1. Tell us about Ancillare. Why did you found the business?
It is a long story that I’ll shorten: One of our sponsors asked us to assist them with issues they were having with ancillary supplies for their clinical trials. These issues involved numerous areas because of increased global regulatory oversight, including approved product selection, maintaining current calibrations of equipment, standardization of supplies utilized, and so forth.
We began working with this sponsor and soon realized this was a pain point that most pharmaceutical, contract research and biotechnology organizations were experiencing. They had little transparency to the overall supply chain and a limited grasp of the associated costs, processes and regulatory and compliance requirements of this diverse global supply chain.
My team began conducting extensive field research. My son, an MBA student at Cornell University at the time, also utilized university experts and research centers to assist with this project. Our research confirmed my hypothesis – this was indeed a universal problem that needed a solution. In 2006, I took my more than 35 years of supply chain experience and launched the market-leading model Clinical Trial Ancillary Supply Chain (CTASCTM) management.
2. Like many businesses, Ancillare was greatly impacted by the events of 2020. What role has the business played throughout the COVID-19 pandemic?
COVID-19 posed numerous supply chain challenges never experienced in any of our lifetimes. Borders and countries were shut down, commerce was all but halted, patients feared venturing outside of their homes and trials were paused. Critical clinical trial supplies required to conduct COVID-19 trials, such as needles, syringes, caps, IV lines, thermometers, etc. – all of which were readily available prior to the pandemic – were in extreme short demand. Plus, the U.S. government and hospitals were first in the factories’ lines of production to receive shipments. Furthermore, requests for medical devices and equipment surged, and Ancillare, as the preferred supplier for our sponsors for numerous COVID-19 trials, needed to formulate our response to achieve success. Again, it is a long, arduous story: Ancillare identified and qualified factories ready to accept our large quantity of more than 1 million purchase order requests for various supplies. Factory orders were placed, and shelves were stocked – all in advance of Ancillare’s receipt of sponsors’ purchase orders. The result was that 100% of all sponsor requests for shipments were released prior to first patient first visit at global clinical sites.
Trumping these supply chain challenges was the need to maintain the physical and mental health of our essential workers and our work-at-home teams. Managing clinical trials, and especially COVID-19 trials, involves demanding, difficult work. Ancillare team members embrace our mission that our shipments touch the most critically ill patients looking for cures to what ails them; thus, the need for perfection is necessary in our areas of performance. This is a very heavy burden, and I personally am very sensitive to the needs of our people.
3. What lessons have you learned about leadership through crisis?
The biggest lesson that Ancillare has learned during these very unfortunate times is that proactivity and teamwork are essential to deliver success. Ancillare teams worked 24/7 during the course of the pandemic. Essential elements of focus were engaging factories and funding the pipeline to initiate prepayments, so that all Ancillare purchase order requests were pushed to the front of the factory production lines. Even though the pandemic is subsiding, the supply chain issues, recalls and shortages will continue for the next few years, and Ancillare’s approach to CTASCTM management remains as diligent as in the first months of the pandemic.
4. What role is the business playing to support advancements in women’s healthcare and pharmaceuticals?
Ancillare assists sponsors worldwide to manage their women’s health clinical trials and deliver patient-centric CTASCTM management. In addition, we have a medical director on staff whose expertise is in women’s health, and this professional advises our sponsors specifically in this therapeutic area. Over the past five years, we have seen our clients focus more on women’s health clinical trials, and we are confident that Ancillare’s expertise will enable us to not only educate but also help to bring novel therapies to market.
5. What advice would you give your younger self?
I am a perfectionist and want every aspect of our work to be perfect in all deliverables. CTASCTM management is difficult. Many areas are totally outside of our control, such as changes in the clinical trial protocol, border strikes, availability of supplies in the marketplace – all this and more can impact our success. I would tell my younger self to breathe, be calm and think through the solution. These suggestions would have served me and my teams well over the course of my career.