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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.

Why Should You Attend:

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.

Areas Covered in this Webinar:

This session will examine multiple case histories, where seemingly small errors led to serious problems, like the aforesaid example of a manufacturing plant making a money-saving change that resulted in the release of life-threatening intravenous units of heparin, containing low, or no, drug.

Discussion points: What went wrong? Why must the lesson learned be applied to all pharmaceutical R&D/manufacturing plant interactions?

An expensive joint venture was contracted between Dr. Marsh’s ophthalmic drug delivery group and a small company, which had successfully brought a sub-dermal drug delivery implant to the U.S. market. The initial objective was to have the partner prepare a tiny version of their marketed device, using an ophthalmic drug. Over several months, the partner consistently showed data supporting zero-order release. However, about eight months into the program, it was discovered that the partner’s work was fatally flawed; the program was halted and the project was terminated.

Discussion points: Could this failure have been anticipated and prevented? Does this same error show up in other drug delivery literature/patents?

A little more than a decade ago, Dr. Marsh’s group developed a novel drug delivery drug-device combination, designed to heat and injects a low-melting formulation into the eye, where it solidified into a sustained-release depot. The prototype injector, which was built in his lab, was modified and scaled up for mass manufacture, by his company’s Engineering Department. The politics/egos surrounding a single failed lot [1 in 35 lots] scuttled the entire program.

Discussion point: How might “cooler heads” have prevailed and saved this innovative drug-device program?

The transfer of a novel contact lens cleaning product from Dr. Marsh’s group to the pilot plant went amuck. The heat-sensitive enzyme in the formulation became denatured. The Director of the pilot plant—a smart and trustworthy individual—insisted that each failed batch was held well-below denaturization temperature and, indeed, the thermocouple documentation supported his position.

Discussion points: What went wrong with scale-up? How was the problem identified and corrected? How might the lessons learned be applied to other R&D to Pilot Plant formulation transfers?

Other examples and analysis of critical R&D formulation/drug delivery errors will be presented, as time permits.

Learning Objectives:

Learn, from the errors of others, how one might minimize or avoid:

Technical errors
Strategic planning oversights
Political blunders

Who Will Benefit:

Pharmaceutical R&D scientists, pilot and manufacturing personnel, and their administrators.

Speaker Profile:

Dr. Marsh is a highly- accomplished pharmaceutical scientist with a solid reputation for innovation, research management, and CMC team leadership. He is experienced in collaborating and coordinating projects with Marketing, Manufacturing, Pilot Plants, PK, Toxicology, Analytical Chemistry, Packaging and other Functions. He has extensive knowledge of drug delivery, medical device development, ICH guidelines, and FDA regulations and is a globally-recognized Ph.D. with numerous international patents/patent applications, 55+ published papers, and a solid network of contacts within the scientific community. He’s familiar with, and proponent of, Quality by Design (QbD).

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