Product Development (2)

Challenge: A UK university had developed a technology that permits the creation of surface-immobilized functional RNAs in a microarray format. The technology has the potential to impact both...

Challenge: A biopharma company asked Alacrita to provide expert input on the clinical development of a microbiome therapeutic (LBP, live biotherapeutic product) in the context of first line and...

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories...

Challenge The UK HIV Vaccines Consortium needed expert advice. The consortium was supporting and coordinating the development of several new HIV vaccines in academia. They needed guidance about which...

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...

Challenge: Our client was developing a novel iron treatment with potential to be best-in-class for iron deficiency anemia (IDA). The product used nanotechnology to mimic the natural structure of...

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of...

Challenge: A newly-formed US biotech company has acquired the intellectual property and assets of a legacy cancer vaccine company that had ceased trading several years ago following disappointing...

Challenge: A prominent researcher at an academic research institution had developed a class of small molecule compounds with in vitro antiviral activity against a family of RNA viruses. The...

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...