Introduction by Chad Briscoe
I am very pleased and proud to have Naidong Weng of Janssen Pharmaceuticals as my first guest author. I never reported directly to Naidong but he was one of my first scientific mentors in bioanalysis. This is something I am looking forward to discussing in detail in a future column. Although he and I have changed companies a few times since we first met about 15 years ago, he’s continued as a mentor to me in the industry. I’m honored that his column picks up where I left off with his discussion of his ‘pillars of bioanalysis’ I think you’ll find it both an interesting and educational read.
Guest column by Naidong Weng
Pharmaceutical companies (Pharma) have been going through very dynamic changes in the last decade – mergers, acquisitions, closing of sites, outsourcing or off-shoring, in- and out-licensing, co-development and risk-sharing to improve their pipelines while minimizing the risk of failure. It may be safe to say that there are no Pharma companies that haven’t gone through some type of reorganization or downsizing in recent years. We are all asked to do more with fewer resources. Bioanalytical departments in Pharma are no exception. I hope in the next few paragraphs I can share some of my leadership and management insights for bioanalytical managers, many of which I was fortunate to learn from my own managers.
As illustrated by Chad in his previous column, the bioanalytical ‘milking stool’ has evolved from ‘good, fast, and cheap’ to ‘quality, timely and value-added’ in the last two decades. I will say that if you do all these three things right, you will grow the fourth leg – business sustainability. Nature prefers symmetry and I feel there are four equally important pillars of bioanalysis.
The first pillar is quality. Quality (or lack of it) is ultimately the make or break for any bioanalytical laboratory. Quality must be in the DNA of all personnel of a bioanalytical laboratory, but it is the responsibility of bioanalytical laboratory managers to make it happen and to maintain it. Quality comes from careful planning of the laboratory infrastructure and quality check system. A check-and-balance should be in place so that issues can be identified, promptly escalated and resolved in a timely fashion to avoid any quality issues. Important systems for both paper and electronic raw data acquisition, transferring and archiving, and/or electronic laboratory notebook (ELN) should be thoroughly evaluated, validated and maintained. Regardless of the kind of bioanalytical support a laboratory is providing, data integrity and study reconstructability must be kept as the highest priority. Depending on the type of support (stage of the development and purpose of the study), a tiered or fit-for-purpose approach for batch acceptance criteria, laboratory documentation and report generating can be adopted. Quality also comes from sound scientific understanding of the projects so that proper bioanalytical methods can be built early on to minimize any repeat work. Many bioanalytical scientists and/or their managers also serve as study monitors for outsourced work at CROs. They also carry the responsibility of ensuring acceptable data quality coming back from CROs. Often, they will also participate in the initial evaluation of the CROs and in the annual quality audit of the selected CROs. While as bioanalytical managers, we maintain a high standard for quality, we must also guard against unnecessary self-imposed quality elevation as pointed out by a recent EBF article for Bioanalysis. To apply unnecessary quality standards to everything would not only add significant resources and costs, (a luxury we don’t have under the current environment), but also undermine those that truly need these high standards.
Timely is the second pillar, and I am in agreement with Chad that quality cannot be sacrificed for timely delivery. I haven’t heard of any laboratory that was shut down due to missing one or two timelines, but I do know a few who were bankrupted due to lack of quality/compliance. Timely delivery comes with careful planning and good communication. Bioanalytical support should be in the overall planning of any given study. Bioanalytical managers do need to push back on unrealistic requests while understanding that occasional last-minute changes to a study plan or requests for a new study are possible. This should not occur frequently. In order to accommodate these unexpected requests, bioanalytical managers need to plan some level of excess capacity (so-called ‘white space’ or ‘buffer zone’) for their chemists. Similarly, the bioanalytical study monitors need to communicate in a timely manner with CROs about upcoming studies and any changes.
Value addition is something we discuss frequently at Pharma and is the third pillar. The days of competing with CROs on cost saving are long gone, and cost saving alone is also usually not the driving force for selecting CROs. Many CROs hire quality scientific staff (including many from Pharma), purchase state-of-the-art equipment, and run a highly efficient organization at reasonable cost. From my perspective, the value addition of internal bioanalytical labs is two-fold. First, internal bioanalytical staff are in general more closely involved in the programs and study designs, and are in constant communication with project teams. They have a better understanding of the overall information on programs they are working on, while their colleagues at CROs may work on many different compounds, different projects and therefore may lack or have limited in-depth knowledge of a given compound. The internal bioanalytical scientists can definitely help their CRO colleagues to avoid detours and provide insight with in-depth knowledge of the compound. Bioanalytical managers should have courage to conduct fair investigation when assays are not working well at CROs. Investigation may answer questions such as “did your scientists or study monitors transfer all necessary information to the CROs?”, or “did they provide any technical consulting during the transfer?” There are also many types of studies that would be better handled internally – quick turnaround studies, investigational studies, some biomarker studies, preliminary method development to understand the compounds, and studies that may not fit the expertise of selected CROs, etc. Also important is the active participation of the bioanalytical scientist/manager with the internal program/project teams. Often, the project teams actually design the study based on bioanalytical inputs, especially for biomarker studies and studies that require very special sample handling. Bioanalysis should not be only viewed as a data provider. Instead, bioanalysis should be viewed as a business partner with value addition inputs for the team.
Business sustainability is my last, but not least pillar. I already mentioned when discussing the quality pillar that infrastructure plays a pivotal role in securing quality, but it is also vital for business sustainability. Succession plans must be in place for key positions, including the manager himself/herself. The bioanalytical managers must have the willingness to attract, retain, and develop talents, including some who may someday replace the manager. While it is important to meet study timelines, managers do have the responsibility to provide appropriate development opportunities to all staff. Even though it may carry some risk of failing to deliver the results on time, in the long run it will build a stronger department if many of the departmental staff can handle challenging projects. Accepting responsibility and learning from failure, as well as giving credit to the staff, will build stronger relationships with subordinates and colleagues. Managers should not be afraid of giving constructive feedback to the staff. Managers need to constantly evaluate and align the mission of the group with the overall goals and objectives of the division and company to ensure that contributions from the bioanalytical group won’t go unnoticed. Managers need to anticipate future bioanalysis needs (for example exploring new scope of work like LC–MS of biologics, biomarkers, etc.) and be willing to adapt for future business by attracting talents to fill the gaps.
To be a bioanalytical manager in Pharma is not easy. You will have to be adaptable, but if you stick to the four pillars, they will help you navigate through the uncharted waters.