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Strategic Guides insights.

Definitive how-to guides for BD and licensing professionals

20 piecesUpdated Oct 22, 2026
Strategic GuidesOct 22, 2026

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.

8 min
Strategic GuidesOct 22, 2026

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.

10 min
Strategic GuidesOct 22, 2026

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.

9 min
Strategic GuidesOct 22, 2026

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.

9 min
Strategic GuidesJun 27, 2026

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.

8 min
Strategic GuidesJun 27, 2026

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.

8 min
Strategic GuidesJun 27, 2026

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.

8 min
Strategic GuidesJun 27, 2026

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.

7 min
Strategic GuidesFeb 28, 2026

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.

6 min
Strategic GuidesFeb 28, 2026

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.

6 min
Strategic GuidesFeb 28, 2026

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.

6 min
Strategic GuidesFeb 28, 2026

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.

5 min
Strategic GuidesFeb 28, 2026

Biotech Partnerships: Types, Structures & How They Work

A guide to biotech partnership models including co-development, platform licensing, and equity alliances.

4 min
Strategic GuidesFeb 16, 2026

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.

4 min
Strategic GuidesFeb 16, 2026

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.

4 min
Strategic GuidesFeb 16, 2026

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.

4 min
Strategic GuidesFeb 16, 2026

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.

4 min
Strategic GuidesDec 22, 2025

Pharma Business Development: The 2026 Definitive Guide

Transforming the BD function from a transactional support role into a core scientific strategy engine.

4 min
Strategic GuidesDec 19, 2025

In-Licensing vs Out-Licensing: The Complete Guide

A strategic framework for cross-border asset acquisition, monetization, and partnership structuring.

4 min
Strategic GuidesJun 28, 2026

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.

9 min
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