For decades, patients in low- and middle-income countries have waited years longer than those in richer regions to receive new therapies. The cause was rarely scientific, but procedural. Global approvals followed a slow, sequential pattern known as the 'wave model', with each country reviewing in turn. For patients waiting on life-saving treatments, that delay often meant lost time and opportunity.
Amgen, working with Accumulus, decided to break that pattern. By combining Amgen's Structured Content and Data Management systems with Accumulus's cloud-based collaboration platform, the team delivered the first digitally generated, cloud-submitted regulatory dossier to nearly two dozen health authorities simultaneously. For the first time in history, regulators around the world reviewed the same submission simultaneously, cutting approval times from 4 years to less than 1.
The gains were substantial. More than 70 per cent of regulators approved the submission within six months, global lifecycle timelines fell by 90 per cent, and Amgen achieved 75 per cent efficiency gains across the process. The model also unlocked manufacturing capacity worth millions of dollars, reduced waste, and brought treatments to patients years sooner.
A senior member of Amgen’s global regulatory team reflected on what this meant for equity. “When regulators in emerging markets can review alongside their peers, they are no longer at the back of the queue,” they said. “This changes more than process; it changes power dynamics and patient outcomes."
Scalability is built into the model. In just 18 months, the Accumulus platform has connected with more than 70 regulators globally and is available at no cost to participating agencies. With only an internet connection required, the technology removes traditional barriers of geography, infrastructure, and budget.
Amgen's partnership with Accumulus demonstrates that digital regulatory transformation is not a vision for the future but a working reality. The project's success shows that faster, fairer access to medicines is achievable today, if organisations are willing to collaborate and trust new models of global exchange.
Chengda Pharmaceutical: Scaling Reliability into Global Patient Access
Chengda Pharmaceutical has grown from a local Chinese manufacturer into a trusted global partner, supplying active ingredients and intermediates to more than 1,000 customers across over 60 countries. Behind that growth lies a commitment to reliability, innovation, and patient access that has made Chengda one of the world's most dependable contract development and manufacturing organisations (CDMOs).
The company's approach is deeply collaborative. Its teams work alongside biotech innovators and major pharmaceutical companies to bridge the gap between discovery and large-scale supply. In one example, Chengda's intensified process for oral GLP-1 drugs increased yields by 25 per cent, cutting production costs and supporting affordability for patients worldwide. In another, the company rapidly scaled up production of Lenacapavir intermediates, ensuring uninterrupted clinical development for a breakthrough HIV therapy.
A Chengda operations leader described the philosophy simply, “Our role is to turn scientific promise into reliable supply. When patients are waiting, every batch and every delivery matters.”
Chengda's performance record supports that claim. The company has delivered more than 200 GMP batches with no critical deviations, backed by over 600 audits conducted in accordance with international standards. Its teams maintain compliance with FDA, EMA, ICH, and Chinese GMP requirements, providing partners with confidence that complex molecules can be manufactured safely and consistently at scale.
Scalability and resilience are Chengda's hallmarks. Advanced capabilities in organolithium, chiral, and enzymatic chemistry enable the production of complex compounds, while dual sourcing of raw materials safeguards against supply interruptions. The company's lifecycle management approach reduces waste, lowers costs, and supports equitable patient access across markets.
“Every partnership we build is about long-term trust,” said a Chengda quality executive. “When you deliver on time and at the right quality, you are not just supporting a company’s pipeline, you are sustaining patient hope.”
Chengda’s success shows how manufacturing excellence can become a force for equity, ensuring that life-saving therapies reach patients everywhere, not only where systems are strongest.
Find out more about the Reuters Events Global Pharma Awards 2025 - visit the website here.
For more insights on commercial pharma, including latest articles, interviews and more – click here
