Biostór on quality and the future of healthcare

By April Lara

May 09, 2024

Photo of Biostór Ireland logo

The pharmaceutical industry faces many challenges, from healthcare access to technological integration. In this Q&A, we discuss these challenges with Gerard McCabe, chief operating officer of Biostór, one of our shortlisted candidates for the Pharma Industry Awards.

What are some of the biggest challenges you face in developing new products?

• Access to Healthcare: Availability of access to healthcare services remain a significant challenge, with many people lacking access to affordable and quality healthcare, or to the optimum solution for their ailment.
• Rising Healthcare Costs: The increasing cost of healthcare services and medications puts a strain on individuals, families, and healthcare systems.
• Aging Population: As the global population ages, there is a growing need for healthcare services, particularly for elderly individuals with complex medical needs.
• Healthcare Data Security: Protecting patient data from breaches and ensuring data privacy is an ongoing concern, especially with the digitalization of healthcare records.
• Technological Integration: Adapting to and effectively integrating new technologies, such as electronic health records and telemedicine, can be challenging for healthcare organizations.
• Global/International healthcare Policy and Regulation: Frequent changes in healthcare policies and regulations can create uncertainty.
• Patient Engagement: Encouraging patients to take an active role in their healthcare and adhere to treatment plans is an ongoing challenge.
• Future Global Health Crises: Events like the recent pandemic highlighted the need for global preparedness and response in the face of health crises, including PPE, transportation, Quarantine, storage, regulatory etc.

Noting the above challenges, at Biostor, we are 100% committed in providing as many patients access the very best treatment solution possible for them. Working with many global providers, we have been able to ensure that more people in the EU have access to treatments that weren’t available to them previously, in areas such as Orthopaedics, Ophthalmolgy, Cell & Gene Therapies, IVF & Sports Medicine.

How does Biostór ensure the quality and integrity of the biological materials it stores?

Prioritising patient safety requires a comprehensive and proactive approach that involves stakeholders at all levels of the team, especially regulatory oversight. It's an ongoing commitment to safeguarding the well-being of patients.

• Regulatory Compliance: Health products and services should adhere to all relevant regulations and standards. Regulatory bodies, such as the FDA in the United States or the EMA in Europe, play a crucial role in setting and enforcing safety standards.
• Continuous Monitoring: Implement systems for ongoing monitoring of products and services once they are in use. This may include 24/7 temperature/moisture monitoring, lane validations, post-market surveillance and adverse event reporting in accordance with regulation.
• Transparency: Maintain transparency in all aspects of product development and delivery. This includes clear labeling, instructions, and sharing safety information with healthcare providers and patients.
• Quality Control: Implement strict quality control measures in service delivery to maintain consistency and reduce the risk of defects or errors. At Biostor, our in-house team includes our own RP, Quality Manager and Regulatory Manager.
• Interdisciplinary Collaboration: We actively promote collaboration with our peers to prioritise patient safety and ensure an open minded approach in finding solutions collaboratively.
• Ethical Considerations: Ensure that ethical considerations are integrated into decision-making processes, especially in cases where safety may be compromised for financial or other reasons.
• Adverse Event Reporting: Encourage and facilitate the reporting of adverse events and safety concerns by healthcare providers and patients to regulatory agencies and manufacturers
  

What upcoming developments are you most excited about -- can you take us through what Biostór is currently working on?

At Biostor, we are seeing strong growth across almost all of our services, especially in the CGT space and bio storage and sample procurement. Our future will likely be strong growth not only domestically but also internationally where our strategic vision includes a presence outside of the EU, allowing our regulatory and operational teams support our global partners with a strong global network.

Biostór can cater for a wide range of sample types: Active Pharmaceutical Ingredients (APIs) and Finished Products, Clinical Trial Samples, Donor Materials, Plasma, Serum and Body Fluids, Human Tissues and Cell Products i.e., Bone Marrow, Cord Blood & Reproductive Cells. We currently maintains the national archive of Bone Marrow, Peripheral Stem Cells and Donor Lymphocytes for the country’s main cancer hospital and we work with many international companies managing their critical MCB’s/WCB’s and their regulatory requirements in gaining access to/from the EU for a range of patient critical and life changing tissue & cell products.

Our Mission: At Biostór Ireland Ltd, our success is driven by a culture of collaboration, innovation and determination. We believe in progressive thinking, in challenging ourselves and each other, with the goal of enhancing patient outcomes and patient lives. Our mission is to serve our customers with the highest quality, ethics and practices, and to provide best in class customer service & client experience.

What are some key takeaways you'll be bringing back to your organisation from attending the Pharma Industry Awards?

We were humbled and proud to be shortlisted, and even more so to win the category of SME - Pharma company of the year. For us, it was extremely validating to win the award and to be celebrated by our peers for the work we are doing to support them, and of course patients. The pharma industry awards, in bringing all of us together to celebrate all of our successes, is a fantastic event, and very much one that provides a huge amount of credibility and confidence to those lucky enough to be shortlisted.

Gain recognition for your accomplishments in the pharmaceutical sector. Register for The Pharma Industry Awards 2024. Secure your spot at the upcoming awards ceremony, where you'll have the chance to mingle with industry trailblazers and showcase your success.