Press Releases (Card Grid)

PDA’s 2012 Universe of Pre-filled Syringes & Injection Devices - the Best Mindshare in the Industry

Our industry is entering a challenging phase for the next decade in the area of pre-filled syringes & injection devices. Costs and regulatory demands exert downward pressure on our ability to introduce devices that are safe and effective. Patients and their needs continue to grow while ever more complex molecules continue to challenge our material selection. Regulatory requirements, industry experience and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes and injection devices to drug delivery.

To address the challenges we are facing, it is crucial to continue on the path of innovation as we have been for many years. New advances in materials of construction, manufacturing processes, injection processes and novel delivery devices create a dynamic environment in the drug delivery arena. The success of new product introduction and support of existing products require that companies be aware of these new developments and innovations across the industry.

Companies such as Amgen, Eli Lilly, SCHOTT, Groninger & Company, University of California San Francisco School of Nursing, Sandoz International, Novartis Vaccines & Diagnostics, BD Medical, GlaxoSmithKline, Sanofi Pasteur as well as Federal Agencies will be present at this event.

Richard M. Johnson, PDA President added, “Developing technologies of the future, regulatory issues, safer injection design and practices, complexity of combination products, glass and polymer syringes, human factors, vaccine delivery all have a part in this important discussion.  Creating and delivering the safest devices possible to the marketplace is truly a global problem that is not going to change any time soon – companies should invest the time to send people to join PDA and engage in this timely and outcome orientated conference.”

For more information, go to http://www.pda.org/prefilled2012

Press inquiries about registration should be directed to PDA’s Vice President of Marketing, Adrienne Fierro,fierro@pda.org.

PDA Pres. Signs Landmark Agreement with The St. Petersburg’s State Chemical Pharm. Academy (SPCPA)

Bethesda, Md., July 16, 2012 – St Petersburg, Russia (June 22, 2012) – The Parenteral Drug Association (PDA) and The Saint-Petersburg State Chemical-Pharmaceutical Academy (SPCPA) have signed a Memorandum of Understanding to develop a GMP and Regulatory Affairs Training Center in the area of pharmaceutical manufacturing in St. Petersburg (the Training Center). The Training Center will carry out ongoing training programs for Russian GMP inspectors, SPCPA students and Russian pharmaceutical manufacturers. This timely project is supported by the Government of Saint-Petersburg and the Ministry of Industry and Trade of the Russian Federation.   It is an important step in implementing high standards of quality production in Russia.

The aim of this project is to conduct hands-on training programs at the GMP center for inspectors and professionals of the healthcare industry, improving knowledge of current Good Manufacturing Practices (GMP), advancing Russian manufacturing pharmaceutical technology and quality control. The project will also facilitate the exchange of experiences and information on legislation and regulatory procedures in respect of pharmaceutical production and inspection.

The knowledge gained by students during education in the Saint- Petersburg Academy, will be used to conduct inspections of the pharmaceutical industry in Russia. The measures will ensure the proper level of quality and efficiency of medical care, which meets in the first place, the interests of Russian patients.

Richard M. Johnson, PDA President said, “PDA is proud to partner with the SPCPA on this critical global project.  With 600+pharmaceutical manufacturing plants in Russia it is clear that Russia has made it a priority to enhance understanding and implementing internationally consistent current GMPs.  PDA considers this project critical to the overall health of the global pharmaceutical pipeline since there will be more and more of a push for international pharmaceutical companies to partner for manufacturing.”  He added, “We are pleased that the SPCPA decided to choose PDA as their premier partner in this significant endeavor.”

PDA Announces a Landmark Workshop on QbD

“PDA has always allowed for unique and exciting discussions and Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop is a workshop that will bring together the big five vaccine manufactures for a unique and landmark case study review” says Sam Venugopal, Director, PricewaterhouseCoopers, LLC.  “One of the key and novel aspects of the case study is to develop and explore the application of QbD principles in vaccine development. Our hope is that the case study will help stimulate the discussions needed to help find a common understanding related to how and where QbD can be applied when developing vaccines.  More specifically, the vaccine case study proposes a hybrid approach to implementing QbD in biologics,” he added.

PDA has partnered with the consortium to disseminate the case study via public posting and to facilitate public discussion through the Applying QbD Principles in Vaccine Development: PDA/FDA CMC Workshop.  While the case study will be released to the public in May, participants who attend the workshop will receive an advanced copy and detailed explanation of the study.

FDA will be present to hear the dialogue and offer their perspective on the study.

For more information, go to www.pda.org/CMC2012.

Press inquiries about registration should be directed to PDA’s Vice President of Marketing, Adrienne Fierro, fierro@pda.org.

PDA Announces the Results of the 2012 Board of Directors & Officers Election

PDA is pleased to announce the results of the 2012 Board of Directors and Officers election.  The elected candidates will fill their term beginning on January 1, 2012. Thank you to all who voted!

Officers

Anders Vinther, PhD, VP, Head Quality Biologics at Genentech, was elected in 2010 to the Chair-elect position and will serve as Chair from January 2012 through 2014. Harold Baseman, Principal and Chief Operating Officer for ValSource, has been elected as the Chair-Elect, Steven Mendivil, Executive Director of Corporate Quality External Affairs for Amgen, Inc.has been elected as the Secretary and Rebecca Devine, PhD, Regulatory Consultant, has been elected as Treasurer. 

Maik Jornitz, Senior Vice President, Marketing Bioprocess Sartorius Stedim North America, has become the immediate past chair and will serve in that position for two more years.

Directors

The PDA Board of Directors welcomes Ursula Busse, PhD, MBA, Head of Project Office for Biopharmaceutical Operations at Novartis, John Finkbohner, PhD, Senior Director of Regulatory Affairs at MedImmune.  Re-elected Board members areJunko Sasaki, Quality Assurance Principal, Dainippon Sumitomo Pharma. Co., Ltd. and Christopher Smalley, PhD, Associate Director, Merck & Company.

PDA would like to extend a sincere thank you to John Shabushnig PhD, Sr. Manager/Team Leader, Quality Systems and Technical Services, Pfizer, and Amy Scott-Billman, Head, Worldwide Regulatory Strategy, Cancer Immunotherapeutics GlaxoSmithKline for their years of service on the Board of Directors.

More information is available in the January issue of the PDA Letter.

PIC/S Celebrates 40th Anniversary

USFDA Commissioner, Dr. Margaret Hamburg, calls for closer and more global cooperation on GMP at PIC/S' 40th Anniversary

PICS Press ReleaseThe Pharmaceutical Inspection Co-operation Scheme (PIC/S) celebrated its 40th anniversary at a landmark symposium in Geneva (Switzerland) on 31 May 2011. PIC/S is a technical arrangement between 39 Competent Authorities in the field of GMP inspections of pharmaceutical manufacturing sites. The symposium was opened by PIC/S Chairman, Mr. Tor Gråberg (Sweden / MPA), who underlined the need for PIC/S to further promote co-operation based on communication, mutual trust and harmonisation.

Over 160 participants from all continents participated in the event, including Competent Authorities from Argentina, Australia, Brazil, China, Chinese Taipei, Croatia, most EU/EEA Member States, Georgia, Hong Kong SAR, Indonesia, Iran, Israel, Japan, Malaysia, New Zealand, Nigeria, Russia, Singapore, Saudi Arabia, South Africa, South Korea, Switzerland, Thailand, Turkey, Uganda, Ukraine, and USA. The long list demonstrates that the organisation, created by 10 European Authorities back in 1971, has now become truly global. PIC/S co-operates with the European Commission and has partnership agreements with the European Medicines Agency (EMA), EDQM, UNICEF and WHO; it also co-operates with non-profit organisations like ISPE and PDA and industry associations such as APIC, EFPIA, IFPMA, in the field of training.

The 40th Anniversary symposium coincided with the first-time attendance of the Ukrainian State Inspectorate for Quality Control of Medicines (SIQCM) and the US Food and Drug Administration (FDA) as full Members of the Organisation. US FDA Commissioner, Dr. Margaret Hamburg, delivered a key note address to the symposium and called upon all Regulatory Authorities to co-operate more closely and share information on GMP inspections, in particular in third countries. PIC/S' main advantage over a Mutual Recognition Agreement is that it is not legally binding, thus allowing Participating Authorities to co-operate and share information informally (subject to confidentiality) while keeping complete control over imported medicinal products. For more information on PIC/S' 40th Anniversary, see www.picscheme.org.

PDA is pleased to announce the launch of a new web site (www.pda.org)

Bethesda, M.D.– The Parenteral Drug Association (PDA) is pleased to announce the launch of a new web site (www.pda.org) on April 15, 2011

PDA is working on improving member engagement and their satisfaction is at the forefront of our decision to invest in a new web site with enhanced navigation.  “The website is a key area for all PDA activities and we are pleased to announce a new and improved www.pda.org.  We think this new site will offer PDA members and non-members a chance to see all the opportunities that PDA has to offer.  We look forward to hearing feedback on the new site,” said Richard Johnson, PDA President.

The new PDA web site is designed to work across a large range of browsers – if you are using Microsoft’s Internet Explorer we recommend using Internet Explorer (IE) Version 7 or later – for a free download visit the Microsoft website at http://www.microsoft.com/windows/internet-explorer/ie7/ or contact your IT department to upgrade your browser so you can optimize your interaction with the new PDA website.

Please contact us at Kolivand@pda.org or 301-656-5900 ext. 125, if you have any problems on need support.

Hear from the FDA, National Institute of Health and More at PDA Freeze Drying Workshop

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory and industry speakers at this year’s Pharmaceutical Freeze Drying Workshop.

“The application of lyophilization to preserve health care products continues to expand, with new and innovative products being introduced at a growing pace. Novel formulations and delivery systems for administration and use present new challenges,” remarks Ed Trappler, President, Lyophilization Technology, Inc. and Chair, 2010 PDA Pharmaceutical Freeze Drying Workshop Program Planning Committee, “A goal of this workshop is to bring together professionals from the diagnostics and therapeutics industry involved with lyophilization in order to further develop skills and knowledge of the wide range of activities required to develop a lyophilized product,” he added.

Confirmed speakers include:

  • Enrico Corona, Formulation and Process Development Manager, Patheon Italia S.p.A.
  • David Doleski, Team Leader, CBER, DMPQ, FDA
  • Fred Lim, PhD, Principal Engineer, Genentech, Inc.
  • Shanker Gupta, PhD, Program Director, Pharmaceutical Resources Branch, NCI, National Institute of Health
  • Edward Trappler, President, Lyophilization Technology, Inc.
  • Sharon Thoma, PharmD, National Expert Pharmaceutical Investigator, FDA

The PDA workshop and exhibition is scheduled for November 17-18 at the Sheraton San Diego Hotel Marina in San Diego, California. There is a pre-workshop course, Fundamentals of Lyophilization scheduled for November 15-16 at the same location.

The agenda includes sessions on advances in lyophilized health care products, product and formulation design, aspects of process development, industrialization of lyophilized products, quality of lyophilized products and current regulatory expectations.

For more information, visit www.pda.org/freezedry2010. Press inquiries about registration should be directed to PDA’s Adrienne Fierro, fierro@pda.org.

Maik Jornitz, Was Promoted to Head, Operational Marketing of Sartorius Stedim Biotech

Bethesda, Md. – Effective immediately, Maik W. Jornitz will now head the entire operational marketing division of Sartorius Stedim Biotech as the Senior Vice President of Marketing, except for marketing of laboratory technologies.

There is an increasing demand for integrated complete solutions, which requires teamwork and cooperation among marketing units. This is the reason for Sartorius’s organizational development. “I am pleased to have found such an exceptionally experienced and knowledgeable individual as Maik Jornitz for this highly challenging and sophisticated position,” said Reinhard Vogt, Member of the Sartorius Stedim Board.

Richard Johnson, PDA President said, “We congratulate Maik on this well deserved promotion and wish him continued success.” 

Maik Jornitz is the Chairman of the Parenteral Drug Association’s (PDA) Board of Directors for 2010 and PDA is pleased to announce this organizational change within Sartorius Stedim Biotech.

Over 800 Regulators and Scientists Attended the 2010 PDA/FDA Joint Regulatory Conference

Bethesda, Md. – PDA/FDA's Joint Regulatory Conference recently held in Washington, D.C. has been an overwhelming success with over 800 regulators and scientists attending and discussing current and upcoming regulatory trends and quality requirements.

“We are very pleased to be the facilitator for the industry and the large attendance shows that the industry appreciates PDA's efforts,” states Richard Johnson, PDA President. "The PDA/FDA Joint Regulatory Conference is a network and discussion platform very much required by industry and regulators and we have seen both working close together to achieve the product quality needs for our joint client - the patient.”

The 2010 PDA/FDA Joint Regulatory Conference has been the 19th with a history of exceptional content and topics. “It is always a pleasure to be part of the PDA/FDA Joint Regulatory Conference, as it represents the best venue for networking, learning and discussions with peers and regulators,” says Maik Jornitz, PDA's Board of Directors Chair. “No other conference lets industry and regulators partner this close together. Learning being the prime objective, it has been always achieved without a doubt.”

Next years 2011 PDA/FDA Joint Regulatory Conference will be held September 19-23, 2011 in Washington, D.C.

Hear from the US FDA, the Australian Therapeutic Goods Administration, the Japanese at PMDA

Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory speakers at this year’s Global Conference on Pharmaceutical Microbiology.

Thomas J. Arista
, Investigator, National Expert, Pharmaceutical/Biotechnology, ORA/ORO, Division of Field Investigations,FDA will discuss Practical Regulatory Guidance on Risk Assessment for Microbial Controlled Issues.

The agenda includes discussions on topics such as objectionable microorganisms, investigations of microbial data deviations, manufacturing and product attributes impacting sterility assurance, new technologies and more.

A highlighted session at this conference, scheduled for October 25-28, 2010 in Washington, D.C., is Global Regulatory Perspectives on RMM. It will provide an overview on current perspectives and future directions of various regulatory agencies across the globe (FDA/CDER, FDA/CBER, TGA and PDMA) in the area of Rapid Microbiology Methods (RMM) as it applies to product testing and release.

Confirmed speakers include: Vivienne Christ, PhD, Chief Microbiologist, OLSS, Therapeutic Goods AdministrationDavid Hussong, PhD, Director, Microbiology, CDER, FDARajesh Gupta, PhD, Deputy Director, Division of Product Quality, Office of Vaccines Research and Review, CBER, FDA and Tsuguo Sasaki, PhD, GMP Expert, Office of Compliance and Standards,PMDA.

For more information, visit www.pda.org/microbiology2010. Press inquiries about registration should be directed to PDA’s Adrienne Fierro, fierro@pda.org.

PDA/FDA Joint Regulatory Conference Announces Key Industry and Government Speakers

Bethesda, Md., July 15, 2010 – The Parenteral Drug Association (PDA) is proud to announce key industry and government leaders as presenters at the 2010 PDA/FDA Joint Regulatory Conference, Sept. 13-16, Renaissance Washington Hotel in Washington, D.C.

The Parenteral Drug Association (PDA) is pleased to announce the addition of key industry representatives as well as government officials to the already impressive speaker line-up.  “PDA has been actively involved with the latest technology and regulations concerning high-quality pharmaceutical and biopharmaceutical production.  With the high profile compliance issues and the “mega” mergers and acquisitions that our industry is experiencing, now is the time to focus on strengthening Quality Systems, and thereby safeguarding the public interest,” said PDA President Richard M. Johnson. “We are pleased to host such high level speakers at our meeting,” he added.

David Brennan, CEO, AstraZeneca will speak on the topic of Patient Responsibility.
Pat Yang, Head of Pharma Technical Operations, F. Hoffmann- La Roche will discuss the challenges of managing merging global organizations. Barbara A. Ryan, Managing Director, Research Analyst, Deutsche Bank Securities, Inc. will be back to discuss insights, trends and the financial outlook for the pharmaceutical industry, and Vicki L. Seyfert-Margolis, PhD,FDA will be part of a dialogue and is a Senior Advisor within Science Innovation and Policy for the FDA Commissioner’s Office.

FDA Commissioner, Dr. Margaret Hamburg will be delivering the opening Keynote presentation.

For more information, go to www.pda.org/pdafda2010. Press inquiries should be directed to PDA’s Adrienne Fierro,fierro@pda.org.

Pharma Supply Chain Best Practices Identified at Manufacturer/Supplier/Regulator Workshop

Bethesda, MD– Quality, procurement and operations experts representing global pharmaceutical manufacturers, working side-by-side with the U.S. Food and Drug Administration (FDA), articulated tangible solutions for securing components and finished products during high-level breakout discussions at the 2010 PDA/FDA Pharmaceutical Supply Chain Workshop.

Concerned over the growing problem of cargo theft and a myriad of other security and quality vulnerabilities in the pharmaceutical supply and distribution chain, and the threat to public health that these pose, FDA championed the workshop in an effort to get drug manufacturers to share and implement best practices. Janet Woodcock, MD, Director, CDER, U.S. FDA, gave the keynote address at the workshop.

Over 200 experts representing quality, procurement, operations divisions within pharmaceutical firms, suppliers of active ingredients and excipients, the FDA, and other stakeholders answered the call to action. Attendees broke into five different brainstorming sessions to share ideas and identify best practices that can be implemented immediately at their respective firms. These were summarized and presented during the meetings final day.

Priority solutions identified include proactive mapping of the ingredient supply chain for each product, the use of risk models to identify which ingredients pose the highest threat to patients, the implementation of standardized global auditing practices, and the development of an industry-wide alerting process to help identify unethical and criminal suppliers.

The Parenteral Drug Association (PDA) will continue to support the industry and FDA’s efforts to protect the public health from insecure pharmaceutical supplies. The Association will send out preliminary reports from the workshop to all attendees in the near term. In the coming weeks, PDA will work with conference planners and discussion facilitators to develop and publish detailed reports on the best practices identified.

Deborah Autor, JD, Director, Office of Compliance, CDER, U.S. FDA, said that industry needs better systems in place for safeguarding its products and must start thinking about where the gaps are and what is missing in its supply chain controls “The biggest risk is the risk we haven’t thought of,” she said.

“The public and the industry should appreciate FDA’s role in helping to find and pushing for common solutions to the serious challenges and risks inherent to the global pharmaceutical supply chain and marketplace,” PDA President Richard Johnson said following the workshop.

The FDA took advantage of the forum to announce that it was sending a letter to companies and a wide range of key stakeholders regarding the serious and growing problem of cargo and warehouse thefts of FDA-regulated products. The letter requests that companies report thefts immediately to FDA, and notify the public through news releases and possible product recalls.

The FDA held a stakeholder teleconference just hours after the PDA/FDA workshop concluded to explain the letter in more detail. Ilisa Bernstein, PharmD, JD, Director of Pharmacy Affairs, Office of Commissioner, Office of Policy, U.S. FDA, who also presented at the workshop, spoke at the teleconference about the importance of industry reporting cargo thefts to ensure patient safety.

NASA Spaceflight Expert Confirmed Keynote Speaker for 2010 PDA Annual Meeting

Bethesda, MD -  The Parenteral Drug Association (PDA) has confirmed that Janice V. Meck, PhD, Director, Cardiovascular Laboratory, NASA-Johnson Space Center will present "Development of a Pharmaceutical Countermeasure for Post-spaceflight Orthostatic Intolerance" during the Opening Plenary Session of the 2010 PDA Annual Meeting.

Janice V. Meck is the Director of the Cardiovascular Laboratory at the Johnson Space Center. Dr. Meck is also the Chief Scientist for the NASA Bed Rest Project, developed in partnership with NIH and the University of Texas Medical Branch, where she holds a faculty appointment. The Bed Rest Project designs and implements multi-disciplinary, multi-investigator research protocols on human subjects during bed rest, with the aim of developing and refining countermeasures for spaceflight. 

For over 15 years, Dr. Meck’s major research focus has been the development of appropriate treatments for the untoward effects of spaceflight on humans. She has received many awards for her work including the President’s Early Career Award for Scientists and Engineers, the VCU Alumni Star Award, and many spaceflight achievement awards.  

Dr. Meck will join two additional keynote speakers for the 2010 PDA Annual Meeting:

  • Martin Lafleur, Project Director, AéroMontréal, presenting “Manufacturing Excellence: Industry Perspective”
  • Per Carlson, PhD, Professor, Elementary Particle Physics, KTH and former member of the Nobel Prize Selection Committee, presenting “The Link Between Academic Science and Industrial Science”

The 2010 PDA Annual Meeting will be held at the Gaylord Palms Resort & Convention Center in Orlando, Florida, March 15-19. PDA Training and Research Institute (PDA TRI) courses and a post conference workshop on Lean Manufacturing are also scheduled to accompany this conference.

For more information, visit www.pda.org/annual2010.