Latest Projects
Our projects transform R&D innovation through pre-competitive collaboration. We bring together the key constituents to identify the root causes that lead to R&D inefficiencies. We develop best practices and technology pilots to overcome common obstacles.
Project one: IDMP Common Core Ontology Project
A well-defined common core ontology that bridges between regional and functional perspectives on common substance-related data objects and global and scientifically objective representations is required. The goal of our project is to build an IDMP Common Core Ontology that enables deep, semantic interoperability based on FAIR principles to enhance and augment the existing ISO IDMP standards.
The European Medicines Agency (EMA) will be the first health agency to mandate compliance with ISO IDMP (Q1, 2023), with the FDA not far behind. Governance of essential IDMP standards and implementations is not assigned to a specific, overarching governing body. Diverging implementations of IDMP across geographical regions and jurisdictional domains are already causing inconsistencies in the interpretation across implementing organizations. Given that there is no semantic alignment between regulatory bodies, there exists a risk that regulatory compliance needs will lead to large integration and interoperability costs and that the benefits from IDMP in drug safety, innovation, and other areas will not be fully realized. Rather than concentrating on the discovery of new medicines, organizations will be struggling with data issues, e.g., the need to map product data across the organization, throughout the product lifecycle.
Due to our robust framework for pre-competitive collaboration. the Pistoia Alliance was selected to manage this initiative with the goal of creating a minimal viable product (MVP) ontology that demonstrates added value to the ISO IDMP standards for data usability across organizational boundaries and regulatory jurisdictions. We have pulled together a core team consisting of Pharmaceutical stakeholders, regulatory bodies, standards organizations, non-profit groups, and solutions providers for this project.
The key success factors for the project include:
- Phase 1 implementation of a quality MVP that can be used by pharmaceutical companies and others.
- Demonstration of the usability and added value of the ontology, which will be the foundation to obtain investment for the next phase of the project to build out the ontology more fully.
- Demonstration of governance capabilities.
- Open communication with all relevant stakeholders with results being shared openly.
Project two: Diversity & Inclusion in STEM Leadership Program
The goal of this program is to develop leadership and mentoring skills in diverse leaders at life science companies, enabling them to support, initiate, and/or lead diversity efforts at their respective companies.
While women make up 53% of the world’s STEM bachelor’s and master’s graduates, only 16% of management and 3% of CEOs are women. Data also suggests that women are more likely to leave the STEM career pipeline than men, widening the gap. In order for life science companies to build more inclusive cultures, it is important to understand the root causes that result in statistics like these and develop leaders that are committed to change from the top down.
This program will commence with a kick-off session followed by weekly training and monthly networking sessions.
The participants will be guided in the discussions by an accredited trainer and coach that will help them increase their leadership skills with the support of the group participants and better understand how to support D&I initiatives from their leadership role.
In the end, each leader will be equipped to support, diversity programs at their respective companies and will have a global community they can engage with for coaching, mentoring, or for further discussion.
The Pistoia Alliance with more than 200 member companies is perfectly positioned to run an industry-wide program. By deploying our framework for collaboration, we can effectively bring together diverse leaders from major players in the life sciences industry to provide training, networking, and sharing insightful knowledge that can result in bringing more diversity and inclusion at a global scale.
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A stream for leaders of teams in life science who are interested in improving their leadership effectiveness in executive roles and augmenting their existing company programs to more effectively attract and retain talent.
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A stream for Human Resources and Diversity & Inclusion leaders to help develop and share best practices and D&I programs across the industry.
Project three: Unified Integrated Knowledge Base
This project aims to create a community-led knowledge base for R&D Application, Instrument, Data, and Services Integrations.
The precompetitive approach to this program allows all types of R&D organizations, instrument and hardware manufacturers, software vendors and professional service organizations to come together to solve one of this industry’s biggest challenges.
Accomplishing the above-mentioned integrations is one the costliest efforts undertaken by R&D organizations. Better practices and sharing of knowledge will dramatically reduce this burden.
Project members will receive a software solution that allows them to populate data and processes as well as interrogate the data for better practices and approaches.
Project Funders
