Clinical protocol review in oncology

Challenge A biopharma company developing microbiome therapeutics asked Alacrita to conduct a detailed protocol review of a clinical study designed for its lead asset in patients with advanced solid...
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Asset scouting for small molecule assets in CNS

Challenge: An early-stage biotechnology company with several assets in pre-clinical development for CNS diseases wanted to supplement its internal pipeline with external innovation. The company...
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Asset Scouting for Psychoactive Drugs

Challenge: A biotechnology company with clinical-stage assets positioned in several neuropsychiatric disorders wanted to supplement its internal pipeline with external innovation. The company wanted...
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Gene therapy technology opportunity assessment

Challenge: A cell and gene therapy platform company developing a scalable AAV production system, requested Alacrita’s guidance on the priority order for AAV vector capsid serotype release and the...
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Indication triaging for AAV-based gene therapies

Challenge: A biopharmaceutical company developing novel immunomodulatory technology was exploring the potential clinical use of its lead candidate in combination with AAV based gene therapies to...
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Regulatory analysis of rejected marketing authorization & response strategy

Challenge: Our client, a major generics and biosimilars player, was developing a generic version of a major therapeutic. It had submitted a dossier for marketing authorization in the EU which was...
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Regulatory strategy for an ophthalmology product based on repurposing

Challenge: An ophthalmology specialty pharma company, for whom we had previously conducted due diligence, retained Alacrita to advise on the regulatory strategy for a new product based on repurposing...
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Technical and commercial due diligence of antibody against metastatic cancers

Challenge: A VC firm was exploring investment in a spin-out company with an antibody targeted at metastatic cancer indications. Before committing to the financing round, the investor required...
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Pre-DD on re-purposed ophthalmology product

Challenge: A private investment firm was interested in a European drug re-purposing company and asked Alacrita to perform top-level due diligence to help the firm decide whether it wanted to proceed...
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Due diligence for a microbiome therapeutic

Challenge: Our client, a mid-cap pharma, was planning to extend its portfolio in the gastrointestinal (GI) disease space. It was considering microbiome-based approaches, specifically live...
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Due diligence for in-licensing opportunities in oncology

Challenge: A lean pharma company reached out to Alacrita for due diligence support regarding three oncology assets of interest, prior to entering into licensing negotiations. The client requested an...
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Clinical due diligence of an NK cell therapy

Challenge: A leading NK cell research group had developed a novel process for manufacturing NK cells with highly differentiated properties. The technology had been licensed to a start-up company that...
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