How can Manufacturing Companies Keep Pace with the Shifting Trends of Oncology Drug Development

Trends in Oncology Drug Development

Cancer is a largely intractable disease with high unmet medical needs. In Asia Pacific, it is the second leading cause of death with about 5.5million deaths in 2018 alone. Nonetheless, the healthcare industry has made significant breakthroughs in cancer treatments over the years, leading to an increase in the development of novel therapeutic modalities. Within the same period, we noticed three trends of interest:

(1) the increase in patient self-administration,

(2) the increasing number of biological therapies, including RNA therapeutics and gene therapies, and

(3) increasing complexity of drug formulations which inevitably caused an increased concern around drug potency and safety.

Traction for self-administration of medication is growing due to its speed, and less invasive mode of cancer care delivery. In a survey of 488 patients, suggests that 89 percent of patients prefer subcutaneous injections over intravenous therapy and 82 percent of those who experienced both showed a higher level of satisfaction with subcutaneous injections. There are more molecules than ever in the biologics pipeline, and the greatest focus of all therapy areas is oncology. Both have led to subcutaneous oncology treatments growing faster than IV/infused administration. This increasingly popular treatment offers lower drug delivery costs, patient convenience, drug safety and better treatment outcomes. The trend is reinforced by the US$22 billion industry’s 11 percent annual growth rate.

Modern biopharmaceutical drug molecules are often complex protein structures or fragile RNAs that need to maintain the molecular structure in order to convey full potency. So, the drug exhibit challenges for the selection of appropriate containment and delivery systems, particularly due to their viscosity and molecular sensitivity. This is where we see great potential for premium packaging components or ready-to-use containers. Unbeknownst to most, there is a US$99.9 billion packaging industry that supports patients in getting treatment administered whether in the comfort of their own homes or at clinic. The rise in demand for self-administered therapies, expanding biological therapy pipeline and increase in drug formulation complexity are driving innovation in both containment and delivery of injectables. Manufacturers such as West Pharmaceutical Services (West) play a critical role in the supply chain that ensures patients get access to treatments. This motivates us to constantly innovate, adapting to a shifting landscape, facilitating the best possible drug delivery options and help to improve patient health worldwide.

Meeting New Needs

West utilizes a unified innovation process to efficiently bring the latest technologies in drug delivery from concept to market while keeping a clear focus on the needs of the patients and customers, and an eye on the developing regulatory demands within Asia. This process entails experimentation and rapid prototyping to accelerate our developments. Some of our latest innovations are the FluroTec® barrier film and SmartDose® Drug Delivery Platform

In the case of FluroTec®, we were approached by a client for a traditional storage solution which could meet container closure integrity during cold storage and sterilization. The solution must not be susceptible to the usual limitations of cryovials such as mechanical strength and flange consistency, while retaining the standard oncological containment requirements such as silicone and molecule sensitivity.

 A unique challenge arising from the increasingly complex drugs that are being discovered for oncological treatments. Our solution was to use our FluroTec film-coated stoppers in conjunction with Daikyo Crystal Zenith® vial. The combination allows cells to be stored up to six months in cold storage, and yet have >95 percent viability rapid recovery after two hours of thawing. Today, our FluroTec film has the US FDA’s approval for use with over 125 drugs, including vaccines. With the Center for Drug Evaluation (CDE) of National Medical Products Administration of China (NMPA) recent publication of technical guidelines for biopharmaceutical research and evaluation highlighting the need for quality risk management within the industry, we are confident that more researchers will find our innovation helpful.

In another scenario, we develop a convenient and integrated solution for the administration of biological therapies to enhance patients’ well-being, the SmartDose® wearable injector, a platform designed for high-viscosity and silicone-sensitive biologic formulations. It allows users to eliminate the need for a nurse and enhance treatment compliance through its automatic needle protection and portability feature. Through SmartDose drug delivery platform, we broadened our ability to balance the safety and well-being of patients with the technical demands of our pharmaceutical partners, particularly for wearable drug delivery systems.

Innovation with customers

Asia Pacific is a diverse and dynamic region. As an industry leader, we strive to deliver the best quality products and offerings while ensuring we meet the varied unique needs and demands of the industry. We do this by encouraging collaborations, fostering the conception of new ideas and promoting the adoption of new technologies.

Within the region, we support a wide range of research initiatives with over 15 different academic partners and partnered with biotechnology companies to co-develop new biologics and therapeutics. Our efforts have led to more than 100 scientific publications, presentations and book chapters that furthered the science of injectable medicine containment and delivery. It has also empowered our customers to focus on meeting the industry’s evolving needs speedily. While our participation allows us to be privy to exciting new developments, it is a humbling reminder for us to pursue constant innovation.

Looking ahead, new developments will continue to emerge from within pharmacology and new drugs will arise. We must adopt new tools such as the Industrial Internet of Things (IIoT) to enhance our abilities in developing new innovations. Since the start of the pandemic, we have invested over US$265 million and hired over 1,000 new members to increase our global manufacturing capacity. We will continue to invest further in our production capabilities to enhance the resilience of our supply chain in order to live up to our commitment of enabling our customers to improve the well-being of patients.