PIPELINE_75

Issue 75

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

September 2024

µPIPELINE

Windsor Framework and Pharmacovigilance – Briefing Notes Understanding Strategy: A Guide for Medical Affairs and Pharmacovigilance Professionals Regulatory Intelligence: A Crucial Aspect of Pharmacovigilance Transforming Pharmacovigilance and Improving Patient Safety: The Role of New Technologies

£12.00

or Free for Members

CONTENTS 03 04 07 10 13

Announcement

Windsor Framework and Pharmacovigilance – Briefing Notes John Barber

Understanding Strategy: A Guide for Medical Affairs and Pharmacovigilance Professionals Liz Clarke Regulatory Intelligence: A Crucial Aspect of Pharmacovigilance Paulina Valuskova and Marcela Fialova

Transforming Pharmacovigilance and Improving Patient Safety: The Role of New Technologies Iain Barnden

Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use.While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented. The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.

PIPELINE Editor: Dora Amene

WELCOME to the September 2024 edition of µPIPELINE! It is with regret that we announce the resignation of PIPA President Pooja Patel and committee members Janine Gavin-Poulter, Catherine Kenny, and Ron Ward. We appreciate their dedication and hard work over the years and will miss their contributions.

Pooja Patel

Janine Gavin-Poulter

Catherine Jenny

Ron Ward

Committee members Chris Isaacs and Sinem Castro have assumed the positions of President and Vice President, while Jo Elsden, Aneka Shamla, Tazneem Anwar, Helen Lowe and Ashish Vyas have joined our Committee.

We are delighted to welcome them aboard and look forward to working together with them!

Thank you to all who came to the 2024 PIPA Conference and made it such a success this year. It was fantastic to have so many of you join us for such an engaging and impactful gathering. If you have any feedback or questions about the conference, please do contact us at pipa@pipaonline.org.

To the edition itself- this month, we have an article that explores the significance of strategy in medical information and articles that delve into the possibilities of artificial intelligence and the crucial role of regulatory intelligence in PV. We welcome any feedback on PIPELINE, or any ideas for articles you may have, so please feel free to submit them to us at the above address.

Remember to check out the discussion forums on the PIPA website which are there for you to share your ideas, knowledge and best practices on the range of topics and challenges faced within the industry.

3

Written by Em Norman PIPELINE Co-Editor

Windsor Framework and Pharmacovigilance – briefing notes

In February 2023, the UK Government and the European Commission announced the terms of the Windsor Framework1.

This is a post-Brexit legal agreement between the European Union and the UK and which adjusts the operation of the Northern Ireland Protocol. The Framework included references to medicines regulations though with no explicit reference to pharmacovigilance.

In August 2024, the MHRA issued guidance on how pharmacovigilance operations will change as a consequence of the Framework2.

SCOPE The impact of the Framework on pharmacovigilance is dependent upon whether a marketing authorisation is within scope or out of scope of the Framework.

Within scope are products directly or indirectly linked with a Centralised Procedure (CAP). These products are subject to UK regulations and guidelines.

Products out of scope are those associated with national authorisation procedures. These products are subject to EU regulations and guidelines.

These two sets of products have been categorised as either UKMA (UK) Category 1 or Category 2. The following table is taken from the MHRA’s guidance:

UKMA (UK) Category 1

UKMA (UK) Category 2

Authorised products: Products that were authorised in the EU through the centralised procedure and subsequently grandfathered at the time of EU Exit.

Authorised products: Products that do not fall within the mandatory scope of the centralised procedure Or

Or

In the case of the optional scope, products were authorised through national procedures.​

Are within the mandatory scope of the centralised procedure but authorised by the MHRA since 1 January 2021.

Or

Or

Products were authorised prior to the introduction of the centralised procedure.

Are within the optional scope of the centralised procedure but authorised by the MHRA since 1 January 2021, unless authorised by one or more member states through EU national procedures (including mutual recognition or decentralised procedures) New applications for products that fall within the mandatory or optional scope of the centralised procedure

New applications for products that do not fall within Category 1 (products that do not fall within the mandatory or optional scope of the centralised procedure). This will not include products authorised as conditional marketing authorisations.

This includes products authorised as conditional marketing authorisations.

1

https://www.gov.uk/government/publications/the-windsor-framework

2

https://www.gov.uk/government/publications/pharmacovigilance-following -agreement-of-the-windsor-framework 4

UKMA (UK) Category 1

UKMA (UK) Category 2

The generic, hybrid or biosimilar products of category 1 reference products. ​ For already authorised products, this will apply regardless of whether the centralised procedure was used for the generic, hybrid or biosimilar application.

The generic, hybrid or biosimilar products of Category 2 reference products.

These products will be authorised by the MHRA in accordance with UK law on a UK-wide basis.

These products will be authorised by the MHRA in accordance with UK law and applicable EU law on a UKwide basis.

For clarification, a generic authorisation for which the reference medicinal product is a Category 1 product will also be a Category 1 product. If the reference medicinal product was a Category 2 product, then the generic MA will also be a Category 2 product.

IMPLICATIONS The implications for pharmacovigilance operations will be dependent upon a MAH’s product portfolio and in which categories they fall and whether the portfolio includes UK-only or UK and EU authorisations: • If the MA is UK-only and is a Category 1 product, then only UK regulations apply, there are no reporting obligations to the EMA • If the MA is a Category 1 product but with corresponding MAs in the EU, then UK and EU regulations apply, there are reporting obligations to the EMA as well as to the MHRA • If the MA is UK-only and is a Category 2 product, then EU regulations apply, there are reporting obligations to the EMA. If an MAH has a mix of Category 1 and Category 2 products, it will have to implement dual reporting procedures to ensure appropriate reporting to the MHRA and the EMA. NOTIFICATIONS Notifications to the EMA are also dependent on product categorisation. For Category 2 products, notification to the Article 57 database and the MHRA will be required. This means that the UK QPPV and UK PSMF location will need to be notified to the Article 57 database. In addition, product information for Category 2 products will need to be submitted to the Article 57 database.

Category 1 products only require notification to the MHRA. QUALIFIED PERSON RESPONSIBLE FOR PHARMACOVIGILANCE The requirement for the location of the UK QPPV will be dependent upon the product categorisation. The following table is taken from the MHRA’s guidance:

3

UK QPPV

EU-QPPV

EU-QPPV

Can reside in EU/EEA or UK

Must reside in EU/EEA

Can reside in UK or EU/EEA

Category 1 – UK only licence

YES

NO

NO

Category 1 – UK and EU licence

YES

YES

NO

Category 2 – UK only

YES

Subject to EU Directive (EU) 2022/6423

Subject to EU Directive (EU) 2022/6423

Category 2 – UK and EU licence

YES

YES

NO

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022L0642 5

The EU Directive allows for the EU QPPV to be located anywhere in the UK as long as the MAH does not have any associated EU MAs. For Category 1 products, this is not an issue as they are not subject to EU regulations. For Category 2 products which are subject to EU regulations, even if the MAH had UK-only MAs they would have been required to have an EU-based QPPV because Northern Ireland is subject to EU regulations. The Framework and the EU Directive (EU) 2022/642 allow for the EU QPPV for UK-only Category 2 products to be based in the UK if an EU based QPPV had not been nominated by the 1 January 2022.

Updates to the Human Medicines Regulations and the MHRA’s Guidance Note, Exceptions and Modifications EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorisation Holders and the Licensing Authority will be issued in due course. In addition, the MHRA has committed to further engagement with the industry on the implementation of the new requirements.

TIMELINES The new pharmacovigilance obligations under the Windsor Framework come into effect on the 1 January 2025. MAHs have between now and the end of 2024 to review and revise their procedures and where necessary, to make the appropriate notifications to the Article 57 database.

John Barber

Managing Director & Lead Consultant Plain Pharma Consulting Ltd

6

UNDERSTANDING STRATEGY:

A GUIDE FOR MEDICAL AFFAIRS AND PHARMACOVIGILANCE PROFESSIONALS This is the first of three articles on strategy. The upcoming articles will delve into the tools and approaches used in business strategy, as well as the skills of strategic thinking and how to cultivate them.

In the fast-paced and highly regulated environment of pharma, strategy plays a crucial role in guiding decisions and actions.

Whether you are directly involved in developing strategy or responsible for its implementation, understanding the fundamental principles of strategy can greatly enhance your effectiveness. This article offers an overview of strategy, why it is essential, and how you can engage with it more effectively in your daily work.

WHAT IS STRATEGY? Strategy permeates various aspects of our lives in pharma: from brand, pricing, and regulatory strategies to market access and communication strategies. In the field of medical information, we employ search strategies for literature searches. But what exactly is strategy?

At its core, strategy is the way you go about achieving a long-term or overall aim. One of the biggest challenges in understanding strategy is its abstract nature. We find it easier to process concrete, certain data and actions, so understanding and embracing the abstract concept of strategy can be difficult. This challenge is especially relevant for people more used to working with concrete data such as in medical information and drug safety.

The concrete, specific actions taken to achieve strategy are tactics.

The saying, “Tactics win battles; strategy wins wars” illustrates the relationship.

ORIGINS & ESSENCE OF STRATEGY Strategy can be traced back to ancient civilisations. In his famous writing, “The Art of War” Sun Tzu noted, “All men can see the tactics whereby I conquer, but what none can see is the strategy out of which victory has evolved.”

The more contemporary nature of strategy in sport provides further perspective. For example, a tennis player might have a strategy to play at the net as much as possible. Whilst they may plan to serve and volley, they also take opportunities to move forward on a midcourt ball. By having a strategy it’s possible to react quickly when opportunities arise. Just as Sun Tzu noted, their strategy is invisible although it can be deduced by watching how they play (the tactics).

In team sports, strategy is crucial so players can make aligned choices without direct communication on the field. Without such alignment, players’ energy goes in different directions. In a business context, this can be considered a loss of efficiency, as people pull in different directions.

7

One of the simplest models of commercial strategy was developed

by A.G. Lafley and Roger L. Martin and described in their business classic, “Playing to Win: How Strategy Really Works”.

Their framework consists of five key questions: 1. What is our winning aspiration?

2. Where will we play?

3. How will we win?

4. What capabilities must be in place?

5. What management systems are required?

Note how these two central questions of where to play and how to win articulate choices – it’s impossible to be everywhere and do everything.

DIFFERENTIATING BETWEEN STRATEGY, TACTICS & PLANS Strategy, tactics, and plans are separate but interlinked; unfortunately, they’re frequently interchanged in day-to-day usage, causing confusion.

Strategy provides the overarching direction and long-term goals and informs tactics. Tactics involve specific actions to implement the strategy, focusing on immediate objectives and practical execution. Without strategy, tactics lack alignment and waste resources; without tactics, strategy goes unexecuted. See table 1 for a comparison of strategy and tactics.

“Strategy without tactics is the slowest route to victory.

Tactics without strategy is the noise before defeat.”

Sun Tzu

Plans are the structures which provide a detailed actionable roadmap for how tactics will achieve strategic goals. This interconnected relationship ensures that day-to-day actions (tactics) align with broader organisational strategy, while plans provide structure and timelines for implementation.

DEVELOPING STRATEGY: CLARITY AND COMMUNICATION If you’re tasked with developing strategy, a situational analysis enables you to predict as much as possible and develop strategy for those circumstances. However, you also need to remember that your strategy must also enable aligned reactive decision making so that when opportunities present themselves, they can be taken.

Establishing a feedback loop between these elements is crucial since most brands have multiple interconnected strategies & tactics that require coordination. This also facilitates monitoring.

A well-crafted strategy needs to be concise and memorable. It should be communicated in a way that is easy to recall for those responsible for carrying it out. Overly detailed strategies that require constant reference can lose their effectiveness. Instead, aim for brevity and clarity.

Due to their tangible, concrete nature, tactics are often written straight into plans without first considering strategy. If your first ideas when you plan are concrete actions, take a step back and consider what strategy they might serve, then think of additional tactics that might also be helpful.

Strategy

Tactics

Definition

Overarching framework to achieve long-term goals

Specific actions taken to implement the strategy

Timeframe

Typically longer term (months to years)

Shorter term (days to weeks)

Scope

Broad, high-level

Narrow, detailed

Focus

Defining choices: ‘Where to play’; ‘how to win’

Specific concrete actions

Planning level

Typically senior leadership

Operational

Measurability

Achievement of high-level goals

Easily measured with specific metrics

Table 1. Comparing strategy and tactics

When communicating strategy it’s crucial to give clear examples of tactics that would align with it in various circumstances. This helps make the strategy more tangible and understandable and increases the chance of team members recognising opportunities when they occur. For instance, when developing a therapy area or brand strategy, consider what opportunities for collaborative work might be proposed by external stakeholders. Field-based staff will need to know which ones are likely to be of interest.

The “strategy house” model is a helpful way to present strategy because it summarises all elements of strategic implementation on a single page. If your strategy needs a lengthy slide deck to explain, it will be too complicated to be easily remembered and consistently implemented.

Vision for the Organisation / Therapy Area / Brand

Strategic Choice #1

Strategic Choice #2

Strategic Choice #3

Strategic Choice #4

Strategic Goal #1

Strategic Goal #2

Strategic Goal #3

Strategic Goal #4

Tactics to Achieve Strategic Goal #1

Tactics to Achieve Strategic Goal #2

Tactics to Achieve Strategic Goal #3

Tactics to Achieve Strategic Goal #4

Milestones

Milestones

Milestones

Milestones

Core values, principles, or fundamental elements that support the entire strategy Figure 1: The strategy house framework

8

STRATEGIC AWARENESS AND UNDERSTANDING

IN CONCLUSION

Even if you aren’t responsible for creating strategy, it’s still important to understand it. Recognising the strategies that influence your work helps you make informed choices that are aligned with the strategy for your therapy area or brand.

Understanding strategy is not just for those in leadership roles or for the office alone. Whether you are developing strategy or following it, recognising its importance and abstract nature can help you be more effective. By ensuring that strategies are clear, concise, and wellcommunicated and by understanding how they relate to your day-to-day work, you can contribute to the success of your organisation and improve outcomes in your role.

Once you become more aware of the concept of strategy, you are more likely to notice it shaping tactics and running through plans. This is strategic awareness and allows you to align your actions with your organisation’s broader goals. For example, you might see medical information enquiries or safety reports which point to an unmet information need which undermines the strategy for a product or opportunities for a disease awareness or medical education project.

For further information, please contact Liz Clark at Liz@Kissanes.co.uk

BEYOND THE OFFICE As we have seen, strategy is not limited to the office; creating strategies for important aspects of life, such as your career, wellbeing and personal finances makes sense. By applying the same core strategic principles to career planning, ask yourself where you want to focus your efforts. For example, the choice between depth of expertise and breadth of experience, and how you will succeed - which opportunities will you pursue, and which will you pass by.

Liz Clark

Consultant Pharmaceutical Physician & Visiting Lecturer & Patient Engagement Theme Lead, Centre for Pharmaceutical Medicine Research, King’s College London

9

REGULATORY INTELLIGENCE: A crucial aspect of Pharmacovigilance

There are several approaches companies can take to gather regulatory intelligence:

WHAT IS PHARMACOVIGILANCE (PV) REGULATORY INTELLIGENCE (RI)?

• Internal Investigations: Conducting research using in-house teams to explore local regulatory requirements.

Pharmacovigilance (PV) Regulatory Intelligence (RI) is the process of gathering, analysing, and interpreting regulatory information from diverse sources, such as health authorities, international organisations, and scientific literature. In the fast-evolving world of PV, RI is crucial in ensuring that companies stay compliant with regulations and are well-prepared to navigate new challenges.

• Local Affiliates/Distributors: Leveraging the expertise of local affiliates or distributors to provide country-specific regulatory insights.

• Regulatory Knowledge Management Centres (RI databases): Subscribing to services that offer centralised, pre-collected regulatory information.

More than just a tool for compliance, RI helps companies anticipate and manage risks, streamline decision-making, and adapt their safety practices. By continuously tracking regulatory changes, companies can safeguard the effectiveness of their PV systems, maintain public trust, and respond proactively to any new obligations or expectations from regulatory bodies.

Once the relevant regulations are gathered, companies typically store these requirements in a central database or tracking system. This can range from a simple Excel spreadsheet to more sophisticated RI systems designed to track, monitor, analyse and distribute regulatory updates.

PV teams rely on timely and accurate regulatory information to ensure compliance with evolving global safety standards. Access to up-to-date regulations allows them to adapt quickly to new requirements, ensuring patient safety and maintaining trust with regulatory authorities.

2. What Does PV Need to Keep Regulatory Intelligence Up to Date?

PV requires access to up-to-date, relevant regulatory guidelines and requirements to stay compliant with global standards.

This article will address how PV teams build and maintain their RI systems, the methods they use to keep these systems current, and what the ideal system should look like for optimal efficiency and compliance.

Key needs include: • Access to current PV regulations in each country where the company operates.

• Timely alerts about new regulations or changes in existing regulations.

1. How do companies build their PV RI system?

Building a PV RI system begins with establishing a foundation based on a company’s specific market needs and regulatory scope. At the initial setup, companies must gather and collect PV requirements for each country or region where they plan to operate.

This includes researching local safety standards and regulatory requirements to ensure compliance with both global and local regulations.

1.

Build the PV Reg Intel System

2.

Keep the Reg Intel up to Date

• Insights into regional or country-specific requirements, guidelines, and interpretations.

3.

Define Channels for Data Collection

4.

Distribute Within a Company

Fig. 1: Key Steps in Building and Managing a PV RI System

10

5.

Analyse Received Reg Intel

6.

Track the Reg Intel

• Internal employees (e.g., Regulatory Affairs (RA) teams, RI specialist, PV Intel Specialist)

• Larger Companies: May have a dedicated PV Intel department that specialises in tracking global and local PV regulations and communicating with different departments as necessary.

• Local affiliates and distributors

5. How does PV Analyse Received RI information?

Sources of Regulatory Intelligence:

• Partners and vendors

Answer: The process of assessing RI can be challenging due to the complexity of regulations and the need to properly interpret specific requirements. PV departments often conduct an internal impact assessment to determine how new regulations or changes will affect their processes.

• Local experts or consultants • Regulatory Knowledge Management Centre and other databases (with alert functions)

3. How Can PV Departments Receive Regulatory Intelligence Information?

This analysis may include:

Information may reach the PV department in several ways:

• Emails or notifications from internal teams (RA, PV Intel).

• Reports from local affiliates, distributors, or external consultants.

• Direct access to RI databases, which allow for active searches and alerts.

• Internal Review: Regulatory Affairs, PV specialists, or dedicated PV Intel teams assess the regulatory changes to determine their relevance and potential impact.

• Consulting Local Experts: For country-specific regulations, companies may rely on local affiliates, distributors, or external consultants to provide insight into regional nuances.

Method

Pros

Cons

Emails or notifications

Easy to implement

Can be easily overlooked in a busy inbox

Direct communication without special tools

No central repository for tracking

Real-time updates when shared

Limited ability to analyse and archive No confirmation of ”zero” update

Reports from Local Affiliates, Distributors, or Consultants

Provides region-specific insights

May not always be timely

Custom, tailored to company needs

Dependence on external parties

Can include detailed analysis

May require follow-up for clarification Additional archiving & compilation required

Regulatory Knowledge Management Centres (RI Databases)

Real-time access to regulatory information

Learning curve for users

Guaranteed update cycle of RI

If not PV-specific, filtering relevant PV data from broader RI information can be challenging

Centralised and structured GxP validated with an audit trail for compliance

Requires subscription or access fees

Active search and automated alerts Table 1: Pros and Cons of different RI Delivery Channels

4. How is RI Flow Organised Within a Company?

Answer: The organisation of RI flows will usually depend on the size of the company: • Smaller Companies: Typically have one main RA department responsible for gathering and distributing regulatory information to relevant departments that may need RI information: Pharmacovigilance

• Competent Authorities: Companies may reach out to health authorities for clarification when the regulatory language is ambiguous or unclear.

• Third-Party PV Providers: Some companies choose to work with external providers who specialise in analysing and interpreting complex PV regulatory requirements.

6. How does PV Track Received RI information?

Answer: Tracking regulatory intelligence can be done through various tools and vary by company, but common methods include:

Clinical Operations Regulatory Affairs

• Excel: Basic tracking using simple sheets that note regulations and any updates.

Quality Assurance

• SharePoint: Collaborative tracking with access across departments.

Manufacturing Others

• Regulatory Knowledge Management Centres: More advanced GxP Validated Systems where alerts, analysis, documentation, and archival processes are automated.

11

CONCLUSION: WHY IS STRUCTURED RI CRUCIAL FOR PV?

External Consultants

Regulatory Affairs

• Compliance and operational continuity: Staying updated with regulatory changes helps companies avoid compliance risks and operational disruptions.

• Proactive decision-making: The growing need for dedicated PV RI teams is becoming evident, as it allows PV departments to focus on the specific regulatory challenges relevant to PV. This ensures quicker, more focused responses, rather than relying on a centralised RA team managing RI across multiple areas.

PV Department

Reg Intel Database

Local Affiliates/ Distributors

• Enhances cross-functional alignment: By sharing accurate regulatory intelligence, PV teams can ensure better coordination across departments, improving overall efficiency.

Analysis/Impact Assessment of Reg Intel

• Audit readiness: Having a GxP-validated system allows companies to demonstrate proof of RI monitoring and thorough assessment of updates during audits and inspections, ensuring transparency and compliance.

Tracking of Reg Intel

SharePoint Tracker

Excel

GxP Validated Reg Intel Database

Fig. 2: PV RI Workflow: From RI Information Receipt to Centralised Tracking

Marcela Fialova

Paulina Valuskova

COO, Board Director iVigee

Head of PV Intelligence, GVP Auditor, Deputy QPPV iVigee

12

TRANSFORMING PHARMACOVIGILANCE AND IMPROVING PATIENT SAFETY: THE ROLE OF NEW TECHNOLOGIES

We have seen among our pharmacovigilance customers significant interest and excitement generated by the recent upshift in the capabilities of artificial intelligence (AI) technologies. The pace of innovation has accelerated dramatically since the launch in late 2022 of the next-generation Large Language Models, in particular OpenAI’s virtual assistant tool ChatGPT1.

We believe pharmacovigilance applications of AI hold clear promise, from managing case intake to generative AI for narrative writing and the use of AI techniques for signal detection. Machine Learning (ML) is already beginning to transform drug safety monitoring through its ability to process and analyse massive amounts of data in real-time and speed up responses to adverse events to help reduce safety risks2.

But what is the reality – versus the hype – for the use of AI technologies within pharmacovigilance today? Further, what are likely to be the main business use cases and potential gains for biopharmaceutical safety teams?

THE DRIVE FOR NEW PV TECHNOLOGIES

WHAT BUSINESS PROBLEMS COULD AI IN PV SOLVE?

We are seeing biopharmaceutical organisations investigate new technologies that can automate data-intensive vigilance processes, with the goals of boosting efficiency while ensuring high standards of quality and compliance. This quest is assuming critical importance given the backdrop of often constrained safety resources among our customers, together with the ever-increasing number of safety cases3, and the proliferation of data sources for safety signals – from electronic health records to social media content4.

There are two key areas where we see AI technologies delivering significant productivity and efficiency benefits. One area is improving automation. Business Process Automation or rules-based automation may be reaching its natural limit in terms of productivity improvement, driving many of our customers to look to AI to drive new levels of automated efficiency.

In our view, this immense and growing data burden creates clear opportunities to implement advanced technology innovations that can reduce manual effort, boost accuracy and oversight, unlock valuable data insights, and enhance patient safety.

13

Another potential focus is AI for augmented insights. Deep learning algorithms have the capability to handle substantial data volumes and perform sophisticated data mining tasks, recognising complex patterns that humans may not see. AI could not only help automate the process of identifying, analysing and prioritising potential safety signals, but could also reduce false positives, noise and bias, significantly elevating quality and efficiency.

DATAPOINT: WHERE IS YOUR ORGANISATION IN YOUR AI JOURNEY FOR PV?

Figure 1. Where are PV departments in the AI journey to improve PV processes? Source: Webinar attendees of “How New Technologies are Transforming Pharmacovigilance and Improving Patient Safety”, hosted by PharmaLex on June 5 2024.

HIGHLIGHT PV USE CASES FOR NEW TECHNOLOGIES Business Process Automation – still a natural fit for PV Good candidates for automation tend to be high-volume, time-sensitive and recurring tasks involving multiple people and subject to compliance and audit trail requirements. BPA could therefore be considered a natural fit for pharmacovigilance.

For safety teams, implementing BPA or rules-based automation offers the ability to build dynamic workflows into a case processing system. The example below shows a BPA workflow in use today at multiple biopharmaceutical companies. In this scenario, vaccine safety cases are dynamically prioritised, with low-value cases fast-tracked so that they may forego the rigorous QA stage typically followed for a Suspected Unexpected Serious Adverse Reaction (SUSAR) case.

PV USE CASE EXAMPLE: BUSINESS PROCESS AUTOMATION

Figure 2. Dynamic workflows that adapt to case data. (Source: PharmaLex)

14

Several of our customers have automated clinical trial safety reporting via rules-based techniques, leveraged across three key areas of SUSAR distribution: report generation, creating an accurate list of recipients, and applying relevant regulatory intelligence.

MACHINE LEARNING (“CLASSIC” AI) For safety teams managing high levels of incoming data flow, machine learning can improve productivity by extracting data from multiple source documents and performing initial pre-screening and filtering.

Machine learning is also now being harnessed to address a common key PV challenge – literature surveillance. Tools could automatically go out to a source – for example, PubMed® – and look for relevant literature references to bring into internal PV systems. AI and ML techniques could then be applied to initially classify each reference to confirm whether it is a potential ICSR, safety or efficacy-relevant, or simply “noise”, for subsequent review by human experts.

GENERATIVE AI GenAI creates the opportunity to introduce chatbots that can ask questions (“prompts”) about the data held in PV systems.

These could be relatively simple questions, for example, what the reporting or regulatory requirements are for a particular country, or a comparison of regulatory requirements between different countries.

Other regulatory intelligence use cases of GenAI could range from researching, collating, interpretating and standardising regulatory requirements across geographies, to generating drafts of dossiers, understanding competitor regulatory strategies, and monitoring changes in strategic information (such as when regulations change) to help teams manage the compliance impact5.

FOCUS: AI-SUPPORTED NARRATIVE WRITING Narrative writing is perhaps one of the best examples of where generative AI and Natural Language Generation (NLG) could assist human PV effort. Large Language Models are demonstrating impressive capabilities in generating text, and we are now seeing early efforts to assess what may constitute relevant training sets for narrative writing, including use of legacy cases.

Within PV management systems, rules-based approaches are today providing useful assistance in generating case processing narratives and templates, so a solid degree of automation already exists. As a first step towards more extensive GenAI integration, a combination of rules-based approaches and AI could be explored, using AI to refine BPA automations to improve quality and drive higher volumes.

VALIDATING AI OUTCOMES AND DATA PRIVACY Validating outcomes from use of AI technologies is subject to debate and evolving regulations. In Europe, the EMA recently put forward a draft reflection paper on the use of AI in the medicinal product lifecycle6, outlining its current thinking.

Our view is that AI should be treated as any other element in the PV process – implementing quality reviews and random sampling to confirm that human errors are not progressing through the case processing system.

The data privacy implications of using AI is also a live and important discussion. Organisations should determine whether to “lock out” staff from using tools such as ChatGPT to prevent sensitive information from being integrated into external systems. Some organisations are building their own internal chat tools that leverage a GenAI engine but do not allow Personally Identifiable Information (PII) to flow out into third-party AI chatbots.

DATAPOINT: WHAT DO ORGANISATIONS SEE AS THE BEST NEAR-TERM PV USE CASES FOR AI TECHNOLOGIES?

Figure 3. What do organisations see as the best near-term PV use cases for AI technologies like machine learning & ChatGPT? Source: Webinar attendees of “How New Technologies are Transforming Pharmacovigilance and Improving Patient Safety”, hosted by PharmaLex on June 5 2024.

15

LOOKING AHEAD: AI’S FUTURE IN PV References

Amid the spiraling growth and complexity of datasets within pharmacovigilance workflows as noted in this article, the predicted productivity and quality gains of AI are compelling. However, the usefulness of these potentially transformative technologies may only be realised if organisations take a holistic view of the implications.

Before implementing AI technologies within the PV workflow, we recommend that organisations evaluate projects from a range of perspectives – spanning logistical, integration, security and stability considerations, to economic, regulatory and ethical issues.

Ultimately, the journey of digital transformation is not merely a technology project but a people project. In our experience with similar initiatives, the best results stem from a balanced alignment of experienced people, trained in effective processes, and using the right technology. By taking this approach, biopharmaceutical organisations and CROs could be better-positioned to maximise the AI opportunity – capitalising upon the promised gains, enhancing operational efficiency and regulatory compliance, and improving safety for patients.

The contents of this article are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent Cencora Inc. PharmaLex and Cencora strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

1.

McKinsey Technology Trends Outlook 2024, July 16th 2024

2.

Application of artificial intelligence and machine learning in early detection of adverse drug reactions (ADRs) and drug-induced toxicity, Artificial Intelligence Chemistry, December 2023

3.

Uppsala Monitoring Centre Annual Report 2012-2022

4.

A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring, Clinical Pharmacology & Therapeutics, January 25, 2021

5.

Unleash AI’s potential: Measuring the return from pharmaceutical innovation – 14th edition, Deloitte, April 2024

6.

Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle, European Medicines Agency (EMA), July 13th 2023

Iain Barnden

Pharmacovigilance Business Partner, Digital Innovation, PharmaLex

16

pipa@pipaonline.org | https://pipaonline.org

PIPA, PO Box 254, Haslemere, Surrey, GU27 9AF

PIPELINE