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.
Realizing the Benefit of 21st Century Cures through Standards Development: A Workshop Convened by FDA, NIST, SCB, and Nexight Group
Please save the date for a workshop featuring updates from Standards Development Organization (SDO) representatives and industry organizations on the benefits of standards and 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 workshop is intended for individuals from the regenerative medicine community who can drive the development and adoption of standards based on their role within their organization. These individuals should be strongly focused on improving the quality and safety of regenerative medicine products throughout the product development process, including research and development, manufacturing, and clinical translation. Targeted stakeholders include: RM manufacturers, clinical trial sponsors, contract manufacturers, academic institutions, raw material providers, and logistics delivery providers.
Stay tuned for official invitation and registration information. Contact us with any questions.
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.
Gene Therapy for Rare Disorders Europe is the uniquely focused conference uniting industry leaders to discuss late-stage challenges that need to be overcome to deliver more gene therapies to market. SCB’s Vice President, Sven Kili, will be at the meeting to provide insights on standards development efforts for gene therapies.
Automation and Data Management for Manufacture of Tissue-Engineered and Regenerative Medicine (TERM) Products Workshop
ARMI | BioFabUSA, IEEE, and Rockwell Automation will be sponsoring a workshop on the Automation and Data Management for Manufacture of Tissue-Engineered and Regenerative Medicine (TERM) Products at the Rockwell Automation Facility in Cleveland, OH.
The AABB Annual Meeting is an educational and networking meeting for health care providers in the field of transfusion medicine and cellular therapy. Attendees from over 50 countries from around the globe will come together to discuss the latest cutting-edge developments in their field.
AABB is committed to providing continuing education that focuses on optimizing patient and donor care and safety.
The Cell & Gene Meeting on the Mesa is a three-day conference bringing together senior executives and top decision-makers in the industry with the scientific community to advance cutting-edge research into cures. The meeting features a nationally recognized Scientific Symposium, attended by leading researchers and clinical experts from around the globe, in conjunction with the industry's premier annual Partnering Forum, the first event of its kind dedicated solely to facilitating connections in this sector. Combined, these meetings attract over 950 attendees, fostering key partnerships through more than 1,450 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.
SCB is proud to be an exhibitor at the BioFabUSA 2018 Fall Summit. The focus of the summit will be accelerating the commercialization of engineered organs and tissues. BioFabrication industry leaders as well as special guests will discuss the type of strategies that exist to transition from research to clinical trial to commercial market to patient populations. In order to ensure that this nascent industry has the talent to grow and thrive, the summit will also have a focus on needed workforce development outcomes and strategies.
Registration is open for Cord Blood Connect, the international congress that embraces all components of the cord blood community – public and private banking, clinical and laboratory investigations, manufacturing, administration, training and education.
Biomanufacturing Summit 2018 will mark the seventh annual event of the Biomanufacturing Science and Technology Consortium. Expected summit participants are scientists and engineers from bio-pharmaceutical manufacturers, technology/system providers, raw material suppliers and agencies in the areas of development, manufacturing, and engineering. We hope professionals and leaders of biopharmaceutical industry will be able to get together and talk about future biomanufacturing challenges and breakthrough technology. It will also be a great chance to network with professionals from major bio-pharmaceutical manufacturers and various technology providers such as Biogen IDEC, Genzyme, Pfizer, Momenta, MilliporeSigma, BMS, GE, SAFC and many more.
The Gene Therapy Bioproduction Conference will bring together leading scientists, clinicians, executives and experts who can collectively disperse information on the impact of recent findings on gene therapy and how it can be applied. This conference will highlight scientific breakthroughs, use of innovative technologies and approaches to tackle gene delivery and the translational challenges, and bring together the right people to discuss existing challenges and future opportunities in this field.
This one-day workshop will focus on fiber-based scaffold characterization including batch-to-batch variability, measurement validation and release criteria. This workshop is co-sponsored by ASTM and ARMI | BioFabUSA, with participation from the Standards Coordinating Body.
Registration for this event is now open and will close August 3, 2018.
The American Society of Mechanical Engineers, the International Society for Cellular Therapy, the International Society for Biological and Environmental Repositories, the Organ Preservation Alliance and Society for Cryobiology will be hosting a stakeholder roundtable on July 25th focused on leveraging cryopreservation research to improve practices in cell therapy.
Annual Congress on Advanced Tissue Science and Regenerative Medicine is delighted to welcome all the interested and enthusiastic participants across the globe with the theme “Discover the Advancements in Tissue Science and Regenerative Medicine” Which includes prompt keynote presentations, Oral talks, productive Poster presentations and Exhibitions providing insights to the importance and Developments in Tissue Science and Regenerative medicine.
The Standards Coordinating Body (SCB) and Nexight Group will be hosting a workshop on the development of standards for regenerative medicine therapies at the CASSS Cell and Gene Therapy Products Symposium on Wednesday, July 11th.
The inaugural meeting of Cell & Gene Therapy Products (CGTP): Manufacturing, Quality and Regulatory Considerations will be held July 10-12, 2018 at the Bethesda North Marriott Hotel in Rockville, MD. The success of the 2017 Summer CMC Forum, which focused on cell and gene therapies, demonstrated the benefits and the need to provide an ongoing open forum for dialogue and exchange of scientific and technical advances that are the basis of evolving regulatory practices for this diverse array of innovative products. This symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed. In the tradition of CASSS forums, all of this will be explored in an open and transparent format with regulatory, industry and academic professionals.
The Standards Coordinating Body (SCB) and Nexight Group will be holding a webinar on Tuesday, June 26, at noon ET on the regenerative medicine standards development process and ways you can get involved. During the webinar, we will review how the SCB proposes to complement existing standards development processes to improve coordination, increase community engagement, and enhance regenerative medicine standards awareness across the community. You will hear from industry experts about the benefits of becoming engaged in the standards development process, and we will answer questions and facilitate discussion on your experiences and needs regarding regenerative medicine standards.
Please register for this webinar at this link. We look forward to speaking with you then!
International Conference on Stem Cells & Regenerative Medicine - Genome Editing for Targeting Genetic Diseases
Allied Academies invites all the participants from all across the globe to attend "International Conference on Stem Cells and Regenerative Medicine”, on June 18-19, 2018 in Osaka, Japan, which includes prompt keynote presentations, poster presentations, oral talks, and exhibitions.
The Standards Coordinating Body (SCB) and Nexight Group, along with BioFabUSA, will be hosting a workshop on the development of standards for regenerative medicine therapies which will precede the BioFabUSA Spring Summit on Tuesday, June 5th from 6:00 - 9:00 PM.
The 2018 Cell Therapy conference, hosted by IABS and CIRM, will identify key unresolved issues that need to be addressed for the manufacture and testing of pluripotent stem cell-based therapies and provide scientific consensus on selected aspects to inform the drafting of future national and international guidance.
SCB will present the latest project status and future directions at an evening session, "Breaking News in Standards for Regenerative Medicine".
FDA Workshop: Accreditation Scheme for Conformity Assessment of Medical Devices to FDA Recognized Standards
The Food and Drug Administration (FDA), is announcing the following public workshop entitled "Accreditation Scheme for Conformity Assessment (ASCA) of Medical Devices to FDA-Recognized Standards." The purpose is to present a draft design of the ASCA pilot program and to discuss and obtain input and recommendations from stakeholders on the draft accreditation scheme, including its goals and scope of, and a suitable framework and procedures and requirements.