Originally Aired: December 12, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Thanks to cell and gene therapies, diseases considered untreatable a few years ago, now have treatment options that not only manage clinical symptoms but can be curative. The R&D process of such novel therapies, however, involves novel complexities, which require software solutions that are tailored to constantly evolving, cutting-edge approaches. R&D scientists and their IT partners must work together to establish a digital foundation that models their science accurately, provides complete traceability throughout the R&D process, and makes data easily accessible for actionable insights.

In this session of Learning Labs, we talk to David Kugler,Ph.D., Vice President and Head of Immunology at Cartography Biosciences, and Zachary Reinert, PhD, Scientific Solution Consultant at Benchling, about how you can set up your cell and gene therapy R&D for success with data and software strategies aligned with the complexity of these exciting new areas of science. David will share his industry perspective as a tenured scientist in the field of immune-based therapies. Zach will share representative software solution models and case studies for cell and gene therapy R&D. They’ll both discuss the value of using a centralized software solution to help teams establish traceability throughout the R&D process, work in close collaboration, and generate meaningful insights faster. You’ll see a demonstration of solution capabilities specific to cell and gene therapy, including the modeling of different approaches for CAR-T, TCR, and CRISPR, designing plasmids, cell engineering workflows and experiments with structured data capture, and organizing data for quick search and analysis. All examples will be demonstrated on the Benchling R&D Cloud, a cloud-native platform for biotechnology R&D. In use by over 1000 leading biotech innovators, the R&D Cloud provides a modern experience for R&D scientists with capabilities for biological entity design and registration, experimental data capture, process development and orchestration, inventory, automation, and analysis.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert speakers.

Originally Aired: November 21, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Drugging traditionally undruggable targets is witnessing a sea change due to the development of novel therapeutic modalities. A revolution that began with the therapeutic use of monoclonal antibodies in the 1970s, has expanded into novel therapeutic modalities that involve antisense oligonucleotides, recombinant proteins, viral gene therapies, cellular immunotherapies, ex vivo gene therapies such as CAR-T cells, mRNA and RNAi therapies, microbiome, PROTACs and more. Such novel modalities are creating new hope for patients suffering from diseases like cancer, Alzheimer’s disease and multiple sclerosis, and various diseases that were previously untreatable. Research shows novel therapeutics modalities can accomplish complex functions in ways that traditional drugs cannot. The design of Certified Good Manufacturing Practices (cGMP) manufacturing facilities to produce novel therapeutics requires detailed planning and consideration of several factors, including throughput, biosafety levels, product segregation and contamination control, regulatory environment, time to market and tech transfer challenges.

In this session of Learning Labs, we talk to Katarina Stenklo, Enterprise Solutions Commercial Activation Leader at Cytiva, about the production of therapeutics based on viral vectors, plasmid DNA and mRNA. Katarina is part of a dynamic team at Cytiva that provides integrated manufacturing solutions for advanced therapies with a focus on accelerated timelines and quality.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.

Originally Aired: November 18, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Data analytics is critical at every step in designing, optimizing & controlling state-of-the-art biomanufacturing processes. Software for data analytics must accommodate a range of bioproduct modalities and bioproduction applications, and provide actionable insights that save time and money while minimizing variability and risk in increasingly complex biomanufacturing workflows. 

In this session of Learning Labs, we talk to Marcel von der Haar, PhD, Head of Product Strategy, Data Analytics at Sartorius, about how you can use data analytics software to simplify your process development by identifying critical process parameters, optimizing combinations of parameters, developing process models, and predicting critical outcomes. Marcel will discuss applications and advantages of the industry-proven Umetrics^® Suite as well as the all-new, cloud-native Cell Insights by Umetrics Studio developed at Sartorius to increase the efficiency and scalability of biomanufacturing workflows through advanced analytics, in silico simulations, and visual tools and features that place actionable insights at the fingertips of not only data scientists, but also lab scientists and process engineers.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.

Originally Aired:  August 15, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

In this Learning Lab, we discussed the development of respiratory airway and alveolar organoids derived from human iPSCs and how these are used in modeling respiratory diseases such as cystic fibrosis. Airway organoid models can be used for testing the therapeutic efficacy of candidate drugs for respiratory diseases. Regenerated airway and alveolar cells derived from human iPSCs express proteins that match human respiratory cell biomarkers and play an important role in pathogenesis, such as ACE2 receptor protein in SARS-CoV-2 infections. Our panelists will discuss scaling, standardization, gene editing, co-culture and imaging of these organoid disease models, as important resources for pharmacologic, toxicologic, functional and efficacy studies in respiratory drug development initiatives. 

Clinical development of drugs for respiratory diseases such as COVID-19, idiopathic pulmonary fibrosis, cystic fibrosis, pneumonia, COPD and lung cancers has met major obstacles, particularly during phase 2, when therapeutic efficacy the candidate drug is typically first assessed. Pluripotent stem cells have the innate potential for unrestricted self-renewal and the ability to differentiate into any cell type in the body. However, isolating these cells from live animals is challenging. In 2012 Shinya Yamanaka and Sir John Gurdon were awarded the Nobel Prize for directly generating induced pluripotent stem cells (iPSCs) from somatic cells by introducing four genes, now collectively called the Yamanaka factors (Myc, Oct3/4, Sox2 and Klf4). Regenerative medicine aims to derive specialized cell types from iPSCs that can provide disease models for therapeutic development and can be used to transplant, replace, engineer or regenerate diseased cells. 

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelists.

Originally Aired:  July 18, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

Being a professional in a successful life science company–be it a CRO, a CDMO, a startup, a mid- to medium-sized biotech firm, or an established company with a track record of popular products–requires much more than academic credentials, research expertise and technical knowhow. Soft skills are the competencies required to perform effectively in a biotech team and understand the corporate culture. These are complementary to technical knowledge necessary to acquire and maintain employment in the biotech and biopharma industry. Active listening, critical thinking, time management, negotiation, conflict management, networking are just some examples of soft skills needed in the biotech workplace. Knowing and practicing effective soft skills can help you navigate the unwritten rules of the business world and are essential in growing your professional career. 

Due to an overwhelming number of requests from our audience transitioning to jobs in the biotech industry, in this GEN Learning Lab, we will discuss soft skills needed to fit into the constantly evolving corporate culture of the biotech and biopharma workforce. 

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.

Originally Aired:  June 27, 2022
Time: 8:00 am PT, 11:00 am ET, 17:00 CET

In this Learning Lab, we discussed the development of respiratory airway and alveolar organoids derived from human iPSCs and how these are used in modeling respiratory diseases such as cystic fibrosis. Airway organoid models can be used for testing the therapeutic efficacy of candidate drugs for respiratory diseases. Regenerated airway and alveolar cells derived from human iPSCs express proteins that match human respiratory cell biomarkers and play an important role in pathogenesis, such as ACE2 receptor protein in SARS-CoV-2 infections. Our panelists will discuss scaling, standardization, gene editing, co-culture and imaging of these organoid disease models, as important resources for pharmacologic, toxicologic, functional and efficacy studies in respiratory drug development initiatives. 

Clinical development of drugs for respiratory diseases such as COVID-19, idiopathic pulmonary fibrosis, cystic fibrosis, pneumonia, COPD and lung cancers has met major obstacles, particularly during phase 2, when therapeutic efficacy the candidate drug is typically first assessed. Pluripotent stem cells have the innate potential for unrestricted self-renewal and the ability to differentiate into any cell type in the body. However, isolating these cells from live animals is challenging. In 2012 Shinya Yamanaka and Sir John Gurdon were awarded the Nobel Prize for directly generating induced pluripotent stem cells (iPSCs) from somatic cells by introducing four genes, now collectively called the Yamanaka factors (Myc, Oct3/4, Sox2 and Klf4). Regenerative medicine aims to derive specialized cell types from iPSCs that can provide disease models for therapeutic development and can be used to transplant, replace, engineer or regenerate diseased cells. 

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelists.