Commercial development plan for a mesenchymal stem cell therapy in acute GvHD

Challenge: Our client was a leading UK research institute requiring assistance in assigning internal commercialization funding to the most promising research groups within the university. Alacrita...
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Cell and gene therapy manufacturing facility planning

Challenge: A new GMP facility for the production of investigational cell and gene therapies needed regulatory, market and technical advice before committing to a capacity expansion.
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Due diligence on a new medical imaging technology

Challenge: A well-capitalized Swiss pharma company needed a clinical and commercial reality check for a new imaging technology being developed that was under consideration for acquisition.
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Providing expert due diligence for the reformulation of a marketed biologic

Challenge An established European pharma company needed an opportunity assessment for a reformulation of a marketed biologic.
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Opportunity map for 3D Printing Technology for medical products

Challenge: A university commercialization institute asked Alacrita to review its technology for 3D printed, customised silicone medical products. The main task was to determine the prospective value...
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Medical oversight support for oncology clinical trials

Challenge: A listed biotech company conducting Phase III clinical trials in an oncology indication needed Chief Medical Officer support for multiple clinical activities in Europe and the United...
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Development & Refinement of a Patient-Reported Outcome (PRO) Strategy

Challenge: Alacrita was approached by a company developing an enzyme approved by the FDA for the treatment of toxic plasma chemotherapy concentrations in patients with delayed clearance due to...
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Planning cancer immunotherapy combination trials

Challenge: A client, developing a first-in-class small molecule with potential to treat a range of cancer types, wanted to gain a deeper understanding of the competitive landscape in certain cancer...
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Documentation gap analysis in preparation for FDA scientific advice meeting

Challenge: Our client was committed to applying a deep understanding of axon regeneration and neuronal signaling pathways to transform the lives of patients afflicted with neurotrauma or...
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Supporting a CTA submission for the oral form of an approved biologic drug

Challenge: Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II...
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Providing CTA submission support for a monoclonal antibody

Challenge: Our client specialized in the development of proprietary monoclonal antibodies directed towards novel targets for the treatment of immune-mediated and fibrotic disorders, including orphan...
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Pipeline strategy for gene therapy company

Challenge: A leading biotechnology company with a focus on development and commercialization of gene therapies for bleeding and other debilitating disorders had developed a next-generation AAV gene...
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