Hi, I’m Michael H. Cohen, I’m founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today’s video, we’ll talk about how biotech companies can navigate FDA IP and clinical trials, lots of topics very quickly.

So, biotech and life science companies face a maze of regulatory hurdles, from FDA compliance to intellectual property challenges.

Let’s explore a couple of strategies to help get through some of these obstacles.

So first, regulatory planning is critical. By developing a roadmap for FDA approval early on, companies can avoid costly setbacks later. We work with a biotech startup that initially had overlooked some of the key FDA requirements.

With strategic planning and legal input, they streamline their process, saving time and resources later in their negotiations with FDA.

On another front, IP protection is obviously critical. Patents, trademarks, trade secrets, they safeguard innovations. We had a client who was at risk of losing a key innovation to a competitor until they filed for a patent.

So, getting your IP early on prevents competitors from infringing on your own research.

And last, clinical trials, they have to meet a ton of legal and ethical standards. We advised a life sciences firm conducting trials on a new therapy, ensuring that they were able to comply with IRB regulations. Get through the IRB and meet the ethical standards.

And this helped them stay compliant. They got to get their trials through, and they also had a lot more credibility with their investors.

In the biotech field, you really can’t skip any legal advice because that could really mean sacrificing your company’s most valuable assets, protect them early on, figure out whether you need trademark, copyright.

Or patent or rely on trade secrets. Understand your FDA roadmap, get it all mapped out and don’t risk your future. It’s really worth the investment early on. Again, I’ve seen people just fall on their inadequate planning, failing to plan, plan to fail. So get experience advice. It’s worth it.

If you’d like to dive deeper into any of the topics we’ve talked about today, reach out to us, click below.

We’d love to talk to you. We look forward to it.