BIO International Convention 2026: Biopharma meetings confirm the need for Regulatory Agencies Experienced Regulatory Affairs & Product Development Consultants
Peritus S2PD have been speaking with business development associates, industry partners and long-standing collaborators who are attending BIO International Convention in San Diego to understand the needs and concerns of biopharma companies.
One message has emerged consistently from discussions taking place across BIO 2026: emerging and mid-sized biotech companies are under increasing pressure to achieve critical development milestones with lean internal teams and limited capital.
Across partnering meetings and networking events, companies are seeking experienced external partners who can provide strategic leadership without the cost and commitment of building large in-house functions.
Several themes are dominating conversations:
Firstly, regulatory uncertainty continues to be a significant concern. Companies are seeking greater clarity around global regulatory expectations, expedited pathways, first-in-human study requirements and interactions with agencies such as FDA, MHRA and EMA. Organisations are looking for senior regulatory expertise to challenge development assumptions, identify gaps (early) and maximise the probability of successful submissions.
Secondly, cash preservation remains a priority. Investors continue to demand disciplined spending and clear value inflection points. As a result, many biotech companies are increasingly adopting virtual operating models, outsourcing specialist activities while retaining strategic control internally.
Thirdly, advanced therapies, including cell and gene therapies, continue to attract substantial interest. However, these programmes frequently present complex regulatory, toxicological and CMC challenges that require highly specialised expertise, particularly when preparing for IND, CTA and Scientific Advice interactions.
From the feedback received, the organisations generating the greatest demand for external support are typically companies preparing for first-in-human studies, entering Europe for the first time, undertaking due diligence activities, scaling CMC operations or preparing for major financing or partnering discussions.
These are precisely the situations where Peritus S2PD delivers value.
Peritus S2PD provides senior-level expertise across Regulatory Affairs, Toxicology, CMC and Product Development strategy. We work alongside biotech companies as an extension of their internal teams, helping clients navigate complex development pathways efficiently and confidently.
Whether supporting IND and CTA preparation, regulatory strategy, Scientific Advice meetings, toxicology gap assessments, CMC development programmes or global development planning, our focus remains unchanged: providing pragmatic, commercially focused advice that accelerates development and reduces risk.
In an increasingly challenging environment, access to experienced senior expertise has never been more important. The conversations taking place at BIO 2026 reinforce what we have seen across the industry for many years: companies value flexible, highly experienced partners who can help them move programmes forward with confidence.
Peritus S2PD supports innovative biotech companies worldwide as they advance the next generation of medicines.