On June 29, 2021 Remegen reported that National Medical Products Administration (NMPA), China’s first novel antibody-drug conjugate (ADC)- Disitamab vedotin, which was just approved to market has been officially included in the breakthrough treatment category for HER2-positive late-stage breast cancer patients with liver metastasis who have received Trastuzumab and taxane therapy in the past (Press release, RemeGen, JUN 29, 2021, View Source [SID1234594765]). The indication is currently in phase Ⅲ clinical trials in China.

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This is the third time that Disitamab vedotin has been granted breakthrough therapy. In September and December 2020, Disitamab vedotin was granted breakthrough designation by the Food and Drug Administration (FDA) and National Medical Products Administration (NMPA) respectively for the treatment of urothelial cancer, becoming the first ADC drug to be dual recognized by both the US and China as breakthrough therapy and Disitamab vedotin is so far the only ADC from China that recieved breakthrough designation from US FDA .

The criteria for breakthrough designation are significantly higher than the other accelerated review pathways of FDA, such as Fast Track, Accelerated Approval, and Priority Review. However, since breakthrough designation emphasizes on significant improvement over currently available treatment, the application drugs must have clinical data with clear advantages, and approvals in the United States are extremely hard, making it very rare for a single drug to be granted both in the United States and China.

On June 29, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a commercialization partnership with San Diego-based human identification specialist Verogen that will provide customers of both companies with superior tools and comprehensive support for human identification (HID) workflows in their laboratories (Press release, Qiagen, JUN 29, 2021, View Source [SID1234586594]).

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The deal enables QIAGEN to offer Verogen’s preeminent HID sequencing and analysis solutions that run on MiSeq FGx sequencers from Illumina, decisively expanding QIAGEN’s forensics leadership that already covers sample collection and preparation, genetic testing analysis and workflow automation. The agreement grants QIAGEN the rights to distribute the Verogen portfolio globally – including kits based on the proprietary Verogen ForenSeq assay, the Verogen MiSeq FGx Sequencing System and the Universal Analysis Software – and covers an expansion of the partnership through future ForenSeq-based assays.

Verogen and QIAGEN will also cooperate to commercialize a menu of forensically validated workflows for next-generation sequencing (NGS) that combine Verogen’s library-prep products with QIAGEN’s QIAseq products, automation solutions and expertise. QIAGEN will market Verogen products globally alongside its portfolio of forensics instruments, kits and services. Financial details of the deal are not being disclosed.

"This combination brings together Verogen’s innovative NGS workflows with QIAGEN’s leading portfolio of Sample to Insight solutions, creating the most comprehensive product offering for forensics applications," said Thierry Bernard, Chief Executive Officer at QIAGEN. "The partnership will drive the adoption of NGS in human identification as it will enable our customers to gain even better insights from their casework samples. This will ultimately strengthen justice systems all over the world."

"Our mission is to empower the human identification community with innovative tools that can deliver an identification, not just a DNA profile," said Brett Williams, Chief Executive Officer at Verogen. "This partnership with QIAGEN will make it easier for laboratories to provide more impactful answers. By combining Verogen’s industry-leading NGS-based product portfolio with QIAGEN’s gold-standard extraction, assay and automation solutions, we will accelerate adoption and use of NGS in forensics."

NGS is used in many biotechnological fields, from cancer research to rare-disease testing. In forensics, it opens completely new opportunities for criminal casework, missing persons and disaster-victim identification. While traditional STR-profiling requires a suspect or a database hit to compare with a crime sample, NGS provides additional intelligence options such as estimation of externally visible characteristics like hair or eye color, thereby elevating DNA testing from a passive forensic support to a proactive investigational technique.

Experts expect the market for NGS in forensics to grow at a double-digit rate annually because of its promising applications.

This collaboration of market leaders addresses important hurdles in areas like workflow integration, automation and vendor support that have slowed adoption of NGS in forensics. The partnership bolsters the workflow solutions offered by QIAGEN and Verogen by offering forensic customers a new level of end-to-end support across the globe, from sample collection to data interpretation and analysis.

QIAGEN is a world leader in HID and forensic testing. It offers a full range of forensic-grade chemistries and high-quality instruments, such as the new EZ2 Connect Fx that address the challenges of crime scene investigation and more. Covering every step from sample to insight, QIAGEN has shaped the development of forensic standards, supporting criminal justice and missing persons identification. QIAGEN’s top-quality forensics products and services are helping customers unlock vital molecular insights to make improvements in life possible.

On June 29, 2021 Bioneer reported to participating to the ISSCR 2021, the Global Stem Cell Event Virtual, on June 21st and presenting at the focus session on developments to simplify and accelerate iPSC research with EBiSC (Press release, Bioneer, JUN 29, 2021, View Source [SID1234584840]).
The presentation if part of the Focus Sessions of the ISSCR Annual Meeting, where Dr. Benjamin Schmid and Dr. Mikkel Rasmussen from Bioneer will be presenting.

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Focus Sessions provide in-depth coverage of specific topics of interest and are presented by interested academic and industry groups. These educational opportunities in science, society, and education are organized by members and open to all meeting attendees. Sessions are held live, with Q&A and chat, and will be available as on-demand programming for 30 days after the meeting.

The Focus Session on developments to simplify and accelerate iPSC research is organized by The European Bank for induced Pluripotent Stem Cells (EBiSC).

The European Bank for iPSCs (EBiSC) is a centralized repository, currently in a second project phase including both non-profit and commercial iPSC researchers (EBiSC2), working to make iPSC tools available and developing protocols which improve and simplify their use. This focus session will share how EBiSC2 partners are adapting and consolidating iPSC expansion, differentiation and cryopreservation approaches to help ease transition into high volume applications whilst also ensuring accessibility for non-expert users. We will discuss how the inclusion of iPSC tool lines in these protocol developments enables rapid generation of functionally mature derived cell types and how the associated iPSC datasets can be broadly shared in an ethically compliant manner. Lastly, common stumbling blocks will be discussed to raise awareness across the community.

See below the full program of the session:

The European Bank for iPSCs Program

Julia Neubauer, PhD, Fraunhofer-IBMT, Germany
Alfredo Cabrera-Socorro, PhD, Janssen Pharmaceutica NV, Belgium
Welcome and Overview

Julia Neubauer, PhD, Fraunhofer-IBMT, Germany
Approaches Towards Expansion, Differentiation and Banking Of iPSCs At High Volume

Mikkel Rasmussen, PhD, Bioneer, Denmark
Emilie Lemesre, PhD, Servier, France
iPSC-Derived Hepatocytes in Drug Screening and Toxicology

Alfredo Cabrera-Socorro, PhD, Janssen Pharmaceutica NV, Belgium
Development of A Fully Human Neuronal and Astrocyte Co-Culture Assay Amenable For Electrophysiological Studies In Functionally Mature Neurons

Benjamin Schmid, PhD, Bioneer, Denmark
Gene-Editing in iPSCs – Unexpected Pitfalls: On-Target Effects

Andreas Kurtz, PhD, Fraunhofer-IBMT, Germany
Collection, Standardisation and Sharing Of iPSC Associated Datasets Using Open Tools

Eugenia Jones, PhD, Fujifilm Cellular Dynamics, USA
Common Non-Scientific Challenges in The Generation, Use and Sharing Of iPSC Lines.

Panel Discussion: Upcoming Challenges In iPSC Research from An Academic and Industry Perspective.

On June 29, Bioneer reported that we will be participating in the Nordic Life Science Days 2021, from April 20th to 23rd (Press release, Bioneer, JUN 29, 2021, View Source [SID1234584839]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Nordic Life Science Days is the largest Nordic partnering conference dedicated to the life science industry. This year the event will be in a digital format, where Bioneer will have a virtual booth, where you will find all information about our company and our high quality service.

You can book a meeting with our Sales and Business Development Manager Lovisa Sunesson on the Nordic Life Science Days platform, contact us via the available online chat or by mail .

Moreover you will be able to hear more about our company and specifically our disease modelling in our company presentation featuring Christian Clausen, Chief Scientific Officer at Bioneer.

On June 29, 2021 Bioneer reported that has initiated two very exciting and ambitious R&D programs that during the next four years will strengthen our capabilities and service solutions that we offer to life science companies (Press release, Bioneer, JUN 29, 2021, View Source [SID1234584838]). We look forward to seeing our R&D organization move these programs forward and be able to assist a broad range of companies with the best services that can contribute to new therapies and medicines.
The first program within "In Vitro Modelling" aims at developing a new generation of in vitro models within CNS, immunology, cancer and the gastro-intestinal system. Our ambition is to develop the best-in-class in vitro models matching the industry needs where especially the CNS track will take us into the area of screening and automation. We are also excited to enter the fast-moving field of Artificial Intelligence that we will couple to our new generation of in vitro models.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The other R&D program within "Early Stage Development of Drug Candidates" will further strengthen our ambition to assist companies from "gene to protein" and with peptide and small molecule development. This ambitious program will move our capabilities in the field of recombinant protein manufacturing to a new level both in terms of production efficiency and the ability to complete CMO transfers. We also look into the exciting world of peptides, where we will use our strong formulation competences to strengthen the service offering.

Bioneer encourages companies, universities and hospitals to contact us. If you would like to know more about the R&D programs, learn how you could benefit from the development activities, or would like to collaborate on one of the topics, feel free to contact CSO Christian Clausen (e-mail).