Networking Core Committee

John Boehm, CPC, Board Sponsor

International Summit (ISUS) Planning Committee

The ISUS Planning Committee is tasked with planning the agenda for BPSA’s annual International Single Use Summit.

Committee Chairs-
Dominic Clarke, Charter Medical
Ralph Daumke, Filtrox
Scott Herskovitz, Qosina
Amy Plancon, Sabic
Sabrina Restrepo, Merck & Co., Inc.
Jim Vogel, The BioProcess Institute

BPSA European Advisory Council

The European Advisory Council (EAC) was formed in 2016, due to the success of BPSA’s first European Summit, held in September 2016 in Barcelona, Spain. The EAC was formed to identify specific challenges or areas of interest within Europe regarding single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. The EAC will also be tasked with shaping the 2018 BPSA European Summit’s program and location. (BPSA will host a European Summit every other year.)

Committee Chairs-
Hélène Pora, Pall Life Sciences
Stephen Brown, Biological E. Ltd.

End-User Committee

This committee is comprised of BPSA’s end-user members only. The goal of this committee is to identify and support end-user priorities and deliverables, as well as expand BPSA’s end-user membership.

Committee Chair- Mark Petrich, Merck & Co., Inc.

Promotion/Marketing Core Committee

Ken Davis, Nordson Medical, Board Sponsor

Marketing Committee

The Marketing Committee focuses on the marketing of BPSA meetings, BPSA social media strategies, publications, and other BPSA initiatives. The committee supervises BPSA’s social media presence and BPSA’s press releases. Marketing teleconferences are held several times a year, as scheduled by the Committee Chair.

Subcommittees include: 1. Social Media 2. Website 3. Project Support (meetings, membership, publications, etc.) 4. Journal Interface/Press

Committee Chair- Ken Davis, Nordson Medical

Membership Committee

The membership committee identifies and recruits new members and crafts and monitors member retention strategies.

Committee Chair- Sandra Medlin, SaniSure

Technical Core Committee

Jeff Carter, GE, Board Sponsor

The Scientific and Technical Advisory committee manages BPSA’s stand-alone technical projects, as well as the joint BPSA/BPOG technical committees, identified below with an asterisk. A Scientific Advisory committee may be established to oversee technical publications/initiatives as identified by the BPSA Board of Directors.

Integrity Testing Task Force Committee

The BPSA Integrity Testing Task Force meets monthly via teleconference to address the issue of SUT leak integrity testing. The committee’s white paper will be released in 2017. The paper will identify industry best practices and current available technology to help SUT users and suppliers address this issue.

Committee Chair- Hélène Pora, Pall Life Sciences

Change Notification Committee

The BPOG/BPSA Change Notification Committee has been meeting for over a year to address change notification issues. The team’s first white paper, The Management, Notification and Documentation of Single-Use Systems Change Orders, was published in BioProcess International magazine in October, 2015.

Committee Chairs-
Eric Isberg, Entegris
Sabrina Restrepo, Merck & Co., Inc.

Single-Use Requirements Committee

The BPOG/BPSA Single-Use User Requirements Committee was formed in the fall of 2015. Its charter is to develop industry-wide harmonization between suppliers and end users by creating a consistent and complete technical package that will include a quality audit guide and internal/external quality release procedure.

Committee Chair- Sabrina Restrepo, Merck & Co., Inc.

External Organizations Committee

This committee monitors, reports on, and represents BPSA with the alphabet soup organizations as follows:

• ASME-BPE: Ken Davis

• ASTM E55: Janmeet Anant

• BPOG: Jeff Carter

• DECHEMA: Ralph Daumke

• SUTAP: Hélène Pora

Raw Materials Variability Committee

This BPOG/BPSA committee is in its initial planning phase, and is tasked with addressing the risk to the SUT users’ supply continuity due to the variability of raw materials used during the drug manufacturing cycle. The committee will identify best practices and issue recommendations to mitigate this risk.

Committee Chair- Janmeet Anant, Millipore Sigma

Cell and Gene Therapy (CGT) Committee

BPSA has created the cell and gene therapy (CGT) committee with the purpose of taking the lessons learned from adopting single use technologies in bio-processing of proteins and Mabs and applying them to the CGT market. We also have recognized the complexity involved with CGT and the more precision approach to smaller population therapies which require new issues to be addressed in single use technologies. As a result, bringing suppliers of the technology together with users will allow us to provide best practice guidelines to aid in the creation of new CGT’s.

Committee Chair- Dominic Clarke, Charter Medical

Industry Data Core Committee

Paul Priebe, Sartorius-Stedim Biotech, Board Sponsor

The industry data core committee is currently engaged in a pilot program with the intent to establish a single use technology complaint rate database. The goal is to allow suppliers and end users to benchmark their own performance or experience to ultimately improve the reliability of single use technologies.

Education Core Committee

Ken Baker, AdvantaPure/NewAge Industries Board Sponsor

Sustainable Single-Use Disposal/Recycling Committee

This committee was formed to provide member stakeholders with information about the environmental impact of Single-Use Technology and to take actions to show that sustainability is important to BPSA. The team’s immediate goals include organizing member tours of waste management sites, developing an effective social media program, summarizing available SUS studies, compiling a list of existing recycling/reuse programs, investigating related efforts by similar groups, and other projects as agreed to by BPSA membership.

Committee Chair- Mark Petrich, Merck & Co., Inc.

Sustainable Skilled Workforce Committee

This committee’s goal is the expansion and improvement of knowledge of the workers of SUS (single use systems) in the pharma and biotech industries in order to better prepare the MUS (multi use systems) workers to transition to SUS and new workers entering the industry to obtain the knowledge they need to be a productive member of their companies. The end result – have proper SUS skills and techniques used in the manufacturing of biologics and pharmaceuticals in order to have less mistakes and consistent quality of the manufacturing process.

Committee Chairs-
Karen Green, Millipore Sigma
Gary Gilleskie, BTEC, NC State

Scholarship Award Committee

The BPSA Board created the Jerold Martin Legacy Scholarship Fund in 2015. The fund’s scope, guidelines and application process were established via a committee chaired by Honorary Directors Jerry Martin and Rick Sullivan. The fund has awarded scholarships to Worcester Polytechnic University’s Biomanufacturing and Education Training Center (BETC), NC State’s Biomanufacturing Training & Education Center (BTEC) and Texas A&M’s National Center for Therapeutics Manufacturing (NCTM). This committee is comprised of its two chairmen and the BPSA Executive Board.

Committee Chairs- Jerry Martin and Rick Sullivan, BPSA Chairmen Emeriti

Advocacy Core Committee

Board Sponsor/Staff-Led

The Advocacy on Demand Core Committee’s role is to facilitate BPSA members’ participation in meeting with their legislators and regulatory representatives in Washington, DC to advocate for policies that impact their company, workers and their bottom line in a meaningful and impactful way. BPSA will coordinate with SOCMA’s government affairs staff and invite BPSA members to SOCMA’s 2017 DC Fly-In.

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