New whitepaper from Pearl Pathways “Types of In Vitro Diagnostics: Clearing up the Confusion”

By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much can be easily understood: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are many roadblocks to bringing a medical device to market, but spending time on product classification and sifting through FDA guidance documents doesn’t have to be one of them.

Pearl Pathways has published a new whitepaper entitled “Types of In Vitro Diagnostics: Clearing up the Confusion.” The paper discusses the many categories of IVDs and their requirements and regulations. These categories include RUOs, IUOs, ASRs, LDTs, Companion Diagnostics, and IVDMIAs. This paper is a must read for anyone involved in the development of IVDs.

Click here to read!

Pearl Pathways to attend, present at 5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference

Pearl Pathways is excited to be attending the Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference next week in Alexandria, VA. This conference provides a forum for discussion on the challenges regulators face and strategies used to successfully bring a companion diagnostic to market. This year’s attendees include FDA reviewers, accomplished industry representatives, and numerous regulatory experts.

We encourage you to stop by our booth to meet our talented staff. In addition, we invite you to join us for the Clinical & Regulatory Strategies for Companion Diagnostics Workshop on Wednesday, October 29. Pearl’s own Gretchen Bowker will be serving as the moderator for the 11:20 discussion on Establishing Realistic Timelines for Companion Diagnostics & Personalized Medicine Development.

Click here to register for the conference. We hope to see you in Alexandria on Monday!

FDA moves to reduce cybersecurity threats in medical devices

FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests that manufacturers identify potential security risks and submit action plans to FDA to reduce vulnerability.

FDA’s additional partnership with the NH-ISAC will help foster the relationship between healthcare providers and security experts and provide programs to further minimize cyber-security threats. These threats came to light last year when two Department of Homeland Security researchers discovered a hard-coded password vulnerability affecting approximately 300 medical devices.

Click here to read Patrick Ouellette’s article on For additional information, read FDA’s final guidance and memorandum of understanding with the NH-ISAC.

NICE is pursuing more transparency from pharma companies

The National Institute for Health and Care Excellence (NICE) serves as the U.K.’s primary auditor for drug products, ultimately deciding whether or not the value and efficacy of each drug is worth the cost. With this information, it is evident why pharma companies have historically expended a significant amount of resources toward staying within NICE’s good graces; however, the Institute has recently released a statement and corresponding guidance requesting more transparency.

NICE has established a requirement for new drug submissions to include a signed document “declaring that all clinical trial data have been identified.” If the data provided by the submitter is deemed insufficient for the drug appraisal process, the agency will contact the European regulatory authorities directly to obtain the information, as NICE’s statement suggests.

Although these new requirements will likely add to the existing tension between the agency and major pharma companies, NICE hopes to see an upward trend in transparency as part of the AllTrials campaign effort to register and report the results of all past and present clinical trials.

Click here to read NICE’s statement. For more information, read Arlene Weintraub’s article on

New FDA study to examine the effects of distractions in drug ads

FDA has been granted approval to move forward with a May 2014 study proposal to analyze the effects of distractions in drug advertisements. In the study announcement FDA explains, “We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”

To conduct the study, FDA has created two drug advertisements: one with minimal distractions and the other with significant distractions. As each ad plays, the viewers’ eye positioning and movement will be examined to determine if the major risk statement is appropriately recognized.

Click here to read FDA’s study announcement. For additional information, refer to Alexander Gaffney’s article on

Gretchen Bowker to speak at 2014 RAPS

Pearl Pathways is pleased to announce that our own Gretchen Bowker will be speaking at the 2014 RAPS Preconference Workshop entitled Regulatory Strategy Forum for Biologics. She will be presenting at the 11am session on conducting clinical trials, which will cover the roles and responsibilities of sponsors, investigators, IRBs, and regulatory authorities as they relate to the development of biologic products.


What: Regulatory Strategy Forum for Biologics

When: 9 a.m. to 5 p.m. on Saturday, September 27

Where: 2014 RAPS Preconference Workshops (Meeting Room 16A)

Register here!


We hope to see you soon at 2014 RAPS: The Regulatory Convergence in Austin!

Diana Caldwell to be featured at 2014 Site Solutions Summit

Pearl Pathways’ own President and CEO, Diana Caldwell will be featured at the 2014 Site Solutions Summit as a moderator for the Crowdsolving topic entitled Tweet, Post, Like, Engage In Social Media For Results. In aligmnent with the structure of Crowdsolving sessions, Diana will be joined by a cross section of expert panelists, who will provide unique perspectives on your sites’ pain-points. The session will be highly interactive with attendees.  Diana’s industry and social media expertise provides valuable insight into creating best site practices.


Session Type: Crowdsolving

Title: Tweet, Post, Like, Engage in Social Media for Results

Date: Saturday, October 11, 2014

Start Time: 3:15 p.m. – 4:15 p.m.

For more information, please refer to the 2014 Site Solutions Summit agenda.


Register now and save! As a special guest of Pearl Pathways, we invite you to save $200 on the Standard Registration Price of $1597.  Please email if you are interested and we’ll provide you with our discount code. We hope to see you at Amelia Island in October!

FDA announces new “Purple Book” for biological products

Similar to the pharmaceutical “Orange Book,” FDA has recently published the first edition of the “Purple Book” of biological products, which is intended to provide the regulatory community with information on the interchangeability of biosimilars.

The book is divided between two sections: products approved by the Center for Drug Evaluation and Research (CDER) and products approved by the Center for Biologics Evaluation and Research (CBER), and contains information such as the BLA number, product name, date of licensure, reference product exclusivity date, withdrawn, and more. In addition, FDA has proposed a four-tier assessment for biosimilar interchangeability, which presents the implication that not all products approved through the 351(k) biosimilar process will be considered interchangeable by the agency’s standards.

Although the U.S. market for biosimilar products is relatively small, FDA expects to see many additions to the Purple Book in the near future.

Click here to read Alexander Gaffney’s full article from

Pathways’ co-founders speaking at Indiana Life Sciences Conference Series Event

In addition to sponsoring the 2014-2015 Indiana Life Sciences Collaboration Conference Series, Pearl Pathways is proud to announce that both of our co-founders, Diana Caldwell and Gretchen Bowker, will be serving as moderators for this year’s first conference entitled An Update on the FDA and Global Regulatory Bodies. We invite you to join us at the event on Friday, September 12th, where a panel of experienced industry professionals will discuss the potential affects of new approval procedures and quality compliance requirements.

What: An Update on the FDA and Global Regulatory Bodies

Where: IU Robert H. McKinney School of Law, 530 W. New York Street, Indianapolis

When: September 12, 2014 8:00am-3:15pm

Click here for the registration link.

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.

Diana Caldwell to serve as panelist for upcoming Kelley School career event

The Kelley School of Business Indianapolis Career Network is hosting a Career Momentum Event featuring Pearl Pathways’ own President and CEO, Diana Caldwell as a panelist. This event provides the opportunity to network with experienced executives and gain expert insight on how to push your career to the next level. We encourage you to join us on Thursday, September 11 from 5:30pm-8:00pm at the IU Advancement Office in Indianapolis. Register today!

As stated on their website, the Kelley School of Business Career Networks are an initiative to build strong, industry-focused networks in communities throughout the country. Career Networks is focused on meaningful events, in a professional environment, with the objective of utilizing the Kelley Network for career advancement.