Outsourced development and manufacturing are not new and is generally beneficial for access to technology, improved schedules and cost reduction. But there are pitfalls, especially in the selection and agreement phases, that can accept this risky undertaking and make it a near impossibility. Potential partners often decide in contract negotiations that, at best, delay the project and, in the worst case, reduce the partnership. Here are three examples of short-term thinking, common on both the client and contracting sides, that make each partnership a growing boost. A Master Services Agreements (MSA) governs the relationship between the sponsor and the CDMO. Not all pharmaceutical companies and sponsors we work with have internal advice to establish these agreements. This article will focus on how you can ensure that your master service contract with a CDMO is structured so that the job works properly. Report: Pwc.de. 2020.
[online] Available at: www.pwc.de/de/gesundheitswesen-und-pharma/studie-pharma-cdmo-market.pdf [Access May 4, 2020]. Mechanisms should be put in place to quickly inform and approve amendment requests and all other issues. This can be a procedure when technical issues require additional resources and a quick process for processing paperwork and authorizations. They want the paperwork to go to the right people. This avoids delaying the project for weeks, while waiting for paperwork to filter through the bureaucracy for signing, while an oral agreement has been reached. Ideally, the MSA should provide project managers with decision-making powers, which is extremely useful in meeting the agreed deadlines. An important aspect of the MSA is the definition of IP, IP control and IP ownership. For us, it is clear that when a customer enters into contracts with us for the development of an API and compensates us as agreed, the IP belongs to the customer.
We also follow strict rules on confidentiality and non-competition. The authors also suggest that the business trend will continue in a large number of business sizes, but that agreements be carefully studied and planned before entering into agreements. At the end of the day, the agreement must clearly define what is paid and who owns it accordingly. The easiest way to start the discussion is to say that "what I put on the table is mine, what you bring is yours, and what is created is properly shared." For the latter, a good rule of thumb is that the IPs that form, which are exclusively related to the product, generally stay with the customer and that the IP remains in the CDMO as part of the process or technology platform. Although M-As offers an opportunity to develop and develop, the report states that they need to be carefully considered before entering into agreements; a failure to acquire it can threaten even the most successful companies of both parties. Since the funds required to invest in another CDMO often require more capital than a CDMO is generally available, the company`s dependence can also be compromised by the company`s dependence if it depends on external funds. In order to ensure the quality of pharmaceuticals and to move projects forward as quickly as possible, a master service agreement includes how raw materials are purchased and how their quality is determined; Sets the appropriate specifications defines ip ownership and has mechanisms for resolving disputes and processing amendment applications. And of course, as in all industries between pharmaceutical companies and LCOs, lines of communication should be open, clearly defined and well used. . In less than five years of balance sheet production, Samsung Biologics has been successfully tested more than 30 times by supervisory authorities and has received more than 50 marketing approvals.
The proven approach of an outsourcing project is to apply with several qualified partners, compare the price offers received and select the lowest bidder