Alignment - Regulatory

Once a plan has been developed it must be implemented. Most organizations can develop good plans, but only the successful ones implement those plans.

Agency Management

The regulatory agency is identified as our gatekeeper stakeholder. If we do not pass this gate, we will be unable to meet the needs of any of the other stakeholders. The drug will not be accessible to the patients in need and the investors will not benefit from the risk they undertook. We must be clear and transparent to ensure that the Agency and Sponsor share the same objective and agree on the information required to meet that objective.

Our approach to FDA interactions is open, transparent and respectful. They can be considered to be the best drug development consults in the world because they know about all drugs under development. While they are prevented from disclosing confidential information, if you know how to listen you can learn a lot.

We encourage direct interaction with FDA personnel whenever it is possible and appropriate. These meetings must be well managed to achieve the maximum benefit.

  1. Questions: The questions posed must be designed to engender meaningful and useful responses.
  2. Background: The briefing package [backgrounder] for the meeting is critical and must be well crafted and organized. It creates an initial impression for each meeting and sets the tone for the dialogue.
  3. Meetings: The FDA is well prepared for each Sponsor meeting and has a pre-meeting to prepare. We conduct pre-meeting rehearsals to ensure that the Sponsor is prepared to answer the FDA questions and has an understanding of what to expect.
  4. Commitments: It is important that agreements made are clearly stated and agreed. Any ambiguity must be resolved.

Alignment - Sponsor

Project plan

We first develop with the Sponsor an overall project plan that clearly describes the overall objective, the deliverables and the key milestones. We have internal weekly staff meetings to review and track our progress against the plan. We issues monthly project reports to the Sponsor and encourage periodic meetings [t-cons and face-to-face] to keep the project on track and make adaptations as and when necessary. The plans will almost always change based on either new data from the development program or changes in the external environment. These must be expected, anticipated and managed to ensure that we remain aligned with the Sponsor and address any changes that effect our agreements with the FDA to ensure we stay aligned with them as well.

Pangea Partners

If you reverse the process of continental drift, all of the land masses reassemble to one continent that is called Pangea. While the pieces are all valuable and essential, it is important that everything fits together.

The real expertise in regulatory is not just being a technical expert, it is more an ability to understand and coordinate each discipline to create an integrated plan that has been developed with the regulatory authorities. Many consultants provide expertise in a single area but don't offer the critical integration. Our broad experience and association with experts in nearly all phases of drug development and approval ensure that all of the 'notes' play a harmonic song.

We have long term working relationships with experts in device registration, non-clinical toxicology, pharmacokinetics, metabolism, clinical statistics, Phase 1 studies and promotional activities.