Excipient GMP Workshop for Auditors and Auditees, by the International Pharmaceutical Excipients Council. April 4-6, 2017. Hosted by Baxter in Deerfield, IL. See here for more information or to register.
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.
Jim O’Reilly as he gives expert analysis on the newly passed “21st Century Cures” Act in this webinar recording.
Learn more here.
In support of FDA’s intent to allocate its resources based on risk, Xavier University and PwC launched a Metrics Initiative in August 2014 to identify product quality risk metrics linked to patient safety that could be viewed during an inspection.
Xavier University and PwC led a team of 30 industry professionals that developed a framework of 11 metrics across the Total Product Life Cycle (TPLC). The framework is built upon driving a mindset of continuous improvement that includes feedback loops across the entire enterprise to design quality in product proactively at the source, instead of reactively catching bad quality after manufacture. The team recommends that this framework of metrics be incorporated into FDA’s inspection protocol as a roadmap for investigators to evaluate drug manufacturing and control operations during an inspection.
View and download the white paper through this link: Xavier University – PwC Pharmaceutical Metrics White Paper.January 2016.
Dr. Ilisa Bernstein, Deputy Director (CDER) at FDA will be attending and speaking at PharmaLink 2016. Her session, “Office of Compliance Key Initiatives” will kick-off the Conference. The top strategic priorities of the CDER Office of Compliance will be shared so attendees can understand how these key initiatives involve and impact industry. This session will address topics, such as domestic and foreign enforcement trends, surveillance activities and drug shortages.
To view all of the Speakers and Moderators for the 2016 please click here.
Each year we receive some great testimonials following our conferences. Bill Mullin, Senior Advisor, Keystone Compliance Partners, and former Vice President, Merck Manufacturing Division recently had this to say about his experience, “I sincerely believe it is the best and most impactful professional meeting I have been able to attend in my career. If you want to achieve a strategic difference in your company or site; the partnership of Xavier Health, Regulatory Agencies and Industry, is beyond measure.”
Each year the members of the Strategic Committee, which is comprised of FDA and Industry Experts, develop an impactful agenda but also look to create an atmosphere of learning and sharing for three days on the Xavier campus. To register for the 2016 PharmaLink Conference click here.
Xavier Health is proud to announce that Vince Caponi will be the Keynote Speaker at the 2016 PharmaLink Conference. The Keynote Dinner will be held on Thursday, March 17th at Paul Brown Stadium, home of the NFL Cincinnati Bengals.
Vincent Caponi serves as an Executive Vice President of Ascension Health and the Executive Chairman of the Board of Directors for Ascension Health Texas. He is also currently serving as the Interim Ministry Market Executive for Ascension Wisconsin. Ascension Health is the nation’s largest Catholic and not-for-profit health system. Caponi is a 40 year veteran of healthcare and has been a CEO since 1979.
Prior to assuming the Executive Board Chair position of Ascension Health Texas in February 2015, Caponi served as the Executive Board Chair and CEO of St. Vincent Health in Indianapolis, Indiana, for 15 years, and for four years as the Ministry Market Leader for Indiana and Wisconsin. During this tenure, he led the integration of critical access hospitals: St. John’s Health System in Anderson; the St. Vincent Heart Center of Indiana; St. Vincent Women’s Hospital; and St.Vincent Medical Group, into a comprehensive health network. He also oversaw the addition of the Peyton Manning Children’s Hospital at St. Vincent, Seton Specialty Hospital, and St. Vincent Hospital Fishers. Caponi led multiple joint ventures, program developments, hospital expansions and affiliations with health providers and community partners.
Prior to joining St. Vincent Health, Caponi served as the President and CEO of St. Vincent’s Hospital in Birmingham, Al. Earlier in his career he served as the President and CEO of St. Joseph Hospital in Augusta, Ga., and as the President and CEO of United Memorial Hospital in Greenville, Mi. He also served as an Assistant Administrator at the Memorial Hospital in Owosso, Mi.
Mr. Caponi previously served as an outside director for the Welch Allyn Board of Directors where he chaired the Management and Board Development Committee, and served on the Audit and the Science and Technology Committees. He currently serves on the Board of Directors of Medizone, where he chairs the Compensation Committee and serves on the Audit Committee.
Mr. Caponi holds an honorary doctorate in Business Administration from Marian University, a Master’s degree in Health Services Administration from Central Michigan, and a Bachelor of Arts from Xavier University. He is on the Board of Directors of Xavier University; Indiana Hospital Association (past chair); the Indianapolis Symphony Orchestra (chair); and Central Indiana United Way (past chair). He is a past board member of the Boy Scouts of America – Crossroads of America Council; Brebeuf Jesuit Preparatory School (past chair); the Indiana Health Forum; the Indiana Health Information Exchange (past chair); the American Heart Association – Midwest Affiliate; and St. Mary’s College. In May of 2015 Mr. Caponi received the “Distinguished Alumni Award” from Xavier University.
Caponi and his wife, Robyn, have been married for 43 years. They have three grown daughters and five grandchildren.
To view the list of excellent speakers at PharmaLink 2016 please click here.
An article regarding the Xavier Health Medical Device Leadership Program was featured in a recent issue of Med Device Online. The article discussed Xavier University’s response to a challenge by creating a Certificate of Graduate Study for medical device industry professionals, designed to take their performance and leadership skills to a higher level. The effectiveness of the 10-month course stems from the process Xavier University used to establish conferences and programs that improve global health. Read the article here.
Cincinnati, OH – In July of 2015 the Xavier Health was asked by FDA to host a new event dedicated to Combination Products. Having only 90 days to produce and market a new event is no small task but the organization is well equipped having the experience in putting together similar events as the PharmaLink and MedCon Conferences.
Attendees from across the country came together from both the pharmaceutical and medical device communities. Following breakfast the attendees were welcomed to Cincinnati by the new FDA District Director, Steve Barber. During the first session, FDA’s Director of Combination Products, Thinh Nguyen, addressed the newly issued “Combination Product Review – Intercenter Consult Process Study” that was conducted by the Office of the Commissioner. In an effort to maximize efficiency and speed to market, he discussed the barriers they have recognized that are internal to FDA operations, and shared tips on how to maximize success while they work to remove those barriers.
Brad Thompson, Counsel for Epstein, Becker & Green then shared and facilitated an advanced case study. Experts (Steve Binion from BD, Francis Blacha from Eli Lilly, Kirsten Paulsen from Pfizer and Steve Niedelman from King & Spalding) joined the stage and explored challenges facing industry through case study investigation and discussion. Attendees collaboratively discussed, debated and proposed solutions that will address industry concerns. Experts and attendees jointly navigated unchartered product lifecycle challenges as small groups of round tables worked together and then used the microphone to share solutions.
Following a networking lunch, Francis Blacha, Gobal Quality Leader – Drug Delivery System Development for Eli Lilly kicked off the first afternoon session by presenting, “How to Implement a Lifecycle Risk Management Framework.” Recognizing the growth rate of combination products through 2019, this session identified challenges associated with integrating risk management models for drug/device constituents and how utilizing a “System of Quality” approach can help overcome those challenges. He shared an example on how to develop an integrated risk management process using Safety Assurance Case methodology for managing patient risk across the product lifecyle.
Nolan Baird, Associate Director of Combination Product Development at Abbvie presented a session, “Challenges Implementing Part 4 GMP Regulations and Expectations.” It was learned that this streamlined approach to cGMPs for combination products can benefit manufacturers, but the question of how to navigate the gray areas of the 21 CFR Part 4 regulations is key to your company’s approach. Questions were raised as to successfully merging requirements from the QSRS or the Drug GMPs without missing obligations or duplicating requirements being critical to meeting FDA and customer expectations while placing a reliable product on the market. Insight was be shared on topics such as the incorporation and start of design controls, term confusion across regulations, purchasing controls, as well as stability and expiration dating pain points.
Brad Thompson returned to the front of the room to present a “How To” dedicated to Digital Health Solutions. Digital health tools including smart syringes, smart pills and databases used to track a myriad of information about patients are becoming more common. The session began by examining the regulatory classification for the digital health adjuncts to pharmaceutical care. After tackling the classification issue, attendees examined the implications of those classification on approval routes, GMP requirements and adverse event reporting.
Members of the Combination Products Summit Committee took the stage for the final session titled, “Key Takeways for FDA and Industry” and engaged each table in the audience in facilitated discussion on next steps and action plans for FDA and industry. This information was captured and will be shared in the future.
The success of this first event prompted the Committee to share tha next year’s Summit will be held over two days and take place on November 2-3. 2016.
Pharmaceutical and Medical Device professionals from Ohio, Indiana and Kentucky came together on October 27, 2015 for the Xavier Health Cincinnati Chapter breakfast and welcomed the new FDA Cincinnati District Director, Steven Barber.
Mr. Barber provided details about his background and 25 years at FDA – spanning 6 districts. He started his career in the laboratory doing analysis and spent many years as a Field Investigator. He comes to us from Detroit where he served as the Director of the Compliance Branch, and has now been on the job in Cincinnati for seven weeks.
Mr. Barber gave a brief presentation on FDA’s new Program Alignment Initiative that will affect investigators in FDA districts across the country. ORA will align by programs, rather than geographical zones, in an effort to enable investigators and supervisors to focus on their areas of expertise. Mr. Barber shared that he has been designated as a Director for Human and Animal Food (formerly “food and feed”), while other district directors will be designated for the remaining programs – pharmaceuticals, devices and radiological health, biologics, bioresearch monitoring (BIMO), tobacco, and imports. In the meantime, it will be business as usual as FDA continues with the implementation. Mr. Barber took questions from the audience and it generated a very good back-and-forth discussion.
Xavier graduate, Jessica Zeller was introduced to the Chapter attendees as the ORA Ombudsman nationally and will be based in Cincinnati. She spent many years at FDA in Washington, served as Counsel for Procter & Gamble, and now returns to FDA for her new role. Mrs. Zeller provided her contact information and invited members of the Chapter to reach out to her for assistance.
Chapter attendees took time at their tables to have a short discussion regarding Inspection Readiness. Once again, Mr. Barber fielded questions from the audience and discussed the importance of transparency from both FDA and Industry.
Thank you to our sponsor of this event… Allergan.
Please take advantage of the early bird discounts for the upcoming conferences and register now…
PharmaLink – www.pharmalink2016.com
MedCon – www.medcon2016.com
See you soon.
Xavier University offers 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.”
“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 firstname.lastname@example.org or 513-745-4957. Interviews for Fall 2015 admission are currently underway.
About Xavier University
Xavier University is home to Xavier Health which focuses on FDA’s top strategic priorities and toughest industry challenges.
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.
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.
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.
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 Medical Device Leadership Certificate homepage or contact Program Manager, Marla Phillips at email@example.com or 513-745-3073.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Steve Wolfgang Presents FDA-Driven Inititives Through FDASIA Implementation at 2015 PharmaLink Conference
Understand what is driving FDA action, the status of key initiatives, and expected impact to both FDA and industry.
To view the 2015 PharmaLink Program & Agenda click here.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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That discussion suggests Boehner is committed to passing Paulsen’s medical device tax bill this month — despite opposition from President Obama and Democratic leaders on Capitol Hill.
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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.
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