Cindy Reiss-Clark, VP & GM of West‘s (NYSE:WST) global biologics business, comments on the drug delivery trends that stood out from 2018 and what she’s keeping an eye on in the coming year.
What were the trends that drove the biopharma and drug delivery markets in 2018?
Many of 2018’s key trends revolved around increasing regulatory requirements. However, as the market continues to move toward more personalized medicine, such as cell and gene therapies, the overall cost of health care is a driving factor. While the majority of large patient population indications, including diabetes and rheumatoid arthritis, have available biologic treatments, there are exceptions. Those suffering from Alzheimer’s or Parkinson’s still need a breakthrough drug. Currently, the pipeline consists mostly of smaller patient population molecules or orphan drugs, which means that the treatments, while needed, are extremely expensive.
Another trend we are seeing is the combination of technology and healthcare. Companies such as Google are partnering with pharmaceutical manufacturers to aid in the diagnosis and understanding of biomarkers and to enable patients to access data more conveniently. As the market moves forward, expect to see an increase in the use of mobile devices and apps to capture data that may help to increase the health of the population and capture trends for education, care, adherence to treatment regimens and convenient drug delivery.
For biologics, the trend toward complex molecules has continued. While monoclonal antibodies (mAbs) are still the largest molecules in the pipeline, newer more complex proteins based on cell and gene therapies have seen a significant increase. These more complex formulations have highly sensitive APIs, which can result in the need for more complex delivery systems and materials. Delivery and device manufacturers now have to take into account extreme temperature controls that work not only for the drug product, but also for the delivery system. As these trends grow, manufacturers must consider the impact of other components used in a formulation and be sure to have the appropriate containment and delivery systems to address those sensitivities in the molecule.
What is propelling the movement toward home-based administration of pharmaceuticals?
The need for a convenient patient experience is definitely driving the trend toward home-based administration. A trip to the hospital, IV center or doctor’s office to get treatment means a disruption to a normal lifestyle. An adult patient may miss a child’s soccer game, while a child may miss a birthday party or other event because their lives need to be organized around the treatments. Self-administration in the home environment can help to give patients their lives back. If we can improve the patient experience through home care and self-administration, then we may also help to improve the patient outcome through better adherence to treatment regimens.
In terms of delivery systems, the trend toward self-administration has required innovation around devices to ensure they are capable of delivering a large dose. West’s SmartDose drug delivery platform offers wearable injector options that can provide a variety of dose options ranging from 1mL to up to 10mL. As we continue to develop and enhance the platform, we are looking to provide additional benefits for patients through the use of our systems.
What are the challenges and opportunities for drug-delivery and combination products in 2019?
When it comes to combination products, the challenges become opportunities for advancements in drug delivery. We see challenges related directly to regulatory changes, and some related directly to the delivery approach. Each challenge requires a different strategy, and companies will have to develop those strategies in order to meet the guidelines for combination products. Because a combination product is a complete system, we have the opportunity to work closer with our clients, designing solutions for better patient outcomes through the use of human factors testing. Both the drug and the device must ultimately have the patient in mind, so developing them together over the drug’s lifecycle can help to enhance the patient experience in the end. Thinking about the appropriate dose with the right safety levels, as well as the convenience and ease of delivery of that dose, will ultimately help to improve patient well-being.
