While much of the world continues to cancel events and defer projects in light of the COVID-19 pandemic, drug development often doesn’t have the luxury of going on hold. Preclinical drug testing and the submissions that follow can’t afford potential delays, which could lead to costly setbacks or even the end of life for certain projects.
As the global pandemic and its implications add various obstacles to progressing projects, it’s imperative to rely on a strategic laboratory testing partner to keep compounds on track. There are multiple qualifying factors sponsors should consider when entering these partnerships – especially amidst COVID-19. A laboratory testing partner with the following characteristics can help bring your compound through preclinical testing successfully.
Pandemic response: Is testing back to normal?
Though much of the world operates at reduced capacities, it’s crucial to find the confidence and peace of mind that your laboratory testing partner is still operating at a level that can support your needs. While taking the necessary precautions to keep staff safe, many global laboratories are open and running at full capacity.
During a pandemic, there are specific considerations to ask a potential laboratory partner:
- Clarify that they are currently executing the tests that you are most interested in, whether this is bioanalysis, toxicology or DMPK.
- Establish that they are still sending reports to clients regularly.
- Be transparent about your timeline and make sure that it is practical for the laboratory. Even if laboratories are fully operational, they could still be recovering from backlogged work.
It’s also key for companies to inquire about SEND data packages and ensure that the laboratory will compile the information in appropriate formats for FDA submission. Better yet, ask the laboratory testing partner if clients have had any recent submission approvals to get an idea of how the laboratory is operating when so much of the world is at a standstill.
Communication is key
Digital communication is nothing new, though COVID-19 has certainly increased popularity in video chat technology. This trend has also carried over into the drug development industry. For example, virtual audits of testing sites have increased with travel restrictions and work-from-home requirements. This added flexibility allows sponsors to easily communicate with scientists, review the facility, cut down on travel time and, overall, expedite the audit process.
Besides auditing, other communication factors are critical to consider when selecting a laboratory testing partner, pandemic or not. Laboratories should adapt to the communication needs of the sponsor. If you prefer daily reports, weekly reports or a hands-off approach, the laboratory should work to satisfy the level of communication needed for each project.
Customer service is another vital communication factor that cannot be stressed enough when it comes to preclinical testing. A molecule’s success rides on the outcomes of these results, so it’s best to partner with a laboratory that is going to act as just that – a partner. Stateside sponsors working with laboratories abroad will experience testing across different time zones. While this may seem to be an obstacle, there are tangible benefits. It allows for a continuous cycle of testing and review between the laboratory and the sponsor for a streamlined communication process.
Finding a testing partner that has excellent communication methods and meets your standards will pay dividends during the testing process.
An integrated approach
When your internal capacity has depleted, project timelines get tighter, but taking an integrated approach to testing can streamline processes. By selecting a laboratory testing partner to handle all of your testing needs, you avoid confusion.
Additionally, reducing the number of laboratories you work with can cut down on costs and alleviate confusion. Seek a full-service testing partner with an integrated communication management system to conserve time. The integrated approach allows the laboratory to transfer documents between departments and testing sites, which cuts back on miscommunication and errors. Having a single testing partner also reduces the number of contacts communicating with your team and streamlines the correspondence between the laboratory and the sponsor. Additionally, partnering with one laboratory for all of your needs frees up internal resources and capacity.
Finally, consolidating testing also allows increased timeline responsiveness and flexibility. For example, if a sponsor faces setbacks with one area of testing upstream, the laboratory can easily adjust the program downstream to stay on track with the original schedule.
Consider the facilities
Testing facilities are essential to consider when vetting a laboratory. Investigating facilities to ensure quality performance starts with reviewing their Standard Operating Procedures (SOP), which should be readily available. These documents should be specific enough to achieve technical consistency but remain easy to understand and customizable to your product.
When it comes to planning and timelines, it’s important to remember that the supply chain has also taken a hit from the pandemic. Transportation limitations have inhibited access to critical supplies and left some facilities without available resources. Check with your testing laboratory to ensure they have reliable means to support your testing needs.
Another component that brings facility quality to fruition is the study director. When selecting a laboratory, be sure to consider the experience of the study director. The study director should have a distinguished educational background, a track record of investing in continuous education and experience working with similar compounds to yours. More importantly, they should deliver reliable results. It is common for sponsors to inquire about the number of team members with PhDs working on the project to verify proper background and skill level. Make sure there are high standards for facility excellence.
When selecting a testing partner, keep in mind that your regulatory compliance goals are critical for making the decision. Testing partners often have reputations with regulatory bodies and undergo frequent government inspections to ensure the laboratory complies with standards. Inquire about recent inspection and the results for a better understanding of their compliance.
Putting it to practice
The selection process can be time-consuming, but creating a working relationship with a laboratory that will prioritize your tests during a global pandemic is crucial. Look for the components that will directly impact your test results, timeline, costs and can deliver upon your needs. WuXi AppTec is working diligently to surpass their sponsor’s expectations as they continue to move projects forward. Talk to an expert about your testing needs and how they can help. Contact us here.
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.