Press Releases (Card Grid)

Parenteral Drug Association, Inc. (PDA) and UK-based Euromed Communications today announced the publication of Industrial Pharmaceutical Microbiology: Quality Control. This 500-page book includes 20 chapters from 19 industry leaders in pharmaceutical microbiology quality control. Electronic copies are sold on both publishers' bookstores for $299.00. Hardcopies can be purchased for $340 at Euromed Communication's website.

Industrial Pharmaceutical Microbiology: Quality Control is an in-depth, comprehensive survey of quality control methods in the pharmaceutical microbiology laboratory to enable better understanding and to ensure better developed, more compliant, expedited procedures. The reference text brings together the hitherto unavailable background, fundamental science, principles, development, intended purpose, and specific answers to questions of execution and qualification of compendial and related microbiological test methods. Key topics include the types of microbiological tests, reference strains and culture collections, and equivalence of reference strain.

"This book should become a staple reference for the PDA membership, as pharmaceutical microbiology quality control is a topic central to the challenges faced by many working in our community," said Walter Morris, Senior Director of Publications and Press Relations, PDA. "Edward and Radhakrishna have done an excellent job assembling well-known authors who are frequent participants in other PDA activities."

PDA today proudly announced at its 2024 Annual Meeting in Long Beach, Calif., ANSI/PDA 02-2021 Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing has been included in a listing of recognized standards for regenerative medicine therapies by the U.S. FDA Center for Biologics Evaluation and Research. FDA released the list following the publication of "Guidance for Industry: Voluntary Consensus Standards Recognitions Program for Regenerative Medicine Therapies" in October 2023.

ANSI/PDA 02-2021 received the status of "Complete Recognition," a designation meaning the entire content of the standard is recognized. This is the first standard published by ANSI/PDA recognized by FDA since PDA became an ANSI-accredited standards developer in 2017.

FDA's recognition of ANSI/PDA 02-2021 represents an important milestone for PDA and our standards-setting program.

Post this "FDA's recognition of ANSI/PDA 02-2021 represents an important milestone for PDA and our standards-setting program," said Glenn Wright, PDA President & CEO. "We cannot thank the teams of experts enough that work diligently with PDA's staff to bring these standards to fruition, and recognition by FDA further demonstrates the scientific and technical value of their work."

The full title of ANSI/PDA Standard 02-2021 is: "Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing: An Introduction and Best Practices Approach on How to Prepare, Cryopreserve, and Recover Cells, Cell Lines, and Cell-Based Tissue Products." The standard provides guidance on how to establish suitable procedures for the cryopreservation and recovery of biological cells for use in cell and gene therapy products and regenerative medicine manufacturing either as an intermediate step or when cryopreservation is the final step. It presents cryopreservation as a modular process and describes key details that should be considered when developing a cryopreservation and recovery process for a specific use-case.

BETHESDA, Md., Oct. 17, 2023 /PRNewswire-PRWeb/ -- The Parenteral Drug Association (PDA) today announced the winners of the 2023 PDA Drug Delivery Innovation Awards during the opening plenary session of the 2023 PDA Universe of Pre-Filled Syringes and Injection Devices conference in Gothenburg, Sweden. Awardees were recognized for their technical innovations in advancing the field of bio/pharmaceutical manufacturing.

This year's Innovation Award is presented to Merck KGaA, Darmstadt, Germany, for the Digital Platform for Enhanced Adherence Tracking. The innovation is a secure and scalable ecosystem helping to monitor real-time data received from auto-injectors. To give doctors better access to autoinjector data, the devices send information to a centralized repository, which, in turn, dispatches data to a healthcare professional web platform and to patients and their caregivers via a mobile app. Doctors and patients rely on those visuals to track whether they are making progress in the patient's medical condition. The system aims to address the most important pain points in the journey of patients, their caregivers, and healthcare professionals without becoming intrusive.

The Partnership Innovation Award is presented to Stevanato Group, Bayer US LLC and Vetter Pharma-Fertigung for the innovation of Diluent PFS for reconstitution and administration of a lyophilized biologic. This partnership innovation involved the close collaboration of the development groups of three parties: the glass barrel manufacturer (Stevanato Group), the diluent PFS manufacturer (Vetter), and the combination product manufacturer (Bayer). The goals of this partnership were to solve a potential compatibility issue with the diluent PFS and biologic drug product and reduce the gliding forces of the diluent PFS during drug product reconstitution. This collaboration highlights the benefits of bringing together stakeholders with their own process expertise to solve a complex issue with a combination product that benefits each of these stakeholders.

"The companies recognized for the 2023 PDA Drug Delivery Innovation Awards are well-deserving of this honor and I congratulate them for their achievements and tireless effort to move the industry forward," said PDA President & CEO Glenn Wright. "They, and all the companies that were considered for this award presented technology innovations that will certainly benefit patients worldwide and for that we are all grateful."

PDA recognizes the award winners each year at its annual Universe of Pre-Filled Syringes and Injection Devices conference, which is held in the U.S. in even years and the EU in odd years.

The PDA Drug Delivery Innovation Awards were created in 2019 to recognize technical innovations advancing the field of bio/pharmaceutical manufacturing. The Innovation Award recognizes a new device, manufacturing process, method, or automation that brings value to the industry; the Partnership Innovation Award recognizes achievement in partnering to successfully launch or introduce a new product to the market or modifying an existing product to make it significantly better or scalable.

PDA today announced the establishment of the Jette Christensen Early Career Professional Grant in memory of the Immediate-Past Chair of the PDA Board of Directors, who passed away on October 24 after a long battle with cancer. As a PDA member, Board Member, and PDA Chair, Jette’s dedication to PDA’s mission of advancing pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients benefited not only PDA members but the entire industry.

Created through the PDA Foundation for Pharmaceutical Education, Training, and Research, the Jette Christensen Early Career Professional Grant will provide funding for the development of the next generation of industry leaders which is reflective of one of Jette’s many passions. Early Career Professionals selected to receive this prestigious developmental grant will receive funding to enable their attendance at PDA’s technical conferences and training courses.

"The PDA organization is very saddened by the recent loss of our Immediate Past Chair and long-term PDA Member Jette Christensen,” said Glenn Wright, PDA President and CEO. “For over 25 years she was an active contributing member of PDA serving on various Conference Planning Committees, Advisory Boards, TR teams, Board of Directors including as Board Chair. Jette was very active even until just a few weeks before her passing, continuing as a member of the PDA Executive Committee in her role as Immediate Past Chair. Her commitment to PDA was unfaltering and we cannot thank her enough for all she has done. Knowing Jette personally for over 20 years, I will miss not only her love of life, engaging attitude but her insightful questions and wise counsel. She will be greatly missed by the entire PDA family."

“Jette was a great lady with a beautiful and welcoming demeanor,” said Sue Schniepp, PDA Chair. “She taught me so much during the time I worked with her. I will miss her and will always remember her dignity and grace in everything she undertook.”

“I had the honor to work with Jette for her entire term on the PDA Board of Directors, up to and including her term as Chair of PDA,” said Richard Johnson, past PDA President and CEO. “Over the years I came to know her and her courage and determination. She was a leader who always included everyone's input. She was considerate and kind and maintained her dedication despite her challenges. Jette also enjoyed interacting with a wide variety of people from around the world. Those of us who were fortunate to know her will always remember her with fondness.”

The Parenteral Drug Association, Inc. (PDA), today announced Pulitzer Prize winning journalist Dominic Gates of the Seattle Times will present, "The Devastating Impact of Design and Manufacturing Quality Lapses at Boeing" during the second plenary session of the 2023 PDA/FDA Joint Regulatory Conference in Washington, DC, Sept. 18-20.

Gates was a co-recipient of the 2020 Pulitzer Prize in National Reporting alongside Steve Miletich, Mike Baker, and Lewis Kamb for their coverage of the Boeing 737 MAX crashes and investigations. After two fatal crashes of the Boeing 737 MAX in late 2018 and early 2019 killed 346 people, that jet was grounded worldwide. His investigation of the causes of the crashes won numerous awards, including the 2019 George Polk Award in Business Reporting, the 2020 Gerald Loeb Award for Best Reporting, and the 2020 Scripps-Howard award for business reporting. His work featured in a documentary about the crashes: Flight/Risk, streaming on Amazon and nominated this year for an Emmy.

"PDA is very excited to have Mr. Gates join us at the 2023 PDA/FDA Joint Regulatory Conference to share such a compelling, although tragic, case-study on the life-and-death outcomes that poor quality practices and decisions can have," said Glenn Wright, PDA President & CEO. "PDA's commitment to our mission of advancing manufacturing science and regulation so members can better serve patients is fully aligned with helping our members and industry learn from these types of tragic and preventable events."

Gates has covered aerospace manufacturing for 20 years for the Seattle Times. Originally from Northern Ireland, Gates graduated from Queen's University Belfast with a degree in Pure Mathematics. He worked for ten years a Mathematics teacher in Ireland and then, on an Irish government development program, for three years in Zimbabwe.

PDA is pleased to announce that CDER Director Patrizia Cavazzoni, MD, and CBER’s Peter Marks, MD, PhD, will headline the opening and closing plenaries at the 2023 PDA/FDA Joint Regulatory Conference, in Washington, D.C., Sept. 18-20.

Dr. Cavazzoni will discuss maintaining quality assurance of medicines through sustainable compliance. Dr. Marks will address topics related to how the field uses scientific discovery and innovation to overcome pitfalls and consistently achieve robust quality for patients, deliver production efficiencies, and facilitate rapid patient access to safe and effective next-generation cell and gene therapies.

These sessions will bookend an information-packed agenda focused on important issues related to manufacturing and quality assurance. The conference will cover many pressing issues, including data integrity and innovation, CGMP training, and supply chain relationships and risk management.

Other representatives of the U.S FDA participating in the event are:

PANELISTS

• Paul Balcer, Program Manager, OMQ, OC, CDER
• Ashley Boam, MSBE, Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER (INVITED)
• Victor (Ray) Gaines, Branch Chief, OMQ, OC, CDER
• Marea Harmon, Consumer Safety Officer, OSC, CVM
• Brooke Higgins, MS, Acting Branch Chief, OC, CDER
• Lauren Howard, Drug Specialist and Pre-Approval Manager, OMPTO, ORA (INVITED)
• Laura Huffman, MS, CVM Pre-Approval Facilities Assessment Program, Lead, CVM
• Anthony Lorenzo, Branch Chief, OCBQ, CBER
• Kevin Maguire, Public Health Analyst, OMQ, OC, CDER
• J. Kevin Rice, PhD, CVM Pre-Approval Facilities Assessment Program, ONADE, CVM
• Obinna Ugwu-Oju, MS, Division Director, OPQ, CDER
• John Wan, MBA, Supervisor, OPQ, CDER
• Barbara Wilimczyk-Macri, Senior Compliance Officer, OMPTO, ORA (INVITED)

SPEAKERS

• CAPT Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER
• Cindy Burnsteel, DVM, Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM
• Carol Cave, Deputy Associate Commissioner for Regulatory Affairs, ORA (INVITED)
• Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA (INVITED)
• Daniel DeCiero, Consumer Safety Officer, OCBQ, CBER
• Tracey Forfa, JD, Director, CVM (INVITED)
• Jill Furman, JD, Director, Office of Compliance, CDER
• Milind Ganjawala, MS, MBA, Division Director, OC, CDER (INVITED)
• Francis Godwin, MBA, Office Director, OC, CDER
• Julianne McCullough, Senior Mutual Recognition Program Officer, OMPTO, ORA (INVITED)
• Melissa Mendoza, JD, Acting Director, Office of Compliance and Biologics Quality, CBER
• Marta Sokolowska, PhD, Deputy Center Director for Substance Use and Behavioral Health, OCD, CDER
• Alex Viehmann, Division Director, OPQ, CDER
• Nicholas Violand, Investigator/Drug National Expert, OMPTO, ORA (INVITED)

Crowd-favorite sessions, including Center and Compliance Office Updates, Current CGMP Compliance Trends and Topics, and Lunch with the Regulators; plenty of networking opportunities; and a packed exhibit area combine to make this the manufacturing and quality assurance conference you cannot miss.

The exhibit area includes Silver Supporters Honeywell, Sparta Systems, and Lachman Consultants.

The Parenteral Drug Association (PDA) and Innerspace have announced a long-term strategic partnership to develop PDA training courses that incorporate the use of VR Simulators designed with frame-by-frame risk profiling capabilities. This partnership aims to create a series of hybrid lecture/VR data-driven, immersive, and effective training courses for professionals in the pharmaceutical and biopharmaceutical industries.

The first new PDA/Innerspace training course is called Fundamentals of Aseptic Processing, which will be held in Carlsbad, Calif., in July.

"We are thrilled to partner with Innerspace to provide our members and the industry with innovative and effective training solutions that brings the VR cleanroom into any location,” said PDA President and CEO Glenn Wright. "I really like the built in frame-by-frame risk profiling capabilities that can provide trainees with immediate feedback on errors made. When combined with PDA course content, it allows us to offer a new way to reach the industry. We believe this partnership will greatly benefit our industry and our shared goal of delivering world class trainings in locations where a traditional cleanroom environment is not available.”

All PDA training courses are designed to meet the pharmaceutical industry's specific training needs and the health authorities' expectations.

“We plan to gradually connect PDA training material with information from Innerspace's frame-by-frame risk profiling, which is a new technology used to create extensive data libraries about risks related to specific processes.” Innerspace’s Managing Director and Chief Methodologist Sebastian Scheler said. “This approach will help us offer participants a deeper understanding of the risks involved in aseptic processing and help them apply this knowledge to their manufacturing facilities as needed."

“Through the integration of expert insights, regulatory requirements, VR technology and risk profiling data into our course content, we aim to establish a data-driven approach to training by leveraging these resources,” said PDA VP of Education David Talmage. “We are excited to initiate this partnership with Innerspace to deliver cutting-edge training courses for the pharmaceutical industry.”

The 2023 PDA Annual Meeting at the Hyatt Regency New Orleans, April 3-5, is organized around the theme, “Back to the Future: Learning from The Past in A Patient-Centric World.” Besides placing the spotlight on the connection between patients and manufacturing, the meeting will offer attendees a full evening to explore the historical host city.

A new feature of the 2023 conference is a “free” night on Tuesday, April 4, to explore all New Orleans, La. has to offer. The Hyatt Regency New Orleans is walking distance to many of the city’s renowned tourist attractions, including the historic French Quarter, Arts District, and Mississippi Riverfront. There’s no better place from which to explore the eclectic vibrancy of New Orleans.

PDA will offer attendees the opportunity to purchase tickets to three different tours a haunted history walking tour, a haunted pub crawl, and a culinary demonstration. Former PDA President and CEO Richard Johnson will be recognized throughout the 2023 PDA Annual Meeting for his 13 years as the head of the association’s professional staff. He will receive the PDA Honorary Membership award and will be available during the conference to greet attendees who wish to congratulate him on his retirement. The 2023 PDA Annual Meeting exhibition hall will host more than 80 exhibitors, including Platinum Sponsor Körber and Silver Sponsor Lachman Consultants.

The 2023 PDA Annual Meeting, April 3-5, in New Orleans, La., is organized around the theme, “Back to the Future: Learning from The Past in A Patient-Centric World.” The meeting will spotlight the critical connection between our patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor.

Learnings based on the patient experience start with the opening session. EveryLife Foundation’s Executive Director, Julia Jenkins, will share key takeaways from a 2019 study which looks at the economic impact of rare diseases in the U.S. Followed by Kelly Baker, a member of the Young Adult Rare Representatives group, who will reflect on her journey and the technologies she uses that have significantly evolved in an effort to improve both safety and patient quality of life.

“I’m looking forward to the impressive agenda and exciting networking opportunities at this year’s PDA Annual Meeting. The planning committee has certainly done an outstanding job in designing a great experience for the attendees,” said Glenn Wright, incoming PDA President & CEO. “I am also excited and looking forward to standing before the PDA membership in the opening session for the first time as PDA’s president.”

Following the opening plenary sessions, the meeting breaks into tracks focused on a variety of industry-important topics, including emerging technologies and contamination control. Twelve PDA Interest Groups are also meeting at the Annual Meeting.

Networking events are planned throughout the meeting in the Exhibit Hall, which will host more than 80 exhibitors. PDA is also scheduling Tuesday as an open evening so that attendees can take the time to explore New Orleans, this year’s host city. The Hyatt Regency New Orleans is walking distance to many of the city’s renowned tourist attractions, including the historic French Quarter, Arts District, and Mississippi Riverfront. There’s no better place from which to explore the eclectic vibrancy of New Orleans.

The PDA Contamination Control Workshop, based on the upcoming PDA Technical Report No.90: Contamination Control Strategy Development in Pharmaceutical Manufacturing, will take place immediately following the Annual Meeting as well as training courses focused on foundations of quality risk management, quality culture assessment, and root cause investigation for CAPA.

The Parenteral Drug Association (PDA) today announced the winners of the 2022 PDA Drug Delivery Innovation Awards during the opening plenary session of the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices in Palm Springs, CA. Awardees were recognized for their technical innovations in advancing the field of bio/pharmaceutical manufacturing.

The Innovation Award is presented to Ascendis A/S and Phillips-Medisize A/S for the SKYTROFA® Auto-Injector. The device is designed to support delivery of the SKYTROFA drug product, which is a lyophilized human growth hormone powder provided in a prefilled dual chamber cartridge. The cartridge is simply clicked into the device and an electromechanical motor controls reconstitution, air-shot, and injection of the mixed drug. The electronics and the user interface assist the user, by ensuring that the needle points upwards during reconstitution and air-shot, by keeping timing of passive mixing and by guiding a manual mixing procedure. Finally, the device injects automatically when it is pressed against the injection site and delivers a clear confirmation of dose delivered.

The Partnership Innovation Award is presented to the Stevanato Group and Bexson Biomedical for the innovation Pain Management Therapy through On-Body Injector System. Optimizing the target product profile opportunity with minimal time to market combination product therapies requires an innovative approach to development and commercialization. Bexson Biomedical and the Stevanato Group collaborated to optimize subcutaneous delivery of a novel pain management therapy based on a controlled substance. This therapy provides an alternative to highly addictive and easily misused opioids. Through this real-time collaboration, the companies are co-developing a novel combination product with a device constituent that is specifically designed to inhibit abuse and misuse of the pre-filled and preloaded integrated drug while providing ease of use to the patient.

"I want to congratulate the companies that received the 2022 PDA Drug Delivery Innovation Awards," said Richard Johnson, PDA President & CEO. "We are pleased to recognize the winners and all the companies considered at the first in-person Universe of Pre-Filled Syringes and Injection Devices Conference since 2019."

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) once again are cosponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 31st year. The previous two PDA/FDA Joint Regulatory Conferences were offered as virtual events due to travel and other restrictions brought about by the COVID-19 pandemic.

This year’s Joint Regulatory Conference will emphasize the role of implementing effective quality systems to ensure an ongoing state of control throughout the pharmaceutical product lifecycle by vigilantly managing quality risks. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management will be emphasized.

Case studies will be presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable Current Good Manufacturing Practice (CGMP) compliance establishes the foundation for drug quality and a reliable supply chain. The conference will also address international collaborations that aim to improve drug quality and benefit the consumer.

The Conference features the ever-popular FDA Center Office Updates, provided by the Office Directors of CDER, CBER, CVM, and by the Associate Commissioner of Regulatory Affairs of ORA. The FDA Center Directors and ORA’s Associate Commissioner of Regulatory Affairs will discuss recent programs, initiatives, and trends with respect to regulatory inspections and enforcement. The conference will also drilldown even deeper into compliance matters. Many sessions with practical GMP solutions and case studies throughout the conference culminating in the Current GMP Compliance Trends and Topics session, which will be held near the end of the conference (a perennial standing-room-only session). Just before the closing plenary session, attendees can have Lunch with the Regulators, another popular way for attendees to hear from FDA experts.