I look forward to meeting collea

2022.07.31
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I look forward to meeting collea

I look forward to meeting colleagues past and present in person for the first time in over two years. International Media Relations Suite 1102 This 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. 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. Mnemonic: ALSEN. | Top Company News To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Your membership opens the door to free learning resources on demand. | Turquoise +44 7561 424788 | Pharmaceuticals Presenter: Otmane Boussif, Sc.D. This will be a great symposium for anyone working to bring cell and gene therapies to patients in need. 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. 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~)$ Hope to see you at Cell and Gene Therapy Products 2021. P 510.428.0740info@casss.org. 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. 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. The focus of this Symposium is the practical application of mass spectrometry (MS) in the biotechnology industry. For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 The WCBP Symposium series has established a reputation as the most highly-regarded annual conference addressing the role of current and emerging CMC analytical technology among evolving US and international regulatory perspectives. Mary-Jane Elliott/Jessica Hodgson 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. +44 7739 788014 The text version of this document is not available. CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory Considerations. This webinar highlights potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients. 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. | Technology This webinar discusses the implementation of value-based payment models for innovative therapies.

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 -. +33 6 72 18 00 22 Register now to lock in the lowest prices for CGTP 2022 by March 11. | Health View the Scientific Program and Register here: https://bit.ly/3sALGCN The security settings of your browser are blocking the execution of scripts. Thats a wrap on CASSS Cell and Gene Therapy Products symposium 2022. 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. Date: Thursday, July 21, 2022 Regulatory Affairs Professionals Society. <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.4 841.8] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>>

Event: CASSS Bioassays Symposium. There are many great presentations and discussions lined up. 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. Visit Mission Bios virtual booth to learn about implementing single-cell analysis in advanced therapy development and our Pharma Assay Development (PAD) services. Your submission has been received!

Grab your copy today! Panel Discussion: Dealing with Post-Marketing Activities for Cell & Gene Therapy For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 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 %PDF-1.7 5900 Hollis Street Suite R3Emeryville, CA 94608 endobj 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. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. CASSS meetings bring together industry, regulatory and academic professionals for critical discussions to solve technical and regulatory challenges in the field of biopharmaceutical development. | Science ISIN: FR0012596468 This highly anticipated keynote will take place on Wednesday, June 8, 2022.

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. Presenter: Christine Le Bec, Ph.D. ;W&k. CASSS symposia and fora provide venues for biopharmaceutical 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. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 Proof of Concept clinical study of SENS-401 in Cisplatin-Induced Ototoxicity (CIO) and, with partner Cochlear Limited, a study of SENS-401 in patients scheduled for cochlear implantation. CASSS' Virtual Platform powered by Digitell, CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory. Please select the service you want to use: Please use the above public link if you want to share this noodl on another website. Label: SENSORION Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. endobj If this is the first time you are logging in on the new site, you will need to reset your password. Belgium. If you have changed your browser's security settings, you can click here. The presentations and workshops will be devoted completely to practical concerns to strengthen the use of CE within the biotechnology and pharmaceutical industries. Head of Investor Relations & Communication In this role, Ms. Tyson will help lead and grow CASSS event portfolio a key member value in a post-COVID world. Presenter: Otmane Boussif, Sc.D. Gain a deeper understanding of the many manufacturing and industrialization hurdles unique to bringing durable and even curative therapies to patients in need. 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. Workshop: Gene Therapy for Novel indications (Laurent Desires contribution will focus on the inner ear) 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.

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.

Biggest Discretionary ETF Gets Lift by Cost-Conscious Consumers, The Great Resignation Worked: Most Job-Swappers Got a Raise, T-Mobile Gets Chance to Mend Airwaves Patchwork in New Auction, Alibaba Added to SEC List of Chinese Firms Facing Delisting, Vodafone Agrees to Sell Stake in Ghana Operations to Telecel, Sunak Defends Change of Heart on Tax Cut in UK Leadership Race, US Pushes Expansion of China Chip Ban, Key Suppliers Say, FDICs Message to Crypto Investors: Digital Assets Arent Insured, Vince McMahon Exits WWE With $3 Billion After String of Scandals, Shark Sightings Get More Common At New York Beaches, Manfred to Senators: Antitrust Exemption Stops City Switches, Manufacturers That Sell to Consumers Feel the Pinch. 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. 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. Webcast: Update on China NMPA & US FDA Emergency Approval - Implications to Life Science Companies Relating to COVID-19.

Not long now til CASSS CGTP 2022. This webinar discusses how a comprehensive control strategy for pharmaceutical products including gene therapies is the key to achieving process consistency, product quality, safety, and efficacy. This fiscal stimulus program went live April 3, 2020 and loans will only be available until funds are exhausted, so the government is advising borrowers to apply as soon as possible. Washington, D.C. 20036, 2-4 Schuman Roundabout | OTC Markets 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. Theres a New Centrist Political Party. Investor Relations 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. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Event: Gene Therapy Neurological Disorders Europe. We are pleased to welcome you back to the in-person CMC Strategy Forum Japan. But how will they be paid for?

Oops! 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. Sensorion@consilium-comms.com, Sensorion to present at the at the Gene Therapy Neurological Disorders Europe, CASSS Bioassays Symposium and Cell & Gene Therapy Summit conferences, Internet Explorer presents a security risk. 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. 3 0 obj | Biotechnology Mass Spectrometry is a critical analytical technology used in the discovery, development, and commercialization of biopharmaceuticals. | Euronext Paris, Copyright 2006-2022 Public Technologies Inc. | 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. https://lnkd.in/gMMSGfe. Consilium Strategic Communications | Sensorion SA 1 0 obj Learn More: https://lnkd.in/g3_mcag. Now, just as crypto disrupted the concept of value, decentralized finance is poised to disrupt finance itself. Save the Date for the Cell & Gene Therapy Products 2021 Manufacturing, Quality and Regulatory Considerations virtual symposium: June 7-10, 2021. Time: 2.40 pm 3.05 pm EDT (8.40 pm 9.05 pm CEST) 1015 18th Street NW 2 0 obj He will also give a presentation on Advancing Gene Therapy for Hearing Disorders: Dual AAV Manufacturing & Control Strategy, on July 21, 2022. Please see our Privacy Policy for more information. 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. 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. Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. 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. Smartlinks 5635 Fishers Lane, Suite 400

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Rockville, Maryland 20852, 2022 The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. 4 0 obj Hope to see you in the DC Metro Area, June 26 - 29, 2023! 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. Join us in-person for in-depth conversations on trending topics in the field, including roundtable discussions on the EMA paper on Comparability Considerations for ATMPs, CGTP Manufacturing Challenges, Starting and Raw Materials, and more. endobj Roundtable Discussions Featured at CGTP 2022 To ensure the most secure and best overall experience on our website, we recommend the latest versions of, Gene Therapy Neurological Disorders Europe. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies. Held in partnership with the Alliance for Regenerative Medicine (ARM), ARM, Informa Pharma Intelligence, and representative from Abeona, Athersys, and Enzyvant discuss the RMAT designation and its implications on the sector. Want to volunteer to facilitate or scribe for a roundtable? <>/Metadata 370 0 R/ViewerPreferences 371 0 R>> If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. Next Generation Investigator Awards application deadline approaches! 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. The webinar also provides a brief introduction to ARM and ARMs role in improving the landscape for ATMPs in Europe and globally. Potentially curative cell and gene therapies are changing the face of medicine and providing hope to patients where there was once none. 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. #casss #sharingsciencesolutions #cellandgenetherapy #celltherapy #genetherapy. The City of Light May Go Dark This Winter, The Indian Governments Fight Against Fake NewsTargets Political Dissent, Jazzercise Is Alive and Kicking Decades After It Got Started, US Banks Passed the Latest Stress Test, But Are Still Unhappy, UAW Head Says Battery-Worker Pay Must Match Assembly Wages, Teen Has Raised $1.5 Million for Abortion Funds in the Week Since Matt Gaetz Mocked Her, Over Half of Britons Were Net Welfare Recipients During Pandemic, Iran Raises Death Toll From Mudslides, Floods to At Least 53, Exxon CEO Loves What Manchin Did for Big Oil in $370 Billion Deal. A Legal Showdown Over Section 8 Discrimination Is Brewing in Dallas Suburb, Troubled Crypto Lender Babel Lost Big While Trading Client Funds, Ex-Voyager Executive Explores Competing Restructuring Plan for Crypto Lender. | Public Companies Sensorion has entered into a broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. <> Integrating Human Factors into Your Next Regulatory Submission: Lemons or Lemonade? Will Restaurant Week Be the Ticket? of industry, academic and regulatory professionals to work together to resolve scientific challenges in the field of biopharmaceutical development and regulation. This press release contains certain forward-looking statements concerning Sensorion and its business. Even if youve been living under a rock, youre probably familiar with Bitcoin.

This webinar discusses the vector manufacturing process and how it culminates with the formulation and vialing of the purified vector product. Date: Thursday, July 21, 2022 Only one month until CGTP 21. 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. But with DeFis promise of inclusion comes risk and uncertainty. Discussion topics include assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. NYC Wants In-Person Dining Back. 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. Please contact us at raps@raps.org if you need assistance. Privacy Policy | Terms of Use | Contact. Todays spotlight shines on Patsy Lewis, Director of CMC Development-Virtual at Tonix Pharmaceuticals. Please change your browser's security settings to enable javascript. 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. Time: 3.15 pm 4 pm SGT (9.15 am 10 am CEST) Check out the Member Knowledge Center for free webcasts, publications and online courses. x=r?95&AT*Uq7^>l dIkF;q!g Z[AF_v/Y>_T*lsO^xn_(f70$_3{/fo|fgw"a$7?} To use noodls, javascript support must be enabled. Thank you! The Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS community. Date: Tuesday, July 19, 2022 You will also be able to download resources and schedule a meeting with us. 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. Presentation: Characterization of Dual AAV Vector Otoferlin Hope to be able to attend next year! Its shaping up to be a great conference! Something went wrong while submitting the form. View the most up-to-date program information: https://bit.ly/3v6PF9W ir.contact@sensorion-pharma.com Submit your interest by May 6. https://lnkd.in/gssnrcbE 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. This webinar provides guidance to sponsors and developers on the best practices and recommendations in managing manufacturing changes during early development. 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. Presenter: Laurent Desire, Ph.D. You can access the original document here. #casss #sharingsciencesolutions #celltherapy #genetherapy. Wished I could have made it this year. Regulatory Affairs Professionals Society (RAPS) B-1040 Brussels 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. 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]. Catherine Leveau Time: 4.20 pm 5.15 pm SGT (10.20 am 11.15 am CEST) % Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. | Biotechnology I hope to see you there! CAR-T cell therapy is now approved in the U.S. stream 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. 6fjn\)58s~u_)>q9E%mBX-HMJY6X7%.$8-vEWfM+v;+& | Brse Stuttgart The communication of this press release in certain countries may constitute a violation of local laws and regulations. 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. Event: 7th Cell & Gene Therapy Summit. Welcome to our new website! 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. | Pharmaceutical Companies Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". 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. | Research 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. Announcing the new Tapestri Solution for Solid Tumor Oncology Research. 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. | Corporate and Financial Calendar Dont miss Peter Marks, Director, CBER, FDA. CASSS is pleased to announce hiring Necoya Tyson as the new Director of Meeting Operations.