biotech Consulting

Opportunity Assessment

Prioritize the opportunities for a Novel biomaterial drug delivery Biotechnology

Tags: Strategy, Pipeline Development, Product Market Fit, Novel Therapy, Startup, Drug Delivery

The Engagement

Conduct opportunity Assessment to Prioritize therapeutic options

The Client

A PE-backed biotech startup founded by an interventional cardiologist and an engineer who developed an endogenous drug delivery patch.

The SOW

Assess the landscape to prioritize product indications based on disease state, unmet need, technical feasibility, therapeutic efficacy, and regulatory requirements.

The Challenge

Explore and prioritize the market opportunities for a drug delivery biotechnology derived from a human protein.

The PE-backed startup founded by an interventional cardiologist and an engineer had an idea for a novel innovation that could impact how drugs are delivered or promote healing by using biomaterials produced within the human body.

However, the promising technology had dozens of applications. The startup needed a better understanding of the most feasible pathway to market by determining the disease states or injuries to pursue, the indication strategy, and potential regulatory hurdles.

The Game Plan

The client knew they wanted to pursue drug delivery in the form of a bioabsorbable patch made from a particular human protein essential to healing. While this narrowed the possibilities, the field was still wide open. The methodology to assess and prioritize the possibilities involved narrowing the field to five opportunities by applying two filters and then scoring against a well-defined rubric.

Filter 1: market size, addressable market, unmet medical needs, general technical feasibility, regulatory pathway

Filter 2: drug interaction with the biomaterial, difficulty of clinical trials, complexity of disease state or injury, drug efficacy

Scoring rubric: medical benefit, strategic fit, probability of success, financial impact

The assessment featured a written report and an executive-level presentation detailing the final five recommendations that included a 13-year horizon financial model to estimate the NPV and financial impacts.

Met with the client to understand the product, its origin, and how they envisioned it operating as a drug-delivery patch.

Conducted research into multiple diseases or injuries that require temporary continuous drug delivery via implantation or external adhesion.

Applied Filter 1 to the list of applicable diseases or injuries to develop a list of ten opportunities.

Conducted a workshop with the client to understand their preference and apply the Filter 2 to narrow the list to five core technology applications.

Developed a well-defined scoring rubric to rank the opportunities. Each dimension had at least four sub-criteria to evaluate the potential.

Deep research was performed to inform the score each opportunity and the financial model that included assumptions for development costs, COGS, drug dosage, market size and share, ASP, and operational costs.

Each opportunity was individually scored against the rubric to provide an overall prioritization supported by evidence and rationale.

The final recommendations were presented during a client workshop to carefully walk through the options, rationale, and propose potential next steps for portfolio planning and stage gating product development.

The Outcomes

The assessment wrapped with an 82-page report and presentation detailing the rationale for the five disease states or injuries in rank order: 1) radicular and joint pain, 2) external wound healing, 3) internal surgical adhesions, 4) macular edema, and 5) sinusitis.

The direction was clear. The client needed to prioritize a simple technical and regulatory approach for a broad clinical issue with a large unmet need that allowed them to build the technical complexity of the device over time. The treatment of radicular and joint pain followed closely by wound healing provided the fastest pathway to market with the greatest financial impact and lowest barriers to entry. Success in these two applications could potentially fund a robust R&D pipeline for the portfolio in the future.

The Value Delivered

The clarity to know which way to go and the confidence to take the next step.

The toughest part of clinical innovation is making it matter to those who need it most. While the science is exciting, the innovation must translate into business decisions to gain commercial traction. This startup sought consulting at the exact right moment in its journey. The beginning.

Forty-three percent of startups fail due to poor product-market fit. This client wasn't stepping into the unknown. It received a rigorous evaluation of possibilities before committing additional resources, giving them clear direction backed by evidence and analysis to guide them. Identifying the right market is the foundation of commercial success.

Opportunity assessment methodology

Given the vast number of applications for the technology, carefully defining two filters allowed the opportunities to be viewed objectively based on evidence.

Strategic prioritization Provided Clarity

Prioritizing the opportunities based on the scoring rubric provided the client with greater clarity of each indication, the challenges, and the path forward.

data translated into unparalleled insight

The financial model accounted for drug, dosage and patch size, and was designed to be easily updatable by the client as conditions changed. The competitive landscape and regulatory pathway revealed market entry points.

Next Steps & Portfolio planning

The ranking provided the client with a plan for next steps and a long-term vision. This was a starting point with a potential product portfolio to develop over a 13-year time horizon.

Repeatable Process

The use of a well-defined assessment tool and methodology allows the client to evaluate and compare new opportunities using the same metrics.