It is widely accepted that innovation in drug discovery and development does not happen in isolation. The process is inherently complex, demanding multidisciplinary expertise, coordination across global supply chains, and strict regulatory oversight. Pharmaceutical companies have long relied on partnerships with external organizations to access specialist skills and technologies, particularly given the immense resources required to bring a single medicine to market — often more than a decade of development and billions of dollars in investment.
Despite this, much of the pharmaceutical industry remains highly competitive, with true pre-competitive collaboration still relatively rare. Even among the world’s largest biopharma companies, only a small fraction of approved drugs in recent years have been developed collaboratively. The COVID-19 pandemic demonstrated what is possible when competitive boundaries are temporarily relaxed, with unprecedented levels of cooperation accelerating vaccine development. Outside of crisis conditions, however, structural barriers often limit such efforts.
Collaboration is key for overcoming challenges that are too large, too systemic, or too risky for individual organizations to tackle alone. Recognizing this and its relative underuse in small-molecule manufacturing, BioPhorum has launched the Synthetic Molecule Process Innovation Phorum. The new initiative brings together pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and regulators in a structured, pre-competitive environment, with the goal of addressing shared manufacturing, regulatory, and sustainability challenges.
Extending a proven collaborative model
Since its founding in 2004, BioPhorum has built a reputation as a trusted convener for the global biopharmaceutical industry. Its Phorums provide structured environments where companies can openly share experiences, benchmark practices, and develop consensus guidance on shared challenges. To date, much of this work has focused on biologics and advanced therapies, with initiatives spanning standard and modular facility builds, extractables and leachables, and BioPhorum’s Digital Plant Maturity Model.
The Synthetic Molecule Process Innovation Phorum is extending this collaborative model into synthetic molecules at a time when the sector is undergoing rapid change. Breakthroughs in precision oncology, neurology, and next-generation oral therapies are driving a resurgence in small molecule innovation, while new modalities such as peptides and oligonucleotides are blurring the traditional boundaries between biologics and chemistry.
“There was a real gap in the small molecule space,” Phil Peach, Global Change Facilitator at BioPhorum, told DDN. “Collaborations had to be set up individually and bespoke every time. That’s slow, expensive, and inefficient. The industry needed a neutral place where these conversations could happen more easily.”
An ecosystem approach
The Synthetic Molecule Process Innovation Phorum launched with 20 founding organizations spanning the small molecule ecosystem. Alongside large pharmaceutical companies such as AstraZeneca, GSK, Takeda, and Eli Lilly, the group includes CDMOs and specialist technology providers with deep expertise in areas such as solid-form science, kinetic modelling, and advanced process control.
“The days of large pharma operating as independent silos ended decades ago,” Peach noted. “Manufacturing today is done across an ecosystem, and if you want to change how the industry works, everyone has to be in the room.”
While BioPhorum provides the framework and facilitation, members of the Synthetic Molecule Process Innovation Phorum define the agenda themselves. Through workshops and working groups, participants identify shared challenges and agree on projects designed to deliver measurable value.
At launch, the Phorum is running six projects in parallel. One early focus is regulatory alignment around synthetic peptide manufacturing. In the US, peptides can be manufactured under either a New Drug Application (NDA) or a Biologics License Application (BLA), but there is limited clarity around when each pathway should be used. This is especially complicated as companies often want to manufacture peptides under a BLA to benefit from longer periods of regulatory exclusivity.
Through the Phorum, members can develop industry position papers and engage regulators as a unified group, giving them greater confidence that their regulatory submissions will be aligned with regulatory expectations. “Without that confidence, companies tend to default to the most conservative approach, which is often the most expensive,” said Peach.
This also works better for regulators. Instead of responding to multiple, slightly different interpretations from individual companies, agencies can engage with a single, consensus-driven industry view. That simplifies discussions, highlights where guidance may be unclear, and allows feedback to shape best practice across the sector, rather than on a case-by-case basis.
Tackling manufacturing challenges in small molecules
To define the initial program for the launch, the Phorum leadership team convened for a two day event in Cork, Ireland. One of the major priorities that came up was raw material constraints, particularly in peptide manufacturing. Demand for peptide therapeutics has surged, driven in part by GLP-1 drugs, while supply chains remain geographically concentrated.
“There are shortages, price increases, and underlying inefficiencies in the chemistry itself,” Peach said. “We need new methodologies that move beyond traditional solid-phase peptide synthesis and deliver much better process mass intensity, but bringing those technologies online requires regulatory certainty.”
Solvent use represents a parallel challenge. Traditional peptide purification primarily relies on reversed-phase chromatography, which involves substantial acetonitrile usage and generates disproportionately high amounts of waste relative to product yield. This creates a large dependence on acetonitrile, but supply can be volatile since it’s produced only as a byproduct of acrylonitrile manufacturing, which is itself in decline.
“As a near-term goal, we want to help drive global regulatory alignment on solvent reuse in peptide manufacturing to alleviate the supply and cost pressures around acetonitrile,” said Peach. “We know that acetonitrile can be purified to a standard that exceeds virgin material, and some regulators already accept its reuse — but others do not.”
For manufacturers supplying a global market, this lack of alignment makes reuse impractical. A process that is acceptable in one region may prevent products from being sold in another. By helping to drive global alignment, the Phorum could enable widespread solvent reuse, reducing costs, improving environmental standards, and strengthening security of supply.
Beyond individual technologies, the Phorum is also addressing the need for standardization — particularly around technology transfer. As more manufacturing is outsourced, company-specific processes are increasingly inefficient for CDMOs managing multiple clients.
“Harmonizing terminology, data formats, and data standards sounds simple, but it only works if the whole industry agrees,” Peach said. Drawing on successful precedents from biologics, the Synthetic Molecule Process Innovation Phorum aims to define common approaches that reduce friction and improve efficiency.
Preparing manufacturing for what comes next
Small molecule therapies are increasingly central to high-volume treatments in oncology, neurology, obesity, and immunology. As these medicines move from niche applications to global patient populations, manufacturing infrastructure must evolve to support rapid scale-up, flexible capacity, and resilient supply chains. The Synthetic Molecule Process Innovation Phorum has been created to help the industry respond collectively to these pressures, providing a pre-competitive space to address challenges that no single organization can solve alone.
The stakes are significant. The global small molecule API contract development and manufacturing market was valued at $46.6 billion in 2025 and is projected to reach $80.7 billion by 2033. This expansion reflects both rising demand and increasing complexity — from new modalities and advanced chemistries to greater reliance on external manufacturing partners. By aligning on best practices, regulatory approaches, and enabling technologies, the Synthetic Molecule Process Innovation Phorum aims to help the industry modernize small molecule manufacturing in a way that is scalable, sustainable, and fit for the next decade of drug development.
