By: Ebey P. Soman
Meet Dr. Parnali Chatterjee, a new faculty member in our St. John’s University family. I had the opportunity to meet Dr. Chatterjee at the doctoral seminar hosted by Dr. Lin Mantell entitled, “Drug Metabolism and Pharmacokinetics in Drug Discovery and Development.”
I was introduced to Dr. Chatterjee through Dr. Frank Schanne, and had the wonderful opportunity to speak to her about her professional background and her vast experiences in industrial pharmacy. What better way to welcome the new Assistant Professor in the Department of Pharmaceutical Sciences than to be featured in Rho Chi Post?
Dr. Chatterjee is a pharmacist from the University of Mumbai. She attained her PhD in Pharmaceutical Sciences from the University of Louisiana at Monroe. She majored in Natural Products and Medicinal Chemistry. Dr. Chatterjee began to focus on isolating and identifying metabolites derived from bacteria and fungi. She worked at the University of Utah as a postdoctoral research associate, focusing on drug-drug interactions, especially in the pediatric patients. She joined Hoffmann-La Roche in 2003 where she started her first industry job in the Non-Clinical Drug Safety Department as a Drug Metabolism (DM) project representative and worked in her research role developing in vitro – in vivo correlations for various compounds. Dr. Chatterjee then joined Celgene Corporation in 2006, and continued her work in Drug Metabolism and Pharmacokinetics (DMPK) and bioanalysis of drug metabolites.
Soon afterwards, she worked for one semester at Kean University to familiarize herself with the academic field and to see if it was something that interested her. Dr. Chatterjee then joined MPI Research, Inc in 2009, where she worked together with numerous scientists to ensure the ADME (absorption, distribution, metabolism, and excretion) profile of avanafil, a phosphodiesterase type 5 inhibitor similar to sildenafil (Viagra®, Pfizer).
She joined St. John’s University in August of 2011 to continue her role as a professor while pursuing DMPK research in her own lab.
Recently, I asked Dr. Chatterjee some questions regarding the pharmaceutical industry.
Q: You were a Principal Scientist at Hoffman-La Roche. What did that position entail?
A: In the industry, titles do not mean anything, it is the actual job content or the work you are doing that matters. With titles and positions, you tend to have more responsibility such as project manager and lab head and people working under you but in the end, you are cooperating with various groups, departments, and fellow researchers on a specific project. Every company has its own bureaucratic layers so you can expect to find different organizational structures with varied work environment but it’s your specific project that matters. In a big company, work is more structured and the researchers are very focused on their own specific work. It is very normal for a researcher to spend 37 years doing only in vitro to in vivo correlation for compounds.
Q: What is the drug development phase like in the industry?
A: In any given time, a company is working on a vast array of studies for a staggering amount of drugs. For a small to medium sized company, it is perfectly normal to spend $100-$200 million dollars on drug development and of course this figure will change for the bigger companies. For a clinical candidate to be selected by a company, it generally takes 3-4 years with numerous scientists working on various phases of the project.
Q: Are there any developing trends in the industry for drug discovery?
A: Companies are now starting to “outsource” this phase of drug development to contain costs. They are mostly letting third parties carry out bioanalytical work and the initial preclinical selection of a compound from vast array of natural or untested compounds. This is simply due to the time constraints, the length of time it takes to find an adequate candidate for further DMPK studies and later for clinical studies. The outsourcing is actually more cost effective for companies in the long run.
Q: How are in vitro – in vivo correlations made for a specific compound?
A: We use an in vitro system, specifically animal models, to attain data sets in the preclinical stage. We use the hepatocytes from five different species such as rats, dogs and other animals to identify the metabolites and PK parameters of the drug. We use one rodent species like a rat, one non-rodent or non-human primate species like monkey or dog and the human cell types. The models that are somewhat similar to the human hepatocyte data with regards to the metabolites produced and PK parameters are chosen for generating safety data.
Q: What made you switch between companies and eventually to become a faculty member?
A: I wanted to branch out and work on new challenges. This is why I joined Celgene Corporation in 2006, a company famous for the thalidomide drug that was withdrawn during the 1960s for teratogenicity. This company was a great opportunity for me because I was able to set up the DMPK and bioanalysis operations for the company. Bioanalysis refers to the quantitative measurement of drugs and their metabolites and biological molecules in biological fluids. Going from the industry to faculty was a big jump for me because I did not teach before; however, the lab work is the same.
Q: Can you discuss anything particular you are working on in your lab?
A: In the lab, we are looking mainly at DMPK related studies including drug-drug interactions and transporter drug-excipient interactions. Many times, we have drug formulations with excipients in them and we are not sure what their effects are. We are looking to see how the excipient reacts with the drug, if it has any effects on the body, and if it can cause any adverse effects. We are also interested in improving the bioavailability of certain water-insoluble drugs using excipients that are solubility and bioavailability enhancers.
Q: You mentioned drug development as an expensive process. Can you comment on the need to balance the patent rights of companies with the need to make cheaper drugs available to the poorer nations in this world?
A: This is a very good question. I remember that we (industry) used to fight for patent rights. When I was at La Roche, the company was fighting with Cipla for enfuvirtide (Fuzeon®, Trimeris and Genentech) patent rights. This is a very complicated issue. Cipla is doing a great job of providing drugs cheaply for people who cannot afford them, and it is a great humanitarian gesture. However, someone has to make the drugs and it is not a cheap process. Drug development and new treatment procedures will begin to lag behind. Already we are seeing a big shift in drug discovery and the development paradigm, with a big push for cost containment. Companies are realizing that the traditional models for research and development are no longer profitable. We are seeing smaller companies working on preclinical research and developing a drug candidate and letting the bigger companies do the clinical trials. If companies lose the patent rights, they are not able to recoup the money. The companies lose millions in failed tests to find a single drug candidate that can pass a Phase II trial. So, without the patent to guarantee that they will recoup such costs, companies will not have incentives to develop a new drug.
Q: We have seen a drop in Research and Development (R&D) during the past decade. Can you suggest an alternative to the traditional R&D model that might work better?
A: I think if academia works together with industry for the drug discovery and development phases, we can make a difference in the R&D process. Already, academia is involved with research that deals with specific drug targets and mechanisms of action in disease models. The basic research is already done at the university level. So, if the collaboration between academia and industry can be strengthened, we can reduce the upfront drug development costs. We can select better drug candidates that are more tailored to a disease model with specific drug targets. It will reduce some of those initial costs, as the drug discovery process will be streamlined.
Q: What advice, if any, would you give pharmacy students regarding the industry setting?
A: Try to understand what it is like to work in the industry. It is very different from the traditional roles as a pharmacist. I highly recommend that students do rotations in the industry and perhaps obtain a summer internship or job at the industry. As I discussed above, it involves much focused work and it is better to have an idea of how that will be like before you graduate.
You can find Dr. Parnali Chatterjee in the same office as Dr. Frank Schanne in St. Albert‟s Hall, 2nd floor. She is interested in working with students who would like to learn more about Drug Metabolism and Pharmacokinetics research. Please stop by her office and inquire about working in her lab if you are interested. Additionally, you may email her at [email protected]