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.
ARM's 9th Annual Dinner & Legislative Fly-In will include a full day of meetings and programming leading up to the Annual Dinner including an RMAT Policy Lunch Briefing, a State of the Industry Mid-Year Update and an interactive panel discussion featuring the patient's experience.
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.
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".
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.
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.
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 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.
The Standards Coordinating Body (SCB) and Nexight Group will be hosting a workshop on the development of standards for regenerative medicine therapies at the ASGCT meeting on Wednesday, May 16th from 6:30 - 9:00 PM.
ASGCT’s 21st Annual Meeting will take place May 16-19, at the Hilton Chicago.
The Standards Coordinating Body (SCB) and Nexight Group will be hosting a workshop on the development of standards for regenerative medicine therapies at the ASGCT meeting on Wednesday, May 16 from 6:30 - 9:00 PM. LEARN MORE
Gene Therapy for Rare Disorders 2018 will focus exclusively on overcoming the late-stage commercial challenges drug developers face when delivering gene therapies to market. Incorporating insights from Spark, Bluebird Bio, Pfizer and GSK, this unique conference will delve into the key regulatory, reimbursement, clinical and manufacturing hurdles that need to be overcome to realize the commercial potential of gene therapies.
Lentviral and retroviral vectors are at the forefront of advanced therapeutic medicinal product (ATMP) development. This one-day conference aims to give attendees an overview about the successes, challenges and areas for future development. Key national and international speakers including Adrian Thrasher and Luigi Naldini have accepted the invitation to speak at the conference.
Cell & Gene Therapy Meeting 2018 will be organized around the theme “An insight into Cell & Gene Therapy for sound lives”. This Global Meet will bring together world-class personalities working on cell and gene therapy, stem cells, tissue engineering and regenerative medicine to discuss about the Frontiers in Cell and Gene Therapy: From Bench to Bedside.
NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for regenerative medicine products and advanced therapies. These collaborations leverage NIST expertise in measurement sciences to address specific analytical scientific challenges as well as FDA regulatory science, research and review expertise in regenerative medicine products to ensure that the science and standards developed address significant regulatory challenges that recur across the field.
Targeted genome editing technologies are being leveraged across many sectors including in the development of novel therapeutics. NIST and FDA are convening a public workshop with stakeholders across industry, academia, non-profit, and government to define a path forward for developing pre-competitive measurement and standards solutions to address the wet lab, dry lab and terminology needs for confident use of genome editing technologies, particularly for the development of human therapeutic products. The outcomes of this workshop will help clarify current regulatory perspectives and supply additional information to the newly launched NIST Genome Editing consortium (now accepting members) towards the path forward for developing solutions. The workshop will be organized into both general session talks with discussion as well as breakout sessions to get detailed feedback and engagement.
The Stem Cell Summit provides information on cutting-edge developments in all areas of stem cell research from bench to bedside, including the biology, medicine, applications, regulations, product development, and the commercialization of stem cells. This summit comprises of presentations, panels and round-table discussions to highlight pre-clinical and clinical studies in regenerative medicine, immunotherapy, stem cell reprogramming, cell therapy in diabetes, regulatory policies regarding stem cell research, manufacturing and other relevant topics.
The Standards Coordinating Body (SCB), with co-sponsorship from NIST, BioFabUSA, and NIIMBL, would like to invite key stakeholders from industry, regulatory and academic institutions to attend a workshop focused on rapid microbial testing methods (RMTM) in Rockville, Maryland at the National Cybersecurity Center of Excellence (NCCoE), on April 10, 2018.
The RMTM workshop will review existing technologies and associated standards/regulatory guidance, survey a selection of existing analytic technologies that could be adapted to cell therapy as well as next-generation devices and technologies to fill current gaps and significantly reduce processing and release times. The workshop will also provide an opportunity to personally contribute to the future focus of standards development in this area.
The current schedule of events includes:
- Workshop registration and breakfast (8:00 – 8:30 AM)
- Welcome and introductions (8:30 AM)
- Overview of current methodologies (Speaker: Spencer Hoover, CCRM)
- Review of standards and reference materials (Speaker: Scott Jackson, NIST)
- Overview of FDA Guidance (Speaker: FDA representative TBD)
- Panel discussion on current methodological gaps
- Roundtable discussion: Building user requirement specifications (URS) for new technologies
- Rapid presentations of applicable technologies
- Review of URS exercise, discussion of overall strategy, and next steps
- Close of meeting and departure (5:00 PM)
Registration for this initial event is limited to 70 participants (please limit to two attendees from your organization).
Back for its 11th Annual edition, this global bio-pharma industry forum addresses through its conference programme the main challenges for 2018 in investment, partnering and alliance management. Key players contribute their insights in panels which cover the macro picture as well as innovation in the different therapeutic sectors. The Forum also features keynote speeches by KOL, about 70 selected corporate presentations from established (public and private) and emerging biotechs seeking to promote investment and partnering opportunities. There is also a focus on early stage innovation and an elevator session with 20 companies.
The 22nd annual Regenerative Medicine Workshop will focus on “Synergizing Science, Engineering, and Clinical Translation,” and is co-organized by the Regenerative Engineering and Medicine Center (a research consortium between Georgia Tech, Emory, and the University of Georgia), the University of Pittsburgh, the University of Wisconsin Madison, and the Mayo Clinic.
The CAR-T Congress gathers thought leaders from biotech, big pharma, academia and investment to address the challenges and opportunities of CAR-T therapies in both liquid and solid tumors. Discussing the potential of CARs in alternative cell types, mechanisms behind toxicity and tumor targeting, this event will provide an in depth view into this expansive area.
Cell and Gene Therapy Conference is to ameliorate the knowledge, awareness, and education on cell and gene therapy leading to the discovery of genetic and cellular therapies which aid to alleviate the human disease as it is the most significant emerging technology in the eyes of Medical, Biotechnology, Pharmaceuticals and Academia. Cell and Gene Therapy Conference 2018 is an excellent opportunity for the delegates from Universities and Institutes to interact with the world class Scientists.
The advanced therapies summit is a multi-stakeholder, interactive forum that seeks to exchange views and make recommendations on how best to advance the ATMP sector in Europe. The conference brings together the top executives, clinical researchers, public policy makers and other members of the advanced therapies community to highlight the major achievements as well as the main challenges experienced along the path from discovery to delivery of transformative – and even potentially curative – therapies. This year’s program will feature interactive roundtable discussions and networking opportunities.
The Nexight Group and Standards Coordinating Body invite you to join us for a webinar on Tuesday, March 13, at noon EDT. This webinar will share some highlights from a recent study of the regenerative medicine standards landscape and pair that with a case study that illustrates how an effort to advance rapid microbial testing is seeking to advance a potential standard. We will also answer questions and facilitate discussion on your experiences and needs regarding regenerative medicine standards.
By attending this event, you’ll participate in the most exciting and challenging discussions on the industry’s most difficult applications including viral gene vectors and vaccines, adeno-associated virus (AAV), and other products derived with baculovirus technology, plus cellular therapies and three-dimensional, cellular structures. You can attend any talk you choose from the three concurrent programs, plus you’ll participate in a number of fun and stimulating networking events throughout the meeting that you can attend at no additional cost. This meeting offers unique opportunities to share technology with some of the most talented people in the biotech industry, plus key regulators and essential supply firms.
The 3rd Annual Genome Editing & Engineering Conference taking place on 8th - 9th February 2018 in San Diego, USA aims at bringing together the key industry leaders, experts and researchers to address the most recent case studies and research on functional genome screening and precision gene editing to reveal their potential applications.
At the Winter 2018 Summit, attendees will explore the theme of "accelerating the commercialization of engineered tissues" through three lenses: optimizing regulatory pathways, enabling workforce readiness and development and securing direct sources of government funding.
The NIH and FDA will be hosting a Regenerative Medicine Innovation Workshop at the Bethesda North Marriott & Convention Center. The purpose of the workshop is to explore the state of regenerative medicine science involving adult stem cells with a focus on approaches to the development of safe and effective products.
The TERMIS-AM Meeting is the key annual meeting held in the Americas each year, and brings together researchers, scientists, trainees, and students from both academia and industry to discuss critical developments in the field. The meeting is led by keynote speakers each day, and consists of parallel technical sessions as well as poster presentations.