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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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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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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Investor pitch deck for biotech developing non-opioid analgesic

Challenge A start-up US biotech developing a non-opioid analgesic drug and delivery device was preparing to raise its first round of external funding. They engaged Alacrita to help frame the target...
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Asset scouting for in-licensing opportunities in fibrosis

Challenge: A biotech company focused on developing therapeutics for fibrotic diseases was looking at acquisitions or in-licensing as a way to grow its development pipeline with additional assets....
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Business plan for opioid overdose detection device

Challenge Our client was a start-up looking to raise external venture capital funding for development of a biosensor for early detection of opioid overdose. The company had drafted a business plan...
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Commercial viability of a bacterial biomarker test

Challenge A leading UK university and an executive agency of the DoH were collaboratively developing a rapid (30 min) bacterial ID and antimicrobial resistance test platform. The technology...
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Distressed company analysis for asset scouting

Challenge: Our client was a publicly-traded precision oncology company with whom Alacrita had previously supported with a long-term asset scouting engagement. This cash-rich biotech company wanted to...
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Regulatory due diligence for A-Fib development drug

Challenge: Our client was a US-based venture capital fund, with whom we have a long-standing retainer agreement to provide specialized due diligence support for their fund investment decisions. In...
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