The 7th SAPA-CT Annual Conference: Bringing Breakthrough Discoveries and Advanced Therapies to Patients

第7届美中药协康州年会：以技术突破和疗法创新造福病人

November 14th, 2020  (Saturday)

2020年是攻坚克难的拼搏之年--COVID-19大流行使各国经历感染高峰和经济低谷。在这至关重要的一年，康州美中医药协会(SAPA-CT)年会将于2020年11月14日（星期六）在线上隆重举行。医药界学术精英、行业专家、投资人、管理人员、项目主管将齐聚一堂，在金秋时节以网络会议的形式畅谈精准医学的技术突破，生物制药的市场化战略，以及对工作机会和移民政策的最新解读。

生物医疗领域近些年飞速发展，免疫治疗在基础研究和临床应用中崛起，大数据、人工智能在药品开发中逐步推广，细胞疗法、基因疗法等新型疗法深入拓展。本次会议，我们将邀请全球药品研发和管理领域的一线专家，分享他们对疫情、未来制药、生物技术行业、创新疗法的看法。本次会议由科学专题讨论会和小组讨论会议组成，提供了一个前沿交叉的平台，用于讨论精准医学方面的突破性创新，治疗方法的基础和临床研究，以及美国的商业机会和移民政策。各位来自康涅狄格州的学术和临床专家，以及生物制药技术的专业人士也将就地区疾病诊断和疫苗开发进行讨论，发表各自对于科技前沿、医疗创新、商业金融和文化教育的建设性意见。其中，有致力于全球药品开发的行业巨头，有致力于临床研究和管理的开发总监，有致力于创业投资和技术培育的领军人物，还有致力于单细胞和多重组学技术开发的耶鲁教授…… 总有你感兴趣的！

会议注册链接：http://www.sapa-ct.org/sapa-ct-2020-annual-meeting-register

Usman“Oz”Azam, M.D.

Plenary Session II: Digital Trends

Mohammed Ali, Global Head of Digital Trials, Boehringer Ingelheim gave a presentation, entitled “Leveraging Innovation for Trials of the Future”.  In his presentation, Mr. Ali explained how digital tools can help reduce the cost of clinical trials.  He mentioned smartphone has 80% of the market penetration, and has become the access point to the end-consumer. Thirty percent of US smartphone owners use at least one health app.  With all internet-connected individuals, there is the opportunity to monitor and track patients’ health status outside the hospitals. Clinical trials with remote platforms can achieve more efficiency compared to the traditional approach.    

In her presentation, “Blockchain for Healthcare & Life Sciences”, Dr. Jia Chen, Offering Leader Blockchain for Healthcare and Life Sciences, IBM,  first described the current problems in data sharing in the healthcare sector,  inefficient, expensive, and vulnerable. Then she explained how the IBM blockchain solution can be used to solve the data sharing problems. She said blockchain created a new style of business processes and transactions. She used financing and food supply chain industries as examples to illustrate the values of blockchain in creating efficiency, and highlight the cross-industry potential of the technology.  

Dr. Yaning Wang, Director, Division of Pharmacometrics, Office of Clinical Pharmacology, FDA, gave a presentation, entitled  “Regulatory Perspectives on Model Informed Drug Development”. He first gave a high-level overview on what is model informed drug development (MIDD), which in a nutshell, uses mathematical/statistical models to evaluate or predict drug disposition, safety, efficacy, and product quality.  He explained from regulatory perspectives on how MIDD can be used to support informed decision-making during drug development process, and thus save cost and improve efficiency. He also shared the history of Pharmacometrics departement in FDA and highlighted the agency’s efforts and goals on modelling and simulation.

The morning sessions ended with a big round of applause from the audience.

In the afternoon, the conference was split into two parallel parts.

Parallel Session A1: Cutting-Edge Approaches

Dr. Yixian Zhang, Senior Director, American Association for Cancer Research gave a presentation, entitled, “On the Mission to Cures: How Close are We”. He described the current progression in Cancer research and provided his vision on future cancer research. He mentioned that the number of cancer cases increase every year, and immunotherapy is an innovative method for many different cancers.   He highlighted the value of precision medicine in cancer therapy, and emphasized the importance of reliable screening methods and biomarkers for early detection and prevention.  

Dr. Yide Jiang, Chief Strategy Officer, XtalPi Inc. gave a presentation, entitled “Creating an Effective, AI-Driven Company for Drug Development on the Cloud”. He pointed out that AI has been widely researched and utilized in both pharmaceutical and technology companies. AI does help the drug discovery process, however, there are still many aspects to be improved, such as data accessibility, data quantity, and data quality. He emphasized the importance of fitting AI computing results into the specific goals in the pharmaceutical industry. As an algorithm and cloud computing-oriented company, XtalPi has successfully and cost-effectively used AI technology to predict crystal structures of drug molecules. 

Another two experts in artificial intelligence –Mrs. Hong Sun, Associate Director, Data analytics, Bayer and her collaborator, Dr. Alan Labouseur, Professor of Marist College demonstrated their research on machine learning and graph analytics.  In their joint presentation, “Digital Age Insights with Machine Learning and Graph Analytics”, they mentioned that one of the biggest challenges in informatics was how to efficiently link the big data to the insight of a specific problem. To address this, they use machine learning and graphs. With machine learning, they could stack different models together using different datasets, which yields better predictions. Graphics with elegant metrics collected in their integration platform could also help with target prediction effectively.

Parallel Session A2: Regulations and Laws 

Dr. Louis Liu and Dr. Yong Chen, partners of Liu, Chen & Hoffman LLP started the session by providing the basic knowledge on corporate and IP laws. In their presentation, “Corporate and IP Law Primers for Life Science Professionals”, they first shared their career experience in corporate and IP (intellectual property) law. Then Dr. Chen explained what IP law was, and how to successfully and effectively protect intellectual property using lawful methods. After that, Dr. Liu, as a corporate law expert, emphasized the importance of having law consultation before getting into a case. They concluded that knowing some basic laws or having some experts in law is necessary step to protect the assets. 

Dr. Yan Wang, Scientific Lead for Long Acting Injectable and Implantable Products, Office of Research and Standards, Office of Generic Drugs, FDA, then gave a presentation, entitled “Regulatory Challenges and Considerations in Developing Complex Generic Formulations”. She shared with audience the implementation of GDUFA and Pre-ANDA to improve the approval process of generic drugs, and discussed some challenges of developing complex generic drugs, such as inefficient clinical endpoint, complicated and sensitive manufacturing process, and lengthy approval process. 

In the last presentation of session, Dr. Xianfeng Shen, Associate of Sterne Kessler, presented the 505 (b) (2) drug approval pathway. He explained that the 505(b) (2) application is a hybrid of full NDA and ANDA, used for modifications such as dosage change for already approved drugs. He suggested 505 (b) (2) could be a potential solution for the distressed generic pharmaceutical industry. With some modifications such as dosage change, companies could potentially use the 505(b)(2) for some generic drug application to speed up the approval process.

In another conference room, a business discussion forum is held in parallel.

Parallel session B1: Connecticut Bioscience Community: Success Stories    

This session was hosted by BioCT (formly CURE). In this session, Ms. Kimberly Kelly, Innovations Operating Director of BioCT first gave an introduction on BioCT. She mentioned that BioCT is dedicated to growing bioscience in CT by supporting innovation, networking, and advocacy engagement. It serves as a bridge to investors and government bodies, and hosts middle school and high school programs to promote STEM jobs.  

She then joined a panel discussion with 4 other panelists, Dr. Todd Arnold, Chief Laboratory Operations Officer of Sema4, Dr. Mostafa Analoui, Executive Director of Venture Development & Technology Incubation Program (TIP) of University of Conneticut, Dr. Christine Broadbridge, Executive Director, Research & Innovation, Southern Connecticut State University, and David Wurzer, Executive Vice President and Chief Investment Officer, Connecticut Innovations.  The panel was moderated by Dr. Sandra Bulmer, Dean of School of Health and Human Services of Southern Connecticut State University. The panel shared with the audience some encouraging successes in CT, and emphasized the importance of branding in order to attract more bioscience businesses to CT.

Parallel Session B2: Cross-Border Business Development

In this session, hosted by Abpro, Dr. Karen Liu, founding Partner of 3E Bioventures, first gave a talk, entitled “Biotech Investing in the New Era”. In the talk, she emphasized that nowadays it is essential to conduct biotech investing with a global perspective. She also examined opportunities in global integration and utilizing comparative advantages in pursuit of capital efficiency. She also highlighted the important resources China can offer such as clinical resources. Subsequently, 6 panelists shared their views of new trends and opportunities in healthcare business development, as well as the problems and challenges. The panel was moderated by Mr. John Xu, Senior VP of Strategic Alliances of Abpro. The panelists included Bob Ai, PhD, MBA, Senior Vice President, Solebury Trout, Peter Farina, PhD, Executive in Residence, Canaan Partners, Jimmy Hao, PhD, JD, Partner, Fox Rothschild LLP, Karen Liu, PhD, EMBA, Partner, 3E Bioventures, Jun Xu, MS, President & CEO, HLK Pharmacin, and Yixian Zhang, PhD, Senior Director, American Association for Cancer Research.

At the end of the conference, Jun Xu, President & CEO, HLK Pharmacin, and Co- Chair of the 5th SAPA-CT annual conference concluded the conference by sharing her key learnings from the conference. She thanked everyone for participating and wished to see everyone in the next SAPA-CT conference.

Organizing Committee:

Conference Chair: Jin Zhou, PhD; Conference Co-Chair: Jun Xu, MS;

Zhuo Chen, Yirong Wang, MS; Ming Cheng, PhD; Zhongyu Wang, MS, JD; Yongmei Li, PhD; Ruobing Xia, MBA, Alan Lin, MS; John Xu, MS, MBA; Helen Luo, MS; Kai Ying, PhD; Xiuling Lu, PhD, Yan Zhang, MS, Li Wang, PhD, Xiaobo Zhong, PhD

Conference Advisors:

Peter Farina, PhD; Dawn Hocevar

Volunteers:

Liming Chen; Mingzhou Fu; Daniel Huang; Yangzhou Li; Melissa Liu; Xiaoyu Lu; Ruochen Sun; Lian Wang, PhD; Tianzhou Yu; Chao Zhang.