Australia releases framework for regulator’s performance

On June 10th, Australia announced that it has created a new way to gauge the performance of regulators. This framework is called the Cutting Red Tape and it sets out to reduce the costs of regulations for individuals and businesses in Australia. Not only has Australia created this framework, but they also included six key performance indicators (KPI) and outputs that are likely to occur.

To find out what these six KPI’s and outputs are, read more here.

Pearl Pathways recently partnered with Brandwood Biomedical, an Australian regulatory compliance firm to deliver seamless on the ground services across Asia Pacific. . Interested in finding out more about our services in Asia Pacific? Email us at

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

Smartphones, apps, and biotech all tied together

Smartphones and biotech are not closely related subjects but Nick Paul Taylor, of, explains that app centers powered by Google, Microsoft, and Blackberry are closing the gap on Apple’s dominance in the app marketplace.  Big Pharma and biotech apps traditionally have been exclusive to Apple devices first and then later released to other app stores. But the high growth of Android devices, especially in emerging markets, has forced these apps to be simultaneously released for both devices. Biotech apps have been growing since 2011, and 2013 has not alluded to any signs of this industry slowing down. For the complete article and list of 2013 biotech apps, click here.

Pathways’ President & CEO Diana Caldwell to be panelist in upcoming Site Solutions Summit

The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator; and Your Circle of Friends: Why social media matters. The Summit focuses on encouraging dialogue and sharing of information to arrive at best site practices. Diana adds to a group of panelists with years of experience and wisdom to share. Below are the two discussions Diana will partake in:

Roundtable TitleInvestigator Insider: What your site needs to know about your next potential investigator.
Roundtable Date: Saturday, October 12, 2013

Roundtable Start Time: 1:45

Roundtable Duration:    45 minutes

Roundtable Location:    Magnolia E



Roundtable Title:  Your Circle of Friends: Why social media matters.
Roundtable Date: Saturday, October 12, 2013

Roundtable Duration: 45 minutes

Roundtable Start Time: 2:45

Roundtable Location: Cumberland E


For more information please refer to the Site Solutions Summit 2013 agenda.

Bowker leads FDA supplier audit webinar

Are you a supplier of raw materials, component parts or finished product to biopharma or medical device companies? The supply chain for pharmaceuticals, biologics and medical device companies are increasingly being audited by their clients and FDA.  On July 25, 2013, Pearl Pathways’ own Gretchen Bowker will lead a webinar on FDA audits discussing the best practices and provide practical tips to prepare for FDA audits, as well as client audits. The webinar will be held through

Where: Register here.

Fee: $199.00

When: July 25, 2013

Duration: 60 minutes

For more information and registration click here.

The use of Big Data in biotech

Biotech companies are starting to accumulate Big Data, consisting of gene expression profiles, biomarker reliability, patient outcomes and numerous other measurable aspects of drug development. The hope is that the mass amount of data can help streamline R&D. During the JP Morgan Healthcare Conference, FierceBiotech Executive Editor Ryan McBride asked a panel of drug development executives about the potential applications and implementation of Big Data in drug development. The bioteh executives discussed the pros and cons of using Big Data to generate hypotheses, and how Big Data can be used to target the right patients for the right drug trial.  Another issue discussed was the unstructured, handwritten notes taken by physicians and the challenge of merging and indexing this data with the newly collected high tech data. Nevertheless, the executives agreed at the conference that Big Data is a great source of information for R&D, provided one knows how to use it, and it is just a matter of time before R&D companies do what is necessary to merge all the data into one integrated system. To read the full article on FierceBiotech, click here.

ASQ, MWDG holds meeting on biocompatibility and GLP: November 29, 2012, Indianapolis

The MWDG of the ASQ Biomedical Division is next meeting to discuss the topic of biocompatibility in regards to medical devices.

When: November 29, 2012 from 5:30-8:00pm

Where: University of Indianapolis, Schwitzer Student Center Building #7, Room 013, Indianapolis IN 46227

Cost: Buffet dinner, $12.50 for members and $15.00 for nonmembers

Click here to register for the upcoming event. This link will be available until 5pm on Monday, November 26th. If you are unable to use the link, contact Ann Stankiewicz at

MWDG devision of ASQ Biomedical presents “Human Factors in Medical Device Development” in Indianapolis

The Midwest Discussion Group (MWDG) of the ASQ Biomedical Division presents Human Factors in Medical Device Development on Thursday, October 25, 2012. Jim Kershner from Eli Lilly will share his experience dealing with issues around human factors in medical device development. Kershner will share his extensive knowledge and hands-on experience on human factors investigations. The meeting will be held at the University of Indianapolis. Hot buffet, beverage and dessert will be served at this event.

When: Thursday, October 25, 2012

Where: University of Indianapolis, Schwitzer Student Center Building #7 Room #013 (on lower level)

Time: 5:30p.m. – 8:00p.m.

Cost: $12.50 for members, $15.00 for non-members

For full details of this event, click here.

Thursday, May 24th–ASQ MWDG Process Validation Game

The Midwest chapter of Biomedical ASQ presents the Process Validation Game!

When: Thursday, May 24th, 2012 from 5:30-8 pm.

Where: University of Indianapolis in the Schwitzer Student Center Building #7 Room #013 Indianapolis, IN 46227

Cost: Buffet dinner  $12.50 for members and $15.00 for non-members.

For additional information and to register for this event, click here.

New FDA guidance on device approval considerations

FDA recently issued new final guidance for medical device manufacturers navigating the premarket approval (PMA) and de novo decision pathways.  The document, entitled Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications was issued on March 28, 2012 and describes in detail how FDA will weigh the risks and benefits of a device during premarket review—both in the future and for devices currently under review.

Featured in the guidance is a worksheet designed to streamline the risk-benefit analysis of submissions by providing in advance several key features of the device’s potential to do both harm and good, including: the duration, type, and magnitude of risks and benefits; as well as risk likelihood, patient tolerance, reported value to patients, and available alternatives. According to the guidance introduction, “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process.”

For more information about the premarket process or for help with premarket device strategy, planning, and submissions, contact Pearl.