tHEORetically Speaking

From Data Access to Evidence Usability: Connecting Payer Policy, Real-World Data, and Clinical Context to Close the Evidence Gap

In this episode of tHEORetically Speaking, we sit down with Becky Hollenberg, MPH, Senior RWD Strategy Lead at Norstella, to explore why data access is no longer the ulti

Weekly News Roundup — Wegovy Pill’s Historic Debut, Lilly’s Manufacturing Expansion, and Robotic GI Breakthroughs

This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s oral Wegovy pill shattering market expectations with $355 million in first-quarter sales, and Eli Li

Weekly News Roundup — Real-Time Clinical Trials, Canadian Breast Cancer Standards, and FDA Data Integrity Concerns

This week’s tHEORetically Speaking News Roundup covers the FDA’s new real-time clinical trial initiative utilizing AI for faster drug development, and Breast Cancer Canad

INsights & OUTcomes with Mark Larkin

On this episode of INsights & OUTcomes, we sit down with Mark Larkin, real-world evidence expert at Vitaccess, to explore why the "gold standard" of clinical trials often

Weekly News Roundup — PhRMA Leadership Transition, The ICHRA Shift, and MDUFA VI Preliminary Deal

This week’s tHEORetically Speaking News Roundup covers Steve Ubl’s planned departure from PhRMA after a decade of navigating the industry through landmark legislative shi

Weekly News Roundup — Medtech Mega Deals, EU Regulatory Delays, and Global Supply Chain Shock

This week’s tHEORetically Speaking News Roundup covers Abbott’s $21 billion acquisition of Exact Sciences, signaling a major expansion in cancer diagnostics, and Boehring

Weekly News Roundup — Medicaid Maternal Care Expansion, Breakthrough Diabetes Data, and SMA Market Shakeups

This week’s tHEORetically Speaking News Roundup covers Nadia Care’s $12M raise to expand Medicaid-focused maternal care, Eli Lilly’s breakthrough Phase 3 results for its

Weekly News Roundup — Biosimilar Policy Changes, mRNA Leadership Shifts, and Rare Disease Market Growth

This week’s tHEORetically Speaking News Roundup covers the FDA’s new guidance aimed at streamlining biosimilar development and reducing drug costs, leadership changes at

Weekly News Roundup — mRNA Vaccine Milestones, Obesity Drug Manufacturing, and Gene Therapy Regulatory Tensions

This week’s tHEORetically Speaking News Roundup covers Moderna’s progress toward European approval of its combination COVID-19 and flu mRNA vaccine, Novo Nordisk’s $501 m

INsights & OUTcomes with Radek Wasiak

This episode features Radek Wasiak, an expert in real world data generation, and real-world evidence. He has provided research services to the life sciences for more than

Integrated Evidence Delivery: Why HEOR belongs at the heart of the Modern CRO

In this episode, we explore why the traditional 'clinical-first, value-later' model is becoming a strategic liability and why integrating HEOR into CRO operatio

Weekly News Roundup — RSV Breakthrough Data, Psychedelic Approvals on the Horizon, and Major FDA Policy Shifts

This week’s tHEORetically Speaking News Roundup covers new real-world data showing Sanofi’s Beyfortus delivering multi-season protection against RSV hospitalizations, Com

Weekly News Roundup — AI Drug Discovery Deals, mRNA Regulatory Setbacks, and Global Investment Shifts

This week’s tHEORetically Speaking News Roundup covers Takeda’s $1.7B AI-powered drug discovery partnership with Iambic, Moderna’s FDA setback for its mRNA flu vaccine, a

Weekly News Roundup — Regulatory RWE Battles, Capital Market Moves, and Cash-Pay Drug Pricing Disruption

This week's tHEORetically Speaking News Roundup covers Humana’s rollout of a Google Cloud–powered AI tool to streamline 80 million annual member calls, Amgen’s pushb

INsights & OUTcomes with Taylor Hirschberg

This episode features Taylor Hirschberg, an award winning writer, activist, and academic. He is the CEO of Metli Consulting, an inclusive consultancy firm focused on help

Weekly News Roundup — Rare Disease Funding Risks, Medicare Advantage Reform, and Global Trade Shifts

This week’s tHEORetically Speaking News Roundup covers the looming funding crisis for rare disease biotechs as FDA priority review vouchers expire, CMS’s proposed crackdo

Weekly News Roundup — Oral GLP-1 Momentum, Trade Tensions, EU Drug Security, and AI Risk Warnings

This week’s tHEORetically Speaking News Roundup covers Novo Nordisk’s early momentum with oral Wegovy amid intensifying GLP-1 competition, rising geopolitical trade tensi

Weekly News Roundup — Neurodegeneration Deals, Generative AI, and Drug Pricing Politics

This week’s tHEORetically Speaking News Roundup covers Novartis’ $1.5B Alzheimer’s licensing deal, the FDA’s push to accelerate drug development through Bayesian trial me

Weekly News Roundup — Oncology Shakeups, FDA Wellness Crackdown, and AI-Powered Drug Discovery

This week’s tHEORetically Speaking News Roundup covers GSK’s abrupt exit from its five-year synthetic lethality partnership with Ideaya, Whoop’s escalating regulatory cla

Weekly News Roundup — Tariff-Free Pharma, Biologics Modernization, Duchenne Trial Success, and Maternal Health Advances

This week’s tHEORetically Speaking News Roundup breaks down four major developments shaping policy and biopharma. We cover the new US–UK trade deal exempting pharma from