Will we see you at the upcoming RAPS Indiana Chapter meeting, June 16th?

raps indianaThe RAPS Indiana Chapter, chaired by Pearl Pathways’ COO & RAC, FRAPS, Gretchen Bowker, is hosting an evening of networking and expert presentation by Susan Resnick, PhD of 3D Communications. The presentation is entitled, “Practices and Preferences of CDRH Advisory Committee Members – Know Your Audience”. The event is the evening of June 16th, 6:00pm – 8:30pm, at The Rathskellar Restaurant, Indianapolis, and is for promoting education and networking among local regulatory professionals. To get the latest understanding of practices and preferences of advisory committee members and how to prepare for panel meetings, don’t miss the presentation – click here for more details! Register today.  You can also register by calling +1 301 770 2920 ext. 200. We hope to see you at this special event!

Using Comparability Protocols for CMC postapproval changes

FDA issued a draft guidance in April with recommendations on using a Comparability Protocol (CP) when implementing a chemistry, manufacturing and controls (CMC) postapproval change. FDA defines a CP as a comprehensive plan for “assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product (i.e., product), as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” When assessing how a CMC change may affect product quality under a CP, be sure to have the following established for continuous improvement:

  • An understanding of the product and manufacturing process
  • A robust control strategy
  • Risk management activities over a product’s life cycle
  • An effective pharmaceutical quality system

 

For more information, read Dan Stanton’s article at in-PharmaTechnologist. Let Pearl Pathways help you with your CMC approach and regulatory submissions for both drug substance and drug product. Contact us here.

Pearl Pathways proud sponsor of Indiana Life Sciences Collaboration Conference Series at Cook Medical World Headquarters, May 13th

life sciencesPearl Pathways continues to be a proud sponsor of the 2015-2016 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. This is an excellent forum bringing together key players in Indiana’s life science and healthcare arenas for intriguing business discussions on business strategy, solutions and development to promote growth.

Diana Caldwell, President and CEO of Pearl Pathways, shares that “The conferences add value for all of the major life science players in the state. It’s a great means to get us together, hear relevant topics from thought leaders, stay up to date, and network.”

Please joins us for the May conference — The Shift from In-patient to Alternate Care Settings to listen to stakeholder perspectives on how companies, providers and payers are seeing and responding to technology advances, cost pressures, and patient visits and treatments moving out of traditional hospital settings.

What:          The Shift from In-patient to Alternate Care Settings

Where:       Cook Medical World Headquarters 750 Daniels Way, Bloomington, IN

When:         May 13, 2016

To join in the May conference, please register here. To find out more about the Indiana Life Sciences Collaboration Conference Series, see this link.

Deadline fast approaching for Class II medical device compliance with UDI

September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID (Global Unique Device Identifier Database). Device labeling documentation planning is key since once the DI is submitted for a device and entered into the GUDID; further, there are rules for editing during a grace period only and companies may find themselves in situations requiring them to have to obtain a new DI for a device. Keep watching for any FDA updates that may post as this deadline approaches.

More details can be found in Michael Mezher’s informative article posted on RAPS. Pearl Pathways has an experienced team ready to help with your UDI compliance planning and execution, contact us here.

Reflection on the IBJ Life Science Power Breakfast panel discussion

The Indianapolis Business Journal (IBJ) hosted the IBJ Life Science Power Breakfast Series this morning at the Marriott Hotel downtown Indianapolis.  It was a great panel discussion with industry leaders and well represented by many of the regional life sciences companies and service providers, including  (and proud sponsors) Pearl Pathways’ CEO Diana Caldwell and Director, Business Development Chad Pannucci.  In addition to an interesting presentation and panel discussion, we enjoyed conversation and getting better acquainted with some of our life science clients & colleagues from Indiana startups, universities and industry experts hosted at the Pearl Pathways table.  The impact of the Indiana life science industry cannot be overstated.  As mentioned, the output by Indiana life science companies (#medical device, #pharmaceutical, #biotech, #diagnostic etc) represents a $59B per year economic impact and almost $10B in worldwide annual exports where 1 out of every 10 Hoosiers (or ~56,000) work in the life sciences sector.  There is tremendous innovation happening right now at places like Purdue University where current president and former State of Indiana governor Mitch Daniels have done a tremendous job to accelerate innovation by creating a framework to spin up startup companies and pursue licensing opportunities with Purdue based research and intellectual property (IP).  For example, Purdue recently gained national press and media coverage when researchers recently deciphered the structure of the #Zika virus which will help to more quickly identify and develop therapeutics to treat it, while #GE and #Rolls Royce announced significant multi-year and multi-million dollar investments to further their partnership with the university and leverage engineering talent and facility capabilities to develop and built out new technologies related to jet engine research and advanced manufacturing.  Closer to Indianapolis mentioned was the 16 Tech project which will be anchored by the new $250M Indiana Bioscience Research Institute on 60 acres of land situated just northwest of downtown along Indiana Avenue between Indiana University School of Medicine, IUPUI and downtown Indianapolis, not to mention only 20 minutes from the Indianapolis International airport.  16 Tech will be designed as an #innovation hub and a conduit between life sciences research institutions, industry, expertise and facilities to foster and speed development of new products and technologies for medical innovation in Indiana.  Events like the IBJ Life Science Power Breakfast Series are important to showcase the progress we have collectively contributed as a state under the guise of not just as a national, but a global effort to push forward technology and breakthrough medical advances to help patients around the world.

What is your company doing about Cybersecurity for Medical Devices?

cybersecurityEarlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software (firmware) and includes the ever important postmarket management. Risk to device functionality or loss of important data due to a cybersecurity risk is a consideration that could result in bad outcomes for patients. Device manufacturers need to take a look at their own risk management programs and assure they have a comprehensive plan established.

Pearl Pathways looks forward to the opportunity to work with you and provide support to your ongoing successful product development activities including risk management program development as part of your overall Quality System. Contact us to set up a discussion.

Image courtesy of thomasdinnocenzi.wordpress.com

Next Wednesday, April 20th… Join in a complimentary webinar on Post Market Compliance from Pearl Pathways partner, Brandwood Biomedical

brandwood logoBrandwood Biomedical is hosting a webinar, Post Market Compliance – keeping those hard won registrations. For the latest news on staying on top of your post market obligations including customer feedback, post market reporting, advertising & labeling compliance join in next Wednesday, April 20th.  Registration here today. Find Brandwood Medical by clicking here.

Gretchen Bowker speaking at the IMDMC REG 101 workshop on April 21st

imdmcThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st for those new to the medical device industry or for those looking for a regulatory refresher. Pearl Pathways’ own, Gretchen Bowker COO & RAC, FRAPS, will be presenting on, Pathways to Market – 510(K) Requirements at 10:15am. The workshop provides a background in FDA regulations of medical devices.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Thursday, April 21st, 2016, 8:00 AM to 5:00 PM EDT

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today! (Lunch will be provided.)

To learn more about the workshop and register for REG 101 & 102 Workshop, click here. We hope to see you there on April 21st!

What’s your take on Outsourcing Pharma’s phrase “Chindia” for drug substance market?

Check out Melissa Fassbender’s intriguing article on API contract manufacturing trends to “Chindia” and perhaps back West again.  Have we come to understand API outsourcing to China and India as the new normal? 

According to Oursourcing Pharma‘s Fassbender, there are over 1,500 suppliers of API in China and 2,300 in India with an output of $27 billion. Dr. Enrico Polastro was quoted from his recent DCAT session entitles “Pharma fine chemicals outsourcing:  Back to the West?”

Check out the article here.  Need API supplier audits in China or India?  We can help with expert auditors on the ground in both countries.  Contact us to discuss your auditing needs. 

Pearl Pathways’ own Gretchen Bowker speaking at Roche Devices and Diagnostics for a Purdue University Course, April 8th

Gretchen Bowker, Pearl Pathways COO and Co-Founder, is teaching a class to Purdue students on the campus of Roche Diagnostics in Indianapolis on “Ethics, Quality and Human Safety in Clinical Trials: The Role of the IRB in Medical Device Studies”. The lecture will be held at Roche during a two-day event, April 8-9, and will provide current industry perspective on devices and diagnostics. This presentation is an excellent opportunity for Purdue students to learn from industry experts.