Course Information

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

Day 1

Introduction to Pharmaceutical Due Diligence

• Overview of the due diligence process in the biopharmaceutical industry
• The role of due diligence in strategic decision-making for both internal and external assets
• Key phases of the due diligence process: preparation, execution, and post-due diligence actions

Assessing Internal Assets for Portfolio Prioritisation

• Techniques for evaluating the scientific and commercial potential of internal assets.
• Balancing risk and reward in portfolio decision-making.
• Strategies for maintaining a healthy and diverse pipeline.
• Case studies on internal portfolio prioritisation and management
  

Due Diligence for External Assets

• Conducting due diligence for in-licensing, partnerships, and acquisitions
• Identifying and evaluating scientific platforms, technologies, and therapeutic assets
• Best practices for cross-functional collaboration in due diligence activities
• Managing confidentiality and legal considerations during the due diligence process

Day 2

Cross-Functional Due Diligence Processes

Pharmacology and Differentiation Hypothesis

• Evaluating the pharmacological basis and mechanism of action
• Assessing the robustness of the differentiation hypothesis
• Identifying potential challenges in clinical translation

Competitive Landscape Analysis

• Mapping the competitive landscape and identifying key competitors
• Assessing market dynamics, barriers to entry, and potential for market differentiation
• Strategic positioning of the asset in the current and future marketplace

Regulatory and Safety Considerations

• Navigating the regulatory landscape and understanding key requirements
• Evaluating safety profiles and risk management strategies for preclinical and clinical stage assets
• Planning for regulatory submissions and interactions with health authorities

Legal and Intellectual Property (IP) Due Diligence

• Assessing IP strength, freedom to operate, and potential litigation risks
• Reviewing licensing agreements, contracts, and other legal documentation
• Mitigating legal risks and ensuring compliance with relevant regulations

Practical Applications and Case Studies

• Real-world examples of successful and unsuccessful due diligence efforts
• Lessons learned from high-stakes due diligence in the biopharmaceutical industry
• Emerging trends and innovations in due diligence methodologies and technologies

Strategic Insights for Effective Due Diligence

• Building and leading a cross-functional due diligence team
• Managing timelines, budgets, and resource allocation during the due diligence process
• Communicating findings and making recommendations to senior management
• Preparing for post-due diligence integration and operational planning

Gareth is an experienced biopharmaceutical R&D professional, drug hunter and global project lead with 10+ years of leadership in project/program management, portfolio governance and scientific strategy. He has a successful record of progressing complex, multi-million-dollar drug development programs through internal and external initiatives. He has furthered his practical experience in both Europe and the US, in clinical, pharmaceutical, VC and academic environments facilitating the preclinical -> clinical transition of novel medicinal products. Relevant former roles and institutions include Principal Investigator/Lecturer (Harvard Medical School & Boston Children’s Hospital), Fellow and Project Lead (Vertex Pharmaceuticals), Global Project Lead (Boehringer-Ingelheim) and Asset and Scientific Evolution Lead (invoX Pharma).

In his current role(s), he leads a dynamic cross-functional global team that pushes scientific and drug development boundaries, developing novel medicinal products and drug-device combinations (modality and indication agnostic), to meet unmet patient needs worldwide. He has a wealth of experience in establishing agile governance frameworks to oversee a diverse clinical and preclinical portfolio. Notably, he has extensive experience in translational biomarker strategies, indication expansions (repurposing), and effective tech-transfer for up-scale bioprocessing of biologics.

Overseeing a global team, Gareth has a proven track record in increasing pipeline visibility and executing external collaborations. He has bridged the gap between preclinical -> clinical, implementing novel ‘first-4-patient’ initiatives, such as 5’R research frameworks, relevant clinical biomarker strategies and optimising human dose prediction models to enhance the probability of success of medicinal products.