This report was created to clarify a question most radiopharma leaders feel but rarely articulate: why does a sector with billions in investment still behave like a system on the edge of failure? Rather than analysing isolated bottlenecks, it maps the full architecture of radiopharma – from precursor scarcity and equipment oligopolies to dual-regulatory friction, human-capital shortages, and the cascading interdependencies that create systemic fragility. By connecting upstream physics, midstream execution, and cross-stack economic pressures, the report shows how infrastructure, capability, and credibility – not science – now determine value. For CEOs, investors, and operators, it is a strategic framework for understanding where the real risks lie – and where fragility becomes advantage.

This report was built to answer a simple but uncomfortable question: why do some programs never come back from a Complete Response Letter? Drawing on 89 FDA rejections where products never reached approval, it reveals the deeper strategic patterns behind terminal failure – when data breaks, trust collapses, and fixes no longer matter. Rather than analysing execution risk, this briefing maps the fatal flaws that make a program unapprovable – and outlines how leadership teams can detect them early. For executives, boards, and investors, it is a blueprint for spotting when a program is not just at risk – but unapprovable.

Ahead of the 7th Annual TRP Summit, this briefing distils the four strategic tensions defining radiopharma’s next phase – target selection, dosimetry, manufacturing, and commercialisation. It explores ProGen Search’s “Gold Rush Paradox” – an industry rich in capital but constrained by isotope fragility, dual regulation, and scarce talent. From the Target Dilemma to the Dosimetry Debate, the Supply-Chain Crisis, and Europe’s Commercial Gauntlet, the report outlines the inflection points that will separate scientific promise from executional success. Featuring new leadership archetypes – the Triad Master, Head of Clinical Dosimetry, Dual-Mandate Navigator, and Market Maker – it provides pre-summit intelligence for CEOs, boards, and investors navigating radiopharma’s era of Execution Under Decay.

This report dissects the fragile but fast-maturing alpha radiopharmaceutical sector, projected to grow tenfold by 2035. It charts the chokepoints in isotope supply (Ac-225, Pb-212, At-211), dual regulation, aseptic manufacturing, and just-in-time logistics – showing why execution, not science, will decide winners. Case studies include BMS’s Phase 3 halt due to Ac-225 shortage and the rise of Indianapolis “super-sites.” It profiles the five leadership roles that will make or break launches, while mapping M&A, CDMO capacity, and clinical trial maturation. For investors, boards, and executives, it is a roadmap to navigating execution risk in radiopharma’s most valuable modality.

Commissioned to chart the hidden chokepoints in next-generation antibody development, this report exposes the true cost of deferring manufacturability. It dissects the recurring failure modes in Chemistry, Manufacturing, and Controls (CMC) that derail bispecifics, IgMs, and ADCs, quantifying the value destruction and timeline resets that follow. Profiling platform enablers, investor disclosures, and the emerging archetype of the Translational CMC leader, it connects boardroom priorities with bench-level design. Drawing on case studies, financial analysis, and talent market data, it forecasts how CMC readiness will define valuations, partnerships, and IND success rates over the next five years – and provides a blueprint for CEOs, boards, and investors to protect pipelines and secure competitive advantage.

Commissioned to provide the first operational-level map of the global radiopharmaceutical industry, this report dissects the “Triad of Scarcity” in isotopes, manufacturing, and talent that defines the sector’s future. It profiles the five strategic archetypes of RLT developers, the indispensable manufacturing and logistics infrastructure, and the specialist clinical networks underpinning successful execution. Drawing on market data, partnership mapping, and talent analysis, it identifies where capital is flowing, predicts next-generation isotope and AI-driven clinical trends, and outlines a 5-year roadmap for investors, executives, and boards seeking to secure competitive advantage in a modality now at the forefront of oncology.

This report was commissioned by a global CDMO evaluating upstream capability gaps in bispecific antibody programs. It maps the critical manufacturing failure points – from cell line instability to mispairing and aggregation – and analyses why many bsAb candidates are “engineered to fail” long before CDMO tech transfer. Drawing on insights from CDMOs, sponsors, and platform innovators, the report outlines upstream strategies, tech adoption trends, and hiring implications for executives building competitive advantage in complex biologics.

This report was created for a biotech executive team preparing for NDA submission, who asked us to identify the most common reasons for FDA rejections in recent years. After the FDA released 202 Complete Response Letters in July 2025, we analysed the full dataset to help the team better anticipate areas of regulatory sensitivity — especially in CMC, process validation, and facility inspection history. The insights were used internally to inform cross-functional risk reviews and hiring strategy around quality and regulatory leadership.

Commissioned by a Series B-stage gene therapy company evaluating manufacturing partners, this report was built to clarify how CDMOs in the CGT space differ — not just by capacity, but by modality expertise, regional exposure, and platform maturity. It also helped their board understand the structural pressures driving pricing, lead times, and strategic partnerships. The report was used as part of a board presentation on outsourcing strategy.

This briefing was created for a private equity sponsor entering the radiopharmaceutical space via acquisition. They needed to understand which leadership roles were most difficult to fill — and how talent constraints might affect the growth plan. We mapped executive hiring patterns across CMC, regulatory, clinical, and commercial functions, to help them anticipate where external search or succession planning would be most critical post-deal.

Developed for a biotech CEO evaluating whether to initiate a first-in-human RLT trial, this report mapped the global landscape of active and recent trials — with a focus on alpha- and beta-emitting agents, isotope sourcing constraints, and common trial endpoints. The goal was to provide strategic context on CRO selection, trial design precedent, and competitive positioning. It was also used during internal planning discussions around regulatory timelines.

This report was commissioned by a growth equity fund assessing a potential investment in a radiopharma-focused CDMO. They needed a market-wide view of infrastructure readiness, isotope supply risk, regulatory complexity, and competitive positioning. We compiled this report to support their early-stage due diligence – giving a macro-level breakdown of value chain chokepoints without evaluating specific targets.