We have worked with clients across the U.S. Europe, the U.K. and Asia Pacific and have a keen understanding of the unique natures of their environments.

Our service offering is global and we have insights and networks in all regions of the world.

We have in the last eight years consulted for over 70 companies, on more than 170 different projects in a diverse range of therapeutic areas.

Case study 1

Opportunity and market potential for a new allergy treatment in children
  • Biotech company aims to develop its first product for novel allergy treatment in children through to clinical proof of concept before partnering with a global pharmaceutical firm and its currently raising capital to support pre-clinical development program
  • Assess the opportunity and market potential for this treatment for potential investors
  • New company with limited experience and international network in therapeutic area
  • Unclear prescribing path in US and EU
  • Incomplete pitch deck covering mostly pre-clinical science data
  • Desktop research to review market potential, competitive landscape, treatment pathways in EU5, US and Australia, identify KOLs and review burden of disease for each jurisdiction
  • Develop a discussion guide and interview KOLs to validate desk top findings and gain further insights
  • Develop several Target Product Profiles (TPPs) and test them with KOLs
  • Develop supporting report covering desktop research and KOL interviews and an epidemiology-based early forecast for the indication to inform on potential opportunity for key markets (to be used in company’s pitch deck for investors)
  • Company has clear picture around the patient pathways, key decision makers in key jurisdictions and the preferred TPP by KOLs
  • Several KOLs expressed interest in being involved with further clinical development of the treatment
  • Company is investor ready with completed pitch deck, including market assessment and epidemiology-based early forecast for the indication for key markets

Case study 2

Development of commercialisation business case for NHMRC grant application
  • University research group has discovered and patented a novel product to break antibiotic resistance
  • To further develop this technology, they are submitting funding application to the NHMRC Development Grant Scheme
  • As a general requirement for NHMRC development grant application, applicant must provide comprehensive evidence of their strategies to commercialise their product and bring it to market
  • Research group has limited knowledge in route to market, size of addressable market, how to develop TPP, competitive landscape and regulatory pathway to get this product approved locally and in EU and US market
  • Review of relevant literature and market reports for the development of novel antibiotics and combination products (focus on US, EU5 and AUS) as well as draw from internal expertise in commercialisation and regulatory, including in the field of infectious diseases, AMR and drug repurposing
  • Develop commercialisation business case, including commercialisation work plan (route to market, reference annual milestone, risk management and partnering strategies, regulatory pathway in key jurisdictions)
  • Compelling commercialisation business case, which incudes commercialisation work plan – route to market, reference annual milestone, risk management and partnering strategies, regulatory pathway in key jurisdictions etc.
  • NHMRC grant was awarded.

Case study 3

Pan-tumour HTA policy
  • Provide advice to Industry sub-committee on PBAC review of pan-tumour issues in immuno-oncology
  • Increasing number of PBAC and MSAC immunotherapy submissions across different product and tumor types leading increased workload and delays in reimbursement
  • Minister directed PBAC to examine potential streamlining opportunities
  • Contacting HTA experts to analyse and learn from experiences in other countries that may apply
  • Review, map and advise on potential opportunities for adaptation in Australia for incorporation into industry response
  • Project output well-received by Industry sub-committee
  • Individual companies accepted offer for further consultation with Biointelect on possible solutions
  • Request from leading company to present findings at international symposium in Japan
  • PBAC did not conclude that a change is needed to policies and processes but agreed to monitor the issue and consider future advances in biomarkers

Case study 4

Industry engagement strategy: data linkage
  • University network of linked data sets needed industry engagement strategy
  • Strategic intent was to identify uses of linked data to support therapeutic development
  • Needed to understand the industry/private sector and key stakeholders
  • No background knowledge on industry opinion on linked data for therapeutic development
  • Desk top research to map entire sector involved in therapeutic development
  • Online survey developed and implemented to understand knowledge, needs and barriers
  • Selected interviews with key stakeholders conducted to gain greater insight
  • Best value proposition understood and key stakeholders identified
  • Baseline need for education, communication and product awareness understood
  • High level industry engagement strategy presented to Board and approved

Case study 5

Technical due diligence for an acquisition target
  • Assess the scientific and commercial value behind a US-based platform technology company
  • The company needed technical assistance assessing the robustness of the science / potential commercial value of the technology
  • Technical due diligence on >50 data files
  • Regulatory pathway to FDA approval
  • Market analysis of technology and indication
  • Manufacturing scale-up feasibility analysis
  • Report covering all elements of scientific and commercial diligence presented to the board of directors
  • Term sheet in place with acquisition being negotiated
  • Follow-on work conducting diligence on a separate technology to potentially be integrated into the platform

Case study 6

Nanoparticle drug reformation product development strategy
  • Biotech company is reformulating 3 approved oncology drugs (small molecules and biologics) for US and EU market
  • Assess the opportunity and market potential for these lead candidates for potential investors
  • Generate pitch deck for presentation to investors to include market assessment and revenue projections for key global markets, along with strategic, regulatory, clinical and HEOR considerations
  • New company with limited experience and international network in therapeutic area
  • Incomplete pitch deck with no market assessment and revenue projections for key global markets
  • Review of oncology market dynamic for key markets and analysis of current standard of care and patient treatment pathways
  • Identifying unmet needs and defining value proposition for three lead candidates
  • Market assessment and top line revenue model for key markets
    Advice on licencing and exit strategies
  • Development of 25-30 slides pitch deck for presentation to investors
  • US and EU revenue forecast that supports investment case
    Defined unmet need and value proposition for three lead candidates
  • Advice on regulatory strategy, clinical design, licencing and exit strategies provided
  • Company is investor ready with complete pitch deck, including market assessment and revenue projections for key global markets

Case study 7

NPP: Reimbursement strategy
  • Australian MNP company needing to develop reimbursement strategy for novel rare cancer therapy
  • Recent changes to regulatory and reimbursement pathways with new provisional approval process
  • Ambiguity about the best path forward
  • Independent interviews with relevant key stakeholders including: clinicians, professional society, HTA agencies, government department, patient advocacy group
  • Development of overarching strategy and key tactical elements
  • Key stakeholder buy-in to de-risk the path forward for the company

Case study 8

Go to market: Pneumococcal conjugate vaccines (PVC)
  • MNP company wanted to develop Go To Market strategy for a novel pneumococcal conjugate vaccine
  • Context focused on evidence gaps to support reimbursement and likely disease burden studies to fill gaps
  • Team new to vaccines in country that was the scope of the engagement
  • No background knowledge of product, or key stakeholders for funding and reimbursement of vaccines in public market
  • Desk top research to identify international and local evidence base for PCV, gap analysis
  • Interviews with KOL’s to validate findings and identify study opportunities
  • Stakeholder map of vaccine policy and funding decision making bodies and processes developed
  • Local evidence gaps identified with 3 potential study designs developed for global medical affairs to consider
  • Clear and realistic expectations set around pricing and reimbursement timelines and outcomes
  • Go to market strategy clearly articulated with critical milestones and events
  • Foundational relationships established with supporting KOL’s and potential investigators