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...
Newsletters & Blogs
The Importance of Partnering with Outside Counsel on Strategic Planning
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 inna...
5 Startup Equity Mistakes and How to Avoid Them
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 going after that vending machine Snickers bar (or two!!) when your stomach is gr...
Representations and Warranties: What Life Sciences and Technology Startups Need to Know
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...
Demystifying the Investigational Device Exemption Process
The FDA regulatory gauntlet can be a daunting challenge. That's especially true for startups new to the field. But it need not be. The process serves an important purpose—ensuring that new drugs and medical devices marketed to the public are safe, effective, and result in the intended health outc...
6 Risks Hiding Inside Your Contracts
Are you overlooking areas of risk that may be lurking in the contracts you have entered into? Below are 6 commonly missed issues. 1. FAILURE TO OBTAIN A CONTRACT IN WRITING Lack of a written contract can lead to misunderstandings about what was agreed to – which can ultimately lead to litigation....
Tips to Follow and Mistakes to Avoid in the FDA Investigational New Drug Process
Drug sponsors face a long and winding path to take a drug from discovery to market. The Investigational New Drug Application or IND is a key step in this journey. The IND application is the process by which a new drug sponsor must receive approval from the Food and Drug Administration (FDA) to be...
Patents For Humanity Program Improvement Act – Acquisition And Sale Of “Acceleration Certificates” By Small Biotech Companies
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 Patents for Humanit...
The Benefits Of Orphan Drug Designation
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 t...
Insider Theft and IP Protections – A Cautionary Tale
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. ...
FDA Developments – How The FDA Is Streamlining Its Approval Process For New Therapies
The FDA (Food and Drug Administration) is the regulatory arm of the United States Federal Government that promotes public health through the supervision of food and drug safety, cosmetics, dietary supplements, veterinary medicine, and many more facets of the health care industry. Their oversight ...
New SEC Rules Broaden Definition of “Accredited Investor”
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...
Conducting Clinical Trials During the Pandemic
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 ...
Coronavirus Infection Waivers: The Good, The Bad – and The Ugly
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 aw...
What Happens When It’s Over? Part Three
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 well. Virtual Learning Here's...
What Happens When It’s Over? Part Two
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 this month's newsletter, I will walk you through the chan...
What Happens When It’s Over? Part One
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 – have you considered some of the changes this public he...
Getting to Yes – How to Negotiate Contracts
Before coming to any type of business arrangement, the parties involved really need to negotiate the details of a written agreement or contract. Knowing how to negotiate contracts to protect your best interests is essential to a positive outcome. There's much to discuss about this complex “dance”...
Why is it Crucial to Develop an IP Strategy for Your Startup?
Launching a startup can be overwhelming – from hiring the right employees, developing an effective and impactful website to sourcing business. With multiple initiatives competing for bandwidth, it's easy to neglect your organization's most valuable assets—intellectual property (IP). Why Should Yo...
Building an Engaged and Cooperative Team
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, you'll be working with your team every day ...
How to Prepare for a Licensing Negotiation
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 company to help with manufacturing, marketing, product development, selling and oth...
Creating a Long-term Growth Plan for Your Business
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 be able to h...
The Right Way to Plan and Protect Intellectual Property
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 every year new bu...
Demonstrating Strong Potential to Strategic Partners and 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 the most important things an actionable, realistic and well-thought-out busin...
Avoiding Legal Risks Early in the Business Formation Process
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 turn that idea it into a great busines...