2017 - Avoiding Critical R&D Formulation/Drug Delivery Errors

We hopefully learn from our mistakes. But, it is far better to learn from other people’s errors and avoid them in the first place. In nearly 40 years of R&D in the pharmaceutical industry, I’ve made--and seen-- some doozies? technical errors, miscommunications, strategic planning oversights, and quite a few “political” blunders. Many, if not all, were preventable. All were costly! For example, over a multi-year period, our manufacturing plant had an occasional release-assay failure, for commercial heparin in intravenous bags. The plant did not consider it a serious problem because re-testing, with a larger sample size, nearly always was successful; the problem was attributed to assay-error and most of those lots were released. Suddenly, every batch failed. It was only then, that the Manufacturing Group got our R&D involved. What we discovered made my jaw drop: Over the preceding five years, each batch contained a few units with low, or no, heparin. Could this life-threatening error have been prevented? Clearly, many mistakes that derail projects and commercial products are avoidable. In this presentation, we’ll be discussing my experience with critical errors, and how you can avoid falling into the same traps.This presentation will focus on the speaker’s negative experiences, in the belief that, through recognition of mistakes and their underlying causes, similar errors can be avoided. Even the brightest and most experienced pharmaceutical scientists and administrators make mistakes. Seemingly minor errors in judgment, communication, planning, technology, or personal interactions may lead to costly catastrophes: Important and expensive projects and programs may be terminated, costly joint ventures can go amuck, personal interactions may become strained, products could be recalled, and the company’s reputation can be tarnished. Worst of all, patients may be injured or die from a subtle mistake, such as substituting a “less expensive” filter on a commercial batch of drug or, speeding up an assembly line to “improve” productivity. Lawsuits, of course, may follow. Through case histories, Dr. Marsh will demonstrate the critical importance of anticipating potential errors, providing clear and multi-way communication, and fostering a spirit of cooperation between all facets of R&D and, between R&D and other groups, including pilot plant, manufacturing, marketing groups, administrators, and venture partners. If just one product is saved from failure, or a single life spared, this webinar will be of tremendous value to you and your company.