Strategic Guides insights.
Definitive how-to guides for BD and licensing professionals
Most-Favored-Nation Drug Pricing, Explained
What most-favored-nation (MFN) drug pricing means, the 2025 executive order and its mechanics, how it interacts with IRA negotiation and international reference pricing, and what it means for pharma strategy, launch sequencing, and cross-border licensing economics.
The 505(b)(2) Pathway, Explained: A Dealmaker’s Guide
What the FDA 505(b)(2) pathway is, how it differs from a full NDA and an ANDA, eligible product types, bridging studies, patent certifications and exclusivity, and why 505(b)(2) assets are attractive, lower-risk in-licensing candidates.
FDA Breakthrough Therapy Designation: Criteria, Benefits & Strategy
FDA Breakthrough Therapy Designation explained: the criteria, the benefits, how it differs from Fast Track, Accelerated Approval and Priority Review, the grant statistics, the NMPA analog, and what BTD signals in BD diligence and valuation.
FDA Fast Track Designation: What It Is & How to Get It
FDA Fast Track Designation explained: eligibility, benefits, how to request it, and how it relates to Breakthrough Therapy, Accelerated Approval and Priority Review — plus what it signals for cross-border BD and diligence.
Clinical Trial Patient Enrollment: Strategies to Accelerate Recruitment
80% of trials miss enrollment deadlines. Evidence-based strategies for faster patient recruitment — including why China's 2-5x faster enrollment advantage is transforming global drug development timelines.
In-Licensing China Biotech Assets: Strategic Guide 2026
A practical playbook for Western BD executives on scouting, evaluating, and acquiring Chinese biotech innovation. Due diligence, deal structuring, NMPA data strategy, and BIOSECURE compliance covered.
Life Sciences Consulting: The Complete Guide for 2026
Comprehensive guide to life sciences consulting: types of services, when pharma and biotech companies need it, how to choose a firm, and 2026 industry trends.
Top Life Sciences Consulting Firms 2026: Complete Guide
Compare MBB, Big 4, mid-size specialists, and boutique deal advisors. A strategic guide to choosing the right life sciences consulting firm for your needs.
Biotech Partnerships: Types, Structures & How They Work
A guide to biotech partnership models including co-development, platform licensing, and equity alliances.
Drug Development Stages: The Complete Guide from Discovery to Approval
A definitive walkthrough of every stage in the pharmaceutical development process—with timelines, costs, success rates, and strategic deal implications.
Cross-Border Licensing Term Sheet Guide: Structuring Pharma Deals That Work
A practical, clause-by-clause walkthrough of pharmaceutical licensing term sheets—with real-world benchmarks and China-specific negotiation strategies.
rNPV Valuation Guide: The Gold Standard for Pharma Asset Valuation
A practical, step-by-step guide to risk-adjusted NPV—the methodology behind every major pharma licensing deal and acquisition.
Pharma Due Diligence Checklist: The Complete Guide for Licensing & M&A
A comprehensive, practical checklist covering scientific, IP, regulatory, commercial, financial, and manufacturing due diligence for pharma deals.
Pharma Business Development: The 2026 Definitive Guide
Transforming the BD function from a transactional support role into a core scientific strategy engine.
In-Licensing vs Out-Licensing: The Complete Guide
A strategic framework for cross-border asset acquisition, monetization, and partnership structuring.
Investigator-Initiated Trials (IIT) in China: Why Dealmakers Care, and Whether the Data Travels
China runs ~90% of its early cell-therapy studies as investigator-initiated trials (IITs) — cheap, fast human proof-of-concept that de-risks assets before a registration trial. A dealmaker's guide to IIT vs IND, Order No. 818, and whether IIT data supports an FDA filing.
The Vision Lifesciences brief.
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