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by Louise Place
The Drug Delivery and Formulation Summit held in Berlin from March 12-14th offered a great opportunity to catch up on the current state of the industry. As a panellist in two sessions at the conference, here are the key regulatory insights I took away.
The impact of changing regulations
The new Medical Device Regulation (MDR) is having a wider impact than originally anticipated by the industry. Presentations from Bjørg Hunter (GSK) and April Kent (Amgen) highlighted the need for companies with devices, especially those with integrated medicinal products (either ancillary or not) to act now. It was also a pleasure to participate in a panel discussion with Bjørg, April, James Mellman (Novartis) and Torsten Kneuss (Bayer) on ‘EU Medical Device Regulations impact on Combination Products – What to be aware of across drug delivery’ standing in for an unwell Beat Steffen.
Article 117 has been recently highlighted as key for companies with a medicinal product incorporating as a single entity a device element. In this case the MDR has amended the Medicinal Product Directive (MPD) resulting in the need to obtain a Notified Body (NB) opinion on the device element if a separate CE mark cannot be obtained. Many manufacturers with existing drug products on the market under the MPD will be heaving huge sighs of relief however, as the latest Q&A document from the European Medicines Agency (EMA) has indicated that a NB opinion will not be required for existing authorised Medicinal Products with an integral device element - unless there is a substantial change to the design or intended purpose of the device component (including introduction of a new device). Whilst the exact definition of a substantial change has yet to be defined, this is a clear step forward.
Classification Rules 20 and 21 have both resulted in the need to update the classification of several products. With the ban on grandfathering, many products will be relying on the transition period for existing marketed products (up to 2024) before the need to fully comply with the MDR. For those with inhalation products classified as Class I under the Medical Device Directive, this is not an option. Rule 20 re-classifies inhalation products as Class IIa or Class IIb (depending on risk profile) which means that self-certification is not possible, and a NB assessment is required. Because these products have no NB history or certificate, the date of application of the MDR is the date when these products must comply or be taken off the market– 26 May 2020. With only one NB designated under the MDR at the time of writing, limited guidance and advice available and an ever-ticking clock, this places significant pressure on manufacturers of these products, some of whom may never have engaged with a NB before to keep these products on the market.
The importance of patient-centric design
I was also fortunate to be a panellist on a second discussion ‘Are we prepared for the Regulations of Patient-Focused/ Patient-Centric Drug Development? with Sven Stegemann (Lonza/ Graz University of Technology) and Leonie Wagner-Hattler (F. Hoffman-La Roche. As someone whose career has focused primarily on the delivery of formulations from a device perspective, it was fascinating to listen and discuss how to consider the patient from a formulation perspective.
There appears to be a drive to consider the patient earlier in the formulation process, encouraged perhaps by the recent Food and Drug Administration’s (FDA) ‘Draft guideline on patient-focused drug development’ and the EMA ‘Reflection on pharmaceutical development of medicines for use in the older population’. Consideration is being given to the capabilities of the intended user population, whether that be the ability to swallow a drug presentation or changes in the underlying physiology in a geriatric patient, resulting in reduced absorption.
The shift towards biologic therapies and delivery of protein-based molecules for therapeutic means is also having an impact on formulation and delivery. The first-pass effect in humans means that traditional small molecule oral delivery is not suitable for these products and consideration needs to be given to alternative delivery mechanisms. Conventionally this means parenteral delivery in some format however, there is an increasing trend away from formulating for Intravenous delivery towards Subcutaneous delivery - perhaps as patients become more involved in their treatments and hospitals and healthcare providers need to reduce time spent per patient and associated costs. Ultimately, this is likely to mean that the patient role in drug delivery will continue to rise in importance and the need for early consideration of delivery mechanisms, including devices, becomes ever more key.
For more information on how these changes affect your device development and how CDP can help you manage them, contact us at firstname.lastname@example.org.
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