By: Ebey P. Soman
Dr. Abu Serajuddin is a true inspiration for student pharmacists who wish to enter the pharmaceutical industry setting. He attained his Bachelors of Pharmacy with honors at Dhaka University in Bangladesh and majored in Pharmaceutics to get his Master of Sciences degree at Columbia University in New York. He obtained his PhD in Industrial Pharmacy at our very own St. John‘s University in 1982. Dr. Serajuddin then went on to work at Revlon Health Care, which became Sanofi-Aventis through mergers and acquisitions. He later joined Bristol-Myers Squibb for around 9 years and was a three-time recipient of the BMS President’s Award. He also received the Productivity for Growth Award in recognition for his work.
Through hard work, he became the Associate Director for early phase drug development. He was responsible for the accelerated development of new drug candidates (non-biologicals) from Drug Candidate selection to Go / No Go decision for Phase III clinical testing. Dr. Serajuddin was also the Chair for Preformulation Focus Group and Pharmaceutics & Drug Delivery Section at the American Association of Pharmaceutical Scientists (AAPS). In April 1999, he became Executive Director and U.S. Head of Pharmaceutical product development at Novartis.
In 2003, Dr. Serajuddin joined the Long Island University (LIU) as an Adjunct Professor and taught classes in Integrated Drug Product Development Process. In August of 2003, while still at LIU, Dr. Serajuddin became the Executive Director and Global Head of Science and Technology Forum at Novartis. He joined St. John‘s University (STJ) as the professor of Industrial Pharmacy in 2008, teaching various courses such as Pharmaceutics I & II, Pharmaceutical Materials, and Industrial Pharmacy. While teaching at STJ, Dr. Serajuddin received AAPS Research Achievement Award in Formulation Design and Development, one of the highest awards given by the American Association of Pharmaceutical Scientists (AAPS).
Some of our well-known Teaching Fellows (Anuprabha Meena, Amol Batra, and Simerdeep Singh Gupta) work in Dr. Serajuddin‘s laboratory. The lab facilitates research that improves drug bioavailability via drug formulation techniques. These include enhancing the rate of solubility of poorly water-soluble drugs, stabilization of the amorphous drug structure, examination of the salt forms, and the development of novel dosage forms.
This month, I had an opportunity to speak to Dr. Serajuddin and explore some of his accomplishments. His words will hopefully inspire the future generation of pharmacists interested in the pharmaceutical industry.
Q: You attended the University of Pisa in Italy; how was your experience there?
A: I was the Winner of an International Merit Scholarship from the Government of Italy which enabled me to attend University of Pisa in Pisa, Italy. I applied for the scholarship when I was doing Bachelor of Pharmacy in East Pakistan (now Bangladesh). It was a two year scholarship, but I had such an interesting time there. At that time, when you finished your bachelor’s degree, your title was “Doctor.” Any further education beyond the four years was considered a “specialist” in Italy, but this system was not recognized in the rest of the world. This prompted me to apply for a school in the United States, and I was able to get into Columbia University.
Q: What was one big project you worked on during your time in the Industry?
A: I helped initiate the formulation of the drug known as Gleevec (imatinib). They discovered the compound, and it was given over to my development department. The company had two development sites: one in Switzerland and one in the United States. The project was assigned to me, and I developed the first formulation that worked miracles during the clinical testing. Quickly, the news of the drug spread, and patients with leukemia were pressuring the company for the release of the drug. It takes over a week for raw materials to be processed and transported from Switzerland to the United States for development, but since there was so much public interest in the drug, the company decided to expedite the drug development process. Thus, the project was transferred to Switzerland to reduce the development time. I also worked on Diovan (valsartan) and numerous other projects during my time in the industry.
Q: Do you see any concerning trends in the Pharmaceutical Industry?
A: One alarming trend in the United States is how so many pharmaceutical companies are closing or going out of business. This begs the question: why are they being forced to close? Companies that were big names, like Upjohn (which had over 34 patented drugs on the market), Burroughs-Wellcome, Schering-Plough, and many others, do not exist today. They simply went out of business or were forced to merge with large companies like Pfizer or GlaxoSmithKline. This is alarming because we have fewer players in the pharmaceutical market, which may be indicative of increased competition from generic companies and the difficulty that companies have in being economically sustainable.
Q: Do you see generic companies as problems or solutions to drug development and innovation?
A: Well as I mentioned earlier, the pharmaceutical companies are having a difficult time already recouping the costs of research, which makes it harder for them to be economically sustainable. This may be a reason why many drug companies went out of business in the United States. I actually wrote a published article discussing this same issue in great detail. Drug companies have 20 year patent life, but 10 to 15 years of that time is spent researching and developing a drug that may not be clinically viable. Thus, the time and money placed into the development may be wasted. Even after companies finish making a product, they only have 5 to 10 years to market the product before the patent expires. When the patent does expire, pharmacists generally dispense the generics due to the law or due to the cost effectiveness; so, the companies are forced to calculate the price to recoup their research costs within the limited amount of time left before the patent expires. This is the reason why brand name drugs tend to be expensive and once a generic is available, the brand product is rarely sold. So, the company with the brand name product is slowly forced out of the market, and may even go out of business, as seen with Upjohn. This phenomenon is also driving U.S. Pharmaceutical research and innovation down, especially as companies find it easier to simply modify an existing drug to continue to keep it a brand name drug (rather than to research and develop a new product).
Q: How would you suggest we fix this problem? Should we modify patent expirations?
A: Changing patent length, on a broad basis, is not a feasible option for this problem. For example, Intel chips have patent, but when it expires, there is no “generic” Intel chip for that chip maker to compete with. So, changing the patent length is meaningless for that industry. Unlike other industries, in the pharmaceutical industry, the patent length can have a huge impact on drug development and drug market share. The government has to specifically address this problem and create new legislation targeting this sector of industry (instead of trying to institute a broad general law that may not be viable for the pharmaceutical industry). Another solution is that when a patent expires and a generic drug is marketed, the generic companies should pay a small royalty fee towards the brand name manufacturer. But, then, what would be a fair royalty fee? Would it be enough? Is this a sustainable practice?
Q: Wouldn’t a royalty fee raise prices?
A: Yes, it may raise the prices slightly, but it is not significant. For example, captopril tablets used to sell for two dollars, but now it sells for ten cents. If you were to put a ten percent royalty fee then 10% of ten cents is one cent. So, the overall raise in price would be 1 cent, and the price would become 11 cents. This is the price before the retail pharmacy markup, and it may provide a way for brand name companies to be more sustainable. Unfortunately, this is a very complicated issue with no clear answers.
Q: Do you have any predictions about the future of the pharmaceutical industry?
A: Currently a majority, around 70%, of the prescriptions dispensed are generics. In the future, we will not have too many patented products. At one time, we used to have over 20 new drug products coming to the market, but that rate has dropped sharply to about 10-15 products. This indicates a decrease in innovation; and around 80-90% of the drugs on the market will be available generically. Generic companies will dominate the market and compete with each other, while big companies will slowly disappear.
Q: What made you leave the industry after an almost-30-year career?
A: My whole life, I was thinking that I needed to do more research and join the academia. However, this was not possible because job openings for a faculty position are rare. Although it was hard to make the transition, it was always my dream to teach. In 2008, an opportunity arrived from St. John’s University. For a long time, I drove almost 45 miles to my work in New Jersey, and, here, I was being offered a job at a prestigious university literally 3 miles from my house. This was an opportunity of convenience and a fulfillment of my lifelong dream; these factors helped me make the decision.
Q: What advice or recommendations would you give to Pharmacy students interested in the pharmaceutical industry? What opportunities are available for pharmacists?
A: The industry has many opportunities. At one time, most of the scientists in product development were pharmacists. However, over the last two decades, our pharmacy education focus has shifted from the basic sciences to the clinical aspect. This is a driving factor in the reduction of the number of pharmacists in the industry. For product development, a pharmacist needs a strong foundation in pharmaceutics and mathematical calculations, but the main problem is the starting salary. Many pharmacy students do not want to go into product development because of the initial low salary rates. The salary varies, but it is around $70,000 for starting positions.
There is actually a great opportunity for pharmacists in clinical research, though. The clinical research is conducted mainly in hospitals all over the world; so, the pharmacists are in a great position to be successful in this area of work. With our education, we have well-rounded clinical knowledge that is essential for research. The pharmacists here will generally be involved with designing project protocols and monitoring ongoing studies. They are the onsite project managers of sorts and also visit clinics to carry out projects. You generally work together in a team of two to three pharmacists and one to two doctors.
There is also the marketing division. Pharmacists are involved with verifying and approving drug information, checking the reliabilities of statements, and providing research data for product promotions. You also have administrative opportunities open in companies for pharmacists. These are just a few opportunities in the industry, but they all provide an avenue for success. Your success depends on how well you network with fellow professionals and researchers, and there is no limitation on how well you can do in this setting.
Q: Would you recommend a fellowship for pharmacy students interesting in joining the industry?
A: Absolutely! Doing a fellowship is a great opportunity for students to begin networking with fellow professionals early on. One program I recommend is administered by Rutgers University, known as the Rutgers Pharmaceutical Industry Fellowship Program. You also gain experience in the division you want and get to see if clinical research, marketing, or product development is right for you. Another avenue for networking is the St. John’s Alumni office. You can find already-established alumni to mentor you and possibly gain an opportunity for research, fellowship, and internships.
Q: How are you working to expand the industrial pharmacy program at St. John’s University?
A: On campus, we have a graduate research program for industrial pharmacy already. We needed a new state-of-the-art facility to do research and work in collaboration with pharmaceutical companies for product development. It was actually Dean Mangione’s idea for this new facility – he and I raised over half a million dollars from St. John’s alumni and pharmaceutical companies for the remodeling of an existing laboratory into a full pharmaceutical processing pilot plant. The construction of the facility completed in January 2011. Currently, we are working on raising funds to purchase the necessary equipment for the plant. Once completed, the new facility can host training programs for new scientists at industrial companies, as well as develop and research new drug formulations, while in compliance with existing standards and regulations. Through this new facility, we can also train our St. John’s University students in necessary skills and experiences needed to be readily-appointed to lead research positions in the industry. We can also run programs for retraining and skill development, along with courses for industrial professionals on campus. I thank Dean Mangione for being very supportive of this idea and for working on this project.
You can find Dr. Abu Serajuddin in St. Albert Hall, Room G012. He is currently working on the problem of sustainability in the pharmaceutical industry with Michelle Pernice, PharmD Candidate c/o 2012. Dr. Serajuddin is also a 1975 Rho Chi member from Columbia University College of Pharmacy. He has 11 students working in his lab currently and would love to have a Pharmacy student participate in his research.
You can reach him by calling his office phone (718-990-7822) or sending an email to: [email protected].