Reducing Time to Market is Essential
Time is of the essence in drug development and commercialization, which is why being first to the clinic and first to market is essential in the industry. According to the Tufts Center for the Study of Drug Development, the cost to bring a drug to market in 2013 was on average $2.6 billion, up from $802 million in 2003 ($1 billion in 2013 dollars).¹ Over that same period, the average approval rate for drugs entering clinical development declined from 21.5% to just 12%.
Trials are more expensive because they are more complex (larger, global, multi-center, with comparator testing) and target a mixture of rare diseases with limited patient populations and chronic and degenerative diseases that require lengthier trials.¹ ² Payers are increasingly assessing the cost-effectiveness of new drugs and looking for evidence that efficacy is significantly enhanced over existing medicines.² In fact, real-world evidence is increasingly being used to establish value-based pricing structures.³
Further complicating the situation is the rapid advance of new types of drugs through the clinic – many of them biologics, patient-specific medicines, cell and gene therapies and other specialized treatments that did not exist even 10 years ago. Simultaneously, the U.S. Food and Drug Administration (FDA) has focused on reducing the approval time for novel medicines. In 2018, 73% of the 43 new drugs approved by the FDA were approved through one or more of four4 accelerated review programs.5 As a result, it has become more essential than ever to reduce development timelines, which includes speeding the delivery of clinical trial materials and biological samples.
Challenges of Increasing Trial Complexity
The number of clinical studies registered with the National Institutes of Health increased from 1,255 at the beginning of 2000 to 295,474 as of the beginning of 2019, with nearly 50% of these trials performed outside of the United States.6 According to the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), trials were being conducted in more than 50 different countries in 20184, and nearly 40% of therapies in the pharmaceutical pipeline were biologics.8 A growing portion are intended for the treatment of rare diseases with small patient populations (orphan drug or equivalent designation), leading to trials with fewer but widely scattered participants.
Efficiently and effectively managing the supply of the specialty clinical materials and patient samples used in and generated by less centralized, international trials has become more challenging. Navigating varying and rapidly evolving regulations in each country requires detailed knowledge, as does compliance with data protection laws, which are also rapidly evolving and vary from one region to another, and ensuring data security and protection against digital attacks. Access to advanced packaging solutions that provide active temperature management combined with real-time tracking capabilities has become essential.
Many trial sponsors have turned to clinical logistics organizations (CLOs) to ensure that high-quality clinical trial materials are delivered to the right locations at the right times. Globally, the clinical trial logistics market was estimated to be worth $3.4 billion in 2018 and is projected to increase to $3.7 billion in 2022.9
An Integrated Logistics Partner Can Increase Efficiency
Partnering with a clinical logistics provider that has an established, global network of depots, demonstrated knowledge of the regulations in these regions, centralized management and tracking systems, and a highly trained workforce is often the key to successful management of clinical trial supply.
Effective project management teams and online monitoring and tracking solutions combined with integrated clinical packaging and transportation services ensure a seamless process from packaging to warehousing to distribution to delivery. Arranging packaging, warehousing and shipping all with a single CLO allows pharma companies to significantly reduce their lead times. Global access to an extensive network of experts, systems and proven processes enables ongoing and real-time support and the assurance of a high-quality, high-throughput supply chain from start to finish.
Providing the Full Gamut of Integrated Services
With our global transportation footprint and clinical packaging services, Yourway offers the unique combination of highly responsive, personalized logistics support and the full gamut of integrated services, enabling both traditional and hybrid/virtual trials to run more smoothly, efficiently and cost-effectively.
Yourway is the only truly integrated premium courier and clinical packager, offering –– along with our comprehensive transport capabilities – primary and secondary pharmaceutical packaging services, warehousing and distribution support, including cold-chain solutions, unused product return services and assistance with logistics project management. The latter services include sourcing of comparator drugs and other supplies, establishing optimal delivery strategies across global trials, documentation support and the provision of regulatory advice regarding country-specific requirements.
Our team of pharmaceutical transport specialists is capable of supporting customer needs for the shipment of phase I, II, III, IV clinical trials materials, finished goods and production raw materials. Worldwide customs pre-clearance capabilities proactively expedite delivery so that our experienced agents and associates located around the world can immediately clear and deliver shipments to their destinations. We guarantee speed of delivery with highly customized transport solutions and work with each client and every shipment on a one-to-one basis to ensure the highest level of service. Our goal is to ensure the fastest, most secure and most reliable delivery possible, anywhere in the world, with no size or weight restrictions.
Shortening Turnaround Times
Unlike the few big players in the clinical trial logistics space, Yourway offers highly personalized services that can only be found with small to mid-sized companies. We have the bandwidth of a large firm but are responsive to our customers' individual needs in a way that only small companies can be. We offer true one-on-one customer service that ensures high-quality, responsive, tailored support from start to finish.
As importantly, our people have decades of experience in pharmaceutical logistics. They help clients avoid wasting resources and ensure the adoption of the most efficient clinical trial logistics strategies. As such, the greatest benefit that Yourway provides to our customers, who range from small virtual biotechs to midsize and large pharma companies, is shortened turnaround times. We are structured to get materials out the door today –– never tomorrow.
- Thomas Sullivan, "A Tough Road: Cost To Develop One New Drug Is $2.6 Billion; Approval Ratefor Drugs Entering Clinical Development is Less Than 12%," Policy and Medicine, March 21, 2019. https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html.
- Dominic Trewartha, "First-in-class innovation a key strategy for harsh pharma market environment," European Pharmaceutical Review, May 16, 2017. https://www.europeanpharmaceuticalreview.com/news/51476/first-in-class-innovation/.
- Arnaub Chatterjee et al., "Real-world evidence: Driving a new drug-development paradigm inoncology," McKinsey Article, July 2018. https://www.mckinsey.com/industries/pharmaceuticalsand-medical-products/our-insights/real-world-evidence-driving-a-new-drug-developmentparadigm-in-oncology
- FDA, "Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review," https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthroughtherapy-accelerated-approval-priority-review.
- Advisory Board, "'A new normal': FDA is fast-tracking more drugs than ever, but is that safe?," Daily Briefing, July 10, 2019. https://www.advisory.com/daily-briefing/2019/07/10/fast-tracked
- National Institutes of Health, Trends, Charts, and Maps, accessed January 29, 2019, https://clinicaltrials.gov/ct2/resources/trends,
- World Health Organization, "Monitoring processes to R&D," April 2019. https://www.who.int/research-observatory/monitoring/processes/clinical_trials_1/en/#what.
- Ian Lloyd and Alexandra Shimming, "Pharma R&D Annual Review 2018," Pharma Intelligence presentation, May 16, 2018. https://pharmaintelligence.informa.com/resources/product-content/sitecore/shell/~/media/informa-shop-window/pharma/files/pdfs/pharma-rd-annual-review-webinar-2018-slides.pdf.
- Pharmaceutical Commerce, "The 2018 market for pharma cold chain logistics is $15 billion," May 8, 2018. https://pharmaceuticalcommerce.com/clinical-operations/the-2018-market-for-pharma-cold-chain-logistics-is-15-billion/.