ATMP Catalyst Program
The program lasts for three years, divided into three phases that adapt to the needs and maturity of the projects.
Each year, 6 new projects join Phase I, and advanced projects complete their phases up to 3 years.
Phases
- Phase I
- Phase II
- Phase III
TRL 2-3: Basic research and proof of concept
Objectives:
- Formulation of the technological concept: Clear definition of the idea and how it can be materialized into a product or technology.
- Initial in vitro preclinical studies: Initial tests in laboratories to evaluate the viability and safety of the concept.
- Development of the first prototypes: Creation of initial models to test the functionality of the project.
- Evaluation of technical feasibility: Analysis of feasibility and potential technical challenges.
- Scientific documentation: Collection of data and results to structure a solid base for the project.
Key Areas:
- Regulatory Roadmap: Initial considerations of regulatory requirements.
- Market Access: Preliminary market analysis and potential applications.
- Intellectual Property: Identification of patentable elements.
- Financing: Funding options to continue development.
- Business Model & Business Basics: Initial business model sketch.
TRL 3-4: PoC – Preclinical development
Objectives:
- Validation of the experimental proof of concept: Confirmation that the technology works in controlled conditions.
- Development of the first prototypes: Improvement of initial prototypes with more solid experimental data.
- Validation of the mechanism of action: Detailed study of the product’s functionality and effectiveness.
- Preliminary safety evaluation: Initial tests to ensure the technology is safe for further use.
- Documentation and scientific reports: Preparation of reports to validate the obtained results.
Key Areas:
- Regulatory Roadmap: Identification of specific regulatory requirements.
- Market Access: Study of market viability and identification of potential clients.
- Intellectual Property: Legal protection through patents or copyrights.
- Financing: Search for new funding sources to advance research.
- Business Model: Definition of the business model and commercialization strategy.
TRL 4-5: Preclinical development
Objectives:
- Technology validation in the laboratory: Final confirmation of its effectiveness in controlled environments.
- Preliminary regulatory interactions: Initial communication with regulatory authorities to ensure compliance.
- Determination of regulatory and reimbursement strategy: Definition of how the product will be marketed and how investments will be recovered.
- Strategy for scaling the manufacturing process: Planning for large-scale production.
- Clinical trial design: Preparation of protocols to start clinical studies in humans.
Key Areas:
- Regulatory Roadmap: Compliance to move forward to clinical trials.
- Market Access: Development of market entry strategies.
- Intellectual Property: Expansion of intellectual property protection to prevent competition.
- Financing: Obtaining funding for the next phases of development.
- Business Model: Final definition of the commercial strategy.
Training program
Regarding the training program, it is divided into 5 main blocks: regulatory, financing, intellectual property, market access and business model.
Additionally, the teams will have access to a pool of hours (25 hours during Phase 1 and 50 hours in Phases 2 and 3) for individual consultations or more personalized training with a pool of mentors.
Phase I | Basic research and proof of concept
- Analysis of scientific versus business competencies
- Creative process with a focus on the market
- Process of identifying technology valuation:
- Licensing
- Company creation
- Practical case examples in the field of advanced therapies
3 hours
- Introduction to Advanced Therapy Medicinal Products (ATMPs)
- Lifecycle of an ATMP: From Concept to Commercialization
- Global Regulatory Requirements for ATMPs
- Common Regulatory Challenges and Solution Strategies
4 hours
- Tools for protecting industrial and intellectual property for advanced therapy projects.
- Patents in the field of advanced therapies: When to apply for a patent and what technical information is needed based on the case.
- Case Study 1: Protection in the field of cell therapy and tissue regeneration.
- Case Study 2: Protection in the field of antibodies and derivatives.
4 hours
- Public Funding Opportunities for Biotech Projects
- Overview of financing strategies in life sciences
- Non-dilutive funding sources
- Private funding mechanisms
- In-depth analysis of venture capital (VC)
- Practical case study: Real-life example of company creation in ATMPs
5 hours
Phase II - PoC – Preclinical development
- Identification of specific regulatory requirements.
- Market feasibility study and identification of potential clients.
- Legal protection through patents or copyrights.
- Seeking new funding sources to advance the research.
Phase III – Preclinical Development
- Regulatory compliance to advance toward clinical trials.
- Establishment of market entry strategies.
- Expansion of intellectual property protection.
- Securing funding for next development phases.