NCSL COVID-19 WEBINAR SERIESapril 17, 2020 ncsl covid-19 webinar series covid-19 therapies and...
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APRIL 17, 2020 NCSL COVID-19 WEBINAR SERIES COVID-19 THERAPIES AND VACCINES
Transcript of NCSL COVID-19 WEBINAR SERIESapril 17, 2020 ncsl covid-19 webinar series covid-19 therapies and...
APRIL 17, 2020
NCSL COVID-19 WEBINAR SERIES
COVID-19 THERAPIES AND VACCINES
The National Conference of State Legislatures is the country’s most trusted bipartisan organization serving legislators and staff. We promote policy innovation, create opportunities for lawmakers to share knowledge and ensure state legislatures have a strong, cohesive voice in the federal system. We do this because we believe in the importance of the legislative institution and know when states are strong, our nation is strong.
COVID-19 WEBPAGE
Information on state policies and responses related to continuity of government, education, fiscal, elections, criminal justice and more.
Go to www.ncsl.org
April 17| COVID-19 THERAPIES AND VACCINES
▪ FDA update on development of COVID-19 therapies and vaccines
▪ Pharmaceutical industry response▪ Generics and biosimilars industry response
FDA UPDATE
Haley NicholsonSenior Committee DirectorHealth and Human ServicesNCSL State Federal Affairs
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▪ Coronavirus Treatment Acceleration Program (CTAP): working on therapies as well as clinical trial conduct, drug shortages, hand sanitizers, fraudulent activity, drug imports and stakeholder engagement, among others
▪ With CTAP, triaged requests from developers and scientists that are working develop or evaluate new therapies
▪ This includes ultra-rapid interactive input, prioritizing products on their scientific merits
▪ CTAP support includes redeployed medical and regulatory staff, redeployed medical, operations and policy staff, all helping to streamline processes for developers and scientists as well as health care providers and researchers
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▪ FDA has been working with companies to identify potential new treatments with 284 clinical trials underway, along with 10 therapeutic agents in active trials and another 15 in planning stages
▪ For vaccine development, the FDA has been able to help accelerate development timelines to enter into clinical trials in humans as quickly as possible
▪ Last month, the FDA and European Medicines Agency jointly chaired the first global regulators meeting to discuss strategies to facility the development of a SARS-CoV-2 vaccines
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Resources:
▪ https://www.fda.gov/drugs/emergency-preparedness-drugs/coronavirus-covid-19-drugs
▪ https://www.ncsl.org/ncsl-in-dc/publications-and-resources/covid-19-daily-announcements-from-federal-agencies.aspx
FDA UPDATE ON THERAPIES, VACCINES AND OTHER RELEVANT ACTIONS
Anand ShahDeputy Commissioner for Medical and Scientific AffairsOffice of the CommissionerU.S. Food and Drug Administration
NCSL Briefing:Biopharmaceutical Industry Efforts to Combat COVID-19
April 17, 2020
How Industry is Working to Combat COVID-19
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Developing Treatments and
VaccinesPartnerships
Monetary & In-Kind Support Supply Chain Integrity
Factors Contributing to Industry’s Quick Response
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Armed with experience garnered from
previous outbreaks and a vast
storehouse of knowledge about
infectious diseases like influenza,
malaria and HIV, researchers are
working to develop and deliver
diagnostics, treatments and vaccines to
save lives and restore the rhythms of
daily life for billions of people.
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As of April 8, 2020, of the more than 300 global clinical trials for COVID-19 treatments and vaccines, more than 40 of these trials are taking place in the United States.
Overview of the R&D Pipeline
Timeline for a COVID-19 Vaccine
It will take a minimum of 18-24 months for potential FDA approval of a COVID-19 vaccine –
this is significantly less time than it took previously without compromising safety
o In 2003, it took 20 months from sequencing SARS to the first human study of a vaccine
o Today, less than 4 months from sequencing COVID-19 to the first human study of a vaccine
Some approaches offer speed – knowing the virus’s genetic sequence, companies can
synthesize and scale up production of a RNA vaccine in a matter of weeks
Some approaches can boost the impact of a potential vaccine – adjuvants can boost the
immune response and minimize amount of vaccine needed
There is a high failure rate – Only 5-10% will succeed, meaning we need lots of shots on goal
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Ensuring Continuity in the Drug Supply Chain
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Companies FDA
• Companies report substantial data on potential
shortages to FDA and they work closely with the
agency to prevent and mitigate shortages
• Companies have robust inventory management
systems that include:
➢ Data on anticipated demand reflecting historical
demand and supply data
➢ Risk management plans that address additional or
alternate manufacturing sites, inventory reserves,
and/or a range of global external suppliers
➢ Logistics planning to ensure continuity in shipping of
supplies
• FDA is working with individual companies to
facilitate ramping up manufacturing to
address surges in demand and expediting
approvals of changes in the drug supply chain
• FDA is working closely with companies to
expedite development and availability of
COVID-19 treatments and vaccines, including
helping companies to leverage scientific and
clinical trial data from the United States and
other countries
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Resources for You and Your Communities
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What is MAT?
The Medicine Assistance Tool (MAT) is a web platform designed to help patients, caregivers and health care providers learn more about some of the resources available to assist in accessing and affording medicines.
950+Public and private programs
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How can MAT help patients learn more about their medicine costs?
PhRMA member companies are committed to helping patients make more informed health care decisions by providing more transparency about medicine costs. Through MAT.org, we share links to member company websites that include:
• List price of a medicine
• Average estimated or typical patient out-of-pocket costs
• Other context about potential cost of the medicine
Each member company has individually and independently determined the content of any cost information provided on their websites.
PhRMA has joined forces with Healthcare Ready to facilitate the financial support and in-kind donations of personal protective
equipment, medicines, and critical medical supplies.
These requests can be made by contacting [email protected].
Examples of requests Healthcare Ready can support include:
• Personal protective equipment
• Medical supplies
• Assistance in helping a constituent fill their prescription
PhRMA and Healthcare Ready
Healthcare Ready Resources
RX OPEN: Provides access to open and closed pharmacies in a disaster-stricken area.
RX ON THE RUN: Personalized wallet card to document prescriptions and other important medical information.
COVID-19 Resource Hub: Resources for individuals and patients including state-level insurance emergency orders on prescription refills and telehealth coverage policies for COVID-19, and relevant pandemic business continuity resources.
Healthcare Readyprograms for constituents
Resources and Information Available at PhRMA.org/Coronavirus
Full list of member company efforts to combat COVID-19
Factsheet on the pipeline for new vaccine and treatments
Open letter from PhRMA CEO and Chairman
Links to blog posts on The Catalyst
Infographic on how the industry is fighting COVID-19
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PhRMA’s Team in Your States (East to West)
Name Region Email
Kevin Bourque MA, ME, VT, CT, RI, NH [email protected]
John O’Connor NY, NJ, DC [email protected]
Nicole Wood PA, VA, DE, MD [email protected]
Andy Corsig OH, IN, KY, WV [email protected]
Thomas Hardaway NC, SC, TN, GA [email protected]
Mike Anway FL, AL, AR [email protected]
Peter Fotos IL, MI, MO, WI [email protected]
Brynna Clark TX, LA, MS [email protected]
Linda Carroll-Shern MN, IA, ND, SD, NE [email protected]
Dana Malick CO, UT, NM, WY, OK, KS [email protected]
Jodi Hack WA, OR, MT, AK, HI [email protected]
Flo Kahn CA, AZ, NV [email protected]
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April 17| COVID-19 THERAPIES AND VACCINES
Questions and Answers
Please type your questions into the chat box in the lower left-hand corner of your screen.
COVID-19 WEBPAGE
Go to:
www.ncsl.org or
https://www.ncsl.org/research/health/ncsl-coronavirus-covid-19-resources.aspx
