Biotechnology


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Chappell 
Law Firm, P.L.L.C.

P.O. Box 5243
Edmond, OK 73083-5243
405.340.7755 voice
405.340.7757 facsimile

General Information:
cmc@chappelllawfirm.com

 


"The difficulty lies not in the new ideas, 
but in escaping the old ones..." 

- John Maynard Keynes *


   What does an attorney bring to the table in a Biotech world? 

The ability to minimize risk and help a company navigate the regulatory pathway.

It is no longer sufficient for legal counsel to advise a company on merely what it can or can't do.  The competitive marketplace demands that attorneys provide their clients with practical advice for on-going ways to accomplish their business goals.

In addition to concerns over regulatory issues, it is necessary for biotech companies to obtain financing for continued research and development as to grow as a business.  Attorneys should oversee day-to-day business issues like contracts, licensing, patenting, employment issues, and lease agreements, as well.


The process of deciphering the human genome has revolutionized the biotechnology field.  Scientists are finding themselves immersed in legal and regulatory changes as well as ethical dilemmas.  

Issues that affect biotech companies include: the patentability of genetic information, the conduct of clinical trials involving gene therapy, the approval process for new drugs developed from genes, proteins and other biological components, tissue engineering, fetal tissue research, confidentiality of patient health information, bioengineered food, conflict of interest disclosure requirements for researchers and the transferability of tax credits for research and development.  

Chappell Law Firm, P.L.L.C. can help biotech companies navigate these legal and regulatory pathways and define business strategies that will help them grow and succeed.


THE BIOTECH CENTURY

Science and biotechnology face some daunting challenges in the next decade. 

Some of the legal and regulatory issues that will need to be addressed, include:

  •     Research Restrictions

  •     Disputes over Intellectual Property Rights

  •     Genetic Discrimination

  •     Privacy Concerns

  •     Regulatory Compliance

  •      Financial concerns over developing and 
    commercializing technologies


Biotechnology gives us stonewashed blue jeans, laundry detergent, human insulin and home pregnancy tests. These products and many others are made by living cells and their molecules.

Since early humans began selectively breeding the best plants and animals thousands of years ago, biotechnology has improved our lives. Bacteria and fungi helped make several foods, including cheeses, breads and yogurts.

Today, scientists use many techniques, all grouped under the label biotechnology, to research new treatments for disease, create safer food products and formulate less-damaging chemicals. The techniques allow researchers to insert into an organism a single gene, and the desirable traits it produces, without also transferring other genes and undesirable traits. It's more efficient than breeding whole organisms.


The History of Biotechnology


Biotech Resources:

Access Excellence - a national educational program for high school biology teachers, sponsored by Genentech.

AgBioForum - an on-line quarterly magazine covering the economics and management of agricultural biotechnology.

American Journal of Law and Medicine

American Society of Law, Medicine and Ethics

Bio Online - home page of the Biotechnology Industry Organization, an international trade association.

BioSpace - a commercial site promoting biotechnology.

BioTech - a free educational resource and biotechnology reference tool sponsored by four midwestern universities.

BiotechBasics a biotech food information site sponsored by Monsanto.

Biotech IndustryHome - a new commercial clearinghouse for nationwide industry events, products and services.

Biotech InfoNet - general information on biotechnology policy.

Biotechnology Information Center - one of ten information centers at the National Agricultural Library of the U.S. Department of Agriculture.

Biotechnology News/Newsletters/Journals - a collection of links to online newsletters in biotechnology.

Biotechnology Public Education Program - sponsored by Iowa State University.

Council for Biotechnology Information - a clearing house of information on biotech agricultural products.

FDA's Center for Biologics Evaluation and Research (CBER)

Institute for Biotechnology Information - a provider of biotechnology and pharmaceutical business information and consulting services.

Informagen - a provider of strategic intelligence on commercial biotechnology, including U.S. company listings

The Microbial Underground - a collection of Web pages that contain medical, microbiological and molecular biological material, with links to other such material on the Internet.

MicrobeWorld.org - a gateway to two Web sites, one geared to adults and one designed for children, about microbes and their role in life.

National Center for Biotechnology Information

National Bioethics Advisory Commission

National Institutes of Health - Office of Technology Transfer

Oklahoma Medical Research Foundation 

SciWeb - a web site for life science professionals

United States Food and Drug Administration (FDA)


* Quoted in: K. Eric Drexler Engines of Creation: the Coming Era of Nanotechnology, Bantam, New York, 1987, p 231.


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Last modified: September 19, 2001