立足中国，走向国际 | 资深海外科学家展望复宏汉霖发展未来

Alvin Luk（陆英明） 复宏汉霖首席医学官

是的，很高兴来到中国工作。我在全球生物技术药物开发领域已经有超过25年的工作经验，在最近的15年里主要致力于再生药物和孤儿药的研究。在加入复宏汉霖之前，我曾在Spark Therapeutics、Biogen-Hemophilia（现Bioverativ）、Bayer Healthcare, Avigen、Tularik（现Amgen）等企业就职，累计为14种产品提供临床研发和医学事务服务，这些产品现在已经获得市场认可。

选择回国的原因也很多。从我的前一份工作来看，一般情况下，生物药的制备工艺和放大生产都极为复杂，由此产生的巨额费用无论对病患还是政府来讲都是很大的经济负担。我认识到，在如此高昂的成本之下，这些药是难以真正地造福众多病患的。

早在2010年，我第一次接触到中国的GCP，虽然还不够完善与可靠，但是它毫无疑问是全球药物开发中的一个关键部分。当时，我与同事首次在全球21个国家进行融合蛋白的国际三期临床关键数据研究，根据FDA/ICH的指导原则，中国等几个亚太国家也在数据研究范围内。我选择了中国的四个中心（位于上海、天津、北京和广州等地的四个医院）进行GCP标准的教育与普及。

而2014年，在加州与复宏汉霖两位创始人刘世高博士、姜伟东博士的一次偶然碰面则给我留下了深刻的印象，也为后来的合作埋下伏笔。那时复宏汉霖的产品大多还处于临床前研究阶段，但是公司对一次性生物反应器与其他核心技术的应用已经初步开展，刘博士对于复宏汉霖的定位——“患者可负担的创新”这一理念也与我不谋而合。

我很高兴地看到，在复宏汉霖的临床团队中，不仅有众多经验丰富的国内肿瘤研究者，也不乏众多国际性人才来共同开展全球临床关键数据研究。整个临床团队对科学工作和病患都抱有极高的热情，也始终将病患的安全与临床研究的严谨性作为第一要务。

但CMA（Clinical Medical Affairs）团队也有亟待加强的地方，即我下面讲到的对CMA团队未来发展的规划。首先，在CEO刘世高博士“立足中国，走向全球”的理念下，我们的目标是提升整个团队的国际化水平，这将是一个由CMA向GCMA（Global Clinical Medical Affairs）转变的过程。团队的整体架构将发生一些调整，在产品按时间线规划的基础上，临床团队将通过增设全球战略规划来推动项目（产品）管理的制定、维护与执行的一体化进程。同时，对标国际生物制药公司，我们将对团队的临床研发、IND能力提出更高的要求。新的组织构架下，我们将增设生物信息、转化医学以及人工智能的岗位，紧跟大数据时代的步伐，我们的临床运营团队也将进一步壮大。

通过这些调整与改变，我们将为公司的商业化决策提供更充分的数据支持，更精简高效的临床运营模式，以国内外医疗市场变化为导向，在合规与质量决策方面迅速作出回应。

在过去数年里，中国的医疗市场一直备受关注，许多大型国际制药公司纷纷入驻。而事实上，中国工艺创新历史悠久，只要产品严格遵守国际质量标准，生物制药的发展前景大好。不得不提的是，CFDA对此作出的极大努力。自2015年起，CFDA以欧洲药物管理局（EMA）标准作为主要参考，推出生物仿制药研发及评价指导方针，对国内的临床试验质量提出规范要求。这样的质量标准是极具挑战性的，但效果也是显而易见的。国内的药企通过雇佣经完善培训的员工，并严守新的质量标准，将有很大希望在未来几年中把中国发展成为另一个主要的国际生物制品中心。

很荣幸的是，我们有一位勇敢的领导者，在刘世高博士的带领下，复宏汉霖持续引进创新成果，不断优化公司的生产工艺，强化对公司员工的ＧＭＰ体系培训，这也让复宏汉霖在同行业中逐步脱颖而出。未来，我期待看到复宏汉霖作为国内生物制药的引领者，在全球生物制药的发展过程中贡献自己的力量，并最终实现成为全球最受景仰的生物制药公司这一美好愿景。

爱好主要是音乐和旅行两个方面。我十几岁的时候曾经在维也纳学习过一年音乐，后来去到香港，在美国的四年，我继续练习高音。认真讲起来，音乐不仅是我生活的一部分，也是我职业生涯的一部分。记忆比较深刻的是，我曾经在卡耐基音乐厅进行过一次演出，后来我还在这里举办了我的婚礼，当时是请到了两位比较知名的歌手。我之前比较喜欢巴赫的音乐，乐器的话弹过古典吉他和钢琴。来到中国以后，我喜欢看电视节目“中国好声音”，最喜欢里面的两位导师那英和周杰伦。我已经爬过北京的万里长城，近期我的计划是去爬莫干山。

I have over 25 years of global drug development experience in the biotechnology and pharmaceutical industries with the focus on regeneration medicines (such as gene therapies) and biologics for the treatment of rare diseases for the past 15 years. Prior to joining Henlius, I have held roles at companies such as Spark Therapeutics ,Biogen-Hemophilia (now Bioverativ), Bayer Healthcare, Avigen and Tularik (now Amgen) and was responsible for clinical development operations and medical affairs leading to regulatory marketing approvals of 14 products as of today.

As stated earlier, I have been working on biologics and regeneration medicines for the past 15 years. These therapies are expensive to produce from living cells and manufacturing process is extremely complex. Cost is a huge financial burden for both the patients and governments. I realized that curable therapy was not a solution for improving patient access to treatment.

China has always been in my mind as part of the global drug development. In 2010, my colleagues and I were first conducted the global Phase 3 pivotal studies of clotting protein products including China and Asia Pacific in accordance with FDA/ICH guidelines. That time, I chose five center in China to be educated with GCP firstly which located in  Shanghai, Tianjin, Beijing and Guangzhou.

In 2014, I met Dr. Scott Liu, CEO of Henlius, as well as Dr. Weidong Jiang, CSO of Henlius at the California facility. Though Henlius was at the infant stage, I was already impressed with the state-of-the-art single-use bioreactors and core technologies and was resonant with Dr. Liu’s vision of affordable innovations.

Henlius is very fortunate to recruit talents such as seasoned oncologists and international clinical operations personnel to manage and conduct global clinical pivotal studies. I was impressed by the team with the amount of passion with science and patients as well as the efforts of putting patient safety and scientific integrity as their highest priority.

In term of the future for the team, there will be big changes: Aligning with our CEO’s vision of “Manufacturing in China for Globe”, the CMA department has already begun the transition to a new organizational structure, namely the Global Clinical Medical Affairs (GCMA). Under the new structure, Program Management will drive the process for elaboration, maintenance and execution of the integrated global program strategy and develop short- and long-range integrated development and operational plans with realistic timelines, budget and resources planning. Clinical R&D will also expand its function from clinical research to translational medicine, bioinformatics and artificial intelligence while Clinical Operations will include clinical business planning and clinical trials competitive intelligence functions.

These changes are meant to drive business decision with scientific evidence, streamline clinical operations globally, enhance compliance and quality and speed decision-making in the current rapidly changing healthcare marketplace both in China and outside of China.

For the past few years, China has been in the spotlight for its efforts to attract big international pharmaceutical companies into the country. In fact, China has a long history of process innovation which is beneficial for biologic development as long as the productions are strictly adhered to the international quality standards. Furthermore, CDE under the CFDA also published the “Technical Guidelines for the Research, Development and Evaluation of Biosimilars” on February 28, 2015, mainly followed the European Medicines Agency (EMA) approach, to ensure quality of the clinical trials in the nation. Implementing stricter standards by the CFDA and striving for such levels of quality are extremely challenging. By employing properly trained personnel and adhering to the new CFDA standards, I expect China will be a major international biologic development hub in the next few years.

Being led by our fearless leader, Dr. Scott Liu, Henlius has been focused on implementing new technology for manufacturing improvement, training personnel on GMP and GCP, and most importantly, bridging the gaps between industry and regulators in China. In the future, I hope that Henlius will strive to become a global leader originated from China and place footprints in global biologic drug development for the domestic pharmaceutical companies to follow.

This question is interesting because I have spent too much time in China. One thing interesting for me is to learn Chinese, and I’d like to give a little background of myself. When I was 12 years old, I was abroad for the Vienna Boy Choir at the Vienna Music Conservatory for a year. After that, when I returned to Hong Kong and immigrated to USA, I continue to have voice training for four years at the San Francisco Music Conservatory and also song opera such as Turandot during that time. A profound memory was that I have once performance at the New York Carnegie Hall, where I also held my wedding in 2014 with two famous performers (Martha Wash and John Legend) who I appreciate were invited to my wedding. I prefer Bach’s music, and played the classical guitar and piano. When I came to China, my assistant taught me how to use TV and then I’m now in love with the program “The Voice of China”.  I prefer two of the advisors, Jay Zhou and Na Ying. You can see that, music is an important part of my life, maybe ever part of my career. Traveling is another hobby for me, I have been to the Great Wall of China, and will be visiting the Mountain Mogan soon.