Vicki A. Barbur, Ph.D., Senior Director, Battelle, Columbus OH, discusses the driving forces for biologics and new delivery methods. –KB
Contract Pharma: What are the driving forces for biologic drugs and new delivery vehicles?
Vicki A. Barbur: Pharmaceutical research continues to expand in search of solutions to address chronic conditions that can be impacted by treatments received daily, weekly, bi-weekly, or even monthly. Progressively, these treatments require underlying chemical compositions that are frequently incompatible with traditional forms of systemic delivery to the body (e.g., oral capsules), and among the compatible delivery pathway options the preference among many pharmaceutical companies has been liquid formulations for subcutaneous injection. Many drugs in this class are characterized by physical properties and sensitivities that challenge the drug commercialization ecosystem. For example, monoclonal antibodies, perhaps the most significant category in terms of therapeutic and commercial importance, typically possess viscosities that are well above the normal limits of subcutaneous injection techniques. Drug developers and device designers are increasingly working in collaboration to address the goal of patient self-administration for biological injectables, and to increase compliance, they are also focused in parallel on reducing the ‘dosing’ burden by making each dose last longer in the body.
This resulting delivery pathway has been well characterized and is confirmed to be well tolerated by millions of patients each year. For example, according to the Centers for Disease Control and Prevention (CDC), in the U.S. between 2013-2015, approximately 54.4 million adults have been diagnosed with various types of inflammatory disease such as, gout, lupus, rheumatoid arthritis or fibromyalgia. It is primarily these diseases that are treated with injectable therapeutics, and most likely going forward, with biologics that have large molecules as their base. This is driving the need for new and innovative autoinjectors and its subsequent growth potential as a market opportunity. An auto-injector is a small, pen shaped device, which contains a hypodermic needle used for delivering a fixed dose of drug to patients. Autoinjectors are intended to be easy to use and intended for self-administration by patients or any other caretaker.
CP: Why are the design factors in autoinjectors being challenged by biologics?
VB: The subcutaneous injection treatment pathway has subsequently created an industry of providers that offer delivery solutions that accommodate most traditional forms of liquid drugs. However, the rise in the use of biologics based on large molecules and often higher viscosity liquids linked in part by the concentration of active ingredients along with subcutaneous delivery, are driving the need for new and innovative autoinjectors, thus its subsequent growth potential in the market. A traditional liquid drug is generally characterized by a stable liquid requiring 1ml of delivery per dose/injection or less. Currently, there are few solutions that adequately address the combination of larger volumes (greater than 1ml) and higher viscosity doses, and where the needs of the patient are also considered, namely, with comparable injection times (less than 10 seconds), insertion forces (lowest pain threshold possible), and injection forces (lowest pain threshold possible and maximization of mechanical advantage). These new requirements entail a complex combination of needle length, needle bore, viscosity and syringe forces in order to comfortably deliver the required system for patient use without the resulting pain profile or other tradeoffs that limit the product’s success in the market.
CP: What accessibility is there to new autoinjectors?
VB: Novel autoinjectors are currently in development to address the large molecule, high viscosity, and higher volume liquid drug delivery challenges noted above. This next generation of autoinjectors leverages mature technology in novel ways, for example using combination compression and torsion springs, to power the injection through controlling force applied to plunger.
It is expected that next generation autoinjectors will deliver substantial benefits for patients and manufacturers. As the number of high viscosity drug formulations increase, these newer autoinjectors will enable comparable delivery to existing low viscosity formulations and make delivery more comfortable for patients. Potential benefits include:
• Reduced delivery time for lower-viscosity drugs
• Soft, controlled insertion for a more comfortable injection experience
• Reduced risk of breaking the syringe during use
• A quieter and more discrete delivery mechanism
• Smaller device package size
Overall the autoinjectors market is projected to grow at a CAGR of 24.2% during the forecast period of 2018-2023. The global autoinjectors market is expected to reach $85.3B by 2023 from an estimated $28.9B in 2018.
Longer lifespans are expected to translate to a growing number of patients diagnosed with chronic conditions. To counteract the financial and medical infrastructure implications of this trend, pressure from federal programs and managed care organizations will place high significance on therapeutic self-administration, an expectation that is creating an increased interest in approaches for routine delivery that are patient-friendly, can be self-managed and are also cost-effective. Pharmaceutical companies are realizing that for many products, success no longer solely depends on the medication itself delivering therapeutic success, and that they also need to increase focus on providing a consumer-compatible form of packaging and an application methodology that maintains patient satisfaction.
Vicki A. Barbur, Ph.D., is Senior Director, IP and Technology Commercialization, Commercial Business at Battelle. She brings dual expertise in science and business as well as broad experience in several technical disciplines to her overarching role as an innovative growth leader associated with technology commercialization and IP management. Her primary areas of focus are Health and Medical Devices, as well as Genomics and BioSecurity. Previously, Barbur was SVP and CTO for Concurrent Technologies Corporation and VP, R&D for Cardinal Health. In October 2016, she joined The MITRE Corporation supporting the Technology Transfer Office. Barbur earned a PhD and BSc in physics from Imperial College, University of London, and a MSc in Applied Statistics from the University of Oxford, both in the UK.