Editor’s note: Healthcare Packaging interviewed Alex Guillen, Fisher Clinical Services’ Global Cold Chain Director, in a unique, question-and-answer session where we threw out issues important to the industry and he responded with his best expertise.
• In a nutshell.
Fisher Clinical Services, with U.S. headquarters based in Allentown, P.A., operates 16 purpose-built GMP/GDP-compliant facilities strategically located across five continents. They provide the global presence, information systems and quality standards to provide clients with the flexibility, access and assurance needed for their clinical trial and device supplies. Supplementing these 16 facilities are 30+ partner depots worldwide, specifically chosen to facilitate drug type or local regulatory requirements.
• Area of expertise.
Each facility is staffed with a team of professionals with expertise in managing the clinical trial supply chain, supporting drug management from protocol design to site receipt of clinical materials. Their sole focus is on managing the unique nuances of clinical trials. Global expertise and understanding of local requirements and regulations, language proficiency and established working relationships with key parties across the supply chain allow Fisher Clinical Services to support the regulatory compliant movement, management and delivery of supplies to more than 150 countries across all therapeutic indications.
• ‘Cold chain.’
The Fisher Clinical Services product mix is balanced between pharmaceuticals and biologics, although the strongest growth comes from biologics, which has increased the need for cold chain management of shipments. This is a blend of state-of-the-art cold chain capabilities and the use of the latest technologies in packaging and effective monitoring of supplies, combined with robust training of all parties to the supply chain. Technology today is advancing so fast that unless you have full-time people keeping track of it, your capabilities can become quickly obsolete and you will fall behind your competitors. The company’s continued investment in cold chain storage, as well as distribution capability across the network, mirrors the industry’s evolution to handle increased quantities of complex cold chain biologics across many continents.
• Clinical trials.
Focusing on the unique nuances of clinical trials for 25 plus years, Fisher Clinical Services offers packaging, labeling (blinded and open label), storage, handling and distribution of ambient and cold chain clinical trial materials, import/export services (including Importer of Record capability in more than 25 countries), comparator sourcing and ancillary supplies sourcing, all the way through to returns and destruction of supplies. The company supports all therapeutic areas with most of its work split between Phase 2 and 3 clinical trials, with the balance in Phase 1 and 4. Its services adapt to phase type.
The company’s clients range from innovative, biotech start-ups to the largest multinational pharmaceutical or biotech companies, across all continents. Traditionally, clinical supplies have shipped from the U.S. and Europe to the Eastern and Southern hemispheres, yet in the last few years Fisher Clinical Services has experienced an increase in shipments westbound. This is becoming more common due to increased drug development in Asian countries, particularly in Japan and South Korea. Pharmaceutical companies are now conducting a larger percentage of global trials in these regions.
• Packaging specifics.
The company provides clinical packaging services in its core facilities in Allentown, Basel, Switzerland, Horsham, U.K., Ahmedabad, India, Beijing and Suzhou, China, and secondary packaging in facilities throughout a global network that is strategically located all over the globe.
The company’s Clintrak Division handles all types of labeling at its core facilities and also at the point of dispatch. There is much more curiosity on what technology can bring, such as e-labels to capture the information now provided on paper or provide access to this information electronically. Due to regulatory constraints the progress here is slow compared to other industries, but the change will come.
• Small company trials.
For customers that are perhaps managing their first clinical trial, the company’s Clinical Supply Optimization team can takeover every aspect of the study and the relationship is very consultative. Team members recommend the ideal packaging and monitoring clients should be using, the most effective couriers on the routes they need to cover; and it supports clients in their cold chain management strategy. This expertise helps clients to realize cost and performance efficiencies while reducing coverage.
• Large corporation trials.
For large corporations, the company can handle all aspects of the clinical trial or manage just one element of the study supply chain, whatever is needed by the Sponsor. In any case, the company assigns a team that will interact with the Sponsor to identify their needs. Together the two sides work on the protocols and define the best processes to conduct a successful study within specified timelines.
• Clinical trials vs commercial applications.
Clinical trials packaging must always consider the blinding element, something not factored into commercial packaging. Another major difference is in the logistics and timing to get a drug to the patient. Commercial drug distribution can take weeks or months, while clinical trials can be in hours.
Guillen says that having worked in commercial pharma as Director of Commercial Operations Public market for Novartis Vaccines, this was the first difference that struck him. Drugs must reach patients in hours and the consequences of this not happening are critical. Distribution management must be just right or the trial can be compromised.
One of the major challenges is that regulations and guidelines are sometimes open to interpretation in individual countries. This is why it is important to manage this and understand the local requirements. In addition, regulations can change, which can dramatically impact on the clinical research potential of a country.
Fisher Clinical Services acts many times as a consultant, educating local regulatory goodies on processes followed in other countries/regions. It is imperative to keep updated on new regulations so as to limit unnecessary delays in getting supplies to patients. While the total volume of product is much more limited in clinical supplies, the complexity can be higher since there are usually more restrictions with unapproved drugs compared to commercial pharmaceutical products.
• Global trends.
One of the major changes is that there has been a notable increase in the volume of studies being generated in the Asia-Pacific region. In the past most studies were conducted in the U.S. and Western Europe. Therefore there is a need to have local expertise in those countries ready to assist start-ups and even large corporations to manage clinical trials in their regions.
In terms of packaging one major change has been on the increased demand for reusable shippers to distribute clinical supplies globally. The ultimate goal here is to reduce waste.
More and more Sponsors are requesting that clinical supplies are monitored at all times. There’s a demand for smarter ways to monitor product protection, not only in terms of temperature for cold chain supplies, but also for light or shock.
Today there are many couriers facilitating the distribution of clinical trials. In fact, some are specialists solely focused on this one segment. Because of this Fisher Clinical Services provides a service called Total Transportation Management. The company proactively monitors 20+ couriers across 150 countries, objectively measuring their service for cost and performance efficiencies. To that end, the logistics teams assist the Sponsor in identifying optimal courier use depending on their specific needs. In terms of global shipments, the company’s footprint delivers a high volume of shipments on time in full within 48 hr worldwide.
• Biologics and combination products.
The complexity of larger-molecule biologics—combined with their sensitivity and in many cases lack of stability data—leave less room for error when handling investigational medical products (IMPs). This has forced Fisher Clinical Services to invest in its cold chain capabilities globally and in the expansion of its global cold chain footprint. Technology developments have extended supply chain visibility end-to-end. This is from product production at our customer sites all the way to the patient in a clinic.
New innovations such as cell therapy and regenerative medicine bring additional challenges, from the handling of extreme cryonic temperatures of -194°C to the management of complex reverse logistics of samples from patients to labs and back again. A sister company, Fisher Bioservices Inc., which is also part of Thermofisher Scientific, is a specialist in this area.
• Serialization, authentication, and counterfeiting.
Serialization concerns mainly commercial product. Authentication and counterfeiting, however, are major issues in clinical trials and this is particularly the case when handling comparator products since they are approved drugs. Fisher Clinical Services has a Center of Excellence dedicated to managing comparator products used in the clinical trials.
The company has invested in capabilities for handling cold chain comparators, which requires a higher level of expertise securing the authenticity and integrity of the product during transport. As the value of comparator products are usually extremely high, a high level of protection is needed.
• Cost reduction efforts with customers.
The company assists customers in three ways: First, on their choice of shippers that are appropriate for the product, the right route, and transport time. Selection guidance is needed to prevent use of over-engineered shippers. Second, advice is given on using reusable shippers when possible to reduce the amount of waste and help reduce cost.
The company also recommends considering the proper reverse logistics to reduce the carbon footprint of a shipper. Note that the return journey may add energy and environmental expense that increase the total cost compared to single-use packaging. Third, the company works with clients to reduce expense by optimizing the couriers used based on performance data and cost in each country or across countries.
In closing out the interview, Guillen points out, “Our teams at Fisher Clinical Services know that every day brings another opportunity for a life-saving, world-changing breakthrough. We are driven by a deep appreciation of all that is at stake as we make every effort to get clinical supplies to those who need them.”