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May 2012 FILS Clinical, Medical Affairs, Regulatory Career Paths Event Blog by Benjamin Leung 

June 8, 2012 
by Lauren Celano 

When people think about pharmaceutical or biotech industry, the first thing that often comes to mind is the lab research that leads to identification of candidate therapeutics. But an equally important component is the clinical trials that demonstrate the therapeutic is safe and beneficialThese are extremely important for getting the therapeutic approved by the FDA. The May edition of the Propel Careers/MassBio/MassBioEd Futures in Life Sciences Panel Discussion and Networking Event, sponsored by the Halloran Consulting Group and the Massachusetts Chapter of the Association for Women in Science, focused on career paths involved in clinical, regulatory, and medical affairs. The evening's panel included Eric Silberstein, CEO, TrialNetworks, Joanne Lager, MD, Project Head for PI3K Inhibitors, Sanofi Oncology, and Shawna Cullen, PhD, Clinical Trial Head, Oncology Translational Medicine, Novartis Institutes for Biomedical Research. Laurie Halloran, President and CEO, Halloran Consulting Group, skillfully guided the discussion.

In the US, clinical trials for new drugs are regulated by the FDA and consist of three phases, which sequentially increase in size, complexity and cost. Phase I is to test the safety of the drug, phase II is to test for efficacy, and phase III is to assess the drug in a larger population and to prove the drug is better than existing alternatives. Unlike laboratory research, which is generally located in a few research buildings, clinical trials are routinely distributed around the country or world, sometimes involving hundreds of sites and thousands of patients.

Clinical trials are expensive to run, costing many millions of dollars, and can require the efforts of hundreds of people. In addition to the doctors and nurses necessary to attend to patients in the clinical trials, there are many people required to collect, oversee, and manage the analysis of clinical samples and data. Companies either have their own internal clinical trials division to manage these studies, or they outsource to a contract research organization that specializes in running clinical trials. The managing entity contracts with specific study sites, which are often hospitals or medical centers, to identify and test groups of patients in the specific research protocol. Each test site is headed by a practicing physician and has its own personnel who execute all aspects of the study. A critical element of clinical studies is patient recruitment. Studies typically need patients with particular medical criteria, which may not be very common in the general population. As a result, not only is recruiting appropriate patients important, but also retaining them throughout the length of the study, because incomplete data sets can cause the entire trial to be inconclusive and fail.

While RN, MD, and PharmD degree holders are commonly involved in clinical trials, it is also possible to become involved in clinical trials as a basic scientist with a PhD. The scientific training in data analysis and experimental design is helpful in designing clinical trials, but there is additional training in clinical data/medicine that must be eventually acquired to become proficient in this arena. A typical entry-level position is a monitor, who is tasked by a company or clinical research organization with liaising with an individual research site to make sure patients are properly recruited, records are accurately maintained, and protocols are followed. The corresponding position on the study site side is the study coordinator, who is responsible for overseeing and managing the data collection.

Interpersonal skills are a critical element to all positions in clinical studies, because the team-based approach of medicine requires constant cooperation. A monitor or clinical study coordinator will need to affect people outside their organization routinely to ensure the study proceeds smoothly. At the same time, monitors/study coordinators must be detail-oriented, flexible, and problem solvers to address unexpected or unforeseen issues that arise during the study.

Panel members uniformly believed that the clinical study industry is poised for a major paradigm shift in the coming years. The financial pressures facing the biotech/pharmaceutical industry overall are forcing clinical studies to better manage costs as well. As a result, there is a move to reduce the amount of personnel and manual labor involved in managing studies and automating or remotely managing aspects as much possible.

There are other positions within the life sciences space where a research-based PhD can be used in new ways. Medical science liaisons are representatives of a pharma/biotech company who visit scientific institutions and reach out to researchers to facilitate studies involving the company's drug compounds. According to the evening's panelists, regulatory affairs positions are another career path with great opportunities and growth potential in the life sciences industry. Success of a potential therapeutic not only relies on a company's ability to demonstrate its efficacy, but also on the company's skill in navigating the ever-changing laws and procedures governing drug approval in the US and other countries. Regulatory affairs people play central roles in interfacing with both external and internal parties. The guidance issued by the national regulatory bodies tends to be broad in nature, requiring a company's regulatory personnel to discuss with the government agency over the specific requirements for a drug's approval. Internally, the regulatory affairs division conveys to company leadership these requirements and assists in outlining a strategy to best ensure a drug's chances of approval. Even after a drug is approved and released to the public, regulatory affairs remains involved in monitoring unforeseen complications or off-label use of the drug that arise over time.

The 2012 Futures in Life Sciences is taking a summer break, and will resume on September 11th with a panel on Bioinformatics/Modeling Career Paths at the MassBio Technology Square offices. To register, see the following link: http://fils62012.eventbrite.com. We look forward to seeing you there!

Enjoy the summer and we look forward to seeing you in September!

 

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