Pharmaceutical Thought Leadership
Fig. I — Drug Lifecycle Continuum
Ink on parchment · 2026
From discovery to dispensing: the evidence obligations that define each transition point — and where most organizations underinvest.
Market Access
Three recent formulary decisions reveal a structural shift in how commercial payers are interpreting real-world outcomes data — and why your evidence package may already be obsolete.
Dr. Margaret Osei-Bonsu
Former FDA Medical Officer · Medical Affairs, Roche
18 min read
February 2026
Current Issue
Pipeline Strategy
Vol. XII · Q1 2026 · 4 articles
47
Long-form analyses
31
Contributing experts
12
Volumes published
Editorial Contents
Four thematic issues, each built around a single question the industry is getting wrong.
The gap between clinical evidence and payer acceptance is widening — and the organizations that bridge it earliest capture disproportionate formulary position.
Dr. Priya Nambiar
·22 min
SVP Medical Affairs, Novartis
James Whitfield, PharmD
·16 min
Former CMS Policy Analyst
Market Access
Issue I · 2 analyses
Post-approval commitments are the new regulatory frontier — the organizations that treat them as strategic assets rather than compliance burdens will define the next decade of drug lifecycle management.
Dr. Elena Vasquez
·28 min
Former FDA Office of Drug Evaluation
Marcus Chen, JD, PhD
·19 min
Regulatory Counsel, Sanofi
Regulatory Intelligence
Issue II · 2 analyses
The RWE hierarchy is collapsing — registry data, claims analysis, and pragmatic trials are converging into a single evidentiary language that regulators and payers now speak fluently.
Dr. Aisha Okonkwo
·24 min
RWE Lead, Johnson & Johnson
Prof. David Osei
·31 min
Biostatistics, Harvard T.H. Chan
Real-World Evidence
Issue III · 2 analyses
The evidence architecture for a drug must be designed at IND — organizations that retrofit evidence strategy post-approval pay a compound interest penalty that no launch excellence can overcome.
Dr. Rekha Sharma, MD, PhD
·20 min
Chief Medical Officer, Protagonist Therapeutics
Thomas Okafor, PhD
·17 min
Clinical Development, AstraZeneca
Pipeline Strategy
Issue IV · 2 analyses
Diagnostic Assessment
Seven questions. Seven minutes. A personalized brief identifying the specific lifecycle stages where your evidence architecture has gaps — delivered to your inbox.
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Editorial Board
31 contributors across medical affairs, regulatory, HEOR, and clinical development. No ghostwriting. No sponsored content.
Dr. Margaret Osei-Bonsu
Former FDA Medical Officer
Medical Affairs, Roche
"The evidence package is not a document you submit. It's an argument you've been building for seven years."
Dr. Elena Vasquez
Former FDA Office of Drug Evaluation
Independent Regulatory Counsel
"Post-market commitments are where the real lifecycle strategy happens — and where most organizations go silent."
Dr. Aisha Okonkwo
RWE Strategy Lead
Johnson & Johnson
"We keep designing RWE studies to answer questions that payers stopped asking two years ago."
Prof. David Osei
Professor of Biostatistics
Harvard T.H. Chan School
"The most consequential decisions in drug development are made by people who have never read a methods section."
James Whitfield, PharmD
Former CMS Policy Analyst
Health Policy Consulting
"ICER doesn't move formulary decisions. It moves the conversation. Most companies are still missing the conversation."
Dr. Rekha Sharma
Chief Medical Officer
Protagonist Therapeutics
"Biomarker stratification before Phase II is not a scientific luxury. It's the only way to build a defensible evidence architecture."
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