Development plan validation for novel small molecule for cancer

Challenge: For a university with an early stage novel inhibitor of the JAK2/STAT5 pathway intended to treat hematologic malignancies, Alacrita was asked to validate a development plan to support...
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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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Valuation of a novel oncology program to support fundraising and M&A opportunities

Challenge An early stage virtual company developing a siRNA knock-down technology to increase chemo-sensitivity of tumor cells had developed a specific formulation of its siRNA therapeutic using a...
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Supporting a PE Fund with Radiopharmaceutical Opportunity Mapping & Market Landscaping

Challenge A private equity fund which had successfully invested in the advanced biologics CDMO space was considering entering the radiopharmaceuticals CDMO space through investment in an established...
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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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Characterizing the European commercial opportunity for a microbiome company

Challenge: A clinical stage microbiome company was developing a microbiome therapeutic for the treatment of recurrent C. Difficle infection (rCDI). The company was progressing through clinical...
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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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Glycan biomarker discovery market research in North America

Challenge A glycan biomarker research company with a proprietary platform offering biomarker discovery and characterization, diagnostic development and commercialization asked Alacrita to help them...
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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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