Due diligence on competitive advantage and market potential
Background:
- A biotech company developing an investigational drug in gastric cancer.
- Phase 2A trial indicates 3L treatment potential but company faces developmental financial issues.
- Investor seeks clarity on drug’s competitive advantage and market viability for potential investment opportunity.
Approach:
- Public data review:
- Gastric cancer landscape: current treatments, effects and unmet needs in 3L
- Competitor drugs: potential treatments and impact.
- Past regulatory decisions, therapy labels and clinical endpoints for registration support
- Review of clinical data of product
- study population, design, efficacy and safety data of phase 2A trial.
- Comparative Analysis: Product vs. existing and future therapies: competitive advantage assessment.
- Target population size: 3L gastric cancer estimates in key regions.
Solution and recommendations
- Reported potential advantage over current and future potential therapies and commercial opportunity.
- also suggested potential clinical development path and plan for registration.
Assessment of Academic asset for potential drug development opportunity
Background:
- A biotech to in-license a research product from an academic institution and advance it to the market.
- The product targets molecules found in cHL and certain NHL subtypes.
- Early-phase trials in cHL indicate it’s safe and shows potential anti-tumor activity.
- To assess its clinical and market viability and to devise a plan for its development up to the NDA submission, with lifecycle management.
Approach:
- Review phase 1 data and preclinical data from the academic institute
- Review disease areas:
- Identify potential population based on the expression of the target in cHL and some NHLs
- Estimated size of patient population for Market opportunity
- Current treatment options in HL and NHL to understand the area of unmet medical need in target population
- Examine treatment effect of current available therapies and future potential drugs for competitive advantage
- Define Priority development area and develop CDP including sequence of development(life cycle management)in HL and NHL.
- TMI research consulted with key opinion leaders about CDP.
Solution and recommendations
- Crafted clinical strategy, including TPP and laid out a detailed Clinical development plan leading up to the NDA of first indication
- Recommended lifecycle management in HL and NHL
- Presented risk assessment and mitigation exercise
Priority indication and Seamless development in multiple indications
Background:
- A start-up biotech firm is working on a TKI that targets a molecule present in various tumor types.
- With promising preclinical results, they aim to initiate a first-in-human phase 1 trial.
- The objective is to create a clinical development strategy that allows for a quicker entry into the market.
Approach:
- Reviewed the disease areas with target expression and identified the area of unmet need, the available treatment options and market potential.
- Prioritized the target indication for initial drug development and formulated lifecycle management strategies.
- Worked out clinical development plan with some scenario of seamless /adaptive study design until NDA for accelerated approval
Solution and recommendation:
- Recommend target diseases and priority indication.
- A clinical development plan detailing the phase 1 trial design and demographics, transitioning seamlessly into a phase 2 basket trial, pivotal registration phase 2 trials and confirmation trials
- Recommended criteria for go/no-go decision and timing along the clinical development.
- Presented risk assessment and mitigation plan for the whole CDP
- Suggested clinical organization to execute the plan.
Medical Launch: Medical affairs plan and team set-up
Background:
- A regional pharmaceutical company is planning to launch EGFR TKI(generic product) in NSCLC in Asia.
- While it has marketed some drugs in other disease areas, it has no experience in oncology area.
- Seek formulation of medical affairs strategy and plan and to set up team of medical affairs in NSCLC in Asia.
Approach:
- Review NSCLC landscape in Asia and current treatment options to figure out opportunity and challenges.
- Identify target markets(countries)
- Situational analysis of the product -SWOT analysis to understand competitive advantage and differentiation.
- Customer mapping and feedback-KOL, treating physician, patients
- Work out requirement for regulators and payor and patients
Solution and recommendation
- Recommend targets market with NSCLC landscape in Asia
- Formulate medical affairs strategy and plan for launch excellence including KOL engagement and medical education, medical communication and publication plan
- Recommend in applying available data and in making evidence generation plan in support of registration and reimbursement
- Suggest in set-up of medical affairs team in Asia