Case Study: Indication expansion assessment and evidence requirements for a novel agent in alpha-thalassemia
The client was preparing for an indication expansion of Product X, which was already indicated in other blood conditions, into alpha-thalassemia, an inherited blood disorder
Case Study: Negotiation Training and Strategy for a Product Indicated for Prevention of Migraine
A global pharmaceutical company was preparing to file a reimbursement dossier for the prevention of migraine in Canada and Europe.
Case Study: Stakeholder Mapping and Launch Opportunity Assessment for a New Oncology Product
Our client had recently received EMA approval for a novel androgen receptor inhibitor, indicated within several solid tumors.
Case Study: Global Payer Value Proposition Development for a Biosimilar in Febrile Neutropenia
Our client had a Phase III biosimilar for the treatment of febrile neutropenia in the pipeline, with an estimated 5-years to launch
Case Study: Demand & Copay Sensitivity Analysis for an RSV Vaccine
Our client had a late-stage vaccine candidate targeting older adult (OA) respiratory syncytial virus (RSV), and wanted support with its US pricing and access strategy.
Case Study: Global Pricing & Market Access Strategy for a Novel Enzyme Replacement Therapy in a Rare Genetic Disorder
A global pharmaceutical company had a Phase II/III enzyme replacement therapy in development for a rare genetic disorder that targeted symptoms not addressed by current standard of care.
Case Study: Pre-Launch – Product Positioning & Value Assessment
Windrose conducted a pricing, market access and evidence gap assessment across US, EU4 and UK for two novel agents in a muscle weakness disorder
Case Study: Ex-US Orphan Indication Expansion & Launch Sequence Development
Our client was evaluating an orphan indication for Product X, which is currently indicated for another orphan indication in Europe, Japan, and Latin America.
Case Study: Biosimilar and branded competitor assessment for a JAK inhibitor
Our client has a successful JAK inhibitor, “Product X”, which has large volumes of sales in the US; Product X sales are expected to continue to grow in the EU5, particularly through indication expansion.
Case Study: Strategic Planning for Competitor Loss of Exclusivity
Our client had a novel oral anticoagulant (NOAC) indicated for thromboembolic disorders on the market, which had seen significant commercial success and sales growth since its launch.
Case Study: Rapid US P&MA Assessment of a Product with Potential Indications in Ulcerative Colitis and Atopic Dermatitis
Our client had to make a business development decision regarding a potential new asset which would be developed in ulcerative colitis (UC) and atopic dermatitis (AtD).
Case Study: In-License P&MA Assessment in Migraine
A global pharmaceutical company was exploring a potential partnership with one of several companies developing a new anti-CGRP to treat and prevent migraines
Case Study: Framework and Policy Development
A global pharmaceutical company’s R&D portfolio included several combination products across multiple different disease states.