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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Valuation of pipeline for fundraising activities

Challenge: An oncology biotech company with a proprietary therapeutics development platform technology was in the process of fundraising activities. The company's pipeline included three main...
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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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Valuation and deal making for oncology antibody

Challenge: A biotechnology company developing novel multi-specific antibody therapeutics to treat a range of cancers asked Alacrita to develop valuations for its four leading assets, as well as...
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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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Accelerated commercial readiness strategy and launch plan

Challenge: A European immune-oncology biotech with a proprietary platform had generated a broad and deep pipeline of oncology assets, which had demonstrated an advantage due to their ability to...
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Opportunity analysis of phage technology

Challenge: An Israeli university technology transfer organization asked Alacrita to explore the different potential commercialization pathways for a novel platform technology. The overall effect of...
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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 of...
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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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Commercial infrastructure & launch plan for orphan disease drug in EU & US

Challenge: Alacrita was engaged by a biopharma company developing a therapeutic for a severe orphan disorder. With Breakthrough status designation from the FDA and a Prime designation from the EMA,...
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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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