How to Protect Your Business From These 6 Startup Contract Risks Will a “handshake” seal the deal? As a startup founder, you already know this: written contracts establish the enforceable framework through which your startup operates, raises capital, transfers rights and enters key collaborations. Decisions ...
Artificial Intelligence is Transforming the Medical and Healthcare Industries Just about every industry is experiencing a dramatic evolution with the sudden rise of artificial intelligence (AI). Healthcare and pharmaceuticals are no different. As we recently wrote, the area of oncology is showing promising applications of AI. ...
Why Entrepreneurs Should Rely on a Trusted Advisor to Forecast What Lies Ahead Founders of startups and leaders of young companies have plenty on their plates. It’s tempting for entrepreneurs to focus their attention on immediate priorities. Others prefer to spend their time scratching their ...
Don’t Let Common Equity Pitfalls Derail Your Startup Keeping to the fundamentals can be tough. As an overtasked and overwhelmed startup founder, it’s tempting to look for DIY stop-gap solutions for equity issues with a mantra of “we can deal with this later.” It’s like ...
Time and money. Innovative business ventures are often short on both. So, in the face of competing priorities, it can be tempting to gloss over standard contractual terms—like representations and warranties—with the assumption that they are boiler-plate and relatively unimportant. “We don’t have the time ...
Demystifying the FDA Investigational Device Exemption (IDE) Process The journey to bring a new medical device to market is a complex regulatory gauntlet. For innovators and startups, one of the most critical and often misunderstood steps is securing an Investigational Device Exemption (IDE). An IDE ...
Why the IND Process Matters Drug sponsors face a long and winding road from discovery to market. A critical step on this journey is the investigational new drug application (IND). This is the official process where a sponsor must get approval from the Food and ...
Patents For Humanity Program Improvement Act The Patents for Humanity Program Improvement Act, H.R. 7259, was introduced on June 18th, 2020 and became law on January 5th, 2021. It was a bill that had bipartisan support to improve the United States Patent and Trademark Office’s ...
According to the National Institutes of Health (NIH), there are over 7,000 diseases classified as rare, affecting an estimated 25-30 million Americans. These diseases range from genetic disorders to infections, cancers, or auto-immune diseases. These diseases can be chronic, progressive, and in the worst cases, fatal. Thanks ...
Recently Phil Crowley was asked by Marianne Kolbasuk McGee, the Executive Editor of the Information Security Media Group (ISMG) to weigh in on data security measures that should be implemented by healthcare entities, research labs and other related facilities to help prevent and detect IP theft. Marianne was ...
What You Need to Know to Get Approved Bringing a new drug therapy or medical device to market is a journey fraught with risk and complexity. For innovators and pharmaceutical companies, the path to regulatory approval can feel like an insurmountable challenge, filled with delays ...
The Securities and Exchange Commission recently announced a rule change to expand the definition of “accredited investor” ultimately allowing more participation in private offerings. The rule amends one of the principal eligibility tests to include financially sophisticated investors whose income or net worth is below ...
The COVID-19 pandemic has disrupted just about every national and global industry, and drug companies are certainly no exception.One of the primary concerns for the pharmaceutical industry is the impact on clinical trials of drugs, medical devices, and biological products. These trials are an important ...
No business wants unexpected liabilities. People across the country are returning to work in high-contact and other industries. It’s not just retail and the restaurant trade that are involved. Think of workers in a laboratory, prototyping, or design space. High technology industries need to be ...
The after-effects of the pandemic will be multi-faceted and far-reaching. In Parts One and Two of this discussion, I analyzed changes I expect in the workplace and in the delivery of healthcare services. And I wager you’ll see new approaches in the following areas as ...
Make no mistake – the Coronavirus pandemic is a serious matter. There is no doubt we will see the ripple effects of COVID-19 for months and years to come. None of us will know the full repercussions of our decisions for quite some time. In ...
Make no mistake – the Coronavirus pandemic is a serious matter. There is no doubt we will see the ripple effects of COVID-19 for months and years to come. None of us will know the full repercussions of our decisions for quite some time. BUT ...
Setting the Stage for Successful Contract Negotiations Successful business deals rely on clear agreements. Before you commit, the parties involved must carefully negotiate every detail. This includes crafting a strong, written binding agreement or contract. Mastering how to negotiate contracts effectively is paramount to safeguarding ...
Why Every Startup Needs a Intellectual Property (IP) Strategy Launching a new business is a whirlwind of activity, from hiring talented employees and building an impactful website to securing funding. In the midst of this all, it’s easy to overlook one of your most valuable ...
You have a great idea for a new business, and you’ve passed the concept stage. Now it’s time to start building your team. Putting together the right team for your startup is one of the most important parts of creating any successful business. After all, ...
Bringing Your Innovation to Market: The Licensing Path You have what I call a “high-quality problem.”You’ve created a new technology, idea or invention and you want to bring it to market. Now the fun really begins. Often people with new products look for an outside ...
If you are starting a new business or looking to take your existing business to the next level, the right strategic planning attorney can provide vital assistance in nearly every area, from business incorporation and taxation to trademark and copyright advice. Your lawyer should also ...
If you’re an entrepreneur launching a new technology startup, then you know how important intellectual property is to your business. In fact, for most technology startups, IP is their most valuable asset and often the reason they’re launching the business in the first place. Yet ...
Your Business Plan: The Cornerstone for Attracting Investors If you are a technology entrepreneur or new business owner trying to attract investors and strategic partners, then you need a solid business plan to get their attention. A business plan serves many purposes, but one of ...
Starting a new business is a lot like building a house. The foundation must be strong and well-constructed, or the house comes crashing down. Over the years, I’ve seen hundreds of technology startups and new businesses start off with a great idea and fail to ...