Product Development (3)

Challenge: A prominent researcher at an academic research institution had developed a class of small molecule compounds with in vitro antiviral activity against a family of RNA viruses. The...

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...

Challenge: A clinical-stage company developing novel transdermal patch technology asked us to validate two potential hormone replacement therapy products with KOLs. The main focus was to evaluate the...

Challenge: A startup with a novel technology for enzymatic synthesis of dsDNA approached Alacrita to assess potential opportunities for the technology in the biopharma space. Hitherto the company had...

Challenge: A privately held biotech company using AI/machine learning/Big Data to develop novel liquid nanoparticles (LNPs) and LNP formulations for particular payloads instead of using a traditional...

Challenge: For a discovery stage microbiome company, Alacrita supplied a senior biologics manufacturing specialist to act as Interim VP CMC.

Challenge: Our client was working with a family office which had invested in a novel IV formulation of a repurposed asset for the treatment of ischemic stroke. With a promising completed phase II...

Challenge: A biotech company developing novel gene therapy approaches for in vivo cell trans-differentiation had lead programs in IND-enabling studies for two indications. The client requested...

Challenge: A biotech client had developed a generic version of a major anti-diabetic peptide drug, and wanted a clearer understanding of the product's registrability, as well as support with defining...

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...

Challenge: Alacrita developed techno-commercial development plans for selected top priority projects. The client, King's Commercialisation Institute, convened an expert panel which then selected...

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...