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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Preclinical & clinical asset pipeline valuation

Challenge: A young biotech company with a portfolio of clinical and pre-clinical stage bispecific antibodies (BsAb) to treat various cancers was in the process of completing a Series A funding round....
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Regulatory strategy for a novel drug delivery technology

Challenge: Our client was developing a highly novel and versatile intracellular delivery vehicle which could readily penetrate cells without compromising membrane integrity or inducing cytotoxicity....
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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 IDA. The product used nanotechnology to mimic the natural structure of dietary iron and promised...
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Regulatory support in obtaining EU Orphan Drug Designation for a gene therapy

Challenge: Our client was a biotechnology company developing life-enhancing gene therapies designed to restore vision in patients suffering from blindness due to inherited retinal diseases. The...
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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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Presenting technology & clinical programs at ASH & SABCS

Challenge A biotech company focused on developing therapeutics for oncology indications was looking to contract a clinical consultant to support their in-house team in presenting its technology and...
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Business plan and fundraising for cell therapy company

Challenge An early stage, European cell therapy company focused on developing novel off-the-shelf NK cell therapy solutions for the treatment of a variety of cancers had developed a platform...
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