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Eligibility to participate on BIO staff-level committees varies with each committee, but is based on one of the general four policies set forth below. Please refer to each committee to determine eligibility. Please note that committees may have additional, committee-specific eligibility requirements not listed below depending on the nature and focus of the committee (e.g., BIO's General Counsels Committee is limited to General Counsels or Senior Legal Officers of BIO member companies).
General Eligibility Policies:
- Participation limited to a full-time employee of R&D-intensive ("core") member companies only.
- Participation limited to a full-time employee of or 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, the consultant 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.
- Participation is open to a full-time employee or representative of all BIO member organizations.
- Participation is by invitation only.
Biodefense and Pandemic Influenza Working Group
Advocates for policies that facilitate the biotechnology sector's contribution to national preparedness, including strong federal pandemic influenza funding across an array of technologies to address near-term, mid-term, and long-term opportunities, antitrust protections, biodefense procurement reform, and authorized funding for advance development projects.
Staff Contact: Sara Radcliffe
Eligibility Requirements: 3
Biopharmaceutical Law Committee ("BLC")
Provides additional legal support in the development of BIO analyses and positions on FDA-related legal/regulatory and legislative issues. The committee also helps to identify issues of concern to be proactively addressed by BIO, and advises BIO and its other committees as to how particular issues may affect member companies from a legal perspective.
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
Working Groups/Subcommittees:
BLC Steering Committee
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
Clinical Trials Working Group
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
BLC Interim Steering Committee
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
Follow-On Biologics Task Force
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
Company/Physician Relationships Working Group
Staff Contact: Sandi Dennis
Eligibility Requirements: 1
CFO/Tax Vice President Committee
Concentrates on financial services, accounting, tax and other policy areas regarding capital formation that impact member companies. This committee advises BIO staff about legislation and regulation affecting these policy matters. Specific subject areas of interest include Sarbanes-Oxley, revenue recognition, illegal short selling, and tax policy, including improvements to the R&D tax credit, orphan drug credit and the federal tax treatment of Net Operating Losses (NOLs).
Staff Contact: Shelly Mui-Lipnik, Paul Poteet
Chairs: Lynne Sullivan, Biogen Idec
Will Waddill, Oncomed
Eligibility Requirements: 1 (or by invitation)
Communications Committee
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.
Staff Contact: Jeff Joseph
Chair: Open
Eligibility Requirements: 1 (or by invitation)
Subcommittees:
Food & Agriculture Section Advisory Group
Staff Contact: Karen Batra
Eligibility Requirements: 2
Industrial & Environmental Advisory Group
Staff Contact: Paul Winters
Eligibility Requirements: 1
Economic Staff Working Group
Concentrates on the economic issues associated with a broad range of policy issues, including - but not limited to - comparative effectiveness, neglected diseases, IP-related issues, and health care reform.
This group does not set policy, but rather is an information gathering, creating and distributing working group.
Staff Contact: Ted Buckley
Eligibility Requirements: 1
Federal Government Relations Committee
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 and their 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.
Staff Contact: Brent Del Monte
Chair: Walter Moore, Genentech
Eligibility Requirements: 1
Economic Staff Working Group
Concentrates on the economic issues associated with a broad range of policy issues, including - but not limited to - comparative effectiveness, neglected diseases, IP-related issues, and health care reform.
This group does not set policy, but rather is an information gathering, creating and distributing working group.
Staff Contact: Ted Buckley
Eligibility Requirements: 1
Federal Government Relations Committee
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 and their 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.
Staff Contact: Brent Del Monte
Chair: Walter Moore, Genentech
Eligibility Requirements: 1
Subcommittee:
Food & Agriculture Subcommittee
Staff Contact: Bill Olson
Eligibility Requirements: 1
Food and Agriculture Animal Acceptance and Credibility Working Group
Improves acceptance and credibility of the animal biotechnology industry. The Work Group prioritizes, implements and coordinates member company efforts regarding communications and stewardship of animal biotechnology. The Work Group provides guidance to the Animal Policy Committee and the other Work Groups. The Work Group works in liaison with the BIO Food & Agriculture Communications Advisory Group.
Staff Contact: Barb Glenn
Chair: Leah Wilkinson, ViaGen
Eligibility Requirements: 2
Food and Agriculture Animal Science and Regulatory Working Group
Advances BIO's policies regarding science and regulatory issues affecting the animal biotechnology industry. The Work Group manages issues associated with regulations of the FDA, USDA, and other federal agencies, and prioritizes, implements and coordinates BIO member company efforts. The Work Group provides expertise to the Animal Policy Committee and the other Work Groups, including liaison to the Food & Agriculture Section Federal Government Relations, State Government Relations, Law, and Communications committees.
Staff Contact: Barb Glenn
Chair: Jerry Pommer, Hematech
Eligibility Requirements: 2
Food and Agriculture Law Committee
Identifies, implements, and coordinates member efforts on legal issues of interest to the Food and Agriculture Section. It provides legal expertise to support the science and regulatory, federal and state government relations, communications, and international issues committees.
Staff Contact: Peter McHugh
Chair: Chris Good, BASF Corporation
Vice-Chair: Margaret Keating, Bayer CropScience
Eligibility Requirements: 2
Food and Agriculture Plant Regulatory Policy Working Group
Provides strategic analysis of developing and evolving regulatory policies related to plant agricultural biotechnology and promotes harmonization of science-based regulatory policy in the U.S. and in targeted countries worldwide. Manages issues associated with relevant regulations of the EPA, USDA, and FDA. This working group also provides expertise to support the government relations, communications and international issues committees. Production Agriculture Policy Committee and Emerging Plant Technology Policy Committee member company staff members are eligible to participate in this working group.
Staff Contact: Michael Wach/Sarah Lukie
Chair: Ali Scott, Bayer CropScience
Vice-Chair: TBC
Eligibility Requirements: 2
Subcommittees:
Beyond Compliance Task Force
Staff Contact: Kate Walker
Eligibility Requirements: 1
EPA Task Force
Staff Contact: Mike Wach
Eligibility Requirements: 1
FDA Codex Task Force
Staff Contact: Mike Wach
Eligibility Requirements: 1
Stewardship Task Force
Staff Contact: Mike Wach
Eligibility Requirments: 1
USDA Task Force
Staff Contact: Mike Wach
Eligibility Requirements: 1
Database Task Force
Staff contact: Kate Walker
Eligibility Requirements: 1
General Counsels Committee
Provides a forum for BIO member-company General Counsels to build collegial relationships and exchange information, experiences, and best practices relating to a wide variety of legal and law department issues, including the development and organization of General Counsel offices, and issues relating to corporate governance, securities, antitrust, supervision of outside counsel, and other practice management activities. Committee participation also keeps members up-to-date on the myriad legislative, regulatory, and international issues impacting the biotechnology industry, through - among other avenues - participation on relevant subcommittees, and in-person committee meetings several times a year.
Staff Contact: Tom DiLenge
Chair: Dolly Vance, Rigel Pharmaceuticals
Vice-Chair: Mark Boulding, PTC Therapeutics
Eligibility Requirements: 1
Subcommittees:
Executive Committee
Staff Contact: Tom DiLenge
Eligibility Requirements: 1
Amicus Subcommitte
Staff Contact: Tom DiLenge
Eligibility Requirements: 1
Health Care Reform and Reimbursement Committee
Focuses on federal legislative and regulatory proposals regarding health reform and existing and future drug coverage, particularly within the Medicare and Medicaid programs. This committee develops positions to maintain and expand market-based delivery systems to ensure patient access to biotechnology therapies. The committee focuses on federal, state and third-party reimbursement for biotechnology-derived drugs and biologicals. 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 meet routinely with government officials regarding legislation and agency regulations.
Staff Contact: Laurel Todd
Chair: Sara Froelich, Genzyme Corporation
Vice-Chair: Greg White, Johnson & Johnson
Eligibility Requirements: 1
Human Resources Committee
Addresses human resources issues within the biotech community and those specific issues that are unique to the industry. The committee serves as a source of information related to human resources and is involved in the programming and planning of the annual Human Resources Conference.
Staff Contact: Ellen Fernandes
Chairs: Erin Campany, Human Resources Consultant
Max Donley, MedImmune
Eligibility Requirements: 3 & 4
Intellectual Property Counsels Committee
Promotes strong, predictable intellectual property (IP) protection and efficient transfer of IP rights for the biotechnology industry domestically and internationally. This committee is open to in-house and outside patent counsels of BIO member companies. 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.
Staff Contact: Lila Feisee
Chair: Tom Kelley, Monsanto
Co-Chairs: , Ken Dow, Johnson and Johnson, Maggie Shafmaster, Genzyme Corporation
Eligibility Requirements: 2
Subcommittees:
Amicus Subcommittee<br>
Staff Contact: Hans Sauer
Eligibility Requirements: 4
Biotechnology Patenting Working Group
Staff Contact: Lila Feisee
Eligibility Requirements: 2
International IP Working Group
Staff Contact: Lila Feisee
Eligibility Requirements: 2
PTO Working Group
Staff Contact: Lila Feisee
Eligibility Requirements: 2
International Advocacy Working Group
Guides BIO efforts to pursue the international advocacy work plan objectives set forth by the Board Standing Committee on International Affairs.
Staff Contact: Sean Darragh
Chair: Joe Damond, Pfizer
Eligibility Requirements: 1
International Health Policy Working Group
Addresses international issues related to health policy, specifically, but not limited to, follow-on biologics, regulatory harmonization standards, and comparative effectiveness.
Staff Contact: Kelly Lai
Eligibility Requirements: 1
Alliance Development Committee
The Alliance Development Committee exists to build ties with third-party stakeholders in the patient and medical communities in order to create strong, long-term relationships that create opportunities for these groups and industry to collaborate and assist each other in policy development, advocacy, public awareness and research and product development.
Staff Contact: Tricia Brooks
Chair: Patrick Plues, Wyeth Pharmaceuticals
Eligibility Requirements: 3
Regulatory Affairs Committee
Addresses regulatory and scientific issues, including FDA regulatory reform initiatives and implementation of the Prescription Drug User Fee Act (PDUFA). Through its technical expert groups, the Committee seeks to ensure a transparent, science-based regulatory environment for healthcare biotechnology innovations.
Staff Contact: Sara Radcliffe
Chair: Jonca Bull, Novartis
Chair-Elect: Tricia DeSantis, J&J
Eligibility Requirements: 2
Research Tools & Molecular Diagnostics (RTMD) Working Group
Addresses issues affecting the development and application of research tools and molecular diagnostics, including intellectual property, regulatory oversight, reimbursement, and federally-funded research programs at the National Institutes of Health and other entities. The RTMD Working Group also monitors and responds to policy proposals and initiatives to advance personalized medicine.
Staff Contact: Daryl Pritchard
Eligibility Requirements: 1
Security Committee
Shares information relating to security threats and best practices among security officers of BIO member companies. When appropriate, the committee also oversees and monitors security activities relating to BIO events.
Staff Contact: Peter McHugh
Chair: Russ Bouchard, Biogen Idec
Eligibility Requirements: 2
State Government Relations Committee - Food & Agriculture
Oversees the industry's sub-national policy management activities on all issues related to agricultural biotechnology. The committee is comprised of representatives from seed manufacturers, plant-made pharmaceutical companies, and cloned and transgenic animal developers. BIO maintains relationships with state and regional biotechnology and agribusiness organizations, and retains contract lobbyists in 15 states under the guidance of the committee.
Staff Contact: Ab Basu
Chair: Scott Kohne, Bayer CropScience
Vice-Chair: David Flakne, Syngenta
Eligibility Requirements: 2
State Government Relations Committee - Health
Deals with state legislative and regulatory healthcare issues and is comprised of BIO members and state affiliate organizations with an interest in state government health-related issues. The committee meets on a monthly basis and receives a weekly BIO State Update detailing healthcare and prescription drug-related activities and news at the state level.
Staff Contact: India Valentine
Chair: Ray Frost, Eisai
Eligibility Requirements: 2
Technology Transfer Committee
Promotes public/private partnerships including technology transfer for the biotechnology community both domestically and internationally. Committee members include persons involved in industry and academia partnerships, such as university technology transfer officers, company licensing officers, business development officers, and others responsible for public/private partnerships. Committee members review the current mechanisms for technology transfer and Cooperative Research and Development Agreements; member and public outreach on technology transfer in biotechnology product development; and areas in public/private collaborations that may need reforms. Members also review and comment on proposed technology transfer legislation, and tech transfer-related regulations from federal agencies, including the National Institutes of Health. The committee actively participates in efforts to influence legislation, treaties, jurisprudence and practice with the goal to continue the positive development of biotechnology.
Staff Contact: Lila Feisee
Chair: Mark Crowell, Scripps Institute
Eligibility Requirements: 3
Vaccine Policy Working Group
Addresses vaccine policy issues, with a primary focus on federal domestic issues, but also addresses select state-level issues as needed. The working group interacts with government policy-making bodies and non-government partners. Examples of government policy-making bodies include the National Vaccine Program Office (HHS/NVPO), the National Vaccine Advisory Committee (NVAC), the Advisory Committee on Immunization Practices (ACIP), the Centers for Disease Control and Prevention, and the Food and Drug Administration. Issues that have been addressed or are being addressed include vaccine financing, vaccine safety, influenza vaccine awareness, and policies to support vaccine innovation.
Staff Contact: Sara Radcliffe
Eligibility Requirements: 1
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