25th May 2023

PharmaLex newsletter: Spring 2023

25th May 2023

Twitter: @pharmasol
LinkedIn: https://www.linkedin.com/company/pharmasol

- Corporate Update
- Customer Success
- Regulatory Moves
- Product Spotlight
- Industry Insight
- Event Review
 

CORPORATE UPDATE: The future is PharmaLex

Tim Billington, Commercial Director of PV Digital Solutions, shares an update on pharmasol’s transition into the PharmaLex brand.

Notice something different about us…?  We’re very pleased to confirm that our legal integration into PharmaLex is now complete. The process has been smooth and seamless, and the whole team is very excited about the opportunities ahead for us as part of the consolidated organisation.

Over the next few months we’ll be getting to know our expanded global network of colleagues – who represent an unparalleled breadth and depth of specialist expertise, delivered across the pharmaceutical, biotech and medical device industries – and exploring how this comprehensive new set of services can enhance our solution offering.

So, what does this mean for our customers? Well, in many ways it’s ‘business as usual’, with the gold-standard solutions, service and support that we hope you’ve come to expect from the pharmasol team. Within PharmaLex, our industry-leading psiXchange and rapidLIVE solutions are now at the heart of our PV operations, and we’ll be playing a central role in how this key strategic group moves ahead as it continually evolves to support our customers’ business success.

If you have any questions about the additional core services and capabilities that are now available to your organisation as PharmaLex customers, please get in touch and we’ll be happy to provide an overview of the opportunities. You can also head to the PharmaLex website and explore the full range of global solutions covering the entire product lifecycle – from strategic and scientific consultancy to integrated product development, post-launch outsourcing, and portfolio mergers & acquisitions.

We’ll be keeping you updated with the latest corporate news over the months ahead, including introducing you to our new senior management colleagues.

Meet the PharmaLex management team:

Dr Raphael Troost, EVP Pharmacovigilance

A physician with over 20 years’ experience in clinical pharmacology, clinical trials, medical informatics and pharmacovigilance, Dr Raphael Troost serves on the executive board at PharmaLex Group as EVP Pharmacovigilance.

“PharmaLex has built an impressive track record of specialised service delivery spanning almost three decades and, in that time, has demonstrated its strong commitment to exploring innovative solutions for customers. It is fantastic to have pharmasol’s technology solutions fully embedded into the PharmaLex brand, and we are looking forward to working together to innovate even further – developing the integrated solutions that will drive growth for our customers worldwide.”

CELEBRATING CUSTOMER SUCCESS

Recent rapidLIVE wins

Highlight psiXchange win

• We are shortly set to begin Safety Letter Notifications for a US-based pharma company pioneering innovative solutions for neurological diseases. Together with their partner CRO, psiXchange will provide controlled distribution, with increased oversight as our customer expands into larger clinical trials.

With our release of psiXchange 2.4.1, we introduced a number of key remote monitoring capabilities for customers – delivering to CRAs a clear overview of what’s happening on sites, including flagging potential issues with distribution such as non-receipt of emails, bounced emails, and incorrect contact information.

With psiXchange v3, we’ve boosted these capabilities further, incorporating status bars and a raft of new visual features that give CRAs total at-a-glance clarity for even greater oversight and control.

Here we share a sneak preview of the enhanced remote monitoring capabilities in psiXchange 3.0 – still under development and subject to adaptations. Watch this space for further updates soon on psiXchange v3 availability!

INDUSTRY INSIGHT: Pharmacovigilance and AI – a drug safety revolution?

In this Industry Insight, PharmaLex Technical Analyst Iain Barnden looks at the potential applications of AI for pharmacovigilance…with a little help from ChatGPT.

In the pharmaceutical industry, the need to adapt to constant change – whether that’s evolution in standards, regulations or new technologies – has been a dominant feature of the landscape for decades. With the recent dramatic acceleration in the advance of AI, including the first public releases of generative AI and Large Language Models (LLMs), there has been much discussion of the potential disruptive applications of AI technologies in core functions such as pharmacovigilance. So, how might it be applied in the future?  Can we predict what AI might be able to do well within pharmacovigilance and, crucially, what it might not?

As an experiment in exploring the current capabilities of generative AI, I asked ChatGPT to help me write this article about AI in pharmacovigilance. What it said, what it perhaps overemphasized, and what it missed, is quite revealing. ChatGPT provided a good overview of how the emergence of AI and Machine Learning (ML) has “revolutionized pharmacovigilance, offering new ways to analyze and monitor drug safety data” and how “by applying AI and ML algorithms to vast amounts of data, researchers can detect patterns and trends that may be missed by traditional methods, and identify potential risks earlier.”

Here, ChatGPT summarises the opportunities for AI specifically in relation to data management and reporting:

“AI algorithms can be used to automate the collection, management, and analysis of pharmacovigilance data, reducing the burden on human operators and improving accuracy and efficiency. By analyzing data from various sources, such as electronic health records, social media, and clinical trials, AI can identify potential safety signals and generate reports that can be used by regulators and healthcare providers to make informed decisions.”

Interestingly, in its summary, ChatGPT missed key steps in the PV process, which is the vital medical (human) review that occurs prior to reporting. Touchless processing may be the ultimate ambition but, at the moment, it’s hard to imagine a scenario where we let AI alone decide if a case is related to treatment. For some time to come, we should expect that medical experts will continue to play a defining role in the quality control and review process, and that qualified people will always be needed to deliver human oversight and ensure that we arrive at the right decisions.

Leveraging AI capabilities to smooth and speed the initial data entry process certainly offers significant promise – taking unstructured data from an ever-growing list of data sources and entering it efficiently into pharmacovigilance software. However, many organisations have yet to invest in implementing even the basic algorithmic automation capabilities currently available within their PV systems. Right now, organisations already have the opportunity to take advantage of major efficiency improvements and gain measurable ROI from advanced process automation – without waiting for fit-for-purpose AI solutions to enter the market.

AI is undoubtedly set to play a pivotal role in transforming the pharmaceutical life cycle of the future, and offers exciting possibilities for improving drug safety and speeding drugs to patients. For the immediate term, organisations should be looking to fully harness and exploit the powerful PV automation capabilities that are already here, to reap the efficiency benefits and cost savings that will put them in the best possible position for the seismic changes that may be ushered in by AI over the coming years.

Here’s the final word from ChatGPT, on the potential evolution path beyond automation to an AI future:

“In conclusion, AI has the potential to transform pharmacovigilance data management and reporting by automating processes and analyzing large amounts of data to detect potential risks and adverse reactions earlier. While automation can be useful for basic tasks, AI offers greater flexibility and the ability to learn from data, making it a more powerful tool for pharmacovigilance. However, there are also challenges to overcome, and it is important to ensure that AI is used in a responsible and transparent manner to protect patient privacy and safety.”