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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EU, US and Japan payer research for a novel immunotherapy in advanced RCC

Challenge: Our client was developing novel, precision immunotherapy, delivering individualized treatments that recognized each patient’s disease. Its lead product was in Phase III clinical...
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Providing regulatory strategy for T-cell therapy

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether...
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Clinical development strategy & plan for novel small molecule

Challenge: For a leading university with an early stage novel small molecule to treat prostate cancer, Alacrita was asked to validate a development plan in order to support activities for securing...
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Valuation of a cancer therapy for licensing deal

Challenge: A biotech company developing small molecule drugs for oncology was in the process of licensing negotiations with a pharma company for its lead asset. The asset, set to enter the clinic in...
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Treg cell therapy commercialization plan

Challenge: The commercialization arm of a leading university wished to identify its most promising therapeutic programs within its purview in order to allocate internal translational funding to...
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Due diligence on a novel T cell therapy and discovery platform

Challenge: A VC investor wished to make an investment in a California-based preclinical biotechnology company with a discovery platform and novel T cell therapies for cancer and other diseases....
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Acquisition & licensing landscape for technologies in fertility & women’s health

Challenge: In order to better review potential acquisition and licensing opportunities, a pharma company asked Alacrita to landscape the companies, medical devices, digital technologies, research...
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