The Q1 Scientific Stability Studies Conference 2024, held on October 17th at the Killashee Hotel in Naas, Co. Kildare, Ireland, brought together leading experts and professionals from pharmaceutical and medical device companies. This annual event is essential for those dedicated to the science of stability studies, offering a platform to share best practices and innovative strategies.
The conference provided a comprehensive overview of challenges, emphasising the importance of robust stability programs. In this blog post, we will summarise the key takeaways from the conference, exploring the expert presentations and discussions that made this event a valuable experience for all participants.
Key Takeaways from our Stability Studies Conference 2024
- Importance of Stability Studies: Stability studies are crucial for ensuring the safety, efficacy, and quality of pharmaceutical products and medical devices over their shelf life. The conference emphasized the need for robust stability programs to address environmental factors like temperature, humidity, and light.
- Addressing Out-of-Trend Data and Regulatory Requirements: The event highlighted the significance of addressing out-of-trend data and navigating complex regulatory landscapes to maintain product quality.
- Reducing Scheduling Resources for Testing: Stan O’Neill compared a traditional ICH approach with a modified approach aligned with Chapter 6 guidelines. This modified approach, which does not include matrixing or bracketing, significantly reduces scheduling resources. Stan’s slides illustrated this potential opportunity and became a key talking point at the conference.
- Patient Safety and Product Quality: A strong focus was placed on patient safety and product quality, underscoring the critical role of stability testing in the lifecycle of pharmaceutical products and medical devices.
Speaker highlights at the Stability Studies Conference 2024
Kate Coleman, VP Regulatory Affairs, Quality and Compliance (Principal Consultant) at Arriello on ‘How to build a stability program’
One of the standout sessions at the Q1 Scientific Stability Studies Conference 2024 was led by Kate Coleman, who provided invaluable insights into constructing robust stability programs. Her presentation emphasized the importance of a well-designed stability program in ensuring the long-term safety and efficacy of pharmaceutical products and medical devices.
Kate is the VP of Regulatory Affairs, Quality and Compliance at Arriello and has over 20 years of experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a Qualified Person, Principal Consultant, Lead Auditor and an SME in several areas including Quality Control and Stability.
Presentation highlights
- Strategies for constructing robust stability programs
- Importance of climatic conditions and stability-indicating parameters
- Preventing deviations and out-of-specifications (OOS)
Dr. Mark Powell, Director at MP Scientific on ‘Addressing out-of-trend and variable stability data’ and ‘Stability challenges in biopharmaceuticals: Design and evaluation’
Dr. Mark Powell, delivered two insightful presentations at the Q1 Scientific Stability Studies Conference 2024. His first session focused on the common causes of variable stability data and practical tips for improving the quality and consistency of stability studies. In his second presentation, Dr. Powell addressed the unique stability challenges faced by biopharmaceutical products. The physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions, making stability studies for biologics particularly complex.
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry with over 30 years of experience as a senior analytical chemist. He has held significant roles in various companies, focusing on analytical development and equipment qualification.
Presentation highlights
- Valuable insights into the complexities of stability studies for both traditional pharmaceuticals and biopharmaceuticals.
- Addressing the common causes of variable stability data and unique challenges faced by biologics
- Dr. Powell equipped attendees with the knowledge to design robust stability programs and improve the quality and consistency of their stability data.
Nuala Calnan, PhD, CEO BioPharm Excel, Founder, the Quality Risk Management Institute Adjunct Research Fellow, TU Dublin on ‘Stability testing from bench to bedside – understanding the why’
Dr. Nuala Calnan’s presentation at the Q1 Scientific Stability Studies Conference 2024 emphasized the critical role of stability testing in ensuring patient safety and fostering a culture of excellence within Quality Control (QC) laboratory operations. Her insights highlighted the importance of a patient-centric approach in all aspects of pharmaceutical and medical device development.
Dr. Nuala Calnan is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the development of practical, patient-focused excellence. She has conducted research for the FDA (USA) and HPRA (Ireland) on risk surveillance, patient safety, and product quality in drug manufacturing and distribution.
Presentation highlights
- Critical role of stability testing in patient safety
- Fostering a culture of excellence in QC laboratory operations
- Importance of regulatory compliance and continuous improvement
Conor Gleeson, Customer Account & Sales Manager at Q1 Scientific on ‘From storage to success: navigating stability storage challenges’
Conor Gleeson’s discussion at the Q1 Scientific Stability Studies Conference 2024 provided valuable insights into the strategic decision-making process involved in stability storage. His presentation focused on the critical choices between insourcing and outsourcing stability storage, and how these decisions can impact the overall efficiency and effectiveness of stability programs.
Presentation highlights
- Strategic decision-making in insourcing vs. outsourcing stability storage
- Real-life case studies and flexible approaches for effective stability program management
Stan O’Neill, Managing Director of The Compliance Group on ‘GMP considerations for Stability Testing’
Stan O’Neill, Managing Director of The Compliance Group, delivered an insightful presentation on the Good Manufacturing Practice (GMP) considerations for stability testing. His extensive experience in regulatory affairs, quality assurance, and GMP inspections provided a comprehensive perspective on the obligations and best practices for ongoing stability testing during the post-approval stage of a product’s lifecycle.
After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (as a QP). He then joined the Irish Medicines Board (IMB, now the HPRA). As a Senior Inspector, he performed GMP inspections throughout the world and represented Ireland at European level for the negotiation of standards of inspection for medicinal products. During his time with the IMB Stan trained Inspectors for Sterile Medicinal Products, non-Sterile Medicinal Products and Good Distribution Practice and Pharmacovigilance.
Since founding The Compliance Group in 2009 Stan has consulted for many Pharmaceutical Companies, Hospitals, Governments, the World Health Organisation, and NGOs.
Stan holds the positions of Adjunct Assistant Professor, School of Pharmacy and Pharmaceutical Sciences in Trinity College Dublin and Honorary Associate Professor, RCSI, University of Medicine and Health Sciences.
Presentation highlights
- Obligations for ongoing stability testing post-approval
- Adopting a lean approach and addressing problems effectively
- A eureka moment in stability testing! Stan compared a traditional ICH approach with a modified approach aligned with Chapter 6 guidelines. This modified approach, which does not include matrixing or bracketing, significantly reduces scheduling resources. Stan’s slides illustrated this potential opportunity and became a key talking point at the conference.
Catherine McHugh, Owner and Director of Imbolc Pharma Consulting on ‘Navigating stability data challenges: Insights from regulatory experience’
Catherine McHugh’s presentation at the Q1 Scientific Stability Studies Conference 2024 provided a deep dive into the regulatory challenges associated with stability data submissions. Her insights were invaluable for professionals navigating the complex landscape of pharmaceutical and medical device regulations.
A Pharmacist by training, Catherine started her career in the pharmaceutical industry in product development with 3M Healthcare and subsequently spent >8 years as a Pharmaceutical Assessor with the Health Products Regulatory Authority (HPRA) in Ireland assessing all types of applications for small molecule drug products (e.g. Clinical trials, CHMP scientific advice, National, MRP, DCP, and Centralised marketing authorisation applications, variations, renewals). During this time, she was a designated national expert at the EMA and a member of the Joint CHMP / CVMP Quality Working Party.
Catherine spent the last 10 years as a Regulatory / CMC consultant with global consulting organisations providing leadership to the consulting team and technical support to international clients and set up Imbolc Pharma Consulting in May 2024 to provide personalised services to the Pharma and Biotech industry in Europe.
Presentation highlights
- Emphasizing compliance throughout the product lifecycle and managing post-approval changes are also crucial for maintaining product quality and ensuring patient safety.
- Practical strategies to overcome regulatory hurdles and enhance stability programs.
Q&A Session at the Stability Studies Conference 2024
Throughout the day, attendees had the opportunity to submit their questions anonymously to our incredible line-up of guest speakers.
Here are some common themes emerging from the questions discussed at the Stability Studies 2024 conference:
- Regulatory Compliance and Guidelines: Handling missed time points, objections, and compliance with regulatory requirements.
- Stability Testing and Methodologies: Impact of pharmacopoeia changes, bulk stability testing, and industry standards.
- Practical Considerations and Best Practices: Managing stability programs, sample handling, and program design.
- Challenges and Solutions: Initiating or managing stability programs, dealing with OOS results, and introducing rapid testing methods.
Save the date and join us at the Stability Studies Conference 2025
Overall, the Stability Studies Conference 2024 highlighted the focus on improving regulatory compliance, enhancing stability testing methodologies, and adopting best practices to manage stability programs effectively.
We are excited to announce that the next Q1 Scientific Stability Studies Conference will be held on October 23rd, 2025. This event promises to build on the success of this year’s conference, offering even more opportunities for learning, networking, and professional development.
Why Attend?
- Best Practices: Stay ahead with guidance on stability studies.
- Expert Speakers: Learn from industry leaders.
- Networking Opportunities: Connect with peers and thought leaders.
- Professional Growth: Enhance your skills and knowledge.
Whether you are a seasoned professional or new to the field, the Q1 Scientific Stability Studies Conference is an invaluable opportunity to expand your knowledge, network with industry experts, and stay updated with best practices in stability studies. We look forward to seeing you next year!
To register your interest in attending or exhibiting, contact us.