Laboratory image courtesy of Pexels.
Drug development is a hyper-competitive industry, and pharmaceutical developers are increasingly turning to outsourced laboratory testing partners to gain an edge. Choosing the right partner can maximize efficiency and play a critical role in gaining regulatory approval quickly.
Still, outsourcing critical research comes with an element of risk. It is crucial to vet research partners to ensure rigorous and reliable work.
Additional factors need to be considered when working with a laboratory testing partner in the COVID era. Supply chain disruptions are impacting research laboratories around the globe, delaying trials and causing drug development timelines to balloon. But the right laboratory testing partner can help set expectations and mitigate many potential obstacles. Selecting a partner that fits your organization’s goals can mean a fruitful and profitable research relationship.
Here are some of the critical questions drug developers should ask when selecting a new laboratory testing partner.
1. What expertise and experience do you bring to the table?
Some laboratory testing partners offer the entire range of testing services a sponsor might need. Others are more specialized. One of the first things to ask a potential research partner is whether they have experience relevant to your research, disease state and methodology.
A reputable testing partner should be able to point you to examples of past successes applicable to your field. Ask for client references and review the research team’s credentials—both expertise and experience matter. Experienced partners can problem-solve and suggest solutions when they encounter unexpected results or technical issues—suggestions that can prevent frustrating delays. And while scientific acumen is vital, it’s not the only thing to look for. An effective partner should have streamlined workflows and project managers who communicate well and keep developers in the loop.
2. How do you ensure quality and regulatory compliance?
Outsourcing does not mean lowering standards. When evaluating potential testing partners, ask what quality assurance frameworks and monitoring systems are in place.
It is also vital that partners adhere to regulatory guidelines in the regions they seek approval. Science is a global industry, and working with partners worldwide can provide multiple benefits. But no matter where the laboratory is, it must comply with the local regulatory standards. Toxicology studies offer a good example. The U.S. FDA recommends histopathology exams conducted by pathologists certified by the Diplomate of the American Board of Toxicology or European Registered Toxicologists. Regulatory approval in Europe, Japan or China will inevitably require familiarity with the nuances of those markets. Overlooking such steps could result in regulators rejecting data and test programs stalling. Ensure your laboratory testing partner has experience working in your chosen regulatory environment to avoid such outcomes.
3. What measures are in place to store and secure client data and testing results?
If your intellectual property fell into the wrong hands, it could be devastating. A reputable partner should have rigorous data security protocols in place to protect your trade secrets and study results. When vetting them, ask whether data is stored in the cloud or on servers and what measures are in place to safeguard those data against leaks and hacks.
It is also essential for sponsors to understand how their partners plan to share data. Will the sponsor have access to all of the raw data? What is the lag time between when the data are collected and when sponsors can access them? How will partners transfer data to the sponsor—and how will they protect data during the transfer?
4. How much will the research cost, and when can you deliver?
Cost is an important consideration, but it is often true that you get what you pay for. The lowest-cost option is not necessarily the best value. When discussing pricing with a laboratory testing partner, consider how payments are structured. Do quotes contain all line items, or could there be unexpected add-ons later? Will payment be due at certain milestones? If a study terminates early, will the price be adjusted accordingly, or will sponsors still be responsible for the entire fee?
With so many drug developers outsourcing research, delays are becoming increasingly common. In an industry where every day counts, those delays can be costly. When vetting a laboratory testing partner, discuss timing early on so sponsors and partners can build a realistic and achievable timeline. If an organization promises speedy results that seem out of line with what other laboratory testing partners offer, there’s reason to be skeptical. Do you want the research done fast, or do you want it done well? Good science takes time, and a reliable testing partner can be efficient without cutting corners and transparent about the timing of each step.
5. What can you do to mitigate supply chain issues?
Supply chain disruptions are an unfortunate reality these days. Production and shipping challenges have delayed everything from pivotal reagents to pipette tips in recent months. Such setbacks are affecting the industry broadly, and no partner is immune. Still, research organizations can create business continuity plans to minimize disruptions. Ask potential partners about their backup plans and backup suppliers.
The bottom line
Drug developers who vet laboratory testing partners have to ask plenty of questions. However, perhaps the most important question they will ask is to themselves. Specifically, how flexible can we be? How flexible is our budget? How much flexibility have we baked into our timeline? Would we rather rely on one large laboratory testing partner that can handle everything we need? Or do we prefer to work with a suite of different partners who possess specialized skills?
Taking some time to assess what sponsors hope to gain from their partnerships will position them better to forge a strong and mutually beneficial working relationship.
Dr. Xiaoxia Li is the executive technical director, toxicology at WuXi AppTec.
Joining WuXi AppTec with more than 15 years of preclinical drug development experience, Dr. Xiaoxia Li provides scientific support to clients and will enhance the quick response rate for technical questions. She began her career at a preclinical Contract Research Organization (CRO), BOZO (Biology and Zoology), in Tokyo. She then spent over 13 years working as a Study Director at ITR Laboratories in Montreal, Canada. Afterward, she worked as a scientific leader in nonclinical development for a pharmaceutical company in Toronto, Canada, before starting her own consulting firm, Sunrise IDD Inc. Dr. Xiaoxia Li is a Diplomate of the American Board of Toxicology (DABT). She completed her Ph.D. in Pharmacology in Japan and received her MD and MSc in China.