DIA 60th Anniversary
Interview with Andrzej Czarnecki
lobal Forum founding Editor-in-Chief and former DIA board member Andrzej Czarnecki (Eli Lilly and Company) shares his reflections on DIA’s 60-year anniversary and prospects for the future with his successor, current Editor-in-Chief Alberto Grignolo.
Former DIA Board Member and Founding Global Forum Editor-in-Chief
Andrzej Czarnecki (AC): I am a medical doctor. I finished university studies with a specialization in internal medicine and cardiology, and subsequently in clinical pharmacology. Over the years, I worked in clinical medicine in different hospitals and environments but predominantly university hospitals and post-graduate medical schools in Poland and in the UK. In the UK, it was the Royal Postgraduate Medical School, located at the Hammersmith Hospital, now part of the University College in London. I also worked in experimental pharmacology and later in experimental physiology at the University of Cambridge.
Because of my work in experimental physiology and pharmacology and years in clinical medicine, I started shifting toward clinical pharmacology, maybe because I wanted to use all the knowledge pulled together instead of using it in separate silos. Later, I got involved in drug safety and drug clinical trials.
AC: This wasn’t really a transition. I started being a junior investigator early in my clinical work and then a more advanced investigator during my time in Poland. When I started working at Hammersmith Hospital, I worked with Professor Sir Colin Dollery, whom some people may remember as one of the most prominent clinical pharmacologists in Europe in those days. He had a unit for phase 1 and phase 2 trials, so progressing to later-stage clinical trials was natural for me; basically, I was “transitioning on the job.”
DIA: Sir Colin certainly was a luminary. I did cardiovascular research in graduate school and saw that name in many publications; he was legendary. You were fortunate.
AC: Yes, I knew him quite well. Later in my professional life, I used to chair some of the sessions in which he was a speaker, and he used to chair some of the sessions I was presenting, so we had a continuum of earlier connection. Unfortunately, he passed away about four years ago. But he, together with Folke Sjokvist from Karolinska Institutet, were the two most prominent people in clinical pharmacology in Europe in the 1980s and ’90s, and maybe late ’70s as well.
DIA: How did your career evolve after your entry into clinical trials?
AC: In the early 1990s, with the change in the political situation, we moved back to Poland. I had a clinical appointment and, using the experience of running clinical trials and drug safety assessments, I started some drug safety and clinical trial activities in the Drug Institute in Warsaw. Both of these activities were not organized and needed a lot of work. I headed the Unit for Drug Safety, and I submitted a proposal to the Ministry of Health to create a register of clinical trials for the country, and they agreed. In short, the Central Register of Clinical Trials (CRCT) was created thanks to my proposal and activity, and this is how many people remember it to this day. I have a couple of publications relating to these activities.
The CRCT was reviewing, accepting, and licensing clinical studies to be conducted in Poland. All the studies that industry or academia wanted to conduct in Poland had to go through the register I was heading at the time. The department that I created is now part of the Polish regulatory authority, just as the Drug Safety Unit that I headed in those days is part of the current Polish regulatory authority. In a way, I feel that I left some “babies” behind when the family and I moved back to England a couple of years later.
Somebody told me that I need to start writing notes on what I call “babies” that I left behind in science and work in different places. The two mentioned above are probably some of several, but it’s quite important that they survived and are useful within the system.
DIA: What happened then?
AC: Let’s remain in Poland for a minute, as this is when and how I started with DIA. I think somebody heard about me doing something “sensible” there, so I became “visible.” You may remember DIA starting in Europe in 1989 with Alex Anderson; shortly afterwards, DIA Europe decided that they might try to expand into Central and Eastern Europe. This was initiated with a clinical trial, regulatory, and drug safety meeting in Prague in November 1993, and I got invited to this meeting as a session co-chair and speaker. This was my first encounter with DIA.
DIA: Where were you working at the time?
AC: This was the work I just described, my clinical appointment plus the Safety Unit and the Clinical Trial Unit, which were not part of the regulatory authority yet. The Clinical Trial Unit was kind of under the auspices of the Ministry of Health; however, drug safety at the time was still independent. In any case, this was my first encounter with DIA. During the Prague meeting, I had several conversations with Alex, and we agreed to meet in January ’94 in London to continue.
This was a very important meeting, because we agreed what to do next to expand DIA into Central and Eastern Europe and help patients and industry move forward. We agreed that the best way to gain credibility with regulators and academia was to start running training courses in GCP (and potentially safety) and start inviting local regulators into these meetings to assist and get acquainted, to help with their perception that DIA was an industry organization with which regulators and academics didn’t want to have anything to do. With my assistance, DIA ran three courses–one in Tallinn, one in Warsaw, one in Prague–and some other workshops, and we started gaining the recognition and support of medical professionals and regulators from different countries.
To move on with my activities with regulators, I ran a session on running clinical trials in Poland at the DIA EuroMeeting in Berlin and subsequently on clinical trials in the Czech Republic, Hungary, and Poland during DIA EuroMeetings in Paris and Copenhagen. Following a substantial number of activities (and successes), I started being seen as a good contributor to DIA and was invited to join the DIA Steering Committee of Europe, as it was then called, which I joined in June 1996.
Seeing developments and growth of DIA in Central and Eastern Europe, the board decided to expand more and formed a Steering Committee for International Development (SCID) in 1996 to think about how DIA should develop into other regions. I was one of the members of this committee. We were looking at Southeast Asia, China, Japan, Australia, and as far as South America. Those activities did not go as well as the Steering Committee of Europe, but we managed to set up some development structures and concepts. Ric Day from Australia serving on the DIA Board and later as Board President was introduced to DIA following SCID activities. This committee was very successful in preparing the ground for future DIA development.
In terms of work, at that time I moved back to London and I joined the Medicines Control Agency, now called the Medicines and Healthcare Products Regulatory Agency (MHRA). I remained engaged with DIA as a regulator. In the meantime, the Central Register of Clinical Trials was incorporated in the new structure of the regulatory authority in Poland. I eventually left the MCA to go into my own consultancy.
During my time at the MCA, I continued to contribute and provide guidance to DIA sessions and workshops, and the Steering Committee, and I started chairing the EuroMeeting drug safety tracks. In 2003, I was a co-chair of the EuroMeeting in Rome that was a big success.
In 2004, I left the Steering Committee after two terms because that was the rule. But then the Board asked me to become Editor-in-Chief of the DIA Forum. The publication at that time was in the back pages of the quarterly membership newsletter DIA Today. I took the job seriously. Within three years, it grew and gained readership, and I proposed to the Board that it should be a standalone publication called Global Forum because we were expanding to other areas; the publication was growing, and DIA was moving more vigorously into Japan, China, and other areas as well.
DIA: You started this publication. Its name, Global Forum, was your idea. And you were its first Editor-in-Chief.
AC: Yes, it was my idea, supported by the Board, and the publication developed well. I was the first Editor-in-Chief until I was elected to the Board of Directors, which happened in 2013. As you know, the rule is that one cannot hold two positions in DIA, so I had to resign from the Forum, which was fine after running it for more than nine years. Nevertheless, I left Global Forum in good shape and it has developed even better since, and I continued to contribute to DIA while on the Board.
In the meantime, on the heels of my work at the MCA and in my consultancy, I joined Eli Lilly and Company, where I still am today. So, I went through the full spectrum of work activities, from academia to basic research, clinical medicine, international organizations (WHO, DIA, learned societies, etc.), consultancy, and finally to industry. This broad and vast experience provided me with a very good understanding of drug development from “cradle to grave,” which is very useful in my work and academic activities over all these years.
I was on the DIA Board of Directors for two terms–efficient, visible, and useful enough to be reelected for the second term in 2016. I do not remember the details, but I think it was early in this second term (so late 2016 or early 2017) when we were debating how to move forward in a difficult time. I organized two workshops for the Board of Directors in Washington. We had big sheets of paper all over the place and were wandering around and I said, “This is the only way we are going to move forward: We need to decide the three, four, maximum five major topics/areas we are going to concentrate on.” One of them was obviously regulatory science. That’s why we have our journal Therapeutic Innovation & Regulatory Science (TIRS). The other one was to adapt to the changing environment and move to web-based courses and other online offerings. I think this was my biggest achievement on the Board. This achievement was validated specifically during and after COVID, when people stopped traveling and wanted to have more web-based trainings and web-based courses. DIA was prepared to handle this in advance of this unexpected problem. The reason I’m saying that this was my main achievement is that during my farewell dinner, when the Board was saying “goodbye,” they specifically picked up on that. I must have done something good for them to remember it several years later!
DIA: You’ve been involved with DIA for three decades. Are there particular aspects of DIA’s history that you believe deserve special recognition or celebration?
AC: There are several things, but I wouldn’t pick a “winner” here. The highlight, I think, is the expansion of DIA. Remember the early 2000s, when DIA became the platform for the European regulators. Winning over the regulators in the early 2000s, when regulators convincingly started wanting to use DIA to share their experience, share the new laws and regulations, and use it as a well-established platform for communication and training. When I look back at the 1990s, DIA was a “bad boy” that no regulator wanted anything to do with.
DIA: Why was that?
AC: They were always saying “This is industry money. This is bad. We do not want to have anything to do with industry money.” I was telling them: “I pay my dues. This is MY money. I am not an industry person. I am a regulatory person, and I don’t feel that sharing the platform and working with people from different environments is wrong. I think it is right to sit at the same table and raise the same concerns (or different concerns) and come to a common solution.”
The thing that I value most about DIA is this common platform. Regulators finally understood and accepted invitations to speak at DIA meetings. We started inviting them, wanting them to contribute, to meet industry people and see that these people are not bad, that they actually have great knowledge that everybody can use and benefit from.
DIA: Was there a perception on the part of regulators that DIA was an industry group, like a trade association?
AC: Yes, for a very long time.
DIA: DIA was founded in 1964 as a neutral forum. That was in the DNA of the association. Did you find it surprising that regulators, 20 years later or longer, had a different image and perception of DIA?
AC: This is how I felt it, specifically in the 1990s, and that’s why I put a lot of effort into getting regulators in.
The change that helped this happen in Europe was setting up the first MCA (it was 1991) in the UK, and secondly the EMEA (now called EMA) in 1995, because they employed some ex-industry scientists or people directly from industry and saw that there was a lot of knowledge they could benefit from. Seating people from industry and government regulators at the same table finally started a good partnership. I understand what you are saying: DIA was created as neutral organization. But if you look back, nearly 90% of the members at the start of DIA were industry. An association wasn’t seen by regulators as “neutral” if nearly all its members were from industry.
DIA: It’s very important to understand how that happened and the evolution of regulators’ perception of DIA over time. In your observation, how do regulators look at DIA today?
AC: They now use it as a platform, as they should, I believe.
DIA: Do you continue to participate in or attend DIA events?
AC: I do not attend any of the big meetings anymore. When I stepped down from the Board, I decided that it’s time to make space for the new generation. I decided I shouldn’t get involved anymore and they should, as I did with my people in academia and in industry. My role as an academic was to develop younger generations, to help them get up to speed and get into the right positions and not to hold them off; if you hold them off too long, they find some other place to utilize their energy. I thought it was time to dissociate myself completely. I closed my attendance with DIA last November: Thirty years, because it was from November ’93 to November 2023.
DIA: You said that regulators now use DIA as a platform. This is really true. For example, at the most recent Global Annual Meeting in San Diego we had an FDA Town Hall, an FDA-EMA Town Hall, a PMDA Town Hall, a China Town Hall, and an ICMRA Town Hall, so senior regulators clearly show up at DIA, and they return year after year.
AC: This is, I think, one of the bigger achievements of DIA: Convincing the main regulators, the FDA and the EMEA (or EMA), PMDA of Japan, and now others, that this is the place where they should meet with industry and academics, where they should share, let people meet them, and meet the people who are the reason they are there. If there was no drug development, they wouldn’t be there. There would be no need for regulators, right?
DIA: Notably, DIA has for several years had a Council of Regulators, a Board-level grouping of regulators from many different agencies.
AC: I remember that we were creating it when I was on the Board.
DIA: Andrzej, we’re celebrating the first 60 years of DIA in 2024. You’ve always been visionary. What closing message or wish would you like to share with DIA and our members for the next 60 years?
AC: I think there is always something to learn from the past. Think about what was achieved under much different conditions. I will digress a bit: You and I remember EuroMeetings with only a couple of hundred people and annual meetings with only 1000 people, and they were considered a success, right? Now both are far larger. We’ve managed to grow and contribute so much.
It was volunteer work that contributed to other people who became volunteers themselves. So, think about what was achieved when you can pull together the energy of people. Think how to use it in a positive way, how to draw from it, and how you can better contribute to healthcare, to patients.
Because this is what we are for, not only in the industry and regulatory worlds. The variety of scientists, the statisticians, the people that develop new equipment, they are all with us because we managed to attract them in the past. Take good care of it all and look forward to new developments. Don’t miss the opportunity to lead important things for society and patients.
DIA: You’ve noticed, no doubt, that DIA now has a more explicit focus on the welfare of the patient. From your standpoint as a somewhat external observer, is this a good thing?
AC: It is. I can tell you exactly what I told regulators in Europe. You need to think: What is the mainstream? Do not use niche groups of patients to represent all patients. I said to regulators in Europe: Get me someone with metabolic disease, someone with hypertension, get me someone with pulmonary disease, cardiovascular, because then you will have 60% or 70% of patients covered. I know that niche diseases are important. They cost a lot of money to treat. They represent a very vocal, small group of patients and they are very visible, easy to find and work with. They should be there, but they should not be the only ones.
I’m still a practicing physician. If you go to the hospital, who do you see? You do not see a single individual. You see the bulk of patients with most of the diseases, and this somehow should be addressed. To tell you the truth: I don’t know how, but I think that we missed the point. We as DIA or we as regulators, at a certain point in time, should have had five or 10 representatives of patients instead of one or two with a specific disease. Because they were representing their own niche group of patients, instead of the patients that we are supposed to take care of: All of them.
DIA: There are more than 7000 rare diseases in the world. In your observation, as an experienced physician, what is the best way to represent the voice of the patient, given the enormous number of different diseases in the world? What is the voice of the patient, and who has the right and the ability to express the voice of the patient?
AC: I wouldn’t use the word “right,” because every patient has the “right.” With 7000, you cannot have all of them. But you should rotate, or if not rotate, pick and choose a patient from a different rare disease every few years. But at the same time, you should choose a couple of patients from the most prevalent diseases, the ones that represent the bulk of patients in a hospital. These are the people affected by everyday use of syringes, needles, treatments, equipment, etc. Rare diseases are important, but they are rare. And I’m not saying there should be a lower degree of interest in rare disease. I’m saying all of them should be there.
DIA: You will have noticed that a number of organizations have recently created the role of Chief Patient Officer. What is your opinion of that role?
AC: I don’t think that industry ever failed to look at patients, because this is what industry is for: to find and properly deal with the “target population.” But it’s always important to have someone deal with it not from the health perspective or marketing perspective but as the whole picture. So maybe the Chief Patient Officer should be the person that sits down with the marketing people, the development people, the manufacturing people, the device people, and whatever other people, and patients, to get the best outcome for them. This is why they should be there, and their role should be a normal role like everybody else: not any better, not any worse, but someone combining all important aspects for patients’ benefit.
You’ve been involved in clinical trials all your life. Maybe I’m guessing, but this is what I remember: I don’t believe any of the people involved in drug development or clinical trials ever forgot about the patient. Never, ever. Like me as a practicing physician. You do not need a special role. But you need someone who will look at other aspects that the people directly involved may not consider, because it will never cross their minds as there are other people who take care of it. I think this role is a good concept.