Article of the Year

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About the Roger F. Sherwood Article of the Year Award

ISPE’s Roger F. Sherwood Article of the Year award was established in 1993 to increase article submissions and improve the quality of those received. In the early years, judges rated each issue's technical articles against a set of six criteria, then selected an annual winner.

Almost three decades later, while recognizing the merit of the original intent, the award has been refreshed to showcase the best content in Pharmaceutical Engineering® magazine, increase industry recognition, highlight ISPE’s reputation as a global knowledge leader, and bolster magazine content quality.

Although various judges have taken part in assessing articles over the years, one constant remains: recognition of quality and excellence in content through identifying finalists and a single winning article for each publication year.

2021 ARTICLE OF THE YEAR

The 2021 Roger F. Sherwood Article of the Year is “Medical Device UDI Components Management in the European Union” (July-August 2021) by Laurence Azoulay, Marie Coulon, PharmD, Christophe Devins, Bernard Durand, Etienne Granier, Amel Guerrida-Marchand, Ye-Lynne Lee, Valérie Marchand, Patrick Mazaud, Brigitte Naftalin, Michel Raschas, and Nadim Wardé.

The article focuses on the unique device identification (UDI) portion of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), which are binding on all EU member states. The general application dates of the two regulations were 26 May 2021 for medical devices and 26 May 2022 for in vitro diagnostic medical devices; however, different timelines apply for certain specific provisions.

“The article contributes a lot to clarify the complexity of medical devices in combination products use,” said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering Committee (PEC). “It is known that 80% of new pharmaceutical products under development are combination products, where the medical device is the tool to deliver the active pharmaceutical molecule to  the patient. Clearly knowing the requirements of the European Union with its 500 million-plus people is critical for the success and timely availability of new products to patients.” Aspesi added that the article will help many readers involved in developing such products and treatments.

JUDGING

A subcommittee of the Pharmaceutical Engineering Committee (PEC) served as judges for the 2021 award competition, reviewing articles and providing assessments on the following criteria: usefulness to ISPE readers; how the articles improve the knowledge of key topics; and clarity/ease of reading.

The PEC subcommittee was headed by Michelle Gonzalez. Thank you to Michelle and the PEC subcommittee for the work on the 2021 competition.

Finalists for the award were selected by a subcommittee of the Pharmaceutical Engineering Committee (PEC) from 35 feature and technical articles published during calendar year 2021.

AWARD FINALISTS

2020 ARTICLE OF THE YEAR

The 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.

The article describes a formal energy-efficient design (EED) process that has been in use across all industries in Ireland since 2014 and addresses the benefits of integrating this type of study into the design process. Improving efficiency in a highly regulated environment can be a challenge, but companies in even the most regulated industries in Ireland (e.g., pharmaceutical, biopharmaceutical, and semiconductor manufacturers) are adopting the methodology. The article was derived from the authors’ experiences across many projects and in the development of the Irish standard I.S. 399, which establishes energy-efficient design as a management system (complementing ISO 9001 and ISO 50001). It provides companies with a robust strategy for delivering energy, environmental, quality, and competitiveness objectives.

Finalists were selected by a subcommittee of the Pharmaceutical Engineering Committee (PEC) from 35 feature and technical articles published during calendar year 2020.

Previous Article of the Year Award Winners and Finalists

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  • About the 2019 Article of the Year

    The 2019 Roger F. Sherwood Article of the Year is “Regulating Online Pharmacies and Medicinal Product E-Commerce” (Nov-Dec 2019) by Sia Chong Hock, Mervyn Ming Xuan Lee, and Lai Wah Chan. The article explores the growth of e-commerce for prescription and over-the-counter (OTC) medicinal products.

    The 2019 award was given to content published during that calendar year. The announcement was delayed from last year because of the pandemic. Finalists were selected by a subcommittee of the PEC from 35 feature and technical articles published during calendar year 2019.

    The 2019 finalists were:

  • About the 2018 Article of the Year

    The winning article for the 2018 Roger F. Sherwood Article of the Year award was:
    Continuous Manufacturing In Biotech Processes: Challenges for Implementation (November-December 2018)
    Robert Dream, CPIP, PE, Christoph Herwig, PhD, and Emilie Pelletier

    The article explores the promise and challenges of continuous manufacturing (CM) for biotechnology. CM in biotech offers the potential for greater product quality while reducing costs and shortening time to market. Challenges to be overcome include research and development efforts to characterize certificates of pharmaceutical products (CPPs) on single-unit operations and integrate them into the process; integrated control strategies or operations; technology available on the market; approaches to validation and quality; and regulatory compliance.

    The article “clearly confirms that efforts are underway to have continuous manufacturing in biotechnology, but not all the process steps are ready for a CM implementation,” said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharmaceutical Engineering® Committee (PEC). “The authors describe well the challenges and the work ahead that we have to undertake in the industry. The article deserves the award because it is encouraging readers to invest time, science, and technology to achieve continuous manufacturing in biotechnology.”

    The 2018 finalists were:

     

  • About the 2017 Article of the Year

    For 2017, a panel of judges was assembled, comprising two Board members, the Knowledge Network Council Chair, Pharmaceutical Engineering® Committee Chair, Guidance Documents Committee Chair, one PEC member, two Young Professionals, and two senior ISPE staff members.

    To be considered, each article was required to meet the following criteria:

    • Cited in other articles or presentations 
    • Describe or provides industry-leading concept/position/development
    • Be well written and referenced
    • Demonstrate a progressive and productive approach for the industry

    After reviewing all articles published in 2017, the judges chose a unanimous winner:

    A Holistic Approach to Production Control: From Industry 4.0 to Pharma 4.0
    By: Prof. Dr. Christoph Herwig, Christian Wölbeling, and Thomas Zimmer, PhD

    The current submission-based control strategy plays a key role in ensuring that critical quality attributes are met, and the quality target product profile is realized. It does not, however, consider GMP, facilities, utilities, equipment and other production-specific controls to mitigate risk and ensure an effective, reliable, and stable production process. In addition, the effect of unknown process parameters, raw material attributes, and impurities usually are not sufficiently addressed in the control strategy lifecycle management—it is often impossible to predict such variations for a production lifecycle already in development

    Read Full Article

    The ISPE Pharma 4.0 SIG team is proud to receive this award. This article is a great collaborative work, with contributions from SIG members; it reflects the start of a practical road map for applying digitalization and Industry 4.0 in the pharmaceutical industry. We look forward to developing the "holistic control strategy" concept, based on ICH standards, to bring digital maturity and data integrity by design into the pharmaceutical value network and enable flexible pharmaceutical manufacturing.

    2017 Article of the Year Award Authors
  • About the 2016 Article of the Year
  • About the 2015 Article of the Year
    • "WINNER:" Risk Analysis and Annual Training Program Definition
      By: Luca Falce
    • A Framework for Implementing Stage 3 Continued Process Verification for Legacy Products
      By: Bikash Chatterjee and Wai Wong
    • A Review of the Regulations and International Developments on Quality and Supply Chain Integrity of Pharmaceutical Excipientsn
      By: Sia Chong Hock, Sean Lee Ji Yang, Vimal Sachdeva, and Chan Lai Wah
    • The FDA Observation Response: Seven Common Mistakes
      By: Carol Brandt
    • Scientific and Regulatory Considerations for Implementing Mathematical Models in the Quality by Design (QbD) Framework (Part 1 of 2)
      By: Theodora Kourti, John Lepore, Lorenz Liesum, Moheb Nasr, Sharmista Chatterjee, Christine M.V. Moore and Evdokia Korakianiti
    • Content Uniformity Discussions: Current USP Developments Regarding and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity
      By: James Bergum, William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Sami Patel, and Ravindra Tejwani
  • About the 2014 Article of the Year
    • "WINNER:" Chemical and Media-Free Pretreatment for Biopharma RO – Electrolysis for Scale Precipitation and UV Dechlorination
      By: Nissan Cohen and Shlomo Sackstein
    • A Review of Regulations and Developments in GMP and Supply Chain Integrity of Active Pharmaceutical Ingredients
      By: Sia Chong Hock, Katherine Loh Kai Xin, Vimal Sachdeva, and Chan Lai Wah
    • A Steam Sterilization Principles
      By: Marcel Dion and Wayne Parker
    • Evaluation of Controlled Manufacturing Environments following an Air Handling Unit Shutdown
      By: Catherine E. Anderson and Brian J. Lloyd, PhD
    • Applying a Consistent, Compliant, and Practical Risk-Based Validation Process for Laboratory Systems
      By: Anil K. Rattan, PhD and Michael Rubacha
    • A Changing Landscape: Perspectives on Temperature Management for the Distribution of Non-Refrigerated Clinical Supplies Description
      By: Dr. Nicole Assfalg, Ted Bradley, Tim Brewer, Sébastien Delporte, Kristen DeVito, Bruce Guenter, and Patricia Thomas