Wyeth Holdings LLC

DUBLIN--( BUSINESS WIRE )--The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ResearchAndMarkets.com's offering. The World Compliance seminars team has come up with a detailed course on raw material compliance to understand the intricacy of an ingredient in a product. We have enforced the idea of good manufacturing practices through several pharmaceutical GMP training programs. However, minute elements like raw materials need critical attention to avoid warning letters. Every biotech product is an amalgam of multiple raw materials that add purpose and efficiency to it. Since raw materials are the foundation of these products, it is important to have regulatory norms in place for them. Hence, this seminar discusses raw material compliance to ensure every final product meets FDA expectations and guidelines. Course Overview Did you know more than 5000 firms received the notice for not having cGMP-controlled raw materials? This is not a scenario you dream of while running a pharmaceutical and biotech manufacturing business. As much as the cGMP course plays an essential role, concerned personnel needs to understand regulatory requirements for raw materials. The basic framework of this course is different from cGMP online training. It includes topics like testing and approval of the raw materials, rejection criteria of components, product container management, and closures. As far as the benefits of pharmaceutical cGMP training are concerned, you will learn the following things: Basic guidelines to formulate representative samples for effective testing and inspection Best practices to release each component, packaged product, and closures Appropriate techniques to collect samples alongside preventing contamination, maintaining sterility in equipment, and aseptic processing General criteria for testing and examination of the samples Impact of multiple raw materials on the end user Adhere to the best practices required for commercial-grade manufacturing In addition to these general topics, here are the topics that will be discussed in the seminar. Who Should Attend: Raw material compliance is currently the talk of the town and upskilling yourself will help you in building a positive career. Moreover, additional knowledge of cGMP violations will help you excel in the department. Below are some professionals who will benefit from this FDA compliance training: Regulatory and Compliance Professionals: Develop the ability to identify loopholes and build a better system for raw material procurement and processing. Manufacturing and Quality Engineers: Assess the quality of the product internally and set a benchmark for the entire team to avoid warning letters and product recalls. Document Control Specialists: Gain perspective on documenting the characteristics of the raw material appropriately for future reference. Quality Auditors : In-house auditors play an essential role in product examination and are responsible for giving critical feedback on the entire system. Project Managers: The course will help them understand basic regulations related to raw materials so they can take suitable action and manage product development. 12.0 RAC CREDITS RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit https://www.researchandmarkets.com/r/w04u4w About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

OSE Immunotherapeutics Provides Business and Corporate Update Three pharmaceutical agreements signed during the last three months: New strategic partnership with AbbVie for OSE-230, a novel preclinical potential first-in-class program for the treatment of chronic inflammation. Major partnership expansion with Boehringer Ingelheim: Amendment of the collaboration and licensing agreement on first-in-class SIRPα compounds already developed in immuno-oncology, now expected in Phase 2 in cardiovascular-renal-metabolic diseases later this year.New asset acquisition of a preclinical program which will be launched from the OSE’s cis- targeting anti-PD1/cytokine platform. Solid financial position to support implementation of the strategy until 2027, integrating the recent ‘France 2030’ public funding for Tedopi® pivotal clinical Phase 3 in lung cancer.Additional new experienced international executives who will support the next stages of the Company’s growth on the Board of directors will be present at the upcoming General Shareholders’ meeting. NANTES, France, May 30, 2024 – 6:15pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided business and corporate update after reinforcement of the Company’s business-model based on strategic pharmaceutical partnerships following the three recent new agreements concluded with AbbVie and Boehringer Ingelheim. These steps allow strategy implementation relying on both proprietary late-stage immunotherapy assets in oncology (Phase 3 in NSCLC to be launched) and inflammation (Phase 2 in Ulcerative Colitis with other potential indications), and in accelerating and strengthening first-in-class preclinical programs from its innovative discovery platforms. A strategic evolution of the Board of directors will be presented at the next General Shareholders’ meeting with seasoned pharmaceutical and global executives who will reinforce the Company’ international positioning. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We achieved major industrial partnerships from our differentiated immunological pipeline and our sustainable innovation engine. Our business-model, which is based on recurrent and strategic pharmaceutical partnerships, has been reinforced and allows us to develop our first-in-class clinical late-stage multi-products. We look forward to reaching new milestones in 2024, a transformative year for the Company with potential clinical inflection points from our proprietary and partnered assets, the anti-IL-7R monoclonal antibody Lusvertikimab in Phase 2 in Ulcerative Colitis and cancer vaccine Tedopi® in pivotal Phase 3 in Non-Small Cell Lung Cancer. We are preparing the next steps of the Company’s growth via our promising preclinical programs in immuno-inflammation and immuno-oncology.” Dominique Costantini, Chairwoman of OSE Immunotherapeutics, comments: “In just a few years, we have built a fully integrated biotech company with a rich and differentiated drug-candidate portfolio of both proprietary and partnered programs with pharmaceutical companies, highly recognized as experts in their development fields and markets. The OSE team has already delivered significant achievements and is working to discover and develop innovative immunotherapies. All these significant milestones position 2024 to be a transformational year for OSE with the ambition to become one of the key European biotechs in immunotherapy. We propose a strategic evolution of the Board of directors with both highly experienced and international pharmaceutical and financial experts who will be able to support the Company in its future strategic choice growth.” Corporate Evolution Four new independent directors will be proposed to the General Shareholders’ meeting on June 19th: Markus Goebel, MD, PhD, MBA Markus is a seasoned executive with 30+ year experience in the Life Science industry. He has deep understanding and broad hands-on experience across the entire value chain in various Pharma and Bio/Medtech positions including as a board member. Managing Director Novartis Venture Fund (2004-2019) in the United States & Europe with a top quartile track record. He is also founder & CEO of M&G Advisors GmbH (Bio-and Medtech consulting with a focus to fundraising and transactions). He completed his MBA with dissertation on innovation in the pharma industry to characterize blockbuster drugs. He is a certified MD in Oncology/Haematology (plus additional certifications) with more than 10 years in academia. Martine George, MD, M.Sc.Martine has a rich pharma and academic international expertise mainly in the United States. She is a proven leader of large development teams for global Fortune 500 pharmaceutical organizations and small biotechnology companies. She was Principal, Senior Executive consultant, Life Sciences in Global Development Associates, Inc., Skillman, NJ, a key contributor to strategies leading to multiple drug regulatory approvals or licensing/acquisitions and significant M&A. She was Vice President, Global Medical Affairs, Oncology, at Pfizer Inc., New York, NY, driving global medical strategy and worldwide medical affairs and reimbursement activities for oncology drugs. Previously, she served as Senior Vice President, Drug Development and Chief Medical Officer at GPC Biotech Inc., Princeton; Senior Vice President, Head of Oncology at Johnson & Johnson, Raritan, NJ; and Vice President, Medical Affairs at Rhone-Poulenc Rorer (Sanofi-Aventis), Collegeville, PA. She began her carreer at Sandoz Pharmaceuticals Corporation (Novartis), East Hanover, NJ, and previously at American Cyanamid Pearl River, NY. She has a strong expertise in clinical research, medical affairs, and regulatory affairs specializing in oncology and other therapeutic areas. Her extensive Board experiences were also acquired in large and small companies; in public and private (i.e Phaxiam/ Erytech/ GammaMabs/ Cytomics, Inc/ Non-for-profit organizations Breast Cancer Research Foundation, New York, NY/Ressource Center for Women & Their Families, Hillsborough, NJ). Cécile Nguyen-Cluzel:Cécile has extensive experience in financial engineering and healthcare private equity. After nearly 30 years investing in French small cap funds (Initiative & Finance, MBO +), Cécile joined the London-based pan-European fund Apposite Capital in January 2024 as Senior Advisor in healthcare for France and Europe. Over the course of her career, she has acquired specific expertise in the growth and buyout of companies (investments of between €10m and €40m) in a variety of healthcare sectors, such as diagnostics (spin-off of Cerba in 1998), healthcare services (orthoprosthetists, nuclear medicine), CROs and digital health. Cécile has regularly held positions on the strategic committees of her portfolio companies. Cécile holds a Master “Ingéniérie financière” Dauphine and the ‘Leading the digital transformation in healthcare’ certificate from Harvard medical school. Marc Dechamps Marc is a biologist with extensive experience in the pharmaceutical industry dating back more than 35 years. During his career, he has worked for corporate pharma companies including GSK & ViiVHealthcare, building his expertise in market development for new products in infectious diseases, immunological disorders, oncology, CNS disorders and vaccines. In 2016, Marc founded and became Managing Director of XMF consulting, a company which supports biotech and biopharma businesses with strategic advice. He has also served as Managing Director of Delphi Genetics (CDMO) and interim CEO of eTheRNA Immunotherapies (mRNA biotech company). Presently, he is CEO of Bioxodes, a phase 2a clinical stage biotech company (prevention of thrombosis and neuroinflammation in hemorrhagic stroke patients). He also serves also as President of the board of InvestSud Tech (group InvestSud) and board member of HealthTech for Care (HT4C). Marc is co-academic Director for the advanced masters in biotech & medtech ventures at the Solvay Brussels School of Economics & Management. Strategic announcements since early 2024 On February 28th, OSE Immunotherapeutics and AbbVie announced partnership to develop OSE-230, a novel monoclonal antibody for the treatment of chronic inflammation. OSE received a $48 million upfront payment upon signature of this strategic partnership and is eligible to receive up to $665 million potential additional milestones. On April 10th, OSE Immunotherapeutics received €8.4 million in non-dilutive public funding as part of the France 2030 “i-Démo” program to support the Phase 3 registration clinical trial of cancer vaccine Tedopi® in lung cancer. On May 24th, OSE Immunotherapeutics and Boehringer Ingelheim expanded their collaboration to develop first-in-class treatments for cancer and cardio-renal-metabolic diseases. OSE received a total €38.8 million payment after strengthening its partnership with Boehringer Ingelheim for the development of anti-SIRPα programs in oncology and cardio-renal-metabolic diseases, as well as the launch of a new preclinical asset from OSE’s cis-targeting anti-PD1/cytokine platform; and up to €1.1 billion in potential additional milestones. About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: Tedopi® (immunotherapy activating tumor specific T-cells, off-the-shelf, neoepitope-based): this cancer vaccine is the Company’s most advanced product; positive results from the Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure. Other Phase 2 trials, sponsored by clinical oncology groups, of Tedopi® in combination are ongoing in solid tumors.OSE-279 (anti-PD1): first positive results in the ongoing Phase 1/2 in solid tumors.OSE-127 - lusvertikimab (humanized monoclonal antibody antagonist of IL-7 receptor); ongoing Phase 2 in Ulcerative Colitis (sponsor OSE Immunotherapeutics); ongoing preclinical research in leukemia (OSE Immunotherapeutics).FR-104/VEL-101 (anti-CD28 monoclonal antibody): developed in partnership with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsor Nantes University Hospital); successful Phase 1 in the US (sponsor Veloxis Pharmaceuticals, Inc.). Anti-SIRPα monoclonal antibody developed in partnership with Boehringer Ingelheim in advanced solid tumors and cardiovascular-renal-metabolic diseases (CRM); positive Phase 1 dose escalation results in monotherapy and in combination; Phase 2 in CRM diseases planned to be initiated end of 2024.OSE-230 (ChemR23 agonist mAb) developed in partnership with AbbVie in chronic inflammation. OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Pro-resolutive mAb platform focused on targeting and advancing inflammation resolution and optimizing the therapeutic potential of targeting Neutrophils and Macrophages in I&I. OSE-230 (licensed to AbbVie) is the first candidate generated by the platform, additional discovery programs ongoing on new pro-resolutive GPCRs.Myeloid Checkpoint platform focused on optimizing the therapeutic potential of myeloid cells in IO by targeting immune regulatory receptors expressed by Macrophages and Dendritic cells. BI 765063 and BI 770371 (licensed to Boehringer Ingelheim) are the most advanced candidates generated by the platform. Ongoing additional discovery programs, in particular with positive preclinical results obtained in monotherapy with new anti-CLEC-1 mAbs.BiCKI® Platform is a bifunctional fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target to increase anti-tumor efficacy. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Sylvie Détrysylvie.detry@ose-immuno.comNicolas PoirierChief Executive Officer nicolas.poirier@ose-immuno.comFrench Media: FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooneyPartners LLCKate Barrettekbarrette@rooneypartners.com +1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2023, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Attachment EN_240530 Business and corporate Updates-vf

DUBLIN, Dec. 15, 2023 /PRNewswire/ -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to ResearchAndMarkets.com's offering. This FDA Process Validation Training session is an interactive online Seminar that can provide a channel to augment the understanding of the trainees regarding the Constant Process Verification, will be revised in detail: The training course includes all necessary information regarding where it begins; what it includes; and, when it ends. The Process Validation Guidelines (January 2011) and the EU Annex 15: Requirement and Authentication (October 2015) outline the overall values and methods the two controlling bodies reflect suitable elements of process validation for the production of human and animal drugs and biological foodstuffs, including Active Pharmaceutical Ingredients (APIs). This directive aligns Process Validation activities with a product life cycle concept and with existing FDA and EU guidance, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The life cycle concept, new to these Guidance, links creation and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. This supervision also cares for process development and novelty through sound science and risk management. The new Process Validation Guideline/Practice includes elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing Some general questions asked by the users of FDA Process Validation Training Here are a few common questions that the trainees attending the FDA Process Validation Training must ask to upgrade their initial knowledge: How can one integrate these two different concepts (Phase-wise and stage-wise)? Where do they merge? Can they exist independently or can they complement each other to improve, figure, and deliver a product that neither alone could? To what extent, the users must use them? Does it follow along with Stage 3? Questions that exist include how one manages special situations including viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests including DNA and host cell protein. The experts for FDA Process Validation Training will address these questions in Stage 2 as presented here. It will include the utilization of Procedure Validation and Phase 1, 2, and 3, where their Guidance mixture and where remain distinct. In particular, Stage 3. Important: The seminar insists that the trainees attending the FDA Process Validation Training plan to bring a multidisciplinary cluster from your Establishment to get the most from this very important seminar Objectives of Learning for FDA Process Validation Training: Why are these FDA Guidance/EU Guidelines for Industry-Process Validation so significant to the pharmacological and ergonomics industry? Where does the Process Validation commence? How does Stage 1 integrate with Phase 1? What FDA sections are composed and omitted within the "NEW" Process Validation? What are the Three Stages and Where do They Apply within the NEW Process Validation? The Authentication approaches are included within this Guidance document. The Constitutional and Supervisory Requirements for Procedure Endorsement. An Outline to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation. The Phase 1 Untried Drug Requirements -- What is and What is NOT Required? General Considerations for Process Validation - Stage 2 Process Qualification. Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2. General Considerations for Process Validation - Stage 3 Continued Process Verification. An Appraisal of EU Annex 15 and its Comparison to FDA's Process Validation Direction. Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets