Save as PDF RSS Feed Subscribe

Entries tagged “Biotechnology”

Corporate Governance in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · August 14, 2014
So how do biotech ventures govern themselves to run efficiently while complying with state corporate law statutes and state and federal securities laws and regulations imposed by stock exchanges? Frugality that is often self-imposed by scientific founders and then endorsed by the angel investors and venture capital company investors that follow

Continue Reading…

Capital Structure Particulars in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · July 31, 2014
The public securities markets and the underwriters that lead biotech companies into them dictate a common capital structure suitable for IPOs, which structure almost always deviates starkly from the capital structure of the venture at inception and during its growth phase. Startups frequently commence corporate life structured as limited liability

Continue Reading…

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · July 24, 2014
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

Continue Reading…

Success Protecting Intellectual Property in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO

Insight Mark H. Mirkin Mark H. Mirkin · April 22, 2014
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

Continue Reading…

The FDA Drug Approval Process in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · February 25, 2014
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,

Continue Reading…

Tech Transfers in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · February 19, 2014
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,

Continue Reading…

Introduction to Series on the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Insight Mark H. Mirkin Mark H. Mirkin · February 11, 2014
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 because of

Continue Reading…