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Biotechnology and Life Sciences
Advances in all areas associated with biology, chemistry and physics are increasingly applied to understanding problems of human disease, veterinary medicine, agriculture and the environment. Keeping pace with the entrepreneurial enterprises focused on utilizing technology advances form the basis of a growing portion of the world's developed economies. To maximize the potential for value generation executives in these sectors must continue to be conversant with the ever increasing growth of scientific and medical knowledge.
Diagnostics, especially the growing applications developed in molecular diagnostics are becoming increasingly associated with therapeutic end points and healthcare management decisions. The stunning progress of molecular medicine towards personalize medicine relies on fast paced revolutionary technologies transitioning from the research and development arms of industry and academia into life-saving applications in the clinical laboratory. Understanding the technologies and the information they generate is essential to appropriate executive decision making from portfolio decisions to marketing planning. Being up to date with proteomics, genetics, metabolomics and the technologies associated with them, i.e. next generation sequencing, mass spectroscopy, gene and gene product amplification technologies is key to the working knowledge of the diagnostic executive.
Start up biotechnology and pharmaceutical companies are responsible for the discovery of an increasing percentage of pharmaceutical products. Moreover the majority of new drug applications and approvals by the FDA are biologically based. The developmental pathway to regulatory approval is costly and prohibitive to smaller concerns due to their limited resources in both personnel and capital. As a result of these limitations extracting the maximum value associated with regulatory approval is often surrendered early in the value proposition to larger corporations. Executives assisting with the design, sourcing and management of the pharmaceutical process make the critical the decisions regarding when to license, sell or hold for maximal payout and exit.
The regulatory pathway from pre-IND submission to regulatory approval requires coordination of multiple Contract Research and Manufacturing Organizations (i.e. toxicology, clinical trials, manufacturing and regulatory). Executives who manage product development are charged with controlling expense while meeting regulatory approval standards. Critical decisions include building in-house expertise vs. outside contractors- severly challenging decisions.
The regulatory pathway for diagnostics is becoming increasingly complex with the FDAs recent attention paid to laboratory developed assays and the CLIA labortory services industry. Diagnostic approval depends heavily on whether the diagnostic is considered a 510K or a PMA. Additional progress in developing diagnostics to determine the safety or efficacy of a therapeutic, i.e. companion diagnostics, is a new developing field of opportunity.