Pearl Pathways attending, sponsoring IMDMC annual conference – November 6

imdmcPearl Pathways is excited to be attending and sponsoring the IMDMC Annual Conference tomorrow, November 6 at the Montague Banquet Center in Indianapolis. This conference provides an opportunity for networking, collaboration, and discussion of recent news and trends within the medical device industry. Dr. Kimber Richter from the FDA Office of Compliance will present this year’s keynote speech on “FDA Assessment of Risk/Benefit in the post Market/Recall Space.”

When: Thursday, November 6

Where: Montague Banquet Center, 8580 Allison Pointe Blvd, Indianapolis, IN

We encourage you to stop by our exhibitor booth to meet our talented staff! For more information about IMDMC, click here.

Diana Caldwell to present at Central Indiana WBE Forum

Pearl Pathways’ own President and CEO, Diana Caldwell will be presenting at the Central Indiana Women’s Business Enterprise (WBE) Forum held in Indianapolis in November.The topic for this session is “5 Steps to Up Your Business Development Game.” Please join us for this exciting event!

CEED_WBEC_Logo - CopyWhen: Tuesday, November 18, 2014 from 10AM-1PM

Where: Mid-States MSDC Building, 2126 N. Meridian, Indianapolis, IN

Registration is FREE! Click here to RSVP before the November 14 deadline

This forum is presented by the Women’s Business Enterprise Council-Great Lakes (WBEC-GL), an initiative of the Center for Empowerment & Economic Development (CEED).

We hope to see you there on November 18th!

Pearl Pathways is hiring! Business Development position open

Effective immediately, Pearl Pathways (Indianapolis, IN) is accepting applications for a Business Development Director position. Please click here to view the complete job description. Proven sales and account management experience is required; additional experience in the life sciences field is preferred. If you are interested, please send your resume and all inquiries to contact@pearlpathways.com. For a complete list of career opportunities, click here.

New FDA guidance says new fixed-dose combination drugs are eligible for exclusivity

For the first time, FDA is allowing new fixed-dose combination (FDC) drugs to be eligible for five years of New Chemical Entity (NCE) exclusivity. FDA currently provides market-based exclusivity to pharma companies who have been approved to market new drugs, granting them patent protection and disapproving any outside equivalents over a five-year period. Until now, FDC drug products have been ineligible for five-year exclusivity if they consist of any previously approved entities.

FDA has recently released a final guidance document outlining the new standards for exclusivity. While industry’s reaction was seemingly positive, many companies have expressed concerns with the new policy’s lack of retroactivity. FDA explains in the guidance that these new exclusivity standards will only be effective as of October 10, 2014, which is when the document was published, meaning that FDC drugs with prior approval will remain ineligible for this exclusivity.

To learn more, read Alexander Gaffney’s article on raps.org. Click here to read FDA’s final guidance.

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 healthitsecurity.com. 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 fiercepharma.com.

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 raps.org.

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!