Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all such ventures is to manufacture drugs and commence marketing, sales and distribution thereof as soon as possible. As you read in the previous…

For a drug discovery start-up, patent protection of the intellectual property underlying the commercialization pursuit is critically important. If the company is a university or research institution spin-out that obtained licensed rights to intellectual property through a technology transfer, either the licensor or the licensee – as set forth in the License Agreement — must pursue…

The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and after approval. Failure to comply could have serious business and financial con-sequences to a biotech venture, including the FDA’s refusal to approve…

Many biotech ventures begin life as an invention conceived by a scientist/professor working in a laboratory at a federally-funded university or scientific institute. The intellectual property underlying such inventions is owned by the academic institution, a potentially valuable asset to be nurtured. Since enactment of the Bayh-Dole Act in 1980, academic institutions through their technology…

How common it is to hear groans and complaints in the startup sector of the U.S. life sciences industry about the extreme difficulty facing entrepreneurs who are trying to finance the launch, development and growth of a drug discovery venture. We hear that angel investors – both individuals and funds — lack interest in investing…