FDA finalizes plan for an accelerated review program involving critical medical devices

As of April 15, 2015, a year after its initial proposal, FDA will begin to accept applications to participate in its new accelerated review program. The program is intended for critical devices defined as, “devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions.” FDA plans to increase access to resources including senior management and case managers in order to leapfrog the acceleration review process. Ultimately, this accelerated review program will provide an avenue for potential life-saving devices to reach those patients in need sooner.

To learn more, read FDA’s guidance here.

Upcoming Indiana Life Sciences Collaboration Conference Series Event – May 8

life sciencesAs a sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways would like to announce the upcoming conference entitled The Changing Role of the Consumer in Healthcare. We invite you to join us at the event on Friday, May 8th, where a panel of experienced industry professionals will discuss the responsibility in the healthcare industry shifting more and more to the consumers/patients. Providers are becoming less prescriptive and more of a partner to the consumer/patient due to the dynamics of the industry.

What: A Discussion on the Changing Role of the Consumer in Healthcare

Where: Purdue Research Park, 1 Geddes Way, West Lafayette, IN 47906

When: May 8th, 2015 8:00am-3:15pm

Click here to register for the event.

The Indiana Life Sciences Conference Series is presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss important business strategies and solutions to promote the advancement of the life sciences field. To learn more, click here.

Pearl Pathways sponsoring, attending IVD Conference in San Diego

Q1 Prodcution LogoPearl Pathways is excited to sponsor Q1 Productions’ and attend its upcoming IVD conference on Clinical Affairs and Regulatory Approvals for Diagnostics. The conference provides an excellent opportunity to network with industry experts and gain additional insight on the FDA pathway for next generation sequencing, clinical and regulatory lessons learned in bringing a companion diagnostic to the market, and how to properly prepare for regulatory hurdles outside the United States. Pearl’s own Gretchen Bowker, Co-Founder and COO, will be presenting at the event.

 

What: Q1 Productions’ 6th Semi-Annual IVD West Conference

When: May 4-5, 2015

Where: Hilton San Diego Harbor Island – 1960 Harbor Island Drive, San Diego, CA

Pearl Pathways has access to discount passes, so send us an email at contact@pearlpathways.com to arrange and join us at this event.

Click here to register today. We hope to see you in San Diego!

New FDA Guidance on Critical Path Innovation Meetings

FDA releases new guidance document in April 2015 regarding Critical Path Innovation Meetings (CPIM). The document strives to provide insight to pharmaceutical companies and the public regarding the acceleration of the drug development process through the Critical Path Initiative. CPIM are designed to communicate with industry experts, patient advocacy groups, and government to improve efficiency and success in drug development. The meetings allow FDA to provide its perspective on the use of proposed new tools and methods in drug development as well as gain exposure to new techniques that have potential value in the drug development process. Furthermore, the guidance provides examples of appropriate topics for Critical Path Innovation Meetings and the information needed to request a meeting.

To access FDA guidance document, click here. For additional information, read Alexander Gaffney’s article from RAPS.org.

Updated fee schedule for Pearl IRB effective April 1, 2015

Please note that effective April 1, 2015, Pearl IRB has changed its fee schedule. See our 2015 Fee Schedule to view pricing for your upcoming study. For a price quote for Central IRB services, detailed pricing of your research project, or additional information about our services, please contact us at info@pearlirb.com.

23andMe Plans to Invent its Own Drugs

23andMe, a DNA analysis service company who provides information and tools to individuals to learn more about their DNA has announced its plan to invent its own drugs using customer data. This drastic move will allow 23andMe to capitalize on the economic value its genetic databases can create. The company’s robust database has provided genetic information of great value to Pfizer and Genentech, two of the Big Pharma companies.

By focusing on the customer first and foremost, 23andMe plans to develop a new drug that will provide an excellent benefit to its customers. 23andMe, the company that was providing valuable genetic information to two Big Pharma companies may be one of its greatest competitors in the coming years.

Click here to read Matthew Herper’s full article on Forbes.

FDA requires additional label warnings on multi-dose diabetes pens

To reduce the serious risk of spreading infections and ensure insulin pens and other injectable diabetes medicines are being used appropriately, FDA is mandating these injectable devices display the warning label “For single patient use only.”  Multi-dose pen devices are designed to be administered to a single patient multiple times, not multiple patients. The sharing of these devices amongst multiple patients significantly increases the risk of infection spreading. Over the last seven years, thousands of patients have potentially been victims to infections transmitted through the sharing of these multi-dose injectable devices. The “For single patient use only” warning label is intended to greatly reduce the risk of spreading infection amongst patients.

Click here to read FDA’s full safety announcement.

Upcoming RAPS Midwest Regional Career Day on April 18th

RAPS LogoThe largest global organization for those involved with the regulation of healthcare and related products, Regulatory Affairs Professionals Society (RAPS), is holding its inaugural Midwest Region Regulatory Career Day on April 18th, 2015.

Are you looking for new career opportunities in the regulatory field? Do you plan to transition to regulatory affairs or are you looking for an opportunity to network with hiring representatives within the life science industry? If yes, this will be an advantageous event for you to attend!

What: RAPS Midwest Regional Career Day

When: Saturday, April 18th, 2015 from 10:00AM – 4:00PM

Where: Lambs Farm in Libertyville, IL

Prices will go up at the beginning of April, so register here today! For more information about the event, click here.

Pearl Pathways hires new Business Development Director, Chad Pannucci

Pearl Pathways is pleased to announce the hiring of Chad Pannucci as the new Business Development Director. Pannucci will be responsible for driving overall business development and sales of professional services within Pearl Pathways three business units including Pearl IRB, Pearl ReGXP, and Pearl IDEAS.

“Chad has a proven track record of driving business growth, launching new products and services, and influencing product development decisions in the fast changing medical device industry. His broad sales and product management skills will add value to our clients and help propel Pearl Pathways to the next level of growth,” shares President and CEO, Diana Caldwell.

Click here to read our full press release!

Upcoming IMDMC workshop on Inspection Readiness featuring Pearl Pathways’ own, Heidi Strunk

imdmcPearl Pathways’ own, Heidi Strunk, RAC will be presenting at the Indiana Medical Device Manufacturers Council (IMDMC) workshop in Indianapolis, Indiana entitled, A Deep Dive Into Inspection Preparedness. The workshop will provide an opportunity to hear from experts who will explore the FDA inspection process and offer tips on what you need to know and how to be prepared for an FDA inspection.

What: An exploration of all the perspectives of the FDA inspection process.

When: Wednesday, April 15th, 2015 8:30AM – 4:30PM EST

Where: Montage Banquet Center, Indianapolis, IN            

Are you ready for a FDA inspection? Do you want to learn more about the inspection process? To register for the workshop, click here! (Lunch will be provided.)

Click here to learn more about the workshop! We hope you join us on April 15th!