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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Interim CMO for oncology company

Challenge: With an unprecedented amount of life science investment being put to work, the industry faces a well known shortage of experienced Chief Medical Officers (CMO). Therefore, following an...
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Defining a clinical strategy in oncology for a platform technology

Challenge: A venture capital-backed platform technology company wanted to develop its internal pipeline of therapeutic oncology candidates, while allowing prospective partners to access the...
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Independently reviewing clinical trial data

Challenge: A small biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s...
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Interim Chief Medical Officer for Fibrosis Company

Challenge A well-capitalized, private biotech company with a drug discovery platform identified multiple first-in-class and best-in-class compounds targeting critical pathways widely involved in...
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Development support for first-in-class pediatric oncology drug

Project: For a listed US biotech company with marketed products, Alacrita's pediatric oncologist consultant provided ongoing support with Phase I/II design, protocol development and medical oversight...
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