Supporting Biotech & Pharma Tech Transfer
Alacrita works with universities, research institutes, and centers of innovation to help them understand the commercial viability of their programs, bridge the gap between them and the industry, and guide them towards successfully partnering, licensing or spinning-out scientific discoveries. In the current funding environment, tech transfer offices may be forced to carry programs for longer due to the shortage of private money, placing even more importance on optimizing and prioritizing resource allocation.
Our extensive industry experience and technical and commercial expertise enables us to assess the feasibility of a project, its chance of success, define its realistic commercial potential, and map out its potential go-to-market pathways.
As a consulting firm that also provides support to pharmaceutical and biotech companies and healthcare investors, we have a clear understanding of what these organizations look for when evaluating potential partnerships and licensing opportunities, and can therefore help sponsored researchers and tech transfer offices effectively prepare and position their projects to garner interest from industry and secure a portion of scarce biotech funding.
Typical support we provide:
- Opportunity mapping, which involves identifying and quantifying the commercial potential of a technology, mapping out go-to-market pathways and identifying key risks and sensitivities.
- Advising on the additional data generation and killer experiments necessary to secure scarce biotech funding.
- Program reality checks and assessment of their technical and commercial feasibility.
- Producing or validating development plans, including high-level maps of the required discovery and development steps to attract industry partnerships.
- Market and competitive landscape analyses.
- Support with partnerships and licensing, including partnerability assessments, mock due diligence, and term-sheet and negotiation support.
- Providing hands-on support or general guidance on pitching directly to potential licensees and partners.
Program & Funding Prioritization
We frequently assist tech transfer offices with evaluating their biotech & pharma research projects for funding and commercial support, with the ultimate goal of helping promising IP attract and secure investor and partner interest. This can involve several steps, including:
- IP Audit: an IP audit typically involves surveying principal investigators to identify potentially commercializable projects with filed or patentable IP. This can encompass the entire life science research portfolio of the organization, including therapeutics, biomarkers/diagnostics and medical devices, or only specific technologies.
- Project Prioritization: our consulting team, which includes industry specialists with backgrounds in pharma, biotech, diagnostics and medtech, analyzes the information received from PIs and validates it, often using a combination of, for example, internal analysis, external research and telephone interviews. Projects are then scored by their value in use, market attractiveness and developability.
- Techno-Commercial Development Plans: For selected top-priority projects we develop commercial development plans to aid in prioritization. The focus of these plans is to set out the steps, with associated objectives, timelines and costs, to take the project to the next fundable milestone, be it licensing, spin-out or translational research grant to take the project forward.
Alacrita performs deep technical and commercial assessments of programs and program portfolios. This can include a critical analysis of each market opportunity and establishes the competitive positioning for each program and identifies key competitor programs at stages from early discovery through to clinical development. We can also evaluate the sufficiency of an IP position and provide an expert technical critique of the strength of existing data.
We can highlight the key development paths open to each program - considering licensing and spin-out options - and make recommendations on points of industry engagement. Our final recommendations can clearly outline the fundamental research steps needed prior to engagement with potential partners/investors.
Many of our tech transfer clients have large portfolios of programs that span across multiple industries, which can reasonably create gaps in knowledge. Alacrita often provides supplemental support on as needed basis in areas ranging from spin-out requirements and licensing deals to preclinical and clinical strategy, planning and guidance, including help understanding the additional evidence – killer experiments - that should be generated or considered to grab what scarce biotech funding exists.
Recent Tech Transfer & Research Institute Projects:
- Mapping an oncology project opportunity to support fundraising for a leading cancer research institute: The technology transfer function of a leading cancer research institute needed a development plan for a promising small molecule lead series against a novel anti-invasion/anti-metastasis target for solid tumors. The plan was required to support fundraising from venture capital investors with the complication of demonstrating the prospective differentiation of inhibitors for this proprietary target versus recent new entrants.
- Development plan for novel small molecule for cancer: For a university with an early stage novel inhibitor of the JAK2/STAT5 pathway intended to treat hematologic malignancies, Alacrita was asked to validate a development plan to support activities for securing investment.
- Critical assessment of three novel research programs for a tech transfer office: The university tech transfer office required a critical assessment of three novel research programs being developed for the potential treatment of haematological cancers, including chronic lymphocytic leukaemia. Following previous triage exercises evaluating multiple assets for the client, Alacrita was once again commissioned to provide an evaluation of the commercial potential and IP position of the three programs in development, each involving chemically derived analogues of a naturally occurring macrocyclic polyketide with known cytotoxic and immunosuppressive activities.
- IP portfolio review for UK-based charity: A charity with significant revenues from an older patent portfolio was facing a sizable reduction in income from 2017/18 due to patent expiry. With a current research portfolio of 300 active grants, the charity wanted to increase the conversion of its research findings from these investments in to new treatments, products and services for direct patient benefit. The charity wanted to better understand its portfolio, identify investments that could replace the imminently receding revenue stream, and get a better understanding of areas of research that should be supported in future funding rounds.
- Radiopharma R&D strategy for nuclear physics research institute: A major nuclear physics research institute looking to build a capability in nuclear medicine needed support with its R&D plan. Alacrita was engaged to help craft a new R&D strategy.
Opportunity analysis of phage technology for a university tech transfer organization: A university technology transfer organization asked Alacrita to explore the different potential commercialization pathways for a novel platform technology. The overall effect of the system is to ‘convert’ an antibiotic resistant bacterial population into a sensitive population that can be controlled by conventional, inexpensive antibiotics. The unique features of this technology potentially open a differentiated set of opportunities which Alacrita was asked to explore.
- IP portfolio triage of a live biotherapeutic product for a US TTO: A technology transfer office of a leading university 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 in the pharmaceuticals and life science sector to evaluate a portfolio of patents/IP disclosures from multiple principal investigators. Project included a novel probiotic delivery system for antimicrobial peptides against infectious disease, natural product for Alzheimer's disease and another for an antibody-drug conjugate in oncology.
qPCR diagnostic platform business plans: A research group at a leading research-intensive university had developed a qPCR diagnostic/ prognostic platform for patient stratification in autoimmune diseases which they believed could be the basis of a viable spin-out business. A number of prospective VC investors were interested in the project but needed to understand the detailed business model before committing to any investment. Alacrita was engaged to advise on the most appropriate way to commercialize this technology and, if a spin-out were appropriate, to work up a viable investment-ready business case.
Market landscape exercise for three oncology university-based therapeutics: A leading private US academic institution, recognizing the need to further develop early discoveries from the university in order to facilitate industry partnerships and clinical development of their assets, had created a therapeutics accelerator program. The program had identified its three first projects to move forward, and were prepared to take these assets through IND. These assets were in development for oncology indications, and spanned two modalities: two small molecule therapeutics and a lipoprotein nanoparticle therapeutic.
In order to guide the next steps of development for its assets, the university asked Alacrita to perform a market and competitive landscape analysis for each of the three assets based on the target and proposed initial indication for each asset.
- Crohn's Disease research project plan: A university research group 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.
Oncology clinical expert input and asset valuation for university spin-out: A clinical stage immuno-oncology biotech company spun out from a leading university had completed a Phase I clinical trial in ovarian cancer patients with its lead antibody. In response to a request from a potential pharma licensor, the biotech needed to build a model of projected sales for the antibody. Rather than just a revenue forecast, a full valuation model was needed to provide a firmer underpinning for the licensing discussions.
TTO & Research Institute Case Studies
Challenge: A university research team had worked for a number of years on the development of a novel interventional cardiology device. Recent progress had been made with preclinical testing on pigs, as well as a collaboration with a leading medical device company. This recent activity had led the university to seek clarification on the status of the project from a third party with specialist expertise. The team needed a reality check on the status of the project, including current activities and a top-level sanity check on its technical feasibility.
We conducted the following to meet the objectives of the assignment:
- technical expert review of the history of the project, its current status, the principles and technologies behind the product concept(s), and the clinical implications of the proposed innovation
- desk research, drawing upon public domain information and our databases
- interviews with interventional cardiologists to gain their views on the deficiencies of existing devices and the need for improvements in performance
- a top-level review of the technical feasibility of the proposed concept(s) to highlight any potential red flags on performance or manufacturing.
Challenge: The technology transfer function of a leading cancer research institute needed a development plan for a promising small molecule lead series against a novel anti-invasion/anti-metastasis target for solid tumors. The plan was required to support fundraising from venture capital investors with the complication of demonstrating the prospective differentiation of inhibitors for this proprietary target versus recent new entrants.>
Our consultants reviewed the scientific literature and the lead academic’s proprietary results to determine therapeutic areas where the known activity provided the most compelling rationale. We then assessed the competitive landscape, both for marketed drugs and for those in clinical development, to determine the most likely options for positioning.
Next we created a credible target therapeutic profile and positioning for a successful agent, developing an outline screening cascade, combining the academic’s proprietary in vitro and in vivo assays with others relevant to the mechanism of action and a cascade of standard ADME, PK and toxicology screens. This was to create an optimization and a preclinical development plan for the lead product. Indicative costs for process development and primary and secondary production of clinical trial materials were then produced.
We assessed strategic options for early-stage clinical development and produced an integrated project plan and timetable. Finally, we costed the overall plan, with a range of contingencies, to provide a funding requirement for the project. The client then successfully used the plan to obtain a term sheet from a venture capital investor.
Challenge: A research group at a leading research-intensive university had developed a qPCR diagnostic/ prognostic platform for patient stratification in autoimmune diseases which they believed could be the basis of a viable spin-out business. A number of prospective VC investors were interested in the project but needed to understand the detailed business model before committing to any investment. Alacrita was engaged to advise on the most appropriate way to commercialize this technology and, if a spin-out were appropriate, to work up a viable investment-ready business case.
Alacrita first confirmed the value proposition and determined the scale of the commercial opportunity for a prognostic biomarker for relapse risk in prospective autoimmune indications, and evaluated the competitive landscape and existing competing technologies, both marketed and developmental. We then developed and evaluated options for the commercialization strategy and business model and confirmed that a spin-out option, as a contract lab, was indeed viable. We then developed a written investment-ready business case for a spin-out to exploit the technology platform, describing the opportunity, business model, development strategy and plans, costings and timelines, based on our experience and appropriate industry-standard metrics, and outline financial projections. We also introduced the academic team to a prospective diagnostic lab partner, enabling a rapid start to the business.
Challenge: A leading research institute developing novel approaches for the production of ophthalmic treatments wanted to conduct a market and competitive assessment of the current supplier base and prospective novel technological approaches.
Our consultants conducted the project in two parts:
1. Assessing the market size, the structure and segmentation of related products (e.g. by application and geography) and demand growth rates. This was followed by structure characterization of the supply chains and identification of the current and developmental competing production technologies, or other technologies that could be applied to the production of relevant products. The findings from this part of the exercise allowed us to review the competitive positioning of the client’s technology.
2. Assessing the competitive environment, applying Michael Porter’s Five Forces framework (modified to incorporate the impact of regulation which was an important factor in this particular industry) to illustrate the competitive landscape.
Both parts of the project involved primary data collection, predominantly through selected telephone interviews, to supplement secondary data sources
Challenge: A UK university had developed a technology that permits the creation of surface-immobilized functional RNAs in a microarray format. The technology has the potential to impact both industrial and academic research and contribute significantly to the unravelling of the complex interactions currently hidden within the transcriptome. Previous work on commercialization planning had established interest in the technology among both prospective academic and industrial users. However, feedback from interested parties highlighted that the university needed to better demonstrate utility of the RNA arrays in a practical application. Alacrita was therefore asked to provide further business planning and development support to the project.
We first developed a commercialization roadmap characterizing the identified commercial opportunities, including transcription profiling, monitoring of transcription and monitoring translation, including for market opportunity, competitive environment, technology ‘fit’, routes to market and project readiness for each route.
We then provided business development support including identification of prospective partners/collaborators, development of materials to support discussions, introduction of the technology to prospective partners and where required, support for negotiations with prospective partners. Patenting strategy support was also provided, particularly in relation to ongoing prosecution of US and EPO patent filings.
Challenge: A university research group had discovered a new pathway for regulation of T cell trafficking in the inflammatory response. The group had also identified an anti-inflammatory peptide and its cognate receptor which could form the basis of a novel therapeutic strategy for treatment of inflammatory and autoimmune diseases. After demonstrating efficacy in several animal models, patents were filed and the commercial opportunity was somewhat explored. The university believed the discovery represented a potential technology platform suitable for a spin-out company, and therefore had already identified an ex-industry executive and entrepreneur interested in leading such a spin-out, and had also interested VCs already. Alacrita was asked to conduct a technical and commercial review of the opportunity, as well as provide support for the development of an operations plan and an investment slide deck to support fundraising activities.
Our findings confirmed the attractiveness of the opportunity and the viability of the provisional translational research plan. Our consultants reviewed and commented on the evolving operations plan and underlying assumptions to refine the investment slide deck, ensuring that it conveyed the key messages for prospective investors in the planned pre-seed round. Subsequently we drafted a successful application for a translational research grant which provided cornerstone funding for a pre-seed investment round enabling a spin-out company to be formed.