Pharmaceutical development, manufacturing, and quality efforts are often advanced by the work of industry associations and members through conferences, training sessions, publications, and working groups. These efforts continued during the past 18 months, despite restrictions posed by the COVID-19 pandemic. The American Association of Pharmaceutical Scientists (AAPS), the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas), and the Parenteral Drug Association (PDA) shared recent activities and industry contributions with 


eBook: Regulatory Sourcebook eBook
October 2021
Pages: 30-33

When referring to this article, please cite it as BioPharm International Editors, "Industry Organizations Assist Pharma During the Pandemic and Beyond," 

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BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future. 

Industry Organizations Assist Pharma During the Pandemic and Beyond

On Jan. 4, 2021, the National Institute of Standards and Technology (NIST) published for notice and comment proposed rulemaking regarding “

Rights to Federally Funded Inventions and Licensing of Government Owned Inventions

 (1).” These regulations relate to the operation of the Bayh-Dole Act, which encourages technology transfer and commercialization of inventions made under research grants from the federal government. The law has always had its detractors, but the COVID-19 pandemic has raised the temperature on the issues of drug pricing, compulsory licensing, patent waivers, and federal march-in rights. These considerations are relevant to the changes NIST is proposing, and the comments—estimated to be more than 1800—reflect the passions the topic has engendered.

BioPharm International’s October 2021 Regulatory Sourcebook eBook.

Kevin E. Noonan is a partner with McDonnell Boehnen Hulbert & Berghoff LLP and co-chair of the firm’s Biotechnology & Pharmaceuticals Practice Group.

When referring to this article, please cite it as K. Noonan, “NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations," 

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Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.

NIST Proposes Clarifications to Bayh-Dole March-in Rights Regulations

In January 2020, Sumitomo Dainippon Pharma, a pharmaceutical company based in Osaka, Japan, and Exscientia, an artificial intelligence (AI) drug discovery company based in Oxford, United Kingdom, initiated a Phase I clinical study of DSP-1181. The drug, designed to treat obsessive-compulsive disorder, was created using AI technology. Through their combined efforts, the two organizations completed the exploratory research phase in under 12 months—a considerably shorter time frame than what is considered typical for this type of project (1). This is one example of AI-based products converging on the regulatory pathways toward mainstream health care.

Rajesh Talpade is is senior vice president of Product at MasterControl.


eBook: Regulatory Sourcebook eBook
October 2021
Pages: 22-25

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How Artificial Intelligence Impacts the Global Regulatory Environment

BioPharm International Regulatory Sourcebook eBook (October 2021).

Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.

Advancing a novel biologic from bench to patient bedside is a complex and arduous process. The chemistry, manufacturing, and control (CMC) strategy that a biomanufacturer employs is as critical to the filing of an investigational new drug application or biologics license application as conducting clinical trials. Because there is no one-size-fits-all approach to CMC, the strategy is often tailored to each compound’s specific platform and method of delivery. This is especially true for biologics because each one is unique to the indication and often involves a shortened development timeline.

Khanh Ngo Courtney, PhD, is senior director of Biologics, Avomeen.

When referring to this article, please cite it as K.N. Courtney, “Selecting the Right CMC Strategy for Biologics," 

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

Selecting the Right CMC Strategy for Biologics

Europe has the most mature biosimilar market in the world, with the European Medicines Agency (EMA) approving the first biosimilar medicine in 2006. Since the first biosimilar approval, and as correct at the time of writing, the region now has 69 biosimilars approved for use, excluding products that have been withdrawn after approval, before approval, or for applications that were refused by EMA.

Market research shows the biosimilar landscape in Europe is set to continue expansion with double digit compound annual growth rate of 22.1% expected between 2021 and 2026. Key driver for this growth includes the loss of patent protection for several blockbuster biologics in Europe, which will lead to increased competition in the market.

When referring to this article, please cite it as F. Thomas, “The Evolving Biosimilar Approach,” 

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The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.  

The Evolving Biosimilar Approach

Enacted by Congress on Nov. 27, 2013, the US Drug Supply Chain Security Act (DSCSA) is intended to build a more secure supply chain in the United States with the ability to identify and trace drug products and limit exposure to counterfeit, contaminated, and otherwise harmful drugs. Everyone in the pharmaceutical supply chain has had to pivot to meet the DSCSA requirements, including manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Manufacturers, specifically, have had to incorporate serialization into their manufacturing and packaging lines and will eventually also have to incorporate aggregation as well. However, FDA won’t require aggregation compliance until Nov. 27, 2023, which was delayed from 2019.

When referring to this article, please cite it as M. Rivers, “Serialization and Aggregation from a Manufacturing Perspective," 

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

Serialization and Aggregation from a Manufacturing Perspective

As the COVID-19 pandemic continues, one pressing concern for the industry is ensuring the supply of legitimate COVID-19 vaccines. It is estimated that 30.7% of people globally have received at least one dose of a COVID-19 vaccine, while 16% of the world population is fully vaccinated, according to Our World in Data (1). In a 2021 report from 

, three different potential scenarios for the future of COVID-19 vaccines were forecasted (2):

Individuals 65 years of age and older will get annual COVID-19 vaccines, while everyone else receives the vaccine every two years.

Individuals 65 years of age and older will get a COVID-19 vaccine every two years, while everyone else receives the vaccine every five years.

No matter the scenario, COVID-19 vaccines will be important in the coming years. Therefore, now more than ever, the supply chain needs to be secure to ensure the population can have access to legitimate vaccines. But substandard and falsified COVID-19 vaccines—commonly referred to as counterfeit vaccines—continue to be a threat globally.

When referring to this article, please cite it as M. Rivers, “The Real Danger of Substandard and Counterfeit COVID-19 Vaccines," 

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

The Real Danger of Substandard and Counterfeit COVID-19 Vaccines

FDA’s January 2021 release of its Focus Areas of Regulatory Science (FARS) report outlines topics that need continued targeted investment to advance regulatory science research that can facilitate the development of innovative products. The report also outlines the agency’s needs for data provision and methodology clarification to inform its regulatory decision-making process in the hopes that this will improve guidance for sponsors. Representatives from Bio-Process Systems Alliance and BioPhorum shared their thoughts on the report and provided feedback from an industry perspective.

BioPharm International’s October 2021 Regulatory Sourcebook eBook. 

Feliza Mirasol is the science editor for 

When referring to this article, please cite it as F. Mirasol, “Collecting Industry’s Thoughts on FDA FARS Report," 

Industry representatives sound off on FDA’s FARS report, released in January this year.

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