Member SpotlightsThe Drug Application Process & a Perspective on US Pharma Stuart Cantor, Ph.D. A Science Advisory Board Member Since 2008 Stuart Cantor, Ph.D., is a Staff Scientist for ICON, a Clinical Research Organization (CRO) that provides services to medical device, pharmaceutical and biotechnology companies. Cantor’s academic background in food science led to his position in the food industry as a chemist. A shift from food science to over the counter (OTC) medication led to a career change; Cantor received his Ph.D. from University of Maryland School of Pharmacy in May of 2008. He currently assists international companies with drug applications to regulatory agencies for ICON. Cantor is a member of the American Chemical Society & the American Association of Pharmaceutical Scientists (AAPS). He is a PDA (Parenteral Drug Association) fellowship recipient & presenter and won the Best Scientific Poster Award for GRASP 2005 (Graduate Research Association of Students in Pharmacy). Cantor has published over forty articles on various topics (food processing and nutraceuticals) in US and European trade magazines, published a book chapter on pharmaceutical wet granulation, is the inventor/co-inventor on three patents, and has authored two regulatory affairs publications and six research publications. Academic & Professional Background My academic background started off in food science with a range of courses covering various chemistry topics as well as food engineering and processing. I started off my professional career in the food industry as a food chemist and had a chance to design every type of food product imaginable for small and large companies. It was a great R&D experience as I got to taste the fruits of my labor! I found it exciting to watch the development of my products from a 1# scale to 1000# scale. I developed the sugarless fiber chews launched by Bristol Myers in 2003. I had the opportunity to write a wide variety of articles on ingredient functionality and chemistry as a freelance writer, and I wrote over 40 articles for leading US and European food trade magazines. In my work, I started moving away from food into OTCs and really enjoyed the projects. My food background served me well as I knew how to make products taste and look great. I started learning more about the pharma industry and was amazed and very interested to learn more about the scientific aspects of this field. I decided to go back to school and received my Ph.D. in pharmaceutical science in May 2008. I was an atypical graduate student as I already had 10+ years of work experience. This made me more focused, adept at time management and I also had a good idea of what I wanted to do with my career. I had interacted with other professionals who had started out in science but then moved into management/consulting. I wanted to try that out and was fortunate to land a job at ICON. In my current position I assist global companies in compiling the scientific data/paperwork necessary for their new drug application submissions to various regulatory agencies. Therefore, I do not generate my own lab work but I review thousands of pages of scientific data per year from around the world. I also do what is known as gap analysis. This is where I identify missing scientific information that companies will need to include with their regulatory submissions. Research Interests My Ph.D. research focused on NIR spectroscopy, extrusion-spheronization, and film coating to produce controlled release tablets. I am interested in polymorphs and solid-state chemistry and spectroscopy. Currently, I write/edit/compile the CMC (chemistry, manufacturing, and controls) section in new drug applications (NDAs) for ICON’s global clients. I provide the scientific input on analytical and drug formulation areas for solid dosage forms (small molecules) as well as protein therapeutics (large molecules). Motivations I know that I write well and I was excited to help other companies launch their new drug products (including small molecule as well as protein therapeutics/biologics). I deal with a variety of different dosage forms as well (solids, liquids, intranasal, parenterals, etc.) and there is always something to learn. I was here less than 90 days and had already written articles concerning NIR spectroscopy/anti-counterfeiting and regulatory issues with oncology/cardiology drugs. Career Expectations I didn’t know I’d have so much variety. I’ve gained research experience in foods, nutraceuticals, pharmaceuticals (Rx and OTC), and analytical chemistry. I’ve also had the opportunity to teach and tutor other students in math and chemistry. If I had it to do all again, I’d start off with a B.S. in Chemistry, and then become a pharmacist, and then get my Ph.D. I just took a more circuitous route! Last week I gave a seminar on my Ph.D. research to students at my alma mater (University of Georgia). My advisor invited me to come over and she told students that I was her first graduate student. She said that she hadn’t ever seen so many students come to a seminar and actively participate. Several students asked me career progression questions and seemed interested how I managed the cross-over from food science to pharmaceuticals, which incidentally is quite rare. I can end this discussion with a good quote from an uncle: “It’s what you do after you know it all that really counts.” We all need to be lifelong learners and to develop problem solving, analytical and technical skills from an early age. Starting off in a technical scientific discipline is the right way to go. Once you prove your competence and commitment, many other doors open up for you that you never could have imagined as a student. Chemistry and biochemistry are the essence of all life and although I spent many years learning and mastering these disciplines, looking back, it was well worth it. I am working towards a promotion to management in the near future. I believe that my scientific abilities, business acumen, interpersonal skills, and hard work will always enable me to reach my goals. Many non-US companies transfer their R&D workforce to the US - where the environment is more attractive for R&D investment and more supportive of pharmaceutical innovation. Likewise, much US pharma work is outsourced to other countries. Do you agree with these statements and can you comment on these trends? Yes, I am aware of pharmaceutical work being outsourced overseas and this can be done to remain cost competitive. However, the work still needs to get done and this labor shift can benefit global CRO (contract research organizations) and CMO (contract manufacturing organizations), which can be selected based on their specializations and expertise in pharmaceutical manufacturing, preclinical research, and/or regulatory knowledge. I was not aware of companies transferring people to the USA, although I believe that Americans are known for innovation. I know that the outsourcing of American jobs is talked about a lot these days. Generally, if there are pharmaceutical products still under patent protection, a company will try and keep their manufacturing in either the US or Europe. Outsourcing such products to a third-world country may cause the intellectual property (IP) information to be compromised and such cases can be difficult to prosecute. What challenges are faced by the US pharmaceutical industry? Many prescription Rx drugs are going off patent in the near future and the pharma industry will lose billions of dollars to generic competition. Also, several of the large pharma companies do not have many new drugs in the pipeline to replace them. It is very difficult to develop new first-in-class therapies (12-16 years R&D timeline and about 1.3 billion for R&D spending). The number of new drug approvals at FDA has also been decreasing in the last 5 years. Are there unique challenges related to R&D costs & regulation specific to the US? R&D costs are higher here than in third world countries because labor and material costs are higher. We have cGMP requirements that drug manufacturers must adhere to. These regulations are often stricter than elsewhere in the world to ensure that we have a safe and efficacious drug supply. However, we also import food and pharma products made in China and we have all heard and read about the recent problems with products contaminated with melamine and also the serious adverse events which occurred in patients and the product recall initiated over adulterated heparin. Can you comment on non-governmental influences that affect the US pharmaceutical market? The rising costs of healthcare. Many seniors cannot afford their medicines and therefore, these people can have a negative perception of the pharma industry. What is your outlook on the future of US R&D? Do you think USA’s government-regulated aspects of the pharmaceutical industry will positively/negatively impact the pharma industry? Actually, USA’s regulatory climate is more favorable than Europe. The FDA offers more help to companies in the early stages of their product development and at no charge. The focus of the USA and global regulatory agencies is on patient safety. If a company does their due diligence and provides a level of high quality scientific documentation and justification of their results they will find that the government-regulated aspects of the pharmaceutical industry are more than willing to assist them to launch their new products into the marketplace. In what way does your position contribute to the drug discovery pipeline? I’m not involved in adding to the discovery pipeline but I am involved in adding to the new drug products in the marketplace by helping companies with their regulatory submissions gain approval from the various regulatory agencies. Also, some types of new drug applications do not involve new drugs but already approved drugs selling in the marketplace that are then put into a new delivery vehicle (a change from tablets to an intranasal formulation, etc., perhaps to improve the drug’s bioavailability) Publications Cantor, SL and Ciftci K. Cardiology and Oncology Drug Development & Regulation. Drug Delivery Technology, Online, March 2009. Cantor SL, Augsburger LL, Hoag SW., Formulation and characterization of a compacted multiparticulate system for modified release of water-soluble drugs – Part 1 Acetaminophen (Drug Development & Industrial Pharmacy (DDIP) – Online 09/08, March 2009, 35(3):337-351). Cantor SL, Augsburger LL, Hoag SW, Pharmaceutical Granulation Processes, Mechanism, and the use of Binders (book chapter in Pharmaceutical Dosage Forms: Tablets (sold on Amazon.com). Cantor SL, Augsburger LL, Hoag SW. Formulation & Characterization of a compacted multiparticulate system for modified release of water-soluble drugs –theophylline & cimetidine (DDIP-Online 10/08). Cantor SL, Hoag SW, Augsburger LL., NIR Spectroscopy applications in the development of a compacted multiparticulate system for modified release (submitted to AAPS Pharm Sci Tech). Cantor SL, Augsburger LL, Hoag SW., Evaluation of the mechanical properties of extrusion-spheronized beads & multiparticulate systems (DDIP-Online 3/09). Cantor SL, Koo OY, Kothari S. Evaluation of the physical & mechanical properties of high drug load formulations: Wet Granulation vs. Foam Granulation (BMS internship, submitted to Powder Tech.). ### << Previous Next >> [ View All Member Spotlights ] |
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