Kelly Gelinne, our Associate Director of Marketing, sat down with Bill Wargin, Ph.D., to learn more about his experience, favorite projects he’s worked on at Nuventra, and how drug development has changed during his 30+ year career.
Bill, one of Nuventra’s co-founders, has more than 30 years of experience working in clinical pharmacology, pharmacokinetics, biopharmaceutics, and scientific writing. In his career, Bill worked on over 20 approved drugs and authored or co-authored over 30 journal articles in pharmacokinetics and biopharmaceutics. Before he became a consultant in 2001, he served as an International Director at Glaxo Wellcome in Research Triangle Park (RTP).
While Bill has improved patient health by bringing numerous drugs to market in the course of his career, his mentorship to the many scientists he has worked with has expanded his impact and scope of influence in the pharmaceutical development world. Thank you for joining me today, Bill!
Bill: Thank you, Kelly for giving me the opportunity.
Kelly: Let’s jump into our 5 questions to learn more about you.
Tell us about your career path and how Nuventra was founded…
Bill: Certainly. I’ve had a really interesting career and as you alluded to earlier, a long career. I decided to pursue a career in pharmacy 2 years into college. So, I got a BS degree in Pharmacy at the University of Minnesota and was initially planning to practice pharmacy either in a retail setting or in a hospital setting, but in my senior year, I got really interested in pharmacokinetics. It was a fairly new discipline at that point in time and I decided to take a stab at getting a Ph.D. by going to graduate school at the University of Minnesota in pharmacokinetics. Fortunately for me, there was a new person who had just joined the faculty—a guy by the name of Ron Sawchuk. Ron had just gotten his Ph.D. in pharmacokinetics from University of California-San Francisco and I was his first graduate student. It was really a great opportunity—Ron tutored me immensely in the area of pharmacokinetics.
At that time, in the early/mid-70s, many of the equations in pharmacokinetics were being derived, so there was a lot of literature and it was really an interesting time in that field. I think that the other thing that happened in the 70s was new developments in bioanalytical techniques that permitted us to measure drugs in biological fluids that we really couldn’t do in the past. From there, after I got my Ph.D., I spent 5 years teaching in the pharmacy school at UNC, so I ended up in North Carolina. Following that 5-year period, I got a job at Burroughs Wellcome in RTP and had an opportunity to work on a large number of drugs there—that was in 1983. In 1995, when Glaxo and Burroughs Wellcome merged to form Glaxo Wellcome, I stayed on and that’s where I became the International Director of Oncology and Critical Care and was head of the group responsible for introducing Glaxo Wellcome cancer drugs into first-time-in-humans, so it was a very interesting job.
In 2001, at the time of the merger between Glaxo Wellcome and SmithKline Beecham to form GSK, I was able to take early retirement and at that time decided to begin a consulting business as a pharmacokineticist. Fortunately, there were quite a few opportunities because there were lots of mergers going on, but I was one of the first ones to go out and start as a consultant, so there was no shortage of work. I worked on quite a few drugs from 2001 to about 2006. When I met Geoff Banks—Geoff was working at a local CRO here in North Carolina and we worked together on some Phase I studies. Geoff was interested in consulting as well, so we formed a company called ClinPharm Consulting, with the two of us, in 2008, and Nuventra has been growing since that time. So, that’s how Nuventra was founded.
Kelly: That’s an impressive career and we are very grateful for you creating Nuventra and all the growth that we’ve seen. And now, your official title is Chief Purveyor of Pharmacokinetic Knowledge, correct?
Bill: That’s correct.
Kelly: I love that.
Do you have any favorite projects you’ve worked on during your time with Nuventra?
Bill: Well, I have to say I’ve probably worked with hundreds of drugs in my entire career in pharmaceutical research and development and I think that I have to actually go back to Burroughs Wellcome to talk about 2 or 3 drugs that I worked on there. I think for anybody who’s working in pharmaceutical development, some of the best drugs/projects are the ones that ultimately get approved and meet an unmet medical need, and fortunately, I worked on a drug called LAMICTAL® which is widely used today in epilepsy. I worked on a drug for pediatric acute lymphocytic leukemia that was approved, and I worked on several neuromuscular blockers for surgery that ware approved. Those tend to be my favorites because they were approved, but when I started consulting, I transitioned from working in big pharma to working with a large number of small pharmaceutical and biopharma companies and, of course, Nuventra today is working on several—probably several hundred drugs. So, it’s a little harder to pick a favorite from Nuventra.
Again, the favorites are those who get approved, but I think the ones that I enjoyed working on the most were the ones where I was involved as a key member of the project team. Drug development is very project team-based. There are various disciplines: clinical, CMC, toxicology, and these various disciplines come together including clinical pharmacology and pharmacokinetics. The ones that I enjoy the most are the ones where I can work as a member of a team. Most of my Nuventra projects have been teamwork and it’s hard to pick a favorite because there’s been so many. But again, favorites are usually the ones where I work in a team and the ones that have a really interesting pharmacokinetic situations. In pharmacokinetics, there’s a lot of problem-solving and there’s a lot of distillation of large amounts of data into understandable knowledge that can go into a package inserts. So to me, that’s what makes it interesting—is that type of work.
How would you say that drug development has changed during your 30+ year career?
Bill: I think one of the main things—and I guess it’s kind of parallel to my career in a way—is that much of drug development and drug discovery now has transitioned from large pharmaceutical companies to small biotechs.
The growth—there’s literally hundreds, maybe thousands, of small biotech companies in the US and around the world. In many cases now, the discovery of drugs is happening in small companies, and then large companies typically get involved with those small companies to develop the drugs and spend the kind of money that it takes to conduct large clinical studies. So, that’s the main thing that I think has changed.
In addition to that, there’s sort of been a change as well in the mentality around what types of drugs to develop. Back in the days, when I was working in big pharma in Burroughs Wellcome and Glaxo Wellcome, the idea was to try to get “blockbuster drugs,” meaning drugs that bring in huge amounts of revenue—but those are few and far between. I think one of the things that we see now is more and more focus on drugs that may not have as large of a population, but meet an unmet need, and I think that’s a change.
I think another thing that has changed is—of course the regulatory environment. I think that there’s probably more regulation today than there was when I started drug development. I started before GLPs (Good Laboratory Practices) and other guidances by FDA and other regulatory agencies. Overall, when I think about FDA in particular (and I’ve had a lot of interaction with FDA), I think FDA has definitely improved over the years. I think the people at FDA are all very dedicated and I think sometimes they get kind of a “bad rap” because they’re a government agency, but my interactions have been fantastic. I think the quality of staff at FDA and the willingness to work with pharmaceutical companies in drug development has been a big improvement.
What advice would you give a new scientist in this industry?
Bill: I really enjoyed being an Assistant Professor at the University of North Carolina, where I had 4 or 5 graduate students that worked with me—I enjoyed that very much. But then I decided after a few years that there were limitations in working in academia because it was difficult to get grants, so I made the move to the pharmaceutical industry, and that opened up a whole world of opportunities for me.
Fortunately, the company that I started working with (Burroughs Wellcome) was viewed, at that time, as an academic style pharmaceutical company. Wellcome was a UK company and was owned by the Wellcome Trust, so we were basically a research organization and not necessarily a marketing organization. I think that because of those experiences and when I started my consulting business, I learned so much about drug development that I couldn’t have learned otherwise. I think that for a new scientist the key is to try to learn as much about drug development as possible.
If I were to give advice to a student who hasn’t decided on a career path, I would certainly recommend pharmacy, but also, there are so many different disciplines that are required to develop drugs that people with very varied backgrounds in biology, in mathematics, in engineering—they can all find a place to work in drug development. One of the things that I pride myself on at Nuventra is that we not only hire people with pharmacy backgrounds, but we hire people with various scientific backgrounds (very bright, young, and freshly minted Ph.D.s). For me, I get a lot of pleasure out of seeing them develop and learn about drug development by doing it with people at Nuventra that have more experience, so I think that would be the main thing—to try to learn as much as possible about the process of drug development.
I think the other thing is that drug development is such a large discipline. There are so many activities involved and I think it’s a good idea to become a specialist in a particular area. It could be a therapeutic area, it could be learning how to be an expert pharmacokinetic analyst, or learn to be a programmer to work in the area—I think there’s a lot of opportunities, but I think being a specialist in one is very helpful.
I also think having opportunities to interact with FDA, if those are available, are great learning experiences. I would highly encourage people to try to get that experience. And, of course, working in project teams. The project team, again, is the machine that develops drugs and I think that getting into a project team and participating in that way is a great experience.
Kelly: Great. Yeah, I know that we offer a lot of that hands-on experience at Nuventra, and like you said, to those new Ph.D.s, that would really give them a nice introduction to the industry so, thank you for that, Bill.
Is there a therapeutic area that you are particularly passionate about?
Bill: It turns out that the first project that I worked on at Burroughs Wellcome was an alpha interferon for an oncology indication. So this alpha interferon was one of the early versions of alpha interferon (Wellcome product) and I spent a fair amount of time working on that, in addition to other oncology projects. Burroughs Wellcome had many cytotoxic anticancer agents at that time, so I’ve been passionate about working on oncology.
Ever since, I’ve probably worked on 30-40 oncology drugs, but the other area that’s of interest to me is the neuroscience area, and I think that’s because of my initial work on the epilepsy drug LAMICTAL®. But out of the numerous drugs that I’ve worked on in my career—one of them that got approval was an extended release clonidine to treat pediatric ADHD, so that was also nice to see an approval like that in a childhood disease.
Those are probably the two main therapeutic areas that I’ve enjoyed working in. But, I’ve dabbled in pretty much every therapeutic area around including antivirals and cardiovascular. I think that’s one of the interesting things about being a pharmacokineticist is that its really not necessarily all that therapeutically-based because almost all drugs require some pharmacokinetics and so we get an opportunity to work on a wide spectrum of drugs.
Kelly: That’s great. Thank you, Bill.
Kelly: Well, it’s always wonderful to chat with you. We always like to end these interviews on a lighter note to get to know you on a personal level. So, would you be willing to share a fun fact about yourself?
Bill: Sure. I think this is a fun fact because it actually affects my life today. It’s about my grandmother on my father’s side. So, my grandmother was half Irish and half French-Canadian and, for whatever reason, that mixture caused her to be a fascinating person who especially loved to travel. So, my grandmother kissed the Blarney Stone in Ireland when she was about 90 years old—she hung down and kissed the Blarney stone—and she lived to be 110. And so, I think that I’ve inherited her curiosity and I love to travel and love the idea of traveling as much as the experience itself, so that’s the fact that I’d like to share.
Kelly: That’s great. I love traveling too and boy, do I miss it these days. It’s a tough time for us travelers. Thank you so much, Bill. It’s been such a pleasure chatting with you.
Bill: Thank you, Kelly.
Kelly: If you have any questions for Bill or for any of our other consultants, please don’t hesitate to contact us.