pharma & biopharma outsourcing association

What pharma & biopharma outsourcing association does

Pharma & Biopharma Outsourcing Association (PBOA) is a 501(c)(6) non-profit trade association founded in March 2014 by Gil Roth, formerly the founding editor of Contract Pharma Magazine, where he spent approximately 14–16 years covering the pharma and biopharma outsourcing industry. Headquartered at 10 Alta Vista Dr., Ringwood, New Jersey, PBOA is — by its own positioning — the only U.S. trade association exclusively representing Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs) in regulatory, legislative, and general business matters. The IRS approved PBOA's 501(c)(6) Business League tax-exempt status in June 2015, retroactive to incorporation.

PBOA's "products" are membership services rather than software or physical goods: regulatory representation before the FDA (notably during GDUFA reauthorization negotiations, FDA Reauthorization Act passage in August 2017, and FDA public hearings), congressional advocacy on legislation affecting contract manufacturers, an annual member meeting and conference launched in October 2017, workshops and webinars on regulatory and legislative topics, industry networking at major pharma events (INTERPHEX, CPhI, BIO, DCAT Week, PDA, AAPS), and content distribution via an active blog, weekly e-newsletter, and Twitter (@PBOAssoc). Member categories include General Members (CMOs/CDMOs), Sustaining Members (higher tier, including founding members Afton Scientific, Metrics Contract Services, and WellSpring Pharma Services), and Affiliate Members (service providers such as PharmSource and TraceLink).

PBOA generates revenue through annual membership dues structured by tier and company size; pricing is not publicly disclosed. Distribution is direct to qualifying enterprises via the association's website, industry event presence, and member referrals. The association does not develop proprietary technology and has no disclosed software platform, AI/ML capabilities, or API products. Notable operational milestones include the first annual conference (October 2017), significant GDUFA II facility-fee reductions secured for CMOs (FY2018), and member commitments to COVID-19 drug and vaccine manufacturing (March 2020). PBOA collaborates with allied trade associations including the Parenteral Drug Association (PDA), Bulk Pharma Task Force (BPTF), and Generic Pharmaceuticals Association (GPhA).

Name

pharma & biopharma outsourcing association

Legal name

Pharma & Biopharma Outsourcing Association

Website

https://pharma-bio.org

Company type

Private

Founded year

2014

Operating status

Operating

Short description

Pharma & Biopharma Outsourcing Association (PBOA) is a 501(c)(6) non-profit trade association founded in 2014 that exclusively represents U.S. pharmaceutical Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs) through regulatory advocacy, legislative representation, annual conferences, and member networking.

Ownership category

akta.pro rank

Product category

Pharmaceutical Industry Trade Association

NAICS

Business Associations (813910), Professional Organizations (81392)

SIC

Services-Management Services (8741)

akta.pro primary industry

Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

akta.pro secondary industries

GMP Scale-Up, Tech Transfer & Process Validation (PPQ) (HLAGAHAL), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Pharmaceutical trade association
• Contract manufacturing advocacy
• Regulatory advocacy services
• CMO industry representation
• Biopharma policy advocacy

Headquarters

HQ city

Ringwood

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Membership Dues: PBOA generates revenue through annual membership dues from CMO and CDMO member companies. The association offers different membership tiers including General Members and Sustaining Members, with dues structured based on company size and membership level.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

PBOA is a non-profit trade association (501(c)(6)) that advocates for the regulatory, legislative, and general business interests of pharmaceutical and biopharmaceutical Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs). It offers membership-based services including industry representation at FDA hearings and congressional proceedings, participation in GDUFA negotiations, an annual meeting & conference, webinars, working groups, and educational resources such as a newsletter and blog.

Product overview

The Pharma & Biopharma Outsourcing Association (PBOA) is a non-profit trade association (501(c)(6)) that provides advocacy services for its member companies. Rather than offering a technology product or software platform, PBOA offers membership services including regulatory and legislative advocacy, industry representation, webinars, networking events, industry news, blog content, and educational resources. The organization represents Contract Manufacturing Organizations (CMOs) and Contract Development & Manufacturing Organizations (CDMOs) in the pharmaceutical and biopharmaceutical sector.

Differentiator

Problem solved

Functional benefit

Products and services

• Trade Association Membership
• Annual Meeting & Conference
• Webinars and Educational Workshops
• Industry Newsletter and Blog Content

Quantifiable outcome

• Successfully advocated for CMO/CDMO representation in GDUFA II negotiations
• +1 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Six partnerships are on record, tiered general member, minor and affiliate member.

• Groupe PARIMAgeneral memberOthers · 11 August 2016Groupe PARIMA, a Quebec-based CDMO specializing in non-sterile liquid, suspension, semi-solid and spray drug products, joined PBOA as a General Member in August 2016. The company has over 20 years of expertise supporting drug product lifecycle from formulation development through commercial scale manufacturing.
• Parenteral Drug Association (PDA)minorStrategic or Co-development Partner · 15 June 2015PBOA connects with PDA for joint regulatory conferences and industry collaboration. PBOA President Gil Roth participated in PDA's Outsourcing Operations Interest Group discussions.
• PharmSourceaffiliate memberStrategic or Co-development Partner · 22 April 2015PharmSource, a leading industry information resource for bio/pharmaceutical outsourcing, serves as an Affiliate Member of PBOA. Founder Jim Miller serves as chairman of PBOA's Advisory Committee and moderates PBOA-sponsored panels at industry events.
• TraceLinkaffiliate memberTechnology or IntegrationTraceLink, a pharmaceutical track and trace solutions provider, joined PBOA as an Affiliate Member. The company provides serialization and track-and-trace technology relevant to PBOA members facing 2017 serialization requirements.
• Bulk Pharma Task Force (BPTF)minorStrategic or Co-development PartnerPBOA collaborates with BPTF on shared concerns regarding GDUFA facility fees and generic drug manufacturing regulations. Both organizations participated in FDA hearings on GDUFA reauthorization.
• Generic Pharmaceuticals Association (GPhA)minorStrategic or Co-development PartnerPBOA works alongside GPhA on FDA regulatory issues affecting generic drug manufacturing, though the organizations represent different segments of the industry.

Scale indicators2 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Bulk Pharma Task Force (BPTF): Trade association representing bulk pharmaceutical manufacturers. PBOA already collaborates with BPTF on GDUFA facility fees and FDA regulatory issues, making it the most directly comparable peer in scope and advocacy focus.
• Association for Accessible Medicines (AAM): Trade group representing generic pharmaceutical manufacturers and suppliers. PBOA partners with its predecessor GPhA on FDA regulatory issues affecting generic drug manufacturing, making it a directly comparable industry association peer.
• Parenteral Drug Association (PDA): International industry association for pharmaceutical manufacturers of sterile injectable and parenteral products. PBOA engages with PDA on joint regulatory conferences and outsourcing operations, making it a directly comparable manufacturing-focused trade body.

Broad incumbents

• International Society for Pharmaceutical Engineering (ISPE): Global not-for-profit association serving pharma manufacturing professionals across development, manufacturing, and quality. Comparable to PBOA in serving CDMO-adjacent audiences, though it operates across the broader pharma engineering profession.
• Drug, Chemical & Associated Technologies Association (DCAT): Industry association serving the pharmaceutical manufacturing value chain, including CDMOs. PBOA participates in DCAT Week, positioning DCAT as a comparable but broader industry networking and advocacy body.
• Biotechnology Innovation Organization (BIO): Largest U.S. trade association representing the biotechnology industry, including biopharma manufacturers. PBOA participates in BIO events, making BIO a broader-incumbent peer that overlaps on biopharma CDMO representation.
• Pharmaceutical Research and Manufacturers of America (PhRMA): Trade group representing innovative biopharmaceutical research companies. Although PBOA focuses on service providers to pharma rather than innovators, PhRMA is a comparable U.S. pharma trade-association peer in advocacy structure and regulatory engagement.
• American Association of Pharmaceutical Scientists (AAPS): Professional association of pharmaceutical scientists covering drug development and manufacturing sciences. PBOA participates in AAPS annual meetings, making it an adjacent peer with overlapping CDMO/manufacturing audiences.

Emerging players

• International Pharmaceutical Excipients Council (IPEC): Federation of regional associations representing pharmaceutical excipient suppliers and manufacturers. A comparable specialized pharma-manufacturing trade association with analogous advocacy and standards-setting scope.

Others

• Society of Chemical Manufacturers & Affiliates (SOCMA): U.S. trade association for specialty and batch chemical manufacturers, including API producers supplying pharma. Comparable in structure as a manufacturing-focused trade body, though it serves a broader chemical industry rather than pharma specifically.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/PBOAssoc

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about pharma & biopharma outsourcing association