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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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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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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Appealing FDA refusal of an orphan drug designation application

Challenge: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for...
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Regulatory plan for a biotech with proprietary nanotechnology

Challenge: Our client was a biotechnology company focused on use of a proprietary nanotechnology invented to allow different combinations of drugs to be encapsulated in a single nanomedicine and...
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Cell and gene therapy regulatory support

Challenge: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell and gene therapies and...
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MHRA scientific advice for a UK PhII trial in PSC

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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Advice for regulatory approval of a new Ancestral DNA device

Challenge Our client offered a genetic ancestry test in the form of a home kit that contained a buccal swab to collect customer DNA and an analysis service using a SNP array-based chip. Results were...
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Supporting BLA submissions

Challenge Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum...
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Regulatory due diligence

Challenge A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.
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