Product Development (5)

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...

Challenge: A biotech developing a novel drug for NASH asked Alacrita to create a project plan outlining costs and timelines for preclinical IND-enabling studies.

Challenge: A UK-based charity with significant revenues from an older patent portfolio was facing a sizable reduction in income from 2017/18 due to patent expiry. With a current research portfolio of...

Challenge: With an unprecedented amount of life science investment being put to work, the industry faces a well known shortage of experienced Chief Medical Officers (CMO). Therefore, following an...

Challenge: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell therapies and proprietary...

Challenge: A research group at a leading university had manipulated autologous regulatory T cells (Tregs) to give them gut-homing properties, making them suitable for influencing the course of...

Challenge: A client, developing a first-in-class small molecule with potential to treat a range of cancer types, wanted to gain a deeper understanding of the competitive landscape in certain cancer...

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the...

Challenge: A small biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s...

Challenge: A leading UK university had patented a cell-based assay which it believed had potential in drug discovery, or as a whole-cell biosensor, and asked Alacrita to review the technology...

Challenge: A biotech company developing a platform technology to improve the safety of CAR T-cell therapies asked Alacrita to conduct a comprehensive competitive landscape to better understand the...