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.

Navidea Leads The Way For Metrics With Success

A leader in the biopharmaceutical industry, Navidea develops novel radiopharmaceutical imaging agents for precision diagnostics.

Jamie Wilson, Associate Director, Global Quality Assurance, attended the 2013 PharmaLink Conference anticipating discussions on supplier management best practices with industry leaders and FDA officials. She and her team also came away with a long-range action plan based on a deeper understanding of the FDA Safety and Innovation Act.

“Insights we gained from Ryan Long, Congress’ Chief Health Counsel for the Energy and Commerce Committee, and Steve Solomon from the FDA helped us develop action plans to improve our Global Management and Supplier Qualification Program,” says Wilson. “Major benefits included removing barriers so we could get products to market faster.”

As the new program was being implemented, Wilson and her team returned to PharmaLink in 2014. They heard Russ Wesdyk, FDA Scientific Coordinator, and Jim O’Reilly, Professor, University of Cincinnati, explain what the FDA is looking for in metrics and how the industry should be involved.

“We then reassessed how we identify leading and lagging metrics, and analyzed unintended consequences from ourselves and our suppliers,” says Wilson. “It allowed us to structure management meetings in an entirely different way, monitoring specific metrics from our suppliers.”

Navidea has seen continued improvement in consistent and reliable quality performance from its contract suppliers due to the changes. In addition, Wilson now leads an industry-wide Pharmaceutical Quality Metrics Initiative, in cooperation with Xavier Health, working to identify metrics that are critical to ensuring the reliability of product quality.

November 14

Cincinnati Chapter Breakfast Meeting

Eighty members of the Cincinnati Chapter of Xavier Health came together on October 17, 2014 to discuss aligning guidance documents with FDA Cincinnati District Regulations. The breakfast meeting was free of charge for Cincinnati-area pharmaceutical, medical device and regulatory professionals. All left with a better understanding of ensuring practices at their facility are aligned with FDA regulations, FDA guidance documents, corporate policy, and procedures.

Paul Teitell, Director, Cincinnati District, FDA welcomed the group and shared his thoughts on the intent and enforcement of FDA guidance documents

Dominick Villani, Associate Director, Quality Assurance Compliance, AstraZeneca shared his experience of managing the quality integration of Amylin Pharmaceutical into Bristol-Myers Squibb in 2013 and now into AstraZeneca in 2014. Mr. Villani’s discussed his responsibility for ensuring that the regulatory requirements and guidance’s across multiple markets (i.e. FDA, EMA, PMDA, etc.) have been integrated into the implemented GMP production processes, laboratory managements systems, and Quality Management systems.

Marla Phillips, Director, Xavier Health led an engaging Q&A session as well. A door prize drawing for 2 free tickets for a Xavier men’s basketball game was presented to one of the attendees.

Thank you to our sponsor of this event… Aptalis Pharmaceutical Technologies.

October 17

The Silver Sheet Discussion of MedCon Survey

Top management at some medical device firms view quality assurance and regulatory affairs in a particular negative light, according to a recent survey of industry professionals.

The results appear to strongly match those from a similar survey conducted 10 years ago, suggesting underwhelming progress in efforts by quality and regulatory employees to convince management of the necessity of their work product.

But QA/RA officials from several major device firms say there are communication and education tactics that can be employed to gain organization-wide buy-in. View the entire article by Shawn Schmidt here.

August 19

Integrity of Supply Initiative Develops Industry-Wide Good Supply Practices

Cincinnati, OH – Pharmaceutical and medical device professionals, as well as their supplier partners visited the Xavier University campus for two days in May to roll-up their sleeves on the Integrity of Supply Initiative. The goal of the initiative is to develop and implement pragmatic Good Supply Practices (GSPs) that increase the reliability of incoming supply across the pharmaceutical and medical device industries. A more reliable supply chain reduces risk to finished product quality and patient safety, which in turn leads to business success.  The members of the group agree that one of the aims of the initiative is to determine the source of dysfunction affecting the Integrity of Supply in these regulated industries. By finding the sources of dysfunction the group is able to implement sustainable solutions that can be tied to return on investment.  Some of the benefits will include increased safety, improved quality and enhanced reliability.

More than twenty of the most well-known companies in these industries sent high level Quality and Supply Chain experts to the two day meeting. Some of the companies represented include:  Eli Lilly, Baxter, Merck, Procter & Gamble, Boston Scientific, and Johnson & Johnson.  Each company was personally invited by the representatives of Xavier Health because of their global standing and proven track records of patient and business success.  When the group, including FDA officials from the Office of the Commissioner, first met in August 2012 they believed the suppliers were causing problems with the integrity and reliability of the supply chain.   The result of root cause exercises, surveys, interviews and focus group sessions pointed toward a major paradigm shift in these Industries that every area of dysfunction related to the reliability of incoming supply is caused by and/or can be controlled by the manufacturers themselves, not their suppliers. This paradigm shift gave the Integrity of Supply Initiative the direction necessary to begin developing solutions to address supply chain issues. Membership of the initiative has been broadened to gain insight through formal involvement of suppliers in solution development.

During the May 2014 meeting the group was divided into three working groups to address dysfunction related to:  (1) incomplete product and process knowledge and development, (2) insufficient supply chain development and management, and (3) inadequate behavior and communication. Each working group brought new ideas to the initiative while folding in historical data to create problem statements relevant to the scope of their group. “We asked everyone to present opportunities for improvement by thinking about what they would do if they were king/queen for a day” said Marla Phillips, Director of Xavier Health. The working groups then prioritized all input, which they will later develop into GSPs. They also created team charters which require them to meet and report their progress on a regular basis.  Each working group plans to apply solutions across product development stages, address legacy products and provide options, decision making tools and best practices throughout the industry.

FDA officials have been deeply involved during the discovery phase of the initiative, and are now serving in an advisory role to the leadership of the initiative.  Dates have been set for follow-up meetings over the next twelve months and the group will announce future plans for sharing the information at a later date.

July 10

Keynote Dinner at Newport Aquarium – March 26, 2015

Join us on March 26, 2015 for the evening event of the FDA/Xavier PharmaLink Conference. It will be held at the Newport Aquarium. The reception will be  in the Riverside Room, which offers spectacular views of the Ohio River and the Cincinnati skyline. You will have an opportunity to explore the one million gallon aquarium that is home to over 90 species including shark rays, jellyfish, alligators, and penguins.

If you would like more information about the aquarium please visit their website at: www.newportaquarium.com.

January 13

Keynote Dinner at Newport Aquarium – May 7, 2015

Join us on May 7, 2015 for the evening event of the FDA/Xavier MedCon Conference.  It will be held at the Newport Aquarium The reception will be held in the Riverside Room, which offers spectacular views of the Ohio River and the Cincinnati skyline. You will have an opportunity to explore the one million gallon aquarium that is home to over 90 species including shark rays, jellyfish, alligators, and penguins.

If you would like more information about the aquarium please visit their website at: www.newportaquarium.com.

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