How can an early legal resolution, like can you drop charges against someone before court, affect the decision-making process concerning resource allocation for a toxicology study? In pharmaceutical and biotech research, eliminating the legal risks and barriers to conducting research is important. Legal risks can come up at various times, including during contract phases, indemnification and insurance negotiations, and the very beginning of a project, which can delay the critical path of research. Proper planning, from a legal perspective, can save time and keep a project on schedule, without unnecessary spending. The legal management of drug development efforts can be critical, and working with experienced attorneys can help save money on projects at the “front end” of a project, which can be beneficial later on.
How does a company manage legal hurdles in drug development? The management of legal hurdles in pharmaceutical research can vary, and it is common for companies that are managing routine legal issues to work with outside counsel, or corporate counsel, for advice and strategy. Companies in the drug development space have consultants who may help build the search firms, order studies, conduct site visits, etc. While legal management is critical in the early phases, most lab management firms do not cover this side of a company’s operations.
How can the management of legal hurdles in drug development affect overall project management decisions? Successful drug development companies seek to optimize their resources, both in terms of the effective management of human resources and in terms of allocating available funds in such a way as to maximize efficiency, while not getting lost in bureaucratic hurdles that affect the overall results. This often includes resolving legal issues with contractors and subcontractors, internal teams and employees, and legal obstacles that arise at any phase of product testing.
What are some legal hurdles that pharmaceutical and biotech companies frequently face, and how can those hurdles affect the “front end” of development? There are a number of legal hurdles that a drug development firm may face, however, most of them can be eliminated through strategic planning from the “front end” of the project, when the research is being planned out, known as the “front end” phase of drug development.
How can a company get rid of legal hurdles, including dropped charges, before a court date? Dropping charges before a court date, which is relatively common among certain types of disputes, can be handled easily by working with experienced litigators, who know how to reduce the litigation burden on companies and read the front end of a project, clearly mapping out likely risks and pitfalls in advance.
For more information on legal processes and regulations, you can visit the U.S. Courts website.