I hope to see you there! Christine Le Bec, Ph.D., Sensorions Head of CMC Gene Therapy, will give a talk on the Characterization of Dual AAV Vector Otoferlin, on July 21, 2022, virtually, at the CASSS Bioassays Symposium, being held in Gaithersburg, MD, USA, July 19-21, 2022. It was great to share challenges and learn best practices from health authority and drug development thought leaders in the field of cell and gene therapy. ISIN: FR0012596468 Gain a deeper understanding of the implications of the Regenerative Medicine Advanced Therapies (RMAT) designation and the significance of its support and advancement by the FDA in this webinar recording.
Theres a New Centrist Political Party. Early bird registration for CASSS CGTP ends tomorrow. Washington, D.C. 20036, 2-4 Schuman Roundabout This webinar highlights potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients. Your submission has been received! The populist movement promises huge returns for daring investors. Gain a deeper understanding of the many manufacturing and industrialization hurdles unique to bringing durable and even curative therapies to patients in need. The Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. As more regenerative medicine products approach clinical testing and commercialization, seize this opportunity to hear detailed insights and industry best practices from preeminent sector experts. | Biotechnology The Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. Webcast: Update on China NMPA & US FDA Emergency Approval - Implications to Life Science Companies Relating to COVID-19.
The communication of this press release in certain countries may constitute a violation of local laws and regulations.
I look forward to meeting colleagues past and present in person for the first time in over two years. <>/Metadata 370 0 R/ViewerPreferences 371 0 R>> CAR-T cell therapy is now approved in the U.S. +44 7561 424788 Head of Investor Relations & Communication Time: 5 am 7 am EDT (11 am 1 pm CEST) Time: 2.40 pm 3.05 pm EDT (8.40 pm 9.05 pm CEST)
x=r?95&AT*Uq7^>l dIkF;q!g Z[AF_v/Y>_T*lsO^xn_(f70$_3{/fo|fgw"a$7?}
Hope to see you in the DC Metro Area, June 26 - 29, 2023! Sensorion has entered into a broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. 1015 18th Street NW
The focus of this Symposium is the practical application of mass spectrometry (MS) in the biotechnology industry. Presenter: Otmane Boussif, Sc.D. You will also be able to download resources and schedule a meeting with us. Regulatory Affairs Professionals Society (RAPS) Event: CASSS Bioassays Symposium. Save the Date for the Cell & Gene Therapy Products 2021 Manufacturing, Quality and Regulatory Considerations virtual symposium: June 7-10, 2021. The webinar also provides a brief introduction to ARM and ARMs role in improving the landscape for ATMPs in Europe and globally. | Turquoise Your membership opens the door to free learning resources on demand. Privacy Policy | Terms of Use | Contact. Investor Relations The goal of the CE Pharm Symposium is to provide a forum for the discussion of recent developments in CE analysis of protein, nucleotide and small molecule pharmaceuticals. Please change your browser's security settings to enable javascript. 5900 Hollis Street Suite R3Emeryville, CA 94608 This webinar discussed the current funding landscape, what investors are looking for when evaluating new and follow-on opportunities, and how companies can best prepare to fundraise in the midst of the pandemic. This highly anticipated keynote will take place on Wednesday, June 8, 2022. <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.4 841.8] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> #casss #sharingsciencesolutions #celltherapy #genetherapy. In this role, Ms. Tyson will help lead and grow CASSS event portfolio a key member value in a post-COVID world. The CASSS Cell and Gene Therapy Products symposium enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. Want to volunteer to facilitate or scribe for a roundtable? professionals to: The meeting will focus on scientific CMC topics relevant to China and global interests and will feature regulatory participation from the Chinese Health Authority (NMPA-National Medical Products Administration), as well as participation from international health authorities that may include FDA, EMA and PMDA among others. These awards recognize graduate students, post-doctoral researchers, and early career professionals in the field of biopharmaceutical development with waived registration to a CASSS symposium where they can network with leading industrial and government researchers, cutting-edge instrumentation and methods developers as well as regulators and policy makers. | Euronext Paris, Copyright 2006-2022 Public Technologies Inc. | endobj Visit Mission Bios virtual booth to learn about implementing single-cell analysis in advanced therapy development and our Pharma Assay Development (PAD) services. 6fjn\)58s~u_)>q9E%mBX-HMJY6X7%.$8-vEWfM+v;+& | Sensorion SA
The text version of this document is not available. Will Restaurant Week Be the Ticket? Thank you! endobj P 510.428.0740info@casss.org. The first product, Novartis Kymriah, is approved to treat pediatric and young adult patients with B-cell acute lymphoblastic lymphoma, and products for other oncological indications are hot on its heels. Grab your copy today! The webinar includes discussion around how COVID-19 changes the way we think about healthcare decision making and places intense pressure on financial management at all levels of the health system. Time: 3.15 pm 4 pm SGT (9.15 am 10 am CEST)
The CGTP 2022 Symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed. If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. <> Submit your interest by May 6. https://lnkd.in/gssnrcbE | Pharmaceutical Companies You can access the original document here. 1 0 obj | Biotechnology This will be a great symposium for anyone working to bring cell and gene therapies to patients in need.
Michael Werner, Co-Founder and Senior Policy Counsel for ARM, and Robert Falb, Director of U.S. Policy and Advocacy, participated in BIOs webinar on NTAP and advanced therapies on May 9. The fast-paced program is the quintessential market close show leading up to the final minutes and seconds before the closing bell on Wall Street with the latest news, data and expert analysis. P 510.428.0740info@casss.org, The William S. Hancock Award for Outstanding Achievements in CMC Regulatory Science, CASSS Award for Outstanding Achievements in Separation Science, Frantisek Svec Fellowship for Innovative Studies, CE in the Biotechnology & Pharmaceutical Industries, Practical Applications of Mass Spectrometry in the Biotechnology Industry, Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations, Gain tangible knowledge for career advancement, Learn best practices from prominent contributors in the industry. Hope to be able to attend next year!
Presenter: Laurent Desire, Ph.D. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. 4 0 obj ARM believes that it is critical that the NTAP program be modernized to facilitate patient access to new and life-saving treatments. Its Going Nowhere. % Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need. Panel Discussion: Dealing with Post-Marketing Activities for Cell & Gene Therapy This press release contains certain forward-looking statements concerning Sensorion and its business. RAPS.org needs your explicit consent to store browser cookies. Next Generation Investigator Awards application deadline approaches! Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and modalities for drug candidates. CASSS symposia and fora provide venues for biopharmaceutical CASSS is pleased to announce hiring Necoya Tyson as the new Director of Meeting Operations.
| Top Company News Event: 7th Cell & Gene Therapy Summit, Presentation: Advancing Gene Therapy for Hearing Disorders: Dual AAV Manufacturing & Control Strategy E-mail address & Password Combo is invalid, Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments, This Week at FDA: New guidance on disposable manufacturing materials, Generic Drug Cluster report, FDA blasts US API firm for lax response to mold contamination, data integrity failings, FDA finalizes guidance on including patients with incurable cancers in oncology trials, Chemistry, Manufacturing and Controls (CMC), Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo, Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition, Risk Management Principles for Devices and Pharmaceuticals, Good Manufacturing Practice (GMP) [4.0 RAC], Medical Devices: Corrections, Removals and Directed Recalls [6.0 RAC]. Wished I could have made it this year. For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 Rockville, Maryland 20852, 2022 Mass Spectrometry is a critical analytical technology used in the discovery, development, and commercialization of biopharmaceuticals. CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory Considerations. https://lnkd.in/gMMSGfe. Analytical Technologies Europe: Symposium on Analytical Sciences and Regulatory Trends in the Biopharmaceutical Industry provides an active forum for the discussion of recent developments, regulatory considerations, and practical applications of analytical technologies in the biopharmaceutical industry. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. NYC Wants In-Person Dining Back. 2 0 obj +33 6 72 18 00 22 The Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS community. Catherine Leveau There are many great presentations and discussions lined up. Thats a wrap on CASSS Cell and Gene Therapy Products symposium 2022. Mnemonic: ALSEN. Post-Effective Amendment to Registration Statement by Investment[], Statement of Changes in Beneficial Ownership - Form 4, City to Spray July 29-30, as Two Mosquito Pools Test Positive for WNV, Amendment to Registration Statement - Specified Transactions - Form S-3/A, 07/07/2022 | Press release | Distributed by Public on 07/06/2022 23:35. Otmane Boussif, Sc.D., Sensorions Chief Technical Officer, will participate virtually in a panel discussion entitled Dealing with Post-Marketing Activities for Cell & Gene Therapy on July 19, 2022, at the 7th Cell & Gene Therapy Summit on July 19-21, 2022. | Pharmaceuticals MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Sensorion (FR0012596468 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, is pleased to announce the participation of members of Sensorions management in three scientific conferences in July 2022. This webinar discusses the vector manufacturing process and how it culminates with the formulation and vialing of the purified vector product. | Public Companies Please contact us at raps@raps.org if you need assistance. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. Presentation: Characterization of Dual AAV Vector Otoferlin CASSS meetings bring together industry, regulatory and academic professionals for critical discussions to solve technical and regulatory challenges in the field of biopharmaceutical development. Mary-Jane Elliott/Jessica Hodgson Potentially curative cell and gene therapies are changing the face of medicine and providing hope to patients where there was once none. The Symposium will be offered in a hybrid format attend live, in-person or watch the live stream from your home or office.
Event: Gene Therapy Neurological Disorders Europe. Date: Tuesday, July 19, 2022 Q>Gzlvj95:-zB,Uc%2sa~5DO#h4RxxlT cHf\%%F2WcEyxz8eG8E>XClfg[=|=t|]z7HK/uG].EX=w5LBY_..{.[|FqI;eLwKMcAx9)81f~%8fX*#~7PW{vig3;/eQ T]D'{.a_C(Wg kT3?fZKOF{9_'paA333t9j+@?uH!gmBR7EL\!9Aq~)$ Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade? He will also give a presentation on Advancing Gene Therapy for Hearing Disorders: Dual AAV Manufacturing & Control Strategy, on July 21, 2022. Its shaping up to be a great conference! 0bE=kZ|X b-"|]vr>>4xh?DAA~5rzg}HW*Uq`/|/fdYE9\B-0k5M(YY!E)H}"%#Q2b_.$nQ|>;enh\b0dfhyJ@ ={[@[O^4b^5fZTJfbu@s\:;i=L`(psV?e,3+x}5b~b VjP4v[(hvOY5/V;#I!$r(EE5:>/QYZ0ZIV|Fb^ N\e`CdhEC'2Ie'9-/A>._@5wr<9&);fB=N CASSS Moments: Front Row Seat to Challenges, CASSS Moments: Power of Connection and Sharing, CASSS Moments: CASSS Forums Leading Scientific Discussion Over the Years, CASSS Moments: Regulatory Differences: Managing Products Globally, CASSS Moments: Scientific Discussions Addressing Real-Time Issues, CASSS Moments: The Power of Regulatory Questions, CASSS Moments: Regulators and Industry Working Together to Improve Patient Outcomes, CASSS Moments: Discovering Hot Topics for Regulators, Franco Puleo, Cell & Gene Therapy Products 2022, The William S. Hancock Award for Outstanding Achievements in CMC Regulatory Science, CASSS Award for Outstanding Achievements in Separation Science, Frantisek Svec Fellowship for Innovative Studies, CE in the Biotechnology & Pharmaceutical Industries, Practical Applications of Mass Spectrometry in the Biotechnology Industry, Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations, CASSS Welcomes Necoya Tyson as the New Director of Meeting Operations. Regulatory Affairs Professionals Society. Presenter: Otmane Boussif, Sc.D.
Laurent Desire, Ph.D., Sensorions Preclinical Development Director, will participate, in-person, in a workshop entitled Gene Therapy for Novel indications, on July 11, 2022 at the 3rd annual Gene Therapy Neurological Disorders Europe meeting, being held in Paris, France, July 11-13, 2022. | News This webinar features FDA representatives Tejashri Purohit-Sheth and Ilan Irony from the Office of Tissues and Advanced Therapies, CBER, as they discuss the effect of COVID-19 on cell and gene therapy clinical trials.
Todays spotlight shines on Patsy Lewis, Director of CMC Development-Virtual at Tonix Pharmaceuticals. Learn More: https://lnkd.in/g3_mcag. International Media Relations This webinar discusses process development and how it aims to establish and characterize a manufacturing process that can be scaled up to manufacture-size batches while continuing to yield a consistent, quality product.
Consilium Strategic Communications Welcome to our new website! | Research
| Science To ensure the most secure and best overall experience on our website, we recommend the latest versions of, Gene Therapy Neurological Disorders Europe. We are pleased to announce the keynote speaker for Cell and Gene Therapy Products 2022 Symposium. 5900 Hollis Street Suite R3Emeryville, CA 94608 | Technology
Two therapeutic developers, Athersys and Pluristem Therapeutics, presented on their treatment approaches and plans for near term clinical trials. stream | Health
However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2021 full year financial report published on April 28, 2022, and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. ir.contact@sensorion-pharma.com Date: Thursday, July 21, 2022 It has two gene therapy programs aimed at correcting hereditary monogenic forms of deafness including deafness caused by a mutation of the gene encoding for Otoferlin, and hearing loss related to mutation in GJB2 gene to potentially address important hearing loss segments in adults and children. Register now to lock in the lowest prices for CGTP 2022 by March 11. | Biotechnology Presenter: Christine Le Bec, Ph.D. If this is the first time you are logging in on the new site, you will need to reset your password. | Corporate and Financial Calendar
P 510.428.0740info@casss.org, Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations, The William S. Hancock Award for Outstanding Achievements in CMC Regulatory Science, CASSS Award for Outstanding Achievements in Separation Science, Frantisek Svec Fellowship for Innovative Studies. But how will they be paid for? The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion on relevant CMC issues throughout the lifecycle of a product. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Event: 7th Cell & Gene Therapy Summit. This webinar is intended to provide members of the press in Europe with an overview of the ATMP landscape in Europe, including major financings, the clinical pipeline, and the potential for these therapies to significantly improve the standard of care for many patients suffering from devastating diseases and disorders. The Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory Considerations enables the exchange of scientific ideas and dialogue with regulators that form the basis of evolving regulatory practices in the development of these diverse and innovative products. CASSS' Virtual Platform powered by Digitell, CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory. | OTC Markets The security settings of your browser are blocking the execution of scripts. Belgium. For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 This webinar features speakers Mary Beth Bosco, Nicole Elliott, and Joel Roberson, Partners at Holland & Knight LLP, to discuss the emergency loan program for small businesses established by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. I wasnt able to join this year but Ill try next year :), Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory, Now Hiring: Sangamo Therapeutics, Scientist II/III, Formulation - Contractor -. B-1040 Brussels Dont miss Peter Marks, Director, CBER, FDA. Date: Thursday, July 21, 2022 3 0 obj Suite 1102 Now, just as crypto disrupted the concept of value, decentralized finance is poised to disrupt finance itself. Only one month until CGTP 21. Please see our Privacy Policy for more information. The CGTP 2021 Symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed. Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Despite the immense economic challenges brought on by COVID-19, investment interest is still strong for both public and private companies in the cell and gene therapy space. Roundtable Discussions Featured at CGTP 2022 `I;{2#l+zA5ndrQvA>C44]jUZ$ \qpx XiV3LP.`q"jj MyKu7~lE1:kL[jML Mpp;hl4 F)iIP!D37/xN-{\FaKw'.V_!q+)Hy(#8Aj Z)QTZn( 2n#'bg#1FDMVr M!YhWX//VG1"#1]*%7P{@^lS(e W\G* 7+UZW?y\50zJe UEh( bQi^2UtV~XfS\/Q1@4 V2}n8:+!]Nfota@$7`nV@rcEyxzxs\(TY5=tV$mr KXm7Lgwge"v('TvWSv of industry, academic and regulatory professionals to work together to resolve scientific challenges in the field of biopharmaceutical development and regulation.
- Rubber Pool Deck Mats
- The North Face Eco Trail Tent
- Brown Palace Hotel Photos
- Jeevan Safety Matches
- Abb Flow Meter Distributors
- Irwin Naturals Stored-fat Belly Burner Side Effects
- Versace Greca Sneakers Men's