Alert: Drug and Device Developers Should Be Aware of the Expanded Access Policy Requirement under the 21st Century Cures Act.

By Vicki G. Norton and Sandra Stoneman

Introduction
With Congress’s recent passage of the 21st Century Cures Act (the “Cures Act”) by an overwhelming majority, and President Obama’s anticipated signing of the bill, we expect that the Cures Act will soon become law. The Cures Act is intended to accelerate development and FDA approval of medical innovations such as cancer treatments, precision medicine and regenerative medicine.
The Cures Act also is designed to provide easier patient access to experimental therapies on a “compassionate use” or “expanded access” basis in response to patient demand for easier access to these therapies before they are FDA-approved. Companies engaged in clinical trials will need to adopt corporate expanded access policies and make them publicly available within the deadlines set by the Cures Act (described below).
If you have any questions about how to develop, implement or manage an expanded access policy or how any other aspect of the Cures Act will impact your company, please contact Vicki Norton, Sandra Stoneman, or any other member of the Duane Morris Life Sciences practice group. Continue reading Alert: Drug and Device Developers Should Be Aware of the Expanded Access Policy Requirement under the 21st Century Cures Act.

“Confidential” vs. “Trade Secret” – A Non-Binary Dilemma

Virtually all life sciences companies use routine protocols which they believe will protect their intellectual property and other confidential or “trade secret” information.  Among these routine proactive protocols are having a standard confidentiality/nondisclosure agreement (sometimes referred to below as “NDA”), limiting access to confidential and trade secret information, periodic internal audits of safeguarding methods, and more.    But are “trade secrets” the same as “confidential information?”  Continue reading “Confidential” vs. “Trade Secret” – A Non-Binary Dilemma

COMMINGLED INTELLECTUAL PROPERTY–LIKE PEANUT BUTTER AND JELLY?

By Jennifer A. Kearns, John M. Neclerio and Vicki G. Norton

Who doesn’t like the favorite sandwich of childhood – peanut butter and jelly? The two substances blend and meld together, creating a delectable gooey, messy, sticky and sweet treat.

In the life sciences, commingled intellectual property can also create “gooey,” messy and sticky problems for companies. Unfortunately, there’s nothing sweet about commingled IP and the complications that can arise from it, and you can be sure that an experience arising from claims of commingled IP will leave a sour taste in your mouth.  Here we discuss proactive or preventative steps that companies can take to reduce the risk of commingling IP.

Continue reading COMMINGLED INTELLECTUAL PROPERTY–LIKE PEANUT BUTTER AND JELLY?

Clean Room Lessons from Abercrombie & Fitch

Abercrombie & Fitch. “A&F.” As a not-infrequent visitor to shopping malls, this blogger is familiar with the brand. It’s nearly impossible to avoid the A&F “brand.” Until recently, A&F stores were infused with a cloying cologne scent, puffed into the ambient air. One couldn’t walk past an A&F store without inhaling a snootful. A&F was also in the news when its CEO declared that the brand’s products were only suitable for “good-looking, cool kids” and suggesting that overweight persons did not belong in A&F clothes. Over the years, A&F has made headlines for its provocative marketing campaigns and products (e.g., a t shirt reading, “it’s all relative in West Virginia”). If the longevity of a company is judged in part by its remaining “relevant,” one has to acknowledge that A&F has managed to consistently stay in the public’s consciousness.

So, how is any of this relevant to life sciences companies, whose work forces tend to be highly educated and unconcerned with measuring up on the A&F “cool kids” meter. Well, A&F has been in the news recently, and in a big way that does have relevance for employers everywhere. I’m talking about the hijab case. Continue reading Clean Room Lessons from Abercrombie & Fitch

Expanding Access to Experimental Drugs

Drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use prior to approval by the Food and Drug Administration (FDA). Over the past year social media campaigns have spotlighted patients seeking early access to potentially life-saving treatments, drawing attention to the growing debate between patient advocates promoting wider access to investigational drugs, and those urging more cautious approaches. Propelled by the plight of critically ill patients desperately seeking new treatments, several states have passed laws giving patients the “Right to Try” investigational drugs or biologics. FDA has also taken steps to make its “Expanded Access” process more user-friendly, and the Agency continues to solicit input from patient groups on risk-benefit analysis and available treatments as part of its Patient-Focused Drug Development Initiative.

Companies may want to monitor regulatory and legislative developments relating to early access to investigational treatments, and to adopt formal compassionate use policies.

Continue reading Expanding Access to Experimental Drugs

American Chemical Society Entrepreneurial Showcase 2015

The American Chemical Society held its annual Entrepreneurial Showcase in San Diego at Jannsen Labs (J&J Research Labs) in April 2015. ACS holds the biannual event, showcasing entrants from across the U.S., at Boston, Washington D.C., or San Diego.

The Showcase was a pitch event for emerging companies to present their technology, business plans, and answer some brief questions in front of angel investors, venture capitalists, corporate scouts, and Continue reading American Chemical Society Entrepreneurial Showcase 2015

Are you Emotional about your Med Device?

Steve Honig reports on the April 10, 2015 MassMEDIC presentation on integrating the “human factor” into medical device design, as well as the March 6, 2015 MassMEDIC presentation on Trends in Med-Tech Device Funding.

Originally posted on the Blog Site of partner Steve Honig, at  www.honiglawblog.com

MassMEDIC, the trade association for the Massachusetts medical device industry, hosted a program this morning built around integrating the “human factor” into device design. The FDA’s 2011 draft guidance (promised to be made final this year) includes the usability of medical devices as one criterion in device approval.

The presenters, from the consulting firm Contiuum and the drug company Sanofi, noted that successful devices (including those which deliver medication) must not only satisfy the fundamental standards of safety and efficacy, but also must be sufficiency appealing to the user (whether a member of the public or health care professional) in order to gain traction in a competitive, consumer-marketplace. “The success of a product depends on your users.”

The panel noted anecdotal experiences wherein products which were both safe and efficacious nonetheless failed in the marketplace because they did not address human factors: is the physical design sufficiently appealing to reinforce use, are the cognitive factors so clear that the manner of use is understandable and comfortable, does the device achieve an emotional reaction in the hands of the user.

Techniques for having usability march hand-in-hand with product design include integrating the human factor early in the design process, undertaking biometric and other studies of devices in actual use (even if they are nonfunctional “dummy” devices), and testing, redesigning and testing again.

Certain products, particularly those not analogous to those already in the marketplace, require careful writing of instructions for use. In these cases, the FDA will focus on the instructions both for their own understanding and in order to make sure that the product in the marketplace will perform safely and as the engineers anticipate.

The emphasis on usability and the consideration of human factors in the design of products reflects society’s growing “consumer” emphasis. Products will not be successful unless they are used as intended, notwithstanding their theoretical efficacy; utilization in the hands of the consumer requires consumer buy-in which in turn depends upon both ease of use and a positive human-emotional reaction to the user experience. It is interesting to hear engineers engaged in the “softer side” of product development but, it seems, the blending of human factors into device development is becoming a standard goal, and the only question is: how can you make sure the engineers are sufficiently exposed to that aspect so that the ultimate products are successful in the marketplace.

Trends in Med-Tech Device Funding

Originally posted on the Blog Site of partner Steve Honig, at  www.honiglawblog.com

At the March 6th meeting of MassMEDIC, the association of the medical device industry, two expert panels discussed both the key attributes which an early stage company must have to attract financing, and the landscape for obtaining that financing.

Requisite Attributes: A panel including Mass Medical Angels, an institutional investor and a large strategic industry investor shared a fundamental viewpoint: you need an appealing story which is well told and understandable, initially in a brief presentation or slide deck (it need not be a full offering memorandum), describing the problem, the solution and its novelty. Intellectual Property should be identified but need not be dwelled upon. For an emerging company, the core team may be important but it can be reasonably small; successful emerging companies are very parsimonious with money, and many problems (such as regulatory and reimbursement) can be farmed out. Good founders are imaginative and make due with short dollars in early stages.

How important is the team? For the angels and the institutional investor, seemingly quite important. When you get to a strategic acquiror, even one which purports to invest in early stage and no-revenue enterprises, the founders are important but, let’s face it, a strategic is liable to impose its own management team, or integrate a company into its own management structure, pretty quickly.

One interesting side note: general consensus that if there is more than one founder, the back and forth process generally creates a superior company than in a single-founder situation.

Where Is The Money? There is hope for financing life science companies, including medical device companies in Massachusetts. One serial entrepreneur on a second panel noted that money was more easily available on the East Coast than in Silicon Valley in the life science space. The venture fund on this panel, Norwich, noted that about half of their investments are in companies run by first time entrepreneurs, so there is hope for that cohort.

Some other interesting take-aways on finance:

No one was big on crowd funding. It is not intelligent money, and a large number of investors will scare away institutional future rounds.

For the new emerging company, angels can often provide sizable amounts of money. There was also advantage in being in an accelerator, and the Boston Medical Accelerator and M2D2 (the accelerator at University of Massachusetts at Lowell) were mentioned.

SBIR grants, while slow and difficult to get, can fund pure startups with no traction. The phase one disbursement of up to $250,000 is often a stepping stone, if progress is made, to phase two funding of up to $1,500,000, although it was suggested that on a strong showing of prior progress some companies might be able to jump directly into phase two.

Other issues in attracting capital (weighted differently as between angels, venture fund and strategic investor): Is the product buildable? Is the idea proven or is there an understandable road to proof through clinical trial? Have the founders thought about a logical exit (the exit may change over time, but are they sensitive to the fact that there has to be a pay day somewhere down the road)?

FDA’s Final Guidance on the Circumstances That Constitute Interference with a Drug Inspection

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.

Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the Food, Drug, and Cosmetic Act (FD&C Act) prohibited drug facilities from denying FDA: (1) entry or the opportunity for inspection or; (2) refusing access to or the opportunity to copy specific records. Section 707 of the FDASIA extends this prohibition, through section 501(j) of the FD&C Act, by deeming a drug adulterated if ” … it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” This provision extends to “any factory, warehouse, or establishment in which … drugs … are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such … drugs … in interstate commerce.” FDASIA also adds section 704(a)(4) to the FD&C Act, allowing FDA to “request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or information that FDA may inspect under section 704(a).”

To read the full text of this Alert, please visit the Duane Morris website.

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include:

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled “Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),” which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA’s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.