bio.org

Use Authorization phase. Authorization Use

technologies in the post-Emergency post-Emergency the in technologies

commercialization of diagnostic diagnostic of commercialization

to provide a roadmap for for roadmap a provide to

infrastructure.

Federal government will need need will government Federal •

agencies with essential capacities and and capacities essential with agencies

weakness. companies and U.S. government government U.S. and companies

interchangeability is a systemic systemic a is interchangeability public-private collaboration among among collaboration public-private

infrastructure to enable platform platform enable to infrastructure projects. extensive require will campaign

The lack of any national diagnostic diagnostic national any of lack The • a rapid funding mechanism for small small for mechanism funding rapid a global or national a for needed scale

planning or early development require require development early or planning the to product manufacturing and

and execute diagnostic tests. diagnostic execute and

Myriad therapeutic initiatives in in initiatives therapeutic Myriad • limited, is capacity fill-finish Domestic •

materials limit the ability to develop develop to ability the limit materials

protective equipment and laboratory laboratory and equipment protective trial designs will be necessary. be will designs trial testing. facilitate to FDA from needed

Constraints on supplies of personal personal of supplies on Constraints • numbers of patients; adaptive clinical clinical adaptive patients; of numbers are protocols design trial Clinical

standards of care and indeterminate indeterminate and care of standards progress. delaying constrained, is

test development. test

will pose a challenge due to evolving evolving to due challenge a pose will develop to needed materials

funders is needed for point-of-care point-of-care for needed is funders

Designing hospital-based studies studies hospital-based Designing • other and reagents of supply The •

diagnostics). Clearer guidance from from guidance Clearer diagnostics).

testing technologies (point-of-care (point-of-care technologies testing testing drug candidates. drug testing development.

testing and forward-deployed forward-deployed and testing serum, are difficult to access for for access to difficult are serum, complicate reinfection patient

both laboratory-based diagnostic diagnostic laboratory-based both research material, including patient patient including material, research of risk the and epidemiology, disease

A joint approach is required using using required is approach joint A • BSL-3 lab capacity, and supplies and and supplies and capacity, lab BSL-3 • mutation, viral about Uncertainty •

Diagnostics Therapeutics Vaccines/Preventives

Specific findings and challenges identified within three primary countermeasure areas include: areas countermeasure primary three within identified challenges and findings Specific

financial risk with an uncertain market. uncertain an with risk financial

As the pandemic spreads, companies must develop technologies and scale up manufacturing in parallel, taking significant significant taking parallel, in manufacturing up scale and technologies develop must companies spreads, pandemic the As

prevent bottlenecks and downstream delays. downstream and bottlenecks prevent

Regulatory, advisory, and reimbursement authorities must be involved with requirement-setting and decision-making early on to to on early decision-making and requirement-setting with involved be must authorities reimbursement and advisory, Regulatory,

trial activity in order to identify the most promising candidates for further R&D and collaboration. and R&D further for candidates promising most the identify to order in activity trial

Early and rapid decisions from government funders will be essential to support immediate research, development, and clinical clinical and development, research, immediate support to essential be will funders government from decisions rapid and Early

likely have difficulty navigating the complex government contracting and regulatory bureaucracy; real-time assistance is needed. needed. is assistance real-time bureaucracy; regulatory and contracting government complex the navigating difficulty have likely

Many promising solutions will emerge from small and mid-sized companies and research laboratories, but these entities will will entities these but laboratories, research and companies mid-sized and small from emerge will solutions promising Many

epidemiologic data and information as quickly and efficiently as possible. as efficiently and quickly as information and data epidemiologic

Successful development efforts will require the federal government to facilitate sharing of all relevant scientific and and scientific relevant all of sharing facilitate to government federal the require will efforts development Successful

Based on Summit discussion, BIO identified the following critical needs and concerns: and needs critical following the identified BIO discussion, Summit on Based

KEY FINDINGS KEY

Secretary for Preparedness and Response, and Dr. Rick Bright, Director, Biomedical Advanced Research and Development Authority. Development and Research Advanced Biomedical Director, Bright, Rick Dr. and Response, and Preparedness for Secretary

government officials, including Ambassador , White House Coronavirus Response Coordinator, Dr. Robert Kadlec, HHS Assistant Assistant HHS Kadlec, Robert Dr. Coordinator, Response Coronavirus House White Birx, Deborah Ambassador including officials, government

industry collaborations and public-private partnerships to advance development of medical countermeasures. Participants heard from key key from heard Participants countermeasures. medical of development advance to partnerships public-private and collaborations industry

of Vir, hosted the two-day summit to identify pressing technical, funding, regulatory and policy challenges, and enable BIO to catalyze cross- catalyze to BIO enable and challenges, policy and regulatory funding, technical, pressing identify to summit two-day the hosted Vir, of

state of the pandemic and accelerate medical countermeasure solutions for COVID-19. BIO CEO Jim Greenwood and Dr. George Scangos, CEO CEO Scangos, George Dr. and Greenwood Jim CEO BIO COVID-19. for solutions countermeasure medical accelerate and pandemic the of state

On March 24-25, 2020, BIO virtually convened more than 500 leaders from across industry, government, academia, and NGOs to assess the the assess to NGOs and academia, government, industry, across from leaders 500 than more convened virtually BIO 2020, 24-25, March On

Launches Ongoing Initiative to Accelerate and Coordinate Development of Drugs, Vaccines, Preventives, and Diagnostics and Preventives, Vaccines, Drugs, of Development Coordinate and Accelerate to Initiative Ongoing Launches

PARTNERSHIPS FOR COVID-19 FOR PARTNERSHIPS BIO’S VIRTUAL SUMMIT ADVANCES MEDICAL COUNTERMEASURE COUNTERMEASURE MEDICAL ADVANCES SUMMIT VIRTUAL BIO’S

bio.org

or (732) 567-4285. (732) or [email protected] at

Communications, Health of Director Segerman, Andrew contact please information, more For

clinical characteristics of SARS-CoV-2 and COVID-19. and SARS-CoV-2 of characteristics clinical

FDA CDC, NIH, should establish a platform for data and information sharing on scientific and and scientific on sharing information and data for platform a establish should and

emergency supplemental funding. supplemental emergency

DOD’s Joint Program Executive Office (JPEO) Office Executive Program Joint DOD’s • must rapidly allocate medical countermeasure countermeasure medical allocate rapidly must

the front lines. front the

approaches, such as quickly implementing a DRIVe initiative to get funds out to the researchers on on researchers the to out funds get to initiative DRIVe a implementing quickly as such approaches,

ASPR/BARDA • must use flexible Other Transaction Authority agreements or other innovative innovative other or agreements Authority Transaction Other flexible use must

be made without delay. without made be

ASPR/BARDA OMB • so that funding allocations can can allocations funding that so to funds apportion and urgency with act must

and researchers to rapidly advance potential drugs, vaccines and diagnostics. and vaccines drugs, potential advance rapidly to researchers and

The Administration must quickly distribute emergency supplemental funds to companies companies biotechnology to funds supplemental emergency distribute quickly must Administration The

development and operational challenges. operational and development

Federal agencies should engage with BIO’s three taskforces to facilitate rapid resolution to shared shared to resolution rapid facilitate to taskforces three BIO’s with engage should agencies Federal

FEDERAL AGENCY NEAR-TERM RECOMMENDATIONS NEAR-TERM AGENCY FEDERAL

access by companies and researchers and will keep this site updated as new announcements are made. are announcements new as updated site this keep will and researchers and companies by access

BIO has consolidated all federal government grant opportunities on the BIO website BIO the on opportunities grant government federal all consolidated has BIO for easy easy for

platform for facilitating research partnering between companies. between partnering research facilitating for platform

in real-time through customized and searchable postings. The Coronavirus Hub will also serve as a a as serve also will Hub Coronavirus The postings. searchable and customized through real-time in

urgently needed resources and announce the availability of supplies and capacities. The portal connects connects portal The capacities. and supplies of availability the announce and resources needed urgently

resources or services with others that have them. have that others with services or resources This new hub enables users to post requests for for requests post to users enables hub new This

to connect companies searching for specific specific for searching companies connect to hub.bio.org) ( Hub Coronavirus the created BIO

preparation for future pandemics. pandemics. future for preparation

immediate-impact actions as well as policy and resourcing recommendations that will enable better better enable will that recommendations resourcing and policy as well as actions immediate-impact

three technical areas and to facilitate industry partnerships. industry facilitate to and areas technical three These task forces will consider consider will forces task These

BIO is establishing three focused collaborative task forces to address challenges in each of of each in challenges address to forces task collaborative focused three establishing is BIO BIO INTERNAL ACTIONS INTERNAL BIO