2024

This presentation will look at how stability programs are built, incorporating relevant climactic conditions, appropriate stability indicating parameters and proactive strategies for preventing and dealing with stability issues.  We will go through case studies detailing how this process can go awry, leaving companies to manage deviations and out of specifications that could have been prevented during stability design and implementation.

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.

Problems with excessively variable or anomalous stability data are not unusual.  It may be that there’s a glaring out-of-trend result for an important marker of degradation, or that variability in assay/potency data shortens the shelf life of the product.  This presentation aims to highlight common causes of variable or anomalous data and to suggest ways to reduce the risk of poor stability data quality.

Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification.

In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits.

He is in demand as a trainer in topics such as chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies, method validation, extractables and leachables, and root cause analysis.

• How does Stability Testing protect the patient?
• What are the Key Regulatory Frameworks and Requirements?
• How do missed stability tests / timepoints act as a canary in the mine for Regulatory Agencies?
• What do missed stability test timepoints say about the robustness of lab operations? Calm or Chaos?
• Stability testing of retains – the last line of defence for your patients.
• How can you ensure your analysts feel their connection to your patients?
• How can you establish and sustain a Patient Focused Culture of Excellence in your QC Laboratory Operations?

Nuala 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 and includes research for FDA(USA) and HPRA(Ireland) on risk surveillance, patient safety and product quality in the manufacture and distribution of drugs.

Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end proactive risk management, implementing knowledge excellence strategies, behavior-based quality excellence and enhancing performance management through people.  She is the founder of the Quality Risk Management Institute and CEO at BioPharm Excel.

Nuala co-leads the ISPE Cultural Excellence Team, acted as Technical Author on the ISPE Advancing Pharmaceutical Quality (APQ) Guide series. At TU Dublin, Ireland, Nuala leads a number of patient focused regulatory science research projects at Masters and PhD level.

Stability chambers — the unsung heroes of quality assurance — shape the destiny of pharmaceuticals and medical devices. Successful navigation of stability challenges involves strategic decision-making, collaboration, and a flexible approach. Get ready as we embark on a journey through the dynamic world of stability storage management:

• Insourcing vs. outsourcing: the great debate
• Real life case studies: lessons learned
• Best practices for success

Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. In this presentation, Dr. Mark Powell will explain the typical approach for designing stability studies for biologics, addressing the unique challenges these products face and the common degradation mechanisms involved.

You can expect to learn more about:

• ICH Q5C – Stability testing of biotechnological/biological products
• Specific stability challenges for biologics
• Protein and peptide degradation pathways
• Evaluating stability – typical tests
• In-use stability
• Stability after reconstitution

You will gain valuable insights into the complexities of stability studies for biologics, equipping you with the knowledge to design robust stability programs and address the specific challenges associated with these products.

While much of the focus for stability testing is at the developmental stage, there are significant obligations for MAHs and Manufacturers for ongoing stability testing during the post-approval stage of the life cycle. Stan will explore the obligations for ongoing stability testing, with a particular focus on what opportunities exist to adopt a lean approach and what is required when problems arise.

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.

In this presentation, Catherine will delve into the intricacies of stability data in regulatory submissions and explore practical solutions to common challenges faced by pharmaceutical companies seeking marketing authorization. From addressing deficiencies to enhancing stability summaries, Catherine will cover it all. You can expect actionable guidance and real-world examples.

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.

Closing Q&A with our panel of guest speakers