Periodic Reporting for period 1 - VITALA (De-Risking the drug discovery process of Oncology and Metabolic diseases)
Reporting period: 2023-07-01 to 2023-12-31
We aim to cement the initial steps for developing a real-time drug testing platform by participating in this project. The funding received from WTE will be used to cover the copyright of the company, develop the initial regulatory strategy, find initial partners and biotech companies and study the market positioning of the company. For the regulatory strategy, we will start preparing the premeetings with the EMA and the FDA in order to discuss the possibility to approve our technology as a routine and complementary technique used in preclinical stages, and understand what needs to be prepared to get the approval. For the partner search, we will scope partners that can take help us in reaching customers. CRO’s, other services companies that could incorporate Vitala’s analysis inside their pipelines of services offered to drug development customers. We are also evaluating to be a distributor of the platform for research purposes. The big players in the field have shown an especial interest in being a consumer of the hardware. The idea after this project is to be able to set up a drug testing service, which could create alliances with CROs and pharmaceutical companies, first to do one-shot validations, and later on include it into their clinical and preclinical trials pipeline.
Task 1. Preparation of pre-meeting with EMA.
As a conclusion it is considered that the feedback from the ITF (given by EMA) is often not highly clarifying, since it does not go into too much detail. If precise detail is required, the ITF
usually directs to a Scientific Advice (SA) process. It would be important to carry out a prioritisation exercise to select the most appropriate type of procedure with the EMA (ITF vs
Qualification Advice). Another extensive process is needed, which is not covered by the budget proposed for the WomenTechEU program. The consultation funding allowed initial review supported by Asphalion. Outcomes from pre-meeting allowed Dr. Ortega and Mr. Bestard to better reviewing the documentation generated by Mr. Prats (PNT and Qualifications reports) for managing the resources for the GLP quality implementation in the new laboratory as well.
Task 2. Investigate our market positioning.
Here are our key learnings:
• Vitala's service is unique and has a fit in the market, which increases in value when adding metabolomics data, and in vivo testing services.
• Local and international CRO companies are seeking partnerships to provide better services to Biotechs and Pharma companies, where Vitala is poised to have an important opportunity.
• Vitala's market size is €5.4bn for 2023 in Europe, the USA, and Asia, with a CAGAR of 12% for the next 5 years, SAM of €1.3bn and SOM of €212M in 2028.
All this work was done under the supervision of Maria Alejandra Ortega Machuca, Gabriel Bestard
Task 3. Analyse our commercialization options and develop our pricing strategy.
Here are our key learnings:
• Pricing is not the primary issue for market traction; initial validation and publication in peer-reviewed journals are critical.
• Presenting services and pricing with the right creative makes the process of asking and gathering information easier, and boosts confidence in the results.
• There is space for discounts in our pricing model to adapt to current market practices.
All this work was done under the supervision of Maria Alejandra Ortega Machuca and Gabriel Bestard
Task 4. Study the customers willingness to pay and perform partner search.
Here is our key take away:
• We are clear on our business strategy and overall business needs All this work was done under the supervision of Maria Alejandra Ortega Machuca and covered.
Task 5. Participate in coaching activities provided by the Women TechEU program.
During this Women TechEU program Dr. Ortega and Dr- Marco didn’t participate directly in coaching activities from the EIC. As ex-participants of the first cohort of the Women
Leadership program we continued in close contact with the mentor assigned during the WLP program. Dr. Ortega sought counsel from Mr. Andreas Wolf at SHIFTHAPPENS Splitt Wolf & partners for three sessions, focusing on resolving management challenges within her startup. Their discussions honed in on complex issues, empowering her to explore tailored solutions aligned with her business's needs. Andreas's expertise in market analysis refined her expansion strategy, offering a clearer market focus and roadmap. His ongoing support ensured steady progress. Meanwhile, Mrs. Kathy Mahoney from Rodetal Ltd. engaged in six sessions with Dr. Marco-Rius, addressing leadership transitions and adapting from academia to a startup. Their thorough discussions shaped her leadership style, guiding subsequent actions in line with her values. These sessions remain invaluable in her decision-making process and navigating challenging situations.
As a conclusion it is considered that the feedback from the ITF (given by EMA) is often not highly clarifying, since it does not go into too much detail. If precise detail is required, the ITF
usually directs to a Scientific Advice (SA) process. It would be important to carry out a prioritisation exercise to select the most appropriate type of procedure with the EMA (ITF vs
Qualification Advice). Another extensive process is needed, which is not covered by the budget proposed for the WomenTechEU program. The consultation funding allowed initial review supported by Asphalion. Outcomes from pre-meeting allowed Dr. Ortega and Mr. Bestard to better reviewing the documentation generated by Mr. Prats (PNT and Qualifications reports) for managing the resources for the GLP quality implementation in the new laboratory as well.
Task 2. Investigate our market positioning.
Here are our key learnings:
• Vitala's service is unique and has a fit in the market, which increases in value when adding metabolomics data, and in vivo testing services.
• Local and international CRO companies are seeking partnerships to provide better services to Biotechs and Pharma companies, where Vitala is poised to have an important opportunity.
• Vitala's market size is €5.4bn for 2023 in Europe, the USA, and Asia, with a CAGAR of 12% for the next 5 years, SAM of €1.3bn and SOM of €212M in 2028.
All this work was done under the supervision of Maria Alejandra Ortega Machuca, Gabriel Bestard
Task 3. Analyse our commercialization options and develop our pricing strategy.
Here are our key learnings:
• Pricing is not the primary issue for market traction; initial validation and publication in peer-reviewed journals are critical.
• Presenting services and pricing with the right creative makes the process of asking and gathering information easier, and boosts confidence in the results.
• There is space for discounts in our pricing model to adapt to current market practices.
All this work was done under the supervision of Maria Alejandra Ortega Machuca and Gabriel Bestard
Task 4. Study the customers willingness to pay and perform partner search.
Here is our key take away:
• We are clear on our business strategy and overall business needs All this work was done under the supervision of Maria Alejandra Ortega Machuca and covered.
Task 5. Participate in coaching activities provided by the Women TechEU program.
During this Women TechEU program Dr. Ortega and Dr- Marco didn’t participate directly in coaching activities from the EIC. As ex-participants of the first cohort of the Women
Leadership program we continued in close contact with the mentor assigned during the WLP program. Dr. Ortega sought counsel from Mr. Andreas Wolf at SHIFTHAPPENS Splitt Wolf & partners for three sessions, focusing on resolving management challenges within her startup. Their discussions honed in on complex issues, empowering her to explore tailored solutions aligned with her business's needs. Andreas's expertise in market analysis refined her expansion strategy, offering a clearer market focus and roadmap. His ongoing support ensured steady progress. Meanwhile, Mrs. Kathy Mahoney from Rodetal Ltd. engaged in six sessions with Dr. Marco-Rius, addressing leadership transitions and adapting from academia to a startup. Their thorough discussions shaped her leadership style, guiding subsequent actions in line with her values. These sessions remain invaluable in her decision-making process and navigating challenging situations.
Vitala's mission focuses on pioneering human-centric tools and strategies, diverging from traditional animal models. They aim to create in-vivo-like in vitro assays, particularly emphasizing Oncology and Metabolic diseases. The proposed Organ-on-a-Chip (OoC) model promises a more accurate representation of human biology than standard cell cultures or animal models. Preliminary results indicate the potential to produce over 30 OoCs from a single mouse liver, offering an ethical and efficient alternative to animal testing.
This revolutionary technology allows simultaneous testing of multiple substances on diverse organoids, expediting research outcomes. The controlled biological systems reduce costs and complexities, promising cost-effective and time-efficient experimentation. While liver-related metabolic changes take center stage, the tools' versatility extends to various organs and diseases.
Vitala's OoC platform is anticipated to transform health technology, improving drug testing, disease modeling, and toxicology research. It aims to boost productivity in discovery programs, mitigate drug failure risks in clinical trials, and potentially enhance the drug discovery and preclinical services market. Disease-on-chip platforms could address unmet medical needs, especially in diseases lacking effective treatments.
The envisioned metabolic imaging strategies are poised to deepen understanding of disease processes, aiding in prediction, prevention, and treatment. Personalized responses to treatments, derived from patient-specific cells, can predict drug responses and toxicity, reducing adverse effects in clinical trials.
To gain regulatory confidence, robust processes and recognition from agencies like the US FDA and EU EMA for New Approach Methods (NAMs) are critical. This shift towards socially accepted and sustainable non-animal biomedical research aligns with global environmental concerns.
Building societal acceptance involves extensive stakeholder engagement and workshops, ensuring the long-term sustainability of these approaches. This approach aims to build trust, mitigate risks, and regulate impacts within the EU region.
Contributing to 'Good health and high-quality accessible health care,' Vitala's initiative aligns with the health cluster's strategic plan. This international collaboration emphasizes the value of global cooperation, enhancing the EU's leadership in health technology development.
This revolutionary technology allows simultaneous testing of multiple substances on diverse organoids, expediting research outcomes. The controlled biological systems reduce costs and complexities, promising cost-effective and time-efficient experimentation. While liver-related metabolic changes take center stage, the tools' versatility extends to various organs and diseases.
Vitala's OoC platform is anticipated to transform health technology, improving drug testing, disease modeling, and toxicology research. It aims to boost productivity in discovery programs, mitigate drug failure risks in clinical trials, and potentially enhance the drug discovery and preclinical services market. Disease-on-chip platforms could address unmet medical needs, especially in diseases lacking effective treatments.
The envisioned metabolic imaging strategies are poised to deepen understanding of disease processes, aiding in prediction, prevention, and treatment. Personalized responses to treatments, derived from patient-specific cells, can predict drug responses and toxicity, reducing adverse effects in clinical trials.
To gain regulatory confidence, robust processes and recognition from agencies like the US FDA and EU EMA for New Approach Methods (NAMs) are critical. This shift towards socially accepted and sustainable non-animal biomedical research aligns with global environmental concerns.
Building societal acceptance involves extensive stakeholder engagement and workshops, ensuring the long-term sustainability of these approaches. This approach aims to build trust, mitigate risks, and regulate impacts within the EU region.
Contributing to 'Good health and high-quality accessible health care,' Vitala's initiative aligns with the health cluster's strategic plan. This international collaboration emphasizes the value of global cooperation, enhancing the EU's leadership in health technology development.