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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Opportunity assessment for functional RNA & protein arrays

Challenge: A UK university had developed a technology that permits the creation of surface-immobilized functional RNAs in a microarray format. The technology has the potential to impact both...
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Clinical development strategy in malignant melanoma

Challenge: A biopharma company asked Alacrita to provide expert input on the clinical development of a microbiome therapeutic (LBP, live biotherapeutic product) in the context of first line and...
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Interim medical director for MAA submission

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories...
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Developing vaccine products

Challenge The UK HIV Vaccines Consortium needed expert advice. The consortium was supporting and coordinating the development of several new HIV vaccines in academia. They needed guidance about which...
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Applying to Early Access to Medicines (EAMS) at the MHRA

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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EU value proposition and market access plan for orphan disease drug

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
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Gap analysis for a CTA submission in the UK

Challenge: Our client was developing a novel iron treatment with potential to be best-in-class for iron deficiency anemia (IDA). The product used nanotechnology to mimic the natural structure of...
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US market access plan for antibody launch

Challenge: A Swiss biopharma company was developing a therapeutic for a severe orphan disorder. The company had successfully obtained Breakthrough Therapy Designation by the FDA and PRIME status by...
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Gap analysis & pre-IND meeting preparation for preclinical compound

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of...
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Due diligence on the developability & investability of a cancer vaccine

Challenge: A newly-formed US biotech company has acquired the intellectual property and assets of a legacy cancer vaccine company that had ceased trading several years ago following disappointing...
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