Assessing a new inhalation device and assisting with partnering

Challenge A medical device company has developed a nebulizer system for pulmonary delivery that can produce droplets below 1.5µm diameter. Initial clinical evaluations of demonstrator compounds used...
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Clinical and regulatory support for respiratory delivery specialist

Challenge A respiratory delivery specialist company was looking at established drugs to assess the attractiveness and risks of developing inhaled or intranasal formulations of selected molecules. It...
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Development plan for a bio-scaffold in spinal cord injury

Challenge: A leading private US academic institution had created a therapeutics accelerator program to support early discoveries and facilitate industry partnerships of its assets. One of its...
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Clinical protocol review in oncology

Challenge A biopharma company developing microbiome therapeutics asked Alacrita to conduct a detailed protocol review of a clinical study designed for its lead asset in patients with advanced solid...
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Clinical development strategy in malignant melanoma

Challenge: A biopharma company asked Alacrita to provide expert input on the clinical development of a microbiome therapeutic (LBP, live biotherapeutic product) in the context of first line and...
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Interim medical director for MAA submission

Challenge: On behalf of a European pharmaceutical company, one of Alacrita’s professionals acted as medical director for the registration of a new agent in a neuroendocrine indication in territories...
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Applying to Early Access to Medicines (EAMS) at the MHRA

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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Due diligence on the developability & investability of a cancer vaccine

Challenge: A newly-formed US biotech company has acquired the intellectual property and assets of a legacy cancer vaccine company that had ceased trading several years ago following disappointing...
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Interim Chief Medical Officer support for an immuno-oncology biopharma company

Challenge: A European biopharma company focused on immuno-oncology therapeutics was developing small molecule and monoclonal antibody agents for three targets of high interest in the I/O field. The...
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Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission

An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist...
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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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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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