Scientific innovation, basis

In principle, this freedom to choose a scientific approach when planning and performing a higher-tier risk assessment provides an excellent basis for any scientific innovation in the regulatory context — including the development and implementation of ecological modeling. 

Thus, in the early days of modem enterprise, engineers were the innovators who developed the methods—the profession—of modem business. As with the scientific inversion, here there is no historical basis for business envy or a nerd inferiority complex. The businessperson who says that engineering is mere technology applied to the needs of business could more accurately be told that modern business is merely the application of engineering method to the design of commerce. 

Biotechnolgy is the integrated application of different scientific disciplines. Professor Kula has always exemplified this together with her staff. On the basis of long-term scientific work, real practical innovations have emerged due to her own qualities and her receptiveness for other scientific fields. Only a few poeple who have cooperated with her as long as I have will be aware of how much she has always enjoyed her work and the humour which accompanies her successes and setbacks. 

Present programs for controlling potential threats to health from new substances and technological innovations are doomed to failure because we lack the scientific knowledge to provide a sound basis for control. 

Acknowledgments This research was partially supported by Grant-in-Aid for Scientific Research (A) (2006-2009, No. 18205016) from JSPS and that on Priority Area Strong Photon-Molecule Coupling Fields (No. 470) and Global COE program (Project No. BOl Catalysis as the Basis for Innovation in Materials Science) from MEXT, Japan. 

The National Center for Toxicological Research (NCTR), a component of the Jefferson Laboratories of the Food and Drug Administration (FDA), is located in Jefferson, Arkansas. Its mission is to conduct innovative peer-reviewed scientific research focused on FDA regulatory needs. Research findings provide the basis for FDA to make sound science-based risk management decisions that promote the health of the American people. 

Little, if any, of the expertise, analytical methods and in-house standards, specifics of the production process, historical process, and validation data or full characterization data required for comparability assessment of therapeutic proteins are available in the public domain. As a rule, they are proprietary knowledge. It is inconceivable, in most cases, that another manufacturer, on the basis of the patent or published data, is able to manufacture a protein pharmaceutical that can be assumed similar enough to the original innovative product that only a limited documentation of physico-chemical characteristics would be sufficient to show equivalence. In most cases only limited data are available in pharmacopoeial monographs and scientific papers. Moreover, even the most sophisticated analytical tools are not sensitive enough to fully predict the biological and clinical characteristics of the product. 

Alkaloids can be divided into three large groups on the basis of their relation to the innovations in the fields of both chemistry and technology (1) natural alkaloids, (2) biomimic and bionic alkaloids, and (3) synthetic alkaloids. This division serves the scientific and practical needs well. 

---