After a history of drug supply management and demand planning for clinical supplies, Peter Trimboli of Bristol-Myers Squibb has moved into what’s known as Pharmacy Services. He interacts with clinical teams and drug development groups to lend his expertise where it’s needed for their clinical sites.
Over the course of his career, Trimboli has encountered a multitude of challenges working within the clinical supply chain from temperature maintenance to constantly changing requirements for packaging and labelling. But among the most enduring challenges Trimboli faced was the regulatory conundrum posed by comparator importation.
In this interview, Trimboli discusses how best to overcome this pertinent issue.
Clinical Trials Arena: What are some of the challenges you came across when importing comparators?
Peter Trimboli: During the course of supporting some of our clinical trials with comparators, we may incur difficulty in importing a particular comparator to a specific region. A comparator provision strategy depends upon the regions in the globe we may need to support, whether we are providing a US or EU sourced comparator, and the countries we plan to ship to. Upon initial or subsequent importation of the comparator to some countries, we may experience some delays, or holds on import approval, as some of the information we may have on file from the innovator for the comparator may not be sufficient enough to allow for import approval. This could include a certificate of analysis, stability data, or a complete batch genealogy listing all manufacturing sources.
As you could imagine, delays in importation, or even not being able to import at all, can present significant challenges for your clinical study enrolment timeline, and it can also affect patient care.
CTA: What would you say is the predominant reason behind the difficulties in importing supplies?
PT: I would think in most cases it’s due to regulatory barriers, which can be created by the importation requirements. What you have to understand is that there is a continual evolution of import regulations that differ from country to country. So, on our end, in a given year you might be able to import a drug without complication however in subsequent years you may not as regulations may change affecting either product labeling or importation documentation requirements. The end result is not being able to import more drug, which could ultimately affect patient care. Additionally, generic markets for medications and the concern for counterfeit drugs could also present the need for such strict importation requirements and changing regulations across the globe.
CTA: How have you been able to minimise the impact of constantly evolving regulations?
PT: In certain regions, if we anticipate any barriers, we try to be proactive to possibly get as much of the required documentation up front at time of purchase. As contingency, we may try to setup a local sourcing model at the clinical site level, which seems to work in some cases but can have its challenges and may present undue burden on our clinical site customers. Another approach would be to setup a locally sourced procurement process with a supplier who may support that particular region. In that model, we might source a large supply and ship it to the sites directly.
CTA: Even though it depends on the trial and the circumstance, what have you found to be the best method?
PT: Get as much product information as you can up front at time of purchase. Additionally, making contact in advance with your regulatory colleagues in that region (or someone to represent you on your behalf) would be a good idea. It’s important to set up a plan letting them know what you’re going to do in terms of making sure you’re compliant with the current regulations. If there are potential changes coming up, make sure you’re in alignment with those changes well in advance and then import the amount of drug you need to conduct the study at the time of initial importation, assuming you dating and quantities are good.
CTA: What advice would you give fellow professionals in terms of navigating changing regulations when importing comparators?
PT: The best advice I could give is to try to secure as much supporting documentation initially at time of purchase. Ifwe are importing to an area for which we have experienced importation issues previously, then working with a supplier to explore local drug provision in that region may be an option. Keeping abreast of current regulations in addition to securing the required product information up front should present less resistance at importation.
*Peter Trimboli is the Group Leader, Drug Supply Management, Clinical Supply Operations at Bristol-Myers Squibb