Parexel: Personalizing Medicine with a Heart

The practice of medicine is becoming considerably more individualized thanks to precision medicine. Pharmaceutical market players and biotechnology companies may create and target precision pharmaceuticals targeting the causes of sickness rather than only treating the symptoms by knowing the molecular basis of diseases. It’s a fascinating field, and it’s expanding.

In fact, a 2018 study Parexel commissioned in collaboration with the Economist Intelligence Unit (EIU) found that medications created utilizing precision-medicine trial designs were 10% more likely to be released than those created without them. Yet in some therapeutic specialties, this risk is significantly higher, rising to 26% for cancer and 17% for neurology.

The demand for tailored medications is only anticipated to increase. In fact, it is predicted that across all disease conditions, the proportion of precision medicine in clinical developments would reach approximately 70% during the next three years.

Precision Medicine at a Glance

Precision medicines are ones that can be tuned to a patient’s unique traits and that target well-known genetic, molecular, or cellular indicators. This helps to give patients a more individualized experience. Precision medicine’s capacity to more accurately forecast a patient’s response to treatment is one of its main benefits. Nowadays, cancer (such as Tyrosine Kinase Inhibitors) and several single gene illnesses are the key areas in practice where this drug development has resulted in advancements (for example, treatments for cystic fibrosis). The possibility for stratifying patients according to illness subtypes holds great promise for improving care, but it frequently necessitates innovation and a change in conventional trial designs in order to more effectively evaluate these drugs.

A Therapeutic Approach Still In Its Infancy

Since 2013 onward, PubMed has seen a substantial increase in the number of precision clinical studies. This pattern suggests that precision clinical trial diffusion is still in its infancy.

In all therapy areas, precision design increases the likelihood of launch. In oncology, the difference between precision and non-precision was 26%, making it the therapy area with the greatest improvement in likelihood of launch. Precision design has been utilized to develop the most pharmaceuticals and participate in the most clinical trials, and oncology has been at the forefront of this field. This illustrates how precision designs are more developed in oncology than in certain other therapeutic fields.

The time it takes to enroll patients varies by therapy area; precision studies took longer than all trials (7 months) to enroll 100 patients (11 months). This is a predictable result since, in comparison to other types of trials, precision trials demand a more thorough eligibility assessment of potential participants. To select these particular individuals from a wide pool of possibly eligible volunteers, for instance, and to wait for test results to confirm eligibility, genetic testing lengthens the recruitment process.

The Parexel Approach to Individualizing Treatments

Parexel is proud to guide you through the emerging field of precision medicine. The company’s well-established methodology thoughtfully leads you through the challenges and opportunities you’ll face along the way.

Biomarker Strategy

The Translational Medicine Services group at Parexel is an expert in creating and implementing early-stage biomarker strategies. Researchers at Parexel are skilled in choosing the best technologies or procedures and the biomarkers that should be examined. Additionally, they have a track record of carefully choosing and managing the laboratories that carry out these specific tests to guarantee that the outcomes comply with legal standards.

Genomics Expertise

The team at Parexel that focuses on genomic medicine has a strong bench of experts who have had success using genetic data to help drug development, marketing, and reimbursement. What genetic variations are relevant for choosing or stratifying patients? are just a few of the important questions the clinical research organization may assist you in answering. How do site choice and feasibility are affected by genetic variation? What technology is better to generate the genetic results? What is the best strategy to reduce the danger of variation in international laws governing genomic testing?

Real-World Evidence

With a multidisciplinary approach, Parexel’s Integrated Real-World Data Services may help you create a solid, personalized real-world evidence strategy and gain insights that are appropriate for your needs rather than merely gigabytes of data.

Operational Excellence in Clinical Trials

Precision medicine clinical trials face a number of novel problems. For instance, because patients must undergo complex biomarker or genetic testing to be eligible for inclusion, patient recruitment frequently takes longer. Trials may be governed by local regulatory subtleties and privacy legislation. Parexel provides full assistance in this area by assisting with sample supply logistics and management, which is crucial for ensuring that samples are properly collected and processed to reduce pre-analytical variability. Parexel also works directly with patients to address their concerns about their participation in trials that use their genomic information.

Executive-Level Strategic Consulting

Your leadership team can work with Parexel’s seasoned consultants to identify and assess unmet needs and opportunities, determine assets and indications to develop, assess the competitive environment and market potential, and finally evaluate the success likelihood, cost, and risk of various development options.

A More Personalized Future Ahead

The potential of precision medicine is already motivating efforts to address these issues and enhance the effectiveness and sustainability of drug research and development. It may be possible to bridge the gap between the bench and the bedside by bringing together stakeholders from the government, industry, academia, and patient organizations to address these concerns and figure out how to use innovation in clinical trial design. To expedite the adoption of precision medicine and guarantee that all stakeholders profit, these efforts can then be broadened and the lessons learned from them shared broadly.

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of its clinical, regulatory and therapeutic expertise, Parexel’s team of more than 20,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.

Parexel’s depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while the company’s innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, Parexel work With Heart^TM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference.

The Parexel Family of Brands

Parexel Academy

Your trusted partner in learning. Parexel Academy is committed to building and enhancing capabilities within the clinical research workforce so that, together, we make a positive impact on the lives of patients around the world. 

Health Advances

As a trusted strategic advisor to healthcare and life science executives, Parexel catalyze our clients’ success with insight, innovation, and integrity.

The Medical Affairs Company (TMAC)

The industry’s leading provider of comprehensive outsourced medical affairs solutions. 

Learn more about Parexel and its services here parexel.com.