Table 2.

Recent Examples of Precompetitive Collaborations

Collaboration	Stakeholders	Purpose	Impact
Data standards including projects on: Natural language processing Ontologies Semantic enrichment Others	Pistoia Alliance leads industry (100 member companies) and NGO/academic (>50) stakeholders	Seeks to lower barriers to R&D innovation by providing a legal framework to enable clear and secure precompetitive collaboration	Identified root causes that led to R&D inefficiencies; developing best practices and technology pilots to overcome common obstacles
Therapeutic area emphasis: Oncology¹⁴	Many with great diversity based on emphasis (e.g., bioinformatics resources and standards, biomarker consortium, I-SPY 2 trial, pediatrics, specific cancers)	More efficient drug candidate identification and selection while minimizing patient exposure to drugs with low PTOS	Shared biomarker data; consensus on data standards Successful completion of platform trials
Parkinson Disease¹⁵	C-Path, MJFF and other Parkinson disease foundations, FDA, industry partners and academic collaborators	Regulatory-approved endpoints, trial designs, and modeling tools Identification of indicators of early disease state markers Development of reliable biomarkers to monitor disease progression Understanding disease subtypes, enable patient stratification for more efficient clinical trials	Regulatory-approved DPMs and CTS tools Shared biomarker data Collaborative clinical trials
Rare Diseases¹⁶^,¹⁷	Global academic, regulatory, and industrial partners and including patients, patient advocates, NGOs, and foundations	Pool resources and knowledge including team science, research networks, novel funding models, shared knowledge platforms, and innovative regulatory frameworks	Data-sharing platforms, clinical trial collaboration, collaboration on biomarker, endpoint, and patient selection.
Genomics: The UK Biobank Exome Sequencing Consortium (UKB-ESC)¹⁸	Private-public partnership between the UKB and eight biopharmaceutical companies	Complete the sequencing of exomes for all ∼500,000 UKB participants	Exome data from 200,643 UKB enrollees available. Data include ∼10 million exonic variants—resource of rare coding variation valuable for drug discovery
HBO Obesity Project The Weight of the Nation documentary¹⁹^,²⁰	NIH, NICHD, CDC, IOM, academic investigators, and HBO	To understand, treat, and prevent obesity, including the work of NIH and NICHD researchers. The program is part of a larger initiative to raise awareness about obesity and its health risks nationwide	Perceived to play a role in influencing beliefs, intentions, and policy support regarding obesity prevention
Food Forum part of Forum for the Future²¹	Leading international sustainability nonprofit running out of offices in the United Kingdom, United States, India, and Singapore; partnership with business, governments, and civil society to accelerate the shift towards a just and regenerative future	Develop a sustainable future for food	Supply chain synergies Secured capital markets investment Bioenergy assessment
Forum on Drug Discovery, Development, and Translation²²	Stakeholders include government, academia, industry—including pharmaceutical, biotechnology, and digital health companies, foundations, and disease and patient advocacy	Provides a neutral platform for stakeholders to highlight critical issues, spur cross-sector collaboration, and inspire action	Held and published numerous workshops on innovative topics including virtual clinical trials, RWD/RWE, diagnostics to detect antibiotic resistance, etc.

CDC, Centers for Disease Control and Prevention; C-Path, Critical Path Institute; CTS, Clinical Trial Simulations; DPMs, Disease Progression Models; FDA, US Food and Drug Administration; HBO, Home Box Office; IOM, Institute of Medicine; MJFF, Michael J Foxx Foundation; NGO, non-governmental organizations; NICHD, Eunice Kennedy Shriver National Institute of Child Health and Human Development; NIH, National Institutes of Health; PTOS, Probability of Technical Success; R&D, research and development; RWD/RWE, Real-world data/real world evidence; UKB-ESC, UK Biobank-Exome Sequencing Consortium