Cancer clinical development strategy

Oncology Scientific Advisory Board An emerging drug discovery company, with a core expertise in molecular modelling, had developed a small molecule inhibitor of a novel cancer metabolism target. The...
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Feasibility study - ophthalmic therapies

A leading research institute developing novel approaches for production of ophthalmic treatments asked Alacrita to conduct a market and competitive assessment of the current supplier base and...
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Medical device technology assessment

A university research team had worked for a number of years on the development of a novel interventional cardiology device. Recent progress had been made with pre-clinical testing on pigs, as well as...
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Wound care - regulatory support

10111A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and has mapped regulatory pathways that pertained to various classes of product. Having...
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GMP facility - feasibility study for biologics production

Drawing on expertise from its regulatory, gene therapy and manufacturing consultants, Alacrita conducted feasibility study and formulated a business case for a new GMP facility for production of...
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Designing and monitoring anti-NGF antibody imaging endpoints

Challenge: Anti-nerve growth factor inhibitors are a new class of powerful analgesics in clinical development. They were put on clinical development hold by the FDA in 2012 due to joint-related...
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Clinical strategy, medical oversight and clinical due diligence

Alacrita's consulting team supports a number of pharmaceutical & biotech companies with medical and clinical strategy. We have particular depth in oncology, but also have expertise in infectious...
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Medical Device Consulting

Medical device 510(k) submission strategy Alacrita’s client had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to...
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Expert report

A venture-backed biotech company, developing a clinical stage asset for the treatment of early stage cancer, was populating a dataroom and preparing for negotiations with a major pharmaceutical...
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Cancer vaccine clinical strategy, valuation and business planning

Alacrita Consulting's founders worked together for over 10 years at Onyvax, a London-based cancer immunotherapy company backed by SR One. We have conducted a number of consulting projects in the...
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Strategy for biomarker identification technology

Alacrita’s antibody consultants were engaged to help a start-up company that had developed a suite of proprietary antibody technologies to identify accessible cell surface proteins for discovery of...
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Novel Antibody Screening Technology

Technology Consulting: Novel Antibody Screening Technology Alacrita's antibody consultants were asked to help assess the market potential and develop a commercialization strategy for a novel antibody...
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