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...
Newsletters & Blogs
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...
HOW TO CONVINCE INVESTORS TO FUND TECHNOLOGY STARTUPS
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”...
The ability to learn and adapt is crucial for entrepreneurs
Before starting a business, some entrepreneurs feel they must spend a great deal of time studying up on every aspect of the process. And that's good – but at some point entrepreneurs need to “pull the trigger” and get started. Part of the job of entrepreneurs is to learn and adapt . Seeking guida...
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...
Entrepreneurs: Laying a strong foundation with planning
There may be a multitude of factors to consider and address prior to starting a business from scratch. Without previous experience in the area, entrepreneurs in New York might not always be fully prepared to tackle every aspect of the process. As having a strategy in place may be a vital step tow...
How entrepreneurs can learn from experience
While taking steps to prepare for what comes next could prove a vital part of starting a business, in some cases, one of the best ways to learn could be from experience. One form of experience that could teach entrepreneurs in New York a multitude of lessons pertains to dealing with failure. Whil...
Developing a financial strategy prior to forming a business
Prospective business owners in New York and elsewhere may encounter a variety of challenges upon deciding to start a new company. For many entrepreneurs, one of the most pressing concerns of forming a business could pertain to the financial aspects of the process. Since the financial well-being o...
Entrepreneurs: Learning how to influence and inspire others
There may be a variety of factors that could influence the level of success a business will be able to achieve. One factor that might be a common concern for many prospective entrepreneurs in New York could pertain to finding ways to inspire and influence those around them. Whether in dealing wit...
Overcoming the hurdles all entrepreneurs may face
While owning a business could come with its own set of potential rewards, there could also be a variety of challenges associated with the process. Entrepreneurs in New York may encounter numerous hurdles as they attempt to cultivate a successful business. Overcoming these hurdles could play a vit...
Entrepreneurs: Building a company that stands the test of time
Entrepreneurs need to plan – and also realize that things often don't go according to plan. Those who wish to improve their chances of success could benefit from having a strategy in place to promote survivability and growth. Recent studies indicate that nearly half of all startups begin to strug...
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 ...
Entrepreneurs: Cultivating healthy business partnerships
Many business owners in New York and elsewhere may feel that developing professional relationships and partnerships is an integral part of building a successful enterprise. However, similar endeavors can also come with a certain level of risk. Prospective entrepreneurs who wish to take advantage ...