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.

CTI Clinical Trial and Consulting Services Partners with Xavier University on New Masters Degree Program

FOR IMMEDIATE RELEASE [Cincinnati, OH ~ June 17, 2015] CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service contract research organization, is collaborating with Xavier University on a new Master’s program that will fill jobs desperately needed in the health care industry.

The U.S. Bureau of Labor Statistics expects the demand for analysts to grow by 14% over the next 10 years, an increase of more than 2,300 jobs. The demand for health analysts in particular will likely outpace that projection.

To meet this demand, the Master of Science in Health Economic and Clinical Outcomes Research (HECOR) begins in Fall 2015. This 40-credit hour program is designed to train analysts to conduct both clinical and economic evaluations that support improved health decisions.

“The program that we have developed in partnership with Xavier is one of only a handful in the country,” said Dr. Candace Gunnarsson, Vice President of Health Economics & Outcomes Research at CTI and former faculty member at Xavier. “Students will study health economics, data mining, statistical modeling and epidemiology as they prepare for careers as analysts, managers and directors in the fast-growing field of health care analytics that includes outcomes research, policy, economics and reimbursement.”

Last year, CTI’s Consulting and HECOR divisions relocated to University Station, adjacent to the Xavier University campus. The company recently moved their Biometrics department to the location as well. When CTI identified a need to hire health economic and clinical outcome analysts, partnering with Xavier to provide the education necessary to fill those jobs was a natural fit.

“A rapidly changing landscape for the healthcare sector, driven in part by the 2010 Patient Protection and Affordable Care Act, combined with an aging population and medical force, as well as technological advancements within the industry make this program highly desirable,” said CTI CEO Tim Schroeder. “We are excited to extend our collaboration with Xavier University and look forward to developing the future HECOR leaders in this exciting and innovative research space.”

The 2 year, non-thesis program is designed to accommodate working professionals and people with a passion for solving problems using the latest health data to improve care. Courses are a combination of lectures, applied analysis exercises, group activities, discussion and case studies led by experienced full and part-time faculty who have practiced in the HECOR field, including CTI employees. Students complete a mentored capstone project during their final term.

Michael J. Graham, S.J., President of Xavier University, said the professional and community connection with CTI is critical to the program’s success. “The Jesuit education model will provide students the opportunity to explore ethical issues inherent in growing big data working in conjunction with an organization that is an industry leader in this important and growing field.”

Learn more about the degree at Xavier.edu/HECOR or contact Dr. Eileen Alexander directly at alexandere2@xavier.edu or 513-745-4957. Interviews for Fall 2015 admission are currently underway.

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com

About Xavier University

Xavier University is a private university located in Cincinnati, Ohio, providing a liberal arts education in the Catholic, Jesuit tradition. Founded in 1831, the university is the sixth-oldest Catholic university in the nation. U.S. News & World Report ranks it No. 5 among master’s-level universities in the Midwest, and The Princeton Review names it as one of the “Best 377 Colleges in America.”

Media Contacts
Allison Schroeder | CTI Clinical Trial & Consulting Services | 513.598.9290 | aschroeder@ctifacts.com
Kelly Leon | Xavier University | 513.745.3877 (o) | 513.235.3836 (c) | leon@xavier.edu

June 25

Marjorie Shulman Responds to MedCon Attendees

Cincinnati, OH – Marjorie Shulman, Director – Premarket Notification (510k) Program, FDA presented “Improving Your Chance of 510(k) Success” at the 2015 FDA/Xavier MedCon Conference. Marjorie fielded questions from the audience following her presentation.

One particular question pertained to “add-to-file” documents sent to FDA in order to keep the FDA’s 510(k) file up to date with modifications that the manufacturer implemented but considered not significant enough to require a new 510(k). Marjorie answered the question from the podium but also indicated she would provide a more detailed response after the conference. Below is more information provided by Marjorie on this topic:

We have used two terms for information the FDA receives that is either unsolicited or does not affect the review clock.
1. If information is received during the review of a 510(k) we consider that an “amendment”. This can happen if the reviewer is working interactively with the applicant or if the information is unsolicited.
2. If information is received after a final decision we called this an “add to file”.

FDA has not advertised anything regarding add-to-files in the past because technically a company should make their own decision on whether or not to submit a new 510(k) for a change or modification. This would explain why one questioner at MedCon had never heard of “add-to-file” documents.

If we receive documents after the decision has been made, we have to accept it, so we log it in under the 510(k) number and send it to the division. If the division looks at it and it appears to be a significant change we will let the company know. If it is not a significant change, then we just add it to the file (hence the name). Again we do not actually want this type of information to come in to us. The decision to file a new 510(k) resides with the company.

Also transfer of ownership is handled through Registration and Listing. The 510(k) database has always been a snap shot in time. The 510(k) holder, device name, etc. is how it is listed in the database on the day of the final decision – and we do not change or update it. FDA does not require information to be sent-in to keep FDA up to date (like an annual report). This information should be kept in the company’s own files.

To view Marjorie’s presentation click here.

June 3

Marla Phillips Presents at ExcipientFest Puerto Rico

April 29, 2015 – Puerto Rico – Marla Phillips took to the road once again to share the information from the Xavier Health Integrity of Supply Initiative, however, this time outside the continental United States. ExcipientFest 2015 Americas was held in Peurto Rico and offered a roundtable of speakers to discuss the harmonization of the supplier-customer interface and have a discussion on industry approaches to standardizing supplier practices.

Excipient manufacturers, other suppliers of excipients and drug product manufacturers share a common goal of ensuring the reliable and safe supply of pharmaceutical ingredients, but there are obstacles in realizing the optimal way to meet that objective. Differing supplier requirements, practices, and expectations among pharmaceutical companies and excipient suppliers make it challenging to optimize the excipient manufacturing and supply chain. Greater harmonization of supplier practices among all industry stakeholders would facilitate a more cost-effective, efficient, and optimal way to advance technical, business, and regulatory goals. The question was raised, “is harmonization possible and is it a paradigm that the industry can work toward achieving?” Leading experts shared current and proposed initiatives to moving toward harmonized supplier practices. Attendees received practical insight into how companies manage these challenges today and perspective on what steps the industry can take to optimize supplier practices from a technical, business, and regulatory perspective.

April 30

“First Class” Certificate of Graduate Study

Earlier this month our first Cohort of Business Success Through QARA Leadership students graduated. The graduation took place at the Cintas Center on Xavier’s campus as twelve students from seven different organizations completed the ten month program and received a Xavier University Certificate of Graduate Study.

Throughout there journey the students viewed online classes taught by FDA and Industry Leaders, completed reflection assignments, participated in Discussion Boards, collaborated with each other during on-campus modules, and took part in one-on-one coaching sessions with the authors of Leadership in Balance: New Habits of the Mind (the cornerstone of the leadership portion of the course). One student described her coaching sessions as an “excellent and amazing experience with my mentor.”

The students were also introduced to several decision making and innovation tools, such as Mind Mapping, Cause & Effect Matrices, Pareto Analysis, and Decision Trees. Many of the students had little or no experience with these concepts and described them as “Great tools for reaching collaborative decisions” and “a nice way to promote collaboration and new ideas.”

These interactions and the knowledge gained by the graduates have truly set them up to be the next generation of CEOs. If you are interested in joining this elite group of Industry Professionals or know of someone who would benefit from this experience visit the Business Success Through QARA Leadership homepage or contact Program Manager, Mason Rick at rickm@xavier.edu.

April 14

Kristi Henderson Speaks at PharmaLink 2015

To view and share a version of Kristi Henderson’s speech at the most recent PharmaLink Conference click here.

She not only enlightened the attendees of PharmaLink but also has been consulted by multiple health systems, technology vendors, policy makers and regulators on her model of care.  She was a featured TEDx speaker in 2014.

Telehealth has the power to solve some of the most difficult problems in health care. Mississippi’s limited resources and rural population created an opportunity for leadership in telehealth and the results have shown decreased cost and improved health outcomes.

Dr. Kristi Henderson paints the picture of the future of healthcare in the United States speaking across the United States.  In her current role as Chief Telehealth & Innovation Officer at the University of Mississippi Medical Center, Dr. Henderson has been asked to testify to the White House Domestic Policy Council as well as the House Energy & Commerce Committee on health system innovation due to her successful models which have advanced the access of health care for patients across the United States.

The PharmaLink Keynote Reception and Dinner was held at the state-of-the-art Newport Aquarium. The Newport Aquarium was named the No. 1 aquarium in the 2012 Readers’ Choice Travel Awards from 10Best.com.

April 9

Healthcare Packaging Feature Article on PharmaLink Conference

Healthcare Packaging featured one of the main topics at the recent FDA/Xavier University PharmaLink Conference.   “FDA’s Pharmaceutical Quality Focus Continues To Expand Globally” provides details from the first day of the conference.  With more products imported into the U.S. from more countries around the world, the focus must remain on patient safety and health outcomes.  Read the article here.

March 31

2015 PharmaLink Conference

The 2015 FDA/Xavier University PharmaLink Conference concluded last week and it was a tremendous success.   Ellen Morrison, Assistant Commissioner, FDA and Marla Phillips, Director, Xavier Health welcomed 185 attendees on the first day.  The presentations and results captured from some of the action-provoking discussions and collaborations can be viewed in the first set of deliverables by clicking here.

March 30

Hatch, Bipartisan Group of Senators Announce Legislation to End Tax on Medical Device Manufacturers

The United States Senate Committee on Finance published a press release regarding a bill to eliminate the Medical Device Tax.  “Every dollar medical device manufacturers spend on this onerous tax is a dollar taken away from American innovation, job growth, and the ability to provide groundbreaking medical technologies to patients in need,” said Senate Finance Committee Chairman Orrin Hatch. “Both Republicans and Democrats understand just how bad this tax really is, and we owe it to the American people to ensure the development of life-saving medical devices are not plagued by high-costs that will, ultimately, be passed on to patients. This is a common-sense bill, and I’m hopeful Congress will act swiftly to repeal this misguided tax once and for all.”

To read the press release click here.

January 15

New Xavier Health LinkedIn Page

Xavier Health is excited to announce it’s new LinkedIn Group! Stay on top of the latest trends, regulations and connect with industry leaders in the medical device and pharmaceutical communities.  To join the group please click here.

January 6

FDA’s Kim Trautman Presents At MedCon 2015

Kim Trautman, FDA’s Associate Director of International Affairs, returns to the MedCon Conference to present “Understanding the Current Activities of the International Medical Device Regulators Forum (IMDRF).”

Ms. Trautman will provide a general overview of IMDRF and its accomplishments as well as describing the IMDRF Medical Device Single Audit Program (MDSAP) and how the pilot, which started January of 2014, applies to you.

To view the 2015 MedCon Conference Program & Agenda click here.

 

 

December 31

A Systematic Approach to Managing Your Global Supply Chain

Zach Johnson, Supply Management Consultant from Dun & Bradstreet will be part of a panel of FDA and industry experts at PharmaLink 2015.  Industry has not fully recognized the challenges that lie ahead in implementing the Unique Facility Identifier (UFI) requirements of the FDA Safety and Innovation Act (FDASIA).  This session will provide a practical approach to utilizing the Data Universal Numbering System (DUNS number), and how this approach can be utilized to manage your material supply chain beyond drug establishments and excipient manufacturers.  The time to start is now…this is not a simple exercise, and those who have been through it are ready to share what they’ve learned.

To see other members of this panel or view the 2015 PharmaLink Conference Program & Agenda click here.

December 31

FDA and Industry Experts Discuss FDA Inspections At MedCon 2015

FDA Inspections:  Are you Headed for Disaster or Success?

FDA’s Phil Pontikos, National Device Expert joins an elite group of panelists  for a session on Day 2 of the MedCon 2015 Conference.  Join your colleagues and find creative solutions to challenges that may occur during an FDA inspection. Hear the results from a pre-conference survey, participate in a small group discussion and learn from an expert panel.

To view the 2015 MedCon Conference Program & Agenda click here.

December 31

MHRA Will Participate At PharmaLink 2015 Again

Richard Andrews, Unit Manager Inspectorate Operations for MHRA will present this year.  Hear directly from MHRA on the challenges that are most prominently facing global ministries of health. Where are they focusing efforts to confront the challenges of globalization and import safety? How are they collaborating with other agencies?  And how does this affect you?

To view the PharmaLink 2015 Program & Agenda click here.

December 31

Jay Crowley Says, “UDI – Implementation “Ain’t” Easy”

Jay Crowley, Vice President and Practice Lead – UDI & USDM for USDM Life Sciences returns to MedCon 2015.  Now that the first compliance wave is complete, what have we learned about the difficulties related to UDI Implementation? Has use of DUNS Number helped or hindered? How has the database software modified the regulation? What do you do when your UPC code doesn’t fit the new form?  How about those conforming amendments, are we ready for MDR reports, recall reports, Annual Reports?  Hear from experts before Wave 2 and 3 hit.

To view the 2015 MedCon Conference Program & Agenda click here.

December 31

Establishing Good Supply Practices (GSPs) at PharmaLink 2015

Dale Carter, Global Director of Quality at Huber Engineered Materials joins Marla Phillips, Director, Xavier Health to discuss our how our industry is not focusing on areas that are proving to increase the reliability of our supply chain.  Understand paradigm shifts uncovered by manufacturers and suppliers working together through the Xavier University Integrity of Supply Initiative that hold the key to the answers we are all looking for.  It is through this renewed focus that our efforts can turn toward meaningful and impactful solutions.

December 31

Sharon Johnson Presents Barriers To Quality And Supply Chain Excellence At PharmaLink 2015

Sharon Johnson, Senior Vice President for Quality & Regulatory Affairs for Catalent will discuss quality and supply issues that continue to plague our industry. In an attempt to understand what we need to do differently we have asked FDA and MHRA to identify the Top 3 flags that tell them there is a higher risk to quality and supply. We have also asked CMOs and suppliers to share feedback on barriers that contribute to quality and supply issues and what works well from their more global perspective.

Take a look at the Program & Agenda for the 2015 PharmaLink Conference by clicking here.

December 31

Learn Advancements in Medical Device Software Technology

Join Francis Blacha, Global Quality Leader, Devices for Eli Lilly and Marian Lee, Partner for Gibson, Dunn & Crutcher LLP at MedCon 2015 as they lead the discussion regarding “Advancements in Medical Device Software Technology.” Attendees of this session will hear from a panel of experts on this hot and evolving topic, including discussion of the following:

  • Mobile Medical Apps (MMA)
  • Standalone Medical Device (SaMD) Software
  • 3D Printing

To view the other tracks or the 2015 MedCon Program & Agenda click here.

December 31

Learn From 2015 PharmaLink Presentation Regarding Toyota Production System

Attend PharmaLink 2015 and you will here Martin Kuhn, Assistant Vice President, Plant Management for Merck and Cindy Kuhlman-Voss, Senior Consultant for VOS break the paradigms by presenting how firms in other industries embrace a culture focused on quality (Toyota).  Partnership approach.  Start with Toyota.  Walk us through the role of the quality professional and how they build quality into the product – starting with the customer feedback and design.

To view the 2015 PharmaLink Conference Program & Agenda click here.

December 31

FDA’s Steve Silverman Office of Compliance Strategic Priorities

At MedCon 2015, Office Director, Steve Silverman will outline the top priorities for CDRH Office of Compliance, including the National Medical Device Postmarket Surveillance System, the newest Case for Quality Initiatives, and other emerging issues. Learn how these priorities can impact you.

To view the 2015 MedCon Conference Program & Agenda click here.

December 31

Dominic Veneziano Will Help You Understand Why Your Products Are Held At The Border

Global supply chains cross borders every day; some drug shipments are held up for reasons you don’t understand. Hear from the FDA and a major broker about common mistakes discovered during import screening, best practices for a smooth importation process, and the new trusted importer program.

Take a look at the 2015 PharmaLink Program & Agenda by clicking here.

December 31

Thinh Nguyen Provides Update from FDA’s Office of Combination Products at 2015 MedCon Conference

The universe of combination products continues to expand, with development of increasingly sophisticated drug delivery systems and companion diagnostics. Join us in this timely session as we hear directly from OCP leadership on key FDA initiatives, the current regulatory environment for combination products, and what to expect from OCP in 2015 and beyond.  In addition to this presentation, when registering, MedCon attendees can sign up for individualized discussions with Thinh Nguyen and John (Barr) Weiner to address specific questions related to OCP and combination products.

Take a look at the 2015 MedCon Conference Program & Agenda by clicking here.

December 31

FDA’s Jeff Shuren Presents On Day One of 2015 MedCon Conference

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will share his views on the importance of  protecting the public health and the collaborative activities shared with industry on the balance of safety, efficacy, quality, access and innovation.

To view the 2015 MedCon Agenda please click here.

 

December 31

Day One of 2015 PharmaLink Conference to Feature FDA’s Melinda Plaisier

FDA’s Melinda Plaisier, Associate Commissioner for Regulatory Affairs will share the vision for implementation of the Program Alignment initiative and will discuss the benefits and risks to the program with participants.  Based on FDASIA, FDA has been given the authority from Congress to conduct risk-based inspections and to utilize its resources using risk-based decisions.  Hear how FDA is working to utilize this authority and the impact it may have on you.  To view the program & agenda click here.

December 27

Proof That Smart People Attend MedCon Conference

We had over 400 people attend MedCon 2014 but little did we know that one of our attendees was planning for his fifteen minutes of fame.  Kurt Fritzsche, Quality Engineer for Johnson & Johnson was a big winner on Jeopardy.  Read more about his recent experience here.

 

December 19

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