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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog

The landscape of clinical trials has evolved significantly with the pandemic and interest in utilization of decentralized clinical trial (DCT) designs as a mitigation and the need for remote data collection. In response to this shift, the US Food and Drug Administration (US FDA) has released draft guidelines to try to provide clarity on the use of DCT models in clinical trials. While the...

iSpeak Blog

The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of medicines requires the close collaboration with regulators, emphasizing innovation, partnership, and a continued dedication to addressing patient needs. This transformation holds the potential to guide significant advancements in the development and delivery of medicines, leading to improved...

iSpeak Blog

Although parenteral products make up only 1% of global pharmaceutical prescriptions by volume, at list price they now make up nearly half of global sales value, a percentage that has been increasing. Many of these are complex products produced in smaller batches for immunology or oncology, and a large majority are biologic therapies, which are generally poorly suited to oral formulations.

iSpeak Blog

In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of asset management programs at each company. The initial sessions were a success, covering topics such as asset condition evaluations and asset management governance. CSL was keen to continue the conversations and gather more insights on certain...

iSpeak Blog

As with all aspects of our life sciences industry, understanding how we can best meet the needs of patients with the timely delivery of life saving and sustaining products is of paramount concern. During the years since the global pandemic, the expectations and pressures on the pharmaceutical industry with respect to development, speed to market, quality and sustainability have increased...

iSpeak Blog

Insight from Austria’s Regulatory Authority Representative

At the 2024 ISPE Aseptic Conference, held March 12-13 in Vienna, Austria, Christina Meissner, a European Union Good Manufacturing Practice (GMP) inspector at the Austrian Agency for Health and Food Safety since 2013, and Chair of the PIC/S Drafting Group on Annex 2A and 2B, published in May 2021, offered a presentation titled...

iSpeak Blog

The ISPE community is saddened by the passing of James (Jim) O'Brien, a founding member of ISPE and a luminary in the field of pharmaceutical engineering. Jim was a recognized expert in the design and engineering of pharmaceutical facilities, whose profound influence has shaped our industry.

iSpeak Blog

Having a universal and uniform Common Technical Document (CTD) for all markets, major and emerging, is an aspiration of all pharmaceutical companies. As markets become more familiar with the CTD, especially the quality portion, some drug regulatory agencies are requesting more regional/local documents and customization to CTD documents in accordance with their local interpretation and...

iSpeak Blog

During the COVID-19 pandemic, vaccines were one of the drug products recommended by the World Health Organization (WHO) to fight the pandemic. The majority of regulators have flexed their local regulatory requirements to bring vaccines to the market with as much supply flexibility as possible, including emerging markets which typically have challenging local requirements that a marketing...

iSpeak Blog

ISPE connected with Sydney Hamilton, Strategic Facility Planner, CRB, and Scott McNallan, Director of Architectural Design, CRB, for a sneak peek look at their planned session, “Blank Slate to Building Excellence,” ahead of the 2024 ISPE Biotechnology Conference. The conference will take place 17-18 June 2024 in Boston, Massachusetts, USA.

iSpeak Blog

Rise of the Machines

It becomes clear that a topic has become mainstream when it crosses multiple Communities of Practice and areas of interest. In preparation for the 2024 ISPE Annual Meeting & Expo, the Digital Transformation track committee worked closely with multiple teams from other tracks on the topic of artificial intelligence/machine learning (AI/ML) to identify the best...

iSpeak Blog

Green chemistry is a field of chemistry that focuses on developing and utilizing more sustainable and environmentally friendly chemical processes and products. Green chemistry is a growing field in pharmaceutical laboratories that aims to reduce the environmental impact of drug discovery, development, and manufacturing processes. It involves the application of sustainable and innovative...