Industry Best Practices

Patent systems can provide an advantage to society by rewarding the development of new inventions, promoting the advancement of technology and protecting the investor.  Patents often are the most important, and sometimes only, asset of a biotech company. Patents and related rights must be obtained in a timely and predictable manner and the ability to enforce those patents is critical.

BIO released a survey on licensing trends between universities and companies.

April 2 2014
BIO joins coalition letter to Chairman Patrick Leahy and Ranking Member Chuck Grassley expressing serious concerns with the direction of patent legislation.
March 1 2012
  Comments on a proposed Texas Administrative Code that would classify biologics as specialty drugs. 
April 18 2011
BIO supports the Agency's efforts to fully utilize new electronic health care data sources for post-approval pharmacoepidemiologic studies. These new data resources offer great promise to revolutionize the practice of pharmacovigilance with more timely and cost-effective methods for conducting post-market studies, but great care must be taken to minimize the potential for confounding and bias. We hope the Draft Guidance will provide additional transparency in scientific exchange between FDA and Sponsors when initiating appropriate pharmacoepidemiological studies in a regulatory context. With this goal in mind, we request clarification of several aspects of the Draft Guidance, particularly around the process for submitting and reviewing study protocols.
April 13 2009
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Good Importer Practices. This guidance provides a useful quality systems framework for importers across all FDA-regulated industries to promote the safety of imported products. Biotechnology companies are currently leading significant efforts to further enhance the safety and security of biopharmaceuticals at every step of the supply chain and we encourage the FDA to minimize the potential for divergence between this guidance and current drug and biologic Good Manufacturing Practices regulations.
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.
July 25 2007
The Biotechnology Industry Organization (BIO) today launched a new program, Excellence Through Stewardship: Advancing Best Practices in Agricultural Biotechnology, the first industry-coordinated effort to address product stewardship and quality management.