Search Courses
About
Home

Health Law: Life Science Research Institutions & Companies

Your Map

Academia
Health Law
Life Science Research Institutions & Companies

Research and development in the biosciences ranges in focus from pure research to the commercialization of new medical technologies and "bio-devices." A lifescience attorney's practice may be equally as varied. Some represent companies marketing new biotech products and assist clients in obtaining intellectual property protection for their technical innovations or in seeking regulatory approval for testing. Others represent young entrepreneurs seeking venture capital funding or negotiate a variety of commercial agreements to develop and market the new technologies. Their commercial agreements may begin with joint development agreements in the early stages and include agreements with manufacturers and distributors in later stages. Lawyers working in this field may represent either the younger companies or the more established companies seeking to partner with them or to develop their own new products and services. In any of these [...]

Open to see details

Research and development in the biosciences ranges in focus from pure research to the commercialization of new medical technologies and "bio-devices." A lifescience attorney's practice may be equally as varied. Some represent companies marketing new biotech products and assist clients in obtaining intellectual property protection for their technical innovations or in seeking regulatory approval for testing. Others represent young entrepreneurs seeking venture capital funding or negotiate a variety of commercial agreements to develop and market the new technologies. Their commercial agreements may begin with joint development agreements in the early stages and include agreements with manufacturers and distributors in later stages. Lawyers working in this field may represent either the younger companies or the more established companies seeking to partner with them or to develop their own new products and services. In any of these practices, an understanding of business law and the relevant scientific discipline is very useful.

Many research institutions and life science companies confront a growing number of ethical issues raised by advances in the biosciences, such as genetic testing and discrimination, investigational drugs, informed consent and end-of-life issues.

Regulation & Enforcement: Life science companies are also heavily regulated. Biotech companies need regulatory approvals to test and market their new drugs or devices. After the initial development of a new compound or medical technology, pharmaceutical and biotech clients need assistance in obtaining approval for clinical trials from the Food and Drug Administration (FDA). After successful clinical trials and FDA approval for marketing and distribution of the product, these clients then need assistance with a variety of state and federal regulations, as well as export laws, that may affect distribution.

Students interested in a career in regulation and enforcement may consider employment with one of the federal or state agencies that monitor the safety of pharmaceuticals and medical devices, such as the FDA, the Federal Trade Commission, the Department of Justice, and state Attorneys General, who may bring cases based on state consumer protection statutes.

International Work: Transactions and partnerships in drug development, manufacturing, marketing and licensing often take place between U.S. parties and others in Canada, Europe and Asia. Before pharmaceuticals and medical devices can be offered in the European Union and elsewhere, the appropriate regulatory authorities must also approve clinical trials and distribution of the products. Clients may then need help negotiating agreements with product marketing partners and distributors as well as gaining access to sources of capital in other countries.

Government Investigations: Representation of private companies in the biotech industry may also involve government agency investigations, such as “whistleblower” cases initiated by employees. In these cases, lawyers representing defendant companies need to team with white-collar criminal litigators to negotiate with and litigate against the agencies that regulate a particular area of health care products and services.

 
Open to see details
Your Map

Related Law Courses by Topic

Courses Outside SLS by Topic

170 items