Q&A Showcase

• The client was a small orphan drug company of less than 20 people, based in France. With no UK base and all their products approved via the Centralised Procedure, the client needed to understand how they could maintain their Marketing Authorisations in the UK following Brexit, including what measures could be put in to place to solve practical considerations such as importation and labelling requirements.The client also needed support identifying if there was any Brexit related impact on the multi-market UK and EU clinical trials they were conducting and what the possible solutions were.

• The first step was a call to understand the client’s position and concerns. The client briefly went through the questions they had one by one, allowing PharmaLex to ask counter questions to really get to the bottom of their specific situation. Following this the client collated all their questions in writing, with input from several team members, and provided to PharmaLex in writing.

• The PharmaLex project lead consulted with their expert colleagues from Development Consulting & Scientific Affairs, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance to cover the full spectrum of fields in scope and provided a written report with answers to the client’s questions including extracts of guidance and potential solutions.

• Based on PharmaLex’s detailed advice, the client is now preparing for the end of the Brexit transition period and putting procedures in place to ensure their research and approved product supply can continue without impacting on the patient. PharmaLex has been providing ongoing support with any further ad hoc questions as they work through this and has also offered its hands-on support to assist with local representation, when it becomes necessary, e.g. local UK QPPV.

PharmaLex took the time to understand their specific needs and promptly provided a bespoke report containing detailed responses and practical advice (in the context of the relevant guidance and best practice) to solve the challenges they are facing.

• Moving from a formal office environment to remote working was actually not entirely as tricky as I first expected.  I was very lucky, in joining Pharmalex I was coming in to an environment where remote working and the associated agility this brings to the business was already well established.  As a frequent traveller in some of my previous roles I had often worked occasional days from home in the past and therefore it wasn’t that much of a culture shock to me.  Onboarding and working remotely straight away however I have had to really try to be clear on who is doing what so I don’t end up overlapping activities and also to fight the temptation to overcommunicate.
• I like to treat remote working as close to going out to work as possible by sticking to an established morning routine and stepping out for 5 minutes to clear my head before sitting down at the laptop and making sure I get my coffee’s and lunch breaks appropriately throughout the day.  I feel that this allows me to keep focussed and productive and not overstretched or distracted by home life.

• Pharmalex have been incredibly agile and were able to pivot immediately to  adapt to the changing needs of our clients.  Most notable is the provision of virtual audits, remote training and providing support to clients who have experienced significant upheaval as a result of Covid19.  We are looking closely at the changing regulations not only around Covid19 but also Brexit and MDR/IVDR, and checking in with our clients to make sure that they have the required support that they need and if we can help in any way.
• The reality is that business must go on, and companies that planned to launch new products or obtain new licences prior to the Covid19 pandemic still need those projects to proceed regardless of the hierarchy changes or pressures within their organisation.  We are here, ready to support and would be delighted to talk to new clients who maybe haven used our services but who need a consultants support to get back on track.

• At Pharmalex  there is a very practical common sense approach to remote working with established two-way communications across the teams.  We video chat on Microsoft Teams directly through the week, in daily catch-ups and huddles which allows us to keep up to date as if we are in the office.  We even have meditation, virtual yoga and virtual coffee breaks where we can share a brew and catch up on the office banter!   This really helps to keep us all motivated and supported while working from home.  I’m incredibly lucky as there is a very supportive team structure already in place and everyone has been really kind and patient with each other.The nature of our work requires daily collaboration across the team, so even though we are all remote working, everyone is actively engaging with each other behind the scenes.

• I am finding increasingly that instant messaging on Teams is the ‘go to’ in place of the stroll over to a colleague’s desk or just waiting to chat to them over lunch.  I will shoot off an IM either for a quick question or to ask “are you free for a quick chat”.  That way if they are stressed, in the zone with a technical piece of work or on a call you are giving them the chance to let you know that they’ll come back to you when they are free.

I have been greatly impressed by the way that the supermarket and food companies such as Supervalu and our local garages and convenience stores have adapted to the Covid19 pandemic.  The immediate availability of home delivery and the way that sanitation and distancing measures were very quickly implemented such as Perspex divisions for the staff, one way systems to minimise pinch points and priority hours for key workers and the elderly.

Also a lot of medium and larger Irish retailers like Eason’s strengthened their online presence and made it easier and more straightforward to do things like click and collect or buy online and collect instore.

• At first it was a challenging adjustment both working from home full time and getting your head around the pandamic and the implications for our families and the community in general.  However I have really settled into working form home and find it so conducive to a good work life balance.  We have a “rule” that we put video on whenever we have a call or catch up, and that keep the engagement real with both colleagues and clients.

• As a company we have responded exceptionally well to the crisis.  Within a few hours of the announcement here in Ireland we were all ready to work from home.  We have daily meetings and the company has introduced some great initiatives such as mediation, yoga, coffee breaks and the occasional cocktail hour (after work of course!) which really helps the team spirit and replaces those “water cooler” chats.

• We have been very active in the industry supporting our clients, specifically our ask the expert campaign and our newsletter have been a great source of help to companies.  We have also done a huge amount of work on Virtual audits to help our clients embrace this new way of working.  Specifically there are some great articles and webinars which have been very useful . Read More

• I think working from home has become the new norm – which could be a positive we take out of this.  Its good for work life balance and for the environment as there is less traffic on the road and less stress on public transport.  I think most companies are seeing that productivity has increased so it’s a win win situation.

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.

Pharmalex has available a risk assessment tool and the associated expertise to draw conclusions from the obtained information. This tool can assist Marketing Authorisation Holders and manufacturers to identify the causative factors that could lead to nitrosamines being present in the drug product, and the level of risk. Pharmalex can also provide a review service in relation to risk assessments already carried out in order to provide confidence that those assessments are valid.

The tests require specialised equipment: GC-MS, LC-MS, and LC-MS/MS. The qualification of the equipment has special requirements. The establishment of limits and the test method validation are dependent on the API in question. Pharmalex has available the expertise to help manufacturers develop a test strategy, including

1. Selection and approval of contract laboratories
2. Instrument qualification and method validation requirements
3. QA controls associated with the testing

Swissmedic, the South Korean authorities and Health Canada each require risk assessments to be carried out and testing to be done based on the conclusions of the risk assessment. FDA has not asked for risk assessments but are themselves reviewing all filings based on their understanding of the risk factors involved. FDA are also pursuing any companies and products where they see a risk. Pharmalex has available the expertise to assist companies in addressing the concerns of these authorities in relation to nitrosamines.

All new MA applications should include the risk assessment, and dependent on the conclusions of that assessment, it may be appropriate to build it into the process validation, especially for the API manufacturing process. As with the risk assessments for existing products as mentioned above, Pharmalex can provide expertise and assistance in that regard.

PharmaLex can support companies in making sure that they understand the regulatory requirements in relation to nitrosamines, that their risk assessment is valid, that they are carrying out appropriate testing, and that they are interpreting the information correctly.

I was interested in joining PharmaLex as I had worked with them when I was in industry and knew that their priority was providing robust solutions to some of the common challenges currently facing the Pharmaceutical Industry. PharmaLex brought a practical hands-on approach to issues and challenges and gave our team a different perspective.  Joining Pharmlex gave me the opportunity to really use my experience while still providing me with many learning opportunities to expand that experience. I love the variety in my role and working with many different people in the industry.

My undergraduate degree was in Industrial Microbiology and my Microbiology knowledge and experience underpins everything I do. This foundation has been invaluable when working with clients involved in Steriles, Biologics, Vaccines and ATMPs. I also have an MSc in Pharmaceutical Quality Assurance which expanded my Pharmaceutical education and allowed me to branch out from Microbiology into other areas of Pharmaceutical Quality. This MSc included a Thesis on Quality Risk Management which is now an area of expertise for me and something I am known to be passionate about!.  I also have a Post Graduate Diploma in Manufacturing Technology which allows me to be recognised as a Qualified Person in the EU and I have enjoyed my time as a practicing QP.

The landscape is changing in the Pharmaceutical industry as we start embracing novel technologies and I’m fascinated by personalised medicine and the impact these types of novel technologies will have on many traditional areas such as QC, QA, Sterility Assurance, Risk Management and QP disposition.. The direction the industry is taking will challenge all of us to move out of our comfort zones and that sort of challenge is always exciting. Also, the continued focus on Quality Risk Management continues to highlight the interdependencies between all the processes and systems in a pharmaceutical facility and working in this more holistic environment is very exciting when compared to the historical approach to Quality which was more siloed and removed from the heart of the pharmaceutical process.

With any change comes uncertainty and the biggest challenge I see in the industry is overcomplication of processes and procedures and a move away from effective simplicity. I often see very complicated processes and procedures that have become far removed from the basic principles of Quality or Risk. The challenge for the industry over the next number of years will be to peel away the complexity in areas where it isn’t required and become comfortable again with processes and procedures that are scientifically sound but easy to implement, follow and maintain. Unnecessary complexity becomes a burden and can be very difficult to manage long term.

• Our first thought and priority was ‘how can we help? What can we do to assist industry at this time?’  So we set up our #AskTheExpert service so clients can engage with one of our consultants on COVID-related technical queries.  We then contacted industry representative bodies to offer support to their members.  We have taken part in a virtual audit Q&A session with BioPharmaChem Ireland, we are conducting a Virtual Audit webinar with PDA Ireland to share our insights with companies as to how to manage their internal/vendor management audit programmes during and post-COVID. We are hosting a COVID-related Supply Chain webinar with Nibrt in June and in August we are hosting a webinar for ISPE India on Virtual Audits.

• For some of our services such as QMS development, it is business as usual. For other typical ‘on-site’ support we looked at how we could adapt our service offering to fit the current circumstances. Whereas we typically provide on-site training solutions, we quickly moved to a virtual setting to enable our clients to continue to deliver their annual training programs to their teams. We also adapted our auditing and PAI services to a virtual model so that clients can continue to meet their compliance requirements and prepare effectively for expected post-COVID regulatory inspections. We are assisting clients with their risk assessments of their supply chains where new suppliers have been on-boarded and new routes require assessment.

Being available as much as possible for them for any questions and give the support needed. Realizing that face-to-face contact was more difficult we embraced virtual options to maintain direct contact, provided training and workhops using platforms like Zoom and Skype. We quickly learned how to adapt to the situation together with our clients and brought some innovative solutions, for example a virtual site audit was completed including a tour of the facility. I see this as a very good opportunity going forward even beyond corona.

• I maintain a “normal” routine as much as possible like before the COVID-19 situation. This means, get up and start at 8. I am fortunate enough that I already had a dedicated desk space in our house, which is now used much more than before. Meetings are still scheduled and happen now through video calls on a daily basis so you still have the feeling of direct contact. At the start I think it was something everybody had to get used to but now you see that after nearly 3 months it has become the “new normal” and people have found their way to participate effectively and get used to the technology available. One thing I had to get use to was forcing myself more to get up and move away from the desk as it is very tempting to stay in your chair all the time and use your coffee and lunch breaks behind the desk. So now I get up and stretch the limbs and get some distraction away from the screen and keep set break times as much as possible. The Pharmalex colleagues are a big help in that as well as besides our daily catch up meetings we have virtual breaks and even meditation and yoga sessions which is a great help to keep in touch with each other as well.

• I maintain a “normal” routine as much as possible like before the COVID-19 situation. This means, get up and start at 8. I am fortunate enough that I already had a dedicated desk space in our house, which is now used much more than before. Meetings are still scheduled and happen now through video calls on a daily basis so you still have the feeling of direct contact. At the start I think it was something everybody had to get used to but now you see that after nearly 3 months it has become the “new normal” and people have found their way to participate effectively and get used to the technology available. One thing I had to get use to was forcing myself more to get up and move away from the desk as it is very tempting to stay in your chair all the time and use your coffee and lunch breaks behind the desk. So now I get up and stretch the limbs and get some distraction away from the screen and keep set break times as much as possible. The Pharmalex colleagues are a big help in that as well as besides our daily catch up meetings we have virtual breaks and even meditation and yoga sessions which is a great help to keep in touch with each other as well.

• I read a poem about the pandemic by Damian Barr which suggests that while we are all in the same storm, we are not all in the same boat. So for me lessons learned include: 1) That those fortunate enough to have an easier ride have a responsibility to care for those who are suffering most. I hope this message continues to resonate within society post-COVID and 2) that we always remember this time when nature truly reminded us that we are all visitors on this planet and as such it is our duty to respect it.

• Our first thought and priority was ‘how can we help? What can we do to assist industry at this time?’  So we set up our #AskTheExpert service so clients can engage with one of our consultants on COVID-related technical queries.  We then contacted industry representative bodies to offer support to their members.  We have taken part in a virtual audit Q&A session with BioPharmaChem Ireland, we are conducting a Virtual Audit webinar with PDA Ireland to share our insights with companies as to how to manage their internal/vendor management audit programmes during and post-COVID. We are hosting a COVID-related Supply Chain webinar with Nibrt in June and in August we are hosting a webinar for ISPE India on Virtual Audits.

• For some of our services such as QMS development, it is business as usual. For other typical ‘on-site’ support we looked at how we could adapt our service offering to fit the current circumstances. Whereas we typically provide on-site training solutions, we quickly moved to a virtual setting to enable our clients to continue to deliver their annual training programs to their teams. We also adapted our auditing and PAI services to a virtual model so that clients can continue to meet their compliance requirements and prepare effectively for expected post-COVID regulatory inspections. We are assisting clients with their risk assessments of their supply chains where new suppliers have been on-boarded and new routes require assessment.

Being available as much as possible for them for any questions and give the support needed. Realizing that face-to-face contact was more difficult we embraced virtual options to maintain direct contact, provided training and workhops using platforms like Zoom and Skype. We quickly learned how to adapt to the situation together with our clients and brought some innovative solutions, for example a virtual site audit was completed including a tour of the facility. I see this as a very good opportunity going forward even beyond corona.

• I maintain a “normal” routine as much as possible like before the COVID-19 situation. This means, get up and start at 8. I am fortunate enough that I already had a dedicated desk space in our house, which is now used much more than before. Meetings are still scheduled and happen now through video calls on a daily basis so you still have the feeling of direct contact. At the start I think it was something everybody had to get used to but now you see that after nearly 3 months it has become the “new normal” and people have found their way to participate effectively and get used to the technology available. One thing I had to get use to was forcing myself more to get up and move away from the desk as it is very tempting to stay in your chair all the time and use your coffee and lunch breaks behind the desk. So now I get up and stretch the limbs and get some distraction away from the screen and keep set break times as much as possible. The Pharmalex colleagues are a big help in that as well as besides our daily catch up meetings we have virtual breaks and even meditation and yoga sessions which is a great help to keep in touch with each other as well.

• I maintain a “normal” routine as much as possible like before the COVID-19 situation. This means, get up and start at 8. I am fortunate enough that I already had a dedicated desk space in our house, which is now used much more than before. Meetings are still scheduled and happen now through video calls on a daily basis so you still have the feeling of direct contact. At the start I think it was something everybody had to get used to but now you see that after nearly 3 months it has become the “new normal” and people have found their way to participate effectively and get used to the technology available. One thing I had to get use to was forcing myself more to get up and move away from the desk as it is very tempting to stay in your chair all the time and use your coffee and lunch breaks behind the desk. So now I get up and stretch the limbs and get some distraction away from the screen and keep set break times as much as possible. The Pharmalex colleagues are a big help in that as well as besides our daily catch up meetings we have virtual breaks and even meditation and yoga sessions which is a great help to keep in touch with each other as well.

• I read a poem about the pandemic by Damian Barr which suggests that while we are all in the same storm, we are not all in the same boat. So for me lessons learned include: 1) That those fortunate enough to have an easier ride have a responsibility to care for those who are suffering most. I hope this message continues to resonate within society post-COVID and 2) that we always remember this time when nature truly reminded us that we are all visitors on this planet and as such it is our duty to respect it.

• The client was a large multi-national pharmaceutical company for whom PharmaLex provides UK and Ireland regulatory support services.
• The client required PharmaLex to utilise in-house expertise in regulatory, pharmacovigilance and quality management to prepare and guide all BREXIT activities. The client particularly required PharmaLex to plan and lead activities for the CAP conversion process to UK national licences.

• PharmaLex held meetings with the client’s Medical Affairs, regulatory, compliance and lifecycle management leads, to discuss the BREXIT guidance and activities, to fully understand the client’s concerns.PharmaLex created a BREXIT preparedness report summarising key activities for supply chain, regulatory and pharmacovigilance. PharmaLex were able to provide detailed responses to follow up questions.

• PharmaLex created a fully scoped BREXIT plan; to map out regulatory activities, responsibilities and timings. PharmaLex presented the plan to regulatory managers so they could understand the process and ask any questions.

• Based on PharmaLex’s detailed plan the client now has a map of activities; client resource may be allocated and mitigating activities have been put in place. The client is reassured of the processes that are ongoing, in order to ensure regulatory compliance post-transition, and continuity of supply.

PharmaLex took the time to listen to BREXIT concerns and explain the process to a wide internal audience. This allowed for the internal team to focus on their ongoing activities, knowing that BREXIT co-ordination activities actions were being led by PharmaLex.