Pharmaceutical Product Development LLC

DUBLIN--( BUSINESS WIRE )--The "Pharmaceutical Analytical Testing Outsourcing - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering. The global market for Pharmaceutical Analytical Testing Outsourcing was estimated at US$10.3 Billion in 2023 and is projected to reach US$16.3 Billion by 2030, growing at a CAGR of 6.8% from 2023 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The growth in the pharmaceutical analytical testing outsourcing market is driven by several factors, each contributing to the increasing reliance on external service providers. One of the key drivers is the rising complexity of drug molecules, particularly in the biologics and biosimilars sector. These drugs require more sophisticated analytical testing methods to ensure their safety, purity, and efficacy, which often necessitates the use of highly specialized equipment and expertise that pharmaceutical companies may lack internally. This has prompted the outsourcing of these tasks to CROs that possess the technological capabilities and regulatory know-how to handle complex biologics testing. Another critical factor fueling growth is the cost-saving potential that outsourcing offers pharmaceutical companies. By outsourcing analytical testing, companies can avoid significant capital investment in expensive equipment and infrastructure while also reducing the costs associated with staffing and maintaining in-house laboratories. This is especially appealing to smaller biotech firms or start-ups that may lack the resources to develop in-house testing capabilities but require access to high-quality analytical services to advance their drug candidates. Regulatory pressures are also driving the demand for outsourcing, as pharmaceutical companies face increasingly stringent requirements from regulatory agencies worldwide. CROs with expertise in regulatory compliance offer a distinct advantage by ensuring that testing processes meet global standards, mitigating the risk of delays or rejections during the approval process. Additionally, the growing trend toward globalization in drug development means that pharmaceutical companies are working across multiple geographic regions, each with its own regulatory requirements. This further increases the reliance on CROs that have a global footprint and the ability to navigate complex regulatory landscapes. Lastly, the rapid advancements in digital technologies and data analytics have made outsourcing an attractive option for pharmaceutical companies looking to optimize their R&D processes. CROs that offer advanced data analytics capabilities can provide deeper insights into testing results, accelerating decision-making and improving the overall efficiency of drug development. These factors, combined with the growing demand for personalized and specialized medicines, ensure that the pharmaceutical analytical testing outsourcing market will continue to experience robust growth in the years to come. What Are the Key Market Trends Driving Outsourcing in Pharmaceutical Analytical Testing? Another major trend influencing the market is the rising regulatory scrutiny in drug development. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are enforcing stricter guidelines on drug safety, quality, and efficacy, prompting pharmaceutical companies to seek out CROs that can provide expertise in regulatory compliance and high-quality testing. This includes testing for impurities, stability, and degradation, as well as ensuring that manufacturing processes adhere to Good Manufacturing Practices (GMP). The increasing prevalence of specialty and personalized medicines is also driving the need for more specialized testing services. Personalized therapies, particularly those based on genetics or rare diseases, often require highly specific analytical methods, which many pharmaceutical companies may not have the in-house capability to perform. As a result, these companies are increasingly outsourcing their testing needs to CROs that specialize in niche areas of drug development. Additionally, the shift toward virtual pharma models, where companies focus exclusively on drug development and outsource all other functions, has further accelerated the demand for comprehensive analytical testing services. Report Features: Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2023 to 2030. In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa. Company Profiles: Coverage of major players in the Global Pharmaceutical Analytical Testing Outsourcing Market such as Bioreliance, Boston Analytical, Charles River Laboratories International, Inc., Dalton Pharma Services, Eurofins Scientific and more. Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments. Key Insights: Market Growth: Understand the significant growth trajectory of the Bioanalytical Testing Service segment, which is expected to reach US$6.4 Billion by 2030 with a CAGR of a 8.0%. The Method Development & Validation Service segment is also set to grow at 6.8% CAGR over the analysis period. Regional Analysis: Gain insights into the U.S. market, estimated at $2.8 Billion in 2023, and China, forecasted to grow at an impressive 6.2% CAGR to reach $2.5 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific. Key Attributes: Report Attribute Details No. of Pages 93 Forecast Period 2023 - 2030 Estimated Market Value (USD) in 2023 $10.3 Billion Forecasted Market Value (USD) by 2030 $16.3 Billion Compound Annual Growth Rate 6.8% Regions Covered Global Key Topics Covered: MARKET OVERVIEW Influencer Market Insights World Market Trajectories Global Economic Update Pharmaceutical Analytical Testing Outsourcing - Global Key Competitors Percentage Market Share in 2024 (E) Competitive Market Presence - Strong/Active/Niche/Trivial for Players Worldwide in 2024 (E) MARKET TRENDS & DRIVERS Rising Complexity of Drug Development and Regulatory Compliance Drives Demand for Outsourced Pharmaceutical Analytical Testing Services Increasing Stringent Regulatory Requirements from Global Health Authorities, Including FDA and EMA, Fuels Growth in Analytical Testing Outsourcing Growing Focus on Cost Efficiency and Speed-to-Market in Drug Development Spurs Demand for Outsourcing Analytical Testing Services Technological Advancements in Analytical Testing, Including High-Performance Liquid Chromatography (HPLC) and Mass Spectrometry, Enhance Testing Accuracy Expansion of Biologics and Biosimilars Development Strengthens Demand for Specialized Analytical Testing Outsourcing Increased Adoption of Outsourcing in Emerging Markets Drives Growth of Analytical Testing Services in Asia-Pacific and Latin America Rising Focus on Quality Control and Assurance in Drug Manufacturing Propels Demand for Outsourced Stability and Microbial Testing Growing Need for Advanced Testing Capabilities in Pharmaceutical Packaging, Including Extractables and Leachables Testing Emerging Use of Outsourced Analytical Testing for Preclinical and Clinical Trials Fuels Growth in Early-Stage Drug Development Rising Demand for Analytical Testing Outsourcing in the Development of Personalized Medicine and Gene Therapies Technological Innovations in Automation and AI-Powered Analytical Testing Solutions Enhance Efficiency and Data Accuracy Expansion of Contract Research Organizations (CROs) Offering End-to-End Analytical Testing Services Drives Market Growth Growing Use of Outsourced Analytical Testing in Generic Drug Development and Approval Processes FOCUS ON SELECT PLAYERS: Some of the 42 companies featured in this Global Pharmaceutical Analytical Testing Outsourcing market report Bioreliance Boston Analytical Charles River Laboratories International, Inc. Dalton Pharma Services Eurofins Scientific Exova Halo Pharma Intertek Group PLC Pace Analytical Services, LLC Pharmaceutical Product Development, LLC SGS SA Toxikon, Inc. West Pharmaceutical Services, Inc. WuXi AppTec, Inc. For more information about this report visit https://www.researchandmarkets.com/r/lrn1tt 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.

是否参会均可转发领奖，详见标题六【有奖转发】 时间：2024年12月6-7日（2天） 形式：在线研讨班 培训目的 近年来，随着ICH指南全面转化实施，化药审评尺度日趋严格，众多企业在药品注册过程中遇到了各种各样的发补问题，走了很多弯路。本次网络研讨班目的在于汇总各类发补案例，并讨论如何在规定的时间内，从科学和法规的角度合理的回答审评老师的发补意见，如何解读发补具体内容，如何与审评老师就存在的问题达成共识，以减少不必要的发补，保证产品能快速通过。鉴于此，药研论坛特组织多位一线知名专家就企业发补存在问题和疑义进行授课与答疑。 主办单位 药研论坛 支持单位 北京天咨医药科技有限公司 斯坦德科创医药科技（青岛）有限公司 北京茗泽中和药物研究有限公司 北京阳光诺和药物研究股份有限公司 广州国标检验检测有限公司 【持续招募中。。。】 一 培训议程 第一天：12月6日（周五） 9:00-12:00 主题：化药IND与NDA申报中CMC常见发补及案例分享 1.IND与NDA申报相关的主要法规汇总 2.IND与NDA申报流程介绍 3.IND与NDA申报CMC工艺相关章节的撰写要求讲解和发补案例分享 4.IND与NDA申报CMC质量相关章节的撰写要求讲解和发补案例分享 5.答疑 周玲——北京金瑞博副总经理、药品注册专家 13:30-15:00 主题：包材相容性与密封性研究案例与常见发补 1.相容性研究国内外法规沿革 2.FDA申报-相容性研究方案设计及操作 3.密封性研究国内外法规沿革 4.FDA申报-密封性研究方案设计及操作 5.研究优势 6.答疑 刘春霞——斯坦德生物医药 药学技术总监 15:10-16:40 主题：2024年注册核查重点内容与常见缺陷 1.药品注册核查的法规背景 2.药品研制现场核查要点 3.药品生产现场核查要点 4.注册核查常见缺陷分享 5.答疑 李老师——国家局资深药品检查员、检查组长 第二天：12月7日（周六） 09:00-10:30 主题：基因毒性杂质常见发补及案例分享 1.基因毒性杂质的定义与分类 2.基因毒性杂质工艺评估 3.基因毒性杂质的致变性评估 4.基因毒性杂质的控制策略 5.常见发补及案例分享 6.答疑 刘雪——斯坦德生物医药 杂质专题负责人 10:40-12:10 主题：仿制药注册常见发补与案例分享 一.仿制药发补问题从哪里来？ 二.仿制药发补问题的分类 1.常见的CTD文件缺陷 2.文件拒收案例 3.原料相关缺陷 4.描述、成分、辅料相关缺陷 5.产品和稳定性相关缺陷 6.生产和包材相关缺陷 7.BE相关缺陷 8.PAI常见问题 三.发补问题回复的技巧？ 1.官方指导原则帮助你回复 2.个人经验分享 四、答疑 陈洪——外专局特聘专家、千金药业研究院院长 13:30-15:00 主题：无菌制剂审评关键点与发补案例分享 一．Q1/Q2一致与否的判断 1.过量投料 2.抑菌剂加不加 3.去掉缓冲剂的后遗症 4.亚硫酸盐怎么用 二．装量问题 1.国内和FDA指导原则的异同 2.FDA指导原则的底层逻辑 3.企业怎么做 三．灭菌验证中的微生物挑战试验 1.从PDA的技术报告说起 2.D值和孢子数的计算 3.站在更高的角度回复发补 四．答疑 张岚——资深无菌制剂研究专家 15:10-16:40 主题：原料药技术审评要点与常见发补分析 一.原料药合成工艺的审评要点 1.申报路线和RSM的选择合理性 2.关键步骤、参数的制定 3.工艺稳定性的控制 二.原料药质量研究的审评要点 1.分析方法的开发原则 2.辅助试剂、起始原料、中间体质量标准的制定 3.API质量标准包含的检测项和相关限度制定合理性 三.原料药常见的发补内容分析及案例分享 四.答疑   刘宝——中山大学药学院博士、上海美迪西工艺部高级主任 注：培训内容和讲师可能会有小幅度调整，请关注最新版通知。 二 专家简介 周玲 北京金瑞博副总裁、药品注册专家 从事药品注册工作13年，曾就职于北京康利华咨询服务有限公司、保诺科技(北京)有限公司两家知名的CRO企业，现任北京金瑞博企业咨询服务有限公司副总经理兼注册部负责人。负责国内制剂向FDA以及欧盟的国际注册咨询业务。同时，负责国产制剂以及进口制剂向NMPA申报的注册法规咨询业务。 周老师近年来承接或指导了多项注册项目，包括： −多项1类新药研发项目 −超过30余项新药以及仿制药注册 −帮助多家企业获得欧盟仿制注射液和仿制固体口服制剂MAA −帮助超过20家客户获得进口药品注册证、国产1类化学药品Ⅰ期/Ⅲ期临床批件、国产生物类似药Ⅰ期临床批件 帮助超过50家企业获得化学合成、植物提取以及发酵类原料药CEP证书，FDA原料药以及包材DMF归档函20余个。 刘春霞 斯坦德生物医药药学技术总监 高级工程师，曾任上市药企质量研发总监,具有10余年药品研发和实验室管理经验，熟悉药品注册和申报要求，成功研发过多个化药和原料药品种。现主持斯坦德生物医药相容性、密封性及杂质研究等药品质量研究工作，熟悉国内外相关审评审批要求，完成10000+个相容性、6000+余个密封性和多个质量研究项目的研究和申报，为600余个国内外申报项目成功获批提供技术支持。 刘宝  中山大学药学院博士 上海美迪西工艺部高级主任 刘博士毕业后从事原料药研究十几年，完成四十多个新药IND申报。完成近六十个仿制药研发申报，获得五十多项临床批文，其中六个品种获得生产批文。负责国家重大新药专项，任项目负责人，工作期间申报中国专利十一项。 刘雪 斯坦德生物医药 杂质专题负责人 药物化学硕士，近十年来深耕于药品研发及质量研究领域，熟悉FDA、EMA、ICH、CDE等药品杂质研究相关法规要求，具有丰富的药品质量研究工作经验，掌握了国内外领先的药物杂质研究技术。现负责主持基因毒性杂质等药物杂质研究、原料药质量研究、生物药工艺残留物等研究工作。 陈洪 外专局特聘专家、千金药业研究院院长 四川省“人才计划”医药专家，河北省“人才计划”医药专家和外专局特聘专家，他于1996年获得美国Cleveland State University分析化学博士学位，之后又在全美心脏科排名第一的Cleveland Clinic Foundation 做了两年生物医药博士后研究。曾担任过全球最大仿制药公司Teva的分析和技术服务总监以及美国Nexgen Pharma的研发高级总监，以岭药业研究院副院长，苑东生物副总经理兼研究院院长，拥有30年在美国Adolor、J&J、Teva和Nexgen Pharma和国内药业公司丰富的工作和管理经历，亲自领导和参与并获得70多个新药和仿制药的批文，其中一个一类新药（Entereg）、20多个美国ANDA和50多个中国仿制药。曾带领国内一科创板上市公司研发团队在五年内实现了5个突破：第一个美国ANDA批文，第一个美国IND批件，第一个生物药lND批文，一年内License out 1.2亿的仿药批件，五年内的仿药批件从每年1-2个到现在11-16个. 2020年后获批的40多个批文100%获得首批集采资格。曾经出版、演讲和展示了120多篇在药物研发，生物医学方面的科学论文。 张岚 资深无菌制剂研究专家 就职于天津市汉康医药生物技术有限公司，资深无菌制剂研究专家，从业20年来一直专注于水针、冻干、滴眼液等无菌制剂的研发、生产和申报。已负责申报100余个项目，获得数十个批件。 李老师 国家局资深药品检查员、检查组长 国家资深药品检查员、检查组长，长期从事药品注册核查、药品GMP和药品飞行检查，近年来各类检查累计近200次。 三 培训对象 1.药品研发总经理、副总经理、总监； 2.药品研发技术人员，生产操作及生产管理人员； 3.药品注册总监/专员、项目管理人员； 4.药事法规教育及药品研究机构的相关人员； 四 时间及形式 1.培训时间：2024年12月6-7日（共2天） 2.培训形式：在线研讨班（腾讯会议），报名人员可投影大屏幕，召集员工集体学习。培训开始前2天进行集中调试。培训全程实时线上授课+互动答疑！ 3.视频回放：培训结束后提供60天不限次免费回放。 五 报名及咨询 1.报名费（原价6800元/账号/企业） 11月30日前交费：3800元/账号 12月1日起交费：4000元/账号 企业会员：按会员价执行  报名人员可投影大屏幕，召集员工集体学习。 2.交费信息： 户名：诺和医药科技沧州有限公司； 账号：0408010809300138975； 开户行：中国工商银行沧州福宾支行； 付款时请备注：药研论坛第104期 如使用个人账户缴费，请付至刁老师微信/支付宝：15911172616 3.报名及咨询 刁老师：15911172616 微信：扫码添加 六 有奖转发（资料、实物奖品） 1.非参会人员 奖品：CDE、CFDI等专家电子版文章合集约850篇（截至2024.12） 获得方式：非参会人员转发本会议通知到朋友圈（所有人可见）或3个制药微信群，满12小时后截图，并在12月6日24:00前将截图上传至下方二维码，即可在12月9日当天邮件获得该电子版资料合集，本活动真实有效。 非参会人员专用 2.参会人员 奖品1：药研定制体重秤1个或药研定制鼠标垫1个 ，2选1（每家报名企业限5人，按登记时间为序）。 奖品2：CDE、CFDI等专家电子版文章合集约850篇（截至2024.12）。 获得方式：参会人员转发本会议通知到朋友圈（所有人可见）或3个制药微信群，满12小时后截图，并在12月6日24:00前将截图上传至下方二维码，即可在培训结束后一周内免费邮寄奖品1（奖品2将于12月9日当天邮件群发），本活动真实有效。 参会人员专用 七 媒体合作 八 药研简介 药研论坛：药研主导的大型培训会议（收费类）已筹办100余期，据统计，中国医药工业百强企业和研发百强企业均超过90%参加过药研培训会议。截至2023年底，已为包括上海强生、辉瑞、阿斯利康、山德士、日本大冢、大鹏、卫材、小林制药、扬子江、华海药业、恒瑞医药、正大天晴、科伦药业、西安杨森、丽珠集团、石药集团、华北制药、香港澳美、东阳光、中国医学科学院、中国科学院、上海医工院、亚宝药业、远大集团、豪森药业、海正药业、天士力、以岭药业、成都倍特、陕西步长、北京协和、华润紫竹、华润双鹤、北京泰德制药、江苏先声药业、鲁南制药、山东齐鲁、山东绿叶、仙琚制药等知名企业在内的2800+企业和机构提供了高质量的专业化培训，均收到良好效果，会后获得参会企业一致好评。药研论坛培训班质量在近几年制药行业培训机构中处于一流水平。 报名及会员咨询： 刁老师：15911172616（同微信） 欲报从速、额满为止！

Co-Founders Nathaniel "Ned" David, PhD, and Norman "Ned" Sharpless, MD, will apply decades of experience to establish a scalable biotech foundry $70 million raised to evaluate, found and operate biotech companies pursuing unmet needs in cancer and disease areas in which cancer biology provides insight Founding investors Mission BioCapital and Mayo Clinic joined by other longtime life science investors SAN FRANCISCO, Nov. 19, 2024 (GLOBE NEWSWIRE) -- Jupiter Bioventures ("Jupiter"), a biotechnology venture foundry that builds bold, science-driven therapeutics companies, today announced the closing of a $70 million initial financing. The syndicate includes co-founding investors Mission BioCapital and Mayo Clinic. New investors include Alexandria Venture Investments, Bioventure Partners, Cedars-Sinai Intellectual Property Company, CU Healthcare Innovation Fund, Eric Ball, Eshelman Ventures, Fox Ventures, The Brent and Julie Callinicos Trust and Vault Fund. Proceeds from this financing will advance eight to ten companies developing therapeutics to treat cancer and other diseases where cancer biology provides insight. Jupiter was founded by two biotech entrepreneurs with decades of experience forming and operating biotech ventures: Nathaniel “Ned” David, PhD, previously co-founded Syrrx (acquired by Takeda), Achaogen, Kythera Biopharmaceuticals (acquired by Allergan) and UNITY Biotechnology. Norman “Ned” Sharpless, MD, was previously Director of both the National Cancer Institute and UNC’s Lineberger Comprehensive Cancer Center, Acting Commissioner of the US Food and Drug Administration, is currently a Member of the National Academy of Medicine and was a co-founder of G1 Therapeutics (acquired by Pharmacosmos). Between them, Drs. Sharpless and David’s previous companies have generated five approved medicines, four IPOs and three corporate acquisitions. Jupiter is built on the premise that a “science first” model can return higher multiples on invested capital than conventional venture funds. Jupiter starts by evaluating potential projects—dubbed “Moons”—using a set of business and scientific criteria. Jupiter then deploys a team and small amounts of seed capital to secure intellectual property and experimentally validate the core idea. The most promising Moons receive additional investment from both Jupiter and non-Jupiter investors to become freestanding, high-value biotech companies with sufficient capital to demonstrate proof-of-concept in humans. “We love bold science, but we hate risk,” said Jupiter co-founder Dr. Ned David. “By experimentally confirming the science first, we kill bad projects early, so we can focus on the winners.” “Ned and I have been building companies and medicines for decades,” said Jupiter co-founder Dr. Ned Sharpless. “We built Jupiter to identify the next set of world-changing ideas and efficiently remove the risks that stand in their way. It is our mission to build companies that improve patient lives.” “Mayo Clinic is committed to producing meaningful, effective change that transforms health and medicine. Clinical excellence requires continual discovery, translation and innovation. We’re eager to see what innovations show promise through this unique biotech model,” said Vijay Shah, MD, Kinney Executive Dean for Research at Mayo Clinic. “Ned and Ned are among the most talented drug hunters and entrepreneurs we’ve worked with. We’re thrilled to work with Jupiter in scaling their approach to build transformational therapeutics companies,” said Zach Collins, PhD, Partner at Mission BioCapital. Coincident with the financing, Jupiter announced that Fred Eshelman, the founder of Eshelman Ventures LLC, an investment company primarily interested in private healthcare companies, will join the Board of Directors. Dr. Eshelman is a successful life science entrepreneur who founded and served as CEO and Executive Chairman of Pharmaceutical Product Development before the sale of the company to private equity interests. He also brings significant board experience as Founding Chairman and largest shareholder of Furiex Pharmaceuticals, Chairman of The Medicines Company and board member of Valeant Pharmaceuticals. “Jupiter’s approach to biotechnology company formation is a truly disruptive innovation, and I’m excited to be part of it,” said Dr. Eshelman. “It will be a pleasure to work collaboratively with Ned David, Ned Sharpless and my fellow directors to execute a science-first strategy to bring groundbreaking therapeutic breakthroughs to patients.” “Jupiter’s strategic mission aligns with Cedars-Sinai’s approach to technology, commercialization and research to improve patient outcomes and advance healthcare solutions,” said James Laur, JD, Chief Executive, Intellectual Property & Health Ventures at Cedars-Sinai. Nirdesh K. Gupta, PhD, managing partner of the Cedars-Sinai Intellectual Property Company, will join the Board of Directors at Jupiter. Dr. Gupta has overseen multiple drug development projects resulting in clinical candidates that are now in late-stage trials in oncology, immune-mediated conditions and rare diseases. This work has resulted in the formation of several companies with significant financial exits, including Prometheus Biosciences. Dr. Gupta expressed, “We look forward to forging a productive relationship with the team through this foundry and to their science-first approach which has worked very well for us all along.” About Jupiter BioventuresJupiter Bioventures (“Jupiter”) is a biotechnology venture foundry that builds bold, science-driven startups from the ground up. Jupiter creates opportunities at scale by validating groundbreaking science quickly to produce de-risked venture-stage companies with therapeutic candidates. Partnering with world-leading scientists, Jupiter supports and manages a system of “Moons”—its portfolio of start-up companies. These Moons address unmet needs in cancer and related diseases. Jupiter’s managing directors are proven serial entrepreneurs with decades of expertise in company-building, strategic transactions and high-impact leadership. For more information, visit www.jupiter.bio. Media Contact:Janine McCargo 6 DegreesPhone +1 (646) 528-4034Email: jmccargo@6degreespr.com