Product Development (4)

Challenge: Our client was committed to applying a deep understanding of axon regeneration and neuronal signaling pathways to transform the lives of patients afflicted with neurotrauma or...

Challenge: Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II...

Challenge: Our client specialized in the development of proprietary monoclonal antibodies directed towards novel targets for the treatment of immune-mediated and fibrotic disorders, including orphan...

Challenge: A leading biotechnology company with a focus on development and commercialization of gene therapies for bleeding and other debilitating disorders had developed a next-generation AAV gene...

Challenge: Our client was developing novel, precision immunotherapy, delivering individualized treatments that recognized each patient’s disease. Its lead product was in Phase III clinical...

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether...

Challenge: For a leading university with an early stage novel small molecule to treat prostate cancer, Alacrita was asked to validate a development plan in order to support activities for securing...

Challenge: A biopharma start-up developing a small molecule to treat a rare kidney disorder sought Alacrita’s advice on its Target Product Profile (TPP) and market attractiveness. Specifically, they...

Challenge: A leading European university identified a gene therapy for the treatment of haemoglobinopathies. Alacrita was asked to support the Principal Investigator (PI) in developing a Commercial...

Challenge: A biotech company developing improved versions of available chemotherapy drugs approached Alacrita for indication strategy support, seeking to sanity check and refine its current clinical...

Challenge: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for...

Challenge: Our client was a biotechnology company focused on use of a proprietary nanotechnology invented to allow different combinations of drugs to be encapsulated in a single nanomedicine and...