What is our Strategic Advisory Panel?

Our Advisory Panel is a team of experienced professionals with expertise across all areas of drug development. We can offer an in-depth review of programmes and development plans to help streamline and improve speed to approval by identifying opportunities or risks early in the process and providing risk minimisation strategies.

Our team are

Highly skilled accomplished professionals passionate about drug development with hands on experience
and in depth knowledge of the regulatory environment.

They will:

Work together on a continuous basis allowing peer review and brainstorming of ideas

Offer a single point of contact to understand needs and coordinate support, with full access to the experts needed

Support KOL Development and Engagement: seeking expert community input either on a one to one basis or through more formal Advisory Boards

Our team includes

Regulatory, CMC, Non Clinical, Clinical, Statistical, Development experts

Network of SMEs

ex-Regulators/Inspectors/Specialists

Our team will

Analyse the situation

AdvizON™ the path forward

Apply the advice to the development programme

Our team offers a flexible approach and can AdvizON whole programmes, specific issues or provide ad hoc support:

Stage one

  • Review development plans before implementation

    • Identify risks and opportunities
    • Offer Clinical and Regulatory Development Proposals with supporting rationale

  • Challenge plans 

    • Identify potential issues/risks e.g.
      • Clinical study designs
      • Outcome measures
      • Develop risk log 
      • Focus on the issues that can make the difference between success and failure
    • Develop risk mitigation plans
    • Challenge normal pathways – are there alternatives?
    • Evaluate risks of alternatives
    • Support Go-No-Go decisions
    • Organise a brainstorming panel to work through issues with company experts to ensure robust argumentation is developed through rigorous challenge and debate

  • Check before you invest

Stage two

  • Review data available preparing

    • Gap analysis
      • What is missing 
      • How do we fix? 
      • What are the time/budget implications? 
      • What are the alternatives?
    • Identify and evaluate precedents
    • Zone into details as required

Stage three

  • Support Agency meetings

    • Prepare Questions for Agencies
    • Develop Briefing Packages
    • Agency meeting preparation planning – questions, positioning, and planning, rehearsals

  • AdvizON global Regulatory pathways

    • Accelerated routes to approval
    • Orphan
    • Paediatric
    • Timelines to market
    • Multiple regions – EU, US, Canada, Japan, Australia, MENA

  • Support the ‘Red Thread’ messaging in your dossier

    • Build a clear viable story
    • Distil the messages
    • Ensure a clear flow of information – this is critical to ensure assessors come to one conclusion.
    • Fill the assumption gaps

Stage four

  • Manage the review period

    • Prepare for the dossier review
    • Prepare key arguments, rationales in advance of questions.

  • AdvizON™ maximising regulatory opportunities

    • Early Access Schemes or
    • Regulatory Incentives, eg ‘US voucher’, Accelerated Approval, conditional/exceptional, SME, ODD

  • Ad hoc follow up throughout the development programme

    • Sounding board
    • Trusted challenge