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George Betts
A graduate of The George Washington University School of Business, Fairleigh Dickinson University and William Paterson University with additional training at Tuck School of Business at Dartmouth College and MIT Sloan Institute of Business, George Betts stands out as an effective and innovative leader in the pharmaceuticals industry. Throughout his career, George Betts has excelled at managing teams and financial budgets for clinical trial operations, and he quickly gained positions of increasing responsibility. In 2000, he became Director and Head of U.S. Medical Affairs Operations with Novartis Pharmaceuticals, a role that grew in responsibilities and entailed creating operational teams as well as managing budgets to support the company’s U.S. Medical Affairs Department. His successful leadership performance led to his appointment as Executive Director and Head of U.S. Medical Operations, a six-year post that required finely honed management skills and interpersonal dexterity. George Betts obtained the position of Executive Director, Head of U.S. Trial Operations and Logistics in 2009. George Betts has contributed his professional strengths and achievements to the pharmaceutical field in unique ways. He was able to improve productivity and greatly increase savings to Novartis Pharmaceuticals by reducing cycle times, effectively decreasing the length of the clinical trial process. In 2008, he received the Best-in-Industry award in recognition of this achievement. George Betts has also developed Standard Operating Procedures for numerous purposes, and between 2000 and 2003, he successfully formed a medical writing group to publish abstracts and clinical study reports. When he has a break from his work schedule, George Betts stays in shape by running and playing sports such as football, hockey, and racquetball. George Betts considers spending time with his children a top priority, and he also enjoys learning about history, cosmology, and physics.
George Betts's Publications
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An Introduction to Contract Negotiation with George Betts, George Betts
May, 2011
George Betts spearheaded a variety of initiatives for Novartis Pharmaceuticals during his long tenure with the company, including clinical research operations, US medical operations, and US trial operations. As a high-performing executive, George Betts personally oversaw contract negotiations for clinical trials, improving efficiency of the process fourfold without sacrificing quality. Successful negotiations begin with preparation. Regardless of the industry or the specific contract in question, negotiators must first overview the mechanics of the agreement to determine what can be negotiated and what cannot. This must be developed and documented by working with internal legal staff to ensure minimally acceptable legal terms are defined. Additionally, it helps by defining back-up language pre-approved by legal department. Be sure to complete this process from the other party’s perspective as well to effectively anticipate their requests and demands as negotiations proceed.
Throughout the process, each side will inevitably have to make some concessions to appease the other, and aligning priorities before talks begin is crucial to ensure the company’s primary goals are achieved. In absence of pre-defined contract templates, drafting an initial contract prior to negotiations represents a sensible way to organize your ideas and present your ideal contract to the other party. In addition to the substantive portions of the agreement covering general terms, compensation, and dates, clauses pertaining to risks, liabilities, intellectual property, and confidentiality will need to be incorporated into the document as well. Adding information on dispute resolution, non-compete agreements, and similar topics is also advisable.
At the negotiating table, be sure to have data, legal precedents, and other facts to support your requests. Establishing trust and a rapport with the other party will help streamline negotiations and ease tensions. This can be accomplished in several ways, including strong supporting evidence, previous experience, and informal interaction. With that said, save small talk for personal time and keep discussions short and to-the-point while at an organized negotiation.
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The Four Phases of Clinical Trials, by George Betts, George Betts
July, 2011
Over the course of his 19-year tenure in the pharmaceutical industry, George Betts has overseen the various phases involved in clinical trials. During his tenure at Novartis Pharmaceuticals, Mr. Betts has presided over various key operational roles related to clinical trial execution including project management, clinical contracting/sourcing, budget/resource management, regulatory document management, and productivity improvement strategies, among others. George Betts describes how clinical trials can be divided into four distinct phases.
Phase I entails first-in-human trials, meaning the first time that qualified professionals test a new drug in humans. The U.S. Food and Drug Administration (FDA) requires that all companies conduct their tests in accordance with its 2006 Guidance on Exploratory Investigational New Drug Studies. While Phase I rarely gives data on a drug’s efficiency or safety, the trials are not designed to do so. They exist to enhance the development of drugs in order to determine if the drugs behave in humans as expected.
In Phase II, roughly 20 to 100, or more or less depending on specific parameters, healthy volunteers come forward to test the new drug. Phase I trials aim to discover the drug’s safety and tolerability, among other, more technical attributes. Most Phase II trials take place in an inpatient clinic, allowing full-time staff to observe subjects. Phase II occurs once a drug’s safety has been determined, and take place on larger groups of volunteers. The testers strive to learn more about the drug’s efficacy.
In Phase III, an even larger group of patients receive the new drug for testing. Often, as many as 3,000 patients are chosen on a volunteer basis. Phase III helps testers arrive at a definitive conclusion regarding the drug’s effectiveness. Often, Phase III tests continue while various regulatory agencies evaluate the drug, allowing patients in need of the drug to continue receiving it until it can be purchased.
After achieving approval to market a new drug by health regulators (FDA in the US and EMEA in Europe), companies begin Phase IV trials which are often aimed to compare the drug to another product and/or test the product further in different sub groups and populations. The drug also undergoes Post-Marketing Surveillance, allowing its creators to continue monitoring its safety and to provide technical support.
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