From the discovery of a new drug to thefirst clinical trials in humans is a long road, with many steps to take and the journey of many companions. Starting with the design of the target product profile, the selection of the best candidate, the production of a high-quality product and the consequent pre-clinical tests, all the way to obtaining approval from the regulatory authorities to carry out the clinical trial. Overcoming all these challenges and finally developing the clinical phase also requires establishing relationships with the different stakeholders: pharmaceuticals, regulatory authorities, CROs or hospitals and healthcare providers.
It is a path that poses a special challenge for the limited resources available to biotech start-ups. For this reason, CataloniaBio & HealthTech brought together five experts from member companies, with knowledge and experience in different phases of the pharmaceutical development process, to share lessons learned in the usual Lessons Learned format. The session took place at the Barcelona Science Park.
Moderating this Lessons Learned was Marie-Eve Beaulieu, co-founder and CSO of Peptomyc. Before opening the conversation with the speakers, she reviewed the different stages of the process, stressing that "benefiting from the perspective and knowledge of others who havealready been through it is especially helpful in situations like these".
First step, hit lo lead
At what point do you know you have the target? The first question was answered by Ruth Muñoz Risueño (CSO of Leukos Biotech), who shared her experience in the transition from basic to translational research and, in turn, the transition to the company. He highlighted the support of the many different people involved in his career, a common denominator in the experience of all the speakers. Leukos Biotech expects to arrive at the clinical phase at the end of this year.
Candidate selection
At this point, Carles Domènech (Executive Chairman and CEO of Ability Pharmaceuticals) summarised some of the cases from his career and the aspects that have decided the selection of candidates. In line with the rest of the speakers, he stressed the importance of networking at all stages of the process, in a context (that of drug development) in which biotech companies do not compete with each other.
Experience in the process and planningfrom the outset
Mercè de Frias, currently COO of ONA Therapeutics, also has experience in clinical trials from the pharmaceutical company's point of view. When asked what advice she would give herself on the management of clinical trials, her answer was clear: "Everything can be learned, but it is not quick. That is why, even more so in small biotechs, it is important to incorporate someone who has already done clinical trials, to help you plan and meet the deadlines".
In this sense, Joël Jean-Mairet (Managing Partner of Ysios Capital) added that it is important to be clear about the process from the beginning. "Pharmaceuticals are very good in the last phase, but the best in innovation are biotechs", he pointed out. On the other hand, biotechs must make more effort in planning and have many clear aspects from the beginning to avoid failing in more advanced phases, such as that the lack of foresight in the price of the product ends up affecting the business case or that the product must be able to be produced and scaled.
Of all the contributions, which were alsoshared in the question-and-answer session with the sixty people attending thesession, there was a clear consensus: networking and seeking advice is veryimportant. The Lessons Learned ended in precisely this way, with a networkingspace for the attendees, where they could finish sharing experiences, questions,and contacts.
We look forward to seeing you at the nextLessons Learned session!
Related information:
What are Lessons Learned?
The Lessons Learned sessions, which kicked off in 2014 promoted by CataloniaBio & HealthTech, are a knowledge forum for professionals in the health, biomedicine and innovative medical technology arena to share experiences and reflections with experts on various strategic areas to boost the competitiveness of companies. The Lessons Learned sessions are also a great opportunity for networking.
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