The start of 2019 has already seen some major developments in the pharma world. Huge acquisitions between Bristol-Myers Squibb and Celgene, or GSK’s consumer healthcare business merger with Pfizer are just two examples of the changing landscape in pharma. The very real prospect of a ‘no deal’ Brexit is causing consternation for UK pharma firms and the introduction of the Falsified Medicines Directive in February aims to strengthen supply chains across pharma.
Here, editor Reece Armstrong catches up with some of pharma’s leading names to see what else is in store for 2019.
Looking Ahead
Alex Bunting - I Holland marketing manager
“The requirement for solid dosage continues to grow and with it increases the pressure on manufacturers to get a quality product out quickly and cost-effectively. At I Holland we are continually working on innovative solutions to help to satisfy this demand in tablet manufacture. A particular area of concentration for I Holland in 2019 will be continuing to develop high quality training and support that we have been known for globally for many decades. By delivering education and guidance through flexible channels, advice can be implemented quickly, therefore impacting deliverables.
“We envisage that multi-media tools that enable businesses to receive expert knowledge at the touch of a button are the future. This style of training, delivered alongside our extensive programme of face to face seminars, hosted by recognised experts in the field focus on specific elements within tablet manufacture and provide the appropriate information to the individual.”
Ben Wylie - senior product manager, Chargepoint Technology
“Pharmaceutical manufacturing using highly potent active pharmaceutical ingredients (HPAPIs) and sterile manufacturing certainly doesn’t appear to be declining into 2019 and manufacturers across the pharma and biopharma industries need to respond to containment challenges if they are to benefit from this continued growth.
Better ways to achieve operator safety and prevent cross contamination of products has been widely discussed during 2018 and as we enter into 2019, we are seeing more innovative containment strategies entering the market. Smart wireless monitoring technology was introduced last year to give manufacturers increased confidence in their containment strategies enabling users to receive crucial equipment usage data quickly and remotely if needed, giving confidence in the health status of the equipment.”
Paul Brooks, executive director, RAPS
“With less than 100 days to go, pharmaceutical companies still do not know how they will be impacted by Brexit after prime minister Theresa May decided to postpone a vote on her deal with the European Union (EU) till mid-January 2019.
A ‘no deal’ Brexit, if it happens, is predicted by many experts to risk huge social and economic impact that will change and burden how all industries that move materials and goods across borders, not least the pharmaceutical and medical device sectors, do business. RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals with the latest news and insights as they develop.”
Paul Cianciolo, SVP, business management, TraceLink
“In 2019, I anticipate that the pharmaceutical industry will progress towards ensuring a more efficient global supply chain focused on increasing patient safety and medicine availability. With the launch of the European Union’s Falsified Medicines Directive (FMD), and the passage of many more serialisation and track-and-trace laws across the globe, clinicians, patients, and caregivers should have more confidence than ever in the quality of medicine products. Additionally, as 2019 progresses, I expect to see significant developments centred on digital information sharing among pharmaceutical industry trading partners to enhance supply chain business processes and patient-centric engagement programmes.”
Jim Streeter - global vice president life sciences product strategy Oracle Health Sciences
“Artificial Intelligence (AI) will become more mainstream in clinical research, starting with drug safety reporting. As the sheer volume of data in clinical trials increases, humans will no longer be able to handle it manually, and AI will need to be leveraged to automate some of the work. Safety case management is an area that is leading the way into the adoption of AI. Some of the immediate areas that AI features may be incorporated into pharmacovigilance include: source document processing, case report narrative processing, call centre log adverse event flagging, product label processing, literature screening for adverse events, and signal detection.”
Nick Giuffrida, sales director at FuturMaster - IoT and a connected supply chain
“Connected objects and the internet of things (IoT) will undoubtedly have an increasing impact on the supply chain, due in part to the falling costs of wireless tracking devices and the ubiquity of internet connectivity. This will profoundly benefit the monitoring and flow of goods from the manufacturer to the retailer and ultimately on to the end-consumer. Take-up, so far, has been confined mostly to more expensive items, such as in the apparel and pharmaceutical industries; but adoption will be become much more widespread in 2019 and beyond.”