每年,BioWorld团队需要时间看back and assess the market-moving and life-changing stories and trends of the year. Without a doubt, COVID-19 shook humanity to the core, again. And like glioblastoma, the tentacles of COVID-19 invaded far beyond the obvious and ultimately changed the world. So that’s our top story of the year. But the biopharmaceutical industry is resilient and responsive. Even though there were tectonic shifts in efforts to bring an armamentarium of COVID-19 vaccines and therapeutics to patients with record-breaking speed, work continued on other fronts, because people are still getting sick with cancer, succumbing to horrible diseases like Alzheimer’s and issues such as the battle over drug prices rage on. Technology is advancing at speeds that, well, only technology such as artificial intelligence can keep pace with. And while regulatory bodies continue to guard the processes to develop human therapeutics and are historically slow to move, they adapted. And who pays for all of these advances? The amount of money flowing into the biopharmaceutical industry was at an all-time high. Finally, we had some notable “firsts,” including the first DNA vaccine.

在这里，您会发现涵盖2021年六个最重要的故事和趋势范围的文章和播客的链接，并着重于2022年的含义。

1. Covid-19统治了……一切

COVID-19 a ball of pandemic confusion that produced great science and powerful revenues
In 2021, progress on preventing and treating COVID-19 was a seemingly endless series of starts and stalls. In spite of the high-profile stumbles, science and finance took startling steps forward.

Pandemic puts spotlight on domestic manufacturing efforts
尽管世界各地的生物制药公司在2021年竭尽全力开发和制造Covid-19-19-19疫苗和疗法，但大流行强调了供应链弱点，许多国家 /地区对更多家庭制造和对其他国家的生产的依赖提出了刺激的需求。应对对中国或其他国家对基本药物的依赖的恐惧反应可能威胁到国家安全，尤其是在每个人都在争夺相同产品的全球公共卫生紧急情况下，一些政府采取了努力来增强自己的生物制造能力。

BioWorld Insider Podcast：Supply Chain Geeky: Managing through the challenges of COVID-19 with an eye to what’s at stake
复杂的制造工艺和供应连锁店一直是生物制药行业故事的一部分，许多国家在此过程中通常参与其中。尽管该观察结果适用于许多其他业务领域，但总部位于东京的Kyowa Kirin执行副总裁Paul Testa向我们讲述了与医学的关键差异：但是病人迫不及待，因为他们的医疗保健受到威胁。”他说。在大流行之前，连续性，供应的可靠性，业务流程和自动化都是他的关键优先事项，此后没有发生巨大变化。但是“但是，Covid还有一层复杂的层面，以及管理我们所有人都处理的这些细节的许多复杂性。”日本的和（wa）概念如何适应？听听。

2.阿尔茨海默氏症的绝望斗争

关于Biogen的Aduhelm的争议很多；图片不清楚其他广告潜在客户
在2021年，没有像Biogen Inc.的Aduhelm（Aducanumab）那样引起毒品批准和辩论。The FDA’s surprise, accelerated approval of Aduhelm for Alzheimer’s disease flew in the face of the recommendation by an advisory committee, causing a stir that included the resignation of three adcom members, along with publicly made claims that the company’s relationship with regulators had become too cozy.

BioWorld Insider Podcast：Aduhelm’s hard lessons and what it means for other Alzheimer’s drugs
FDA于2021年6月批准Aduhelm（Aducanumab），这是第一种斑块靶向疗法，使公司，监管机构和市场震撼。Bioworld汇集了两名专家，以了解他们的想法，因为每个人都参与为阿尔茨海默氏病或​​帕金森氏病开发疫苗或治疗方法。Michael Agadjanyan是Nuravax Inc.的总裁，该公司正在开发防止阿尔茨海默氏病和帕金森氏病的抗体。我们还与Clene Nanomedicine Inc.的首席医疗官Robert Glanzman进行了交谈，后者正在开发帕金森氏病的纳米疗法。两者都对Aduhelm有强烈的看法。他们还就治愈痴呆的科学进行了激烈的辩论。

3.作为发明家的人工智能？

澳大利亚对人工智能作为发明家的裁决是否会触发他人效仿？
澳大利亚在7月引起了国际关注，当时联邦法院裁定人工智能（AI）可以被任命为专利的发明者。Inthaler诉专利专员，联邦法院法官乔纳森·海滩（Jonathan Beach）裁定，根据澳大利亚专利法，发明家不一定是人类。决定挑战了只有人类才能成为发明者的假设。但是，海滩确实裁定，AI系统不能申请专利或获得专利。该案件推翻了澳大利亚专利专员的较早决定，拒绝了斯蒂芬·塔勒（Stephen Thaler）的计算机计划专利申请，即用于人工神经系统的统一感知的自动启动设备（DABUS）。专利专员拒绝了该索赔，因为根据澳大利亚的专利法，机器不能被视为发明者。但是法官对专员提出了质疑，他说“您不能拥有非人类发明者”是不正确的。

BioWorld Insider Podcast: What happens when your inventor is an artificial intelligence?
在药物开发的所有阶段，人工智能（AI）技术的日益增长的使用正在全球提出有趣的新挑战。越来越重要的一个关键问题：AI算法可以成为发明家吗？如果是这样，AI系统可以申请或获得专利吗？我们与Clarivate Innovation高级副总裁Jim Belfiore和人工发明家项目的领导人Ryan Abbott以及Clarivate的高级副总裁Jim Belfiore进行了交谈，以了解有关这些问题的含义以及专利局和法院的影响到目前为止正在处理它们。认识到AI在创新领域中更重要的角色的风险是什么？AI Inventorship可能会产生IP Asset通货膨胀吗？听听。

4.调节性动力，然后有些

Challenges spur regulatory cooperation
Covid-19在2021年作为一种新变体一直对世界的掌握，这是一个新的变种，此前又创造了新的感染浪潮，迫使监管官员在处理毒品和疫苗批准，并购，制造问题以及对毒品和疫苗的批准，制造问题和要求方面面临持续的政治和后勤压力定价改革。

英国 - 欧洲监管分手将两者都处于恢复模式下一年
伦敦 - 英国脱欧和大流行的汇合金今年在欧洲遭受了监管，评估COVID-19-19疫苗和抗病毒药的工作量使EMA和英国药品和医疗保健产品遭受的专业知识的丧失使人变得更加繁重。代理商（MHRA）随着他们的亲密关系被切断。除此之外，是监督针对欧洲监管机构实施新法规的过程，以及设计新的脱欧监管框架的MHRA。欧洲为健康紧急情况准备的大流行断层线，为了解决这一点，EMA将于2022年承担新的责任，一旦与成员国就加强机构的结论进行谈判。

Regulatory focus on innovation raising China’s profile
In China, 2021 saw a number of regulatory efforts aimed at encouraging companies developing novel drugs. As a result, analysts expect that impact investment and investors would allocate capital to “truly innovative oncology drugs” so 2022 could see a more supportive ecosystem for the development of rare disease treatments in China. Meanwhile, they believe that me-too and me-worse drugs, which have accounted for a large portion of China’s drug market, would have a more difficult time getting marketing approval. The Center for Drug Evaluation (CDE) issued a number of guidelines during the year to support new drug development and reduce the waste of clinical resources. Such guidelines include a draft guide on clinical trials of drugs for rare diseases in October 2021, which encourages developers to focus on biomarkers, pharmacometrics and patient-reported outcomes.

Politics, pricing and personalities create regulatory challenges
U.S. regulators continued to be plagued in 2021 with accusations of politicization, most of which revolved around the expansion of the COVID-19 vaccine. Despite the Biden administration’s avowed commitment to follow the science in regulatory decision-making, the White House COVID-19 Response Team appeared to jump ahead of the science Aug. 18 when it announced the Sept. 20 rollout of a nationwide booster program for all adults.

Bioworld Insider播客：监管GEMISH：Covid-19对FDA及其他地区的重大影响
Amid industry’s ongoing drive to speed drug discovery, clinical development and commercial success, government regulation can sometimes seem slow moving. But even a quick look at regulatory highlights from 2021 shows nothing could be further from the truth. From COVID-19 and cancer to Aduhelm and the broader health care ecosystem, so much has changed – and not just in the U.S. Join us for perspective on this fast-changing landscape from Peter Pitts, president of the Center for Medicine in the Public Interest, among other roles. “All of a sudden, everybody is a regulatory expert,” he said. Will free beer get us where we need to go? Listen to find out.

5. Record amounts of money flow into biopharma

研发驱动投资，席位占主导地位，但拥挤，燃烧率上升，新规则，威胁到平稳的骑行
融资在2015年急剧增加，收集了680亿美元，但在过去两年中，金额没有触及生物制药的投资。该行业在2021年筹集了1,130亿美元，低于2020年全年的1,345亿美元，但比2000年至2014年的每五年组合总数高于2015年的65％，比2016年增长了65％，200％比2016年增长。2017年的118％比2018年的68％和2019年的95％。公开募股（237亿美元）和风险投资回合（378亿美元）都在今年的历史记录中达到了历史记录。但是，该行业的金钱冲击会继续吗？

BioWorld Insider Podcast: Another record year for biopharma financings bodes well for 2022
在另一个创纪录的生物制药筹款的年份中，整个行业的钱比以往任何时候都多。制药IPO和风险资本融资的数量和价值是其最高水平。2021年的私人融资很容易超过2020年以来的私人融资，其中大部分由SPAC提供支持。2022年全部去哪里？两位专家加入了Bioworld分享他们的想法。Kleanthis Xanthopoulos是Shoreline Biosciences的联合创始人兼执行董事长。20多年来，他一直是Biopharma Research的高管，公司创始人，首席执行官，投资者和董事会成员。蓝色水疫苗的首席执行官兼执行董事长乔·埃尔南德斯（Joe Hernandez）也加入了讨论，他创立或领导了八家医疗保健和制药公司。

6. For the first time …

The firsts: DNA vaccines arrive, while KRAS drugs and CAR T-cell therapies break new ground in cancer
There was no slowing of biopharma innovation in 2021, even as industry directed significant resources to, while feeling the impact of, the ongoing COVID-19 pandemic. The year saw big wins for developers of DNA vaccines and biosimilars, while CAR T expanded its reach and a drug target once considered undruggable was finally conquered. And as 2021 gives way to 2022, other potentially game-changing technologies and therapeutics are waiting in the wings.