Common Electronic Submissions Gateway (CEGS) targeted by years’ end

Striving for greater alignment in regulatory approaches, both FDA and Health Canada are continuing work to put in place the Common Electronic Submissions Gateway (CEGS) to allow industry to submit simultaneously to both regulators.  Full functionality is expected to be completed at the end of 2016.  CEGS is one initiative of the Canada-US Regulatory Cooperation Council (RCC).  RCC also has other Joint Action Plan Initiatives in developing common monographs for routine OTC drugs and teaming up to eliminate duplicate efforts on routine surveillance of GMP inspection reports.

“Increased collaboration between regulatory agencies in Canada and the U.S. will reduce unnecessary duplicative costs for manufacturers of pharmaceutical and therapeutic products, further streamline regulatory decision-making, and minimize the delays in bringing health and personal care products to the marketplace, thereby expanding consumer choice without compromising the safety, efficacy and quality of products,”  a joint action plan for the RCC says.

For more details and links, check out Zachary Brennan’s article in RAPS.

Pearl Pathways exhibiting at the RAPS Regulatory Convergence

raps regconvergence 2016Join us at the annual RAPS Regulatory Convergence in San Jose, CA from September 17-20.  Learn more about how to drive regulatory excellence and visit us at booth #111.  Some of the biggest challenges in the regulatory industry will be addressed in this year’s informative sessions.  Come together for great networking opportunities and the RAPS 40th anniversary.  To find out more information, visit the event homepage and register now.

RAPS publication features chapter authored by Pearl staff

gretchens bookWe are proud to announce that Gretchen Parker PhD, RAC, CIP contributed a chapter to a recent publication entitled “Global Medical Device Regulatory Strategy” published by the Regulatory Affairs Professionals Society (RAPS, purchase required). This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices.

Discussions cover medical device types, basic strategy components, and assembling a core development team from multiple departments to create a strong, viable strategy to market a product in more than one jurisdiction. There is information on device design and development elements, setting up a quality management system, labeling strategies, and manufacturing information. Other chapters look at the Notified Body’s viewpoint on regulatory strategy and that of regulators.  Additional information is included in the book, including the use of standards that cover global regulatory processes and how patents apply to medical devices.

Further information about this publication may be found on the RAPS website.  https://www.raps.org/ProductDetail.aspx?ProductId=96813130

Register now for a medical device Mock Recall Demonstration

imdmc

Hosted by IMDMC and Stericycle on September 27th, the Mock Recall Demonstration is an excellent opportunity to learn and strategize to increase efficiency in a recall situation.  Attendees will team up to analyze and develop a recall strategy and more.  Follow this link for more information.  Register now!

stericycle

 

 

August 16th…Brandwood Biomedical China Update webinar ‘live’

brandwood logoJoin in a complimentary webinar, China Update – what’s new with CFDA hosted by our partner, Brandwood Biomedical.  For the latest updates, including recent release of ruling on China RoHS coming from the CFDA, learn from Brandwood Biomedical Director of China Operations, Steven Wen.  The webinar is on Tuesday, August 16.  Free registration here today.  Find Brandwood Medical by clicking here.

Newly released PDUFA VI goals letter from FDA

FDA released its “goals letter”  on performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) for 2018 – 2022.  This is important news about the human drug review program — both for industry and patients.  FDA is holding a public meeting on August 15; information can be found here,  and you can register here.

Take a look at Zachary Brennan’s detailed summary in his article on RAPS.  Brennan says the “goals letter” document tells how and where the FDA spends user fees from industry.  It also communicates deadlines for upcoming guidance documents and new projects, and provides new review times for new drug applications (NDA) and biologics license applications (BLA) and more.

Preparation is key in preventing delays for obtaining orphan drug designation

Orphan Drug products give patients with rare diseases hope. The Orphan Drug Act, originated in 1983, features incentives for companies to develop drugs to treat a rare disease or condition by giving tax credits on clinical trials, eligibility for seven years of market exclusivity and no user fees.  More and more companies are jumping on this bandwagon which no doubt means a demanding number of requests for the FDA to review.  FDA continues to work on their review processes as Gayatri Rao, M.D., J.D. explains in her recent article on the FDA voice.  Her message to companies is to prepare designation requests with much attention to detail and requirements.  This preparation will minimize the number of review cycles needed with the FDA and get the therapies to the patient faster.  Call on Pearl Pathways to work with you and provide the attention to detail you require in your orphan drug designation requests.

Pearl Pathways’ Pannucci reflects on the Innovation Showcase

I attended the Innovation Showcase yesterday at the Dallara headquarters in Speedway Indiana.  Aside from the event itself, we were all surprised to be a part of the breaking news when Governor Mike Pence showed up to deliver a speech to announce a new $1B investment in the Indiana entrepreneurial and innovation ecosystem.  Big news for the state that can only help to propel new technology and new startup company formation in Indiana.  There were 75 exhibiting companies at the event consisting of pre-commercialization startups and scale up companies in software, technology and life science sectors.  There were also scores of venture capital groups and investors attending the event to make connections and watch the pitch events.  Fantastic panel discussions and advice from venture capital leaders like, Tim Kopp, Bill Godfrey and Don Aquilano added substance and real world experience that many of the startups in the room were craving to hear.  Ben Pidgeon, Joana Milliken and Ting Gootee did an excellent job to bring this event all together.  All in all,  an incredible turnout for a mid-week event which really underscores the activity level and momentum that central Indiana, and the state as a whole, has been building in 2016.  The appetite for deals, new companies, top notch technology and venture capital has really been building as of late, spurring new investment, corporate relocations, jobs and economic announcements that seem to happening daily.

So what does this all mean and why is this happening in Indiana.  I think that answer is a multi-part answer, but goes something like this:

  1. We have fantastic research and talent coming out of our universities (particularly Purdue via the Purdue Foundry folks)
  2. We have a growing entrepreneurial mindset to start and grow new companies (thanks in part to companies  and success stories like ExactTarget, now Salesforce)
  3. We have state and regional programs creating an infrastructure platform and resources to support startups (recent $1B investment most recent example of that)
  4.  We have seasoned leaders to help lead and advise our startups
  5.  We have venture capital ready, willing and able to help finance startup companies (as evidenced by the turnout at the Innovations Showcase)

Seems like a perfect recipe to succeed.  Next steps: Rinse, lather and repeat.

Could FDA be made into an independent federal body?

Former FDA commissioners recently gathered at the Aspen Ideas Festival’s Spotlight Health discussing ways to minimize bureaucratic and political red tape.  FDA’s science based recommendations of safety and efficacy of food and drugs many times have political pressures and challenges to overcome.  Former regulation executives coming together to share and leveraging their many years of experience may ultimately produce a positive change.   Perhaps there could be a better path forward than the current system we have in place?  Check out Sy Mukherjee’s informative article on Fortune.

cGMP clinical grade stem cells

Outsourcing-Pharma.com’s Melissa Fassbender recently posted an article on a talk she had with James M. Anderson, M.D., Ph.D., Deputy Director, NIH Division of Program Coordination, Planning and Strategic Initiatives. This exchange reveals information on clinical grade stem line development that is hoped to help accelerate early-stage clinical research for diseases including Alzheimer’s, Parkinson’s, spinal cord injury, diabetes and muscular dystrophy.  Anderson talks about how clinical grade cells are developed under regulations and quality control measures that ensure quality and safety standards of the cells for potential clinical applications in humans.  Click here to read Fassbender’s article and contact us if you need help with your cell therapy regulatory filings or clinical trials.  Pearl has extensive experience with cell therapy products.