To address the challenges biobanks face during human biological sample provision, Scientist.com partnered with the UKCRC Tissue Directory and Coordination Centre (TDCC) to host a 3-part webinar series. Although the focus was on UK-based biobanks, the discussions and outcomes are globally applicable to any provider of human biological samples or research organization looking to procure human samples for scientific research.

Hosts:

Matt McLoughlin, VP of Compliance & Categories at Scientist.com. Matt hosted all three webinars and curated the Q&A session. Matt was also able to bring valuable insight as to how Scientist.com is tackling some of the challenges biopharmaceutical organizations and biobanks face when collaborating as well as providing valuable input on the industry perspective of multi-national large organizations.

 

Phil Quinlan, Director at UKCRC TDCC. Phil’s main responsibilities are to oversee the strategic direction of the UKCRC TDCC and to ensure delivery on its mission and objectives. The team works to maximize the use, value and impact of the UK’s human sample resources, helping ensure that UK biobanks are visible to the research community.

 

Jessica Mai Sims, Engagement Manager for Collaborations at UKCRC TDCC. Jessica works with external stakeholders to join up policy across the UK’s biomedical research landscape to achieve the TDCC’s goal. She brings a background in policy research and patient and public engagement to the TDCC’s multidisciplinary team.


Part 1: Maximizing the Use, Value and Impact of Human Samples

The first installment of the series took place on April 22, 2020. Attendees came from a range of universities, patient groups and industry. The aim of the first webinar was to focus on the challenges and the short-comings in maximizing the use and impact of donated human samples for research purposes.

Matt and Phil were joined by Richard Stephens, a key stakeholder within the patient advocacy movement, use MY data and Helen Hind from the Medicines Discovery Catapult. The panelists represented the viewpoints and challenges in accessing and utilizing human samples for research purposes.

Richard Stephens, Patient Advocate at use MY data, Genomics England and the National Cancer Research Institute represents the perspective of donor patients. Richard chaired the NCRI Consumer Forum and now chairs BBMRI-ERIC’s Stakeholder Forum. He sits on strategic groups for NIHR, NHS England, PHE-NCRAS, Genomics England, Cancer Research UK and the ABPI, and works with industry and with patient advocates globally.

 

Helen Hind, Clinical Samples Manager at the Medicines Discovery Catapult provides a perspective from Small to Medium Enterprises (SMEs). Helen has over 25 years’ experience in the life sciences, having previously held both lab-based and clinical research roles at AstraZeneca; she has also worked within sample access for AZ Discovery scientists. Prior to her current role Helen worked in academia on clinical trials methodology and within the NHS.


The common theme that emerged from the discussion was that “Non-use of donated tissue is misuse,” meaning that not utilizing donated samples is just as unethical as utilizing them against the donor’s wishes. Richard shared the Issue with Tissue report from use MY data, which sets the current usage at an estimated ~15%. He also reasoned that tissue donors want to benefit by advancing health research, so their wish is that their donated tissue is being used. Three main issues have been identified preventing the maximization of use, value and impact of human samples donated to research: Visibility, sample “quality” and legal and ethical access. Ultimately, the need for human tissue is there and is only increasing; however, navigating different access procedures, cost recovery models and biobank operations/communications can be time consuming and confusing. The panel concluded that maximizing the utilization and impact of donated tissue is everyone’s responsibility, and everyone involved in tissue use should be accountable.

Part 2: Three Practical Approaches

The second episode of the series took place on May 20, 2020 and focused on three practical approaches biobanks could take in overcoming some of the challenges established in Part 1. The speakers discussed the importance of sustainability and visibility for biobanks. They also discussed ways to manage the expectations of various stakeholders and work within legal frameworks. This webinar also mentioned the impact that COVID-19 was having on the involved organizations.

Alison Parry-Jones from the Wales Cancer Bank joined Matt and Phill in this webinar, bringing an insightful story from the view of a UK-based biobank. The UKCRC TDCC and Scienitst.com also shared their experience and the approaches taken to facilitate the ethical provision of human biological samples by enabling discoverability of samples, ensuring transparency and facilitating collaboration with industry.

Alison Parry-Jones is Operations Director of the Wales Cancer Bank (WCB). Alison is the Designated Individual on the Wales Cancer Bank licence issued by the Human Tissue Authority and is therefore responsible for governance and compliance across all WCB sites in Wales. She has extensive project management experience in academia and is a PRINCE2 registered practitioner.


Last year, the TDCC launched its Transparency Principles to address misconceptions around organizations like Scientist.com. The principles state that transparency throughout the research process is vital, ensuring researchers and biobanks know who they are working with and that all parties are acknowledged. Over 200 UK biobanks, including the Wales Cancer Bank, are registered on the Directory, and their collections can be searched by researchers and can be linked through the directory to BBMRI Directory, isber-irl and the Health Data Research Innovation Gateway.

The Tissue Directory is also integrated into the Scientist.com platform, allowing researchers to filter for registered biobanks, save time and effort in sourcing samples and enabling a seamless transition from the directory and the sample selection to an order. COMPLi®, Scientist.com’s software solution to manage the legal and compliance process, aims to improve the visibility, traceability and control related to the provision of samples. It facilitates conversations between biobanks and researchers, with each party having total control over who they work with and what samples they access/provide. There is no exclusivity or obligation to meet requests via COMPLi, as it is designed to be an extension to a biobank’s existing processes. Through one standard process, time spent on due diligence forms and contracts (e.g. Material Transfer Agreements) is reduced, while maintaining flexibility for both parties. For biobanks, part of this process is support liaising with central legal teams to ensure all requirements are addressed. There is a standard set of T&Cs, but this can vary for each project if needed. This flexibility is a major benefit of the platform as well as making the process of offering samples quicker and easier for both sides.

COVID-19
As expected, biobanks have been impacted amid the Covid-19 pandemic. With most surgeries having been postponed and limited access to patients, collections (especially fresh samples) have been suspended and an estimated 70-75% of biobanks closed. However, the need for samples has not diminished, as Scientist.com is still receiving requests for samples, and there are still companies/biobanks able to provide sample from existing repositories. Scientist.com is also tracking organizations accessing COVID-19 samples. So far, there has not been  a reduction of non-COVID-19 related requests.

In conclusion, it is evident that there is patient support for the donated samples to be utilized by any sector, academia or industry, as donors are very keen to support the best science, regardless of where that is being carried out, especially since there is an enhanced appreciation for new drugs, vaccines and treatments coming from industry.

Part 3: The Industry Perspective

The third and final installment of the series took place on September 24, 2020 and focused on how biobanks can successfully work with industry. As expected, many attended the webinar, representing a range of universities, commercial organizations and industry.

Dr. Kirstin Goldring from AstraZeneca, and Dr. Paul Schröder and Marcela Aguilar Matta from Novartis joined Matt from Scientist.com and Jessica from the TDCC in this webinar, allowing the audience to understand and demystify the processes pharmaceutical companies have in place to acquire human samples and the importance of working with biobanks.

Kirstin Goldring, Director/Head of Human Biological Sample Compliance and Governance at AstraZeneca. Kirstin works with the biobanks globally to ensure that AstraZeneca scientists can access the samples and data that they need in a compliant way. Kirstin chairs the HBS Governance Council and leads the AstraZeneca HBS Compliance and Governance team, supporting compliance in the use of HBS across the business.

 

Paul Schröder, BioSample Compliance Manager at Novartis. Paul works with HBS suppliers globally to ensure Novartis researchers have access to human samples and data, meeting highest ethical principles as set forth by Novartis Human Tissue Supplier Code. Paul is part of the Novartis Human Tissue Council and has previously worked in different compliance areas within pharma and academia.

 

Marcela Aguilar Matta, Global Sourcing Manager Research at Novartis. Marcela works on Global Sourcing Manager Research at Novartis including the scope of the human tissue category strategy, with more than 15 years’ experience across several industries including pharma, agriculture and consumer products. She has an MA in operational research and a BA in Industrial Engineering.


There is an increasing need and importance of human samples in the drug and diagnostic discovery process. With it, pharmaceutical companies such as AstraZeneca and Novartis are taking a firm stance in the standards and criteria required to source human samples. Both have dedicated teams to ensure that the human biospecimens acquired have been sourced ethically and responsibly and that the donors’ wishes are fully respected. Additionally, contractual language, internal checks and tracking processes ensure that national laws and regulations (both at the sourcing country and use country) are registered and followed.

The internal compliance process is aimed to minimize reputational risk, as well as speed up access to samples, by having suppliers pre-assessed and set up. It also allows for alignment with the tracking processes to ensure full ethical and consent compliance for the whole life cycle of the human samples, across multiple sites, across different continents. The Scientist.com platform enables this for both pharma leaders, as it allows a central reference point with all the necessary information in a single point of reference.

Addressing the different biobank ethical and operational considerations, both AstraZeneca and Novartis have confirmed that they have the appropriate processes in place to acknowledge the biobanks in any arising publications. Furthermore, centralizing the process through Scientist.com allows for the necessary visibility and access to the dedicated teams to be able to review and assess the level of necessary information that can be shared to allow biobanks to conduct their own reviews and evaluations.

To conclude, pharmaceutical industry acknowledges the value and efforts of biobanks and has stepped up their compliance standards to enable compliant and efficient interactions to drive high-quality research.

Thank you to everyone that joined us for these live events, and we hope these recordings can serve as a valuable resource.

Please contact Maria Menikou, Category Director | Human Biological Samples, at maria.menikou@scientist.com if you have any questions or comments.