In the high-stakes world of clinical research, the prevailing belief is that speed and quality are mutually exclusive — yet achieving accelerated clinical trials doesn’t have to come at the expense of rigor.
This webinar will demonstrate how integrating quality into every phase of clinical development can not only prevent costly delays but also serve as a catalyst for faster, more reliable outcomes.
Drawing on real-world examples and industry expertise, the featured speakers will explore how early collaboration with a trusted CRO partner, adherence to Quality by Design principles and the strategic use of data and AI can transform quality from a bottleneck into a competitive advantage — ultimately paving the way for a more accelerated clinical trial process.
Join the speakers to explore how:
- Quality can become a catalyst for faster, more reliable clinical trials
- Early CRO/CDMO collaboration helps maintain momentum and reduce costly rework
- Proactive design, data and AI work together to eliminate delays and strengthen compliance
Register for this webinar to uncover practical strategies for achieving accelerated clinical trials without sacrificing quality or compliance.
- AI ,
- CDMO/CMO ,
- Clinical Research ,
- Clinical Trial Acceleration ,
- Clinical Trial Efficiency ,
- Clinical Trial Quality ,
- CRO ,
- CRO Partnership ,
- CRO Performance ,
- Drug Development ,
- Quality ,
- Quality Assurance ,
- Quality by Design ,
- Quality Compliance ,
- Quality Management ,
- Risk-Based Quality Management ,
- Speed vs Quality in Clinical Trials
Speakers
Valerie Brown, Senior Vice President, Quality, Enterprise Learning & EHS, Thermo Fisher Scientific
Valerie Brown is the Global Head of Quality, Enterprise Learning and Environmental Health & Safety (EHS) at Thermo Fisher Scientific. In this role, she leads a global organization responsible for quality and compliance oversight of contract manufacturers producing a wide range of products, including active pharmaceutical ingredients (APIs), drug product intermediates, oral solid dosage forms, parenterals, biologics and medical devices for both development and commercial markets worldwide.
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Valerie joined Thermo Fisher in June 2024, bringing with her more than two decades of experience in quality assurance and regulatory affairs. Prior to joining Thermo Fisher, she served as Senior Vice President of Global Quality Assurance at Gilead Sciences, where she held progressively senior roles and played a pivotal role in advancing the company’s quality systems and global compliance strategy.
Before her tenure at Gilead, Valerie was the Global Director of Quality and Regulatory at ZaCh Systems and PPG Industries. She is an active member of the Parenteral Drug Association (PDA) and the International Society of Pharmaceutical Engineering (ISPE), reflecting her commitment to continuous improvement and industry collaboration.
Valerie holds undergraduate degrees in Biology and Chemistry and a graduate degree in Healthcare Management. She is widely recognized for her strategic leadership, operational excellence and dedication to patient-focused quality systems.
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Robin Kumoluyi, Vice President Global Head Quality & Regulatory, Pharma Services, Thermo Fisher Scientific
Robin Kumoluyi is a visionary leader who consistently moves people and organizations forward. Throughout her career, Robin has expertly crafted complex quality management strategies for multi-billion-dollar matrixed organizations. Her proven track record spans over 30 years of robust experience leading change, holding senior leadership roles in Quality, R&D and Manufacturing Compliance in the pharmaceutical and food industries. Her broad expertise encompasses a wide portfolio of pharmaceutical products, including biologics, small and large molecules, advanced therapies, veterinary drugs, devices, nutraceuticals and food and beverage products.
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Robin Kumoluyi is currently the Vice President Global Head Quality & Regulatory, Pharma Services at Thermo Fisher Scientific. Robin has overall responsibility for quality, compliance, regulatory and EH&S with oversight of Quality Systems, Digital, Quality Strategy and Operations, Drug Product Quality, Drug Substance Quality, Compliance, Sterility Assurance, Clinical Operations, Regulatory and EF&S. Prior to this role, Robin was Vice President and Chief Quality Officer at Johnson & Johnson pharmaceuticals (Janssen).
Robin holds a Bachelor’s degree in Biological Sciences (specializing in microbiology) from Rutgers University and a Master’s degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.
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Helen J Neal, Vice President, Global Head Clinical Operations, PPD clinical research business of Thermo Fisher Scientific
Helen Neal serves as vice president of clinical operations for the PPD™ clinical research business of Thermo Fisher Scientific. She is responsible globally for strategic leadership and oversight of clinical operations including in-country site startup, clinical monitoring and support teams, and centralized monitoring.
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With over 40 years in clinical research and 14 years at the company, Helen has taken on increasing levels of responsibility as director of clinical management, senior director of global project management, executive director of clinical functional service partnership, vice president of regional operations delivery in Asia Pacific and vice president of regional operational delivery for Asia Pacific and EMEA. Helen also serves as a board director for the business partnership with Shin Nippon Biomedical Laboratories (SNBL), a Japanese clinical research organization (CRO). Earlier in her career, she served as a clinical team leader and portfolio director of strategic account management for several global CROs.
Helen earned her registered nurse (RN) degree from Manchester Royal School of Nursing, her registered midwife (RM) degree from Stepping Hill School of Midwifery and an advanced diploma in midwifery from the University of Manchester.
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Who Should Attend?
This webinar will appeal to:
- Biotech and biopharma companies involved in data sourcing, management and analytics and feasibility planning for clinical research
- Clinical Research Investigators/Site Directors
- Patient advocacy groups
What You Will Learn
Attendees will gain insights into:
- Quality as an Accelerator: Emphasizing quality from the outset prevents late-stage issues that can derail timelines, ensuring a smoother path to market
- Strategic CRO and CDMO Partnerships: Collaborating early with a CRO and CDMO provider that integrates quality at every stage — from protocol development to commercialization — helps to maintain momentum and reduces rework
- Quality by Design: Implementing a proactive, risk-based approach through frameworks like Thermo Fisher Scientific’s Process Performance & Improvement (PPI) identifies and eliminates bottlenecks, driving efficiency without compromising rigor
- Leveraging Data and AI: Harnessing advanced data analytics enables real-time monitoring and decision-making, accelerating study timelines and enhancing data integrity
By rethinking the traditional trade-off between speed and quality, this webinar provides actionable strategies to streamline clinical trials, reduce costs and ultimately bring life-saving treatments to patients more swiftly.
Xtalks Partner
The PPD clinical research business of Thermo Fisher Scientific Inc.
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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