Regulatory Affairs (2)

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: 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 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...

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...

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...

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...

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...

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...