Latest News

Check back regularly for news of special interest to the pharmaceutical and medical device industries. We’ll keep you updated on important developments and upcoming events. Also expect to find insights from Xavier Health and other industry thought leaders, as well as vital information from FDA regulators.

Keynote Dinner at Great American Ballpark – March 20, 2014

Join us on March 20, 2014 at the FDA/Xavier PharmaLink Conference as James Mullen, CEO of Patheon  shares his thoughts on how all players in the complex global supply chain have a vital and interdependent leadership role in ensuring our medicines are safe and effective for patients around the world.  The evening event will be held at Great American Ball Park which serves as the home of the Cincinnati Reds, baseball’s first professional franchise. The reception will be held in the Riverfront Club, which offers spectacular views of the Ohio River.If you want to explore the stadium we will be offering a walking tour so you can get a behind-the-scenes look at the ballpark  and visit areas such as the dugout and press box.  Visit www.pharmalink2014.com for more information about the conference.

January 13

Keynote Dinner at Great American Ballpark – May 8, 2014

Join us on May 8, 2014 for the evening event of the FDA/Xavier MedCon Conference.  It will be held at Great American Ball Park which serves as the home of the Cincinnati Reds, baseball’s first professional franchise. The reception will be held in the Riverfront Club, which offers spectacular views of the Ohio River.If you want to explore the stadium we will be offering a walking tour so you can get a behind-the-scenes look at the ballpark  and visit areas such as the dugout and press box.

January 9

Cincinnati Chapter Event A Big Success

The Cincinnati Chapter of Xavier Health came together on January 8, 2014 to discuss the ROI of Regulations and Quality.  The breakfast meeting was free of charge for Cincinnati-area pharmaceutical, medical device and regulatory professionals.  All left with a better understanding of the cost for poor quality.

The speakers delivered presentations that touched on the factors that affect your ability to make quality or regulatory decisions and how you deal with them.  Steve Niedelman, former Deputy Associate Commissioner of the FDA, now Lead Quality Systems and Compliance Consultant, King & Spalding, explained what companies need to understand today to avoid FDA enforcement action.  The audience took good notes as Gina Brackett, FDA Cincinnati District Compliance Officer joined the discussion and shared the top three red flags that tell the FDA a company is out of control.

When asked if there is one thing she wished industry could improve, Gina indicated that she wished companies had the mindset that quality is part of everyone’s job.  She further explained that the “Quality System Regulations help you make good product and are good business.”

The number one red flag that tells FDA if there are serious compliance issues with a firm is when systemic issues signal a breakdown in the culture of the company.  Culture is so hard to change, that companies often have to change the management team to see a difference.  All four speakers echoed this sentiment as the key ingredient to a successful business in the medical device and pharmaceutical industries.

A second red flag is related to product design.  Instead of addressing problems, complaints and non-conformance, companies will come out with the next model and perpetuate the poor design.  Not recognizing when to recall a product is an area of great concern.

Lastly, a third red flag that a company is in a state of serious non-compliance is when they are not assessing streams of data from all sources.  In the device industry, examples would include not including service records and acceptance of non-conformance as part of the Corrective Action Preventive Action system.  Is your risk assessment based on the right data?  And don’t forget “you don’t know what you don’t know,” which could have serious consequences for the patients you serve.

Advice from the day:  spend your time preventing issues, instead of relying on attempts to catch issues.

A newcomer to Xavier Health, Jessica Zeller, Senior Counsel at Procter & Gamble, earned high marks as she shared challenges she faced during her former role at the FDA where she was responsible for litigating pharmaceutical consent decrees.

It’s basketball season at Xavier so along with networking and learning, someone won two tickets to an upcoming Xavier basketball game.  A hot commodity now that Xavier is part of the Big East Conference.
January 9

Next Steps for the CDER Challenge

As an industry we work to achieve quality products that are effective and safe for the patients we serve while meeting their intended use.  Learn what is at the heart of CDER’s challenge to industry to measure the level of quality achieved, and how that information could be used.  CDER will share their vision, goals, status and next steps.

Attend PharmaLink 2014 and discuss these burning issues with Russell Wesdyk and other thought leaders.

October 21

A Confusing Attempt to Cure Compounding Pharmacies

The House of Representatives passed a bill regulating specialty pharmacies, seeking to prevent disease outbreaks like the one last year in which a pharmacy’s tainted steroid injections caused 750 cases of spinal meningitis.
View the original article here.

October 6

Fight against medical device tax

Congressmen Paulsen issues statement after his legislation to repeal the new 2.3% tax on American-made medical devices.

Congressman Erik Paulsen (MN-03) recently lead a special hour-long discussion on the floor of the House of Representatives on the importance of repealing the disastrous medical device tax. Paulsen was joined by a bipartisan group of eight members to discuss the devastating impact the tax has on local economies and on our nation’s ability to develop and bring to market new life-saving and life-improving technologies. So far, the tax has collected more than $1.7 billion at a cost of over 10,000 jobs.

View the original article here.

August 1