How We Help Our Clients

How We Help Our Clients

Our consulting services support senior executives and research teams in the pharmaceutical and biotechnology industries. Our focus is on R&D strategy and core corporate functions.

To learn more about the services we offer, click the options below:

Corporate and R&D Strategy

We have developed a structured approach to help companies adapt and design Corporate and R&D Strategies that link vision and goals

Biopharma is a challenging industry, in which risk and uncertainty as to what will ultimately work in clinical practice and generate profitability reign supreme; insiders often joke that strategies never work prospectively but are conjured up after the fact. At Catenion, our approach to strategy is based on finding compelling answers to three main questions:

What to achieve?
Where to compete?
How to win?

We are convinced that every company needs a rigorous and stable framework for operational decision-making that sets financial and strategic goals and defines how to reach them in terms of primary focus (therapy areas and indications, modalities and geographies), as well as defining the role of external vs internal innovation and partnering strategies along the value chain. Corporate and R&D Strategy also requires an operational model defining governance, incentives, capabilities, structure and key processes – these help shape company culture and should be designed to support goals and strategies to reach them. For biotechs, there is an additional crucial element of timing in terms of inflection points and targeted funding and exit events.

Asset & Company Screening

Catenion's proprietary ASAP (Accelerated Search & Acquisition Process) is a structured and validated process to screen and select the most fitting companies or assets for potential acquisition or licensing.

Biopharma is a dynamic business: emerging technologies, targets and approaches lead to a constant supply of novel, potentially interesting assets. Events such as clinical trial failures or a strategic redirection create a constant demand for a diversified portfolio. In order to find the “needle in the haystack”, Catenion utilizes its proprietary ASAP process. ASAP is an end-to-end process starting with integration of all the relevant parameters leveraging public and subscription databases. We apply Catenion’s proprietary tools and algorithms to qualitatively and quantitatively filter and score assets, companies or targets across relevant dimensions customized to each client. Following this initial automated process, our expert consultants continue with a multi-stage manual review from high-level curation to in-depth analyses, in order to prioritize only the most fitting assets, companies or targets, which are then considered for due diligence. Over the years, the process has led to numerous deals and is applied by some clients on an annual basis, providing a constantly up-to-date M&A or in-licensing radar.

Portfolio Review & Optimization

We apply established workflows to evaluate projects and entire portfolios to support decision-making and prioritization.

The aim of portfolio management is to prioritize assets and allocate resources to achieve the company's goals, which requires appropriate analytics and governance and must reflect the different characteristics of the R&D phases. Simply ranking individual projects by value, risk or commercial potential does not capture the full complexity of this task. There are competing demands for resources from different therapeutic areas, for the early-stage discovery vs. the late-stage development pipeline, for different modalities and therapeutic approaches, as well as revenue gaps due to loss of exclusivity, all of which need to be addressed. In addition, decision-makers have to balance expected returns from their investments with a desired level of innovativeness and risk in the pipeline. To help address these dimensions and choose the acceptable level of risk and desired potential for growth at different stages of a company’s evolution, “value-at-risk” analysis was adapted by Catenion from financial markets for biopharma portfolio management. Once the individual projects have been reviewed, all projects are compared, prioritized and the overall portfolio is optimized so as to best meet the company’s strategic objectives.

Target Selection & Priorization

We conduct an established and comprehensive process for the identification and prioritization of the most fitting and attractive biological targets for an asset or technology platform of interest.

Breakthroughs in biopharma often result from a combination of better understanding of disease biology and the availability of new modalities with which to act on the pathophysiology. We apply data science and machine learning to aggregate and integrate omics datasets per target, phenotypic data, associated diseases, clinical trial results, pipeline, competitive pressure and other relevant data including text mining of scientific literature. We generate a comprehensive and customized knowledge base that serves as the foundation for our systematic screening and initial selection of drug targets that drive disease progression. For the prioritization process, we also take into account strategic considerations from the client (e.g. percentage of de-risked targets vs. novel targets and balance of therapeutic areas). We continue by digging deep into the scientific validation of the role each target plays in a specific disease and patient setting. Key to the analyses is the level of scientific validation: do convincing clinical trial results point towards the target(s) being viable points of intervention? And what is known about the role of the target in the disease etiology and progression?

Therapeutic Area Strategy & Disease Mapping

Our Disease Mapping evaluates the current state, future scenarios and opportunities of an indication or therapeutic area of interest and complements them with internal cross-functional capabilities.

While the establishment of new modalities can take a long time (e.g. siRNA or gene therapy), sometimes major change happens without prediction (e.g. checkpoint inhibitors in oncology, or mRNA vaccination in infectious disease). This is why Catenion’s approach to disease mapping combines incremental extrapolation of visible trends with qualitative “what-if” analyses to highlight the potential for breakthroughs. We can also provide a more detailed view of the main players among the competitor companies that are active in the indication. Based on this review, we then map scenarios of patients' future journeys to highlight the most likely remaining unmet medical needs, as well as most promising fields of R&D focus for the client. Our approach starts with a review of the status quo of disease interventions and the remaining unmet medical need, the industry pipeline and an in-depth look at the early-stage science & technology landscape relevant for the diseases in question in academia and biotechs.

Indication Evaluation & Therapeutic Expansion

Our Therapeutic Expansion process allows for a systematic search, identification and prioritization of indications that best fit our client’s asset, in line with strategy and needs.

Many, if not all, biological targets play a functional role in the pathophysiology of more than one disease. Catenion’s Data Science Unit creates a target biology or technology-specific disease knowledge base by integrating data on disease genomics, mutational burden, epidemiology, animal models, scientific literature and many more project-relevant parameters complemented with development pipeline and competitive intensity. We often employ state-of-the-art machine learning, e.g. natural language processing algorithms, to support our analyses. Such an exhaustive analysis allows to systematically rank associated indications across scientific, clinical and commercial dimensions. This is followed by rigorous scientific deep-dives, covering areas from target biology in disease to unmet medical need, differentiation potential to development feasibility, competitive dynamics and market potential. At the last stage, we often involve KOLs to discuss potential clinical development strategy for different patient settings, delivering an actionable recommendation to the client on how to best move forward.

Clinical Development Strategy

We support companies to develop clinical development strategies that drive competitive differentiation through an adequate choice of trial design elements, such as powering, endpoints and comparators.

In the early translational phase of clinical trials, we support companies to identify potential patient settings and combination strategies and to achieve meaningful proof-of-concept by identifying strong efficacy and biomarker signals, possibly via adaptive trial designs. For late-stage development, the focus then shifts to the design of pivotal trial programs, including the powering of trials, the definition of adequate comparators and primary endpoints, as well as the inclusion of quality of life-related and other relevant secondary endpoints to de-risk the program both from a technical and a reimbursement point of view. We also provide a systematic review of the competitive field, trial designs adopted by others in similar situations (novel modalities might have different requirements) and benchmarks for patient recruitment, patient numbers and trial duration.

Science & Technology Mapping

We map landscapes for a given technology or type of therapy to distil strategic insights for our clients.

New technology platforms and therapy approaches are emerging at an increasing rate: biopharma decision-makers constantly need to update their understanding of the validation status and potential of these technologies, prioritize fields for partnering and internal capability-building, and ask the crucial question of whether and when to invest. Among the parameters we track are dedicated research funding, the number and distribution of scientific publications, patent applications and patents granted, clinical trials, investments in start-ups, deals, adoption by big pharma and KOLs in the field. In addition, Catenion employs both the S-Curve to capture scientific progress and the Hype Cycle to assess industry and investor sentiment for a given technology or therapeutic approach. Our process uncovers not just the tip of the iceberg, but also what is not yet visible in industry pipelines in terms of IP and publication activity. It is precisely in the area beneath the surface where our process yields unique insights that give our clients an edge, years before technologies reach the hype phase.

R&D Risk Assessment

Catenion's proprietary Risk Assessment tool identifies technical and scientific risks of an R&D program based on over 500 criteria with pre-defined scores and weights.

Catenion’s R&D Risk Assessment tool has been designed as an integrated part of a project assessment methodology, but can also be used independently to review technical risk associated with specific assets, e.g. in the context of a due diligence or a phase III investment decision. This proprietary tool was developed with expert input from across the industry and provides a pharma industry view on what constitutes average, high or low risk outcomes for the over 500 criteria captured. It has been applied to more than 1,500 R&D projects so far. To facilitate the analysis, Catenion has developed a proprietary software tool with specific questions and a transparent scoring system for all criteria. Different versions of the tool address specific aspects of small molecules, antibodies, CAR-Ts, gene therapies and other modalities.

Due Diligence

We provide investors with thorough Commercial Due Diligences of lead assets of potential target companies.

We often conduct Commercial Due Diligences of assets of interest, which may involve challenging and revising an existing forecast or the preparation of a bottom-up forecast by Catenion. Stakeholder interviews help consolidate forecast assumptions and often generate unexpected insights – depending on forecast complexity, we conduct multiple interviews with various stakeholders (prescribers, opinion-leaders, payors) for a commercial due diligence. Sometimes we also perform high-volume patient surveys to better understand patient journey and identify specific micro-segments. When reviewing existing client forecasts, we systematically challenge all relevant assumptions, including epidemiology, pricing, patient compliance, dosing and time to peak sales. For bottom-up forecasting, our general approach is to first project patient shares without the candidate under analysis and then assess potential for taking away shares from each competitor based on relative TPP strength. Our proprietary Risk Assessment can also be used as part of the Due Diligence to better understand the PoS of a given project.

The Catenion Academy

Educational programs for professionals to sharpen strategic thinking and improve risk mitigation in pharmaceutical R&D.

In addition to our consulting services, we offer tailored trainings and educational programs upon request for our clients. Selected examples:

Post-merger integration of portfolio management approaches
Roll-out of strategic initiatives such as broadening the understanding of non-standard clinical development strategies and trial designs
Establishing a basic understanding of corporate finance
Risky Business – The Pharmaceutical Industry Board Game: based on real-life industry data, Risky Business is an engaging workshop format to simulate the multiyear product development process in just a few hours and boost strategic thinking at all levels of an organization (groups from 5 to 250 participants)