Saturday, July 21, 2012

Drug Discovery Process Research Paper

The Drug Discovery Process: Challenges Facing Medicinal Chemists and Pharmacologist

Within the scope of this research, we will elaborate on the challenges facing medicinal chemists and pharmacologist in the new drug discovery process. The average new drug requires an investment of $100 million and 11 to 13 years to receive approval by the FDA. (Boyatzis, 2003) Because new drugs are patented at the beginning of their development cycle, a pharmaceutical firm typically enjoys only four to six years to recoup its investment before its 17-year patent protection expires. Increased concentration and global competition have made continuous innovation at maximum speed imperative for enduring success in the pharmaceutical industry. In order to fully analyze various challenges that pharmacologists have to face when discovering new drugs, it would be useful to utilize the example of particular organization.


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Sinclair, Inc. is a Fortune 500 company in health care and pharmaceuticals. It has a worldwide presence in 130 countries. In 1987, the Pharmaceuticals Division described its charter as, “To engage in the discovery, licensing, development, production, and marketing of superior prescription or over the counter products and services which are promoted in the domestic market primarily through professional channels. In addition, the Division will market, sell, and distribute health care goods and services to the domestic physician office market segment. The Division will conduct global pharmaceutical research and provide research and development services to sister divisions.” (McClelland, 2004)

The R&D unit within the Division had the objective, as described in the same 1987 document to, “Become one of the premier Research and Development organizations in the industry based on a consistent flow of new leadership products and a commitment to scientific excellence.” (Jick, 1999) In this same document disseminated within the company, one of the critical success factors relevant to R&D was, “Increase the rate of new products to the market place by increasing R&D productivity and shortening the development and product approval phases.” (Jick, 1999)

The R&D unit was headed by the Vice President of R&D, who was a physician. Also reporting to the Divisional President were the Director of Sales, the Director of Administration; the Controller; and the VP of Operations. Reporting to the VP of R&D were the Heads of Discovery, Pharmaceutical Development, Medical Affairs, Project Management, Regulatory Affairs, R&D Systems (i.e., computer systems), and the Controller. Reporting to the Head of Discovery were scientists in four therapeutic areas representing the strategic focus of the Division. Reporting to the Head of Pharmaceutical Development were scientists, clinicians, and technical staff in Toxicology, Metabolism, Pathology, and Analytic Chemistry. Reporting to the Head of Medical Affairs were physicians in Clinical Studies and scientists in Biostatistics.

In 1985, the VP of R&D and several of his staff began soliciting proposals from selected consulting firms to conduct a study, make recommendations, and assist in implementation. Their objective was “To achieve an optimally efficient and cohesive drug development organization within Sinclair, R&D Division, while maintaining quality.” (Jick, 1999) The project study team consisted of six staff members of McBer and Company, led by Mary Esteves. The implementation of changes resulting from the study were primarily conducted by Mary Esteves and Richard Boyatzis. Three years after completion of the first study and implementation of changes, in 1989, the VP of R&D requested that the same staff conduct another second study. (Dalziel, 1998)

Although not a miracle cure, the Venture Team concept enabled the drug development process to proceed through several key phases in a substantially shorter time period. (Dalziel, 1998) If this translates into approval time at the same rate or faster than previously experienced, the drugs will be entering the marketplace significantly sooner than before. In the pharmaceutical industry, first into the market often means capturing the highest market share for an important period of time and establishing market distinctiveness. The story is not without some cautions and costs, as evident in the challenges to Sinclair in 1989.

The Venture Team concept appeared to successfully address many of the challenges found. There was a clear shift to a rifleshot approach to drug selection and development, rather than the previous “shotgun,” scattered approach. (Boyatzis, 2003) Rather than proceed through several phases of experimentation with multiple indications, dosage, or method of administration (i.e., pill, injection, patch, etc.) typical of the “shotgun” approach, the Venture Teams spent time analyzing and discussing the options as soon as possible. They would then “aim at a specific target” regarding indication, dosage, and method of administration. (Boyatzis, 2003) It resulted in dramatically improved relationships within the R&D unit. People appeared to be pulling together and focusing on the development of specific drugs rather than any other disciplinary, or territorial issues. This even helped improve the relationships among the drug development staff and the business unit, or marketing staff of the Division.

The Venture Team concept, with the development of the Venture Head and Operations Manager roles, appeared to clarify the leadership issues and remove obstacles to effective, multifunctional teams working toward collaborative goals. It also clarified accountability: people were responsible for helping to get the drug through the development phases, or to terminate it. Each professional represented a discipline, or function, but applied his/her talent and perspective to the specific drug. (Boyatzis, 2003) Interface issues became opportunities for communication and collaborative problem-solving, rather than linguistic and disciplinary boundaries that often look opaque and reject intrusion like a force-field.

Progress in addressing some of the challenges was independent of the Venture Team concept. For example, the integration of computer and information systems began during the data collection stage of the first study, and was successfully completed more than a year before the second study. This progress may have contributed to the impact of the Venture Teams.

The Venture Team concept appeared to clarify leadership, but did not necessarily help with the lack of management skills in scientists and physicians. As a matter of fact, the passion generated within the Venture Teams may have become a source of resistance for Venture Team members participation in extensive management development; they were too eager to get on with their drug development. (Boyatzis, 1999) With regard to confusing budgeting procedures, the Venture Teams appeared to have simplified budgeting procedures within their Teams, but created substantial budget planning difficulties.

Innovative projects do not always work, so the effort must be structured so as not to punish failures. One of the Venture Heads made the observation that there previously were “ghost” drugs in the development process (drugs that should have been killed, but no one wanted to stop their projects or studies). (Dalziel, 1998) In the pharmaceutical arena, it was noted that without back-up molecules (i.e., a molecule similar to the one under investigation, but with sufficient difference to suggest other possible effects), a Venture Team might fall prey to the same protectionism when evidence suggested that their specific drug was not performing as expected or desired.

Venture Teams, like other successful entrepreneurial innovations, will change the “heroes” of the organization to those in the Venture Teams from those who may have been in functional, or discipline-based departments. Departments and functional units are necessary and important, but equal value placed on all aspects of the matrix organization will be difficult to sustain. The members of functional departments may begin to feel like second-class citizens. If things are working appropriately, ultimately the Venture Teams will change the perspective of what a service (functional) organization is supposed to do and the functional Heads will catch the “Venture Spirit” (i.e., transform their previous “bureaucratic” orientation to an “entrepreneurial” one). (Boyatzis, 2003)

Cost controls were critically perceived to be antithetical to the entrepreneurial spirit needed in Venture Teams, but the experience did not show that cost controls slowed any aspect of the process. The expected significant cost savings and increased revenue generating capability resulting from getting new products into the market first will be realized in future years. As with all R&D expenditures, this places executives who must account for current quarterly earnings in a dilemma.
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