PharmaLex in Ireland

There are many aspects of the healthcare industry that are exciting at present. The traditional boundaries of different disciplines in medicine discovery and manufacture appear to no longer exist. For example, in the manufacture of medicines, we no longer have just pharmaceutical drug products that are prepared on a massive scale and shipped all over the world for mass consumption. The newer treatments that replace and supplement traditional medicinal drug product provision include individual and combinations of treatments which incorporate biotechnology, cell and gene therapy and medtech technologies. These technologies have revolutionised medicine at a pace that manufacturers, distributors and regulators have found difficult to keep up with.

Healthcare data and its analysis has also become a holy grail for medicine discovery and development. As Stanford University School of Medicine has published “The sheer volume of health care data is growing at an astronomical rate: 153 exabytes (one exabyte = one billion gigabytes) were produced in 2013 and an estimated 2,314 exabytes will be produced in 2020, translating to an overall rate of increase of at least 48% annually.” This huge volume of data is being adopted and analysed by global research programmes using artificial intelligence for cutting edge developments in areas such as robotics, health diagnostics and tracking.

The potential for improving the quality of patient’s lives using new technology and data is what excites me most…it would seem that the future of medicine provision is complex but very bright.

There are many challenges facing the healthcare industry at present and more on the horizon. Brexit, the globalisation of supply chains, decreasing healthcare budgets and technology complexity are some of the well-publicised challenges that currently exist. Over the longer term, climate change will play an influential role in our industry’s development. Pressures for more environmentally sustainable products and supply chains will be brought to bear. The timeliness, logistics and costs of treating patients with severe diseases using some of our new technologies will continue to challenge the industry into the decades to come.

As reported in the news at present, the opening salvos are being communicated between the UK government and the EU regarding the future of trade between the two jurisdictions. It is impossible to predict how this will be play out over the next 10 months but one thing that appears clear is that there is no desire by the UK healthcare industry to deviate significantly from EU rules and regulations such that mutual recognition of each other’s MAH responsibilities, inspections, QC testing and batch release processes will not be possible after the 2020 transition period. Whether this desire is translated into UK government policy is highly questionable, and whether there is any distinct advantage for the UK to deviate from EU regulations on the manufacture and supply of medicinal products remains to be seen. It will be very interesting to see what approach the MHRA ultimately recommends during the implementation of the EU GMP Annex 1 revision later this year.

I believe all organisations should exhaustively strive for effective and efficient systems of work, none more so than an organisation’s Quality Management System which ultimately should reduce risks to product quality and patient safety. I also believe that organisations should use all of its internal resources to resolve complex issues and manage challenging events that arise in medicinal product marketing, manufacture and distribution.

However, what I have come to appreciate and highly respect is that

1. Myopia, complacency and fatigue are natural human modalities and it is frequently the case that when you work with a system closely over extended periods of time, a fresh pair of eyes can lead, inspire and contribute to sustainable improvements with an ROI.
2. Sometimes to take a big step forward in a particular area that requires change and improvement, outside support is necessary to provide the ‘shot in the arm’ to succeed in making effective change.
3. Some problems may appear unique to one organisation but commonplace across an industry.
4. A global outlook and understanding is required for challenges that go beyond international borders
5. There is frequently connectivity between client challenges that span areas such as Quality and Compliance, Regulatory Affairs, Pharmacovigilance and drug development.

In each of the areas (a) to (e) above, PharmaLex play a significant role in providing broad-spectrum and targeted support to their clients. At PharmaLex we are fortunate to get a first-hand comprehensive view of the issues that face multiple clients. PharmaLex’s breadth of services with international expertise in each of our service areas are uniquely placed to provide our clients with the solutions and momentum they require.

Having obtained my PhD in Chemistry and worked in the early part of my career in API development and manufacture, I have a strong background in drug scale-up and technology transfer. Moving into drug product manufacture of oral solid dosage products, veterinary products and topical formulations provided me with a full appreciation of the technical complexity and supporting systems that these operations require. Experience in managing sterile fill finish facilities, becoming QP qualified and being a site Quality lead, in addition to being part of a site senior leadership team, were pivotal in my professional development. Furthermore, working in both France and Denmark has assisted me in understanding different cultures and approaches in the pharmaceutical industry.

Joining PharmaLex in 2018 has been very exciting, fast paced and a learning ladder (not a curve!). I train, audit, advise, risk assess and troubleshoot for clients in all areas of the drug product lifecycle. One of the main elements of my role is to obtain a detailed understanding of a prospective client’s requirements and ensure the right expertise is identified that delivers exactly what is expected. In over 20 years, I have learned where and how solutions can be obtained in the pharmaceutical sector and it is highly motivating to utilise this experience for such a wide variety of clients. It is a privilege to be part of an organisation that has an excellent track record in client satisfaction.