MEDICAL DEVICES
Allergan has produced medical devices and worked to improve treatment outcomes, and expand patient adherence. Can you tell us about your role within Allergan – what are your highlights, concerns, challenges and victories within your current project? The evolving regulatory environment is having a tremendous impact on my role, but the impact is positive as we move into the next generation of combination products, including digital medicine. Leading the EU MDR project for Allergan – as the person responsible for regulatory compliance (PRRC) – has brought opportunities to develop regulatory technical skill sets and collaboration skill sets globally. Overall, the dynamic space of combination products is having a positive impact to my role as we all will be at the forefront of developing novel drug-delivery therapies for unmet medical needs.
What one question would you ask your colleagues at the meeting in 2020? This year, I would ask my colleagues, ‘What do you see as the greatest challenge for you to overcome in the combination product space at the moment?’
With the combination products community striving for new products to enhance patient care, the space continues to progress into the next generation of medical devices and software. What are you excited for in 2020? In 2020, I am excited for the opportunity to work within the combination product space and work cross-functionally with medical device, software, pharmaceutical, and biologic experts. This will be a great experience that will involve a ton of knowledge sharing across the team of experts. While there are similarities, there are also many differences in the development of various combination product therapeutic applications.
The pre-filled syringes market has matured greatly over the past few years, what key differences have you noticed in 2019 regarding significant developments? There is no question that the industry is developing more sophisticated drug delivery platforms. Historically, the industry started with the classic pre-filled syringe and there have been significant developments in the space of
66 | Outsourcing in Clinical Trials Handbook
patient-centric single-chamber, dual-chamber and multi-chamber pre-filled syringes. One main reason for the various development efforts is to support personalised complex therapies. In addition, there is a growing need for customised injection systems to support the increase of specific therapeutic applications, such as the global dermal filler market. Administering dermal fillers and botulinum toxin therapies involves multiple injections of finite low-volume boluses into multiple target sites.
“There is no question that the industry is developing more sophisticated drug delivery platforms. Historically, the industry started with the classic pre-filled syringe and there have been significant developments in the space of patient-centric single- chamber, dual-chamber and multi-chamber pre-filled syringes.”
What do you see as the greatest challenge for you to overcome personally in the pre- filled syringes field at the moment? The greatest opportunity within the pre-filled syringe industry is working cross-functionally with medical device, pharmaceutical and biologic experts. This is a great experience that involves a ton of knowledge sharing across the team of experts. While there are similarities, there are also many differences in the development of various therapeutic applications.
What are your thoughts on the developing regulatory environment for pre-filled syringes and drug-device combination products, and how is this currently impacting your role? The evolving regulatory environment is having a tremendous impact on my role, but the impact is positive as we are moving into the next generation of combination products as well as digital medicine. Not only do you have the USFDA 21 CFR Part 4, for combination products, but you have EU MDR Article 117 as well, which pertains to biologic and drug-device combination products.
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