
Learn about Biosamples
Your Voice Matters. Your Journey Matters.
Every patient’s journey is unique, and so is their voice. At Alexion, AstraZeneca Rare Disease (ARDU), we are committed to transparency and trust in our research and clinical trial processes. Patient testimonials about the Biosample journey reflect real experiences from actual patients or their caregivers. These individuals, by “giving a piece of themselves” are shaping the future of rare disease treatments—because when it comes to research, every sample provides insight, and every insight brings us closer to ground-breaking innovation.
Every patient’s journey is unique, and so is their voice. At Alexion, AstraZeneca Rare Disease (ARDU), we are committed to transparency and trust in our research and clinical trial processes. Patient testimonials about the Biosample journey reflect real experiences from actual patients or their caregivers. These individuals, by “giving a piece of themselves” are shaping the future of rare disease treatments—because when it comes to research, every sample provides insight, and every insight brings us closer to ground-breaking innovation.
I would want to be able to see …where is [my sample] in that process, and then I would feel like it's not just like floating out there in the abyss.
Actual Patient Living with Epilepsy
So, just getting a bit of how the process and the journey [works] will be very helpful, and would ensure that I would be willing, and probably help others to be part of more clinical trials.
Actual Patient Living with Lupus Nephritis
The ‘thank you for your donations’ makes me feel appreciated.
Actual Patient Living with Epilepsy
Listen to actual patients in their own words share their experiences and expectations when providing Biosamples. These audio clips provide a unique and intimate glimpse into the lives of those who are contributing to rare disease research.
Human Biological Samples (Biosamples)
Biosamples include blood, urine, saliva, and other biological materials that are taken during regular medical check-ups, clinical trials, or other research studies. They contain important substances like cells, proteins, DNA, and RNA, which give us valuable biological information.
Unlocking the code of Life: The power of Biosamples in Precision Medicine
- What It Shows: Blood samples can provide information about the immune system, hormone levels, and overall health.
- How It's Used: Blood samples can be used to detect infections and monitor important changes during the course of a disease. In clinical trials, blood tests can measure trial drug levels in the body, like checking their concentrations to ensure they are safe and effective.
- What It Shows: Urine samples give an indication of how well the kidneys are working, how much drug is absorbed in the body, and can also detect a variety of diseases (e.g.: diabetes). During analysis, urine provides insight into levels of glucose, proteins, and other substances.
- How It's Used: Urine samples can be used to indicate a patient’s health status and provide disease progression.
- What It Shows: Saliva contains markers that can indicate hormone levels and immune function.
- How It's Used: It can be used to monitor stress hormones, detect infections, and assess overall health.
- What It Shows: DNA and RNA help us understand changes in genes that can cause different diseases and health problems. They show us how certain gene differences and mistakes might lead to different diseases.
- How It's Used: Researchers study DNA and RNA to understand genetic diseases and develop targeted treatments. For example, sequencing the DNA of patients with rare genetic disorders can identify the mutations causing the disease and lead to specific treatments.
Biosamples are used in medical research to understand diseases, develop new treatments, and improve healthcare. By studying these samples, scientists can make big advances in medicine, leading to better health for everyone.
The Science of Biosamples in Action!
Biosamples help researchers learn how diseases work. By studying blood, and other samples, scientists can find markers (biomarkers) that show how a disease progresses and discover new ways to treat it.
Biosamples are crucial for diagnosing diseases accurately. For example, specific proteins or genetic changes found in biosamples can confirm the presence of certain cancers, helping doctors provide the right treatments quickly. This can lead to better care and outcomes for patients.
Scientists use Biosamples to help develop new medicines. By testing how different drugs interact with these samples in the lab, researchers can often predict if the treatments are safe and effective before giving them to patients.
Precision medicine is about treating patients based on their unique genetic makeup, environment, and lifestyle. Instead of a one-size-fits-all approach, this method tailors treatments to each person's specific needs, aiming for the best possible outcomes. For example, genetic testing of tumor samples can reveal specific cancer-causing mutations. This information empowers doctors to prescribe targeted therapies that are more likely to work for patients with those specific mutations.
Informed Consent and Collection
Before donating a Biosample, patients receive comprehensive information regarding their rights, potential risks and benefits to donating as well as the sample's purpose and usage. Agreement to these terms (known as consent) is confirmed by signing of an Informed Consent Form (ICF).
Protecting data, Preserving Trust: Privacy in Biosample management
Upon donation, each sample is assigned a unique identifier and documented in a secure database. This ensures detailed tracking of the sample's type and collection date while safeguarding patient confidentiality and adhering to privacy laws.
Biosamples are stored under optimal conditions to preserve their integrity over long periods (e.g., cryogenic storage at -80°C or liquid nitrogen for certain samples).
Advanced systems are used to monitor storage conditions continuously, and an inventory management system tracks sample locations and conditions.
Scientists from the Alexion AstraZeneca Rare Disease Unit (ARDU) submit a sample request form to the ARDU Biobank. This form includes details about their research objectives. The ARDU Biobank team reviews the request to ensure that it aligns with patient consent, adheres to ethical guidelines, and possesses scientific value. Before releasing any Biosample to a scientist, a team of experts within ARDU reviews the usage to ensure it meets all necessary standards.
Each sample is stored for a specific duration as outlined in the Informed Consent Form (ICF). This ensures we adhere to your consent and maintain ethical practices throughout our research. Once the storage time expires, it will be respectfully disposed of according to established protocols. These measures ensure that patients’ contributions are handled with the utmost care and respect.
The destruction process is meticulously documented, ensuring that all records reflect the status and history of each sample, thus maintaining accuracy in the ARDU biobank’s database as well ensuring compliance with regulatory and ethical standards.
Initial Consultation and Consent
Collection Phase
End of Study
From Samples to Solutions: Pioneering Success in BioScience!
In the realm of biomedical research and personalized medicine, Alexion, AstraZeneca Rare Disease (ARDU) clinical trials have paved the way for ground-breaking discoveries and therapeutic advancements. Through the generosity and participation of study volunteers in the ALXN1210-DM-310, ALXN1210-ALS-308, and ALXN-ECU-MG-302 clinical trials, we are making significant strides in understanding and treating complex conditions such as Dermatomyositis, Amyotrophic Lateral Sclerosis (ALS), and Myasthenia Gravis.
The ALXN1210-DM-310 and ALXN1210-ALS-308 clinical trials have been instrumental in propelling our research into the exploration of novel biomarkers. By tapping into the invaluable insights derived from participant samples, we have identified potential biomarkers that could revolutionize the way we approach treatment for Dermatomyositis and ALS. These discoveries are crucial steppingstones in our quest to develop new therapies, offering hope to patients who face these challenging conditions.
The ALXN-ECU-MG-302 study has provided profound insights into the mechanistic actions of treatment in varying patient profiles. By analysing Biosamples from patients in this clinical trial, researchers are learning how the drug functions across different patients. This knowledge allows us to tailor interventions specifically to those individuals who are most likely to experience positive outcomes, thereby enhancing the efficacy of personalized treatment plans.
Through these clinical trials, we underscore ARDU’s commitment to advancing patient-centric care and personalized medicine. By leveraging state-of-the-art biomarker research and precision medicine strategies, ARDU aims to deliver targeted, effective therapies that address the unique needs of each patient. These endeavours not only exemplify ARDU’s dedication to innovation but also reaffirm our promise to improving the quality of life for those afflicted by these debilitating conditions.
As we continue to explore the intricacies of these diseases and refine our therapeutic approaches, we remain steadfast in our mission to bring hope, healing, and improved health outcomes to patients worldwide. The collective efforts of our researchers, clinicians, and study participants light the path towards a future where no patient is left behind in the pursuit of effective and personalized care.