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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R&D pipeline planning for gene therapy company

Challenge: A biotechnology company developing proprietary synthetic biology technology in gene therapy expression for several clients was looking to evolve its business model. The company engaged...
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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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Technical & commercial review of anti-inflammatory peptide

Challenge: A university research group had discovered a new pathway for regulation of T cell trafficking in the inflammatory response. The group had also identified an anti-inflammatory peptide and...
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Scouting in-licensing targets in inflammation and fibrosis

Challenge: A pharmaceutical company with marketed therapeutics in several respiratory disorders wanted to supplement its internal pipeline with external innovation. The company had already searched...
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Providing due diligence for a company developing R&D tools using pluripotent stem cells

Challenge: A UK-based VC wished to invest in a biotech spin-out focussed on the development of R&D tools using induced pluripotent stem cells (iPSCs) as organoids to mimic human tissues. These...
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Investor due diligence on preclinical stage vaccine platform technology

Challenge: Following a pre-due diligence exercise, an investment firm asked Alacrita to conduct a deeper due diligence on a biotech company's vaccine platform technology targeted towards infectious...
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