The Complaint: A Contract Manufacturer Was Accused of Failing to Deliver on a Chemotherapy Formulation Agreement
The plaintiff, a pharmaceutical development company, filed a complaint against a CDMO (Contract Development and Manufacturing Organization), asserting claims related to an alleged failure to perform under a service agreement. The agreement required the contracted manufacturer to provide process development, stability testing, and filling for a proprietary formulation developed by the plaintiff.
The plaintiff alleged that the CDMO stated it had the technical capabilities to perform these services but subsequently failed to meet contractual obligations. According to the complaint, the manufacturer placed its performance on hold, resulting in delays that impacted the plaintiff’s ability to meet external milestones and pursue regulatory approval.
The complaint further alleged that the CDMO used proprietary information shared under the agreement to pursue the development of a competing formulation, leading to claims for misappropriation of trade secrets, breach of contract, and fraud.
The manufacturer denied the allegations and asserted that it was unable to perform its obligations due to the plaintiff’s failure to provide a complete and actionable formulation. It further claimed that it had already performed significant work under the agreement and was entitled to compensation for services rendered.
The Ask: An Expert in Pharmaceutical Formulation and Scale-Up
The defense sought a pharmaceutical formulation expert to evaluate whether the materials and data shared under a manufacturing agreement were sufficient to support the reproduction and scale-up of a proprietary drug product. The expert was asked to evaluate whether the provided information was sufficient to reproduce the formulation, enable process scale-up, and yield the intended product. Given the nature of the product at issue, a sterile injectable chemotherapy agent, the ideal expert required hands-on experience with injectable formulations, process scale-up, and industry expectations for data disclosure in contract manufacturing. Additionally, the case called for an expert qualified to consult, prepare a report, and testify at deposition or trial if necessary. Prior litigation experience and testifying credentials were preferred.
How DOAR Was Able to Meet the Expert Need
DOAR actively recruited a diverse group of leading experts to support our clients in anticipation of an influx of pharmaceutical disputes. For this case, DOAR recommended an expert with specialized experience in injectable drug development and formulation scale-up to address the technical questions at issue. The expert is a professor of pharmaceutics with a joint appointment in biomedical engineering at a major research institution. His academic and industry experience spans more than two decades, with a focus on the design and development of injectable drug delivery systems and lipid-based nanoparticle formulations. He has led numerous interdisciplinary research efforts involving chemotherapy agents, nanoparticle delivery, and formulation scale-up, and has worked closely with pharmaceutical and biotechnology companies to translate lab-scale formulations into clinically viable products.
In addition to his technical qualifications, the expert had prior litigation experience and was well-positioned to consult, report, and testify on the feasibility of reproducing and scaling the formulation.
How DOAR’s Experts Can Assist in Pharmaceutical Disputes
At DOAR, we focus on industries facing complex litigation and build expert teams composed of world-class academics, industry executives, and former government regulators. Our pharmaceutical expert team assists counsel in disputes involving the research, development, and manufacturing of drugs, including issues related to clinical trial design, regulatory compliance, formulation and scale-up, and intellectual property. We frequently engage in matters involving breach of contract and trade secret allegations.
Contact us to learn more about DOAR’s pharmaceutical experts and our expert teams across other life sciences and technology sectors.
