Bringing quality medicines to patients is always the ultimate aim for companies within the pharmaceutical industry; however, the route and complexities in arriving at this point can sometimes be underestimated or understated, especially within the off-patent sector. There are a huge number of factors at play within this process, from the development of treatment right through to prescribing to those that need them. Here, Karl Belk, Chief Operations Officer discuss ADVANZ PHARMA’s collaborative processes of bringing medicines to patients and the ways we ensure these reach the specialised patient populations who rely on them.
Ensuring delivery of quality medicines
Off-patent treatments are an integral part of healthcare delivery, helping to meet an ever-growing demand for medicines while contributing to the stability of supply chains throughout Europe and further afield. Following patent expiry, the journey of our medicines begins with the development of the product itself which often includes significant trial work, analytical work and clinical trials. This leads to the building of a product dossier and then the submission of that dossier to the regulatory authorities as part of the application for marketing authorisation or licence; a licence that then requires maintaining and renewing as required with the relevant regulatory bodies.
For our product, a suitable manufacturer is identified followed by product transfer and validation, stability data generation and the supplier themselves will undergo quality audits by ADVANZ PHARMA and by various Regulatory Authorities. The relationship with the manufacturer and licence holder is governed by a Quality Technical Agreement alongside a Manufacturing & Supply Agreement. The manufucature and packaging of every batch of product is rigorously controlled and checked during and post-manufacture, to assure compliance with the Marketing Authorisation, and released to the market by a Qualified Person (QP) – for us, this can mean more than 300 certifications every month.
At this point, we can start to focus our efforts on distributing the products, which means building and maintaining relationships with a network of freight companies and wholesalers to ensure stability and compliance of the Supply Chain, while mitigating any potential disruptions. Ensuring we have the correct inventory policy for each product and each market and from each supplier such that volatility in demand and variability in supply can be buffered to ensure that patients always receive their medicine.
Throughout the distribution cycle all stakeholders, including the Medicines Availability Departments of the various Health Authorities are kept updated on product availability and the risk of shortages. From this point, the medicines can then be sent to pharmacies and hospitals throughout the region, where they can be prescribed and administered to the patients that need them. However, our role doesn’t end here; it’s our responsibility to ensure ongoing monitoring of product usage, implementation of pharmacovigilance systems and provision of medical information to ensure that evaluated, balanced information is provided on all clinical aspects of our medicines.
ADVANZ PHARMA’s role
The process of ensuring essential medicines reach patients has a complex range of moving parts and relies on the efficiencies of each of the components, the relationships that these are built upon and the people at the centre of each operation. The time taken to bring an off-patent product to market varies enormously with the nature and complexity of the product. Simple oral solid dosage forms may be feasible within two to three years where sterile injectable products with complex formulations, manufacturing processes and regulatory pathways can take many more years to achieve. This demonstrates the huge investment of time and resources needed, as well as the dedication of colleagues throughout the process.
At every step, there are many team members at ADVANZ PHARMA with specific roles to ensure we can deliver on our commitments; it is an intricate operation that relies on efficiency and tenacity in dealing with a fast-paced and highly changeable environment. At a functional level, this requires a great deal of expertise, with people who are truly passionate about their disciplines and delivering on their goals for the benefit of the wider network and, ultimately, patients. The astuteness of our employees means we remain incredibly well-connected to our business’ ambitions, which percolates through the organisation so that everyone is aware of their role and the value they bring.
The provision of our medicines would not be possible without the close partnership of our partner networks and we ensure we maintain close, regular dialogue with all of the members of our supply chain so that if challenges do arise, we can tackle them rapidly and collectively.
Broadening reach across Europe
The process of bringing off-patent treatments to market is undoubtedly intricate and takes a large team of experts in the field, who are truly passionate about their disciplines. At ADVANZ PHARMA, many of our medicines are for smaller patient populations or have been lacking in investment, which makes the delivery of these critical treatments all the more important, so that they can reach the people who rely on them. As we continue to expand into the complex and value-added medicines space, we look forward to exploring new challenges and ways of working to successfully bring broader treatment options to prescribers and patients across Europe.