Pearl Pathways’ COO presenting at the Indiana Regenerative Medicine Symposium – May 19-20, 2015

Pearl Pathways will be joining several others in sponsoring the upcoming Indiana Regenerative Medicine Symposium entitled “Regulatory Pathways for Regenerative Medicine: Cell and Biological Therapeutics”. This two day event will include four sessions on Day 1 and an opportunity to register for individual regulatory consultations on Day 2. Attendees are also invited to submit abstracts which will be presented at a poster session. Abstracts can be submitted to Michele Schlegelmilch before May 8, 2015.

Gretchen Bowker, COO of Pearl Pathways will be presenting on CMC regulatory during the conference and offering 1-1 consulting sessions with researchers on Day 2.

What: Regulatory Pathways for Regenerative Medicine: Cell and Biological Therapeutics

Where: The Athenaeum 401 E. Michigan Street Indianapolis, IN 46202

When: May 19-20, 2015: See agenda for session times


Click here to register for the event.

FDA to go paperless with its new drug advertising review process

FDA releases new draft guidance in April 2015 entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drug. The purpose of this guidance is to make it easier for marketing professionals in the pharmaceutical industry to submit their advertisements and promotional materials for review and approval. Traditionally, FDA’s Office of Prescription Drug Promotion (OPDP) required pharmaceutical companies to submit their materials using a paper-based for known as the Form FDA 2253. As these companies are increasingly using electronic media such as websites, emails, social media, etc. to promote a drug, OPDP is proposing the idea of using its electronic common technical document (eCTD) format instead. Two years following the finalized document, all companies will be required to submit their advertisements and promotional materials using OPDP’s electronic form.

If you would like to submit comments to FDA regarding this draft guidance, be sure to submit here by July 21, 2015.

Click here to read FDA guidance document. For additional information, read Alexander Gaffney’s article on

FDA to release draft guidance on approving medical devices using foreign trial data

Set to release Tuesday, April 28, FDA plans to issue a draft guidance document regarding its current policy of accepting clinical trial data performed outside the United States in support of medical device premarket submissions. To be clear, this document is not intended to announce a new policy, but rather articulate specific measures and considerations that must be applied when using such data to ensure the foreign medical device clinical data is adequate under FDA standards.

Such medical device manufacturers planning on submitting clinical data from outside the United States much provide the following information:

  • Detailed information about the research facilities and qualifications of the trial’s clinical investigators
  • Protocol and results summary
  • Full description of the device
  • Demonstration of the scientific validity for all of the gathered data
  • Ample assurances concerning informed consent

Ultimately, this guide document could provide clarity, help ensure the data is compliant with FDA standards, and allow products to reach the global market sooner.

To learn more, read Outsourcing-Pharma’s article by Zachary Brennan.

Pearl Pathways’ own, Diana Caldwell, named Indiana’s Outstanding Achiever on behalf of CEED

Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell, has been honored as the Center for Empowerment & Economic Development’s (CEED) Indiana Outstanding Achiever this year. This award is granted by CEED to individuals or organizations that share the CEED vision and demonstrate the true qualities of leadership.

Caldwell shares, “To be associated with such an impressive group of women leaders, I am honored and humbled to be recognized as this year’s Indiana Outstanding Achiever award on behalf of CEED.”

All award honorees for 2015 will be recognized by CEED on Thursday, April 23, in Novi, Michigan at the 31st Annual Award Celebration. This award will also be presented to Caldwell at the Sheraton Indianapolis Hotel at Keystone Crossing on Tuesday, June 9, 2015 at a luncheon reception. To learn more about the celebration, click here.

Click here to read our full press release.

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 on ‘Interpreting and Applying FDA Draft Guidance’ 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 is offering discounted tickets for the event. For more information or to arrange to join us at this event, please contact our Director of Business Development, Chad Pannucci at

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

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

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.