Guest commentator and president of the Greater Indianapolis Chamber of Commerce, Scott Miller cited the news of Pearl’s expansion as a sign of the growing life science industry in Indiana in a recent article on nwi.com. Miller’s article describes the current state of the life science industry, as well as speculates the outcomes of future legislation impacting the industry. To read the article on NWI.com, click here.
Pearl’s Diana Caldwell to speak at the Feb. 28th Leadership Institute for Women
February 14, 2013 By Leave a Comment
This year’s Leadership Institute for Women: Positioning Your Business for Growth will take place February 28, 2013. Diana Caldwell, Pearl President and CEO will serve on a panel discussion about WBE teaming.
What: Leadership Institute for Women: Positioning Your Business for Growth
When: February 28, 2013, 9am-4pm
Location: Duke Realty, 500 E 96th Street, Indianapolis, IN
Cost: $100.00
To register for the event, click here. For more detailed information on the event, click here.
Pearl Pathways expansion announcement featured in several media outlets
February 6, 2013 By Leave a Comment
We are thrilled to announce our partnership with the state of Indiana to expand, and especially proud of all of the past week’s news coverage. Upon announcement of expansion, the company enjoyed several mentions in online news outlets, and Pearl was featured on the front page of the business section in the Indy Star (print version) on January 29, 2013 and on television on Inside Indiana News TV program on WFYI and WTHR last weekend. The Indy Star article highlighted that the company will add up to 38 new jobs by 2016. Founders, Diana Caldwell and Gretchen Miller Bowker received accolades from the Inside Indiana Business INsiders for keeping and growing their life science company in Indianapolis. To read the full article in the Indy Star, click here. Watch the video from “The Insiders”, by clicking here; Pearl Pathways is mentioned around the seven minute mark in the video clip.
Pearl Pathways awarded IEDC incentive package
January 29, 2013 By Leave a Comment
INDIANAPOLIS (Jan. 29, 2013) – Pearl IRB, LLC d/b/a Pearl Pathways, a life sciences product development and regulatory consultant company, announced plans today to expand its operations here, creating up to 38 new jobs by 2016.
“Founded by Hoosier researchers and growing impressively, Pearl Pathways is a prime example of a dynamic life sciences company that will help advance our economy, while raising the average income for hard-working Hoosiers,” said Eric Doden, president of the Indiana Economic Development Corporation. “Indiana continues to be recognized around the globe as a place where starting and growing a life sciences business just makes sense.
The homegrown-Hoosier company, which provides clinical, regulatory and quality compliance services for the life sciences industry, will invest $355,000 to lease and equip a 2,000 square-foot facility located at 29 E. McCarthy St. in downtown Indianapolis. Pearl Pathways, which plans to move into the new facility in March, is currently hiring additional regulatory affairs, quality compliance and clinical trial specialists.
“We are proud to be one of the expanding companies that positions Indiana near the top in the life sciences industry,” said Diana Caldwell, president and chief executive officer of Pearl Pathways. “Our growth is fueled by our passion to help our clients expedite the development of life saving diagnostics and therapeutics. While we serve clients coast to coast and globally, the strong client base we have developed in Indiana and favorable business environment make this an ideal place to expand.”
Founded in 2010 by former Eli Lilly employees Diana Caldwell and Gretchen Miller Bowker, Pearl Pathways is a life science services company that provides research and product development services for drug, biologic and medical device companies through its three business units: Pearl IRB, Pearl ReGXP and Pearl IDEAS. The company is a certified women-owned business by the Women’s Business Enterprise National Council.
The Indiana Economic Development Corporation offered Pearl IRB, LLC up to $750,000 in conditional tax credits and up to $75,000 in training grants based on the company’s job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. The city of Indianapolis supports this project at the request of Develop Indy.
“Pearl Pathways’ investment in Indianapolis strengthens our role as a leader in life sciences technology,” said Indianapolis Mayor Greg Ballard. “I congratulate Pearl Pathways and wish the company much continued success. We look forward to continuing our commitment to cultivating a community of growth in which businesses can thrive.”
The Hoosier State’s life sciences industry includes the corporate headquarters of such giants as Eli Lilly, Biomet, Cook Group and Dow AgroSciences. The total economic impact of the industry in Indiana is estimated at $50 billion a year by BioCrossroads in a report released earlier this month. More than 1,600 life sciences companies that employ 55,000 Hoosiers call Indiana home.
To read the full press release on the State of Indiana’s website, click here.
Pearl Pathways year end holiday hours
December 12, 2012 By Leave a Comment
Our office will be closed for the holidays December 24th, 25th, 31st and also on January 1st. There will be no IRB Board meeting the week of December 24th due to the holidays. We will resume IRB reviews the week of December 31st and hold a Board meeting on January 4th. If you need to talk to us about your need for an urgent IRB review with Pearl IRB, just contact us and we will see what we can do. We wish our colleagues, clients and all of our readers a wonderful holiday season. Best wishers for a happy, healthy and prosperous New Year!
CDRH Releases Device Review Performance Data
December 11, 2012 By Leave a Comment
The Center for Devices and Radiological Health (CDRH) released a recent report that details how the agency believes their premarket approval (PMA) and 510(k) systems are performing after implementation of many actions. It has been nearly two years since the FDA announced a “Plan of Action” to update and improve the FDA’s premarket review of medical devices. The “Plan of Action” for premarket review includes 36 specific actions that were focused on increasing the predictability, consistency, transparency, efficiency, and timelines of device premarket reviews. Improvements not seen in decades were reported. The average time it takes to clear a 510(k), average time it takes to reach a decision on PMAs, and the percentage of submitted 510(k)s that are cleared and PMAs that are approved have all improved since the 2010 benchmark. The 24-page report can be found here. Need assistance with 510(k) or PMA devices? Contact Pearl at. contact@pearlpathways.com or call us at 317.899.9341.
Save the date- February 8, 2013 join us at the Kelley School Life Sciences Conference
December 9, 2012 By Leave a Comment
Indiana University’s Kelley School Center for the Business of Life Sciences is holding Effects of the November 2012 Election on Healthcare Reform conference on February 8, 2013.
Pearl is a proud sponsor of the 2012-2013 Series.
Title: Effects of the November 2012 Election on Healthcare Reform
Session overview:
While placing some limitations on the Medicare expansion, the Supreme Court’s decision in June left most of the 2010 Affordable Care Act intact. The winner in the presidential contest and the composition of the House and Senate will dictate a lot as to what happens next with healthcare reform. Will it be “full steam ahead” or some version of “repeal and reform?” Government “insiders,” observers and pundits will be sharing their thoughts as to the next phase in the remaking of the nation’s healthcare system.
Date: February 8, 2013
Location: Fairbanks Hall- 340 W. 10th Street, Indianapolis, IN
*Agenda: TBD
Look for our staff there!
Click here to register.
FDA conducts nationwide survey
November 17, 2012 By Leave a Comment
During the month of August, FDA conducted a nationwide 510(K) Pathway Med-tech Industry Survey to measure perceptions of 510(k) Pathway, FDA’s performance, and FDA’s consistency. Nearly 200 of the 2707 people it was sent to responded to the survey, providing a 6.1% response rate. FDA found that the majority of devicemakers are dissatisfied with the way CDRH handles 510(K) submissions. Click here to find a related article pertaining to the survey. Another related article can be found here. Need help with your 510(k) devices? Contact Pearl at contact@pearlpathways.com or call us at 317.899.9341
Are investments in technology and internet coming at the expense of venture capital healthcare funds?
November 17, 2012 By Leave a Comment
Medcitynews recently published an article about potential hard times to come in life science and healthcare investing over the next six to eighteen months. Investing in cloud computing, mobile internet and big data has left life science funds pessimistic. In the following 18-36 months, things start to look better. Mike Carusi, general partner with Advanced Technology Ventures is quoted saying “I believe things will get worse before they get better. However, those firms and companies that survive this very challenging period will be in the cat bird’s seat in four to five years when strategic acquirers are looking for innovation and have limited companies to choose from…” Carusi isn’t the only one that has something to say in this article, Joe Mandato and Lisa Suennen offer other perspectives and insight on how they feel as well. Click here to read this article and other articles pertaining to this topic.
API’s to follow GMP standards under a single global system?
November 13, 2012 By Leave a Comment
In a recent article in In-Pharmatechnologist, Gian Mario Baccalini, chairman of European Fine Chemicals Group is advising active pharmaceutical ingredients (APIs) suppliers to join good manufacturing practice (GMP) standards under one unified global system. Baccalini also encourages other organizations such as the EMA to adopt the system as well. While this process would mean having a stronger unified system, the cost to implement such a system raises some concern. Read more about this article here, and other articles relating to this topic. Need help with your supply chain GMP audits, assistance with your internal auditing program, or in improving your internal quality system SOPs? Contact Pearl at. contact@pearlpathways.com or call us at 317.899.9341.
