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. 
The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. 
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| Biotechnology Gain a deeper understanding of the many manufacturing and industrialization hurdles unique to bringing durable and even curative therapies to patients in need. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies. Catherine Leveau If you have changed your browser's security settings, you can click here. 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. Presentation: Characterization of Dual AAV Vector Otoferlin 4 0 obj
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. I hope to see you there! 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. 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. 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. Uy*f%Pq|,JBK;/>z\hk}`5l4 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. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. Not long now til CASSS CGTP 2022. 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. Hope to see you in the DC Metro Area, June 26 - 29, 2023! If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. #casss #sharingsciencesolutions #cellandgenetherapy #celltherapy #genetherapy. Its shaping up to be a great conference! | Brse Stuttgart View the most up-to-date program information: https://bit.ly/3v6PF9W 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. Even if youve been living under a rock, youre probably familiar with Bitcoin. 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.
`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 Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". | Euronext Paris, Copyright 2006-2022 Public Technologies Inc. | Hope to be able to attend next year!
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. 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. Learn More: https://lnkd.in/g3_mcag. Next Generation Investigator Awards application deadline approaches! Date: Thursday, July 21, 2022 )1[P,9GAu+0R!6gaNW-:J" r:" WN[e!sFQ@98VFP 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. | Biotechnology 3 0 obj The populist movement promises huge returns for daring investors. Time: 4.20 pm 5.15 pm SGT (10.20 am 11.15 am CEST) 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. This webinar highlights potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients. Only one month until CGTP 21. The Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS community. Mary-Jane Elliott/Jessica Hodgson Belgium. Presenter: Otmane Boussif, Sc.D. sirna virology rnai | Sensorion SA 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. ir.contact@sensorion-pharma.com Your submission has been received! Thank you! gene | Top Company News 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. Its Going Nowhere. ARM believes that it is critical that the NTAP program be modernized to facilitate patient access to new and life-saving treatments. Privacy Policy | Terms of Use | Contact. Head of Investor Relations & Communication | Public Companies
+44 7561 424788 browse genomic germline deficiency predictors replication inhibition This webinar discusses the vector manufacturing process and how it culminates with the formulation and vialing of the purified vector product. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. 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. 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.
stream The text version of this document is not available. 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 -. 1 0 obj But how will they be paid for? Rockville, Maryland 20852, 2022 Presenter: Otmane Boussif, Sc.D. 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. 5900 Hollis Street Suite R3Emeryville, CA 94608 Regulatory Affairs Professionals Society (RAPS) Check out the Member Knowledge Center for free webcasts, publications and online courses.
Submit your interest by May 6. https://lnkd.in/gssnrcbE 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. Visit Mission Bios virtual booth to learn about implementing single-cell analysis in advanced therapy development and our Pharma Assay Development (PAD) services. | Technology 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. rajab 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. gene end commercialization integrated manufacturing enable therapy solutions biopharma asia introduction The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. 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. 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. Workshop: Gene Therapy for Novel indications (Laurent Desires contribution will focus on the inner ear) Welcome to our new website! 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~)$ Panel Discussion: Dealing with Post-Marketing Activities for Cell & Gene Therapy | Company News B-1040 Brussels Presenter: Laurent Desire, Ph.D. | OTC Markets NYC Wants In-Person Dining Back. 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. Your membership opens the door to free learning resources on demand. Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. Smartlinks For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 Oops! This highly anticipated keynote will take place on Wednesday, June 8, 2022. Label: SENSORION 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. The Symposium will be offered in a hybrid format attend live, in-person or watch the live stream from your home or office. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, Gene Therapy Neurological Disorders Europe. He will also give a presentation on Advancing Gene Therapy for Hearing Disorders: Dual AAV Manufacturing & Control Strategy, on July 21, 2022. We are pleased to welcome you back to the in-person CMC Strategy Forum Japan. ISIN: FR0012596468 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. CASSS' Virtual Platform powered by Digitell, CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory. 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. The focus of this Symposium is the practical application of mass spectrometry (MS) in the biotechnology industry. International Media Relations Dont miss Peter Marks, Director, CBER, FDA. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. You will also be able to download resources and schedule a meeting with us. 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. 6fjn\)58s~u_)>q9E%mBX-HMJY6X7%.$8-vEWfM+v;+& For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 The communication of this press release in certain countries may constitute a violation of local laws and regulations. Date: Monday, July 11, 2022 View the Scientific Program and Register here: https://bit.ly/3sALGCN 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. Todays spotlight shines on Patsy Lewis, Director of CMC Development-Virtual at Tonix Pharmaceuticals. Presenter: Christine Le Bec, Ph.D. 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. 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 presentations and workshops will be devoted completely to practical concerns to strengthen the use of CE within the biotechnology and pharmaceutical industries. In this role, Ms. Tyson will help lead and grow CASSS event portfolio a key member value in a post-COVID world. Join Informa Pharma Intelligence and ARM for an interactive webinar to explore what this historic approval means for the patient community, as well as how this sector will approach the scientific, clinical, policy and business issues surrounding CAR-T approvals. 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. 5900 Hollis Street Suite R3Emeryville, CA 94608 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. ovarian gene therapy cancer technavio market pipeline wire analysis business research published report 2022 graphic #casss #sharingsciencesolutions #celltherapy #genetherapy.
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. 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. I look forward to meeting colleagues past and present in person for the first time in over two years. Want to volunteer to facilitate or scribe for a roundtable? Wished I could have made it this year.
CASSS is pleased to announce hiring Necoya Tyson as the new Director of Meeting Operations. endobj
Time: 3.15 pm 4 pm SGT (9.15 am 10 am CEST) Two therapeutic developers, Athersys and Pluristem Therapeutics, presented on their treatment approaches and plans for near term clinical trials. P 510.428.0740info@casss.org. rna synthesis cassettes Suite 1102 Grab your copy today! | Biotechnology 5635 Fishers Lane, Suite 400
;W&k. Event: 7th Cell & Gene Therapy Summit. This will be a great symposium for anyone working to bring cell and gene therapies to patients in need. To use noodls, javascript support must be enabled. Now, just as crypto disrupted the concept of value, decentralized finance is poised to disrupt finance itself. 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. | Science 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.
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. 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.
| News | Corporate and Financial Calendar CASSS meetings bring together industry, regulatory and academic professionals for critical discussions to solve technical and regulatory challenges in the field of biopharmaceutical development. This webinar discusses the implementation of value-based payment models for innovative therapies. Early bird registration for CASSS CGTP ends tomorrow. <>/Metadata 370 0 R/ViewerPreferences 371 0 R>> Please see our Privacy Policy for more information. We are pleased to announce the keynote speaker for Cell and Gene Therapy Products 2022 Symposium. %PDF-1.7 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? If this is the first time you are logging in on the new site, you will need to reset your password. <> 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. The webinar also provides a brief introduction to ARM and ARMs role in improving the landscape for ATMPs in Europe and globally. +33 6 72 18 00 22 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. Date: Tuesday, July 19, 2022
https://lnkd.in/gMMSGfe.
You can access the original document here. This press release contains certain forward-looking statements concerning Sensorion and its business. | Pharmaceuticals 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. Time: 2.40 pm 3.05 pm EDT (8.40 pm 9.05 pm CEST) catalent biologics therapies mrna casss phacilitate accelerating wcbp discovery voyage 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. 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]. 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. Register now to lock in the lowest prices for CGTP 2022 by March 11. Please contact us at raps@raps.org if you need assistance.
The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe. 2 0 obj
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| Biotechnology Gain a deeper understanding of the many manufacturing and industrialization hurdles unique to bringing durable and even curative therapies to patients in need. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies. Catherine Leveau If you have changed your browser's security settings, you can click here. 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. Presentation: Characterization of Dual AAV Vector Otoferlin 4 0 obj
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. I hope to see you there! 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. 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. 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. Uy*f%Pq|,JBK;/>z\hk}`5l4 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. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. Not long now til CASSS CGTP 2022. 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. Hope to see you in the DC Metro Area, June 26 - 29, 2023! If you don't allow cookies, you may not be able to use certain features of the web site such as personalized content. #casss #sharingsciencesolutions #cellandgenetherapy #celltherapy #genetherapy. Its shaping up to be a great conference! | Brse Stuttgart View the most up-to-date program information: https://bit.ly/3v6PF9W 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. Even if youve been living under a rock, youre probably familiar with Bitcoin. 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. 
`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 Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". | Euronext Paris, Copyright 2006-2022 Public Technologies Inc. | Hope to be able to attend next year!
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. 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. Learn More: https://lnkd.in/g3_mcag. Next Generation Investigator Awards application deadline approaches! Date: Thursday, July 21, 2022 )1[P,9GAu+0R!6gaNW-:J" r:" WN[e!sFQ@98VFP 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. | Biotechnology 3 0 obj The populist movement promises huge returns for daring investors. Time: 4.20 pm 5.15 pm SGT (10.20 am 11.15 am CEST) 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. This webinar highlights potential treatments for Acute Respiratory Distress syndrome (ARDS) in COVID-19 patients. Only one month until CGTP 21. The Member Spotlight is an ongoing Q&A series focused on getting to know the CASSS community. Mary-Jane Elliott/Jessica Hodgson Belgium. Presenter: Otmane Boussif, Sc.D. sirna virology rnai | Sensorion SA 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. ir.contact@sensorion-pharma.com Your submission has been received! Thank you! gene | Top Company News 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. Its Going Nowhere. ARM believes that it is critical that the NTAP program be modernized to facilitate patient access to new and life-saving treatments. Privacy Policy | Terms of Use | Contact. Head of Investor Relations & Communication | Public Companies
+44 7561 424788 browse genomic germline deficiency predictors replication inhibition This webinar discusses the vector manufacturing process and how it culminates with the formulation and vialing of the purified vector product. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. 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. 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. 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.
stream The text version of this document is not available. 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 -. 1 0 obj But how will they be paid for? Rockville, Maryland 20852, 2022 Presenter: Otmane Boussif, Sc.D. 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. 5900 Hollis Street Suite R3Emeryville, CA 94608 Regulatory Affairs Professionals Society (RAPS) Check out the Member Knowledge Center for free webcasts, publications and online courses.
Submit your interest by May 6. https://lnkd.in/gssnrcbE 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. Visit Mission Bios virtual booth to learn about implementing single-cell analysis in advanced therapy development and our Pharma Assay Development (PAD) services. | Technology 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. rajab 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. gene end commercialization integrated manufacturing enable therapy solutions biopharma asia introduction The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. 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. 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. Workshop: Gene Therapy for Novel indications (Laurent Desires contribution will focus on the inner ear) Welcome to our new website! 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~)$ Panel Discussion: Dealing with Post-Marketing Activities for Cell & Gene Therapy | Company News B-1040 Brussels Presenter: Laurent Desire, Ph.D. | OTC Markets NYC Wants In-Person Dining Back. 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. Your membership opens the door to free learning resources on demand. Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey. Smartlinks For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 Oops! This highly anticipated keynote will take place on Wednesday, June 8, 2022. Label: SENSORION 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. The Symposium will be offered in a hybrid format attend live, in-person or watch the live stream from your home or office. To ensure the most secure and best overall experience on our website, we recommend the latest versions of, Gene Therapy Neurological Disorders Europe. He will also give a presentation on Advancing Gene Therapy for Hearing Disorders: Dual AAV Manufacturing & Control Strategy, on July 21, 2022. We are pleased to welcome you back to the in-person CMC Strategy Forum Japan. ISIN: FR0012596468 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. CASSS' Virtual Platform powered by Digitell, CASSS Cell and Gene Therapy Products Symposium: Manufacturing, Quality and Regulatory. 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. The focus of this Symposium is the practical application of mass spectrometry (MS) in the biotechnology industry. International Media Relations Dont miss Peter Marks, Director, CBER, FDA. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith. You will also be able to download resources and schedule a meeting with us. 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. 6fjn\)58s~u_)>q9E%mBX-HMJY6X7%.$8-vEWfM+v;+& For more information, visit Cell & Gene Therapy Products, 5900 Hollis Street Suite R3Emeryville, CA 94608 The communication of this press release in certain countries may constitute a violation of local laws and regulations. Date: Monday, July 11, 2022 View the Scientific Program and Register here: https://bit.ly/3sALGCN 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. Todays spotlight shines on Patsy Lewis, Director of CMC Development-Virtual at Tonix Pharmaceuticals. Presenter: Christine Le Bec, Ph.D. 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. 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 presentations and workshops will be devoted completely to practical concerns to strengthen the use of CE within the biotechnology and pharmaceutical industries. In this role, Ms. Tyson will help lead and grow CASSS event portfolio a key member value in a post-COVID world. Join Informa Pharma Intelligence and ARM for an interactive webinar to explore what this historic approval means for the patient community, as well as how this sector will approach the scientific, clinical, policy and business issues surrounding CAR-T approvals. 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. 5900 Hollis Street Suite R3Emeryville, CA 94608 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. ovarian gene therapy cancer technavio market pipeline wire analysis business research published report 2022 graphic #casss #sharingsciencesolutions #celltherapy #genetherapy.
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. 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. I look forward to meeting colleagues past and present in person for the first time in over two years. Want to volunteer to facilitate or scribe for a roundtable? Wished I could have made it this year.
CASSS is pleased to announce hiring Necoya Tyson as the new Director of Meeting Operations. endobj
Time: 3.15 pm 4 pm SGT (9.15 am 10 am CEST) Two therapeutic developers, Athersys and Pluristem Therapeutics, presented on their treatment approaches and plans for near term clinical trials. P 510.428.0740info@casss.org. rna synthesis cassettes Suite 1102 Grab your copy today! | Biotechnology 5635 Fishers Lane, Suite 400
;W&k. Event: 7th Cell & Gene Therapy Summit. This will be a great symposium for anyone working to bring cell and gene therapies to patients in need. To use noodls, javascript support must be enabled. Now, just as crypto disrupted the concept of value, decentralized finance is poised to disrupt finance itself. 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. | Science 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.
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. 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.
| News | Corporate and Financial Calendar CASSS meetings bring together industry, regulatory and academic professionals for critical discussions to solve technical and regulatory challenges in the field of biopharmaceutical development. This webinar discusses the implementation of value-based payment models for innovative therapies. Early bird registration for CASSS CGTP ends tomorrow. <>/Metadata 370 0 R/ViewerPreferences 371 0 R>> Please see our Privacy Policy for more information. We are pleased to announce the keynote speaker for Cell and Gene Therapy Products 2022 Symposium. %PDF-1.7 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? If this is the first time you are logging in on the new site, you will need to reset your password. <> 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. The webinar also provides a brief introduction to ARM and ARMs role in improving the landscape for ATMPs in Europe and globally. +33 6 72 18 00 22 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. Date: Tuesday, July 19, 2022
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You can access the original document here. This press release contains certain forward-looking statements concerning Sensorion and its business. | Pharmaceuticals 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. Time: 2.40 pm 3.05 pm EDT (8.40 pm 9.05 pm CEST) catalent biologics therapies mrna casss phacilitate accelerating wcbp discovery voyage 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. 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]. 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. Register now to lock in the lowest prices for CGTP 2022 by March 11. Please contact us at raps@raps.org if you need assistance.
