Me?”
Hosted by: BIO
Table 3

A customizable healthcare model where medical decisions, practices, and/or products are tailored to the individual patient based on an individual’s genetic profile is no longer a fantasy. This discussion will focus on issues surrounding genetic testing such as access, privacy, targeted therapies, and whether patients should get tested.

Discussion Leader:

Phi D. Vu, JD, Director, Diagnostics and Personalized Medicine Policy

Thank you for registering for the BIO Patient & Health Advocacy Summit: Programming and Partnering Webinar. 

You will receive a confirmation email shortly. If you have any questions about the Summit, please contact bioalliancedevelopment@bio.org. 

Next Steps

• Book your hotel room in the BIO Hotel Block at The Mayflower Hotel
• View the Schedule 
• Attendee Testimonials
• Photos and Videos

 

 

 

Schedule meetings with fellow attendees during the 2019 Summit using the BIO One-on-One Partnering(TM) system. BIO One-on-One Partnering will allow you to:

• Post your organization's profile in the BIO One-on-One Partnering system which will be searchable by registered Summit attendees.*
• Request and accept meetings with other attending organizations and companies to explore new collaborations during designed partnering hours.
   

The partnering system will open in early October. Once the system is open, registrants will receive partnering credentials from biopartnering@bio.org within 2-3 business days of registration.

*All attendees will be provided partnering accounts unless they choose to opt-out during the registration process. 

About BIO One-on-One Partnering™

BIO One-on-One Partnering is the most efficient way to connect and explore partnerships with patient advocacy organizations biopharmaceutical companies, and other healthcare stakeholders to advance your public policy and research and development agendas.

Our online partnering system allows you to communicate directly with other  Summit registered attendees. You can request  and accept invitations to meet with other organizations and companies.  Once your meetings are mutually accepted, BIO does the scheduling for you so you arrive with a plan and get the most from your Summit experience!

5 Tips for Successful Partnering

1. Fill out your profile, focus on the opportunities and ideas you have to offer.
2. Mark when you are available to take meetings on your calendar. Make as much time available as you can during the 3-hour period to maximize your number of meetings.
3. Search for and send meeting requests to Summit attendees you would like to meet.
4. Accept, reject or otherwise manage your incoming meetings requests.
5. Repeat steps 3 and 4 every few days since new companies join and send requests regularly.

Need assistance with partnering?

Email: BIOpartnering@bio.org  
Phone: 866-356-5155 (US) or +1-202-962-6666 (Int'l)

“The Pancreatic Cancer Action Network is embarking on a new initiative called Precision Promise, a precision medicine clinical trial system for pancreatic cancer patients. We will be working with collaborators including researchers, clinicians, drug and diagnostic companies, and the FDA. We have funded clinical trials in the past, but never actually sponsored a clinical trial. Sponsoring clinical trials brings about new regulatory issues that we have not faced before, and the topics at the Summit are addressing some of those areas. My hope in attending the Summit is to better understand some of the issues we will be facing, how to address them and who the experts are that can help us.” - Julie Fleshman, President and CEO, Pancreatic Cancer Action Network

 

“The BIO Patient and Health Advocacy Summit enhanced ICAN's relationships with key stakeholders, as well as fellow advocates, which will help us to even more effectively handle upcoming challenges. I learned a tremendous amount from the speakers and learned an equal amount from the attendees. It was a real pleasure to meet so many fascinating people.” - Steve Horn, Director, State Government Relations, International Cancer Advocacy Network

 

“I began my career simply with the hope of doing something in my father's memory, but have since met many individuals whose personal stories and courage have added to my passion and commitment. I hope to connect with companies with a mutual focus on lung cancer to see how we may partner together.” - David LeDuc, Executive Director, Bonnie J. Addario Lung Cancer Foundation

 

“This is an incredible opportunity to connect with stakeholders to learn more about potential collaborations, regulatory issues and the strength in bringing the patients voice early on in the process of therapy development to treat diseases. It would be wonderful to engage with other advocacy groups and other stakeholders that may see our vision and want to join forces in translating therapies for the Charcot-MarieTooth Community. In addition, we would hope that our experiences and successes could help others.” - Allison Moore, CEO, Hereditary Neuropathy Foundation

 

“The opportunity to learn what is working and not working in other areas and the opportunity to learn the needs of other diseases should provide an additional framework in which to operate. The more informed and trained an advocate can be the better chance of making a difference in someone's life.” - Stewart Perry, Secretary, National Diabetes Volunteer Leadership Council

 

“Learning from other non-profits is essential to growing our mission and vision. The American Brain Coalition strives to constantly be aware of what other scientific non-profits are working on so we can align and collaborate.” - Katie Sale, Executive Director, American Brain Coalition

 

“The BIO Patient & Health Advocacy Summit is a very powerful intersection of pharma, biotech, and advocacy. The exchange of challenges, ideas, concerns, and opportunities at this BIO conferences is a very powerful force in refining the perspectives, thinking, and impacting future plans of those attending. The setting is modest in size allowing not just for superficial networking, rather there is time and space for in depth conversation and follow-up.” - Dean Suhr, President, MLD Foundation