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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Payer research for novel treatment for GI indications

Challenge: A clinical stage pharma company with development and commercialization rights to a novel treatment for GI indications wanted to gain marketing authorization in Europe. However, the...
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Payer research for novel treatment for kidney disorder

Challenge: A biopharma start-up developing a small molecule to treat a rare kidney disorder sought Alacrita’s advice on its Target Product Profile (TPP) and market attractiveness. Specifically, they...
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Development plan for beta thalassemia gene therapy

Challenge: A leading European university identified a gene therapy for the treatment of haemoglobinopathies. Alacrita was asked to support the Principal Investigator (PI) in developing a Commercial...
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Indication strategy for reformulated chemotherapy

Challenge:  A biotech company developing improved versions of available chemotherapy drugs approached Alacrita for indication strategy support, seeking to sanity check and refine its current clinical...
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