Development, Regulatory & Market Access strategic alignment – missed opportunities?

Why was G&L Healthcare Advisors recent acquisition of SmartStep Consulting such a significant move by the company to enhance its strategic offerings?

Let me outline why this ultimately brings benefits to biopharma companies, healthcare providers and patients. It’s about building an integrated development and regulatory strategy that includes market access considerations.

A successful drug development and regulatory approval is meaningless if commercialization is a failure, and medicines do not ultimately become available to patients. The imminent changes to EU HTA regulations is also a significant driver to ensure a connected strategy.

Highlighting some of the benefits: -

• Accelerated timelines – building in market access requirements early in development avoids late-stage additional studies/repeated studies and enables faster reimbursement decisions to avoid delayed market entry
• Efficiency and Cost saving – avoids repeated studies but also ensures prioritization of limited resources and focus on the most critical areas for successful regulatory approval AND market access.
• Risk mitigation – considering all factors in a combined strategy, ensures a total risk evaluation and assessment of any setbacks or alternative pathways, in the context of final market access impact.
• Competitive advantage – a tailored strategy to meet the decision makers expectations and the market needs, facilitates first to market opportunities, optimal product positioning and differentiation from competitors
• Improved value proposition – demonstrating the combined development, regulatory and market access strategy, tailored to the market opportunity, adds credibility and reassurance to shareholders and potential investors.

Missed opportunities?

So why do companies often miss the benefits of this “joined-up thinking”?

• For smaller companies and start-ups, it’s often a lack of appreciation of the benefits or a lack of immediately available technical expertise to identify the synergies and linkages to develop an overall combined programme
• For larger companies who have expertise in all the areas, it can be process and governance. The Head of Development is incentivized to deliver a successful development programme; the Head of Regulatory Affairs is incentivized to deliver a successful regulatory approval. Neither are incentivized to deliver a successful launch and market penetration. Improved process and governance can make significant improvements in this area.

Ultimately there are major benefits to be gained for the companies, healthcare providers and patients if industry (big and small) get this right. The G&L Healthcare Advisors and SmartStep Consulting partnership is here to bring the expertise for a combined development, regulatory and market access strategy alongside governance optimization, to maximize the likelihood of success of valuable new medicines.

Bill Griffiths is Chief Regulatory Affairs Officer at G&L Healthcare Advisors

About SmartStep Consulting:
Founded in 2010 in Hamburg, Germany, by Timm Volmer, SmartStep Consulting has grown into a global authority in market access and specialized consulting services, particularly for pharmaceutical and biotech companies targeting the German market.

The company’s skilled team of approximately sixty members serves clients throughout the EU and the US.

Related: G&L expands global reach and service offering with SmartStep Consulting acquisition