Latest Edition of DIA's Content Currents is available (April 26, 2013)

DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.


EDITION PUBLISHED: APRIL 26, 2013


SECTION 1: FDA GUIDANCES
April 23, FDA announced the availability of a draft guidance document for industry entitled, “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” This draft guidance is intended to aid prescription drug and biologic manufacturers in minimizing medication errors by focusing on safety aspects of the container label and carton labeling design. The 60 day comment period will close June 22, 2013. [Draft Guidance] (FDA.gov)

April 23, FDA announced the availability of a draft guidance document entitled, “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’” This draft guidance is intended to aid sponsors in determining the potential toxicity of medical devices contacting the skin, clarify the Office of Device Evaluation General Program Memorandum #G95-1, and replace the memorandum when made final. [Draft Guidance] [FR Notice]

April 25, FDA announced the availability of a final guidance document entitled, “Assay Migration Studies for In Vitro Diagnostic Devices.” This guidance document is intended to provide a least burdensome approach to earn FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when an already approved assay is transitioning to a new system. [Guidance]

April 25, FDA also announced the availability of a final guidance document for industry entitled, “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance document is intended to aid sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) by informing them of the type of data that should be submitted to support the application. [Guidance] Note: the link appears to be temporarily unavailable as of 4/25/13. (FDA.gov)


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Europe Establishes First Facility for Cell-Based Therapeutics

Oct 24, 2012 By: Adeline Siew

On Oct. 22, 2012, a consortium in France announced the establishment of Europe’s first ever industrial manufacturing facility dedicated to the large-scale production of novel, advanced cell-based therapy medicinal products. The plant, located in Les Ulis, near Paris, at the site of the French biopharmaceutical company LFB Biotechnologies, has the capacity to produce 3000 to 5000 therapeutic batches per year. The facility will be used for innovative R&D projects on autologous and allogeneic cell therapies that are progressing from early clinical research stage up to industrial production.

http://www.pharmtech.com/pharmtech/News/Europe-Establishes-First-Facility-for-Cell-Based-T/ArticleStandard/Article/detail/793994?contextCategoryId=35097&ref=25

The New Bio-terrorism? Medical Device Hacking

 

By Jane Sarasohn-Kahn

A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.

Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.
Got the picture?

Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.

see the complete article on The Health Care Blog
 

Importance of Development Strategies for Life Cycle Management of Safe and Effective Medical Products -> 9th DIA Japan Annual Meeting

Don’t Miss this Highly Anticipated Event and Register Today. Informative tutorials, networking with colleagues and informative exhibits, impressive keynote speakers, and registration savings- all crucial elements to a successful meeting. Find them all at the 9th DIA Japan Annual Meeting, with focus on creating new solutions to the life cycle management of safe and effective medical products.   Online Registration     Read More UPCOMING EVENTS Conference Keynote Speakers and Tutorials Keynote Speaker 1: Peter Bachmann, DrSc European and International Affairs Member of the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) on the Latest Regulatory Environment in EU - from Development to Post-Marketing. Keynote Speech 2: Takao Yamori, PhD Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA) to discuss the New Drug Development of Japan Origin through Industry-Academia Collaboration. Tutorials: Tutorial 1: Company Core Data Sheets Prepared by Western Companies Tutorial 2: Roundtable Discussion: What are Preferable Skill Sets in Clinical Development Tutorial 3: Group Work: Action Learning for Six Sig Tutorial 4: Risk Management Plan - Standard (As of 10/30/2012) Tutorial 5: Leadership and Philosophy: Best Practice Tutorial 6: Basic Understanding of Bioequivalence   Online Registration     Read More

Importance of Development Strategies for Life Cycle Management of Safe and Effective Medical Products - 9th DIA Japan Annual Meeting

9th DIA Japan Annual Meeting Program Now Available! Prepare for Japan’s Annual Meeting by choosing what events and sessions you would like to attend. Informative tutorials, outstanding speakers, excellent presenters, interactive sessions and exciting network opportunities await you!   3 days of interacting with biopharmaceutical industry, contract service organizations, regulatory agencies, health ministries, patient organizations, universities and students from throughout Japan and worldwide. Plus, attend the DIA Awards Presentation, with presenter and DIA Board President Ling Su, PhD.   Program now available here!         Register today for the early bird special until October 29!   Online Registration     Read More UPCOMING EVENTS Tutorials and Keynote Speeches Tutorials: Tutorial 1: Company Core Data Sheets Prepared by Western Companies Tutorial 2: Roundtable Discussion: What are Preferable Skill Sets in Clinical Development Tutorial 3: Group Work: Action Learning for Six Sig Tutorial 4: Risk Management Plan - Standard (As of 10/30/2012) Tutorial 5: Leadership and Philosophy: Best Practice Tutorial 6: Basic Understanding of Bioequivalence   Don’t Miss the Keynote Speeches! Keynote Speaker 1: Peter Bachmann, DrSc European and International Affairs Member of the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) on the Latest Regulatory Environment in EU - from Development to Post-Marketing. Keynote Speech 2: Takao Yamori, PhD Director of Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA) to discuss the New Drug Development of Japan Origin through Industry-Academia Collaboration.   Online Registration     Read More

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Register now to win FREE 4-night stay during DIA2012 Annual Meeting - June 24-28 in Philly

To celebrate the launch of our new website, we would like  to extend the opportunity for you to win a free four-night stay in Philadelphia during the DIA 2012 Annual Meeting. Register for DIA 2012 Annual Meeting by Friday, April 20 to be entered to win! With plenty of breakout and plenary sessions, interactive discussions, roundtable presentations, and innovative exhibits, DIA 2012 is the place to be in Philadelphia this June. What You Can Expect at DIA 2012 The 48th Annual Meeting is an incredible resource. Attend jam-packed sessions, hear notable speakers, and network with colleagues. Watch the DIA 2012 Annual Meeting video! Explore expert discussions on today's hottest topics. View DIA 2012 Preliminary Program! DIA 2012 Annual Meeting video

We're looking for the 15 fiercest device developers, Fierce Medical Devices

By Arsalan Arif
 Comment |  Forward | Twitter | Facebook | LinkedIn

We're expanding our yearly franchise report, the Fierce 15, and bringing it to the world of devices. FierceMedicalDevices actively seeks your nominations and our report will be published in early October.
We'll profile the 15 fiercest private device developers for our readers (check out FierceBiotech's 2011 Fierce 15 report). Do you know of private device developers with savvy execs and promising technologies or platforms that deserve to be on the list? Please fill out the simple survey and nomination form we've created here. In years past, we've been pleased to see a number of our Fierce 15 companies go on to IPOs, buyout deals, blockbuster partnerships and big venture rounds. Our goal is for the FMD Fierce 15 to follow that trail.
There are several decisive factors in making the list: Venture backing can be crucial. So is the potential impact of their technology. If the developer has already inked a few partnerships, that would help. And the quality of the executive team, their level of experience and scientific know-how, are also telling factors.
Aside from that, we don't much care where the developer is based, since this is fundamentally a global industry. Liz Hollis and Mark Hollmer will be setting deadlines and providing updates in this space in the coming weeks. -- Arsalan Arif, Publisher (Twitter) | (LinkedIn)
PS: If you missed our note Friday, we're expanding FierceMedicalDevices by moving it to a daily publication schedule. And we've overhauled the website. Check it out and let me know what you think. -- Arsalan Arif

DIA 2012 Annual Meeting: Early-bird Hotel Rates Expire Friday, March 30!

Conferences & Meetings | Exhibits & Advertising | Training | Online Learning | Membership | Get Involved

Nothing Says "Innovation" Like Philadelphia! You probably already know that the Greater Philadelphia region is home to 400 life science companies, with 53,000 workers in the core life sciences industry and 310,200 workers in supporting industries. Large multinational pharmaceutical firms have major operations in the region, and many trace their regional roots back to the 19th century. That's because this region has a strong history in public health and innovation. What you may not know, is that Philadelphia is one of America's top visitor destinations. America's Favorite Cities. Philadelphia has once again been named among the top 30 of "America's Favorite Cities" based on votes of visitors and residents on a range of criteria, including culture, shopping, dining, and for the first time this year, hotels and local airports. What's the word about Philadelphia? Philadelphia's Mayor Michael Nutter can tell you! Lock into the Best Hotel Rates in Philadelphia! Take advantage of early-bird rates as low as $166, and amenities exclusive to DIA attendees. Offer expires Friday, March 30! Since you must be registered for DIA 2012 Annual Meeting to receive full access to all discounted hotels, we urge you to Register and Book Your Hotel Today! The DIA 2012 Annual Meeting includes: NEW! Preconference Program 20+ Preconference Tutorials 270+ Educational Opportunities including: European Town Hall Part 1 and Part 2 June 25 | 10:00 – 11:30AM and 1:30 – 3:00PM Discussion with Former Center for Devices and Radiological Health (CDRH) Management June 25 | 3:30 – 5:00PM Orphan Drug Development: Global Regulatory Challenges and Initiatives June 27 | 1:30 – 3:00PM Implementation of the Physician Payments Sunshine Act: Now What? June 27 | 3:30 – 5:00PM 500+ Exhibiting Companies 6 month FREE access to all Audio-synchronized Presentations Executive Program: Pioneering Partnerships And much more... View DIA 2012 Preliminary Program! Follow us on twitter at #DIA2012

Deadline approaching for Life Science Entrepreneur/Start Up Application | DIA 2012: Collaborate to Innovate | Deadline: Monday, April 16, 2012

DEADLINE TO APPLY - April 16, 2012

DIA 2012 Collaborate to Innovate

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

DIA 2012: Collaborate to Innovate, DIA’s 48th Annual Meeting, is the medical product and health care industries’ largest multidisciplinary event, and brings together a global network of 7,500 professionals to develop safe and effective medical products.

DIA recognizes the innovative seed and early-stage start-up companies that are impacting these industries and we welcome your participation at this year’s event.

Eight entrepreneurs will be given the opportunity to showcase their work at this year’s DIA Annual Meeting.

These entrepreneurs will receive complete and total access within the DIA Annual Meeting Exhibit Hall (which features 500+ exhibiting companies from all around the world) and a small dedicated area (including internet hookup) for a live demonstration or presentation of their innovative product.

For more information, please click on the link below:

http://www.diahome.org/productfiles/27170/12001_EntrepreneurApplication.pdf