Joining a BIO committee is the best way to inform our domestic and international agendas, participate inpublic outreach, advocacy activities, and stay informed. Committee participation is open to all employeesof BIO member companies. Members participate in committee meetings to speak up about issues thatare important to them, or simply network with peers.
Why join?
Committee members have:•••

Access to BIO staff experts with deep policy, regulatory, external affairs, tax, investment,
communications, and legal expertise, and connections to industry influencers and stakeholders;
Ability to help shape BIO’s domestic and international policy agenda; andTimely updates and newsletters on issues of importance to their companies.

Membership
Full-time employees of BIO member companies are eligible to join committees. There is no limit to thenumber of employees a member company can have on committees.
Operation
All committees operate on a consensus basis. If a consensus position cannot be reached among
members on a policy issue, BIO cannot take a public position on that issue. While multiple employees
may participate on a committee, each member company participates as one voice, or one vote, on
policies and issues that come before each committee.
Meetings
Regular committee meetings typically occur via teleconference on a recurring basis with occasional inperson meetings, as needed or appropriate. Attendance is not mandatory.
Communications
BIO communicates with committee members via email, and committees meet via conference call.
Ready to join? Have questions?
Contact biomember@bio.org with questions or to request to join a committee.
Not yet a member? Please contact info@bio.org to join today.

1Table of Contents
Healthcare: Science and Regulatory Affairs ........................................................................................ 3
Regulatory Affairs Steering Committee (RASC)1 ..................................................................................................... 3
Regenerative Medicine Committee .......................................................................................................................... 3
Nonclinical (BioSafe) Committee .............................................................................................................................. 3
Manufacturing, Quality, and Distribution Committee1 ............................................................................................... 3
Pediatrics Committee1 .............................................................................................................................................. 4
Rare Disease and Orphan Drug Committee1 ........................................................................................................... 4
Biosimilars Committee .............................................................................................................................................. 4

Healthcare: Policy and Research .......................................................................................................... 4
Policy, Access and Reimbursement Committee (PARC)1........................................................................................ 4
State Policy, Access and Reimbursement Committee (State PARC)1 ..................................................................... 5

Healthcare: Specialty Markets .............................................................................................................. 5
Vaccines Policy Committee ...................................................................................................................................... 5
Biodefense Policy Committee................................................................................................................................... 5
Vaccines Regulatory Affairs Committee (VacRAC)1 ................................................................................................ 5
Antimicrobial Resistance (AMR) Committee ............................................................................................................ 6

Finance ................................................................................................................................................... 6
Committee on Foreign Investment in the U.S. (CFIUS) Committee ......................................................................... 6
Finance & Tax Committee3 ....................................................................................................................................... 6

Government Relations ........................................................................................................................... 7
Federal Government Relations Committee1 ............................................................................................................. 7
State Government Relations Committee, Health3 .................................................................................................... 7

International Affairs ............................................................................................................................... 7
International Advocacy Steering Committee1 ........................................................................................................... 7
International Regulatory Committee1 ........................................................................................................................ 7

Alliance Development ............................................................................................................................ 8
Alliance Development Committee1 ........................................................................................................................... 8

Legal & Intellectual Property ................................................................................................................. 8
Biopharmaceutical Law Committee1 ......................................................................................................................... 8
BIO General Counsels Steering Committee (GCC)1 ................................................................................................ 8Intellectual Property Counsels’ Committee1 ............................................................................................................. 8
Technology Transfer Committee1, 2 .......................................................................................................................... 9

Communications .................................................................................................................................... 9
Communications Working Group1 ............................................................................................................................ 9
Climate Policy Committee1 ....................................................................................................................................... 9Member Services ................................................................................................................................... 9
BIO Business Solutions Advisory Board4 ................................................................................................................. 92

Healthcare: Science and Regulatory Affairs
Regulatory Affairs Steering Committee (RASC)1The BIO Regulatory Affairs Steering Committee (RASC) acts as a steering committee for all staff-level
science & regulatory committees and working groups. The RASC takes the lead or makes assignments
to committees and working groups on implementation of user fee agreements, including continuous
engagement activities with FDA. The RASC develops and implements strategic BIO responses toscientific and regulatory issues that affect the ability of BIO's human healthcare focused companies toresearch and develop new therapeutics, and to bring these products to market. The RASC responds toproposed regulations and draft guidance documents as necessary and holds liaison meetings with FDA
to identify and discuss regulatory best practices.
Task Forces:• Increasing Diversity in Clinical Trials• Digital Health Technologies• Decentralized Clinical Trials• Patient Focused Drug Development
o Patient Preference Information (PPI) Subgroup• Meeting Best Practices• Real-World Evidence• Artificial Intelligence
Regenerative Medicine Committee1
The Regenerative Medicine Committee focuses on issues relating to regenerative medicine therapies,
including cell and gene therapies and tissue-based products. The group aims to advance policy positions
that support an adequate and flexible regulatory environment for the development of regenerative
medicine therapies.
Task Forces:• Cell & Gene Therapy Manufacturing• Cell & Gene Therapy NonclinicalNonclinical (BioSafe) Committee1
The BioSafe General Membership serves as a resource for BIO members and BIO staff by identifying
and responding to key scientific and world-wide regulatory issues related to the preclinical safety
evaluation of biopharmaceutical products on an as needed basis. General Members can participate invarious expert working groups, task forces and work streams related to the preclinical safety of biologics.
Task Forces:• New Alternative Methods (NAMs) Task Force
Manufacturing, Quality, and Distribution Committee1
The Manufacturing, Quality, and Distribution Committee proactively identifies issues, develops policy
proposals, and provides responses to regulatory and legislative activities regarding biotechnology
manufacturing, including international harmonization of manufacturing requirements. This includes, but is
not limited to, developing comments and white papers, development of or participation in workshops, andinteractions with FDA, as appropriate.

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Task Forces:• Advanced/Innovative Technologies• Inspections
Pediatrics Committee1
The Pediatrics Committee coordinates BIO activities around pediatric clinical research programs andseeks to minimize barriers to maintain incentives for, and communicate the value of, robust drug andbiologic research in pediatric populations. Specifically, the group coordinates BIO’s activities surrounding
the implementation and reauthorization of the Best Pharmaceuticals for Children Act (BCPA) and thePediatric Research Equity Act (PREA). The group also works with FDA and international regulators topromote appropriate harmonization of pediatric regulatory requirements. In addition, the Committee
provides a venue for biologics companies to discuss best practices and lessons learned with respect tothe conduct and regulation of pediatric clinical research and development programs.
Rare Disease and Orphan Drug Committee1
The Rare Disease and Orphan Drug Committee provides a forum for BIO members with a particularfocus on rare diseases to discuss BIO’s major advocacy issues and policies in relation to thedevelopment and marketing of orphan products. The Committee is cross-functional, reviewing both FDA
and development issues as well as market access and commercialization policies (including
reimbursement). As such, the Committee identifies and raises rare disease-specific issues to the HealthCare Reform and Reimbursement Committee (in addition to the RASC). In 2020, the Rare Disease andOrphan Drug Committee prioritized developing consensus on, and advocating for, the Rare PediatricDisease Priority Review Voucher program. The Committee is currently working on developing a robust
agenda for discussion with the FDA in a forthcoming meeting (date TBD).
Biosimilars Committee1
The Biosimilars Committee supports BIO’s broader biosimilars advocacy agenda by coordinating with the
Biosimilars Implementation Committee (BIC) and the Biosimilars Law Committee (BLC) to provide
technical expertise in matters pertaining to the underlying science and regulation of biosimilar products.
Healthcare: Policy and Research
Policy, Access and Reimbursement Committee (PARC)1
The Policy, Access and Reimbursement Committee (PARC) focuses on federal legislative and regulatory
proposals regarding health reform and existing and future drug coverage, with particular focus in the
Medicare and Medicaid programs, as well as other federal health care and drug pricing programs (e.g.
340B program, ACA exchanges, rebate programs). This committee develops positions to maintain andexpand market-based delivery systems to ensure patient access to biotechnology therapies. Members of
the committee review health reform and reimbursement issues from a variety of perspectives, including
legislative, regulatory, economic, marketing, and public relations. Members of the committee meetroutinely with government officials regarding legislation and agency regulations. PARC members also
have the opportunity to join ad hoc working groups that focus more specifically on particular issues. All
policy discussions and recommendations from these working groups are taken back to the PARC for
further discussion and approval. These groups include, but are not limited to:
Task Forces:• Medicare Part B• 340B• Transformative Therapies

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•
•

Small Biotech
IRA Orphan Drug

State Policy, Access and Reimbursement Committee (State PARC)1
The State Policy, Access and Reimbursement Committee (State PARC) focuses on state legislative andregulatory proposals regarding existing and future drug coverage and coding and payment within stateand private markets, with particular focus on the health insurance exchanges and Medicaid. This
committee develops positions to maintain and expand market-based delivery systems to ensure patient
access to novel biotechnology therapies. Members of the committee review health reform andreimbursement issues from a variety of perspectives, including legislative, regulatory, economic,
marketing, and public relations. The committee is responsible for submitting comments, and whenappropriate, engaging directly with state legislators and regulators on issues related to state legislation
and regulation.
Healthcare: Specialty Markets
Vaccines Policy Committee1
The Vaccines Policy Committee addresses vaccine policy issues, with a primary focus on federal
domestic issues, but also addresses select state-level issues as needed. The committee interacts withgovernment policy-making bodies and non-government partners. Examples of government policy-making
bodies include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration(FDA), National Vaccine Program Office (HHS/NVPO), the National Vaccine Advisory Committee(NVAC), and the Advisory Committee on Immunization Practices (ACIP). Issues that have beenaddressed or are being addressed include implementation of the Affordable Care Act (ACA), vaccine
financing, vaccine safety, influenza vaccine awareness, and policies to support vaccine innovation.
Biodefense Policy Committee1
The Biodefense Policy Committee advocates for policies to facilitate the biotechnology sector's
contribution to national preparedness, including federal funding for biodefense, biodefense procurement
reform, authorized funding for advanced development projects, and strong federal pandemic influenza
funding across an array of technologies to address near-term, mid-term, and long-term opportunities.
Member companies include those developing vaccines, therapeutics, and diagnostics for use as medical
countermeasures in the event of a natural, accidental, or man-made biological event.
Vaccines Regulatory Affairs Committee (VacRAC)1
The Vaccines Regulatory Affairs Committee (VacRAC) addresses vaccine regulatory policy issues, witha primary focus on U.S and some international regulatory issues. The committee interacts withgovernment policy-making bodies and non-government partners, such as the Food and Drug
Administration (FDA), the Centers for Disease Control and Prevention (CDC), National Vaccine Program
Office (HHS/NVPO), and the Advisory Committee on Immunization Practices (ACIP). Issues that havebeen addressed or are being addressed include implementation of the Food and Drug Administration
Safety and Innovation Act (FDASIA), drug shortages, and the FDA review process for vaccines, among
others.
Task Force:• Travel & Occupational• International Pandemic-Preparedness (Pan-Prep)
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Antimicrobial Resistance (AMR) Committee1
The Antimicrobial Resistance (AMR) Committee is comprised of companies working on the developmentof novel antibiotics, antivirals, antifungals, vaccines, and therapeutics targeted for resistant pathogens
and nosocomial infections. The committee addresses issues related to infection control, antimicrobial
resistance (AMR), and incentives for both antimicrobial and vaccine development.
FinanceCommittee on Foreign Investment in the U.S. (CFIUS) Committee3
The committee shares updates and guides advocacy on the implementation of reforms to the Committee
on Foreign Investment in the U.S. (CFIUS), which has the authority to review, and potentially alter,
foreign investments into the U.S. biotechnology industry. The committee group is convened throughconference calls on an ad-hoc basis to discuss recent developments in the rulemaking process,exchange insights on the potential impact on the biotechnology industry, and direct BIO’s advocacy
efforts to shape the rulemaking outcome through comment letters and engagement with the Departmentsof Commerce and Treasury, as well as Congress. The overarching goal of this working group is toengage in the rulemaking process to avoid an undue impact on the biotechnology sector’s ability to enter
into global research partnerships as well as attract foreign investments. Working group participants comefrom a range of backgrounds, principally from C-suite and finance functions, as well as technologists that
understand the use and potential applications of emerging biotechnologies.
Finance & Tax Committee3
Concentrates on tax, financial services, securities, and accounting policies that impact member
companies and biotech capital formation. This committee advises BIO staff about the impact oflegislation and regulations affecting these policy matters and supports BIO’s engagement with Treasury,
the SEC, and the IRS, as well as Congress and the Administration. Specific financial services areas ofinterest include the JOBS Act, Sarbanes-Oxley (SOX) Section 404(b), proxy advisory firms, short sellingtransparency, market structure reform, tick size, accounting and auditing standards, and SEC life science
reporting topics. Tax policy emphases include the Orphan Drug Tax Credit, the R&D credit and payroll
R&D credit, federal tax treatment of net operating losses (NOLs), qualified small business stock (QSBS)
capital gains treatment, and international tax.
BIO Early-Stage Advisory Council4
The BIO Early-Stage Advisory Council is comprised of early-stage member company CEO’s andprovides the opportunity for participants to engage BIO staff and provide valuable input on BIO projects
and policy proposals. The Advisory Council engages on projects addressing capital formation andfunding issues broadly up through the point of IPO for a typical biotech. Examples of the type of projects
Advisory Council members may be asked to provide input on include, but are not limited to, the following:
Prioritizing subjects and developing content for future webinars and educational Events; Identifying
issues that may have legislative or regulatory fixes and providing feedback on the development of policy
proposals to address them; Serving as resource for surveys and data collection targeted at early-stage
companies.

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BIO Investor Advisory Committee3
The Investor Advisory Committee is comprised of investors that represent the spectrum of funding dollars
BIO members interact with throughout their product lifecycle and corporate development. Members of
the committee represent major biotechnology venture capital investors across therapeutics and ag-bio as
well as public market investors. The Committee opines on certain BIO policy priorities to lend theirexpertise on how legislation and regulation will impact their investment decisions in the ecosystem.
Government Relations
Federal Government Relations Committee1
Concentrates on educating and lobbying government officials regarding legislative proposals affecting
the biotechnology industry. The committee reviews the BIO legislative and regulatory agenda as a whole
to set priorities and strategies; initiates BIO policy discussions regarding legislation; and provides advice
and recommendations to the Board. Committee members meet with various government officials andtheir staffs to gain information, offer insight and advice, and buttress BIO positions. The committee
collaborates on substance and formulates legislative strategy for major BIO priorities.
Subcommittee:• IP Task ForceState Government Relations Committee, Health3This committee is comprised of BIO member companies and state affiliate organizations and focuses onlobbying state government officials regarding legislative and regulatory healthcare proposals that affectthe biotechnology industry. Each member company also designates one representative to serve as theirvoting member on the committee. Voting members are convened on an ad-hoc basis to set legislative
priorities and provide recommendations to the Board of Directors.
International Affairs
International Advocacy Steering Committee1
Oversees the development of international advocacy strategy and goals, for approval by International
Affairs Committee of the Board. Determines priority countries and issues, including biologics regulations,
intellectual property rights and market access issues in markets outside of the U.S. Implements thestrategy through direct advocacy with foreign governments, U.S. trade and foreign policy officials, andother global stakeholders.
Task Forces:• China• Japan• AES-Int’l Mexico
International Regulatory Committee1
The International Regulatory Committee works with the Regulatory Affairs Steering Committee to set
policy and priorities relating to global regulations of biotechnology products including biotherapeutics andadvanced therapies such as cell and gene therapies. The group has a special focus on harmonization of7

key regulations in priority markets through the International Council on Harmonization (ICH), the Asia
Pacific Economic Cooperation (APEC) and the World Health Organization.
Subcommittee:• ICH Cell Gene Therapy Discussion Support Group
Alliance Development
Alliance Development Committee1
Builds ties with the patient and health advocacy communities in order to create strong, long-term
relationships that yield opportunities for patient groups and the biotech industry to collaborate in policy
development, advocacy, public awareness and research and product development.
Legal & Intellectual Property
Biopharmaceutical Law Committee1
Provides additional legal support in the development of BIO analyses and positions on FDA and related
product legal/regulatory and legislative issues, as well as issues concerning communications with healthcare professionals. The committee also helps to identify issues of concern to be proactively addressedby BIO and advises BIO and its other committees as to how particular issues may affect member
companies from a legal perspective. The committee is made up of in-house lawyers at BIO’s member
companies that focus on FDA-related legal, regulatory and legislative issues.
BIO General Counsels Steering Committee (GCC)1
Provides a forum for the General Counsels from BIO member-companies to build collegial relationships
and exchange information, experiences, and best practices relating to a wide variety of legal and law
department issues. Among others, these may include the development and organization of GeneralCounsel offices, corporate governance, securities, antitrust, supervision of outside counsel, and otherpractice management activities. Participation is open to the General Counsel or Chief Legal Officer, witha limit of one committee member per company.
Intellectual Property Counsels’ Committee1
Promotes strong, predictable intellectual property (IP) protection and efficient transfer of IP rights for thebiotechnology industry domestically and internationally. This committee is open to in-house patentcounsels of BIO member companies. Law firm patent counsels may join only at the designation of a BIO
member company. The committee is responsible for developing domestic and international intellectual
property policy that benefits the biotechnology industry. The committee reviews and comments on
proposed intellectual property legislation and IP-related regulations from federal agencies. The
committee will from time to time approve the filing of amicus briefs in cases that impact the biotechnology
industry and develop IP-related position papers, white papers and educational materials. Participation is
open to in-house IP counsel of member companies. Focus areas: Amicus, Patent Reform, PTO, andInternational IP.

8Technology Transfer Committee1, 2
The Technology Transfer Committee promotes and facilitates industry/academic research partnerships
for the biotechnology community. Committee members include persons directly involved in industry andacademia partnerships such as university technology transfer officers, company licensing officers,
business development officers, and others. Committee members work to improve business development
tools for the industry/university tech transfer community, support BIO’s industry intelligence andeconomic impact analysis of translational research, academic/industry sponsored research bestpractices, and respond to various state, federal and international legislative matters of vital interest to
biotechnology technology transfer partnerships.
Communications
Communications Working Group1
Helps to direct BIO’s Communications Department on the design, implementation and evaluation of
public relations, media outreach and consumer awareness efforts under the direction of the Board
Standing Committee on Public Awareness. The committee includes senior executives from BIO member
companies responsible for public relations, investor relations, public policy, marketing and media
relations within their respective companies.
Sustainability
Climate Policy Committee1
This group is working to ensure biotechnology is favorably positioned globally to meet the health,nutritional, and environmental expectations of society by defining the building blocks and policy drivers
around carbon and sustainability.
Member Services
BIO Business Solutions Advisory Board4
Provides strategic direction to BIO's cost-savings program, BIO Business Solutions. Helps in identifying
and developing programs and offerings that deliver value to members. Composed of senior executives
whose current role and/or industry experience is in finance, sourcing, operations and other related
business functions within their respective companies. Participation requires board chair approval. BIO
Business Solutions® Advisory Board meets in person annually and has quarterly conference calls.
Eligibility requirements
1
Participation is limited to a full-time employee of, or in the discretion of BIO an authorized consultant to,
R&D intensive (“core”) member companies. BIO requires written notice from the R&D intensive member
company that the consultant is authorized to act as an official company representative. Further, theconsultant must sign a BIO confidentiality agreement indicating that he/she will not share any information
learned or obtained through participation on the committee with any client other than the BIO member
company which authorized his/her participation on its behalf. A consultant generally may not represent
more than one BIO member company on any single committee, and any requests for information or for
BIO to take or modify any policy position shall come directly from the authorizing BIO member company
rather than the consultant.
2
Participation is open to full-time employees of R&D intensive (“core”) member companies anduniversities only.
3
Participation is open to a full-time employee or representative of all BIO member organizations.
4
Participation is by invitation only.
9NOTE: Each individual committee also may have additional requirements not listed above. Eligibilities
are subject to change.

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