Portfolio management and asset valuation

Portfolio optimization

Through industry-leading expertise, we help sponsors pursue the right targets at the right time. Our evidence-based, integrated strategies are backed by deep clinical, regulatory, and commercial knowledge. Drawing on that experience, we can recommend ideal models, map the most efficient regulatory pathways, and forecast your asset’s valuation based on complex market factors. Working as a unified team, our consultants fully equip you to identify and prioritize compounds that demonstrate the strongest potential so you can maximize every investment you make.

Asset valuation and indication prioritization

Determining the value of an asset and its optimal indications will set the course for product development. We provide analysis, forecasting, and financial modeling so you can assess every opportunity and make the pivotal calls that move your asset ahead.

By analyzing scientific, clinical, and commercial data, our team delivers expert valuations rooted in our nuanced understanding of market movement and evolution. We use this knowledge, along with our proven regulatory intelligence, to prioritize indications. Our recommendations take into account market access considerations as well as an asset’s prospects for approval and the likely length of its regulatory process as determined by our experts, many of whom are former regulators themselves.

Early evidence review

Through early evidence consulting, we remove barriers to regulatory approval and market acceptance. Our expert team, which includes former regulators, profoundly understands your asset class, the implications of your data, and what global health authorities will look for in your evidence package.

In reviewing efficacy and toxicology assay and formulation data, we provide insight on every facet of evidence package preparation, including regional differences in evidence acceptance. Through nuanced geographic strategy, we keep development progressing in receptive regions as you generate additional evidence for broader regulatory approvals. In addition to consulting, we can analyze and package your data, submit the resulting drug applications, and consult on subsequent health authority interactions — a full-service approach to this critical process. We also bring our commercial focus to early evidence, evaluating packages for market competitiveness.

Model-based drug development

To reduce costs and timelines and mitigate uncertainty, we model and simulate a drug’s likely effects in patients before your clinical trial begins. Modeling can quantitatively justify trial design, dose selection, and mid-trial decisions. It can also support robust regulatory evidence packages.

Because we work with many quality labs, we can recommend the ideal facility for any model-determined test you need to conduct. This partner-agnostic approach ensures that tests are performed by the best-suited vendors — and we can advise on and manage the entire process.

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Integrated development strategy and planning

Successful drug development begins with promising science, but you’ll also need to navigate complex regulatory and commercial landscapes. To give your assets every advantage, begin with an integrated development strategy.

Our strategy and tactical plans consider clinical and regulatory challenges as well as commercial positioning. We work closely with you to develop a target product profile to guide our efforts, and our regulatory experts (many of whom are former regulators) can advise on what designs and data packages health authorities will accept. Our clinical experts provide insight on the feasibility of study design, recommending alternatives if needed. We also test a product’s place in the market to understand how it will likely be received by payers, patients, and providers. Using all of this input, we create a comprehensive strategy that can map your path all the way to approval, maximizing your potential for clinical and commercial success.

Our global team of consultants includes former FDA, EMA, and NMPA regulators, so you can advance your trials with confidence.

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