Gene Therapy Consulting

Worldwide, there are more than 854 companies that develop therapies and operate in regenerative medicine, of which: 460 companies in North America (54%), 234 Europe and Israel (34%) and the remaining part divided between Asia and Oceania. The number of authorized clinical trials has been growing continuously since 1990, where there were only two authorized cases, up to the first decade of the 2000s where the world total reached 100.8 cases. On the other hand, in recent years the peak has been reached in 2015 with 163 authorized clinical and therapeutic studies, with perspectives continuously growing up to 2020 and a CAGR of 18-22% annually. About 300 candidate products are currently in various stages of development for a wide range of indications. Eight gene therapies are commercially available; of these, Imlygic® (Amgen), Strimvelis® (Orchard Therapeutics), Invossa ™ (TissueGene / Kolon Life Science / Mitsubishi Tanabe Pharma) and Luxturna ™ (Spark Therapeutics) have been approved after 2015. Almost 48% of the molecules in the pipelines are in clinical development; of these, 21 molecules have been studied in phase II / III, 8 molecules in phase III (planned), 21 molecules in phase II, 48 molecules in phase I / II and 49 molecules in phase I clinical trials. However, the majority (49%) of the candidates for the product being developed is still in the preclinical and discovery phase. In this context, Prof. Alessandra Biffi, thanks to the high degree of authority in the sector-specific research and development and thanks to her numerous international knowledge and collaborations, can already bring a significant competitive advantage to the initiative with high barriers to entry (towards potential competitors) in terms of know-how and credibility.