Strategic Guides insights.
Definitive how-to guides for BD and licensing professionals
How to Prepare a CDMO Partnership: RFP, Tech Transfer, Quality Agreement and Contract Terms
How to prepare a CDMO partnership: what to send in the RFP, shortlisting and audits, realistic technology-transfer timelines, what the quality agreement must cover, the contract terms that decide outcomes, second sourcing and the BIOSECURE Act.
COINS Act and China’s New Biotech Export Rules: Which China Deals Still Work
What Treasury’s COINS Act biotech proposal and China’s Announcement No. 48 cover, the key dates, and which China licensing, NewCo and equity deal structures still work under both rules.
Pharmaceutical Licensing Agreements Explained: Types, Key Terms and How Deals Are Structured
What a pharmaceutical licensing agreement is, the main deal types, key clauses quoted from real filed agreements, royalty terms, the economics of the largest 2025–2026 deals and the cross-border rules for licenses involving China.
PDUFA Calendar 2026–2027: Upcoming FDA Decision Dates and How PDUFA Dates Work
At least 25 FDA decisions are scheduled from October 2026 to May 2027. The calendar, checked against company filings, plus how PDUFA dates are set, why they move and what they mean for dealmaking.
Pharma Tariffs 2026: How the Section 232 Drug Tariffs Work and Who Pays
The 2026 US Section 232 pharmaceutical tariffs under Proclamation 11020: up to 100% on imported patented drugs and ingredients, 15% for the EU, Japan, Korea and Switzerland, zero for the UK, exemptions, onshoring and MFN deals, and what they mean for cross-border licensing and China-originated assets.
Biotech vs Pharma: What’s the Difference, and How Do They Work Together?
What a biotech company is and how it differs from pharma: biologics vs small molecules, business models and funding, who discovers new drugs, how the two partner through licensing and M&A, big biotechs, China, careers and investing.
Out-Licensing Asia Rights: A Playbook for US Biotechs
How US biotechs license Greater China, Japan and Korea rights to regional partners for non-dilutive capital: real deal terms from BridgeBio, Karuna, Cytokinetics, Deciphera, Blueprint and Exelixis, partners by territory, economics, the clauses that protect a later global deal, the process and the risks.
CRO vs CDMO: What Each Does, How They Differ, and How to Choose
A CRO generates the data that gets a drug approved; a CDMO makes the drug. Definitions, the key differences, CRDMOs, the largest providers by 2025 revenue, how contracts are priced, how to choose each, and the BIOSECURE and China angle.
J.P. Morgan Healthcare Conference 2027: The Dealmaker’s Guide to JPM Week
The 45th J.P. Morgan Healthcare Conference runs January 11–14, 2027 in San Francisco. How the invitation-only conference and JPM Week work, the partnering events around it, the deals it produces, China’s growing role, and a preparation timeline for biotechs and buyers.
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
What life sciences consulting is, the main services, what consultants cost, when pharma and biotech companies need one, and the trends shaping 2026.
Top Life Sciences Consulting Firms for Pharma & Biotech 2026
McKinsey, BCG, Deloitte, L.E.K., ZS, Vision Lifesciences and more: the top life sciences consulting firms of 2026, compared by what each does best.
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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