Issue link: https://www.e-digitaleditions.com/i/1467950
10 BioPharm International May 2022 eBook www.biopharminternational.com market alone reached US$4.6 billion in 2020, and analysts expect this to grow at a CAGR of 8.2% (2). Before a study can move forward, both the sponsor and the CRO need to agree on what work will be done, under what timetable, and at what cost, and then they must solidify these terms in a contract. From a legal standpoint, most sponsors want a signed contract or a conf idential disclosure agreement in place before transferring a test item. For example, it is more difficult for a sponsor to transfer to a client a com- plex bioanalysis assay and move toward validation and sample analysis when the legal framework of their contractual arrangement has not been finalized (3). A contract is also necessary from a regulatory standpoint. When it comes time for IND filings, agencies need to know which parties contributed which data (4). For the CRO, a well-executed contract not only establishes payment for service, but it also allows the proj- ect to move forward in a timely fash- ion. One of the challenges CROs face is lead time to the laboratory. CROs work for multiple clients, all competing for their time and laboratory space. If they are juggling multiple projects, having to wait until one sponsor's contract is signed can mean clients on firmer foot- ing will take precedent (2). There are a variety of contracts exe- cuted between sponsor and contractor, which all have value in the outsourced drug development market and meet the needs of both parties (5). Full-service agreements offer an integrated team of scientists the potential for cost savings through efficiency and increased bar- gaining. A functional contract provides access to specialist providers, cost sav- ings from efficiencies, and f lexibility in terms of team size. Fee-for-service contracts, on the other hand, are open- ended contracts where the sponsor pays the bill according to the hours spent on the project. This type of contract is trust- and experience-based and is often used for consultancy projects where spe- cialist expertise is required. For large companies, establishing contracts is a well-oiled process. But for smaller companies, such as startups in the cell and gene therapy (CGT) space, the terms of the contract can change quite a bit following the initial bid because the sponsor of the research has limited infrastructure to do any of the work and because the development of these products is still not standardized. A CGT developer who asks a CRO to develop and validate three to five meth- ods may eventually need a dozen meth- ods analyzed with very little notice. To navigate in this environment, CROs need to be flexible, and the outsourcing partner needs to be upfront as early as possible about what they need (2). Specialist expertise familiar with the regulatory landscape within the CRO can also help by working with the client to help better define the strategy and ensure that the initial contract is closer to the final in terms of scope and price. Some large biopharmaceutical com- panies have departments that focus on outsourcing business coordination, which acts as a kind of bridge between the company and the contractor by leveraging the needs of their research- ers and event ua l ly putting various opt ions in place. Sim i la rly, la rge CROs are likely to have client service departments that can help the con- tractual process for clients move for- ward smoothly. But for much smaller CROs, it is more likely that the person negotiating the contract is also the one conducting the experiments (2). W hatever t he siz e of t he com- panies or the t y pe of contract exe- c uted, establ ish ing t r ust bet ween parties can help in the execution of the contract. For long-term partners who have worked together on mul- tiple projects and have a high level of trust, the work can begin before the contract is signed. For new part- ners, those first interactions are crit- ical. It is vital that both CRO and sponsor set expectations about what t he pa r t ner sh ip shou ld look l i k e a nd be ad aptable when problems arise. No partnership is perfect, and roadblocks are inevitable. From con- tract to project completion, urgency is critically important and will go a long way toward establishing a long- lasting relationship. At the end of the day, time has a f inancial impact on the end product. WHY QA IS INTEGRAL TO MEETING REGULATORY COMPLIANCE For more than four decades, FDA has had in place good laboratory practice (GLP) guidelines to help establish a level of consistency and reliability in the reporting of non-clinical safet y Partnerships for Outsourcing Development By one estimate, the global preclinical CRO market alone reached US$4.6 billion in 2020, and analysts expect this to grow at a CAGR of 8.2%. To navigate in this environment, CROs need to be flexible, and the outsourcing partner needs to be upfront as early as possible about what they need.