Questions About Drug Development Strategy

The TPP is a strategic document that describes a desired drug or platform's features. It serves as the product specification sheet. Fundamental TPP attributes include: the disease / purpose, patient population / customers, Mechanism of Action (MoA), efficacy and safety profile. TPPs help teams to build fit-for-purpose workflows to develop their Minimum Viable Product (MVP).

A TPP describes the key quantitative and qualitative characteristics of your product. A development plan is a series of integrated workflows to meet these TPP criteria. The TPP ensures you build fit-for-purpose workflows to make the right GO/NO GO decisions to guide your developments.

TPPs are living documents that mature as more data and insights become available. Teams should develop a TPP for a specific product and indication / customer. If a program pivots to a new indication, customer or product, the TPP must be reworked to accommodate new qualitative and quantitative characteristics.

Most engagements begin with a discovery conversation to learn about your project, goals and challenges. From there, we create a consultancy package tailored to your stage of development. As work progresses, we remain available to help adapt the strategy as new data come in and the landscape shifts.

The time frame depends on the stage of your program and the amount of support needed. Our Strategy Sprints and Pitch Scrubs are designed to be short, interactive, output-driven sessions (~3 hrs). Broader consultancy projects are boutique services tailored to your goals and needs.

Yes, we serve clients globally from our home base in Frankfurt, Germany. Our working language is English.

Engagement costs vary based on the scope and complexity of the project. We provide consultancy proposals with a variety of options to suit the client's needs and budget. Consultancy proposals can be based on hourly rates, or priced by project. All prices are in Euros (€).

We work with teams to structure engagements that fit their needs and budget. Engagements can be broken down into phases. Consultancy projects can be built on an hourly or fixed-rate basis. We also offer retainer models for ongoing advisory support. We are happy to discuss all options available during our initial discovery call.

Building a strategy should begin as you begin developing your product concept. Strategy is about making clear choices about what you will and will not do. Once it is clear what you want to develop you can create the plans to build it.

I do not replace the functional expertise of nonclinical, regulatory or clinical subject matter experts. My drug portfolio management experience offers me a comprehensive understanding of the key stakeholders, datasets, milestones and deliverables required to bring products from discovery to the clinic.

I help teams develop the nonclinical dossiers (Modules 2.4; 2.6; 4) and define the key pre-clinical data packages and questions for scientific advice and other meetings with regulatory agencies.

Investors are interested in developments that have demonstrated potential for patient or customer impact, such as in vivo proof-of-concept data, pilot studies or increased product utility vs. competitive offerings. In the current landscape, simply having an innovative scientific idea is not enough. Teams must demonstrate they have a high chance of providing investors with a return on investment (ROI).

Downselecting from multiple indications is a necessary decision as money, time, and resources are finite. Determining the best indication to pursue requires balancing unmet medical need, market potential, and your ability to compete in the market. All of these factors are constantly shifting, so there is no one-size-fits-all approach. We can help guide you to make the right decision for your drug, or platform development.