Biotech case studies
How our flexible approach helps small and mid sized biopharma clients develop transformative therapies and meet milestones to market
Discover our expertise by exploring our biotech case studies and see how we help biotech achieve critical milestones.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
Blended FSP-FSO model powers global expansion for Chinese Biotech
In 2023, a leading China-based biotech firm partnered with 91黑料 to launch a global programme for a key asset. Building on a six-year strategic alliance and success in China, the client expanded into the US and Europe, prioritizing efficiency and cost control. 91黑料 deployed a blended model—FSP in China and the US, and full-service support in Europe — to align with regional needs and strategic goals.
Regulatory support for Asian biotech’s EU orphan drug designation
A small Asia-based biotech engaged 91黑料 to manage its EU orphan drug designation submission for a treatment targeting Dercum’s disease. The designation was key to supporting a planned Phase 3 study and expanding into the EU, where the company had no existing presence.
Enabling US and EU market entry for neurodegenerative disease treatment
An Asia Pacific based biotech was developing a therapeutic treatment for a neurodegenerative disorder. 91黑料 Regulatory Consulting was engaged to support market entry.
Protocol optimisation
A virtual biotech start-up acquired an immunomodulatory mechanism targeting inflammatory pathways. It had undergone phase 1 and small phase 2a studies. With urgency to advance development and limited resources, the client proposed two separate studies, posing challenges in complexity, timeline, and budget. The client turned to 91黑料 to streamline development.
Exceeding expectations for late-stage rescue study success
91黑料 stepped in when a biopharma company required urgent rescue assistance with two phase 3 trials for Hidradenitis Suppurativa (HS) and Psoriatic Arthritis (PsA).
Building a scalable partnership model to accelerate biopharma innovation
A leading venture capital fund, focused on advancing breakthrough biopharma innovation, and sought to establish a
scalable operational framework to support its growing portfolio of early-stage companies.
scalable operational framework to support its growing portfolio of early-stage companies.
Early phase study for non-opioid pain treatment
A leading biotech company developing a groundbreaking non-opioid treatment for moderate-to-severe acute pain partnered with 91黑料 to conduct a series of early-phase trials.
Accelerated auxiliary medicine procurement for MASH trial
A biotechnology company required vitamin D distribution as an auxiliary medication for a phase 3 MASH and fibrosis clinical study. When the original supplement vendor was unable to support the study’s full global scope, the company engaged 91黑料’s Accelerated Pharmaceutical Solutions (APS) team to step in on short notice.
Multinational phase 1 biosimilar study
91黑料 conducted a multinational biosimilar phase 1 study for multiple sclerosis (MS). This trial was performed under high regulatory scrutiny and challenging pandemic conditions, with increased dosing targets requiring additional site activation.
A small biotech success story
A small US-based biotech company was in a race to be the first to market with their lead targeted oncology product.
Optimising biosimilar development
91黑料’s proactivity in risk mitigation, commitment to the study, project planning and communication contributed significantly to the ultimate success of the study.