OUR SERVICES
Science-led strategy across biopharma R&D
OUR SUPPORT
We provide customized support for your R&D strategy along the entire value chain of drug development; from answering focused strategic and technical questions around single assets to full-blown portfolio management and corporate strategy.
Our team’s expertise spans across a wide range of therapeutic areas and modalities – from rare diseases to oncology, from small molecules to the latest cell therapies.
PORTFOLIO STRATEGY
The key challenge for portfolio management is balancing the risk vs. reward such that catastrophic loss is minimized, but upside potential is maximized. At SCITARIS we have extensive experience with asset evaluation and prioritization methodologies, which accurately portray a firm’s risk profile. In context with the firm’s goals we address pertinent questions such as: Is a disease area likely to be more ‘druggable’ in the near-term? Is there any unmet need remaining in an indication in 10 years? Is a technology/modality platform likely to be fundamentally successful? Factoring in all these outlined considerations we help to create a guiding corporate strategy that maps out future growth opportunities.
Non-organic growth and innovation is often required to maintain a competitive position. At SCITARIS we have developed a science-led external opportunities screen, which identifies high-quality assets to complement the existing pipeline or re-position the company. The historical success rate of assets or companies identified by this screen has been >90%.
RESEARCH AND
PRECLINICAL R&D
Some of the key challenges in research and preclinical R&D are identifying and prioritizing the most crucial experiments. These are ultimately forming the basis for any science-driven development strategy and bolster confidence for clinical development hypotheses. In this context, identifying the best CROs and academic collaboration partners, defining timelines and budget estimates, as well as communicating preclinical results to investors are only a small selection of how SCITARIS can support your preclinical strategy development.
EARLY STAGE
CLINICAL DEVELOPMENT
The key challenges in early clinical development are demonstrating proof of mechanism and concept for your asset in addition to establishing adequate safety margins. To achieve proof of concept, choosing the right setup is vital and includes the selection of the appropriate dose, indication and patient subgroup/s. We believe that a lead indication should be primarily science driven to maximize probability of success. In addition, it should also incorporate the specific needs and capabilities of your company with an eye on commercial potential at the program level through follow-on indications. SCITARIS offers tailored science-driven support to help you in selecting and prioritizing these indications for your assets.
LATE STAGE
PIVOTAL DEVELOPMENT
The key challenges in late-stage clinical development are confirming the efficacy and safety of your asset. While the overall development strategy must fit your company’s portfolio and aspirations, small details in patient selection, trial design and combination strategy can wildly influence your assets efficacy margin in pivotal trials. Necessitated by emerging new modalities and regulatory requirements, alternative trial designs are now evolving. Those advances offer new opportunities, but also pose new challenges to developing companies. At SCITARIS, we support your overall clinical strategy and help you navigate the strategic details of trial design to maximize differentiation potential.
CMC & MANUFACTURING
The key challenge for CMC lies in finding a stable drug product with favourable PK/ PD parameters that can be produced in sufficient amounts to ensure steady supply. Specific CMC and manufacturing challenges are encountered by new modalities such as cell therapies. SCITARIS provides expertise in cell therapy manufacturing, from optimizing transduction protocols to increasing the final yield of genetically engineered cell products as well as other modalities. We review and challenge your protocols, capabilities and CRO partners and help you in designing viable processes for commercial-scale production.
COMMERCIAL POSITIONING
& DIFFERENTIATION
In an ever-increasing payor-driven world, product differentiation is critical to drive sales and thus firm success. At SCITARIS we integrate this thinking across all of our projects; is there a scientific hypothesis for clinical differentiation? Is this borne out in the clinical data? Will it still be relevant when the compound reaches the market? This can be at the asset, modality or indication level.
Telling this differentiation story is critical for commercial uptake and/or partnering discussions. SCITARIS offers support in various aspects of deep market profiling, niche identification and story-line creation to guide asset, portfolio or corporate strategy as well as maximize BD&L potential.
