Advanced Business Development in Biopharma Training Course

Advanced Business Development in Biopharma Training Course

Introduction

Advanced Business Development in Biopharma Training Course is meticulously designed for high-potential professionals navigating the complex, high-stakes world of biopharma business development (BD). The industry is rapidly evolving, driven by disruptive technologies like Artificial Intelligence (AI) in drug discovery, the emergence of Cell and Gene Therapies (CGT), and a global pivot toward Precision Medicine. Success in BD now demands mastery beyond basic deal negotiation; it requires sophisticated skills in strategic alliance management, complex deal structuring, advanced valuation methodologies, and leveraging Real-World Evidence (RWE) to de-risk assets. This course provides the next-level framework and practical tools necessary to identify, assess, and execute high-value licensing, merger and acquisition (M&A), and strategic partnership opportunities that drive exponential growth in the pharmaceutical and biotech sectors.

Participants will engage with cutting-edge concepts, including integrating digital health solutions into commercial strategies and executing robust, future-proof due diligence in volatile therapeutic areas. We will explore techniques for mitigating geopolitical risk in global expansion strategies and maximizing portfolio value through disciplined asset prioritization. By focusing on practical application through contemporary case studies from major transactions, attendees will graduate equipped to lead pivotal negotiations, structure innovative, risk-sharing agreements, and ultimately shape their organizationΓÇÖs long-term portfolio strategy in the competitive biotechnology ecosystem. This is more than training; it's a strategic investment in creating a world-class biopharma dealmaker.

Course Duration

10 days

Course Objectives

1. Master advanced valuation models for pre-clinical and early-stage assets, including platform technologies.
2. Design and execute comprehensive biopharma due diligence strategies, focusing on intellectual property, regulatory pathways, and RWE generation plans.
3. Structure complex cross-border licensing and co-development agreements, mitigating jurisdictional and geopolitical risks for global expansion.
4. Analyze the role of AI/Machine Learning partnerships in accelerating drug discovery and integrate these digital capabilities into BD strategies.
5. Develop actionable portfolio optimization strategies using probabilistic forecasting and disciplined asset prioritization frameworks.
6. Evaluate and integrate Cell & Gene Therapy (CGT) and mRNA technology assets into existing pipelines, addressing unique manufacturing and regulatory challenges.
7. Lead the identification and strategic justification for high-value biotech M&A targets, focusing on synergy identification and cultural alignment.
8. Negotiate sophisticated milestone and royalty structures, including tiered, synthetic, and capped royalties to optimize deal economics.
9. Formulate effective strategic alliance management plans to maximize collaboration value and minimize partnership friction post-signing.
10. Implement best practices for the full lifecycle of post-merger integration (PMI), specifically addressing R&D pipeline and commercial field force alignment.
11. Leverage digital therapeutics and digital health platforms as integrated components in precision medicine partnering deals.
12. Conduct competitive intelligence mapping to anticipate market shifts and preemptively position the company for first-mover advantage.
13. Analyze the legal and economic implications of complex 'opt-in/opt-out' clauses and exit strategies in strategic partnering agreements.

Target Audience

1. Business Development Managers and Directors.
2. Strategic Planning and Portfolio Management Executives.
3. Investment Bankers and Venture Capital Analysts.
4. In-House Legal Counsel.
5. R&D Leaders.
6. Commercial Leaders.
7. Management Consultants.
8. Senior Scientists and Founders.

Course Modules

Module 1: The Biopharma BD Mandate & Strategy Alignment

• Defining the advanced BD function.
• Translating corporate strategy into an actionable BD 'Hunting List' and Thematic Search.
• Risk tolerance assessment and balancing early-stage innovation with late-stage derisked assets.
• The impact of therapeutic area trends on BD focus.
• Case Study: Analyzing the strategic rationale and outcomes of a major pharma company's pivot towards RNA therapeutics through multiple bolt-on acquisitions.

Module 2: Advanced Asset Valuation Methodologies

• Mastering the intricacies of rNPV modeling for assets pre-Phase I.
• Scenario planning using Monte Carlo simulations and Decision-Tree Analysis (DTA).
• Valuing platform technologies and non-traditional assets
• The role of comparable transaction analysis (Comps) and precedent deal terms.
• Case Study: Valuation exercise for a first-in-class ADC (Antibody-Drug Conjugate) asset, incorporating clinical trial probability and peak sales risk adjustments.

Module 3: Pre-Deal Sourcing and Opportunity Screening

• Leveraging AI/Machine Learning tools for predictive deal sourcing and target identification.
• Implementing a structured funnel management system for high-volume opportunity screening.
• Building and managing relationships with global venture capital and academic research hubs.
• Competitive landscaping and anticipating partnering intent of rivals.
• Case Study: Examining how a major biotech used non-traditional data sources to identify an early-stage academic spinout.

Module 4: Rigorous Due Diligence

• Structuring a cross-functional due diligence team.
• Deep dive into CMC and supply chain risk for biologics and CGT.
• Assessing the robustness of intellectual property (IP), patent landscapes, and freedom-to-operate analysis.
• Conducting advanced commercial market sizing, payer access, and reimbursement risk assessments.
• Case Study: Analysis of a failed M&A transaction where undisclosed CMC complexity related to a novel formulation led to deal termination post-LOI.

Module 5: Principles of Complex Licensing Agreements

• Drafting comprehensive Term Sheets.
• In-depth analysis of global vs. regional licensing and co-commercialization models.
• Structuring control, governance, and decision-making rights within a joint steering committee.
• Handling exclusivity provisions, retained rights, and future product generation clauses.
• Case Study: Dissecting the structure of a multi-asset, multi-stage out-licensing deal, focusing on the staged transfer of regulatory responsibilities.

Module 6: Advanced Deal Structuring and Negotiation Tactics

• Designing innovative financial structures
• Negotiating tiered royalty stacking and adjusting rates based on sales performance or territory.
• Techniques for negotiating contentious terms.
• Psychology of high-stakes negotiation.
• Case Study: Simulating the negotiation of a CVR linked to an FDA label expansion for a mid-stage asset.

Module 7: Biopharma M&A: Target Selection and Rationale

• Developing a robust M&A thesis.
• Identifying and quantifying financial and R&D synergies and avoiding negative synergies.
• The role of the BD professional in driving the board-level approval process.
• Managing confidentiality, leaks, and regulatory filings
• Case Study: Reviewing the AbbVie-Allergan deal, focusing on the strategic rationale for market diversification and intellectual property access.

Module 8: Post-Merger Integration (PMI) Planning

• The BD role in pre-closing PMI planning.
• Integrating R&D pipelines, data systems, and harmonizing clinical trial operations.
• Managing organizational culture clash and retention strategies for key scientific talent.
• Transitioning financial reporting and establishing integration milestones.
• Case Study: Analysis of the successful integration process following the BMS-Celgene acquisition, specifically detailing talent retention and pipeline continuity.

Module 9: Strategic Alliances and Partnering Models

• Differentiating between joint ventures, co-development, and research collaborations.
• Establishing robust alliance management operating principles and governance structures.
• Measuring and tracking the non-financial success factors of an alliance
• Proactive conflict resolution and restructuring of underperforming partnerships.
• Case Study: Examining the structure and outcomes of the long-term Gilead-Galapagos R&D collaboration and subsequent restructuring.

Module 10: BD in the Age of Cell & Gene Therapy (CGT)

• Unique BD challenges
• Partnering for enabling technologies.
• Structuring deals that account for 'pay-for-performance' and outcomes-based contracts.
• Assessing the global regulatory landscape for novel therapeutic modalities
• Case Study: Analyzing the partnering strategy of a CAR T-cell therapy company, focusing on securing manufacturing slots and distribution rights.

Module 11: BD for Digital Health and RWE

• Integrating digital therapeutics (DTx) and companion diagnostics into biopharma assets.
• Structuring partnerships with tech companies for data capture and Real-World Data (RWD) analysis.
• Legal and ethical considerations for patient data privacy in BD deals.
• Valuing access to proprietary data sets and AI algorithms for drug development.
• Case Study: Reviewing a partnership between a pharmaceutical company and a wearable technology firm to generate RWE for a chronic disease asset.

Module 12: Global BD and Emerging Markets

• Developing geographically specific strategies for high-growth, high-risk emerging markets
• Navigating different regulatory filing processes and intellectual property enforcement challenges globally.
• Structuring local manufacturing and distribution partnerships to meet regional compliance.
• Assessing geopolitical risk and currency volatility in international deal structuring.
• Case Study: Analysis of a company's entry strategy into the Chinese market via a joint venture with a local partner to secure domestic clinical trial capability.

Module 13: Portfolio Optimization and Asset Prioritization

• Using quantitative methods for pipeline visualization.
• Implementing a disciplined process for early termination or divestiture of non-core assets.
• The concept of 'Optionality' in BD and how to structure deals that retain future choices.
• Allocating resources across different therapeutic areas to maximize risk-adjusted return.
• Case Study: A deep dive into a major pharma company's portfolio review, leading to the divestiture of its dermatology unit to focus on oncology.

Module 14: Legal and Regulatory Advanced Topics

• Antitrust review and competition law implications for large-scale biopharma M&A.
• Understanding the legal nuances of Material Adverse Change (MAC) clauses and closing conditions.
• Warranties, indemnities, and escrow accounts in purchase agreements.
• The role of patent thickets and managing the transition of regulatory filings
• Case Study: Review of a landmark court case defining the interpretation of a MAC clause in a significant life sciences acquisition.

Module 15: BD Leadership and Future Trends

• Building and mentoring a high-performing global BD team.
• Measuring BD success beyond deal volume: Focus on value creation and ROI.
• Anticipating the next wave of disruptive technologies
• Ethical considerations and compliance in international BD transactions.
• Case Study: Examining the evolution of the BD function at a top-tier biopharma firm over the last five years and its adoption of a Venture Capital (VC)-like scouting model.

Training Methodology

The course employs a highly interactive, practical, and blended learning approach, ensuring maximum engagement and retention of advanced concepts:

• Interactive Workshops.
• Contemporary Case Studies.
• Negotiation Simulations.
• Expert Q&A Panels.
• Portfolio Strategy Challenge

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.