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Press Releases (Card Grid)

PDA's Glenn E. Wright, To Be Named President & CEO, March 2023; Richard M. Johnson to Retire

The Parenteral Drug Association (PDA) today announced plans to appoint Glenn E. Wright, PDA Vice President of Scientific and Regulatory Affairs, as President & CEO effective March 2023. Richard M. Johnson recently disclosed his plans to retire at the end of his current contract with PDA and will advise Mr. Wright over the coming year to ensure a successful transition.

Mr. Wright joined PDA in March 2020 to direct the Association’s scientific and regulatory affairs activities, following a 30-year career in industry, primarily with Eli Lilly & Co. With PDA, he oversaw the development of technical reports, growth of the standards program through the American National Standards Institute, issuance of regulatory comments, and the operation of PDA’s technical and regulatory advisory boards. In addition, he has served on the PDA JPST editorial board and was recently named Chairman of the Product Quality Research Institute’s (PQRI) Board of Directors.

“I am confident Mr. Wright will be an excellent leader of PDA,” said Richard Johnson. “As a PDA member and volunteer for many years, he has done almost every PDA volunteer activity. Over the last two, difficult years, Glenn has led the Science & Regulatory, Membership and Publishing activities of PDA, including leadership of various regulatory and manufacturing science activities. In the coming months, he will rotate through different areas of PDA activities, in preparation for assuming the role of President and CEO in March 2023.”

Richard M. Johnson has capably presided over PDA since September 2009 after many years as a PDA volunteer and member. During his 13 years as its head, he has hosted PDA’s largest meetings, published a record number of technical reports, extended technical services to include PDA/ANSI standards, and expanded membership and member services globally, particularly in the Asia-Pacific region. Mr. Johnson stabilized the Association through the global financial crisis of 2008-2009 and led PDA members and staff in response to the COVID-19 pandemic, ensuring the continued manufacture and supply of critical product. He has overseen PDA meetings being transitioned to online events and adapted in-office functions to the new normal of hybrid telework.

“Richard Johnson has been a positive, driving force in shaping PDA into an influential premier professional association,” said Susan Schniepp, Chair of PDA’s all-volunteer Board of Directors. “He understands and has mastered the concept of connecting people, science and regulations. He readily and willingly shares his expertise with others. I know his philosophy and professionalism will continue under the leadership of Glenn Wright."

PDA appreciates Mr. Johnson’s dedication and leadership during many trying times and wishes him the best when he assumes his new role as principal fly fisherman in Tennessee.

PDA Return to In-Person Events a Rousing Success in Dallas

The Parenteral Drug Association (PDA) is pleased to announce that its first in-person conference since 2019, the 2022 Annual Meeting, drew almost 700 participants and much relief from members and industry professionals as a step in the direction towards a new normal. The 2023 PDA Annual Meeting will be in New Orleans.

The open plenary session was standing room only as Richard Johnson, President & CEO, and Susan Schneipp PDA volunteer Chair, greeted the audience to rousing cheers as they acknowledged the difficulties everyone had faced over the previous two years.

Both credited the Annual Meeting program planning committee for their dedicated work to develop an agenda to help professionals in the pharmaceutical and biopharmaceutical industry “Level Up: Agility in the New Normal.” They also thanked the meeting’s Gold Sponsors, Samsung Biologics and Smartskin Technologies, and its Silver Sponsor, Alcami.

The co-chairs of the committee, Shelly Preslar, President and COO of Azzur Training Center Raleigh, and Jason Kerr, Sr. GXP Specialist, Redica Systems, took over following the introductions and acknowledgements to introduce the opening speakers.

Jeffrey Baker, Sr. Fellow National Institute for Innovation in Manufacturing Biopharmaceuticals (NIMBL) challenged the audience to think about future emergency responses in his talk, “Pandemic Response, Regulatory Rubric, and the Nature of Rubber Bands.” Donna Boyce, SVP Global Regulatory Affairs, Pfizer Inc., provided the perfect follow up discussion in her talk, “Moving Forward from Abrupt Regulatory Challenges to the New Normal.”

The plenary session remained at full capacity and the audience engaged for the late afternoon session. Benjamin Borgo, Head of Portfolio Management and Product Development, MilliporeSigma, presented “Challenges in CRISPR-based Gene Editing: Is it worth the risk?” Michael Brothers, Technical Program Manager/Principal Scientist, UES, Inc., ended the first day with, “Emerging Pathogens and the Emerging Platforms and Modalities for Bio-Surveillance to Identify Them.”

Following the session, attendees packed the opening of the exhibit hall, to the satisfaction of the more than 70 exhibitors who awaited two-years to greet the PDA community in person once again. Subsequent sessions and exhibit hall activities drew eager audiences.

The post-conference Annex 1 Workshop drew over 120 attendees.

PDA Announces Day 1 Speakers for In-Person Annual Meeting in April

The Parenteral Drug Association (PDA) announces senior regulatory experts to speak during opening session of the 2022 PDA Annual Meeting, the first full in-person signature event held by PDA since 2019. The PDA Annual Meeting takes place at the Hyatt Regency in Dallas, Tx., April 4-6.

Jeffrey C. Baker, PhD, a senior fellow for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIMBL) and former U.S. FDA official, and Donna Boyce, a senior vice president of global regulatory affairs with Pfizer Inc. will discuss new regulatory challenges caused by the global pandemic and anticipated in the “new normal.”

“As we enter 2022, we are pleased to be returning to live meetings starting with the 2022 PDA Annual Meeting in Dallas,” said Susan Schniepp, PDA’s volunteer Chair, 2022-2023. “This Conference will focus on the theme to Level Up: Agility in the New Normal!”

Speakers will examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

“PDA is taking all the necessary precautions to ensure the safety and wellbeing of participants; our top priority,” said Richard Johnson, PDA President & CEO. “Proof of vaccination, as outlined on the conference website, will be required of all participants, with few exceptions.”

Immediately following the conference, PDA is hosting a two-day workshop on Annex 1 at the same facility, April 7-8. The intent of the workshops is to highlight specific sections with critical changes and include interactive sessions to provide attendees with clear understanding of and means to implement the requirements of the new Annex 1. PDA has developed a standardized approach for workshop topics to ensure consistency in the information delivered to the industry.

Click the links for more information on the 2022 PDA Annual Meeting and Annex 1 Workshop.

To request a press pass, click here.

PDA Announces Availability of ANSI/PDA Standard 02-2021 on Cell Cryopreservation

The Parenteral Drug Association (PDA) today announced the availability of ANSI/PDA Standard 02-2021 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.

ANSI/PDA Standard 02-2021 can be purchased at the PDA Bookstore.

This new 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. The guide emphasizes the effect cryopreservation and recovery may have on cell viability and cell function and can provide general guidance during the assessment of regulatory requirements. The best practices and guidance details outlined in the document provide general procedural support for cryopreservation of cell-based products during both early and late phases of product development.

Among the volunteer industry experts who helped draft the standard were representatives of the U.S. FDA/CBER, U.S. HHS, and U.S. NIST.

More information about PDA’s role in standards development and current standards under development can be found here: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.

PDA Announces Election Results for 2022 Board of Directors and Officers

The Parenteral Drug Association (PDA) today announced the results of the 2021 Board of Directors Election for the term beginning January 1, 2022. Each year, PDA’s global membership votes to select directors for the nonprofit Association’s all volunteer Board of Directors, and the Board appoints one Director. In odd years, the membership elects volunteer Officers, who serve two-year terms (except for the chair-elect, who serves for six years as chair-elect, chair, and, finally, as immediate-past-chair).

The 2022-2023 Board of Directors and Officers will be composed of the following volunteers:

Officers

  • Chairs:Sue Schniepp, Regulatory Compliance Associates Inc.
  • Chair-Elect: Anil Sawant, Merck & Co./Merck, Sharp & Dohme
  • Treasurer: Melissa Seymour, Biogen, Inc.
  • Secretary: Emma Ramnarine, Genentech/Roche
  • Imm. Past Chair:Jette Christensen, Novo Nordisk

Directors

  • Barbara Allen, Eli Lilly and Company
  • Bettine Boltres, West Pharmaceutical Services
  • Tia Bush, Centessa Pharmaceuticals
  • Javier Camposano, Celltrion
  • Mirko Gabriele, Thermo Fisher Scientific
  • Ghada Haddad, Merck & Co.
  • Andrew Hopkins, Abbvie
  • Stephan Krause, AstraZeneca Biologics
  • Amy McDaniel, Bristol Myers Squibb
  • Mary Oates
  • Mathias Romacker (ret.)
  • Osamu Shirokizawa, Lifescientia

“The new and returning officers and directors for the 2022-2023 term are extremely committed and qualified members who will assist PDA as we continue to steer the Association through these turbulent times,” said Richard Johnson, PDA President & CEO. “On behalf of PDA, I want to thank all the members who took the time to vote, the other well-qualified candidates for their commitment to PDA, and the outgoing officers and directors.”

PDA thanks outgoing Immediate Past Chair Rebecca Devine and directors Joyce Hansen and Michael Blackton.

PDA Announces 2021 Drug Delivery Innovation Award Winners

The Parenteral Drug Association (PDA) today announced the winners of the 2021 PDA Drug Delivery Innovation Awards during the opening plenary session of the 2021 PDA Universe of Pre-Filled Syringes and Injection Devices. Awardees were recognized for their technical innovations in advancing the field of bio/pharmaceutical manufacturing.

The Innovation Award is presented to Roche Genentech for the Port Delivery System with ranibizumab. The drug delivery device is an innovative, investigational, permanent, indwelling, ocular delivery system that includes a surgically placed implant for continuous delivery of a customized formulation of ranibizumab into the vitreous.  After implantation, the device uses a refill exchange process to replenish the fresh drug.

The Partnership Innovation Award is presented to Syntegon Technology GmbH and Vetter Pharma-Fertigung GmbH & Co. KG for the Versynta microBatch, an innovative system based on a gloveless isolator cell with a versatile robot, responsible for filling, line set-up and environmental monitoring. With the focus on flexibility, a broad range of pre-sterilized packaging components including pre-filled syringes either made of glass or plastic can be handled. A comprehensive monitoring system and 100% fill weigh checks allow a continuous process control.

“I want to congratulate the companies that won the 2021 PDA Drug Delivery Innovation Awards and all the companies that were considered for this award,” said Richard Johnson, PDA President & CEO. “PDA has seen continued growth and visibility of these important awards since they were launched in 2019.”

PDA Announces Early Career Professional Membership Type

The Parenteral Drug Association (PDA) today announced the availability of its newest membership type, the Early Career Professional.

Early Career Professional Members are new to the bio/pharmaceutical manufacturing area, with fewer than five years of professional experience in industry, or within five years post-graduation from an accredited college or university. The membership type can be renewed for five years.

Previously, PDA offered a “young professional” membership, but decided to change it to better reflect the full diversity of new professionals entering careers in the pharmaceutical industry.

To qualify, a prospective Early Career Professional will have to provide a current CV, resume, or social media account showing career history, a letter from a corporate HR department, a copy of a graduation transcript, or a declaration letter from a University Bursar's or Registrar's Office.

The Early Career Professional membership costs US$100 per year.

To join PDA, visit: https://www.pda.org/membership/join-or-renew-today

PDA Announces the Availability of ANSI/PDA Standard 05-2021 Consensus Method for Rating Filters for Mycoplasma

The Parenteral Drug Association (PDA) today announced the availability of industry standard, ANSI/PDA Standard 05-2021 Consensus Method for Rating Filters for Mycoplasma, available now for purchase in the PDA Bookstore.

This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism.

While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim.

This is the third ANSI/PDA Standard released by PDA since it was accredited by the American National Standards Institute (ANSI) as a Standards Developing Organization in 2017. The others are:

  • ANSI/ PDA Standard 001-2020:, Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries
  • ANSI/PDA Standard 04-2021, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters

More information about PDA’s role in standards development and current standards under development can be found here: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.

PDA’s Glenn Wright Named Chairman of Product Quality Research Institute Board of Directors

The Parenteral Drug Association, Inc. (PDA) has announced that Glenn Wright, Vice President of Scientific and Regulatory Affairs, was named the Chairman of the Product Quality Research Institute’s (PQRI) Board of Directors. Mr. Wright has participated in PQRI since 2003.

PQRI is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances global drug product quality, manufacturing, and regulation.

PDA has been a supporting member of PQRI since it was founded in the late 1990s.

Besides, PDA, two regulatory authorities and a number of nongovernmental organizations comprise PQRI. The member organizations are:

Government

  • Health Canada
  • U.S. Food and Drug Administration

NGO

  • Consumer Healthcare Products Association
  • International Pharmaceutical Excipients Council of the Americas
  • PDA, Inc.
  • U.S. Pharmacopeial Convention

The Board of Directors is vested with the administrative management, growth, and operation of the Institute, except for those activities involving scientific decision making, which are delegated to the PQRI Steering Committee. The Board has authority over the collection and disbursement of funds and the administrative procedures required to ensure the effective operation of the Institute.

The Steering Committee has sole authority over all scientific activities conducted under the auspices of the Institute and is responsible for recommending the disbursement of funds towards those activities, to the Board of Directors.

PQRI currently supports three technical committees that guide working groups:

  • Development Technical Committee
  • Product Quality Technical Committee
  • Biopharmaceutics Technical Committee

For more information on PQRI and its work, visit its website: https://pqri.org/about-pqri/

PDA Annual Meeting Marks Start of 75th Anniversary Celebration

The Parenteral Drug Association (PDA) announced the beginning of its 75th Anniversary celebration. The 2021 PDA Annual Meeting (15–17 March) and the Honor Awards Ceremony (24 March), both virtual online events, served as the official launch of the diamond anniversary. 

“Seventy-five years ago, our founders created the Parenteral Drug Association because they saw the value of collaborating to advance the industry to the benefits of patients.  While many things have changed since then, that purpose has not. I think they would be gratified by the achievements of the PDA since those beginnings, and excited about the potential for the next seventy-five years” said Richard Johnson, PDA President and CEO.

In the coming months, PDA will release videos, articles in the PDA Letter, and more in honor of the Association’s enduring impact on the sterile drug industry.  
On 18 November 1946, the State of New York approved PDA’s certificate of incorporation, signed by the Association’s “original six” directors: Harold London of the Estro Company, Rudolph Price of Metropolitan Labs, A. Lincoln Konwiser of the C.F. Kirk Company, Max Gold of Gold Leaf Pharmacal Company, attorney Arthur Herrick, and Abraham Wagner.

Formation of PDA was the brainchild of Arthur Herrick, who represented a number of parenteral drug manufacturers that were facing increasing scrutiny from a newly aggressive U.S. Food and Drug Administration, which had been strengthen by the 1938 Federal Food, Drug and Cosmetic Act.  

Among the eight original goals on the certificate, PDA still actively fosters and advances the art and science of parenteral therapy and provides and disseminates information relating to parenteral drugs and parenteral therapy. 

PDA Announces Availability of ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small and Large Virus-Retentive Filters

The Parenteral Drug Association (PDA) announced the availability of ANSI/PDA Standard 04-2021 Phage Retention Nomenclature Rating for Small and Large Virus-Retentive Filters. This standard addresses virus-removal filters that retain viruses by a size-exclusion mechanism. The objective is to assist users/manufacturers in selecting the most appropriate filter for their specific application needs.

ANSI/PDA Standard 04-2021 is intended to:

  • Provide detailed methods and acceptance criteria for testing bacteriophage (also referred to as phage) retention by large- and small-virus retentive filters,
  • Provide methods for preparing and enumerating suitable sized bacteriophage (PP7 and PR772 as models for small and large viruses, respectively) as test items, and
  • Guide selection of appropriately rated filters as defined by suppliers in a standardized manner using a risk-based approach.

ANSI/PDA Standard 04-2021 can be purchased at the PDA Bookstore.

PDA to Collaborate with Deloitte and U.S. FDA to Improve the Quality of Compounded Drugs

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced it has signed an agreement to collaborate with Deloitte Consulting, LLP and the U.S. FDA’s Compounding Quality Center of Excellence to provide training to large pharmaceutical compounders in a variety of Good Manufacturing Practices (GMP)-related functions critical to improving the overall quality of compound drugs.

PDA is offering training in areas that are core to its educational offerings, including aseptic processing of sterile drug products, environmental monitoring, and manufacturing deviation investigations and Corrective and Preventative Actions (CAPA), as well as other topics to be determined.

“PDA is very happy to continue working with Deloitte and the U.S. FDA to provide this important GMP-related training,” said Richard Johnson, PDA President and CEO. “The agreement we signed includes provisions to extend this training over the next few years.”

PDA’s training is being offered under a larger relationship between the U.S. FDA’ Compounding Center of Excellence and Deloitte to assist large drug compounders, considered outsourcing facilities (under section 503B of the Federal Food, Drug and Cosmetic Act), improve the quality and safety of their pharmaceutical products. The courses will be offered online and in person, with a limited number of seats in the latter cases. Dates and times of the courses will be announced on the FDA website. PDA will offer the training developed for this partnership to other interested parties.

Providing training to the pharmaceutical/biopharmaceutical industry has been a core mission of PDA for 70 years. It conducts hands-on aseptic processing and laboratory training at the PDA Training and Research Institute in Bethesda, Md., and lecture-based training in Bethesda and other locations, and on-site training for companies.

Parenteral Drug Association Announces Partnership with MJM Global Brokerage Group

Bethesda, MD and Englewood, NJ  – Parenteral Drug Association (PDA), today announced it is partnering with MJM Global Insurance Brokerage Group to provide the members of the Association a new benefit: access to healthcare coverage options to its membership, their employees, and their families. This additional benefit will enable members to save year after year on healthcare costs, as well as provide better healthcare coverage. 

 “PDA continues to look for way to assist our members during these challenging times,” said Richard Johnson, President and CEO of PDA.  “While many of our PDA members have great health insurance options through their employers, this is not the case for all of our members.  For these individuals, the cost and quality of health insurance is an ongoing concern.  Challenging times call for real action and, as such, PDA has been working with insurance provider MJM Global Brokerage to take the unusual step of seeing if we can extend, to our members, access to a group health plan.  PDA receives no revenue from this offering.”

PDA®HealthCare.com, the marketplace launched by MJM Global, uses the collective purchasing power of PDA members to reduce healthcare premiums, benefitting all members, while maintaining flexibility in plan design and provider. Bundled with the coverage, at no additional cost and no co-pay, is Prosper Benefits, a suite of non-insurance benefits including TeleMedicine, TeleMental, HealthCare Advisor, and Medical Billing Advocacy. This benefit enables members to take control of their healthcare costs. 

 MJM Global Insurance Brokerage Group is rich in family tradition, spanning three generations over 70 years, providing reliable insurance for all types of commercial and personal risk to the jewelry industry. They launched PDA®HealthCare.com to help association members see immediate and significant savings on one of the largest expenses, in addition to turning an otherwise complicated health insurance buying process into an easy system.  

Michael Malhame, President of MJM Global Insurance added, “I am confident that offering the ability to access healthcare coverage via PDA®HealthCare.com will enable MJM to provide unprecedented service levels.”  Malhame continued.” Since the signing of the ACA, group health insurance plans have increased at over three times the rate of general inflation. Ninety-seven percent of Americans do not know what their insurance covers, and the process of shopping for and enrolling in coverage remains a significant burden to employers and employees. PDA and MJM Global have made significant movement to help resolve the situation.” 

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About PDA – Connecting People, Science and Regulation®

The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its 10,000 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.

About MJM Global

MJM Global, a proud member of the Independent Insurance Agents of America (IIAA) and the National Association of Professional Insurance Agents (PIA), serves the needs of more than 3,000 businesses, professionals, and households throughout the United States and abroad. MJM works diligently to innovate the most effective ways to manage all aspects of the total cost of risk and provide reliable insurance for all types of commercial and personal risk.   

For more information visit www.mjmglobal.com 

Contact:  Michael Malhame, President mmalhame@mjmglobal.com

PDA Announces Results of 2020 Board Election and First All-Female Executive Committee

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the results of the 2020 Board of Directors Election for the term beginning January 1, 2021. Members chose from a slate of candidates to fill three director positions, as the composition of the 2021 Executive Committee was determined in the 2019 BoD election.

The 2021 Board of Directors and Executive Committee is the most diverse in PDA’s 70-year history, and features the only all-female team of Officers in the industry (winners of the 2020 election indicated in parentheses):

Executive Committee

  • Chair:   Jette Christensen, Novo Nordisk
  • Chair-Elect:  Susan Schniepp, RCA
  • Treasurer:   Melissa Seymour, Biogen
  • Secretary:   Emma Ramnarine, Genentech/Roche
  • Imm. Past Chair:  Rebecca Devine, Regulatory Consultant

Directors

  • Barbara Allen, Eli Lilly and Company
  • Michael Blackton, Adaptimmune
  • Bettine Boltres, West Pharmaceutical Services (reelected)
  • Tia Bush, Amgen
  • Javier Camposano, Celltrion (appointed)
  • Ghada Haddad, Merck & Co.
  • Joyce Hansen, Johnson & Johnson
  • Stephan Krause, AstraZeneca Biologics
  • Mary Oates, Pfizer (reelected)
  • Mathias Romacker, Pfizer (ret.)
  • Anil Sawant, Merck & Co.
  • Osamu Shirokizawa, Lifescientia (elected)

“I want congratulate the new officers and directors and thank the many members who took the time to vote.” said Richard Johnson, PDA President & CEO. “The diversity of our all-volunteer board of directors helps PDA continue to meet the needs of pharmaceutical and biopharmaceutical professions around the globe.  I also want to thank the other candidates for their commitment to PDA.”

PDA thanks outgoing directors Masahiro Akimoto, Otsuka Pharmaceutical Factory, Inc. and Stephan Roenninger, Amgen who will end their term at the end of 2020.

PDA Announces 2020 Drug Delivery Innovation Award Winners

Bethesda, Md., – The Parenteral Drug Association (PDA) announced the winners of the 2020 PDA Drug Delivery Innovation Awards at the 2020 PDA Universe of Pre-Filled Syringes and Injection Devices, Oct. 5-8, a virtual event. Awardees were recognized for their technical innovations in advancing the field of bio/pharmaceutical delivery devices.

The Innovation Award is presented to UCB Pharma for its presentation of Product Innovation through a Portfolio of Patient-Centric Self-Injection Devices for Certolizumab Pegol, submitted by Serkan Oray and David Harrison.

The CIMZIA ava electromechanical device (e-Device) is the first reusable device of its nature available for use with biologic treatment in rheumatology and dermatology. The inclusion of enhanced functions, such as on-screen instructions, an injection log and injection date notifications have not previously been included in a biologic self-injection device.

The Partnership Innovation Award is presented to SCHOTT Schweiz AG and CSL Behring for bringing a PFS immunoglobin drug successfully to the market, submitted by Tom Van Ginneken from SCHOTT and Frank Bamberg from CSL Behring.

Due to the collaboration between CSL and SCHOTT, CSL Behring was able to bring the first and only pre-filled Ig syringe is to the market. This syringe provides easier and more convenient drug administration process, reducing the risk for medical errors during manual vial-syringe preparation.

“I want to congratulate the companies and individuals that won the 2020 PDA Drug Delivery Innovation Awards and all the companies that were considered for this award,” said Richard Johnson, PDA President & CEO. “PDA launched these awards in 2019, and already we have seen growing interest in and prestige of the awards. We had an exceptional field of nominees this year. We look forward to the continued growth and visibility of these important awards.”

PDA and BioPhorum Consortium Complete Work on PUPSIT Research and Points to Consider

September webinars will expound on the results of the consortium’s work.

Bethesda, Md., – The Parenteral Drug Association (PDA) and BioPhorum today announced that the Sterile Filtration Quality Risk Management (SFQRM), jointly created by the two organizations, has completed its final publication to help clarify industry thinking on the implications of pre-use post-sterilization integrity testing (PUPSIT) of sterilizing filters. The work product includes two research papers and two points-to-consider technical documents.

The last document, Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT), published today (AUG 25), and is available at the PDA Bookstore www.pda.org/bookstore.

“For almost 75 years PDA has been committed to providing scientific answers to regulators' concerns. The results of this effort on PUPSIT reflects this core PDA goal and we are very excited to have reached this point in the project,” said Richard Johnson, PDA President.

"Until now industry has only had conjecture and compliance as guides to their actions in the great PUPSIT debate. With these publications we have studies, science and best practice so that rationale and common sense can be brought to bear," said Tony White, BioPhorum Director.

On September 1, members of the SFQRM will participate in the first in a series of meetings presenting the background of, reasons for, challenge to, and approach for mitigating the risk of sterilizing filtration, that has prompted the use of PUPSIT. The Sept. 1 virtual meeting is titled, The Role of PUPSIT within the Assurance in Sterilizing Filtration. The next virtual meeting will take place on Sept. 8 and is titled, Assessing the Risk of Filter Masking – Test Description and Results. And the final occurs on Sept. 21, entitled Practical Implication and Decision Making of PUPSIT. More information on these events can be found here: 
In June, Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration published at the PDA Bookstore.

The SFQRM conducted research on PUPSIT to support the Points to Consider documents. It published two research papers in the PDA Journal of Pharmaceutical Science and Technology (accepted articles, May 28). The papers are titled:

  1. Test Process and Results of Potential Masking of Sterilizing Grade Filters  https://doi.org/10.5731/pdajpst.2019.011189
  2. Datamining To Determine The Influence Of Fluid Properties On The Integrity Test Values https://doi.org/10.5731/pdajpst.2019.011387

These papers will appear in their final forms in the September/October 2020 issue.

For more information on the SFQRM PUPSIT effort, contact SFQRM Consortium facilitator Jannika Kremer, email: jannika@biophorum.com.

About the Sterile Filtration Quality Risk Management (SFQRM)
The SFQRM Consortium was formed by BioPhorum and the Parenteral Drug Association to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures. It consists of more than 50 subject matter experts from 25 biopharmaceutical manufacturing companies and filter suppliers.

About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of over 10,500 members worldwide. PDA is an ANSI accredited Standards Developing Organization. Go to https://www.pda.org/about-pda to learn more.

About BioPhorum 
BioPhorum’s mission is to create environments where the global biopharmaceutical industry can connect, collaborate and accelerate its rate of progress, for the benefit of all.

Since its inception in 2004, BioPhorum has become the open and trusted environment where senior leaders of the biopharmaceutical industry come together to share and discuss the emerging trends and challenges facing their industry. Growing from an end-user group in 2008, BioPhorum now comprises over 90 manufacturers and suppliers deploying their top 3,500 leaders and subject matter experts to work in seven focused Phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development and manufacturing IT.

In each of these Phorums, BioPhorum facilitators bring leaders together to create future visions, mobilize teams of experts on the opportunities, create partnerships that enable change and provide the quickest route to implementation, so that the industry shares, learns and builds the best solutions together.

PDA Confirms U.S. FDA’s Douglas Throckmorton as an Opening Plenary Speaker for Virtual 2020 PDA/FDA Joint Regulatory Conference

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced that it has confirmed Douglas Throckmorton, MD, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research (CDER), U.S. FDA, as an opening plenary speaker of the 2020 PDA/FDA Joint Regulatory Conference, which will be held virtually Sept. 14 – 16.

The theme of the 2020 conference is “The Future Is Now: Effective Quality Management and Robust Manufacturing.” Speakers from the U.S. FDA, other regulatory bodies, and industry will explore the continuing evolution of innovative manufacturing capabilities and the potential effect on quality, compliance, and regulatory lifecycle paradigms.

FDA senior officials will discuss Center-specific initiatives as well as provide compliance updates in what has become one of the most popular recurring sessions of the event.
PDA and the U.S. FDA once again are co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 29th year. Because of the ongoing challenges of the COVID-19 pandemic, the U.S. FDA and PDA agreed to hold the event virtually.

This flagship conference consistently provides a unique opportunity to hear from and engage with numerous regulatory and industry leaders concerning the latest manufacturing, quality, supply, and related compliance issues in an ever-evolving landscape.

Tia Bush, Senior Vice President, Quality, Amgen, Inc., is a confirmed speaker for the closing plenary session. PDA had confirmed other industry expert speakers from GlaxoSmithKline PLC, AstraZeneca PLC, Merck Sharpe & Dohme Corp., Eli Lilly and Company, and Sanofi Pasteur.

Among the many topics these and other industry and regulatory authority experts will address are:

  • Commercialization challenges in cell and gene therapy
  • Data analytics in manufacturing
  • De-risking your supply chain
  • Quality assurance role in 2020 and beyond
  • OOS investigations
  • U.S. FDA Emerging Technology program

For more information, visit the 2020 PDA/FDA Joint Regulatory Conference website: https://www.pda.org/global-event-calendar/event-detail/2020-pda-fda-joint-regulatory-conference

Members of the press may request a press pass at the following website: https://www.pda.org/about-pda/press-pass-request-form.

BSR/PDA Standard 02-201x Cryopreservation Standard Available for Public Comment

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of BSR/PDA Standard 02-201x, Cryopreservation of Cells for Use in Cell Therapies and Regenerative Medicine Manufacturing for public comment. To receive a copy of this draft standard, email PDA at standards@pda.org. The public comments period concludes September 7, 2020 EDT. There is no charge for the draft standard.

To better harmonize cryopreservation of advanced therapies, including cell and gene therapies, PDA convened a working group comprising experts from academia, industry, and governmental regulatory bodies to compile and draft current best practices into a single reference document. This standard will assist both commercial and clinical groups with their cryopreservation efforts.

On August 7, 2020 BSR/PDA Standard 04-201x, Phage Retention Nomenclature Rating for Small and Large Virus Retentive Filters will also be released for public comment.

For more information about PDA’s role in standards development, visit: https://www.pda.org/scientific-and-regulatory-affairs/pda-ansi.

Find answers to standard development questions: https://www.pda.org/scientific-and-regulatory-affairs/pda-standards-frequently-asked-questions or reach out to standards@pda.org.

PDA Launches New Website for the PDA Foundation, a 501(c)(3) Organization Site includes a donation section for companies to underwrite certain PDA activities

Bethesda, Md. – The Parenteral Drug Association (PDA) today announced the availability of a new website for the PDA Foundation, a 501(c)(3) nonprofit founded in 1997 to help support PDA and other industry activities. This new website makes it easier for industry stakeholders to donate money for various activities, as it includes an online processing system.

The four pillars of the PDA Foundation’s Mission are:

  • To support the education, training and research activities of the Parenteral Drug Association
  • To generally support education, training and research in the pharmaceutical sciences
  • To increase awareness and educate the public on pharmaceutical sciences by disseminating information and presenting public discussion groups, forums, panels, lectures and other programs
  • To do any and all other things which are consistent with its other goals and objectives.

Some of the activities that can be underwritten are training, “scholarships” for PDA conference attendance, and research activities.

The PDA Foundation has received significant donations in the past:

  • $490,000 in equipment and services to support PDA’s Training and Research Institute in Bethesda, MD
  • $113,000 SMA equipment for use in PDA’s Training and Research Institute
  • $125,000 BioQuell Isolator for use in PDA’s Training and Research Institute
  • $200,000 from Pharmaceutical Manufacturing Forum for funding research into particle loading on elastomeric closures.

You can visit the PDA Foundation’s website here: https://www.pda.org/about-pda/foundation

PDA Forms Coronavirus Pandemic Response Task Force, New Advanced Therapy Advisory Board

Bethesda, Md. – The Parenteral Drug Association, Inc. (PDA) today announced two new volunteer opportunities and changes to its Board of Directors/Executive Committee following its spring Board of Directors meeting.

In response to the current global pandemic and its impact on manufacturing and supply chains, PDA’s Board chose to form a Coronavirus Pandemic Response Task Force. Consisting of volunteers from leading bio/pharmaceutical manufacturers, the Task Force will develop strategies to ensure the continued manufacturing and supply of product during an active outbreak with a specific focus on regulatory requirements as well as good manufacturing practices (GMPs) processes and controls. The end goal is to elucidate steps manufacturers can take to ensure the ability to meet current as well as increased supply demands for pharmaceutical products during these events.  The Coronavirus Pandemic Response Task will be led by Anil Sawant, Merck & Co., who also sits on the PDA Board of Directors.

Recognizing the growing importance and impact of cell and gene therapy products, the Board resolved to create an Advanced Therapy Medicinal Products Advisory Board. This new advisory board will oversee PDA projects and Interest groups in these areas as well as provide guidance to PDA in the development of events, trainings, and technical publications to assist companies developing gene therapy medicinal products, somatic cell therapy products, and tissue engineered products. Michael Blackton, VP Global Quality, Adaptimmune, LLC, and Stephan Krause, PhD, Head of Product Quality, AstraZeneca Biologics, have been appointed to form and lead the new advisory board.

PDA also named new members to its Board of Directors, as Glenn Wright left the all-volunteer body to join PDA staff as the Vice President of Scientific and Regulatory affairs in March. Melissa Seymour, Biogen, Inc., assumed the role of Treasurer; Emma Ramnarine, Roche Pharma, assumed the role of Secretary, and Stephan Roenninger, Amgen joined as a Director.

For more information about PDA, its volunteer boards and committees, and leadership, got to PDA’s website, www.pda.org.