Life Science & Innovation

If you haven’t looked into 3D printing yet, maybe you should.  3D printing started in the mid-80’s but it is now  emerging as a technology that may well change the way many products are created.  Oxford University has demonstrated that a 3D printer can make synthetic tissue, Oxford Performance Materials out of Connecticut has “printed” a skull implant, and Cornell University has fabricated an ear using this technology. A Dutch architect, Janjapp Ruijssenaars, plans to build a house using...

When a company ventures down the FDA approval process, they can expect to communicate with four key groups. These groups include regulators, the medical scientific community, the patient community and investors. Although each group differs, companies should ensure that the messages delivered throughout the process to each of these groups are accurate and consistent.

In this e-book from our Life Sciences Group, we've laid out some tips on how to deliver your message throughout each step of the...

This month's Special Delivery includes:

• Update Your Email Preferences
• Key Tax Elections on 2012 Returns
• A "Perfect Storm" of Tax Deductions
• New IRS Program for Misclassified Workers
• Obama Signs Cybersecurity Executive Order
• Free Life Sciences E-Book: Delivering the Right Message Throughout the FDA Approval Process
   

Update Your Email Preferences

As business advisors, we want to make sure we are providing our clients and business contacts with messages and updates relevant to your individual and/or...

Phase II of the qualifying advanced energy program is now in effect by re-allocating Phase I credits that remain.  The IRS just announced that $150 million are available under this program for clean energy and energy efficiency manufacturing projects in the United States.  To be considered for any of these credits, taxpayers must submit concept papers to the US Department of Energy (DOE) by 4/9/13 and applications to the DOE and IRS by 7/23/13.

Below are definitions per the Notice.

A qualifying...

Just Google “crowdfunding” and you will be rewarded with hours of entertainment.  Main Street’s attempt at bargain investment opportunities held exclusively for years by Wall Street, “accredited investors,” and venture capital firms has taken flight in a big way.  The impact to innovation is immeasurable.

Med City News reports that the new kid on the block is Christie Street, which focuses on products – gadgets if you will – rather than novelties, services, or other Kickstarter-like...

The American Taxpayer Relief Act of 2012 (the Act) extends the Section 41 Research & Experimentation Tax Credit (or the R&D Tax Credit) for two years retroactively from January 1, 2012 - December 31, 2012.  In addition, the Act clarifies the treatment of qualified research expenditures (QREs) in an acquisition or disposition of a trade or business.

The taxpayer acquiring the trade or business is to prorate the target’s QREs, gross receipts and related base year impact using the number of days...

If your company is in a Life Science and Innovation industry, such as biotech, biomed, health IT, nanotechnologies, or communications, you may receive money from local, state or Federal grant programs to fund the research or clinical trials on your drug, medical device, or disruptive technology.  Be knowledgeable about the agreements you’re signing - as a high school professor once taught me, “There’s no such thing as a free lunch.” 

These monies often come with extra responsibilities that can...

Starting a successful business requires more than a great idea, it requires funding. Beyond your traditional sources - banks, credit unions, loans from family or friends - there are other options.

See Seeking funding for your startup? Consider nontraditional sources on Crain's Cleveland Business's Guest Blog for more information.

Overview

The Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act enacted excise tax on sales of medical devices by manufacturers, producers, or importers of such devices.  The tax, which is effective January 1, 2013, is imposed by IRC Sec. 4191 and is equal to 2.3% of the sale price.

A taxable medical device is any device defined in § 201(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA) that's intended for humans....

Beginning January 1, 2013, all sales of medical equipment will be subject to a new 2.3% excise tax.  This tax was enacted through The Health Care and Education Reconciliation Act of 2010.

The tax is on the selling price - not on profits - and is paid quarterly on Form 720.

This tax is being imposed on the manufacturers of devices listed with the FDA.  This includes equipment and supplies for both medical and non-medical uses as long as they are a listed item with the FDA.

Since you should expect...

Life Science and Innovation entities should think about whether their business will be considered a Development Stage Entity (DSE).  DSEs have additional financial statement disclosure and reporting requirements that management, owners, investors, and third-party reviewers of DSEs should understand. 

According to Financial Accounting Standards Board (FASB), startup companies that are devoting substantially all of their efforts to creating a new business may be considered DSEs if either 1) the...

As long as the dividend rate remains at a lower rate than ordinary income rates, the Interest Charge – Domestic International Sales Corporation (IC-DISC) could be beneficial for your exporting business entity.  Four years ago, companies were apprehensive about this due to the potential for increasing the tax rate on dividends.  However, for those that went ahead and set up their IC-DISC, they still are benefiting from the permanent tax savings due to this rate differential.

In general, the...

Did you know that if you’re filing a Form 6765 (Credit for Increasing Research Activities) for your business entity, you are most likely eligible for an R&D credit against your CAT also?  The Ohio credit is called “Credit for Qualified Research Expenses.”  It is a non-refundable credit, meaning it can only be used against a tax liability.  However, keep in mind that the CAT is a tax based on Ohio gross receipts not net income.  Therefore, even if you are not able to use the R&D credits on a...

Don't forget to check out parts one, two, three and four of this five part FDA Approval Process blog.

Our fifth and final step in this five part process is the Approval phase, which states that you must continue to utilize and expand these relationships that you have built.

Regulators – Use the partnership that you’ve created with the FDA.  Listen and use the valuable information and insight that can be provided.  Focus on any flaws of the product and be prepared to defend and embrace those...

Don't forget to check out parts one, two and three of this five-part FDA approval process blog.

After developing, maintaining and taking action on our relationships we continue this process with Phase III, where we will utilize and expand these relationships.

Regulators – Gain agreement on New Drug Application (NDA) filing intentions.  Be transparent with the FDA on your Phase III data and risk management plans.  Prepare for your FDA advisory committee meeting that will occur after approval...

Don't forget to check out parts one and two of this five-part FDA approval process blog.

Now that we know about initiating and maintaining relationships, we will continue on to Phase II where we will learn how to take action on these relationships.

Regulators – Early on you should be establishing your target product profile, looking at doses, regiments, end points and patient outcomes.  Consider whether you should take the Fast Track or Orphan Designation.  According to Wikipedia, the Fast Track...

Don't forget to check out part one (Pre-Clinical Phase: Communication Strategies) of this five-part FDA approval process blog.

Now that we know about initiating relationships in the Pre-Clinical phase, we must continue this process by maintaining and growing these relationships In Phase I.

Regulators – Maintain a dialog and ensure there is sufficient information on your product’s safety and tolerability.  Avoid program delays by making sure all clinical trials are full.

Medical Scientific Community ...

I recently attended an event sponsored by BioEnterprise where speakers from ProEd Communications and Fleishman-Hillard discussed the importance of companies’ communication strategies during the FDA approval process. 

Overall, companies venturing down the FDA approval path want to ensure that the message they’re delivering throughout the process is accurate and consistent.  The product being approved should be solving an unmet need and you should be able to provide clear support for the science...

Generally, when one thinks of a successful grant application, the first concept that may come to mind is “innovative research or technology”. What some may not know is that the grant application process may actually be more of a “who-you-know” game.

According to G2G Consulting, a firm that links organizations with government opportunities, while innovation is important, the key to a successful federal grant application (and future applications) is to develop a relationship with the specific...

One of the most common surgeries affecting our aging population is the hip replacement. However, from reading the news lately it seems like a risky fix for someone’s aches and pains. Especially when it comes to all-metal hips. Over the past year the FDA has had over 5,000 complaints related to all-metal hip replacements, the devices have a 12 to 13% failure rate, and corporations selling these devices have been issuing voluntary recalls and experienced lawsuits. 

Part of the problem may stem...