Time to Reset – For 2021 and Beyond

NSF’s health sciences experts share what they’ve learned over the last year across pharma, dietary supplements, medical devices and IVDs, and how COVID-19 forced us to think differently. They also reflect on how we can move forward.

Big Picture

Martin Lush, Global Vice President, Health Sciences

What have we learned?

Martin Lush

We’ve learned that the pharma industry can move fast when it must. When I joined the industry over 30 years ago, we had the 20-year bench-to-bed rule. Taking a new molecule from the R&D bench to the patient’s bedside took, on average, 15-20 years, if you were lucky. Nothing had really changed – until now. We’ve managed to deliver novel vaccines in less than 10 months. Let’s make sure we reset our mindset and expectations to leverage what we’ve learned. We must move faster. COVID-19 has triggered a biorevolution the likes of which we have never seen before. This new science requires a different way of doing everything.

What has COVID-19 forced us to do (or think) differently?

First up, never underestimate the importance of having a robust health care system available to all. Health care systems, globally, have struggled to cope and some are close to collapse. Secondly, nature is unforgiving. There are thousands of viruses and microbes with pandemic potential just waiting for their opportunity. There will be a next time unless we invest in institutions like the WHO to allow us to detect, contain and eradicate the next pathogen. Finally, 2020 has taught us that fighting a pandemic effectively requires global collaboration, not finger pointing or scare mongering. We need a global reset, not a local one.

How can we take these learnings forward?

Pandemics change societies so let’s make sure we build back stronger. The fix-it list is long: resilient health care systems and the unification of health and social care, greater scientific literacy in government, proper recognition and reward for key workers, WHO modernization, the eradication of live animal markets – I could go on. Governments must also attack inequality with every fiber of their political being. Lastly, the ultimate root cause of COVID-19 – climate change. We all have a part to play so let’s get going.

James Pink, Global Accounts and Key Client Management, Health Sciences Consulting and Training

What have we learned?

James Pink

In March 2020 I was asked by the UK government to be a trusted product safety advisor to the UK rapid ventilator manufacturing challenge. I was involved in nine high-profile, high-pressure projects to design, develop, scale up and clinically validate precision ventilators in the mission to double the UK’s capacity in less than 15 weeks.

I worked collaboratively with teams of people from sectors such as aerospace and automotive, the UK Air Force, Navy, Army REME and Logistics Corps as well as the health service and of course the medical technology, testing and clinical investigation community. Hundreds of people from every race, creed, nationality, culture, sex, age and physical and mental ability worked together creating solutions. Together we demonstrated the very best that humans can achieve, focused on a mission and clearly led, with everyone willing to try out new ideas without hierarchy, social or intellectual suppression or judgement.

We slept in the same laboratories and offices together, ate together and formed bonds and learned so much about each other when we laughed, cried, shouted and grieved.

In a world of social distancing and a belief of a new normal, I realized a pandemic will never change the human need to connect and be part of something. Nor will it change our hard-wired need for recognition, challenge, competition and socializing. Our DNA has not changed in 70,000 years, so no matter what we do to try and convince ourselves about a new normal, it will certainly not be one without human connection.

The way we work, learn and socialize may change a little bit but the rich tapestry of this earth and the fragile coil we have between life and death will always mean that we look toward protecting and improving health. My biggest lesson is that a mission fully embodied and fortified by action creates the most tremendous achievements.

How can we take these learnings forward?

Taking this into NSF we must have clear and brave leaders who stand behind the mission, servant leaders who foster collaboration through direction, challenge and urgency and who trust that life works bottom-up, not top-down. The best leader I saw throughout the challenge made the food, knew how everyone felt and rolled her sleeves up. There is a reason that the most successful and largest market cap pivot to come out of all of this has the word “teams” in its portfolio.

Pharma and Dietary Supplements

Lynne Byers, Global Managing Director, Pharmaceuticals and Dietary Supplements Consulting

What have we learned?

Lynne Byers

The most important lesson for me and for the business is what is possible to do remotely/virtually and how to make it the best possible option for our clients. I was lucky as 2020 started, I had a few long-standing contracts where it was easy to pivot to remote offerings as the clients were already familiar with NSF staff and associates performing the work. Building on existing relationships and delivering the service remotely is easier than trying to persuade a new client to have a virtual audit, gap assessment or training. We have all had to learn new skills, such as how to use Zoom or Teams, and we also had to teach our clients or show them what was possible. Initially, many clients were rather reluctant to switch away from face-to-face activities, but as time passed, they began to realize that travel and face-to-face was not an option. Many switched to the virtual offerings and have been delighted and surprised by the success of the interactions. My lesson from a business perspective is to re-approach clients and ask them again if they might be interested in our virtual offerings.

How can we take these learnings forward?

For the industry long term, being able to offer virtual services and training can mean that we help clients meet their carbon reduction targets and have more value for the money they are spending, due to a reduction in travel costs for both NSF and the clients. As there is increased pressure on sustainability targets many companies will re-examine how they do business, both internally and with others such as NSF.

Maxine Fritz, Pharmaceuticals and Dietary Supplements Consulting

What have we learned?

Maxine Fritz

What I have learned personally is patience. Also, how amazing the human spirit is, how resilient we are and how we can adapt to change and very difficult situations. There is a heightened awareness that there will be uncertainty tomorrow. The pandemic has also created a heightened awareness of science and medicines with a focus on therapies and treatments. One of many lessons to be learned from the pandemic is that we must continually work toward progress in innovations to be able to pivot with science rapidly, and to focus on prevention and cure.

What has COVID-19 forced us to do (or think) differently?

NSF has been able to work across business lines to meet our client needs from hand sanitizers and personal protective equipment, to novel pandemic technologies including virtual auditing and training. We have rapidly created new processes to handle the ever-changing needs of our customers.

How can we take these learnings forward?

One thing is for certain: There will be disruption, and this will be the new normal. It is important to also realize that as disruption unfolds, there will still be a core of critical work--our customers will still require unique custom solutions to complex problems that will arise across the globe.

Today’s incurable diseases will challenge the pharmaceutical biotech industries to develop new medicines that cure and prevent. This pandemic has created a heightened awareness to an industry that was largely focused on therapies and treatments that were not designed on those two criteria: curing and preventing.

The evolution of genetic medicine is the foundation for personalized medicines, which will overcome and largely replace conventional medicines. Personalized medicines have many applications from curative through gene modification through insertion or deletions to biomarkers which can be used as indicators of the actual biology, disease or drug response in predictive trials. This will eliminate the ethical concerns of administering placebos or not providing actual treatment to the patient. Personalized medicine will also improve the speed of drug development by minimizing the cost and time of development.

The consumer/patient will be looking for not only safe and effective medicines, but also other products and services that will enhance and support their active lifestyles.

Nicholas Markel, Pharmaceuticals and Dietary Supplements Consulting

What have we learned?

Nicholas Markel

There is no such thing as normal. The saying “never say never” has never rung truer (I have lost count of the times I have uttered “that will never happen” and then the next day it happens). It is possible to still have human connection through the magic of technology even though I am not physically with people. Millennials and Gen Z are necessary to our survival and we need to embrace what they offer. It is clearer than ever that we can get a lot of work done under circumstances that just yesterday were thought to be impossible.

What has COVID-19 forced us to do (or think) differently?

NSF did what it excels at and pivoted quickly towards a virtual existence where we have been successful at auditing, remediating, training, and consulting (including coaching and mentoring) virtually. 2020 has also reinforced just how critical creativity is, even in a highly regulated and rigid industry that is ruled by procedure and somewhat old-fashioned thinking.

How can we take these learnings forward?

Moving forward, it is necessary to refine our virtual existence and continue to explore and dismantle, where practical, old paradigms and replace them with new fresh thinking.

I don’t have all of the answers as we are all called to task to unlearn our old ways and learn new ways, all without a rulebook. Now more than ever, it is clear just how valuable it is to lean on each other and open our thinking to the world of possibilities. It really is a beautiful world full of potential.

David Trosin, Global Managing Director, Health Sciences Certification

What have we learned?

David Trosin

If 2020 taught us anything it is that change is coming, and it is coming more often and faster than expected. We better be nimble and creative without sacrificing our commitment to quality or the NSF mission.

What has COVID-19 forced us to do (or think) differently?

NSF’s health sciences certification team quickly adjusted our thinking that audits had to be conducted in person, to understanding that in the light of the pandemic, we had to find a new solution. In two weeks, we reinvented our approach and were providing high-quality audits virtually. What had been inconceivable became a reality. We have also worked with our clients to help them understand that their quality commitment (as well as ours) is more important now than when everything was normalized. There is more at stake than ever before, and we have been able to work internally and with our clients to minimize the negative impact to all our businesses.

How can we take these learnings forward?

Going forward, we realize we need to have a strong and focused portfolio of services, but we must also be able to pivot on a dime. To paraphrase Darwin, it is not the strongest or most intelligent that survive, but the ones that are most adaptable.

Clinical Trials

Kazem Kazempour, President and CEO, Clinical Research Services

What have we learned?

Kazem Kazempour

There is room for flexibility and adaptability in even the most unexpected of places. Stringent regulatory policies and restrictions to clinical trial modifications are the norm; but with responsiveness, adaptability and open-mindedness, our industry has evolved over the past 20 years to conduct smarter, faster, more efficient clinical trials while still maintaining patient safety and scientific integrity of an ongoing trial.

What has COVID-19 forced us to do (or think) differently?

An urgency to address the COVID-19 pandemic led to monumental advancements in clinical research that will continue after this crisis is over (e.g. a patient-centered focus over a site-centered one, particularly in oncology research). In general, organizational agility was our strength prior to the 2020 pandemic and we were able to leverage this trait to its greatest capacity so that we were well prepared to meet the demands that COVID-19 placed on us. Our standard was to apply adaptive trial designs and take on added complexities in design and statistical analyses, which allows running efficient clinical trials while saving time and money. In the real world, solving a crisis demands equal levels of competence, ingenuity and speed. Whether triumph or disaster, meet both equally with compassion, determination and collaboration. Rudyard Kipling said it best in his poem If: “If you can meet with Triumph and Disaster / And treat those two impostors just the same.”

Medical Devices and IVDs

Oliver P. Christ, Global Managing Director, Medical Devices and IVD Consulting

What have we learned?

Oliver P. Christ

We have learned that not everything that happened in 2020 has been negative – the COVID-19 pandemic gave us the opportunity to reflect on our thinking and priorities. Like a mirror with a magnification lens, the pandemic showed us what has NOT worked in our societies for a long time:

  • Our health care systems have been crumbling for over a decade.
  • The way we take care of older people in our societies is not acceptable.
  • Strategic country reserves for crises management have been withdrawn for cost reasons.
  • The spirit of partnership has been lost among nations, at least in the EU, and turned into a divorce mentality (between North & South, East & West and of course Brexit).

“Dirty economies” were hit hardest; they may never come back. The way we travelled in the past has been dramatically limited. Microsoft Teams became our day-to-day window for professional communication. Home offices have become the new normal. We can manage and survive a crisis, if we act with team spirit and respond with agile speed.

What has COVID-19 forced us to do (or think) differently?

In a post-COVID-19 era (PCE) each country will suffer for 12-36 months from a lack of normal supply in all areas of life (medical devices, IVDs, pharma, food supplies, basic supplies, income, etc.). Local economies are focused on PCE response only.

The post-COVID-19 world has three crises layers:

  • Health threats and health care systems
  • Global disruption of supply and distribution processes (economic pressures, GDP, market crash)
  • Social suffering (fear, anxiety, grief, depression, loss, finances, etc.)

How can we take these learnings forward?

The pandemic helps us to appreciate new priorities and values:

  • Taking care of each other matters.
  • Having good health care systems in place is important.
  • Less travel and pollution is possible.

Kim Trautman, Medical Devices and IVD Consulting

What have we learned?

Kim Trautman

For me the following quote by Edwin Louis Cole summarizes 2020 and NSF’s medical device consulting contributions: “Winners are not people who never fail, but people who never quit.”

What has COVID-19 forced us to do (or think) differently?

We were able to pivot with non-traditional manufacturing clients from building rockets, planes or automobiles to designing and building medical ventilators. We advised on the medical use of UVC light or other chemicals for disinfection and the risks/benefits for reuse of personal protective equipment. We performed extensive work with new clients on designing and manufacturing new masks, and helping to educate the general population on the key aspects of masks for source control. Many of our first ideas out of the box to help with the global pandemic may not have been perfect, as we too optimistically hoped for a shorter duration of the pandemic.

How can we take these learnings forward?

As a medical device industry, we heavily relied on 3D or additive manufacturing in rapid prototype development which taught us some valuable lessons, both good and bad, on how to use this technology in a regulated and medical environment. We realized greater need and value for telemedicine and benefits of digital health data. All of this learning and perseverance will carry us forward as we continue to innovate both in our medical device industry and at NSF to meet our customer needs.

Robyn Meurant, Medical Devices and IVD Consulting

What have we learned?

Robyn Meurant

I’ve learned that IVD companies doing well in the COVID space are those that really took regulatory science seriously.

A number of those with classic failures jumped into developing antibody tests using old assumptions of how the virus may react (IgM is produced first, which is good for diagnosing, followed by lifelong production of IgG that will indicate immunity). The lack of discipline, partly induced by decades of self-declaration of conformity under the old IVD Directive (where most tests have never had pre-market review), meant that many claims were not supported by evidence. And what happens? We find out that IgM is rarely produced and in a number of tests, the IgG response disappears very quickly. But those that have products that are doing well are those with proper validation with appropriate patient populations, ensuring claims were supported with evidence. No assumptions and no shortcuts were made.

I have also learned that we may be seeing a new generation of IVD manufacturers with no experience in this space, but with histories of successful business ventures. At the start of an outbreak of international concern, there are always many new inventions, innovations and novel ideas. However, there is a big jump from being an inventor to becoming a manufacturer. These new manufacturers are not inventors; they buy the invention and pay for proper studies and other know-how. They don’t leave it to chance to see if the product will be a success. They have seen the opportunity to enter this space and do it well with business-like processes employed to make things happen. The money has matched the ideas. The biggest common failing I have found with this particular group of newcomers is that they don’t know what they don’t know, especially when it comes to the complex world of regulation. Some have realized this, and others will find out the hard way.

How can we take these learnings forward?

Going forward as an industry, we should stick to our core strengths. Bringing excellence and excellent service to our clients and insisting on their excellence in meeting regulatory requirements. They are there for a reason. Having brave conversations with clients when things are not right.

Final Thoughts from Martin Lush

When I read through the comments and thoughts from my colleagues it made me realize, once again, how lucky I am to work alongside such wise, thoughtful and caring people. We all know that the “great reset” will provide significant challenges. We all know the benefits this COVID-inspired biorevolution will bring - providing we seize the opportunity. We also know that none of this is possible without attracting, looking after and developing our people. As you move forward, we are here to help you any way we can.

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