Our Expertise in Key Therapeutic Areas
Rare Diseases
Conducting clinical trials for rare diseases presents unique challenges, including small patient populations, complex study designs, and regulatory hurdles. At WEP, we have extensive experience overcoming these challenges by leveraging our:
- Global rare disease patient networks to accelerate recruitment and enrollment
- Adaptive trial designs tailored to meet regulatory expectations
- Decentralized trial capabilities to enhance patient participation
- Strong collaborations with patient advocacy groups to ensure patient engagement and retention
- Regulatory expertise in orphan drug designation and expedited approval pathways (e.g., FDA’s Orphan Drug Program, EMA’s PRIME)
Our team is dedicated to advancing treatments for rare diseases, ensuring that patients who need them most have access to innovative therapies.
Oncology
Cancer research is evolving rapidly, requiring precision medicine approaches, biomarker-driven strategies, and innovative trial designs. We bring deep oncology expertise across solid tumors and hematologic malignancies, including:
- Immuno-oncology and checkpoint inhibitors
- Targeted therapies and precision medicine approaches
- Hematologic malignancies (e.g., leukemia, lymphoma, multiple myeloma)
- Solid tumors across multiple indications
- Adoptive cell therapies, including CAR-T and TCR-T therapies
Our oncology trial capabilities include:
- Expertise in early-phase trials (FIH, Phase I/II) and accelerated development pathways
- Biomarker-driven trial designs to optimize patient selection and treatment response
- Access to a global oncology investigator network with leading cancer research centers
- Advanced imaging and radiology solutions for tumor assessment and response monitoring
With our integrated oncology trial solutions, we help our partners bring next-generation cancer therapies to patients faster.
Cardiovascular & Metabolic Diseases
Cardiovascular and metabolic diseases remain leading global health challenges, requiring efficient clinical trial execution and real-world evidence generation. We have extensive experience in:
- Heart failure, coronary artery disease, and arrhythmias
- Hypertension, hyperlipidemia, and atherosclerosis
- Diabetes (Type 1, Type 2) and metabolic syndrome
- Obesity and lipid disorders
- Rare cardiometabolic conditions
Our expertise includes:
- Global patient recruitment strategies to access diverse populations
- Advanced cardiovascular imaging and biomarker analysis for endpoint evaluation
- Integration of digital health technologies, including wearables and remote monitoring
- Regulatory guidance for cardiovascular outcomes trials (CVOTs) and metabolic disease approvals
By combining scientific expertise, innovative trial designs, and global operational excellence, we support the development of transformative treatments for cardiovascular and metabolic diseases.
Infectious Diseases & Vaccines
The rapid emergence of infectious diseases demands agile clinical trial execution, global site networks, and expertise in vaccine development. Our experience spans:
- Bacterial, viral, and fungal infections
- Respiratory infections (e.g., COVID-19, influenza, RSV, pneumonia)
- Tropical and neglected diseases (e.g., malaria, dengue, tuberculosis)
- Antimicrobial resistance (AMR) and novel anti-infectives
- Vaccine development and pandemic preparedness
We support infectious disease and vaccine trials with:
- Global site networks with high-incidence patient populations
- Experience with challenge studies and controlled human infection models (CHIMs)
- Rapid-response trial capabilities for emerging infectious threats
- Expertise in vaccine safety monitoring and immunogenicity assessment
Our end-to-end infectious disease trial solutions help sponsors accelerate the development of lifesaving treatments and vaccines.
Central Nervous System (CNS) Disorders
CNS clinical trials present challenges such as long disease progression timelines, complex endpoints, and variability in patient response. We bring deep CNS expertise in:
- Neurodegenerative diseases (e.g., Alzheimer’s, Parkinson’s, ALS)
- Neurodevelopmental disorders (e.g., Autism Spectrum Disorder, ADHD)
- Psychiatric conditions (e.g., Depression, Schizophrenia, Bipolar Disorder)
- Rare and complex CNS diseases (e.g., Huntington’s Disease, Duchenne Muscular Dystrophy)
Our capabilities include:
- Advanced biomarker strategies to enhance trial efficiency
- Digital and remote monitoring technologies for real-time patient data collection
- Collaborations with leading CNS research institutions and KOLs
- Regulatory expertise in neurodegenerative and psychiatric drug development
With our CNS-focused trial solutions, we help bring novel therapies to patients with high unmet medical needs.
Advanced Therapies
The field of Advanced Therapy Medicinal Products (ATMPs) requires specialized expertise, regulatory navigation, and innovative trial designs. Our dedicated team has experience in:
- Gene therapies targeting rare genetic disorders and complex diseases
- Cell-based therapies, including stem cell treatments and regenerative medicine
- Tissue-engineered products for orthopedic, dermatological, and cardiovascular applications
- Personalized medicine strategies that optimize patient outcomes based on genetic and biomarker data
We provide:
- Regulatory support for ATMP classifications and expedited approval pathways
- Supply chain and GMP compliance for advanced therapy manufacturing
- Specialized site selection for ATMP clinical trials
- Long-term patient follow-up strategies to meet regulatory safety requirements
Our comprehensive ATMP trial capabilities help bring cutting-edge therapies from the lab to the clinic.
Cell & Gene Therapy
Cell and gene therapy represents the future of medicine, offering curative potential for genetic disorders, cancers, and rare diseases. We have extensive experience in:
- Autologous and allogeneic cell therapy trials, including CAR-T therapies
- In vivo and ex vivo gene editing technologies, such as CRISPR and AAV-based therapies
- Oncolytic viruses and novel immunotherapies
- Combination therapies integrating gene and immune-based approaches
Our expertise includes:
- Patient recruitment strategies for rare and ultra-rare conditions
- Supply chain and logistics management for gene-modified therapies
- Regulatory support for fast-track and breakthrough designation approvals
- Long-term safety and efficacy monitoring for gene therapy patients
With our industry-leading expertise in cell and gene therapy, we support sponsors in bringing transformative treatments to market.
Partner with a CRO That Understands Your Challenges
At WEP, we understand the complexities of developing therapies in these highly specialized areas. Our scientific expertise, regulatory knowledge, and global trial execution capabilities make us the ideal partner for biotech and pharmaceutical companies advancing the next generation of therapies.
Contact us today to learn how we can support your clinical development needs.