Pharma posts end of year bounce as CPHI Barcelona reports record attendance
4 December 2023
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54,000 attendees at the world’s largest pharma event points to returning growth in 2024
Issue: November / December 2023
The call for greater inclusion: major new survey finds affiliates desire an increased role in co-designing & transforming global RIM
4 December 2023
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For too long, Life Sciences local company affiliates have felt underrepresented in the pursuit of streamlined regulatory information management on a global scale. Now that new research has confirmed this, it’s up to central organizations to determine how to purposefully increase affiliate participation in efforts to improve global regulatory information management (RIM) design so there are no gaps in the data or inefficient processes. Steve Gens of Gens & Associates discusses the findings of a new, far-reaching global regulatory study into the challenges facing affiliates – and what matters to them in the pursuit of solutions.
Pharmaceutical globalisation and the local affiliate model
4 December 2023
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The global pharmaceutical industry must navigate a rapidly evolving regulatory environment, where, despite harmonisation efforts, significant regional or country differences remain. This places huge pressure on the local affiliate model, as Stefanie Lietsch-Dallwig explains.
New efficacy testing requirements for biocidal products
4 December 2023
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In the EU biocidal products are regulated under the Biocidal Products Regulation (BPR). The BPR requires that products are sufficiently effective against the target organisms that they are intended to control. Efficacy testing of biocidal products is a requirement of product authorisation and a key step in ensuring that products are able to be placed on the market. This article looks at some of the more recent changes in the guidance for the selection of relevant efficacy methods. It examines some of the available methods for disinfectants, repellents and biocides used in applications such as industrial water treatment and as slimicides in paper manufacturing. The application of efficacy test methods for the evaluation of treated articles is also discussed.
Expanding the windows of opportunity beyond oncology for conjugate-based therapeutics
4 December 2023
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Antibody drug conjugates (ADC’s) are nascent modalities that open the therapeutic window to allow high potent molecules to target specific tumour cell receptors. ADC’s are already established as the standard of care in breast cancer with Enhertu, Kadcyla and Trodelvy accounting for $4.1 Bn of the total $4.7 Bn ADC revenues in 2022. A further 460 novel ADC’s are in development for lung, gastric, ovarian and colorectal cancer alone with potential to superceed existing small molecule chemotherapies and capture a market of more than $140 bn.
Over the last 20 years, drug developers have invented a phlefora of technologies to supercharge antibodies via the conjugation with small molecules and this has created a toolbox of techniques to allow us to conjugate proteins and peptides with a variety of different molecules. Coupling of proteins with oligonucleotides allows us to create oligo drug conjugates which offer treatment solutions outside of the oncology space with potential in personalised medicines as well as high frequency conditions such as neurodenerative and respiratory diseases.
In this article we explore how we can use our toolbox of techniques to open more windows to hitherto untreated diseases.
Realizing the potential of antibody-drug conjugates
4 December 2023
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Antibody-drug conjugates (ADCs) have long been described as a promising component of the industry’s oncology toolkit. The specificity of ADCs has allowed them to meet the growing demand for targeted, safer treatment options for cancer patients. However, their complex nature has led to some challenges when approaching the development and manufacturing of ADCs. This article discusses some of the main ways in which ADC safety and efficacy can be maximized, and highlights the importance of choosing the right CDMO partner during the development process.
REACH regulation update 2024: what is expected
4 December 2023
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Along the last 2-3 years, an intense debate has developed concerning the systematic revision
Data science as a support for chemical patent management: a case study of the chemical element technetium in oncological area
4 December 2023
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Industrial property studies are urgent in a globalized, competitive world with constant technological innovations. This work presents an analysis of use of technologies in cancer and technological prospecting on patent databases containing the 99mTc radioisotope on the global scene between 2001 and 2021. The documents were retrieved from the ORBIT Intelligence® platform of the company QUESTEL®. The 53 patents analyzed show that China stands out in the number of patent applications filed (55%). Universities played a high role in technology protections (41%). The strategy used to extract and mine technological data proved to be efficient, as it highlighted potential uses in the area of Health, as well as the method can be replicated in other areas of knowledge.
Data integrity in GxP relevant areas has been a hot topic in the pharmaceutical sector in recent years
4 December 2023
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Data integrity has emerged as a crucial topic in the pharmaceutical sector, spanning various areas such as pharmaceutical development, clinical trials, manufacturing, and quality control. This article highlights the significance of data integrity and its impact on ensuring the quality, efficacy, and safety of medicines. It emphasizes the need for the Pharmaceutical Quality System (PQS) to analyze and monitor data integrity throughout the product lifecycle. The ALCOA+ principle, encompassing attributes like attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available, is introduced as a reference for data integrity. Additionally, the article emphasizes the importance of conducting a Data Integrity Risk Assessment (DIRA) to identify and mitigate risks, along with the validation and control measures for computerized systems used in GxP-relevant environments. It concludes value for self-inspections and external assessments to ensure compliance with data integrity guidelines.
Tailor-made enzyme solutions for production processes of biologics
4 December 2023
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Context/Overview Biologics, including mRNA-based therapeutics/vaccines and antibody drug conjugates (ADCs), have demonstrated groundbreaking benefits