Are you joining us at stability studies 2022? This year, we are looking forward to our first ever Stability Studies conference with a full line-up of pharmaceutical industry experts. Joining us at the conference as a guest speaker is Ken O’Shea, Founder and Managing Director of Qbd Pharma Solutions and Co-founder and CTO of new precision nutrition start-up Reso Health.
Before joining us at our conference in October, Ken has taken the time to tell us more about his career in the pharmaceutical industry which spans over 20 years, launching two companies during Covid-19 and what you can expect to hear at the upcoming conference.
Ken O’Shea, can you tell us more about your background?
My education includes primary degrees in both Environmental Science and Pharmaceutical Science, a Post Grad in Business Management, an MBA from Smurfit UCD and a Lean Six Sigma Black Belt.
I started my career in the pharma industry scrubbing pots in the kitchen of Leo Pharma in Dublin back in 1999. This was my summer job while waiting on my final year college results. After everybody had their lunch, I had to clean up, which meant I had my lunch a little later. It just happened that the HR Director at the time also took a late lunch – probably to avoid being bombarded with everybody’s problems while he was trying to enjoy his food. We ate together and as we got talking, he realised I was going to be a science graduate, so he helped me secure a job in the penicillin manufacturing facility. Once in this role the penicillin manufacturing facility manager put me forward for a job in the penicillin laboratory, and the rest is history.
How did you learn about managing stability studies?
While working for Leo Pharma I had my first introduction to stability studies learning all about stability storage and testing and why it’s so important. I had no idea the amount of work and effort that went into releasing a product to the market while ensuring it was safe and effective for its entire registered shelf-life.
Where did your career take you to after Leo Pharma?
I’ve had an unusual career as I’ve worked in both manufacturing and laboratory settings, most people take one path and stick to it.
After Leo Pharma, my next move was to Australia where I worked as a Development Chemist in Pharmaxis Sydney producing inhalation products and then Niche Generics producing oral solid dose products. After gaining experience in Australia, it was time to return to Ireland where I become a Development Chemist at EirGen in Waterford.
At the time, EirGen was producing high potency drugs and the Founders had this idea to take a chemist and teach them how to manufacture product, thereby ending up with somebody who could work in formulation development. This was clever as it’s much more difficult to take somebody from manufacturing and teach them about the chemistry.
From there my career really took off and I went from being a Development Technologist and Formulation Scientist to establishing an R&D function. Initially the R&D function was just myself, but this quickly grew to the point where I was Site Lead of the R&D Centre with a headcount of 120 people.
Can you tell us more about starting QbD Pharma Solutions?
QBD Pharma Solutions is a pharma consultancy company I started in January 2020. I incorporated the company on 2nd March 2020, and we went into the first Covid lockdown 10 days later!
As the Founder and Managing Director of QbD Pharma Solutions, I work with clients in Pharma, Biopharma, Medical devices and Environmental services. We’re an Enterprise Ireland (EI) approved vendor for all things Lean (Start, Plus, Transform and Digitalisation Voucher) and are on an approved tender panel for a dozen county councils.
In addition to my work with QbD Pharma Solutions, I also work with SETU (Carlow IT and WIT) as an industry advisor on course content and sit on interview panels for lecturer and post doc researcher positions at the university. I’m also on the Steering Team Committee for the PMBRC, the EI technology gateway at SETU.
So, you started two new businesses during Covid-19. Can you tell us more about Reso Health?
Reso Health is a new start-up company offering precision nutrition for professionals at work. This was founded in July 2021 with my Co-Founder Dermot O’Riordan. Together we’re working to fuel the future of work by applying what we learned working in pharma developing cancer treatments to the nutraceutical space.
Initially we were thinking about the future of medicine and what the solutions might look like. We had several ideas around how a business might be built in this area and were sure that key considerations would be precision, personalisation, convenience and quality. To begin with we designed a device to deliver precision medicines in the home but decided that the current regulatory environment did not lend itself to this idea just now. So, we looked at applying the idea to the nutraceutical industry, where the regulatory considerations are quite different.
We are solving a huge problem that exists in employee wellbeing by developing a platform for companies who are serious about employee wellness. Our platform combines personal and professional health and wellbeing, using precision nutrition to fuel happier and healthier employees resulting in more attractive and productive workplaces.
Reso Health combines an onsite dispenser with an app (which is confidentially controlled by the employee) that delivers a freshly prepared personalised nutritional supplement drink right there in the workplace, to ensure that employees have optimum nutrient levels and access to the fuel needed to function properly.
Dermot and I are both enthusiastic about health and wellbeing and we want to bring a level of science and technology to the nutraceutical sector which we believe is somewhat lacking at present.
How has the pharmaceutical industry changed since starting your career?
Firstly, competition in the industry, particularly in the generics sector, and the current economic situation with rising inflation and energy costs means there are increased pressures to reduce costs across the board.
Companies are also focusing their attention on the parts of their business that they are experts in, and where they can create most value. As a result, there is a move in the industry to outsource what might be deemed ‘non-core activities’ such as analytical development and stability storage.
Take stability storage as an example. If you want to do it in-house you need space, which is always at a premium. You need chambers, which need to be installed, qualified, validated and temperature mapped regularly. You need to have people trained on the procedures required to operate them and they need to be continuously monitored. Outsourcing this activity makes a lot of sense if your core expertise is formulation development, analytical chemistry or manufacturing for example.
At the conference in October, you are going to be talking about lean stability studies. Can you tell us more about this?
I’m seeing that companies are heavily focused on improving the efficiency of internal processes, through the implementation of things like Lean. Lean, simply put involves the removal of waste from a system. You identify what’s value add, what’s non-value add and what is waste. The aim is to eliminate waste and reduce the non-value add activities, thereby improving value add without applying any additional resources.
As an example, we have 100 units of resource, 50 value add, 30 non-value add and 20 waste. If we can eliminate the 20 units of waste and share these amongst the remaining categories, we end up with 60 value add and 40 non-value add. This means that without applying any additional resources we have increased value add from 50 – 60, an efficiency improvement of 20%.
What is Lean product development?
Lean Product is built on a number of principles:
- We put people first
- We understand before we execute
- Product development works best when we work as a team
- We synchronize work across the company to create flow
- We capture and transfer knowledge quickly
- We focus on value stream mapping and design
What is lean stability?
Lean stability is a science and risk-based initiative which uses the enhanced understanding of drug substance and drug product physical and chemical characteristics to
- Reduce and optimise the design of standard stability protocols;
- Expedite the generation of stability data without impact to safety, efficacy, or quality of the product; and
- Decrease time to market for innovative drugs. In generics for example first to market is key to success as there are usually several players.
Lean stability was introduced in the early 2000s [ICH: Guideline Q1A(R2) (2003), ICH: Guideline Q1D (2002)]. While the concept of lean testing is not entirely new, and it is currently a part of several regulatory guidance’s, it continues to evolve and gain acceptance by both industry and regulators. Lean stability will be a key area in the future.
What is the question you are asked most by your customers?
Our customers for QBD and Reso are quite different.
With QbD Pharma Solutions, we have large companies working in pharma for example, who are trying to get products through development and on to the market. They’re trying to cut costs and work as smartly as they can, and they are trying to do all this whilst competing with other companies who are trying to do the same thing. It’s incredibly competitive.
These companies are usually asking for support in solving technical problems around development and submission of products for approval, as well as ways to improve internal processes and become leaner. I often suggest to clients that they outsource non-core activities to specialists like Q1 scientific, to allow them focus on the things they are expert in and to maximise value.
What do your Reso Health customers look for?
At Reso Health, our customers are large multinationals with Employee Wellness programmes. They are companies who are serious about their employee’s wellbeing and are looking for ways to ensure that their employees are healthy and performing at their best while they are at work.
Our research shows that two in three corporate employees believe that it is not easy to maintain a healthy diet in work. Maintaining a healthy diet requires thought and focus, and this can be difficult when there are so many life stresses competing for a finite amount of mental energy. We believe this presents the perfect opportunity for employers to help tackle this problem. At Reso Health we want to help companies invest in the health and wellbeing of their employees by fuelling their workdays with precision nutritional supplements.
In recent years we have seen massive growth in the adoption of corporate wellness programs. Previously, these programs were adopted as a reaction to the growing preference for work-life balance and seen as corporate social responsibility initiatives. While many companies focus on physical activity in their corporate wellness program, they often don’t prioritise or even address a key element of corporate wellness, namely nutrition.
According to research conducted at the Institute for Health Metrics at University of Washington, poor nutrition has nearly three times the impact on health as low fitness. In fact, poor diet was found to be a greater risk to health than smoking and high blood pressure.
Proper nutrition in the workplace can have a significant impact on overall health and well-being. Good nutrition can improve concentration and cognitive function, boosting an employee’s workplace performance, and it is well documented that employee wellness leads to higher creativity and productivity. The World Health Organization has found that optimal nourishment can raise national productivity levels by 20%, and that healthy employees are happier, calmer, more engaged, sleep better and get sick less often.
Providing targeted nutritional supplements in the corporate setting is an effective way to get employees to stick to smart nutrition habits, benefiting both the company and the individual.
Ken O’Shea, what’s coming up next for you?
At QbD Pharma Solutions we are continuing to work with our clients to help them bring products to market and improve internal performance in all areas across their business.
For Reso Health, we are looking to get to Minimum Viable Product. At present we are initiating our field testing to validate the product and get user feedback. Following this we are looking to hire a Sales & Marketing person, raise funds by Q1 2023 and launch in Ireland in Q3 2023.
Finally, I am a guest speaker at the upcoming Q1 Scientific Stability Studies conference. I’ll be joining an expert line-up of speakers from the pharmaceutical industry to talk about Lean product development in Pharma. During my presentation I will cover:
- Common QbD principles as they are applied in Chemistry, Manufacturing and Controls (CMC)
- How Lean principles can be employed to improve pharmaceutical development and CMC
- The concept of Lean Stability and the potential for its application in regulated environments
I’m looking forward to meeting everyone in October.
Find out more about Ken O’Shea or our Stability Studies 2022 conference
Are you free on Thursday 13th October 2022? To learn more about our Stability Studies 2022 conference or to register to see Ken O’Shea speak live, please visit our conference website. Spots are filing up fast and registration closes in the first week of October.
To contact Ken O’Shea, visit QbD Pharma Solutions or Reso Health.