Richard Levy, PhD, Sr. VP of Scientific and Regulatory Affairs Stepping Down After 13 Years

PDA is pleased to welcome Tina Morris, PhD, as the Association’s new Vice President of Scientific and Regulatory Affairs. Currently, she serves as Senior Vice President of Compendial Sciences at the U.S. Pharmacopeia, with whom she has worked for 15 years. She will join the PDA family effective June 4.

Tina Morris

In her new role, Morris will oversee PDA’s scientific and regulatory affairs activities, which include industry-leading technical reports, the newly launched standards-development program through the American National Standards Institute (ANSI), regulatory commenting, and overseeing PDA’s four technical/regulatory advisory boards.

“Dr. Morris has strong leadership capabilities in a volunteer-based organization that we believe are essential to PDA’s efforts to continue PDA’s legacy of leadership in bio/pharmaceutical science,” said Richard Johnson, President and CEO, PDA.

Morris began her career at USP as a Senior Scientific Liaison in 2003, and saw her responsibilities grow each year before becoming Senior Vice President in 2015. Prior to USP, she worked for Human Genome Sciences, Inc. and at Ciphergen Biosystems, Inc. She received her PhD in molecular virology from the Medical University of Luebeck, Germany and a Bachelor of Science and Master of Science in biology from the Carl von Ossietzky University in Oldenburg, Germany.

Richard Levy, PhD, PDA’s outgoing Senior Vice President of Scientific and Regulatory Affairs, announced his retirement earlier this year after 13 years in the role. Among his many accomplishments in the role, Levy oversaw a marked increase in the number of technical documents published annually, the conversion of the PDA Journal of Pharmaceutical Science and Technology from a print to an online-only publication, and the growth in the number of staff in the Scientific and Regulatory Affairs department to better support the efforts of member volunteers. He will take on the role of Editor of the PDA Journal of Pharmaceutical Science andTechnology on May 21.

Richard Levy

“Dr. Levy’s many contributions to PDA, both as a volunteer for many years and as part of the staff since 2005, are numerous,” said Johnson. “He was most instrumental in ramping our technical activities to a level higher than any time in our history. We look forward to working with Dr. Levy as the editor of the Journal for many years to come.”

On Feb. 19, PDA unveiled an updated version of PDA Connect ^SM, our online networking community, based on user feedback.

If you have not already, log in to PDA Connect^SM to explore new and improved features, such as:

• Mobile-friendly design
• Intuitive navigation
• Community-oriented layout
• Popular “newsfeed” format

You can access the updated version of PDA Connect ^SM with the same login credentials you currently use to log into your PDA account.

PDA Connect^SM provides a forum for PDA members around the world to share information, advice and best practices on a wide variety of important topics.

Representatives from pharmacopeias and regulatory agencies across the globe are scheduled to speak at the PDA Europe Pharmacopoeia Conference scheduled for May 29–30 in Vienna. PDA is honored to welcome speakers from the following pharmacopeias and agencies:

• European Directorate for the Quality of Medicines & Health - Care, EDQM (European Pharmacopoeia)
• U.S. Pharmacopeial Convention
• Japan Pharmaceuticals and Medical Devices Agency
• Russian Ministry of Health
• Eurasian Economic Union Pharmacopeia Committee
• Indian Pharmaceutical Commission
• Brazil Pharmacopeia
• Ghana FDA
• WHO (International Pharmacopoeia)
• MHRA
• British Pharmacopoeia Commission

Learn more about the Pharmacopoeia Conference.

PDA and the editors of the PDA Letter have launched the Article of the Year recognition. Congratulations go to Frithjof Holtz of Merck KGaA, Darmstadt, Ger - many. His January 2017 article, “Formalizing a Risk Assessment for Excipients,” is the PDA Letter Article of the Year for 2017. The article is currently available on the PDA Letter website.

Holtz is working with PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB) on a joint technical report on risk assessments for excipients in partnership with IPEC.

PDA’s Nominating Committee seeks member recommendations for nominees of candidates to fulfill Board of Director positions for the 2019–2021 term. Nominees must be current PDA members in good standing. This year’s committee is chaired by Martin VanTrieste, Immediate Past Chair of the Board of Directors.

If you are interested in being considered or want to recommend someone, send a recommendation (including full name, contact information and rationale for nomination) by email or by regular mail to PDA Global Headquarters, Bethesda Towers, Suite 600, 4350 East West Highway, Bethesda, MD, 20814, USA, Attention: Nominating Committee. Please include any supporting information, which may make it easier for the Nominating Committee to evaluate your recommendation. Nominations are due May 15.

If you have any questions, feel free to contact PDA President Richard Johnson or Martin VanTrieste.

PDA is once again the Premier Association Sponsor for the INTERPHEX show scheduled for April 17–19 in New York City.

In this role, PDA will be hosting three informational roundtables as part of the INTERPHEX Technical Conference. Here, experts will share the latest thinking on key topics, including:

• State of the Industry Practice for Pre- Use, Post-Sterilization Integrity Testing (PUPSIT), Tuesday, April 17, 10:30 a.m. – 11:30 a.m.
• Technology and Process for Cell and Gene Therapy Manufacturing, Wednesday, April 18, 2 p.m. – 3 p.m.
• Use of Big Data for Predictive Process Control, Thursday, April 19, 10:30 a.m. – 11:30 a.m.

To view an agenda for the show and to register, please visit the INTERPHEX website.

PDA was saddened to learn of the passing of longtime volunteer Edwin Rivera-Martinez on Dec. 28. Edwin was a major part of PDA’s family. Many of us remember how he could spin a good yarn and capture an audience with his enthralling presentations. He was heavily involved in supporting efforts to ensure the supply chain around the world, including the Asia-Pacific region.

Edwin made many contributions as a PDA volunteer. From 2012–2017 he was part of the Regulatory Affairs and Quality Advisory Board (RAQAB). As part of this role, he also served as the RAQAB liaison to the PDA Letter Editorial Committee. He also served on the program planning committees for PDA’s supply chain conferences/workshops in 2010, 2011 and 2013 and was a speaker and instructor at a Japan Chapter Annual Meeting. Edwin also spoke at a 2009 PDA meeting in Europe on the supply chain of pharmaceutical ingredients. Additionally, he was an active contributor to the Quality Metrics Task Force. His significant contributions to PDA are part of his legacy that will remain with us.

His extensive industry experience served to benefit PDA and its members. He was proud of his many years of work at the U.S. FDA where he was an investigator. While at FDA, he was the driving force behind ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. As part of CDER, he was actively involved in many initiatives, training programs and conferences with PDA, where he contributed to communicating the Agency’s expectations and industry practice on important technical and regulatory matters.

While working at Sanofi over the past six years, Edwin was always fully dedicated to quality, compliance and patient safety and was a strong contributor to the company’s quality culture journey. He was a true gentleman whose kindness was unanimously recognized by many Sanofi colleagues across the world.

Edwin will be sorely missed by PDA. His passion for ensuring safe medicines was infectious and the Association plans to carry on this legacy.

The following three regulators will offer regulatory perspectives on packaging issues at the PDA Europe Parenteral Packaging conference, Feb. 27, in the opening plenary session:

• Andrew Hopkins, MHRA, will speak on container closure integrity testing and Annex 1, 9:15 a.m.
• Umit Kartoglu, WHO, will speak on secondary packaging considerations, 9:45 a.m.
• Charudharshini Srinivasan, U.S. FDA, will speak on risk-based approaches to assessing pharmaceutical packaging for parenterals, 10:15 a.m.

For more information, visit the meeting website.

PDA is excited to have some new folks join the PDA family, both in the United States and Europe.

• Glenn Wright, has joined PDA effective Jan. 1 in the role of Business Development Fellow. Glenn has been a longtime PDA volunteer and was a member of the Board of Directors for many years.
• Lindsey Navin, Senior Marketing Coordinator, joined PDA Oct. 23 and brings with her a broad background in marketing, having worked in a number of industries, including academia, communications and healthcare.
• Annette Bacchus, Manager of Programs, joined PDA on January 22. Most recently she was Senior Manager of Industry Relations at the American Academy of Otolaryngology- Head and Neck Surgery.
• Teresa Schubach, Manager Programs and Events, joined the PDA Europe office in Berlin on January 15. She has a degree from Johann Wolfgang Goethe University in Frankfurt where she majored in Biology.

4 Academic Speakers to Address Innovation-Related Topics at Annual Meeting in March

This year’s Annual Meeting will feature the following speakers representing academic institutions:

• Steven Spear, PhD, Senior Lecturer, System Dynamics, Massachusetts Institute of Technology will speak on company dynamics in the second plenary, Monday, March 19, 4 p.m.
• Paul Stey, PhD, Biomedical Data Scientist, will copresent on “New Approaches to Harnessing Data at a Portfolio Level” in “B3: Trends in Digital Information and Automated Technology,” Tuesday, March 20, 4 p.m.
• Suzanne Farid, PhD, Codirector, Future Targeted Healthcare Manufacturing Hub, University College London, will present “Streamlining Biopharmaceutical Decision-Making,” in “A3: Agile Bioprocessing,” Tuesday, March 20, 4 p.m.
• Matthias Gromeier, MD, Professor, Department of Neurosurgery, Duke University Medical School, will close out the meeting with his talk, “Polio Virus Vaccine Trial,” Wednesday, March 21, 2:15 p.m.

More information about these and other speakers can be found at the Annual Meeting website.

2018 Annual Meeting to Feature New Format Based on Attendee Feedback from Past Meetings

In response to feedback from attendees at previous Annual Meetings, we are trying a new format for the 2018 PDA Annual Meeting. This event will deliver the same high-quality content you have come to expect, but in a new lineup designed to better meet your needs.

Here are the changes.

• The meeting will now begin with the Opening Plenary at 1 p.m. on Monday, March 19
• A Grand Opening Celebration will kick off in the Exhibit Hall at 5 p.m. on Monday, March 19—this is your first opportunity to meet with exhibitors and learn about the latest products and services
• Interest group sessions will be held at the same time as breakout sessions, giving attendees more sessions from which to choose during the day and allowing for more free time in the evening
• The Closing Reception will be the final event of the meeting and takes place after the close of the meeting on Wednesday, March 21, at 7 p.m.—be sure to stay and celebrate with us!

Learn more about the 2018 PDA Annual Meeting.

PDA is pleased to announce the results of the 2018 Board of Directors and Officers election.

Executive Committee

The following candidates have been elected to serve as officers on the PDA Board of Directors:

• Chair: Rebecca Devine, PhD, Biopharmaceutical Consultant
• Chair-Elect: Jette Christensen, Scientific Director, Compliance, Novo Nordisk A/S
• Treasurer: Michael Sadowski, Director, Research, Baxter
• Secretary: Steven Lynn, Global Head, Group/Corporate Compliance and Audit, Novartis
• Immediate Past Chair: Martin VanTrieste

PDA also thanks Hal Baseman, COO, ValSource, who ends his term as Immediate Past-Chair.

Directors

PDA congratulates the following new and returning directors to the Board:

• Masahiro Akimoto, Senior Manager, Research and Development and Quality Assurance Division, Otsuka
• Kerry Ingalls, Vice President, Site Operations Amgen
• Mary Oates, Vice President of Innovative Operations and Network Excellence, Pfizer
• Emma Ramnarine, Senior Director Global Biologics, Genentech/Roche

PDA also thanks outgoing directors Ursula Busse, PhD, Head Quality Intelligence and External Relations, Novartis, and Deborah Autor, Senior Vice President, Strategic Global Quality and Regulatory Policy, Mylan for their service on the Board.

Below is a sampling of articles that have mentioned PDA in the past few months.

BioProcess International

September 19, 2017

“The Unican Concept: Engineering Dual Capability into Single-Use Vessels”—Terry Hudson, Ekta Mahajan, Kelsey Dent and Edward Chan

European Pharmaceutical Review

August 31, 2017

“A comprehensive review of the newly revised European Pharmacopoeia chapter 5.1.6”—Michael J. Miller

FDANews

September 12, 2017

“PDA Conference: Baxter Cuts 483 Rate With Quality Matrix”

Healthcare Packaging

September 11, 2017

“Live from PDA/FDA: 5 Key Landscape Takeaways”—Keren Sookne

“Live from PDA/FDA: Culture of Quality”—Liz Tierney

September 13, 2017

“Live from PDA/FDA: 3D Printing Applications”—Keren Sookne

September 14, 2017

“PDA/FDA: Trends in Compliance and Enforcement"—Keren Sookne

Outsourcing-Pharma

September 12, 2017

“Cost of bad quality is much higher than cost of producing good quality, says PDA task force”—Melissa Fassbender

Pink Sheet

October 5, 2017

“EU Defends Plans To Keep ‘PUPSIT’ Testing In Revised EU GMP Annex 1”—Joanne Eglovitch

The Annex 1 revision process continues and the document is expected to be out soon. Although, according to Andrew Hopkins, Expert GMDP Inspector, UK MHRA, in his talk at the opening session of the 2017 PDA Annex 1 Workshop on Oct. 2 in Washington, D.C., he did not have a time frame for when the document would be available.

Hopkins’ presentation provided extensive coverage of the reasons behind the revision. In his words, EMA recognized the document needed “tidying up.” The revision is expected to include Quality Risk Management (QRM) principles and address the need for manufacturers to keep up with new technologies.

Additionally, the revised Annex 1 will keep the requirement that manufacturers conduct pre-use, post-sterilization integrity testing, commonly referred to as “PUPSIT.”

Gabriele Gori, VP, Head of Quality Audit and Risk Management, GSK Vaccines, and Hal Baseman, Chief Operating Officer, Val- Source, currently head the PDA task force looking into the Annex 1 revision and working closely with European regulators. Members of this task force published the two-part Points to Consider for Aseptic Processing document in 2015 and 2016 in advance of the Annex 1 revision. Both Part 1 and Part 2 can be purchased from the PDA Bookstore.

October 11, 2017

The pharmaceutical and biopharmaceutical community faces many challenges in our changing global environment. New technologies are required for manufacturing and control of a more diverse product portfolio; new techniques are needed for managing a global supply chain; and regular information is needed about the changing regulatory landscape.

Fortunately, there are nonprofit organizations that work through their members to educate our industry, and also work together to define and disseminate consensus guidance and best practices. Nonprofit organizations fund these activities through membership dues, publication sales, and, in large part, through registration fees from education conferences and training courses. We pride ourselves on providing neutral, high-quality and reliable information to our members and attendees.

Today, we see an increasing number of for-profit conference organizers who duplicate the content developed by nonprofit organizations, employ aggressive marketing techniques and charge high prices for that content. This siphons much needed support from nonprofit organizations such as ours.

As leaders of two global member-driven organizations, ISPE and PDA, with nearly 30,000 members between us, we value the support that the community gives us. We are committed to fulfilling our missions, to guide our members and stakeholders toward using the best science and engineering to continue to provide high-quality, safe and effective medicines to serve patients.

Furthermore, we are committed to continuing our collaborations that provide unbiased platforms for dialogue, such as in cross-industry initiatives and interassociation groups, among others, that benefit the global pharmaceutical and biopharmaceutical community.

The U.S. FDA continues to work on its quality metrics portal, though it will not be completed by the anticipated January date. Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA, made the announcement on Sept. 12 at the 2017 PDA/FDA Joint Regulatory Conference during the “Quality Metrics” session, moderated by Amgen’s Steven Mendivil, Senior Advisor, International Quality External Affairs.

Bizjak went on to explain that the Agency is seeking volunteers to test the portal prior to launch. Inquiries can be made to [email protected].

The session also featured Valerie Whelan, Vice President, Corporate Quality, Amgen, who discussed Amgen’s metrics journey. Following the presentation was a panel discussion featuring Bizjak, Alex Viehmann (CDER, FDA), Barbara Allen, PhD (Eli Lilly), Deborah Autor (Mylan), Harry Jeffreys (Catalent Pharma Solutions) and Susan Schniepp (Regulatory Compliance Associates).

This summer, PDA published its Points to Consider for Aging Facilities document as part of an ongoing focus on manufacturing improvements. In some cases, noncompliant, aging facilities are a reason companies cease manufacturing, which may exacerbate drug shortages.

Points to Consider for Aging Facilities reflects the general thoughts of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. It covers eight critical areas to help companies avoid the traps encountered by other companies: Recognizing an Aging Facility, Impediments to Modernization, Business Case for Modernization, Impact of Changing Standards, Slowing the Aging Process and Regulations.

A team of industry experts developed this document based on responses to a PDA workshop held in March 2015 and a survey of PDA members conducted later that year. This team consisted of:

• Ghada Haddad, Merck & Co./Merck, Sharp & Dohme, Co-Chair
• Maik Jornitz, G-CON Manufacturing, Inc., Co-Chair
• Glenn Wright, Eli Lilly and Company, Inc., Co-Chair
• James Butler, Cimetrics
• Jette Christensen, PhD, Novo Nordisk A/S
• Phil DeSantis, DeSantis Consulting Associates
• Robert Dream, PhD, HDR Company, LLC
• John Lewis, DPS Consulting
• Anette Marcussen, Novo Nordisk A/S
• Morten Munk, NNE
• Shelley Preslar, Azzur Group, LLC
• Susan Schniepp, Regulatory Compliance Associates Inc.
• Chris Smalley, PhD, ValSource
• Matthew Taylor, Eli Lilly and Company
• George Wiker, AES Clean Technology

The document can be purchased at the PDA Bookstore.

Each year, PDA members have an opportunity to help set the strategic direction of the Association by voting for Board of Directors candidates. This year, there are three open Officer seats (Chair-Elect, Treasurer and Secretary) and four open Director positions. Due to the change in PDA’s bylaws, three of these Directors will be directly elected by members with the fourth appointed by the Board.

Elections are open until Nov. 15; members in good standing as of Aug. 24, 2017 can vote online or at conferences held before Nov. 15 in the United States and Europe.

Officer Candidates

• Jette Christensen (Chair-Elect>
• Michael Sadowski (Treasurer)
• Steven Lynn (Secretary)

Director Candidates

• Masahiro Akimoto
• Aaron R. Goerke, PhD
• Kerry Ingalls
• Ivy Louis
• Mary Oates, PhD
• Emma Ramnarine

FDA Representatives to Discuss Impact of DQSA in Special Plenary at PDA Micro Conference

This fall marks the fifth anniversary of the New England Compounding Center meningitis outbreak. In recognition of this tragedy and the importance of ensuring microbial control, three U.S. FDA representatives have been confirmed to speak in a special plenary session at this year’s 12th Annual PDA Global Conference on Pharmaceutical Microbiology. Moderated by CDER’s John W. Metcalfe, PhD, Plenary 4, “FDA Update on Human Drug Compounding: Regulatory Policy and Drug Quality” (Tuesday, Oct. 17, 4:15 p.m.), will feature the following FDA staff:

• Julie Dohm, PhD, Agency Lead on Compounding and Senior Scientific Advisor for Compounding, CDER
• Sara Rothman, Senior Policy Advisor, Office of Unapproved Drugs and Labeling Compliance, Office of Compliance, CDER
• Ian F. Deveau, PhD, Chief, Global Compliance Branch 1, Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance, CDER

All three will discuss the 2013 Drug Quality and Security Act (DQSA) and its impact on FDA’s oversight of compounding facilities. To learn more, visit the website for the conference.

So far, 25 representatives of the U.S. FDA are confirmed to speak at the 2017 PDA/FDA Joint Regulatory Conference.

CBER Director Peter Marks, MD, PhD, will launch the meeting by offering an FDA perspective on innovation for medical products in the opening plenary, Sept. 11 at 8:30 a.m. Confirmed FDA speakers consist of the following:

• Carmelo Rosa, CDER
• Brooke K. Higgins, CDER
• Deborah A. Hursh, PhD, CBER
• James Coburn, CDRH
• Linda J. Ricci, CDRH
• Debra Y. Lewis, Office of Orphan Products Development
• Patricia Y. Love, MD, Office of Combination Products
• Amy E. McKee, MD, Oncology CoE
• Francis Godwin, CDER
• Robert D. McElwain, CBER
• Paula Katz, CDER
• Theresa M. Mullin, PhD, CDER
• Joan W. Blair, CBER
• Shannon M. Hoste, CDRH
• Tamara L. Ely, CDER
• Christopher Joneckis, PhD, CBER
• Robin Newman, CDRH
• Steven Solomon, CVM
• Douglas Throckmorton, MD, CDER
• Donald Ashley, CDER
• Sean Boyd, CDRH
• Martine Hartogensis, CVM
• Mary Marlarkey, CBER
• Douglas Stearn, ORA

Continue to check the website for the meeting as new speakers are added to the agenda.

This September, PDA Director of Education David Talmage will travel to Australia, Singapore and India, to teach the PDA Education course, “Quality Metrics and Quality Culture for Pharmaceutical Manufacturing,” as part of an effort to expand PDA’s educational offerings beyond the United States and Europe.

The course will be held in conjunction with PDA chapter events in those regions. In Australia, the course will be offered Sept. 14–15 at the Victoria University Convention Centre in Melbourne. The Singapore course will be offered Sept. 18–19 at NUSS Suntec City Guild House and the course in India will be offered Sept. 21–22 at the Novotel Hyderabad Airport in Hyderabad.

“I am excited by the opportunity to deliver a PDA Education course to industry and regulatory professionals around the globe,” Talmage said. “This fulfills the requests from our members and I am looking forward to providing training on quality metrics and quality culture as well as other courses in PDA Education’s extensive course catalog.”

Learn more about these PDA Education courses today!

PDA President and CEO Richard Johnson, Chair Martin VanTrieste, and past chairs Maik Jornitz and James Agalloco were recognized by The Medicine Maker in the publication’s “100 Power List 2017.” This list recognizes “the top 100 individuals involved in bettering the pharma industry and bringing life-changing medicines to market.”

The list is divided into four categories of 25 “outstanding professionals.” All four appear under the “Industry Influencers” category. Johnson was recognized as the No. 1 influencer, followed directly by VanTrieste at No. 2. Jornitz ranked eighth and Agalloco ranked 11th.

The complete list can be found on The Medicine Maker website.

PDA member and former US FDA microbiology reviewer Vivian Greenman passed away on April 18. She was 94 years old. In 1973, the FDA recruited her in response to a series of nosocomial infections caused by nonsterile large volume parenterals (LVP) that occurred in 1970 and 1971. Upon her arrival to FDA, she was the first microbiology reviewer in the CMC program. Her participation in the development of LVP standards was important to such regulatory work as the 1976 proposed rule on LVP CGMPs, sterile product container and closure integrity testing, and guidances on filing applications for sterile drugs, aseptic processing, and post-approval changes.

For many CMC review microbiologists at FDA, she was their primary mentor in developing their careers as pharmaceutical microbiologists. Vivian was well respected in the sterile pharmaceutical industry.

She retired from FDA in 2005 and returned to her home state of California to be with family.

PDA members whose contributions have helped the Association fulfill its mission are recognized each year at the PDA Awards Dinner, held during the Annual Meeting. PDA congratulates and thanks each winner for their service to the Association.

Honorary Membership

This is PDA’s most prestigious award, conferring lifetime membership benefits to the recipient. The award has traditionally been given in recognition of long service significant in nature to PDA and requires unanimous approval from the Board of Directors.

Georg Roessling, PhD

Gordon Personeus Award

Presented in memory of the late Gordon Personeus, past PDA President and longtime volunteer, this award is intended to honor a PDA member, other than a Board member, for long-term acts or contributions that are of noteworthy or special importance to PDA.

Art Vellutato

Frederick J. Carleton Award

This award is presented as a tribute to lifetime contributor, past President, past Executive Director, and Honorary Member Frederick J. Carleton, and is designated for past or present Board members.

Junko Sasaki

Anders Vinther, PhD

Edward Smith Packaging Science Award

In honor of long-time volunteer Edward Smith, who led PDA’s packaging science activities, this award is given in recognition of extraordinary contributions to PDA and the packaging science.

Roger Asselta

Martin VanTrieste Pharmaceutical Science Award

Established in honor of long-time contributor and Chair Martin VanTrieste, this award is given annually for outstanding contributions to the advancement of pharmaceutical science.

Kurt Brorson,PhD

Hannelore Wilkommen,

Distinguished Service Award

This award is given in recognition of special acts, contributions, or services that have promoted the success and strength of PDA.

Ed Balkovic, PhD

Cylia Chen-Ooi

Ghada Haddad

Tsutomu Kamikukita, PhD

Morten Munk

PDA Europe Service Appreciation Award

This award is presented annually for special acts, contributions, or services that have contributed to the success and strength of PDA’s European activities.

Brigitte Reutter-Haerle

Service Appreciation Award

The Service Appreciation Award is presented annually for special acts, contributions, or services.

Shannon Bellino

Gaetano Fiorentino

Beth Kirschenheiter

Melissa Morandi

Jonathan Morse

Susan Schniepp

John Shabushnig, PhD

David Spaulding

Brian Underhill

Michael VanDerWerf

Glenn Wright

James P. Agalloco Award

The James P. Agalloco Award is presented annually to the PDA faculty member who exemplifies outstanding performance in education. The award is named for James P. Agalloco, in honor of his work in developing the PDA Education program.

John Ludwig, PhD

Michael S. Korczynski Award

An award established in recognition of contributions made toward the development of PDA’s international activities by Michael S. Korczynski, PhD.

Gabriele Gori

Frederick D. Simon Award

The Frederick D. Simon Award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. This award is named in honor of the late Frederick D. Simon, a former PDA Director of Scientific Affairs. This year’s award went to six recipients for their article, “Semi-Quantitative Analysis of InherentVisible Particles for Biopharmaceutical Products,” which was published in the March/April 2016 issue of the PDA Journal.

Patricia Cash, PhD

Stephan Krause, PhD

Sophia Levitskaya-Seaman, PhD

Maryam Mazaheri

Derek Murphy

Roja Narwal

Distinguished Editor/Author Award

This award recognizes the author or editor selected by PDA members for their contribution to PDA’s technical books. This year’s award went to the editor of the book, Assuring Data Integrity for Life Sciences.

Siegfried Schmitt, PhD

President’s Award

This award recognizes a PDA staff member, other than senior staff, whose exemplary performance has contributed to PDA’s success during the previous year.

Creixell Espilla-Gilart

Trevor Swan

Big Data, personalized medicines, and parenteral manufacturing are just a few of the topics to be discussed at the 2^nd PDA Europe Annual Meeting: Global Healthcare of the Present & the Future, June 13–14, in Berlin. But no meeting in this area would be complete without discussions of the continually changing regulatory environment that poses a variety of challenges for the pharmaceutical industry. The conference will include a discussion of inspection trends from the regulator and industry perspectives.

Leading global regulators will be on hand to offer their perspectives. PDA has confirmed the following regulatory officials for the opening plenary session: Paul Hargreaves, Chair, PIC/S, Emer Cooke, WHO, (via remote), Terence Madigan, MHRA, Rainer Gnibl, District Government of Upper Bavaria, and Rassoul Dinarvand, Head, Iran FDA. Hargreaves will speak on GMP harmonization, and Dinarvand will participate on a panel discussion of international pharmaceutical regulations.

Dinarvand has also been invited to speak in a preconference workshop, Business Opportunities in Iran, on June 12. At another June 12 preconference workshop, Andrew Hopkins of the MHRA and German GMP inspector Beate Reutter will speak about revisions to Annex 1.

Learn more about other speakers and sessions at this meeting.

Two “PDA Papers” authored by members of PDA’s Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force are now available in the “Accepted Articles” section of the PDA Journal of Pharmaceutical Science and Technology.

The papers, “PDA Points to Consider:Technical Product Lifecycle Management:Communication and KnowledgeExchange between Marketing AuthorizationHolders and Health Authorities” and “PDA Points to Consider: TechnicalProduct Lifecycle Management PharmaceuticalQuality System Effectiveness forManaging Post-Approval Changes,” are open access manuscripts available to both PDA members and nonmembers. The two papers are part of an extensive workplan by the task force to address the need for improved post-approval change processes within the industry.

The task force is currently conducting a survey and has begun work on a PDA technical report. In addition, there will be a workshop on post-approval changes Sept. 13–14, following the 2017 PDA/ FDA Joint Regulatory Conference.

“PDA Papers” are special contributions to the PDA Journal and represent the official viewpoint of PDA. The “Accepted Articles” section of the PDA Journal is for articles that have been accepted for publication but have yet to appear in an official edition, commonly referred to as “published-ahead- of-press,” and are fully citable. PDA launched this capability in 2016.

The PDA Nominating Committee is seeking recommendations from members for candidates to fill Board of Director positions for the 2018–2020 term. Nominees must be current PDA members in good standing. Recommendations will be considered and evaluated by the PDA Nominating Committee. This year’s committee is chaired by Immediate Past Board of Director’s Chair Hal Baseman, and includes current Board of Director’s Chair Martin VanTrieste and Board of Director’s Chair-Elect Rebecca Devine.

If you are interested in being considered or want to recommend a colleague, send the recommendation via email or mail to PDA Global Headquarters, Bethesda Towers, Suite 600, 4350 East West Highway, Bethesda, MD 20814, USA, attention: Nominating Committee. In addition to your recommendation, please include any other supporting information that may make it easier for the Nominating Committee to evaluate your recommendation.

Nominations are due May 1.

If you have any questions or feedback about the nominating process, please feel free to contact PDA President Richard Johnson or Hal Baseman.

PDA’s Nominating Committee seeks member recommendations for nominees as candidates to fill Board of Director positions for the 2018–2020 term. Nominees must be current PDA members in good standing. This year’s committee is chaired by Hal Baseman, Immediate Past Chair of the Board of Directors.

If you are interested in being considered or want to recommend someone, send the recommendation by email or via mail to PDA Global Headquarters, Bethesda Towers, Suite 600, 4350 East-West Highway, Bethesda, MD 20814, USA, attention: Nominating Committee. Please include any supporting information which may make it easier for the Nominating Committee to evaluate your recommendation. Nominations are due May 15.

If you have any questions, feel free to contact PDA President Richard Johnson or Hal Baseman.

PDA’s first technical report of 2017 offers the latest best practices on blow-fill-seal (BFS) technology. Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology features practical considerations for companies using this technology as a replacement for standard fill-finish practices.

PDA worked closely with the BFS International Operators Association (BFS IOA) to develop this document.

BFS refers to technology that integrates plastic blow molding and aseptic filling on a single machine with the final container being created within the machine just prior to aseptic filling. The final container is then hermetically sealed immediately after filling in one continuous operation.

Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology is now available for purchase from the PDA Bookstore. Full members can download a free copy of TR-77 until March 16; all members can view it at the PDA Technical Report Portal.

What do adventitious agent control strategies, virus detection technologies, and continuous biomanufacturing have in common? Well, for one, they represent areas of advancement within the pharma industry, and they are also topics that three US FDA regulators will discuss at the 2017 PDA Annual Meeting.

• Patricia Hughes, PhD, Team Leader, Biotech Manufacturing, FDA, will present “Microbiological Control and Adventitious Agents” in session “A1 — Advances in Analytical Sciences & Quality Control Strategies,” Monday, April 3, 2:00 p.m.
• Arifa Khan, PhD, Senior Investigator, CBER, FDA, will present “Virus Control, Safety, and New Technologies for Virus Detection,” in session “A1 — Advances in Analytical Sciences & Quality Control Strategies,” Monday, April 3, 2:30 p.m., following Hughes’ talk
• Rapti Madurawe, PhD, Division Director (Acting), Process Assessment I, CDER, FDA, will present “Small Molecule/Continuous Biomanufacturing” in session “C1 — Future Facility Design,” Monday, April 3, 2:30 p.m.

Additionally, breakfast sessions will feature regulatory-focused talks on implementation of new technologies, post-approval changes, knowledge management, quality risk management, data integrity and GMPs for personalized medicines.

For a more personalized view of the importance of parenteral drug manufacturing, in the opening plenary, keynote speaker ,Suleika Jaouad will chronicle her journey as a twentysomething diagnosed with cancer.

More information about these sessions can be found at the 2017 PDA Annual Meeting website: www.pda.org/2017annual.

The U.S. FDA announced in January it is extending the commenting period for the revised guidance document, Submission of Quality Metrics Data. Originally, the commenting period was slated to close Jan. 24; now it closes March 27.

PDA was one of several organizations urging FDA to extend the deadline for comments. Currently, a PDA commenting task force is drafting a set of official PDA comments on the revised guidance.

To offer your input on the guidance, consider attending the 2017 PDA Pharmaceutical Metrics and Quality Culture Conference, Feb. 21–22, in Bethesda, Md. Those planning to attend can also submit questions for discussion via the website for the meeting.

Expansion Includes Additional Classrooms, Larger Gowning Room, and Modular Cleanroom

PDA has completed a six-month expansion of its Training and Research Institute (TRI) in Bethesda. The expansion will permit PDA Education to increase its capacity for hands-on aseptic processing and lecture-based training at TRI.

The centerpiece of the buildout is a new 400 ft² ISO Class 8 cleanroom that will house an isolator filling system. The cleanroom is enclosed by modular walls from Servicor and the air is processed with a HEPA air system.

“The hands-on aseptic processing instruction offered in an industrial setting at the Training and Research Institute is a critical component of PDA’s educational program,” said Craig Elliott, PDA Vice President of Education. “PDA Education’s ‘Aseptic Processing Training Program’ provides an in-depth experience with the technologies associated with the manufacture of aseptically produced products, and now we have the capacity to train even more professionals each year.”

PDA’s aseptic processing program is highly valued and effective. “We’ve seen a dramatic increase in training demand recently, particularly from US regulators. Last year PDA trained over 300 U.S. FDA personnel, but could not keep up with the increasing demand. This new capacity will allow us to meet the needs of the industry and the demand from regulators around the world,” said Elliott.

PDA leads the pharmaceutical/biopharmaceutical industry in developing technical information and training in the areas of sterile drug manufacturing, aseptic processing, and other areas related to the manufacture and distribution of parenteral drug products.

PDA is pleased to announce the results of the 2017 Board of Directors election.

Directors

Congratulations to the following Directors elected by PDA’s membership to the board:

• Barbara M. Allen, PhD, Senior Director, Global Quality Systems, Eli Lilly & Company, looks forward to shaping “the future to meet the needs of each of the members.”
• Joyce Bloomfield sees this as her opportunity to continue doing “all that I can do to lead the advancement of medicine and manufacturing technology in order to facilitate availability of medicine to patients everywhere.”
• Véronique Davoust, PharmD, Senior Manager, Global Quality Intelligence, Pfizer, wants to contribute “even more actively to the success of PDA by enhancing PDA’s activities in influencing regulations in the Quality/GMP arena.”
• Ghada Haddad, Director, Global Quality Risk Management Center of Excellence, Merck, plans to “devote greater service to the PDA and its members by working to ensure quality, accuracy and relevance to the technical reports, the programs and training events.”

Outgoing Directors

PDA would also like to thank the following outgoing Directors for their service on the board:

• Glenn Wright, Senior Director, Project Management TS/MS, Eli Lilly and Company
• John Shabushnig, PhD, Principal Consultant, Insight Pharma Consulting

Metrics Conference Offers First Chance to Hear from FDA

PDA is preparing comments on the U.S. FDA’s recently revised draft guidance for industry: Submission of Quality Metrics Data. The revised draft was issued after strong public interest and comment on the first draft, which was published in 2015.

The 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference, Feb. 21–22, in Bethesda, Md., will provide industry representatives an opportunity to interact with FDA officials involved with developing the metrics guidance/program, including the U.S. FDA’s Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, the contact person for the current draft.

“PDA is committed to providing sciencebased commentary on the quality metrics draft guidance, as we did with the release of the first draft in 2015,” said Richard Johnson, PDA President. “The quality metrics/culture conference will be the fourth held by PDA on this important topic since the FDA called for industry participation in 2013.”

Learn more about the 2017 PDA Pharmaceutical Quality Metrics and Quality Culture Conference!

Below is a listing of various news articles/websites that have mentioned PDA within the past few months.

American Pharmaceutical Review

July 29, 2016
“Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia”—Radhakrishna Tirumalai, PhD 
[Note: For more from USP on NOE, click here.]

July 30, 2016
“The Hottest Topics in Microbiology”—Karen Ginsbury

BioProcess International

September 15, 2016
“Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and Control Strategies”—Brendan Cooney, Susan Dana Jones, and Howard L. Levine

Healthcare Packaging

September 14, 2016
“LIVE FROM PDA/FDA: Compliance to Quality: Part 1”—Liz Tierney
“LIVE FROM PDA/FDA: Compliance to Quality: Part 2”—Jim Chrzan

International Pharmaceutical Quality

July/August 2016
“FDA, MHRA and WHO Guidances Shed Further Light on Data Integrity Concerns”
“Industry Comments on FDA’s Draft Data Integrity Guidance Reveal Regulatory Challenges”
“Regulator Expectation for Handling Data Integrity Concerns Draws Spotlight”

Pharmaceutical Technology

August 29, 2016
“PDA Issues Call to Action for Faster Postapproval Changes”

The Pink Sheet

September 23, 2016
“Investigation Failures, Root Cause Problems Continue To Bedevil Manufacturers”—Joanne Eglovitch

Process

October 18, 2016
“Optima zeigt Techniktrends” (“Optima displays technology trends”)—Felix Henning and Anke Geipel-Kern

Since the U.S. FDA first introduced and invited industry feedback on its Quality Metrics program in Feb. 2013, PDA has been engaged in the public discussion to advance the principles of the program.

PDA held three conferences on the topic (Dec. 2013 & 2014/Nov. 2015) to gather input from industry and FDA. This input helped a PDA task force develop a position paper that was published in the PDA Journal (Sept./Oct. 2014). In 2015, the task force published results of a Quality Culture Survey in the Journal (Sept./Oct.), wrote comments on FDA’s draft Quality Metrics guidance, and I appeared at FDA’s public meeting on the guidance to present PDA’s position.

This July, FDA published its Quality Metrics Technical Conformance Guide: Technical Specifications Document, on which PDA is commenting independently. All PDA comments are posted on the website.

PDA is a scientific membership association. Our members are independent scientists, academics and regulators. We have no corporate memberships and  do not engage in any activity that represents the interest of any specific company or group of companies. That activity is the purview of trade organizations.

On many occasions, we evaluate the possibility of collaborating with other organizations, including trade organizations, in the development of “industry” positions, but in every case we weigh the benefit of such activity against our Mission “to advance pharmaceutical/biopharmaceutical manufacturing science and regulations....” In adherence to this mission, PDA has developed comments on the draft metrics guidance from a scientific point of view.

Several other organizations are working together on a “cross-industry group” response, but many of their comments are legal in nature and some of these groups have lobbied on this topic. As such, joining with these groups would give the appearance that PDA is lobbying. PDA has no mandate to lobby, so it does not lobby any government or regulatory agency. Based on the input of its all-volunteer Board of Directors, PDA has decided not to participate in an invitation to consolidate its comments on this topic with this “cross-industry group.” We will evaluate future opportunities for collaboration on a case-by-case basis as long as they are consistent with our mission and values.

PDA’s Post Approval Change Innovation for Access to Medicines (PAC iAM^sm) Task Force of volunteer industry experts has issued a call to action, inviting the broader pharmaceutical industry and regulatory community to join with them in tackling this “wicked problem."

Current disharmonized national and regional post-approval change (PAC) regulations require companies to submit filings with agencies worldwide in order to gain permission to make most changes to manufacturing systems, analytical methods, and processes. In many cases, the PAC process takes several years, and manufacturers must produce multiple batches of the same product while they await approval for a change in one region/ country, which has already been approved in others.

PDA’s task force has the following objectives:

• Bring awareness to current challenges and enable stronger collaboration amongst opinion leaders and key stakeholders (within industry, regulatory agencies, and other relevant stakeholder forums)
• Foster a science and risk-based approach to PAC management and regulatory decision making for global product quality, safety, and efficacy assessments
• Encourage international convergence/ standardization in PAC management in a manner that can foster and enable mutual reliance between regulatory authorities
• Manage PACs through the use of an effective Product Quality Systems (PQS)

The task force will produce several position papers for the PDA Journal of Pharmaceutical Science and Technology over the coming months. The group will also be conducting an industry survey to gather information to support a future PDA technical report and examples of global PAC protocols on the topic.