Appealing FDA refusal of an orphan drug designation application

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...
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European market access support for clinical stage biopharma company

Challenge: A clinical stage biopharma company developing a novel small molecule to treat a rare respiratory disorder had conducted an Advisory Board to finalize the design of later stage clinical...
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Regulatory plan for a biotech with proprietary nanotechnology

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...
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IND-enabling studies plan for a small molecule in NASH

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.
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IP portfolio review for UK charity

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...
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Interim CMO for oncology company

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...
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Cell therapy CMC regulatory affairs & pharmacology & toxicology support

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...
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Crohn's Disease research project plan

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...
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Landscape analysis of a PD1-based immunotherapy combination

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...
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Defining a clinical strategy in oncology for a platform technology

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...
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Independently reviewing clinical trial data

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...
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Commercial opportunity scoping for novel cell-based assay

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...
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