Kelly Gelinne, our Associate Director of Marketing, sat down with Suliman Al-Fayoumi, Ph.D., M.B.A., who recently joined Nuventra as a Senior Clinical Pharmacology Consultant, to learn more about his career path into drug development consulting, his predictions for the future of drug development amidst the COVID-19 pandemic, insight into what often gets overlooked by Sponsors, and more. Listen to Kelly’s interview with Suliman above or read the transcript below.
Kelly: Today I’m here with Suliman Al-Fayoumi, who recently joined Nuventra as a Senior Clinical Pharmacology Consultant.
Suliman has over 20 years of experience in regulatory science and the pharmaceutical industry. He has experience in clinical pharmacology, biopharmaceutics, pharmacology, toxicology, and translational sciences. Suliman spent 8 years as a Senior Clinical Pharmacology and Biopharmaceutics Reviewer at the FDA. He also spent over 4 years at Novartis Pharma and 8 years at two small biotech companies. He has extensive experience in designing, executing and overseeing nonclinical and clinical pharmacology study protocols, reports, and programs. He has supported several regulatory submissions in his role as a consultant and has extensive experience interacting with key regulatory authorities including the FDA, EMA & PMDA.
Welcome, Suliman. Thank you so much for joining us today.
Suliman: Thank you, Kelly. Glad to be here.
Tell us about your career path. You started at the FDA, how did you end up as a consultant?
Suliman: A wise man once said, “A mind that is stretched by new experiences can never go back to its old dimensions.”
I honestly don’t believe anyone sets out the gate with the goal of ultimately becoming a consultant. It is really the cumulative experiences and knowledge that one amasses throughout their career that eventually lead in that direction. I’ve always been personally driven throughout my career by the desire to add value in any given role. So, following careers at FDA, large pharma, a couple of small biotechs, and academia as an adjunct professor, I started contemplating the next stop in my career path and I began thinking seriously about consulting at the time.
So, the opportunity presented itself several years ago when I was approached by an ex-colleague at a startup biotech company that was looking for urgent support with a challenging clinical development program and that was really the start of my consulting career. I eventually decided to take the plunge and took up consulting on a full-time basis a few years ago and I have to say, I have not looked back ever since.
Kelly: That’s great. Well, we are certainly excited to have you onboard at Nuventra.
Suliman: Thank you.
In your experience, what do you predict for the future of drug development in the next 10 or 20 years?
Suliman: I wish I had a crystal ball, but notwithstanding the COVID-19 hiccup right now, which really has thrown a curve ball to the industry and also globally to the economies as well, I would say that we truly are in the midst of an exciting era that is rapidly shaping all facets of drug development. I think the novel approaches such as adaptive trial design, real world data, precision medicine trials, among many others, will ultimately become standard components of the drug development paradigm.
I also think that the digital age and the innovative drug discovery technologies such as artificial intelligence will also play crucial roles in revolutionizing drug development and driving down the spiraling drug development cost. Personally, I also believe that there will ultimately be greater reliance on biomarkers and surrogate markers to support clinical efficacy and safety data packages in order to gain regulatory approval. I think those are exciting times despite, you know, the current challenging conditions, but I think the outlook is definitely pretty exciting in the next decade or two.
Can you talk about something that is often overlooked by Sponsors? Perhaps in a certain phase of development?
Suliman: I mean, I can talk for hours about this particular topic. I’ve seen my share of issues consulting for numerous small biotech companies, but if I have to choose, one area I have consistently seen Sponsors overlook is really exposure-response analysis to guide dose selection in Phase 2/3 clinical development and to support regulatory filing for NMEs and NCEs.
That is, in my opinion, a crucial bridge that allows linking systemic exposure to safety and efficacy for any given systemically acting product. Unfortunately, many pharma players—particularly the smaller companies due to a multitude of reasons—tend to overlook that. Many of them end up regretting overlooking exposure-response analysis in development.
Another facet that’s often overlooked is, in my opinion, the development of biomarkers and surrogate markers that can serve as critical supporting evidence for safety and efficacy outcomes. That is definitely a key issue that many companies fall short on.
Is there a certain therapeutic area that you feel particularly passionate about?
Suliman: This is a tough question. I’m personally typically drawn to projects where one can add value and make a difference rather than to specific therapeutic areas. If I had to choose a therapeutic area, I would pick oncology. On a personal level, I have close family members that have been touched by this awful disease.
This is also an area of great unmet medical need—arguably, the greatest unmet medical need out there today. Of course, tremendous strides/advancements are taking place in the field of oncology therapy. There’s tremendous innovation which requires close collaboration amongst all relevant scientific disciplines, including clinical pharmacology, to help bring novel life-saving products to the market.
Kelly: Yeah, I think a lot of people can relate to that sentiment. So, let’s talk about current events.
How do you think COVID-19 will impact the future of drug development?
Suliman: Boy, that is a huge question right there. I mean, COVID-19 has really impacted all aspects of the drug development industry on a scale never seen before. In the short term, COVID-19 has resulted in diversion of resources toward drug development to combat COVID-19, which ultimately has caused disruption of drug development in general. Of course, one should also be mindful that the economic and social impact has forced many small biotech companies to shelf or push out clinical development timelines for novel and exciting investigation products.
CROs as well and clinical sites have had to reduce their capacity to conduct clinical trials—so everybody across the board has been adversely impacted, unfortunately. In the long run, I think the pharmaceutical industry will need to adapt to the new reality and will need to become more agile and efficient at running clinical development programs. I think drug development will likely become more costly with more protracted timelines. Nonetheless, one should never underestimate the human spirit and ingenuity. I believe that the pharmaceutical industry is resilient and it will ultimately evolve to meet the COVID-19 challenge.
Kelly: Thank you. I appreciate that positivity. So, before we close this out let’s throw in a bonus question so we can get to know you on a personal level.
Kelly: Can you tell us what you do in your free time?
Suliman: I have limited free time, to be honest, but during my free time before COVID-19 came along, I enjoyed playing soccer. I actually played on the local amateur team in the area and continue to play it every now and then—not for the past few months, of course. I do enjoy traveling as well. I like to travel, particularly Europe—that is one of my favorite destinations. I’m sure a lot of folks that enjoy traveling have been deprived of that joy. I think over the past few months, we hope that things get better soon and everybody is back to their normal habits.
Kelly: I agree. I hope we can all get back to traveling soon, myself included. Well, thank you so much for your insights today. It was really great talking to you.
Suliman: My pleasure. Thank you, Kelly.
Kelly: If you have any questions for Suliman or for any of our other consultants, please don’t hesitate to contact us.