Evolving Opportunities in the Post Pandemic Era

Dr. Gottlieb, who led the FDA from 2017-2019, has helped create a phased roadmap for navigating COVID-19 and has been a frequent media resource on pandemic-related topics. This LIVE interview will highlight his perspective on the challenges that the biotech industry has had to overcome during COVID-19 pandemic, sustainable innovations and what to expect going forward.

Accelerating manufacturing set up through innovation

The CGT Catapult Manufacturing Innovation Centre in Braintree is the newest addition to the Catapult network, joining the Development Centre in London and Manufacturing Centre in Stevenage. Thermo Fisher DynaDrive single-use Bioreactors were chosen as the core of the new facility. This presentation will first introduce this new facility and how it fits into the Catapult network, followed by why the Dynadrive bioreactors were selected. HEK-293 growth characteristics within the 50L Dynadrive system will also be discussed.

Major contributors to process development acceleration

This presentation will highlight the major contributors to acceleration of development. We will review how organization and  process improvement have an impact on timing to market. We will also focus on some specific technologies such as single use and sensors that can support quick development and we will point out strategy working with suppliers on those technologies to reduce implementation time.

Impact of SARS-CoV-2 on suppliers and biopharma industry

The Covid-19 pandemic has changed virtually every life on the planet. While many industries have been decimated by its effect, the biopharma industry, which has been at the epicenter of the global effort to create vaccines and therapeutics, has been working aggressively over the past 12-18 months to help resolve the crisis with a massive, global effort.  Yet at the same time the industry needs to manage not just these vital cures and treatments, but simultaneously to keep delivering pre-pandemic medicines and cures for patients of cancer, heart disease, diabetes and scores of other ailments, that can’t simply be put on hold.  So when in our 18th Annual Report of Biopharmaceutical Manufacturing we asked the most critical trend, it was no surprise that Covid-19 rose to the top this year.  The brunt of the crisis on suppliers has involved time dealing with supply chain concerns, where 71% of industry suppliers have seen challenges.  At the same time, two-thirds (65%) have expanded their production facilities in major markets.  Budgets and staffing have increased, as new technology and products in R&D are launched at record rates.  In the Post-Covid world, many in the industry are concerned how it will manage the after-effect of this rapid investment and growth.  Yet, it may be business-as-usual as the industry grows to meet global needs.  As one of our respondents to our study said,“…not much has really changed. The industry has been part of the pandemic…response for decades.”  Some pandemic-related changes or trends with long term, strategic implications include: Bioprocessing rapidly accelerating globally, Supply chain strengthening, Single-use systems adoption, Process intensification, Regionalization, Outsourcing, Staffing, Increased Automation. Even before the Covid-19 pandemic all of these trends were evident.  Based on our current research, we have found significant changes being undertaken resulting from the pandemic that are impacting near-term industry dynamics.  But industry executives have expressed some significant, long-term transformational changes that are likely to occur, as well.

Cell therapy analytics and control strategy—challenges and considerations

Cell therapies introduce living cells to patients to cure the disease or regenerate tissues.

They have complicated mechanisms of action and are highly heterogeneous with potential functional differences, which continue to proliferate, differentiate, and migrate after infusion. With these complexities, they often are not well-characterized nor well-understood, posing unique challenges to developing analytical methods and control strategies.

While the principles of control strategy to ensure safe and efficacious products stay the same at a high level, developing a control strategy for cell therapy would need different considerations from traditional pharmaceutical products.

In this presentation, unique challenges and considerations for developing cell therapy analytics and End-to-End control strategy will be discussed.

A patient’s journey to universal CAR-T therapy

After attempting all conventional leukemia treatments and haven been giving a bleak outlook, Matthew went on a mission to find himself a potentially life-saving treatment. After a lot of research and many ups and downs, he was among the first people in the world to receive Universal Chimeric Antigen Receptor T Cells (U-CART).

In this speech Matthew will take us on his patient journey from pre-diagnosis all the way through the roller coaster road to recovery. He will cover the treatments he received, the issues he faced and the emotions he felt along the way.