Sponsor-CMO Conflict Management for Clinical-Phase Biologics - The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts. - BioPharm International


Sponsor-CMO Conflict Management for Clinical-Phase Biologics
The authors present the CMO's perspective on various potential sources of sponsor-CMO conflicts.

BioPharm International Supplements
Volume 24, Issue 3, pp. s4-s8

Sources of conflicts following CMO selection

Assuming the appropriate CMO was selected on the basis of manufacturing capacity, process development, and GMP experience, and was followed by a compliance audit, the potential sources of conflict can be associated with the four broad steps in an outsourced project: business terms, technology transfer and development, project management, and compliance. An efficient contractual strategy can preemptively manage conflicts before they arise and can ensure that expectations, resources, and deliverables are understood mutually and can be allocated as required during project development (4–5). The specific needs of the project are often not definable before the project is initiated, so a contractual strategy that is both flexible and binding offers advantages over contractual approaches that attempt to cover the entire scope of the project, from development to GMP production, under a single technical agreement contract. Because the technical agreement cannot take into account all the eventualities of the project, it is inherently less flexible for the evolution of the project, and hence more likely to give rise to conflicts. A more flexible approach is to divide the contract into three distinct portions: the master service agreement (MSA), the project agreement (PA), and the quality agreement (QA). These agreements will reflect details outlined in the initial project quotation.

Business-term tools Quotation

The quotation should not only serve as a starting point for the selection of an appropriate CMO, but should also be used subsequently as a reference map throughout the lifetime of an outsourced project. It should contain detailed information with respect to price, duration, start dates, development strategies, and deliverables based on the available information provided to the CMO. In the early phases of biologics process development and manufacturing projects, it is typical to define only the delivery date and estimated target amounts of GMP material. The sponsor then expects the CMO to offer a development strategy that meets the sponsor's deliverable requirements. As the development portion is variable from product to product, the quotation should be detailed enough for the sponsor to evaluate the CMO's proposal, and yet be flexible enough to provide pricing and timing outlines that vary with the project's complexity. Quotations that offer this degree of transparency will help educate first-time, early-phase biopharmaceutical developers in terms of the time dependencies of various development steps. A Gantt chart can further highlight which steps are of variable duration (e.g., fermentation development), which are fixed in duration (e.g., GMP batch release), and what the time and cost requirements for each step to budget and plan. As a conflict-resolution tool, the quotation should provide sufficient information to allow a mutual understanding of pricing policy for additional work. For example, the quotation should include the cost and timelines associated with the transfer of a well-defined process as well as a per month, full-time-employee, or batch price for additional, optional optimization work, or other alternatives discussed at the point the CMO is chosen.

Master service agreement

Discussions on the MSA should be initiated in parallel to the quotation. The purpose of an MSA is to lay out the legal contractual framework between the two parties, thereby allowing each party to protect their respective interests. The agreement should cover aspects that are not related to the technical deliverables of the project, including the legal responsibilities of each party with respect to the performance of service, data, reporting, material, intellectual property, licenses, third-party intellectual property, payment terms, warranties, duration, termination, confidentiality, insurance, indemnities, limitation of liabilities, and governing law. It should not include project details and quality matters, which will be respectively addressed in the PA and the QA. Separating contractual terms into these instruments allows the parties to put in place the terms in a stepwise fashion, designating the appropriate persons for each negotiation. The legal experts from both parties should agree on the legal clauses stated in the MSA, while the project managers independently move forward on the technical aspects of the project based on development results in a scientifically sound manner. This contract, once signed, initiates the start of the project as specified in the project agreements.

blog comments powered by Disqus



First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
Author Guidelines
Source: BioPharm International Supplements,
Click here