Observations from the CRISP meeting in San Diego

The month of February started out with an engaging meeting held in somewhat sunny, somewhat rainy San Diego, of the CRISP (California Regional Investigational Supplies Professionals) group. Steve Jacobs and the team from Global Biopharm Solutions put on a great event with a day full of presentations, discussions, and networking with a diverse group of clinical supply chain professionals from the region and around the country. 

Sourcing and Forecasting

The day started off quickly with an interesting presentation by Mike Moro of Cidara Therapeutics on planning and forecasting of clinical supplies. The presentation started out with some good insights on comparator sourcing and tips like listing multiple sources and vendors in your regulatory filing, as well as the data required for comparator documentation. Mike then shared his experiences staying on top of shifting clinical supply requirements as a recent global trial evolved and changed. He introduced the audience to some great tools he’s developed to stay on top of this challenge while supporting proactive communication with other groups in his company. 

The section on country and regional requirements sparked an interactive Q&A session that involved topics ranging from the unique challenges of the Chinese market to handling expiry date changes. A central theme was communication with CMC and Clinical Operations teams. As studies progress and sites are added, the impact to the supply chain can be significant. Discussion about how to educate these upstream groups on this impact was especially lively for the group.

A Site’s Perspective on Clinical Supplies

An often overlooked aspect of the clinical supply chain is how product is received and managed by the participating sites. Making things easier for these partners is vital to conducting successful studies with efficiency and collaboration. That starts the moment clinical product hits the loading dock at the sites. The presentation by Vickie Yang, IDS Pharmacist from City of Hope Hospital, offered a refreshing perspective on the world of inventory management at this critical junction point in the supply chain.

Vickie caught everyone’s attention out of the gate with her first slide showing the number of trials they’re engaged in and the volume of shipments they’re receiving each day. It’s easy to develop empathy for their workload and the importance of making life easier for her and her counterparts on the site side. After giving a detailed outline of the receiving process, she listed several common problems they deal with, offering solutions sponsors can do to alleviate these challenges. Accuracy, speed, and space are their biggest headaches, and the simple fixes around space were especially eye-opening.

Opportunities with Clinical Supply Staff Augmentation

The afternoon session kicked off with a lively roundtable discussion about staff augmentation and opportunities to leverage outside resources to meet the growing complexity of clinical supply chains. Ilene Tat-Tong moderated the conversation with Michelle Friedman, Trinh Le, and Steve Jacobs discussing ways to best integrate consultants into your organization for optimal efficiency. As industry funding has slowed in the post-COVID environment, having a well-rounded strategy utilizing outside expertise to meet specific needs is becoming critical.

The topic can be sensitive, and the panel provided great insights on how to position the need for augmented resources and have an effective conversation with executives. Specific ideas revolved around showing leadership data around the under-resourcing and the risk this is creating, cost optimization that can be achieved, and the importance of demonstrating what’s in it for the executives who have the budget.

Opportunities and Challenges in Latin America

Latin America has a diverse population of more than ½ billion people, yet only accounts for 5% of clinical trials. Lorna Briddick of Brizzy Consulting illuminated the audience on the opportunities, and challenges, of conducting studies in this region in her presentation “Building Bridges to Latin America.” Success requires commitment and fortitude, but the rewards are potentially great for tapping into this part of the hemisphere, and Lorna outlined the risk/reward calculus with a combination of deep expertise and the human side of her experiences there.

The overarching theme was that in many ways the region looks more complicated from the outside than it needs to be. Good preparation, smart resourcing, and active communication are the keys to success. Lorna emphasized the importance of finding your “A-team” of contacts in the region and leveraging their local knowledge early and often in the process. Of particular interest was her education on how each country is different and a strategy (depot or direct) should be developed on a country by country basis, providing helpful examples of these variations.

Future Topics

The CRISP meetings are inclusive and highly interactive, and Steve concluded the day collecting ideas for future meetings. Topics on the group’s mind included AI for the clinical supply chain, requirements for the shift from the Clinical Trials Directive to the Clinical Trials Regulation in the EU, combination products, and labeling requirements for global markets. These topics and more will fuel future meetings both in San Diego and upcoming on March 7th in the Bay Area.