In a recent article on massdevice.com, Brad Perriello shares interesting data from Pricewaterhouse Coopers’ (PWC) US Pharmaceutical and Life Sciences Deals Insights Quarterly report Medical device mergers and acquisition deals in the first quarter fell from eight in the Q1 of 2012 to seven in Q1 of 2013. The same time comparison had the total value dropping from $2.3 billion down to $1.7 billion. Dimitri Drone from PWC purports that this decline is not necessarily reflected of the true deal activity. Active and not yet closed deals are not included in these numbers and Drone says “There’s a lot of talk about M&A among the people we interact with in medical devices.” The report still forecasts a growth overall in medical device M&A activity for 2013. What do you think? Are you seeing more of an appetite for deals? To review the PWC report, click here, and for the full article click here.
RAPS Indiana Chapter to host networking event in February
The RAPS Indiana Chapter is hosting a networking event to promote new connections among local regulatory professionals. A BioCrossroads representative will also present an update about the life sciences in Indiana.
What: Celebration of Life Sciences in Indiana Networking Reception
When: February 25, 2013
Time: 4:30-6:30pm
Where: Faegre Baker Daniels LLP, 600 E. 96th Street Suite 600, Indianapolis, IN
Directions are available online or by calling +1 317 569 9600
Contact Cindy Killion to RSVP at cynthia.killion@faegrebd.com. To learn more about RAPS Indiana, click here.
FDA publishes final cGMP rule on drug, device and biological product combinations
The FDA published a final rule entitled Current Good Manufacturing Practice Requirements for Combination Products to provide clarification of cGMP requirements for products that are made up of a combination of devices, drugs and/or biologics. The new guideline applies to both already existing and new combination products, yet the FDA plans to issue guidance to help manufactures modify systems for products already on the market, as needed. The final rule also clarifies the cGMP requirements for “single-entity” and “co-packaged combination products.” To read an article in MassDevice, click here and to view the final rule on FDA’s website, click here.
Need help with regulatory interpretation of the new final rule? Contact us at contact@pearlpathways.com
The use of Big Data in biotech
Biotech companies are starting to accumulate Big Data, consisting of gene expression profiles, biomarker reliability, patient outcomes and numerous other measurable aspects of drug development. The hope is that the mass amount of data can help streamline R&D. During the JP Morgan Healthcare Conference, FierceBiotech Executive Editor Ryan McBride asked a panel of drug development executives about the potential applications and implementation of Big Data in drug development. The bioteh executives discussed the pros and cons of using Big Data to generate hypotheses, and how Big Data can be used to target the right patients for the right drug trial. Another issue discussed was the unstructured, handwritten notes taken by physicians and the challenge of merging and indexing this data with the newly collected high tech data. Nevertheless, the executives agreed at the conference that Big Data is a great source of information for R&D, provided one knows how to use it, and it is just a matter of time before R&D companies do what is necessary to merge all the data into one integrated system. To read the full article on FierceBiotech, click here.
Pearl Pathways awarded IEDC incentive package
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.
Deloitte and Thomson Reuters Asses Top 12 Life Science Companies
Deloitte and Thomson Reuters recently performed their annual R&D-ROI balance by assessing the finances of the top 12 life sciences companies. The study reports a mixed performance picture in 2012 relative to the previous year. More drugs were approved between 2011 and 2012, yet the total sales value of all approvals has declined compared to the 2010-11 time period. Revenue lost from failed projects still remains a challenge for the assessed companies; however, the proposed solutions include repositioning or repurposing the failed compounds to recoup losses. To read the major findings of the study, click here. For the complete Deloitte and Thomson Reuters report, click here.
INpact Meeting January 23, 2013
Join Pearl staff at the first INpact lunch meeting of 2013 on Wednesday, January 23rd. INpact is focused on supporting the medical device industry in Indiana. Please attend the lunch to network and learn more about the new bimonthly meeting format.
Date: January 23, 2013
Time: 11:30-1pm
Where: Bingham Greenbaum Doll, LLP, 10 W. Market St., Suite 2700, Indianapolis, IN
Cost is $20 for non-members.
To register, click here.
FDA/Xavier PharmaLink Conference to Highlight FDASIA Legislation in March
Xavier University is hosting the FDA/Xavier PharmaLink Conference March 11-14. The event brings together industry experts and the FDA to discuss and solve challenges in the field. The focus of the meeting revolves around the FDA Safety and Innovation Act (FDASIA) which is influencing new regulations. Invited speaker John Taylor, Counselor to the Commissioner will address the FDA’s strategy for FDASIA implementation and the impact of the legislation on global supply chain. John Lechleiter, CEO, President and Chairman of Eli Lilly with provide the Xavier PharmaLink Dinner Keynote speech. For additional plenary topics and the agenda, click here. Early Registration is now open, click here.
Where: Xavier University – Cintas Center, 1624 Herald Avenue, Cincinnati, Ohio 45207
When: March 11-14, 2013
Cost*: $200-$995 on or before 1/22/13
$250-$1,295 1/22/13-2/18/13
$300-$1,495 after 2/18/2013
*depends on registrant affiliation, click here for more details
Save the date- February 8, 2013 join us at the Kelley School Life Sciences Conference
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.
Are investments in technology and internet coming at the expense of venture capital healthcare funds?
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.
