Case Studies

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A pre-clinical client with a cell therapy product wants to identify the root cause of manufacturing variations Variance on the process was too high with too many lots not passing, impacting patient outcomes The release timeline was too long, impacting patients availability to get therapy

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Project teams need governance portfolio context to inform their investment proposals

Commercial Heads need to develop specific disease area strategies and seek Governance approval Teams need guidance on governance-approved TA priorities (e.g., TPP hurdles; prioritized indications and/or MOAs, development plans, diagnostic strategies)

Senior committees need consistent and insightful portfolio reports to help frame investment proposals in the broader portfolio context and upcoming decisions Senior leaders need new or improved processes to enable cross-functional communication and consistent evaluations of pipeline projects

A small, pre-clinical biopharmaceutical company wanted to assess their current website among relevant users (Doctors and Venture Capitalists) and identify areas for improvement

A small Biotech company wanted to understand similarities and differences for their developmental cell transplantation process with current ASCT processes The company was unsure what their process would cost, and wanted to understand what current ASCT procedures cost, and what parts of that cost would carry over to their process

A mid-sized pharmaceutical client desired multi-year support to help define, implement, and market a suite of support services for their portfolio of premium-priced orphan specialty products Support services included enrollment, financial/ reimbursement, patient education, and monthly lab monitoring TA highly competitive with multiple launches expected during the project

A small but highly-valued biopharma client sought to quantify the opportunity for a new hypercholesterolemia product across 6 patient segments and 3 physician specialties More specifically, they wanted to know which product attributes will drive share uptake vs. the market-leading statins and the classes in late-stage development (PCSK9i and CETPi)

A privately-held, development stage pharmaceutical company wanted to understand the prevalence and unmet needs of an ultra-orphan disease and how a new drug might be priced and positioned to optimize uptake More tactically, the team wanted to know how to identify these ultra-rare patients for clinical trials and commercialization

A top 50 global pharma company wanted to know how they could reach $500M US peak sales for a Phase 2/3 drug treating latent tuberculosis (LTBI) The company also sought advice on how to re-frame the large and ill-defined literature prevalence to a more realistically addressable universe of patients, as well as identifying ways to grow that market

What is a starting point for R&D resource needs for a Buy Up? What are the drivers by activity and/or function? What is the expected R&D resource demand across the portfolio?

After a large merger, there was a need to align R&D portfolio data systems, investment valuation methodologies, and data processes Need for a flexible data system and processes that could handle asset valuations for portfolio decision making, 1-off BD valuation scenarios, and global assumptions instead of U.S.-only

Go-to-market strategy in the US and Asia Investment business case for lead product, and impact on company valuation for fundraising Need for a “roadshow” presentation about the company’s U.S. value proposition

What are the biggest IP-driven commercial risks to an oncology portfolio? Which risks are most sensitive to patent, exclusivity, targeted combination, formulation, & line extension assumptions?

A mid-side biotech company wanted to explore adding a small molecule inhibitor to a newly discovered target in their therapeutic area They wanted to determine the cost : benefit ratio of two options Develop the small molecule inhibitor in-house In-license a small molecule inhibitor from another company

Create a disease area strategy to align global and company specific views for an ID area Define commercialization challenges and unmet need in the ID area Enhance PTS for the assets in the ID area

A large biopharmaceutical company wanted to evaluate 3 novel platform technologies in development based on technical merits and feasibility The client wanted to determine the degree to which they would integrate and harmonize with their current portfolio and disease areas of focus Lastly, the client wanted to understand the competitive landscape and recent deal trends for prioritized platform(s)

Understand the competitive landscape for several disease areas Gain insights from the design and success/failures of competitor clinical trials Evaluate strategic importance of PK and/or PD biomarkers Prioritize competitive threats based on a review of competitor MOA, published literature, and execution

A mid-size biotech company has an immuno-oncology therapy with a new MOA in clinical trials They want to determine the current and future landscape for immuno-oncology products, especially with unique MOAs Gain insights from competitors clinical trials and launches and create a differentiation strategy

A venture capital firm wanted to understand the landscape of a new stem cell platform technology for use in the regenerative medicine field They wanted to comprehend the technical advantages, stage of development, therapeutic uses, technical feasibility and intellectual property surrounding the technology.

A privately-held, development stage pharmaceutical company wanted to understand the current and future treatment landscape of prostate cancer, opportunities for novel platform development, and forecast peak year sales across several potential indications TA has complex market dynamics, with other products gaining additional indications and targeted therapies expected to become more prominent in the market

A UniveristyTechnical Transfer Office wants to analyze an internal novel cell therapy product indicated for several cancers They wanted to prioritize the indications and understand the potential market over 20 years for the product across different geographies, including US, EU, Japan and China. The client wanted to negotiate the licensing of the technology based on the market forecast and previous licensing deals

A privately-held, development stage pharmaceutical company wanted to understand the market and NPV potential of its two lead assets in Ulcerative Colitis and Crohn’s Disease to support conversations with potential investors The Company’s TPPs and evolving standard of care required a more complex approach to patient segmentation to allow different uptake assumptions across patient profiles

Our client, a mid-size biotech company, has a platform technology to cross the blood brain barrier and deliver a novel therapeutic modality The client wanted to first identify indications with an unmet need that would benefit from the novel therapeutic modality The client then wanted to build a framework for prioritizing indications, and to create a commercialization strategy for each prioritized indication

Our client is a lean, well-funded early stage company focused on advancing cutting-edge research into development The scientifically savvy senior leadership needed on-demand consultation to tackle recurring analyses and novel strategic problem solving, in order to support key corporate decisions

A mid-size biotechnology company wanted to organize its proprietary therapeutic technology portfolio for 3 disease areas They wanted a framework to for portfolio management to drive growth and realize full potential of the platform technology through product and portfolio assessments Specifically, they wanted to identify opportunities, gaps and risks in the portfolio and enable selection and prioritize new programs for internal portfolio

Our client is a privately-held, clinical stage company in need of communicating a coherent corporate strategy to the equity market The executive committee retained us to poll the opinions of its members, and to design and facilitate an offsite that would result in an informed, aligned strategy for the company

A privately-held, development stage pharmaceutical company wanted to understand the clinical and commercial factors across a breadth of indications in order to prioritize development There were initial thoughts on several broad disease areas, but no concrete goal or therapeutic target

Which indications are best suited as a first indication for a new technology? How do commercial, technical, and clinical considerations inform this recommendation? What makes the indication(s) compelling? What concerns should be addressed?

Our client is a seed-stage startup focused on IND filing for a novel cell therapy, which requires complex protein engineering and an extensive manufacturing supply chain The executive team requested a short-term engagement to assist the team in better understanding its timelines and creating board-ready slides to communicate the status of manufacturing activities

A large biopharmaceutical company wants to assess the regulatory and clinical biosimilars market to enable informed treatment decision making in the best interest of patients

A mid-sized pharma client wanted to evaluate quantitatively the impact of launch messaging and positioning for a orphan specialty product (messages spanned efficacy, safety, reimbursement, and enrollment) In addition, they wanted to ensure the messaging is complementary to the messaging for related products in their portfolio

A mid size biotech company has a drug targeting a rare cancer mutation and wanted to plan an (ideal) CDx test to accompany the drug launch They wanted to determine the current usage and future adoption of different molecular diagnostic platforms (single analyte, NGS and liquid biopsy) Understand the pro's and con's of each platform and determine stakeholders (payers and physicians) perceptions

A top 50 global pharma company wanted to know how they could reach $500M US peak sales for a Phase 2/3 drug treating latent tuberculosis (LTBI) The company also sought advice on how to re-frame the large and ill-defined literature prevalence to a more realistically addressable universe of patients, as well as identifying ways to grow that market

Project team investments proposed to decision-making executives did not use a consistent set of financial valuation data or tools, nor were these easily shared or aggregated into a portfolio view As a result, there was a need for a single system with shared financial assumptions and methodologies for reporting and decision making

Our client is a lean, well-funded early stage company focused on advancing cutting-edge research into development The scientifically savvy senior leadership needed on-demand consultation to tackle recurring analyses and novel strategic problem solving, in order to support key corporate decisions

Which indications should the IO candidates be prioritized for? How does the product positioning affect the overall IO portfolio for the company? Go/no-go decision on mono / combotherapy

A pre-clinical client with a novel drug platform wants to identify the best market for trials and product launch. Client wanted to understand landscape and market potential for five preselected chronic diseases. Client wanted to know if any other diseases for their preselected anatomy were viable markets as well.