Agenda

David Alderman, President & CEO of Molekule Consulting, a keen observer of these market currents, will compellingly argue that sustained competitive advantage hinges not solely on algorithmic power, but on mastering the enduring art of Human Intelligence (HUMINT). This we define as the strategic collection, interpretation, and dissemination of human-sourced insights to understand motivations, anticipate actions, and navigate complex relationships. Where AI adeptly charts past trends and may code the future, the HUMINT “Algorithm” navigates the present and anticipates the future by decoding the unspoken concerns of regulators, the subtle below-the-radar maneuvers of competitors, and the cultural nuances defining success in diverse global markets. Molekule Consulting, leveraging its deep expertise across the globe, will reveal why a purely data-centric approach, for all its analytical prowess, risks overlooking crucial human factors – a decisively risky blind spot in a market driven by human decisions. They will champion HUMINT as an indispensable, often underestimated, guide for navigating biopharma’s complex landscape, offering actionable strategies to assert market leadership. Because, ultimately, even in the data-rich world of biopharma, it’s the human element that remains decidedly… pivotal. Join us to discover how to gain a decisive edge by embracing the human factor, and learn how HUMINT can be applied to achieve success not just in Europe biopharma, but worldwide.

• Explore how the combination of AI augmentation and human expertise is revolutionizing agile, cross-functional decision-making
• Work with future-looking insights from real-time data streams to sidestep hidden pitfalls to ensure long-term success

The US is unarguably the largest market in the world both from a financial and activity , and is therefore understandably the focus of our collective efforts. Within the CI industry we will often give extra attention to preclinical studies emerging from well-funded and well-publicised US academic institutions or companies, published in US journals, and will use the US-centric clinicaltrials.gov as the core of our pipeline asset monitoring activities, and all predictions which result from it. And yet, most estimations show that the US market represents less than half of the global market and so we ask whether we are doing a disservice to most of our customers by giving overweight focus to the US market? In this study we will reflect on decades of collective work with global, regional and country teams to identify areas of global programs which we believe do offer value to European country teams, and those that don’t. We will offer our thoughts on how to use a global or regional view as a core knowledge-base which can allow efficient tactical research into focussed topics to deliver relevant insights which can be value drivers for country teams in the region. In a case study we will suggest that collaboration and agility are critical parameters to build into a CI program which delivers to European teams.

However, the development and commercialization of biosimilars differ substantially from that of generic NMEs. As a result, modern biosimilar manufacturers must stay attuned to key market trends, technological advancements, shifting dynamics, and global collaborations.

This session will shed light on the tailored competitive intelligence (CI) needs of biosimilar companies and how they diverge from traditional approaches used in innovative drug development market monitoring. It aims to help biosimilar manufacturers reassess their essential CI requirements and build a compelling case for securing the necessary budget from leadership teams.

b) Where to start – Building Cross-Functional Teams: Collaborative war gaming thrives when R&D, regulatory, marketing, and CI teams work together. This integration helps simulate a competitor’s behavior and anticipate market shifts from multiple angles.
c) How does this work? Red Team vs. Blue Team Dynamics: A core element of war gaming involves having a “Red Team” play as the competitor and a “Blue Team” as your organization. This dual perspective ensures all possible outcomes are considered and prepared for.
d) Data-Driven Simulations, a way to enhance war -gaming: Integrating real-world data such as patents, market research, and regulatory filings—combined with AI and machine learning—creates simulations that reflect potential market scenarios with high fidelity.
e) How Do You Prepare for High-Stakes Decision-Making?:Real-time exercises preparing teams to make critical decisions under pressure, building the adaptability needed for sudden market shifts.
f) Continuous Improvement through Post-Game Analysis: After each simulation, detailed debriefs help teams identify strengths and areas for improvement. This process creates a living playbook that evolves, preparing your team for future challenges.
g) Real-life case studies- either by presenting my own or involve the audience.

• How to make sure CI deliverables are matching with the appropriate time horizon and geography?
• (short-term) “Alert Intelligence” versus (long-term) “Prospective Intelligence”. When? Where?
• The impact of geopolitical uncertainties on CI methodology
• Scenario planning vs. crisis preparation: shall we spend more time to anticipate or to be prepared?

How are their trials progressing? Who is on the cusp of a merger that will increase their funding and how will this impact your business?

The thing is, an infallible single source of truth is not realistic. But how close can we get? In this session, Alex Bour will investigate the elements that would make up a single source of truth. He’ll address key questions that CI professionals need to ask as they embark on their quest and share guidance on what to look for in the answers.

– How do we conduct an effective business analysis of competitors in our space to spot key opportunities and threats?

– How can I find out how well our pipeline/ asset/ portfolio stacks up against the competition and where will the biggest competitive threats come from?

– What’s the most efficient way to stay on top of market events and catalysts, with industry-leading analyst perspective, implications, recommendations?

1. How do these developments get picked up and monitored structurally?
2. How do they get shared within the company to ensure the relevant people have the relevant information to hand for their decision making?
3. And of course, how to ensure the relevant actions are taken based on the new information.company.
1. How do these developments get picked up and monitored structurally?
2. How do they get shared within the company to ensure the relevant people have the relevant information to hand for their decision making?
3. And of course, how to ensure the relevant actions are taken based on the new information.

1) How can competitive intelligence uncover gaps and opportunities in the oncology market to guide pipeline development? 2) What key factors and indicators should oncology-focused companies monitor during competitive intelligence analysis to strengthen their pipelines? 3) How can CI insights be used to benchmark preclinical and clinical trial progress against competitors, and how does this support strategic decision-making? 4) In what ways can oncology companies integrate CI findings into their drug development processes to streamline cross-functional activities and improve success rates? By addressing these questions, CI can provide actionable insights that drive innovation and efficiency in oncology drug development.

b) The Social Media Dilemma: Monitoring competitors’ social media can offer critical insights, but it also raises questions about privacy and ethics. Where should we draw the line?

c) Avoiding the Espionage Trap: CI in a heavily regulated sector can veer into dangerous territory if not handled with care. How can organizations ensure that their CI efforts remain on the right side of the law and ethics? Given the musical chair within the industry, at times “secret sauce” might be share unintentionally.

d) Creating Ethical CI Frameworks: The key is to develop a transparent yet impactful CI strategy that provides actionable insights while maintaining high ethical standards.

AI and advanced data techniques help transform raw data into actionable intelligence, guiding better treatment strategies and innovations.

In this presentation, you will learn:
How does AI enhance data enrichment in rare diseases?
What are the challenges in combining lab and real-world data?
How do P&I techniques turn raw data into clinical use?
Why is data quality crucial for rare disease outcomes?