Research & IP Evaluation Expertise
Our life science intellectual property practice provides analysis, assessment and strategic advice on life science IP. The practice is focused on both helping clients extract maximum value from their IP portfolios and supporting companies and investors conducting IP due diligence.
Alacrita has considerable experience in working with academic research institutions and has worked with over 40 universities, public- and third-sector research institutes, and research charities worldwide. We also undertake intellectual property due diligence on behalf of an investor or acquirer to support a transaction or asset valuation.
Typical work conducted:
- IP/project portfolio evaluation and triage
- Techno-commercial project appraisal
- Review of effectiveness of translational research fund schemes
- Strategic IP support
- IP/technology licensing
- Business plan development
- Spin-out company creation
- Economic Impact studies and project valuation
- Organizational improvement of technology transfer and incubation services
The service is designed to sit alongside what is offered by established patent firms. We do not file and maintain patents but provide high-level strategic advice. For example, patent applications and procedures can take on a life of their own, with organizational inertia masking the need for a decision. We can provide a realistic, commercially relevant reality check, helping clients rationalize and prioritize IP assets, and plan their commercialization.
Our technical areas of expertise span the following aspects, across therapeutic areas:
- Pharmaceutical chemistry
- Genetic engineering
- Cell and gene therapy
- Clinical diagnostics
- Medical instruments
The below list of recent projects and case studies can help illustrate the type of expertise we typically provide in this area.
Sample of recent projects:
Value potential of a novel cell-based assay: A leading UK university had patented a cell-based assay which it believed had potential in drug discovery, or as a whole-cell biosensor, and asked Alacrita to review the technology platform and develop a commercialization strategy if appropriate.
IP portfolio triage of a live biotherapeutic product for a TTO: A technology transfer office required support in evaluating its life science research programs to help direct internal funding towards its most commercially viable projects. Alacrita was commissioned to provide a specialist commercial and technical knowledge base to evaluate a portfolio of patents/IP disclosures from multiple principal investigators. One such project was a novel probiotic delivery system for antimicrobial peptides against infectious disease.
Economic Impact of a Research Institute: A UK public sector life sciences research institute focused on fundamental mammalian biology required an economic impact assessment of its science, as part of the evidence base accompanying a submission for renewed core research funding. The particular challenge was to link scientific contributions made at the institute, beyond the immediately “translatable” research, to economic value created, given the long time-frames and multiple stakeholders involved. Alacrita was engaged to address this need.
Crohn's Disease research project plan: A research group at a leading university had manipulated autologous regulatory T cells (Tregs) to give them gut-homing properties, making them suitable for influencing the course of inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. The commercial potential for this novel treatment was thought to be substantial if the logistic aspects of harvesting and delivering the autologous cellular therapeutic product could be addressed. Alacrita was asked to produce a commercial development plan to map out the opportunity and value the research program.
University life sciences IP and project portfolio review
Challenge: A leading science university needed support with evaluating and prioritizing life science research projects for funding and commercial support. The objective was to help promising IP attract and secure investor and partner interest.
Solution: This assignment was conducted over several months and was composed of three phases:
- IP audit: Using a project characterization template running on a secure web-based platform, we surveyed several hundred principal investigators (PIs) to identify potential commercially-viable projects with filed or patentable IP. This encompassed the entire life science research portfolio of the university including therapeutics, biomarkers/diagnostics and medical devices.
- Project prioritization: Our consulting team, comprised of pharma, biotech, diagnostics and medtech industry specialists, analyzed the information received from the PIs and validated it through a combination of internal analysis, external research and telephone interviews. In order to enable projects to be ranked into priority categories for the next stage of the analysis they were scored according to their: value in use, market attractiveness, and developability.
- Techno-commercial development plans: We developed development plans for selected top-priority projects. Our client convened an expert panel which selected projects most suited for focused financial support in order to reach one or more value-creating milestones and thereby progress toward partnering and/or spin-out goals.
Case Study: Development plan for novel small molecule for prostate cancer
Challenge: For a leading university with an early-stage novel small molecule to treat prostate cancer, Alacrita was asked to validate a development plan in order to support activities for securing investor, translational grant-funder and/or pharma partner confidence.
Solution: Alacrita reviewed all the documentation already provided by the academic inventor and any available publications validating the target. We held a teleconference with the core team to get a detailed understanding of the project, the nature of the ‘hit’ generation work and the ‘hit’ molecules generated to date, available in vitro and cell-based assays and in silico models, and the basis for the projected costings for discovery, pre-clinical development and Phase I and II clinical trials, as prepared by the team. We found that although evidence to date had been generated for metastatic prostate cancer, this particular target was known to be overexpressed in other cancers and therefore our consultants proposed exploration of small molecule in a range of tumor types, both in vitro and later in vivo.
We developed outline clinical development strategy and plans, costings and timelines, based on our experience and appropriate industry standard metrics, for:
- Hit-to-lead medicinal chemistry, computational chemistry and screening (in vitro activity and preliminary ADME screens)
- Lead optimization medicinal chemistry, computational chemistry and screening (in vitro and in vivo activity and ADME/DMPK screening)
- Pre-clinical development, including non-GMP then GMP, pharmacology and toxicology
- CMC (process development, non-GMP and GMP batch manufacture, formulation development and trial supplies)
- Early clinical development to clinical proof-of-concept (Phase I safety trial and Phase IIa study).