Pearl IRB has Full Board meetings scheduled for December 3, 10, and 17. There will be no meetings on December 24 or 31. The regularly scheduled Full Board meetings will resume on January 7, 2015. If you have an urgent IRB concern, please contact us at least two weeks in advance. Happy holidays to all!
We are pleased to announce our recent updates to the Resources section of the Pearl IRB website, where you will find new and revised forms to serve you in the IRB submission process. Some of these changes include:
- Updated submission guide and policies, which we suggest all new and returning clients to review.
- Updated unanticipated event form.
- And the addition of our Human Research Protection Program plan.
Contact us at email@example.com with any questions, to provide feedback, and for assistance with an IRB submission.
On January 4th, 1983 President Ronald Reagan signed into effect the Orphan Drug Act. For over 30 years, orphan drug development has grown in volume, and has had a major impact on the biopharma and diagnostics industries. With advancement in technology including increased development of novel companion diagnostics as well as the mapping of the human genome, orphan drug approvals by FDA have continued to rise. New data has been released showing that 2013 was a big year for orphan drug approvals. In 2011, FDA approved 26 orphan drugs. The number dropped slightly in 2012 g to 25, but rebounded in 2013 to a record 31. Orphan drug designations were also high in 2013 reaching a record breaking 260.
It is estimated by PHRMA in a 2013 Medicines in Development report entitled “Rare Diseases: A Report on Orphan Drugs in the Pipeline,” that 30 million Americans have one of the 7000 diseases deemed rare. Rare disease is defined as one affecting under 200,000 people in the United States. Further, this report estimated that there were 452 medicines and vaccines in development for rare disease in 2013. To review this report, click here. To review a recent article in medcitynews.com covering the surge in orphan drug development and approvals, click here.
Pearl Pathways has the pleasure of working with several of our clients on developing the appropriate regulatory strategy, executing global regulatory filings, and assisting with clinical trials for orphan drugs. Contact us if you need assistance with your orphan drug or device.
We anticipate that this focus on orphan drug development will continue among both large pharm and small biotechs. Navigating these diseases in small patient populations is complex and can be daunting, but new technologies and the regulatory landscape have made it a bit easier to impact rare and debilitating diseases.
The 2013 Site Solutions Summit features Pearl Pathways’ own Diana Caldwell. She will be involved in the roundtable discussions as a panelist and moderator for topics such as: Investigator Insider: What your site needs to know about your next potential investigator; and Your Circle of Friends: Why social media matters. The Summit focuses on encouraging dialogue and sharing of information to arrive at best site practices. Diana adds to a group of panelists with years of experience and wisdom to share. Below are the two discussions Diana will partake in:
Roundtable Title: Investigator Insider: What your site needs to know about your next potential investigator.
Roundtable Date: Saturday, October 12, 2013
Roundtable Start Time: 1:45
Roundtable Duration: 45 minutes
Roundtable Location: Magnolia E
Roundtable Title: Your Circle of Friends: Why social media matters.
Roundtable Date: Saturday, October 12, 2013
Roundtable Duration: 45 minutes
Roundtable Start Time: 2:45
Roundtable Location: Cumberland E
For more information please refer to the Site Solutions Summit 2013 agenda.
Pearl Pathways’ open house last Thursday the 20th welcomed in the new office with a bang. The afternoon get together was a fun way for visitors to stop by and see the new place. A refurnished interior to an old Indianapolis building on the south side of the city filled with friends, family, clients, and colleagues created a great atmosphere for all. Thank you to everyone that came out for the open house! If you would still like to stop by and see the new office call (317) 899-9341 or email firstname.lastname@example.org
Pearl Pathways has moved to our new office! We are excited to share our new home with clients and colleagues. Please join us if you can. Appetizers and refreshments will be served throughout the evening.
When: Thursday, June 20th, 2013
Time: 4:30-7:00 pm
Location: 29 East McCarty St., Suite 100
Indianapolis, IN 46255
Find us on Google Maps
RSVP at email@example.com or call (317) 899-9341
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.
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
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.
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.