On Tuesday, February 16th… Join in a webinar to learn What’s new with China FDA in 2016 from Pearl Pathways partner, Brandwood Biomedical

Brandwood Biomedical is hosting a webinar, What’s new with China FDA in 2016. Get the latest information on Decree 650 and changes in device guidance, regulations, and in-China clinical trials from Brandwood Biomedical Director of China Operations, Steven Wen. Free registration here today. Find Brandwood Medical by clicking here.

Medical Device “Emerging Signals”

The FDA issued a draft guidance document on December 31, 2015 entitled “Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). This draft guidance has been developed to provide more detail on FDA’s intent to notify the public about “emerging signals” regarding regulated medical devices. FDA defines an emerging signal as “new information about a medical device used in clinical practice: 1) that the Agency is monitoring or analyzing, 2) that has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device, 3) that has not yet been fully validated or confirmed, and 4) for which the Agency does not yet have specific recommendations.”

An “emerging signal” would alert the public to the most current information known about a medical device. The intent is to prevent potential risk to patients. Opponents to this idea are asking why the FDA would release information that has not been fully verified / investigated by the FDA. For more information, read Zachary Brennan’s article on RAPS.org.

Launching @PearlPathways on Twitter

Making it easy for yPPtwitterimageou to keep up on the latest and connect with us, we recently launched the @PearlPathways twitter account. Please follow us here @PearlPathways. As always, we welcome the opportunity to partner with you — please contact us to talk about your next new idea!


Save the date: DA4S conference in Long Beach, CA February 17 – 18, 2016

DA4S Logo

On February 17-18, 2016 the Diversity Alliance for Science (DA4S) conference will be held at the Marriott Long Beach Airport Hotel, in Long Beach, CA. DA4S is a non-profit organization focused on supporting, developing, and connecting with a diverse group of suppliers in the Life Science, Pharmaceutical, Bio-Tech, and Healthcare Industries  Click here to register. To learn more about DA4S click here.

Bioequivalence Complexities

The complex issue of testing for bioequivalence was covered in a recent article by Phil Taylor, In-pharma. It is recognized that the FDA has the very complex job of determining bioequivalence of generics to innovator products. Physicians and patients rely on FDA regulations for safety and efficacy of all drugs approved for use, including generics. To bring the FDA and physicians together to work in concert, the article discusses the benefit that could manifest when the FDA can share and disclose data and information used in justification for bioequivalence with physicians who make drug decisions on behalf of their unique patient needs. The physician, when armed with all of the information the FDA has about a drug, can be the best advocate for the individual patient when recommending drug therapy. The physician / patient relationship conducts the final “clinical trial” of whether a drug, generic or not, is effective & safe for the patient.

For more information on this interesting topic, please view Taylor’s article here.

Omnibus Appropriations bill gives more funding to FDA and NIH in 2016

The House Appropriations Committee announced the Omnibus Appropriations bill providing the FDA more funding this year for medical product safety initiatives. Funding is also directed to the Combating Antibiotic Resistant Bacteria (CARB) initiative, the Precision Medicine Initiative and the Orphan Product Development Grants Program.

The NIH will also receive more funding for Alzheimer’s disease research, brain research, antibiotic research and the Precision Medicine Initiative. An increase in funding will also be available for biomedical and translational research.

The additional funding from this bill means a victory for those patients waiting.

For more information, please read Melissa Fassbender’s entire article at in-Pharma. Pearl Pathways always has the patient in mind – contact us for help in accelerating your product development.


Pearl Pathways sponsors upcoming Indiana Life Sciences Collaboration Conference Series

life sciences

Pearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. It is an excellent forum that brings together key players in Indiana’s life science and healthcare arenas for intriguing business discussions on business strategy, solutions and development to promote growth.

Diana Caldwell, President and CEO of Pearl Pathways, shares that “The conferences add value for all of the major life science players in the state. It’s a great means to get us together, hear relevant topics from thought leaders, stay up to date, and network.”

Please joins us for the first conference of the year — The Continuing Disruption of Healthcare and Life Sciences Business Models for panel discussions on Changes in Healthcare and Medical Products “Space” and The Future of Medical Products in an Era of Reform: Implications of Value and Consumerism.

What:          The Continuing Disruption of Healthcare and Life Sciences Business Model

Where:       One America Tower, One American Square, Indianapolis

When:         February 19, 2016

A great way to start 2016, please click here to register, and put this important date on your calendar. You may learn more about the Indiana Life Sciences Collaboration Conference Series at this link.

Medical Device Tax suspended for two years = good news for Medical Device Companies and Patient Health

President Barack Obama recently signed a bill suspending the Medical Device Tax for two years. It took a great combined effort of many large and small medical device companies to make this happen, many from Indiana. This outcome greatly benefits all medical device companies. Hopefully, now the monies that companies would have earmarked toward taxes could now instead be put into new product development. This investment in R&D could also drive more jobs and ultimately more innovative solutions to improve patient health.

After learning of the suspension, Fred Hite, CFO of OrthoPediatrics of Warsaw, Indiana stated “Luckily now we’ll be able to go back and review that and remove the expense and cash that we had put in to the budget for the medical device tax and instead replace that with incremental programs developing new projects.”

Great news for medical device development. To read Varun Saxena’s full article about this topic in Fierce Medical Devices, click here. The Pearl Pathways team is ready to partner with your team on your new projects to improve patient health, contact us.

Next Tuesday, January 19th… Join in a FREE webinar update on Asia Pacific Regulations from Pearl Pathways partner, Brandwood Biomedical

Brandwood Biomedical is hosting a webinar, The Year ahead in Asia Pacific Regulations.  Get the latest information on emerging trends in the region from Principal Consultant, Arthur Brandwood.

FREE registration here today.  Find Brandwood Medical by clicking here.

Pearl Pathways is excited to sponsor upcoming 2016 WISE Luncheon honoring women in STEM

On January 29, 2016 BioHouston will be honoring women leaders from Houston leading science & technology at the 7th annual Women in Science with Excellence (WISE) Luncheon.  Pearl Pathways is honored to be one of the sponsors of this inspirational event.  The luncheon will be held in Houston, Texas at the River Oaks Country Club, 11am to 1pm.  Join in this great opportunity to honor those advancing science & technology.  To register for this event, click here.