New I-Corps program to bring biomedical innovations into the marketplace

In collaboration with the National Institutes of Health (NIH), the NSF Innovation Corps (I-Corps) is introducing a pilot program that will help biomedical innovations advance into the marketplace. The I-Corps program provides biomedical researchers with the opportunity to work with experienced business instructors to seek potential markets for their innovations and learn how to integrate that into a successful business model.

The NIH has a number of institutes that plan to participate in the pilot program, which will add to the 300 teams that have already completed the I-Corps training. Michael Weingarten, director of the NCI SBIR Development Center, has witnessed the benefit of I-Corps, saying that the program “Will help teach NIH-funded start ups how to build scalable business models around new technologies they’re developing for the detection and treatment of disease.”

The collaboration with NIH and the introduction of this pilot program has greatly contributed to the development and efficacy of the I-Corps network. The National Science Foundation’s assistant director for engineering, Pramod Khargonekar, stated that with the program’s emphasis on life sciences, “We expect biomedical researchers will be better equipped to enter the business arena.”

To read the full news release on the NIH website, click here. Are you a start-up in need of regulatory, clinical, or product development support? Contact us at

Regulatory expert warns of “unintended consequences” following new bill

In June 2014, U.S. Congressmen Steve Stivers and Tim Ryan of Ohio introduced the Speeding Access to Already Approved Pharmaceuticals Act, which is currently referred to the House Committee on Energy and Commerce. This Act would require FDA to begin reviewing new drugs within 90 days of approval in the European Union (EU) as part of an effort to reduce “delays in approval for life-saving and life-changing medical treatments.” Many industry representatives, however, have expressed some concerns.

Regulatory expert Matthew Weinberg, CEO of The Weinberg Group says, “there will be a massive number of unintended consequences.” Weinberg begins by explaining the differences between FDA and the European Medicines Agency (EMA). These differences include varying methods for determining the safety and efficacy of pharmaceuticals.  As a result not all products are mutually approved by both agencies.

Weinberg then provides two significant examples of potential “unintended consequences.” First, Weinberg says that by forcing FDA into a 90-day review, the agency will most likely reject the product due to insufficient information, adding that “it’s not their job to get new drugs on the market as fast as possible; it’s their job to protect American lives.” The second issue is that pharmaceutical companies would choose to apply for approval in Europe rather than the U.S., and then force FDA into a 90-day review of the product, which is “unheard of in this country for good reason,” according to Weinberg.

To read Fiona Barry’s full article, click here.

FDA releases final guidance on GUDID with more revisions to come

Back in 2012, FDA proposed to establish a unique device identification (UDI) system to track and identify medical devices in the US. Following the proposal, FDA released a final rule with a complementary draft guidance for a standardized system to be run through their database known as the Global Unique Device Identification Database (GUDID), which serves as an industry resource for product labeling information.

On June 27, FDA issued final guidance on the use of the GUDID with an approach that surprised many industry representatives. Although some changes were made to the final guidance, FDA removed almost half of the content from the draft guidance stating that future revisions would contain more specific details for sections that have yet to be finalized.

To read an article by Alexander Gaffney’s on explaining the guidance, click here. To review the guidance document on FDA’s website, click here.

Need help with enhancing your UDI processes?  Contact us at

Pearl Pathways honored as one of the 2014 Indiana Companies to Watch

CTW-2014WinnerBadge-SmallPearl Pathways is pleased to announce our recognition as one of the 2014 Indiana Companies to Watch, presented by the Indiana Office of Small Business and Entrepreneurship (OSBE), its Indiana Small Business Development Center, the Indiana Economic Development Corporation (IEDC), and endorsed by the Edward Lowe Foundation.

Companies to Watch is an awards program that recognizes privately held businesses that have demonstrated exceptional growth and established a solid foundation for future development. Pearl Pathways is among the twenty-seven companies that will be honored at the 2014 Indiana Companies to Watch ceremony on August 20th at the Indiana Roof Ballroom in Indianapolis.

To read ISBDC’s announcement of the winners, click here. To read the full press release, click here.

President’s advisory council looking to boost antibiotic development

According to the U.S. Center for Disease Control and Prevention, antibiotic-resistant pathogens known as ‘superbugs’ are the cause for around 23,000 deaths and over 2 million infections in the U.S. every year. Alarmed by this data, the President’s Council of Advisors on Science and Technology (PCAST) has authorized a federal plan to encourage the development of new antibiotics; a field that Big Pharma has largely avoided due to substantial risks. In an effort to regain interest, PCAST is promoting federal funding and additional incentives.

Additional concerns of the council relate to the clinical development path for new antibiotics. PCAST co-chair Eric Lander recommends an “ongoing, continuous clinical trial network” in order to enroll patients with antibiotic-resistant infections as quickly and safely as possible.

To read an article by Emily Millin’s on, click here.

Pearl Pathways has extensive experience in infectious disease and antibiotic product development.  Contact us to learn more.

FDA releases social media draft guidance

Alexander Gaffney of posted an interesting article regarding the use of Internet and social media platforms in FDA regulated industry. Many companies have been using such resources to promote products and answer customer questions; however, FDA has been known to issue warning letters and sanctions for “unapproved” or “misbranded” commentary, leading industry to demand guidance. In response, FDA has released two draft documents outlining the requirements and limitations for the use of Internet and social media platforms among drug and device companies.

Released in June, the most recent draft guidance specifically applies to networks with character limitations such as Twitter and sponsored links via Google or Yahoo. As the guidance suggests, FDA is requiring each individual post to contain “material facts about the use of the product, such as limitations to an indication or the relevant patient population…and at a minimum, the most serious risks associated with the product.” For most companies, the task of generating a promotional message to fit these criteria within a limited number of characters is near impossible. FDA urges these firms to reconsider the use of certain social media platforms in this regard .

To read the full article, click here.

Zac Unger joins the Pearl Pathways Team

We are pleased to announce the recent hiring of Zac Unger as a Regulatory Analyst. Unger brings a strong blend of Information Technology (IT), document publishing, and software systems to the Pearl Pathways team. To read the full press release, click here.

FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

FDA and industry groups working to bring patient perspective into the regulatory process

Alexander Gaffney of posted an interesting article regarding FDA’s new Patient-Focused Drug Development Initiative, created to obtain patients’ perspectives on the severity of their conditions and the treatment options currently available. The goal is to increase patient involvement in the regulatory process.

FDA isn’t alone with this idea. In addition to PhRMA’s patient initiative that launched in November 2013, the advocacy group FasterCures is forming a Benefit Risk Advisory Council. Council members come from a variety of backgrounds including industry, patient and trade groups, rare disease advocates, academic institutions, and government. FasterCures’ intention with this group is provide feedback from stakeholders to drug developers and regulators.

To read the full article, click here.

Heidi Strunk to present at IMDMC Regulatory 101 on August 19th

We invite you to join us at the second session of Indiana Medical Device Manufacturers Council (IMDMC)’s annual Regulatory 101 course on August 19, 2014. Session two will cover the post-market requirements and compliments the discussion of pre-market requirements back in May. Your attendance is encouraged, even if you were unable to join us for session one. Regulatory 101 is a popular event designed for staff who are new to the FDA regulatory world or those who just need a refresher.

Pearl Pathways’ own Heidi Strunk will be presenting an overview of post-market regulatory requirements at 9:00am; we hope to see you there!


What: IMDMC 2014 FDA Regulatory 101 Course, Part 2.

When: August 19th from 8:00am – 5:00pm

Where: Montage Banquet Hall in Indianapolis, Indiana


To register for the event, click here.