ISPE Member Spotlight - Alice Redmond, PhD
You are an active and engaged ISPE Member! You sit on the ISPE Board of Directors, the ISPE Foundation Board, and the Steering Committee of Women in Pharma®. Can you share some of your experiences with ISPE and some of the many successes you have accomplished?
I have been involved with ISPE most of my working career, so it is hard to pick my favourite experiences. I have loved the Community of Practice (CoP)s and am a member of many (Biotech, Fill Finish, SUS, C&Q). The one I have been most active with is the C&Q CoP, where I am past Chair. Chairing the C&Q (ASTM E2500) ISPE Copenhagen conference in 2006 was a real highpoint and the launch point for risk-based C&Q. My involvement in the ISPE Baseline Guide Vol 5: Commissioning & Qualification, 2nd Edition has been a highlight and I have loved doing the training courses in QRM, FSE, and QRM.
My involvement in the Regulatory Quality Harmonisation Committee -Europe-Middle East-Africa Regional Focus Group (RQHC EMEA), the Global RQHC, and the Regulatory Steering Committee has been fantastic, working with the teams to help prioritise ISPE’s global regulatory priorities and being part of the teams that review draft regulatory documents e.g., Annex, ATMPs, Data integrity, Water systems, ICHQ9, etc. A real highlight for me was chairing the Regulatory panel at the 2020 EU Annual meeting on Distant Assessment with Soren Thuesen Pedersen.
One of my highlights the last 2 years has been judging the Young Professional /Emerging Leader Hackathon, I was astounded with the technical knowledge, talent, innovation, energy, and enthusiasm- the future of the pharmaceutical industry is ‘safe in their hands’ of our emerging leaders.
The is my fourth year on the ISPE Board of Directors and my second year on the Foundation Board, and I have loved it all!
You are also active with the ISPE Ireland Affiliate. What are some of the more recent initiatives that the Affiliate has developed, and the roles and responsibilities you have incurred in your home country’s Affiliate?
I recently presented at a Women in Pharma® (WIP) event on Professional Development and Career Advancement with Richard Kilfeather (Organizational Capability Leader, AbbVie) He spoke on creating good development plans and their importance for achieving one’s full potential. I spoke on my career journey with emphasis on how Emotional Intelligence and Influencing Others were key enablers. It was a fantastic event with lots of interaction and lively debate.
The ISPE Ireland Affiliate has 2 very active mentor circles with the intention of setting up more in 2021. The Emerging Leader group is very busy with an upcoming visit to WUXI and in late April there was a seminar on ‘Vaccine manufacturing-COVID’.
You are the Chief Strategy Officer with CAI and have more than 30 years of experience in lifecycle management of pharmaceutical facilities. What can you tell our readers about the state of the industry today, in Ireland, Europe, and around the globe?
In many ways 2021 is a turning point between the pre-COVID and post-COVID worlds. Perhaps more than most other industries, the landscape of pharma was radically altered by the pandemic. Now, with an end to the coronavirus within reach, I think the industry will soon be taking stock of how it navigated the pandemic and what the sudden shifts in operations and regulations could mean in the long term.
More and more therapeutic innovations are in our future, At least 10 future blockbusters could be given a green light by regulators next year, and decisions do not come bigger than that pending for aducanumab, Biogen’s Alzheimer’s project.
The industry will continue to shift towards niche medicines. CDMOs are now working with partners and drug manufacture will evolve accordingly. There is going to be a continued shift away from the large product volumes and increasingly CDMOs will produce at smaller manufacturing scales, which will require new ways of working.
Global vaccine capacity will expand, Historically, vaccines are produced by a few companies. But given the pandemic, the new modality of drugs, the approval of the first mRNA vaccine, and volume of global vaccine production required, the global vaccine realm is really changing. The biologics and vaccine manufacturing capacity needed globally for COVID vaccines and treatments will take a significant percentage of the overall available capacity. The growth in demand for the manufacturing capacity seen in 2020 will continue into 2021, with many companies building their own internal manufacturing capacity to meet demand.
In terms of manufacturing technologies, equipment will be more integrated, 2021 will continue the renewed focus on operational efficiency and digitisation across equipment assets. The market for sterile injectables will expand. There is an increasing need for innovative products to treat the rising cases of chronic diseases and many may be delivered through prefilled syringes. This is linked to the broader trends over the past decade towards home healthcare and self-administration of sterile injectables. The global prefilled syringes market size is projected to reach $9.53 billion by 2026, exhibiting a CAGR of 10.4 percent.
In 2021 pharma companies will need to build a stronger quality culture and focus on operational readiness and operational excellence. COVID-19 had companies shifting to innovation mode to develop therapies, tests, and vaccines to combat the pandemic. With the FDA’s announcement of a Quality Management Maturity (QMM) pilot program, companies will need to shift to focus on this. The purpose of the program is to gain insight from third-party assessments of a manufacturer’s quality management system to inform a future development of an FDA rating system to characterize a manufacturer’s QMM. As stated in the announcement, ‘for manufacturers with a mature quality management system, the FDA can exercise a more flexible regulatory approach. Leading toward the goal of producing high-quality drug products without extensive regulatory oversight.’
There is a shift in the way small-scale manufacturing will grow. Disruptive technologies such as cell and gene therapy will challenge the status quo and drive the industry towards rapidly deployed facilities, with smaller scale, modular, and portable plants becoming increasingly utilized. Design for operational readiness and operational excellence needs to become the way the industry works! This will aid the speed to market, further diversify the manufacturing footprint globally, and increase the desire for real-time supply chain management and planning.
Across the Pharmaceutical industry there is need for a focus on speed to market, design for operational readiness/operational excellence, and a serious need to eliminate the operational and functional silos to look at manufacturing across the lifecycle in a fully integrated way.
The ISPE theme for April 2021 was Mental Health. As a senior level executive in a large professional services firm, you likely have many ideas regarding diversity and inclusion, and are aware of ways in which companies can help employees maintain a good level of mental health. As a Women In Pharma leader, you have probably also led many discussions on confidence, balance, and other important areas that fall within the overall mental health efforts of today’s pharma companies. What would you suggest all company owners, executives, managers, staff, and others do to keep the conversation going and help ensure that members of their organizations maintain a positive attitude, strong motivation, and good mental health in the workplace and in their personal lives?
Minding your mental health and the health of our employees is paramount, it always has been, but COVID has brought this issue to the surface, where it always should be! I would suggest to Senior Leadership to not just ensure mental health and DEI programs are in place, but that they are ‘lived by all’ and fully integrated into the way the company works- what do I mean by this?
A company can organise an employee assist program to help, but managers and leaders need to avail of this themselves and promote the use of same. The day-to-day feedback processes in work needs to deal with the ‘work’ aspects but an employer must find an intermittent 1:1 time asking the employee questions like ‘How are you?’ You could have a top performer who is excelling in work and really struggling with other issues. Managers and Leaders need to allow for a dialogue if an employee chooses to share or to encourage them to take some time off or to use an EAP. With increased screen time and less social activities people feel isolated and unable to process challenges in their life, ensuing a level of social interaction is part of a meeting or organising a ‘social coffee’ is great fun and an opportunity to chat with colleagues.
On the topic of Women in Pharma® and DEI a lot of the same core principles apply, but a level of consciousness across the whole company is required, this cannot just come from a procedure. The culture needs to be there from hiring to career development to acknowledging the varying challenges- this culture must ensure all people feel heard, are valued, and feel included and empowered.