Further Reading On Intellectual Property

Patent Strategy for Researchers and Research Managers. Chichester Wiley, 1996. A description of basic intellectual property concepts, the value of patents, and practical advice on doing research with intellectual property protection in mind, creating a strategy for protecting the fruits of research, and working with patent attorneys. Maynard J, Peters H. Understanding Chemical Patents. 2nd ed. American Chemical Society, 1991. Principles of patent law and practice directed primarily...

Biotechnology Associations

Biotechnology Industry Organization (BIO). 1225 Eye Street, N.W., Suite 400, Washington DC 20005, U.S.A. Phone +1 202962-9200, Fax +1 202-962-9201. E-mail info bio.org. URL http www.bio.org . Represents biotechnology companies, academic institutions, state biotechnology centers and related organizations in the United States and other countries. BIO members are involved in the research and development of healthcare, agricultural, industrial, and environmental biotechnology products. Bioindustry...

Syndicated Market Research

As noted in the introduction to this section, market research is a prime resource for competitive intelligence information. Typical market reports will include a detailed description of the particular market, incidence prevalence mortality data (for disease states), key players in the market, and an analysis of where this market is headed. Information from market studies is often used by corporate departments, such as business development and sales and marketing, to identify competitors,...

International Cooperative Efforts The ICH Initiative

The International Conferences on Harmonisation (ICH) represent global collaboration on a larger scale than ever previously attempted by pharmaceutical regulatory authorities. First convened in 1991, ICH programs have focused on development of mutually acceptable guidelines addressing technical requirements for drug testing and registration worldwide. As a result of this work, ICH recommendations have been adopted by many individual national regulatory authorities, making the task of preparing...

Actoxysclorosel

Agency for Toxic Substances and Disease Registry, U.S.A. Department of Health & Human Services. URL http www.atsdr.cdc.gov. Purpose is to provide trusted health information to prevent harmful exposures and disease related to toxic substances. Tracks special issues as well as regulatory information. American Academy of Clinical Toxicology (AACT). 777 East Park Drive, P.O. Box 8820, Harrisburg, PA 17105-8820. U.S.A. Phone +1 717-558-7847. E-mail msouders pamedsoc. org. URL http...

Regulatory Guidance

Department of Health and Human Services, FDA. Guidance for Industry Drug Metabolism Drug Interaction Studies in the Drug Development Process Studies In Vitro. April 1997. URL 25 October 2005 . U.S. Department of Health and Human Services. FDA. Guidance for Industry Exposure-Response Relationships Study Design, Data Analysis, and Regulatory Applications. May 2003. URL 25 October 2005 . U.S. Department of Health and Human Services. FDA. Guidance for Industry Format and Content of the Human...

News

It would be impossible to list every available pharmaceutical news source. The major media networks all have Web sites, usually available for no cost. There are other free Web sites, which offer industry news from wires such as Reuters and Associated Press among others. Also important are the various Internet news sites that carry industry news such as Yahoo Finance (http finance.yahoo.com), CNNMoney (http money.cnn.com), and Bloomberg (http www.bloomberg.com). News is generally delivered via...

Financial Data

In the United States, public companies are required to report their financial performance quarterly, with an annual report required at the end of the fiscal year. Non-U.S. companies with a stock trading on a U.S. stock exchange must also file quarterly and annual statements. Even foreign, public companies not on a U.S. exchange file annual reports for use by investors, analysts, and employees. Annual and quarterly reports are often found on the companies' websites listed under investor...

Anatomy Of A Patent Document

A patent document begins with a first page that identifies the owner and inventor of the claimed invention and the dates of filing, publication, and grant. The front page usually has a short abstract of the invention and, when appropriate, a chemical structure or exemplary drawing. Figure 2 is the first page of a typical U.S. patent, U.S. 5,250,534, covering sildena-fil as a new chemical entity. Patent applications are assigned a serial number when filed and a document number when they are...

Drug Pipelines

A dynamic drug portfolio is the fuel that propels pharmaceutical companies forward. Through organic growth and in-licensing of worthy compounds, pharmaceutical companies are able to launch new products to the market. Pipeline databases allow users to track, analyze, and monitor the drugs being developed by competitors and to identify products for in-licensing and alliances. The databases offer numerous points of access, including a drug's name, generic name, and mechanism of action. Structure...

Associations

Alliance for Continuing Medical Education (ACME). 1025 Montgomery Hwy., Ste. 105, Birmingham, AL 35216, U.S.A. Phone +1 205-824-1355, Fax +1 205-824-1357. E-mail acme acme-assn.org. URL http www.acme-assn.org. Founded 1978. 2500 members. Provides professional development opportunities for CME professionals. Seeks to promote leadership in the development of CME to improve health-care outcomes and the performance of health-care providers. Publishes monthly Almanac and Journal of Continuing...

Postmarketing Safety Surveillance Pharmacovigilance And Product Recall Information Sources

One regulatory hot topic that invariably sparks interest not only within the pharmaceutical industry, but also among the general public, is adverse effects. Despite rigorous pre-launch testing, many drug side effects are not discovered until after a drug is on the market. The patient population is, after all, much larger and more diverse (medically and genetically) than any clinical trial would attempt to emulate. Long-term use of a drug for chronic conditions and its unanticipated...

Commercial Patent Databases

Text searching for pharmaceutical patents has serious limitations. Because drugs are usually expressed as molecular structures, there may or may not be a text description of the compounds of interest. The earliest patent application on a new class of drugs is often submitted during the discovery research phase, long before a generic name has been assigned, and before systematic chemical nomenclature becomes consistent. There are many ways to write the name of a single organic compound, and...

Key CI Sources Specific to Medical Devices and Drug Delivery

Atlanta, GA Thomson American Health Consultants. ISSN 1049-4316. Available electronically. A leading source of news and analysis on market size and direction in the high-tech medical device industry. Clinica World Medical Device and Diagnostic News. UK PJB Publications Ltd. Weekly. Available electronically. Good source for international information, with excellent articles on FDA activities from a non-U.S. perspective. Espicom Business Intelligence. Various publications. UK...

Biomedical Engineering

Biomedical engineering encompasses multiple disciplines, including physics, chemistry, biology, electronics, mechanics, and materials. The devices and procedures developed by biomedical engineers reflect this multidisciplinary field, and can include anything from computers that analyze blood, lasers for eye surgery, and advanced imaging systems, to miniature implantable pumps and tissue-engineered artificial organs. The field has become so specialized that many biomedical engineers, in addition...

The New Drug Approval Process in the United States

In the United States, the two points in the new drug approval process when the government mandates major submissions of scientific data are known as the investigational new drug IND application and the new drug application NDA . In an IND, the investigational drug's sponsor manufacturer or potential marketer presents results of preclinical testing and describes protocols detailed research plans for initial trials in humans. Preclinical data include results of in vitro and in vivo tests to...

Market Exclusivity Provisions Under US

Another hot topic'' associated with product approvals is market exclusivity statutory protection from competition in the form of generic copies . Market exclusivity terms time period allocations for registered drugs are linked to U.S. patent status. When a new chemical entity is first approved for marketing in the United States, its developer has the option to apply for a term restoration'' to be granted on the basic product patent to extend its commercial life by adjusting the patent...

The Drug Registration Process in Europe

Since the creation of the European Union EU , formed with the intent to create a single market without trade barriers, the community of member countries has become the second largest pharmaceutical market in the world. Consequently, access to information regarding drug approvals within its jurisdiction is important to global manufacturers. Since 1995, there are two alternative routes to achieving marketing authorization in any or all EU countries Centralized Registration or Mutual Recognition....

Associations Government Agencies and Organizations

AdvaMed. 1200 G Street NW, Suite 400, Washington, DC 200053814, U.S.A. Phone 1 202-783-8700, Fax 1 202-783-8750. E-mail info AdvaMed.org. URL http www.advamed.org. The largest medical technology association in the world, representing more than 1200 manufacturers of medical devices and diagnostic products. As the industry's key advocate, AdvaMed works for faster payment and coverage decisions from the Center for Medicare and Medicaid Services CMS , represents industry interests worldwide, and...

Assigning an FDA Center of Authority

The OCP is essentially an oversight body, assigning a combination product to the most appropriate center CDRH, CDER, or CBER based upon the primary mechanism of action. For most combination products, a second center is designated the consulting center. The OCP does not perform the actual regulatory reviews. Where there is no clear regulatory path for a combination product, a manufacturer can file a request for designation RFD with the OCP, recommending the center it proposes for primary review...

Other Key Sources Of Regulatory Intelligence

MediRegs, a Massachusetts-based publisher, offers two large, searchable document collections as separate subscription services. The MediRegs Pharmaceutical Regulation Suite, available on CD ROM, DVD, or the Web, focuses on U.S. publications. It includes the full text of public laws, pertinent Code of Federal Regulations and Federal Register material, citations to court cases back to 1938, and a huge compilation of FDA forms, manuals, guidelines, and other...