The importance of M&As in the pharma industry
Mergers and acquisitions (M&As) have great strategic importance for pharmaceutical companies.
In recent times, the pharma industry witnessed a significant uptick in mergers and acquisitions and a modest increase in the average deal size on the top end of the spectrum.
M&As pose enormous challenges on the regulatory front for pharma companies as the industry is highly regulated. In most cases, companies need to be better equipped to tackle these complexities.
Due diligence is paramount and needs to be consistent to ensure the organization has a robust plan for managing the M&A. Another challenge is selective data migration, considering that organizations often use different systems and applications. So, amalgamation and data management of various applications are enormous challenges.
One of the traditional management practices of mergers and acquisitions is outsourcing M&A activities to CROs. However, not all organizations are able to navigate the complex landscape of regulatory M&A processes successfully.
The rapidly evolving landscape
Industry 4.0 technologies can help manage mergers and acquisitions effectively.
By harnessing the power of Industry 4.0 technologies, such as AI, machine learning (ML), Generative AI, automation, and robotics, companies can streamline the due diligence process, identify synergies, and assess potential risks with greater accuracy and speed. This will ensure faster approvals from the statutory bodies enabling quicker access of drugs and other medicinal products to patients.
These technologies can facilitate data integration, enhance decision-making capabilities, and automate repetitive tasks allowing the regulatory affairs team to focus on strategic initiatives.
Furthermore, the insights derived by AI-ML help implement a knowledge-driven approach in managing M&A, optimizing outcomes, and creating competitive advantage in the dynamic business landscape.
Pharma companies can adopt a few approaches to make mergers and acquisitions seamless from a regulatory perspective.
The regulatory activities for M&A involve the submission of marketing authorization transfer (MAT) applications to the health authorities like the US FDA (US Food and Drug Administration) and EMA (European Medicinal Agency).
Creation of the MAT applications requires data extraction from diverse sources, review of the data, and finally, using this data to create MAT applications per standards.
The technology enablers can aid the creation of MAT applications for submission to health authorities. This can be done through the following steps:
A real-world example of report creation using technology enablers is the collaboration between a technology company and a European pharma major. For regulatory submissions, the natural language generation (NLG) platform built by the technology company extracts data from various sources and transforms it into clear and concise narratives to generate clinical reports. The platform uses AI-ML algorithms to analyze structured and unstructured data such as clinical information, safety reports, and regulatory guidelines.
The idea is to use a similar approach to create reports for submissions necessary for mergers and acquisitions.
Some of the strategic imperatives identified for efficient management of mergers and acquisitions are listed below:
By consolidating the regulatory requirements for M&A from connected sources, the (user) can create smart submission plans and facilitate the reuse of the plans. This AI-ML application will be able to correlate regulatory intelligence with internal precedence to suggest strategies for regulatory submissions for M&A to the user.
The regulatory affairs team will plan and manage submissions using the BPM (business process management) tool using persona-based intelligent dashboards.
This will promote connected business systems to seamlessly exchange meaningful data or information over intelligent and secure network systems. The idea is to bring the data required for regulatory submissions of mergers and acquisitions to a smart data fabric, which ontologies and logical frameworks can leverage to create regulatory submission outputs as per the submission plan.
The approach entails automating structured content creation for regulatory submission using structured data. In this case, with the help of the AI-ML algorithm, the available data will be converted into meaningful text for regulatory submissions. An automated authoring application will leverage a knowledge graph-enabled intelligent system equipped with built-in ontology to create NLG-based text output. This can be adapted to author regulatory submissions.
Enhancing the efficiency and productivity throughout the M&A process
These enablers will reduce dependency on human cognizance and reduce the number of resources that are engaged in the M&A activities.
Industry 4.0 technologies will improve rigor in managing M&As, bring down the time required to plan transitions by leveraging real-time updates, tracking the regulatory status, and simplifying the business processes. Pharma companies can optimize the resources to focus on other core value-adding tasks.
The smart M&A processes will ensure a reduction in errors in the planning and management of marketing authorization transfer applications, leading to improved compliance with statutory regulations and assured patient safety.
The transformation will have significant business benefits. It can reduce the total effort, thus saving costs and time.