Kelly Gelinne, our Associate Director of Marketing, sat down with Betty Hussey, Pharm.D., Nuventra’s Vice President of Clinical Pharmacology and Pharmacokinetics to learn more about her experience in drug development, favorite projects she’s worked on, and some of her thoughts about upcoming changes in drug development. Listen to Kelly’s interview with Betty above or read the transcript below.
Betty has over 30 years of extensive leadership and experience in clinical development, clinical pharmacology, and pharmacokinetics. Betty received her B.S. Pharmacy and Pharm.D. degrees from UNC-Chapel Hill and completed a 2-year drug development fellowship with UNC/Glaxo.
Her work spans across many therapeutic areas and she has worked in all phases of development—from candidate selection to post-marketing commitments. Betty spent most of her career at GSK, where she held various management and team leadership roles including early development lead for a number of assets. Prior to joining Nuventra, she worked at Brickell Biotech as VP of Product Development. In her career, she has worked on numerous INDs, first-in-human trials and about a dozen approved drugs; she has conducted more than 100 international and domestic clinical trials and has more than 40 publications in peer-reviewed journals.
What’s your favorite type of project that you’ve worked on at Nuventra?
Betty: That’s a really good question. I like them all, but the ones in which I can be engaged with the teams and contribute to the overall group thinking versus being solo for a single task are at the top of my list.
The model at Nuventra allows for embedding a clinical pharmacologist into a project team to represent the clin pharm function, which is really important for all stages of product development. I really enjoy digging into the science and helping to form a solid development plan—obviously the clin pharm plan and how it fits into the clinical plan as well. I have experience from candidate selection all the way through launch and post-marketing commitments, so I’m happy to contribute at all stages, as clin pharm should be considered at all stages of development.
What major changes do you predict will occur in drug development in the next 10-20 years?
Betty: And that’s another really good question. If you actually look back over the past few decades, the industry is certainly selecting better druggable compounds. When I first started in the business a couple of decades ago, PK was actually one of the main reasons a compound failed—either due to lack of bioavailability, DDI [drug-drug interaction] liability, or just not simply getting the dose right. Currently, many drugs still fail too late in the overall process following costly patient trials.
Moving forward, better tools are needed to predict target engagement—whether it is an established biomarker or exploratory gene expression. And, obviously, early PKPD modeling and simulations can really help to identify the target exposure and, therefore, the dose. Taking advantage of modeling in drug development to avoid costly and long studies is something that I think we’ll see much more of here in the very near future. Also, in many therapeutic areas, I think combination therapies are going to be needed to improve outcomes. I think an early assessment of the PK characteristics such as the DDI potential is really critical for those to succeed. I also see a lot of repurposing of compounds and I think that’s going to continue to expand the indications and/or delivery by more efficient routes.
What advice would you give to a new scientist in the industry?
Betty: This is a fun question. I think, obviously, experience is a really great teacher so I would advise you to learn all you can from your more seasoned colleagues. Don’t be afraid to ask questions and don’t be afraid to take on new opportunities. I’ve always approached my career moves by keeping sort of one foot in a comfortable space while testing the waters with my other foot. I consider myself a drug developer first with one foot in clinical pharmacology and the other learning various therapeutic areas and ways to develop drugs. I think that the most important thing is to always look to learn from your experiences, even your failures.
Can you talk about something that is often overlooked by sponsors and in a certain phase of development?
Betty: Well, getting the dose right and understanding exposure-response as early as possible in the drug development process is just key. Too often, companies go and they fix a tablet size and don’t give much flexibility into the clinic. Very often, we try to make the trials fit the tablet size and the dose, and sometimes even when you’re very efficient at putting your solid dosage form together and you do it in first-in-human, you might even realize with the first dose that you’re off quite a bit. So you’ve got subjects, and hopefully not patients, taking multiple tablets in the wrong strength.
I think engaging your clinical pharmacologist more to help pick that dose before decisions are made about how to dose, dosage strength, tablet and capsule sizes, and what-not is really key. Allometric scaling is a very useful approach to selecting a starting dose in a first-in-human trial. The data generated in humans should really dictate the dosing beyond the first dose, and you need to have that flexibility in your development.
What do you enjoy about life as a consultant at Nuventra?
Betty: Oh! The things that really come to mind are the variety in the projects that I get to contribute to, how different companies build their models of how they want to develop their products, and the opportunity to work with other top-notch scientists both within Nuventra, as well as within the client companies that we support—those are just really up there on my list of enjoyables. A lot of the scientists that I work with now I also have known from other environments. It’s really a nice thing when maybe they’ve moved from one company to another, but they’re still calling you to be their clinical pharmacologist. It’s really nice to build those relationships, to have built the trust through working with someone, and for them to acknowledge you in that way.
I think also another thing that I really, really enjoy is the opportunity to problem-solve. Sometimes we get situations that require our expertise, and we have to come up with creative solutions. At Nuventra, we can put a team on it as we need to, so you’re not just getting one scientist: you get the benefit of everyone’s experiences.
Kelly: Alright, we’re going to throw in one bonus question to get to know you on a personal level, tell us one fun fact about you.
Betty: Okay, well, I am a Tar Heel. I was Tar Heel born and Tar Heel bred. However, I did grow up in a Duke household. My mom and dad both went to Duke. My dad was a pediatrician, my mom was a pediatric nurse, and I come from a family of health professionals. In addition to my parents, I have two brothers that are physicians. My father was one of 5 brothers that were all physicians, as was my grandfather. However, I am the only pharmacist in my family, so I still needed to kind of fit in but still be different. Especially being able to pursue a career in drug development, you know, having come from that environment growing up has helped me in my career, so that’s a little fact about me.
Kelly: Have they forgiven you for going to UNC?
Betty: Yeah, it does get difficult around basketball season but you know, we do what we can!
Kelly: Well, thank you so much for your insights today, Betty.