Pharmaceutical Industry, New Drug Discovery Research Unit, Anti-bacterial Drug Research - Essay Example

Organization: Pharmaceutical Industry, New Drug Discovery Research Unit, Anti-bacterial Drug Research Introduction of antibacterial drug research: Anti infective drug research is a specialized branch of drug discovery unit in a Pharmaceutical industry. For acquiring the role of a leader a basic qualification of Microbiology or Biotechnology (undergraduate or post graduate) is essential. The scientist has to undergo a few years of extensive training on job as a research scientist in antibacterial drug research. A Ph.D. scientist in the relevant field may be absorbed directly as a leader. Before we look at the role of a leader we must understand the need of the antibacterial drug research. Antibacterial drugs have been the most effective of all medicines. Their success is reflected by their continued use and the decrease in morbidity and mortality from bacterial infections over the past 50 years. In recent years, however, the increase in the number of multidrug- resistant bacteria has led to the prediction that we are reentering the pre-antibiotic era. Even commonly occurring bacteria have been transformed into invasive and toxin-producing pathogens. New antibacterial drugs are needed to fulfill this unmet medical need. The exit of major pharmaceutical companies has created an opportunity for smaller companies to enter the antibacterial field, attracted by the lower development costs and by the concentrated prescribing of antibiotics directed at hospital infections. With smaller companies coming up with drug discovery units, demand of antibacterial drug discovery scientists is also increasing Skills and knowledge required to work as a Discovery working group (DWG) leader in anti bacterial drug research The DWG leader must understand following criteria of scientific projects as suggested by NIH for discovery and development of some drugs: Significance: The DWG leader should find out whether the new drugs of particular class are needed for fulfilling the unmet medical need. He/she should understand how scientific knowledge or clinical practice will be advanced by using this new advanced drug. He/she must have an idea about effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive the antibiotic discovery field. The DWG leader should be able to explain the likelihood that it will produce a new candidate drug for development. Approach:  The conceptual or clinical framework, design, methods, and analyses should be adequately developed, well integrated, well reasoned, and appropriate to the aims of the project. The DWG leader should have scientific knowledge about the assays to be set and should be able to give timelines for standardization of different assays needed for the project by discussing with concerned scientists. The leader should acknowledge potential problem areas and consider alternative tactics.   There should be a sound scientific rationale for the proposed molecular or clinical targets.   The targets, screens, and preclinical models relevant to drug discovery for antibacterial research should be listed by the DWG leader. If pharmaceutical partnerships are proposed, the leader should have capability to facilitate the development and evaluation of candidate drugs, tools for preclinical research, and model validation for testing therapeutics. Innovation:  The discovery should have some innovative concepts. Even though it is a me-too kind of molecule some of the characteristics of the new drug should be novel and advanced than the existing drug. The DWG leader should be able to suggest some innovative ideas at certain stages of discovery. These ideas should be implemented at right time. Interaction and leadership skills:  The DWG leader must ensure effective intra-group communication, interaction, cohesiveness, and coordination among the discovery project scientists. Extensive inter departmental coordination is must for collaboration and sharing of information. The oral, written and information technology skills are required for the DWG leader for effective communication with collaborators, senior scientists and internal management. A broad and extensive knowledge and understanding of the complete drug discovery and development process for pharmaceutical entities is a must for the DWG leader to lead the project team successfully. Strong leader ship skills are required of a DWG leader for implementation of the suggestions given by senior scientists or heads of the different groups. Environment:  The DWG leader should create a technical and scientific environment in which the work will contribute to the probability of success. He /she should work towards getting support from the administrators for implementation of the decisions. For example if any costly laboratory equipment is needed for the scientific work to progress, the leader should be able to convince the institution or higher bosses for purchase and installation of such an instrument. Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the leader should ensure that work is done as per Institutional Animal Ethics Committee rules for all the required animal studies. Biohazards: The leader should have adequate knowledge of the biosafety. Standard operating procedures for discard of animal carcass and in vitro Microbiological material should be there in the working laboratories and he must ensure that discard is done as per the laid down safety rules as per environmental health and safety (EHS) rules. Protocol maintenance and implementation of plans: The DWG leader must go through and must learn whether the proposed plans for making research tools, synthesis protocols, analytical tools, preclinical models, IND filing information, or other resources generated under the project widely available to the scientific community are appropriate after discussions with concerned department scientists or heads. Intellectual property rights and confidentiality: The leader must keep confidentiality of all the discussions and data generated during discovery. The data should not be published in any forum until patent rights are not secured. Timely publication of major findings by the Group members is encouraged once patents are granted. The research scientists groups under the DWG leader must follow the Intellectual Property Patent Rights Agreements for New Chemical Entities or the data and research resource sharing plans as per the contract agreement with the collaborators. Collaborative Responsibilities: DWG leaders should ensure that there is a monthly or bimonthly DWG meeting is held which includes DWG leader, individual laboratory research project leaders, core directors and scientists. In case of collaborative projects it is the duty o DWG leader to collate and present the data to the collaborator group. Duty towards Development group: The DWG leader must ensure that selected candidate molecule after lead optimization goes further for IND-directed toxicology, safety pharmacology to support phase I studies. A plan must be developed for disposition of combinatorial and compound libraries generated in research projects focused on discovery of new chemical entities as clinical candidates for drug development. For proof of concept studies, the leader should give priority to first-time or early trials of IND-ready agents with pre-clinical profiles suggesting the possibility of therapeutic effect in human disease.  Reporting: A final progress report or a clinical candidate nomination document should be prepared by the DWG leader by compiling all the data generated in different departments. Plan for developing the skills and knowledge : Understand how antibiotics work and how resistance to them emerges. Form a clear picture of the variety of ways bacteria are infected by antibiotics and how drugs select for drug resistance. Learn how and why various antibacterial targets are chosen for new drug development. Understand how new technologies (rapid DNA sequencing and analysis, high throughput screening, etc.) contribute to the drug discovery process. Learn how changes to the structures of small natural products can be done by genetic, rather than chemical means. Understand the amazing biochemistry interactions involved in the mechanism of action of antibiotics Learn about different antibacterial drug classes; strategies for drug design--including structure-activity relationships; and issues of oral stability, drug absorption, and drug resistance To implement the biological safety rules in the laboratories Checking of calibration and proper working of the equipment in the laboratory Quality check of all the experiments performed in the laboratory Understand and study pharmacokinetics and pharmacodynamics of the drugs Develop leadership skills by attending leadership workshops and training Learn to interact well with the peer group and other scientists in the discovery working group. Learn to lead the group and give scientific input to the DWG team for the progress of the project Learn to communicate well with the collaborators Learn about the patent filing , pharma regulatory affairs to enhance the knowledge Learn to write the clinical candidate nomination documents, project summary documents, protocols, monthly reports, quarterly reports, experiment reports To teach and guide the research scientists in the DWG team Conclusion: The DWG leader himself/herself is complete package with most of the knowledge and experience required for antibacterial drug discovery in totality. He is able to take all responsibilities required for progress of a new drug till the preclinical toxicity level. He has somewhat grasp of all the related subjects required , for example, Medicinal Chemistry, Pharmacokinetics and Toxicity or drug safety evaluation . Thus a DWG leader has a special and important role to play in a drug discovery organization. He/she works as a link between bench worker scientists and the decision makers in the organization. Finally report making and preparation of IND documents is also a responsibility of a DWG leader. References 1. Role of Scientists in professional development of science teachers Committee on Biological Teacher’s In service Program Board on Biology Commission on Life Sciences National Research Council National Academy Press, Washington D.C. 1996 2. Symposium Article : The changing environment of graduate and postdoctoral training in drug metabolism: viewpoints from academia, industry, and government jeffrey c. stevens, dennis c. dean, peter c. preusch, and maria almira correia Volume 31 No. 4 : 360-366 January 2003 3. Nature Biotechnology Volume 24 Number 12 December 2006 Antibacterial discovery and development - the failure of success? Prabhavathi Fernandes 4. Department of Health and Human Services Participating Organizations National Institutes of Health (NIH) (http://www.nih.gov) Title: National Cooperative Drug Discovery and Development Groups (NCDDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U01/U19) August 29, 2008 - Notice (NOT-MH-08-022) 5. www.acs.org/shortcourses : short courses on drug discovery Antibiotics And antibacterial agents 6. News : New antibiotics are needed as resistance grows, expert says Philip Wilson 12 September 2008, doi:10.1136/bmj.a1660 British Medical journal 2008; 337:a1660 7. Sci Topics : Research summaries by experts Drug Discovery and Development: Traditional Medicine and Ethno pharmacology Perspectives 23 January 2009 Read More