Pathology

What does your future hold ? Are you ready for what is coming as personalized medicine becomes customized pharaceuticals. As a consultant I can show you the way.

The future of drug design is clear and incorporates a new way of thinking to be successful as a pharmaceutical leader. Pathology is the study of the impact of disease on the body. All organ injury and ultimately all clinical disease arise from the derangements in cell structure and function. Pathology studies the structural, biochemical and functional changes in cells, tissues, and organs that underlie disease. Chemical biology involves the application of chemical techniques and tools to the study and manipulation of biological systems as it relates to disease. The combination of these two partners working in concert with other dicsiplines enables the potential of personalized medicine from principle to practice.

Understanding pathology as a defining funtion will play a major role in the future of building customized drugs and will transform the pharmaceutical industry of the future. As a consultant, I can show you how to incorporate pathology as a dicsipline, incorporating stability studies and metabolic studies in to your drug development program to mobilize your thinking. These tools will move your company in the right direction with applied futuristic thinking. All of this will happen at the pre-clinical stage. All of this change will save your company time and money. Be on the front end of the future. I can help you get there.

The pathologist has long served as a consultant in pharmaceuticals. Pathologists oversee clinical laboratories, advise clinicians, choose laboratories to which send-out tests are referred, and decide when to bring referral testing in-house. With increasing demand for pre-clinical testing, there is an opportunity-and perhaps a responsibility- for pathology to play an expanded role in research and development.

Clinical Pathology combines the theoretical and technical knowledge of human anatomy and physiology, clinical chemistry, genetics, immunology, microbiology, hematology, histocompatibility, cellular pathology and other fields as they pertain to the diagnosis, monitoring and prevention of disease. This knowledge can come in the form of a certificate or as a full graduate program. Molecular pathology (including genetics) exposure has been a requirement of residency programs for some time. For the clinician; educational materials are available through professional, government, and private Web sites. National pathology meetings offer molecular pathology courses that include material on genetic testing; an online course in molecular pathology is available through the Association for Molecular Pathology. Molecular Genetic Pathology programs provide advanced training that includes laboratory and clinical genetics. Certification can be added to almost every academic acumen. This study and ultimate certification will become a standard in the future of medicine, pharmaceuticals, and accademics as the drug arena moves in to personalized medicine. It will be the common thread.

The cost impact of late-stage failures of drug candidates has motivated the pharmaceutical industry to develop, validate, and implement a more proactive testing paradigm, including an emphasis on pathology and toxicity. Toxicity is a leading cause of attrition at all stages of the drug development process. The majority of safety-related attrition occurs pre-clinically, suggesting that approaches to identify 'predictable' preclinical safety using pathology early in the development phase will promote better drug candidates.

Recent high-profile drug withdrawals now increase the pressure on regulators and the pharmaceutical industry to improve preclinical safety testing. Understanding mechanisms of drug toxicity is an essential step toward improving drug safety. Applied pathology to the candidate culture paradigm in a pre-clinical development role will change the attrition rate due to safety related issues. Technological advances in the biological, chemical and in silico sciences have transformed many scientific disciplines, including toxicology as it relates to pathology in development process of selecting a drug candidate.

Furthermore, the expression of genes with toxicity potential has elicited the interest of large pharmaceutical companies as customized medicine evolves. It is very likely that an understanding of the genetics of pathology will play a major role in Bioinformatics within the pharmaceutical industry; pre-clinical pathology will drive the industry as it moves to introduce customized medicine at the bedside. It is the wave of the future. Pathology will play a major role in the future of defining customized drugs; transforming medicine and how each interacts with the pharmaceutical industry from principle to practice.

Here is a great example of pathology at work. Developing genetic mouse models for cancer research has been recognized as an "exceptional opportunity" by the National Cancer Institute. The establishment of bioinformatics resources to facilitate access to published and unpublished data on the genetics and pathology of cancer in different strains of the laboratory mouse is critical to developing and using mouse models of human disease. The Mouse Tumor Biology Database (MTB), a free public resource for information on cancer genetics, epidemiology, and pathology in genetically defined mice and the pathology studies will transform research as we know it today. Research and development teams will need to incorporate a more clinical approach to research, bringing in pathology from the back end to the front end of drug design.

Pathology will play a major role in the future of defining more customized (personalized) curative and/or palliative solutions within pharmaceutics. Discovering a new generation of drugs requires that science applies pathology and genetics, and is the anticipated drug based design paradigm of the future. As a consultant, I can show you how to incorporate pathology as a dicsipline, stability studies and metabolic studies in to your drug development program to mobilize your thinking and save money all at the pre-clinical level.