Challenge: 


A European publicly-listed biotech was facing a Phase III milestone for its lead immunomodulator and had a next generation technology in IND-enabling studies. The company was operating in a field which had suffered notable setbacks over the years, partially due to deficiencies in clinical development strategy, and was concerned that its Phase III trial would not show the expected benefits. In this context, the client hired Alacrita to undertake a comprehensive review of all its clinical and preclinical data to assess the best options for developing a sustainably-differentiated position.

Solution:

 

We assembled a team composed of a former Senior Vice President and Global Therapeutic Area Head for Oncology at a Big Pharma and a highly-experienced MD PhD oncologist who had a notable career spanning industry and academia. Together with an Alacrita Managing Partner, they determined that the ongoing Phase III trial was highly likely to fail for a number of reasons (within 12 months, this trial was reported as a failure) but at the same time the next-generation technologies were assessed as potentially game-changing. We constructed a comprehensive yet streamlined set of preclinical studies in a matrix design to provide insight into optimal settings, dose levels and schedules and combination regimens for this product and designed a series of relatively rapid Phase I/II trials for efficient demonstration of clinical proof-of-concept.



Opportunity Mapping Support


Alacrita has extensive experience in mapping opportunities for our pharmaceutical and biotech clients, for individual programs, for multiple programs in a portfolio, for drug discovery platforms, and for enabling technology platforms.

Opportunity mapping involves quantifying the realistic commercial potential, mapping out the go-to-market path, and describing the key risks and sensitivities. The process may also involve primary market research to gain additional expert opinion and to validate assumptions. Such assessments frequently involve making trade-offs between multiple potential lead indications, and sometimes across several geographic territories.

Click here for more information on our Opportunity Mapping expertise.

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