We have consulted to clients across North America, Asia Pacific, and Europe, 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 five years consulted for over 40 companies, on more than 60 different projects in a diverse range of therapeutic areas

Case study 1

Review pitch for novel infectious disease product
  • Identify why partnering approaches had not been successful and adapt investor pitch deck
  • Accessible market and target product profile not well defined
  • Business case therefore not convincing to potential investors & partners
  • Scientific POC needed strengthening
  • Engage industry R&D expert to review science & recommend best next steps for de-risking
  • Revisit global market potential assumptions and adapt valuation model (rNPV)
  • Business case more attractive to investors
  • Pathway to de-risk science is clear
  • Client has now received a term-sheet proposal

Case study 2

Set-up Australian subsidiary for trial
  • Establish subsidiary in Australia to conduct phase 1 clinical trial
  • Access R&D tax credit to support cash flow of early stage biotech
  • Need to develop overall business case for Board
  • Need to navigate Australian tax regulatory and legal system
  • Need to coordinate all Australian service providers (CRO, Legal, Accountants, health authorities) from a distance
  • Develop Commercial rationale for project to justify R&D tax incentive
  • Establish subsidiary including provision of Director and all back office services
  • Coordinate and project manage all local service providers and stakeholders
  • Subsidiary established and compliant, trial underway
  • Ongoing quarterly rebates received from Australian Tax Office

Case study 3

European market access strategy
  • US Biotech needing insight into European markets for clinical development plan and launch prioritization of novel first in-class vaccines
  • Lack of knowledge of vaccine funding and reimbursement processes in Europe
  • No relationships with EU investigators, key opinion leaders or payers
  • Analysis of EU5 market access environment
  • Review phase III protocol and consult with expert European clinicians and health economists
  • Recommended health economic endpoints for trial
  • Provided country by country analysis of policy and reimbursement process including HTA criteria
  • Evaluated likely price, uptake and market potential in EU5
  • Clear launch priority validated

Case study 4

Partnering: gene therapy
  • Determine market opportunity and market access feasibility for novel high priced gene therapy for rare disease
  • Identify potential partners to distribute product
  • Unknown market potential, regulatory & reimbursement feasibility
  • No relationships with local Distributors
  • Market evaluation and stakeholder map completed
  • Regulatory and reimbursement considerations identified
  • Shortlist of potential partners identified, screened and validated
  • Partnering meetings held resulting in term sheet discussions with 3 companies
  • Regional deal now under consideration with mutli-national

Case study 5

Commercialisation strategy: biomarker
  • Determine regulatory pathway options and clinical trial design for cancer biomarker
  • Determine capital raise required to fund trial
  • Evaluate market opportunity to improve chance of success with investors
  • Market opportunity poorly quantified, several potential biomarker applications (screening, diagnosis, post treatment monitoring)
  • IVD Regulatory and clinical expertise needed to determine optimum path forward
  • Market evaluation completed and investor presentation updated
  • Regulatory pathway clearly defined
  • High level clinical trial summary protocol developed and costed
  • Investment case now clear and compelling
  • Discussions ongoing to raise capital to fund trial

Case study 6

Dengue therapeutic market potential
  • Develop business case for dengue therapeutics in SE Asia and Latin America
  • Investor lack of interest in dengue
  • Perception that there is no need for therapeutics with vaccines on horizon
  • Review epidemiology & disease burden in key countries
  • Interview dengue experts with TPP to estimate uptake and price
  • Review likely evolution of dengue vaccine policy & uptake
  • Global revenue forecast that supports investment case
  • Expert interest in dengue therapeutics confirmed
  • Documented evidence on new vaccine introduction & uptake combined with expert feedback clearly demonstrates need for vaccines and therapeutics