Primary market research and patient segmentation mapping in myelofibrosis

Challenge: A venture-backed US biotech company was developing a preclinical biologic for haematological indications and wished to quantify the commercial opportunity for the product in treating...
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Anti-metastasis mAb assessment

Challenge: Alacrita was asked to assess a novel mAB-based approach to suppressing cancer metastases. The client, a biotech incubator with rights to the project, was considering further investment,...
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Regulatory support to understand likelihood of approval of an ophthalmology asset

Challenge: A European pharmaceutical company focussed on ophthalmic care was seeking Well Established Use (WEU) approval in Europe for a small molecule asset. The company commissioned Alacrita to...
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Validating the opportunity for a novel anticoagulant with KOL research

Challenge: A research-focused biotech company developing a novel, first-in-class, next generation oral anticoagulant for the prevention of life-threatening thrombotic events asked Alacrita to...
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Evaluating the attractiveness & potential positioning of a new kinase inhibitor

Challenge: An in-silico drug discovery company requested an expert review of the robustness and potential positioning of a new kinase inhibitor in oncology and inflammatory disease. Alacrita was...
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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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Preparing a EU Paediatric Investigators Plan

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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Applying for PRIME EMA status in the EU

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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AAV gene therapy roadmap to IND, for a cardiac indication

Challenge An academic group was interested in developing and commercializing an AAV vector-delivered gene therapy for a cardiac indication through the formation of a NewCo. They required assistance...
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