The 15th Annual Clinical Trial Supply East Coast 2017 hosted by Arena International took place on Oct. 18-19 in Princeton, New Jersey. The pharmaceutical companies and trial supply logistic providers gathered at the conference to explore the underlying challenges among the clinical supply stakeholders, forging new perspectives and solutions. Our intent with this write up is to provide a summary of the event, and this is by no means is an exhaustive representation of the conference. Apologies to the distinguished participants who may not have been mentioned in this article.
The conference kicked off with the conference chair, Reid Tonik, Global Clinical Supply Chain Director of Teva Pharmaceuticals, welcoming new and familiar faces to the annual event. With great enthusiasm, Reid highlighted the addition to this year’s program: a one day technology stream exploring solutions for clinical trial supply chain complexities. This stream delved into the subject of emerging technologies offering innovative solutions towards the current challenges underlying the clinical supply chain. Achieved through presentations, panel discussions, and interactive roundtable sessions, topics ranged from the challenges of the clinical supply chain to new trends and strategies in logistics, operations, and technology. Additionally, the conference also explored emerging pathways towards supply chain automation, new waves of innovation within packaging and labeling, and temperature monitoring strategies for end-to-end clinical supply chain optimization.
It is important to note the traditional supply chain has been linearly structured from clinical trials to commercialization, conservatively outsourcing only non-core functions. Evolving pipelines have expanded the global supply chain, highlighting the growing complexity of clinical trial design and execution. Supply chain sustainability requires a transformative approach towards addressing the challenges of competitive sourcing, temperature control, new technology, and the rapidly growing area of in-home trials. It is important the clinical supply chain steps up to meet the need for the leaping innovations taking place in the drug development space.
Day 1: Challenges Underpinning Clinical Supplies
First speaker, Sean Walsh, Senior Director of the Supply Chain at Advaxis, emphasized the needs of each player involved in the clinical supply chain, from regulatory authorities to patients. He highlighted the significance of customer needs and expectations that underlie business success, fostering advancement. By adapting a customer-centric mindset, supply chain visibility enhances risk management. Mr. Walsh also outlined the direct impact of partnering with contract manufacturers and research organizations – a smooth, accelerated flow downstream the clinical supply chain.
Next, Jessica Deveau, Business Development Manager of World Courier, explored distribution models for clinical supplies and steered the audience through the logistical complexities of shipping clinical trials. Due to the growing number of new drug candidates, particularly biologics, maintenance of temperature conditions across the supply chain has become a major concern.
Furthermore, Tanya Momtahen, VP of Scientific & Clinical Global Procurement of Sanofi, brought attention to the significance of prioritizing bandwidth over expertise to overcome disruptions to trial times. She provided opportunities to minimize overhead costs by comparing outsourced and internal comparator sourcing strategies between pharmaceutical companies.
Similarly, Dave Lecher, Business Development Executive of PCI Clinical Services, identified technology investment priorities to prevent unnecessary spending. Mr. Lecher assessed the cost-benefits of a new packaging technology. The Blister Inspection System illustrated safety through automated quality control, time through increased production speed, and money through elimination of faulty capsules, making it a worthwhile investment.
Cubixx Solutions introduced another worthwhile investment that addressed the challenges of in-home clinical trials. They offered a solution that combats issues of improper medication storage, increased shipping costs, and data collection and integration from decentralized sources. Striving for centralized control in a decentralized model, their innovative technology aims to reduce patient withdrawal rates. Recognized for global excellence in supply chain innovation, Cubixx Solutions’ pharma-grade compressor-free refrigeration system reduces risk, cost, and error by sending real-time updates and generating automated reports through their innovative networking system.
Discussions continued with new business operation strategies introduced to change the paradigm of the clinical supply chain. Presenters highlighted the benefits of developing a culture of continuous improvement through constantly managing changes. Buz Hillman, Clinical Supply Systems Associate Director of Johnson & Johnson, emphasized the need for responsive forecasting systems to harness the power of historic data. Mr. Hillman explained how this is vital for effectively monitoring controlled room temperature (CRT) clinical trial shipments.
Then, a panel discussion introduced the potential benefits of collaborating with quality assurance teams to minimize disruption and ensure backlogs. Michael Schwartz, Director Quality Assurance of Concert Pharmaceuticals, and David Green, Clinical Supply and Logistics Associate Director of Insmed Incorporated, ran the discussion and provided strategies to ensure effective communication between clinical supplies and quality assurance teams.
Tech Stream: Embracing Disruption with Rapid Adoption of Emerging Technologies
As presentations continued in the ballroom, parallel sessions for the technology stream caused the crowd to diverge to another event space. Centralized around the packaging, labeling, and monitoring components of the clinical supply chain, this stream explored the emergence and adoption of innovative technology.
Rocco Barone, Associate Director Operations of TransCelerate BioPharma, intrigued the crowd with his efforts to facilitate external engagement with an e-labeling technology implementation toolkit. Mr. Barone proposed a replacement for standard multilingual paper booklet labels suggesting a dual approach with a simple, universal label placed on products with translated variations of instructions accessible via smartphone. Mr. Barone discussed the complexities with current standard labels, suggesting such customized technology could encourage increased patient compliance and an expedited regulatory approval process.
Similarly, Paul Larochelle, Senior Manager, Clinical Asset Planning at Biogen, advised careful consideration through a risk and rewards analysis for new implemented technology. Mr. Larochelle described strategies that utilized forecasting and simulation tools for impact assessment. Risk assessment is imperative considering technologies, such as Interactive Response Technologies (IRT) require high levels of customization to the clinical supply chain and its management.
Frank Leu, Chief Executive Officer of Novapeutics, shone a spotlight on the development of IRT technology and its ability to both prevent temperature excursions and minimize drug loss. Mr. Leu also drew attention to cold chain logistics, as well as the unanticipated consequences of cold chain failure, further increasing the complexity of clinical trial management.
The tech stream continued with talks concerning ways to maximize the potential of IRT. Anthony Zuccarello, IRT and Global Clinical Supply Strategy Associate Director of Amicus Therapeutics, analyzed the progression of IRT for the use of global management systems. Sessions continued with ways to shave off the time and cost of study implementation through combining the power of IRT and clinical supply management (CSM), along with the expertise of preferred partners for further improvement.
The technology stream wrapped up with talks regarding automation strategies to simplify drug pooling using complex and adaptive designs. Ray Bacchus, Clinical Trial Supply Manager of Janssen R&D U.S., concluded by drawing on the benefits of customizing current technologies, which can alleviate growing financial pressures on the industry, ultimately increasing growth and change in CSM.
Day One was brought to a close with a discussion about externalizing in-house capabilities. Global import/export strategies were illustrated to increase oversight, emphasizing the significance of vendor-sponsor relationships.
Day 2: Transformative Strategies that can Modernize the Clinical Supply Chain
Anthony Orosz, Assistant Director of Pharmaceutical, Health and Chemicals Center of Excellence and Expertise of US Customs and Border Protection, commenced the day’s discussion with the importance of enhanced border control knowledge. He compared the advantages and disadvantages of multiple manufacturing sites and provided strategies to minimize holdups from FDA inspections. Sanjeev Luther, Chief Operating Officer of Rafael Pharmaceuticals, addressed internal communication challenges, suggesting ways to improve disruption reaction times. Mr. Luther promoted the adoption of multi-user technology platforms to minimize wastage and transform the supply chain to run “one patient at a time.”
Chairman Reid Tonik stepped in to enlighten the audience with an overlooked component of the business operations – office space layout and design. Mr. Tonik provided insight on switching to an open-office floor plan for clinical supply chain operations, which resulted in undesirable outcomes.
Presentations progressed with Matthew Moyer, Director Clinical Supply Technology of Merck, introducing mobile-health technologies and smart trials which foster the patient-centric approach. Smart dosing, smart sampling, and smart analytics will enable rapid clinical decisions with increased patient compliance. Brian Rogers, Packaging Project Management Head of Sanofi, followed Mr. Moyer by exploring the need to adopt a new packaging philosophy that leans towards patient-centricity considering that with biologics, every dose matters. Mr. Rogers outlined the risks with the growth of biologics and the organizational changes required to restructure and optimize cold chain clinical supply.
The event came to a close with interactive roundtable sessions that explored shipping challenges of importing into the U.S. and Europe hosted by Maryam Ahmadi, Senior Director of Pharmaceutical Science of Achillion Pharmaceuticals. A roundtable discussing the challenges of importing into the U.S. and Latin America was hosted by Ken Kube, Associate Director-Global Clinical Supplies of Merck. Steven Awad, Clinical Trial Supply Manager of Janssen, led a roundtable focusing on the successes and failures of sharing demand planning. Lastly, the fourth roundtable was hosted by Cara Sclafani, Supply Chain Lead of Pfizer, whom encouraged conversation on the potential impacts of the health care debate on the U.S. pharmaceutical industry.
In sum, the conference brought new perspective providing a holistic view on the challenges and potential expansion of the clinical supply chain. Speakers engaged the crowd with intriguing topics that lead to stimulating conversation during and after presentations. The conference enabled attendees to expand personal networks while learning from the experience and expertise of those around them. This conference, without question, has facilitated a much needed dialogue and exchange of cutting edge ideas on how best to improve supply chain processes.
*Frank Leu, Ph.D. is the Co-founder and CEO at Novapeutics, L.L.C. and Maria Tsingas, is an Intel Contributor at BioPharMatrix L.L.C.