Registration is open for the ISO/TC 276 Biotechnology US Technical Advisory Group (TAG) meeting being held May 20-21 at the National Cybersecurity Center for Excellence in Rockville, MD. All of the current topics under development at the international level of ISO/TC 276 will be discussed to determine the viewpoint of the US delegation prior to the international meeting being held in June.
SCB will host a workshop to advance process, measurement, and analytical techniques of regenerative medicine products and services on May 15th and attend the World Advanced Therapies & Regenerative Medicine Congress.
Webinar: Using Patient Outcomes Data to Inform and Advance the Development of Emerging Cell and Gene Therapies
SCB’s Senior Technical Program Manager, Dawn Henke, will participate in a panel in this webinar through Cell & Gene Therapy Insights and sponsored by Be The Match BioTherapeutics. The webinar will focus on highlighting the impact outcomes data tracking has on ensuring innovative therapies are safe and effective, while also proving the retrospective data to expedite approvals and delivery.
On Friday, May 3, 2019, NIST will host and convene a one-day public workshop with stakeholders across industry, academia, non-profit, and government to discuss industry-wide measurement challenges and potential standards solutions for genome editing technologies, particularly for the development of human therapeutic products.
SCB, along with ARMI | BioFabUSA and Medtronic, will host a half-day workshop on April 16 in Minneapolis, MN. The workshop will offer an opportunity to provide feedback on the standards needs and priority areas for tissue engineering.
UMN 2019 Manufacturing Needs for Biofabrication of Engineered Tissues and Organs: Raw Materials and Supply Chain Challenges
Breakthroughs in cell technologies, materials science, and biofabrication methods, particularly 3D bioprinting, have laid a foundation for large-scale manufacturing of tissues and tissue-related products. Attendees of this conference will learn from industry and academic experts on what will be needed to bring biofabrication from its current prototype stage to reproducible, manufactured tissue products in the future.
The Gene Therapy for Rare Disorders Conference focuses exclusively on overcoming the late-stage commercial challenges drug developers face when delivering gene therapies to market.
Incorporating insights from 50+ industry-leading speakers, this unique conference delves into the key regulatory, reimbursement, clinical and manufacturing hurdles that need to be overcome to realize the commercial potential of gene therapies.
The 9th International Conference and Exhibition on Advanced Cell and Gene Therapy (CELL THERAPY 2019) follows the theme “Novel innovations and breakthroughs in cell and gene therapy” and will be held on March 21-22, 2019 in Rome, Italy.
Realizing the Benefit of 21st Century Cures through Standards Development: A Workshop Convened by FDA, NIST, SCB, and Nexight Group
This two-day workshop will feature updates from Standards Development Organization (SDO) representatives and industry organizations on the benefits of standards and of participating in the standards development processes. Participants will also have the opportunity to learn about current regenerative medicine standards efforts that need community support and participate in discussions to support their advancement.
This webinar, sponsored by Brooks Life Sciences, brings together speakers who will discuss the governance of biosample collections, standardization efforts and quality control harmonization for biosamples as well as global best practices for the regulatory oversight of national and commercial biobank resources.
Join FACT on January 30th for a webinar where presenters will discuss FACT requirements for exceptional release of commercial cellular therapy products and then share their centers’ processes for release of nonconforming cellular therapy products in the U.S.
ASME’s Bioprocessing Equipment (BPE) Committee meeting will be held January 14-17 in Fort Lauderdale, Florida. This committee is focused on developing standards for equipment in the bioprocessing, pharmaceutical, and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements, including materials, design, fabrication, inspections, testing and certification.
The Regenerative Engineering Society is a new society focusing on the Convergence of areas including Advanced Materials, Stem Cell Science, Developmental Biology and Clinical Translation for solving next generation challenges in regeneration.
The society recently has joined with the American Institute of Chemical Engineers and is now one of its Communities.
The Rock Stars of Regenerative Engineering will feature current exciting leaders of the field who will discuss their work in an interactive fashion.
The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research will be holding a public workshop to discuss best practices when measuring the concentration of AAV vectors and to provide FDA perspective on qualifying such assays. The workshop will bring together academia, industry, and other stakeholders involved in research, development, and regulation of AAV-Based gene therapy products.
This annual meeting provides an opportunity to recognize, educate, and collaborate with the National Marrow Donor Program/ Be The Match network partners to address the challenges of marrow and cord blood transplants for patients in need and share innovative best practices.
ASTM Committee F04 on Medical and Surgical Materials and Devices meets twice each year, in May and November, with about 190 members attending over two days of technical meetings capped by a symposium or workshop on relevant topics in the medical/surgical materials and device industry.
This meeting will bring together experts from industry, government, non-profits, and academia to discuss foundational research, technology development, and product commercialization toward creating an advanced biomanufacturing industry for the United States. Invited speakers and panelists will discuss ongoing research in biofabrication and cell manufacturing, government funding and regulatory considerations for biomanufactured tissues and organs, and clinical implementation of regenerative medicine products.
ASTM Committee E55 on Manufacture of Pharmaceutical Products meets twice each year, in May and November, with about 50 members attending three days of technical meetings (every 3rd to 4th meeting of E55 is held outside of the United States). This Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests.
The 2018 PDA Cell and Gene Therapy Conference will provide a broad overview of current innovations with a focus on what it takes to successfully steward these therapies toward approval and beyond. Hear presentations from a lineup of distinguished industry and regulatory speakers including Dr. Peter Marks, MD, PhD, Director, CBER, U.S FDA, who will present the Regulatory Perspective on Considerations for Development and Commercialization of Cell and Gene Therapies.