ProductLife Group at CPHI Milan 2026: connecting expertise, innovation and market access to bring science closer to patients.
November 2026 | Milan, Italy
The life sciences industry has never lacked scientific ambition. But as innovation accelerates, a different challenge is becoming increasingly difficult to ignore: developing a promising therapy is only part of the journey. Getting it to patients requires an entirely different level of coordination.
This was one of the strongest messages to emerge from CPHI Milan 2026, where ProductLife Group (PLG), including CEO James Burt, joined pharmaceutical and biotechnology companies, start-ups, CDMOs and industry partners for three days of discussions on the challenges facing the sector.
Beyond individual technologies, regulatory developments or market trends, the conversations revealed a common concern: how can life sciences organisations turn scientific progress into sustainable clinical and commercial outcomes in an increasingly complex environment?
For PLG, three interconnected challenges stand out.
The Cost of Fragmentation Is Greater Than It Appears
A pharmaceutical product does not move through development in isolated stages. Yet many organisations still manage regulatory affairs, CMC, quality, clinical development and market access as separate workstreams.
The consequences are not always immediately visible.
A manufacturing decision made during development can influence regulatory flexibility years later. Clinical endpoints selected without considering payer expectations may leave important evidence gaps at launch. Regulatory and commercial strategies developed independently can create delays precisely when speed matters most.
The real cost of organisational silos is not simply inefficiency. It is the loss of opportunities to make better decisions earlier.
At PLG, this is why integrated expertise matters. Connecting scientific, regulatory, operational and market perspectives allows organisations to anticipate challenges across the product lifecycle rather than address them only when they become critical.
The question is no longer whether individual functions have the necessary expertise. It is whether that expertise is connected at the moments when decisions have the greatest long-term impact.
AI Is Becoming an Operational Responsibility, Not Just a Technological Opportunity
Artificial intelligence is moving beyond experimentation. The industry is increasingly focused on implementing AI in real processes, where efficiency gains must coexist with regulatory obligations, data integrity and human accountability.
This shift changes the nature of the conversation.
The central question is no longer simply what AI can do. It is what AI can reliably do within a regulated environment, under which controls and with whose accountability.
For pharmaceutical organisations, this distinction is fundamental.
AI solutions introduced into GxP-regulated activities must be supported by appropriate governance, risk-based validation, traceability and clearly defined responsibilities. Technological sophistication alone does not guarantee operational readiness.
PLG's perspective is that AI creates sustainable value when it strengthens professional judgement rather than attempting to replace it.
By combining life sciences expertise with digital engineering, validation and regulatory knowledge, PLG helps organisations move beyond isolated technology initiatives towards compliant, operationally effective solutions.
The competitive advantage will not necessarily belong to those adopting AI first, but to those capable of integrating it responsibly into the processes that matter.
Regulatory Approval Is a Milestone. Patient Access Is the Objective.
Another recurring theme at CPHI Milan was the growing importance of aligning development decisions with market access requirements.
A successful regulatory submission demonstrates that a product meets the necessary standards for approval. But it does not automatically establish its value for healthcare systems, secure reimbursement or guarantee that patients can access it.
Health Technology Assessment (HTA), pricing, reimbursement and the expectations of payers increasingly influence the evidence required to demonstrate a therapy's value.
When these considerations enter the discussion only towards the end of development, opportunities to generate relevant evidence may already have been missed.
Access strategy must therefore inform development, not simply follow approval.
This requires a broader understanding of evidence generation, connecting clinical outcomes, patient needs, economic value and regulatory expectations from an early stage.
PLG brings together market and patient access expertise with regulatory, clinical and scientific capabilities to help organisations address these requirements as part of a coherent development strategy.
The objective is not merely to achieve regulatory success, but to create the conditions for innovation to reach the patients who need it.
One Industry Challenge, One Connected Perspective
The discussions at CPHI Milan 2026 highlighted something that extends beyond any single function or technology: the pharmaceutical industry's most complex challenges increasingly exist at the intersection of disciplines.
Fragmented decision-making, the responsible adoption of AI and the growing complexity of market access may appear to be separate issues. In practice, they reflect the same underlying need: a more integrated approach to bringing innovation from development to patients.
This is the perspective that guides PLG's work across the life sciences lifecycle.
By combining expertise in product development, regulatory affairs, CMC, quality, market and patient access, and digital innovation, PLG helps organisations connect scientific ambition with regulatory requirements, operational execution and long-term market viability.
The conversations in Milan reinforced the importance of this approach — and the need for industry partners who can look beyond individual challenges to understand how decisions made today influence outcomes tomorrow.
Explore how PLG can support your next challenge: discover our Product Development, Market & Patient Access, Product Compliance and Digital & Innovation capabilities, or explore our specialised support for the Biopharma sector. Contact PLG to discuss how our integrated expertise can help turn your innovation into meaningful patient impact.