For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
We optimize portfolios through strategies that consider every aspect of drug development. Acting on our whole-picture guidance, you can make earlier, faster, more informed decisions about risk and reward — giving each asset its greatest chance for success.
Our team includes experts in clinical, regulatory, and market access strategy. We analyze your assets from multiple vantage points, offering seamless guidance early in development. Through comprehensive and actionable plans, we address development challenges so you can maximize your investments and clinical efforts.
We have the resources to provide you with knowledge across several functional lines, resources that can impact your strategy, the resources that will help you to design the scientific approach at the beginning of a development process and later operational aspect of enrollment, distribution of the medication, collection of a data, and the quality of the data that we produce.
The power of the joint Parexel and Health Advances team is really unparalleled, especially around questions of portfolio optimization early in the journey.
I don't think you'll see a better team that has the depth of expertise across all the functions and dimensions that you really need to think about at the earliest stages.
At Parexel Regulatory, you have ex-regulators that understand I&D submissions, early development decisions, proof of concept.
You really have to make those calls on development that will ensure and increase your probability of success to get through the early regulatory milestones.
We have medical directors that have run clinical trials at almost every therapeutic area so they can bring very early insight about getting to the clinic and that translational thinking that you need to do when you're at the earliest stages of development.
So having that strong depth of knowledge that can really engage with our client stakeholders and provide that integrated perspective along all the critical dimensions that you need to balance through those early stages.
Again, I don't think you'll find that anywhere else. We see the drug development as a holistic structure of a process that we are addressing in parallel in all areas.
Going to the molecule that is still preclinical, we can potentially think about the market potential of this molecule. And according to what we see at the market today, or what we will see on this market five years from now, we can address the development elements properly at the beginning of a development process.
Our Solutions Experts
Patients are central to smarter drug development. We gather and interpret patient input, transforming information into insights that result in more powerful target product profiles (TPPs). When you understand patient needs, you can focus on the assets most likely to find success with target populations as well as health care providers, regulators, and payers.
Our team supports patient-informed portfolio management through rigorous research and our established relationships with a wide range of patient advocacy groups. We engage a diverse mix of people within target populations for a full view of patient challenges and preferences. Because our insights have implications for all stages of compound development, we deliver data early in the process and provide detailed recommendations for putting our findings to use.
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.
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.
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.
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.
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.
The purpose of our Operational Excellence and Delivery Office is to continuously and consistently improve the way we run your trials. By assembling our most experienced, cross-functional team members, we create best practices business wide that accelerate timelines, generate compelling evidence, promote innovation — and empower us to deliver With Heart™.
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