5TH SAPA-CT ANNUAL CONFERENCE

Pharma/biotech in the digital age

Author: Liming Chen, Zhuo Chen, Mingzhou Fu, Yangzhou Li, Melissa Liu, Jin Zhou Photo: Liming Chen, Ruochen Sun Web Editor: Liming Chen

October 10th, 2018

On Sep. 28th, 2018, SAPA-CT successfully hosted its 5th Annual Conference. The conference took place at the beautiful and modern Evans Hall of Yale School of Management, New Haven. Connecticut. Approximately 200 people attended the conference.

At the beginning of the conference, Dr. Jin Zhou, President of SAPA-CT and Chair of the 5th SAPA-CT Annual conference, welcomed everyone to the exciting one-day professional event. She first introduced the agenda of the conference and thanked the organizing committee for the hard work on putting the program together. She shared with the audience the mission of SAPA-CT, which is centered at serving the local pharma/biotech community. She also thanked all the SAPA-CT members and friends for supporting the organization in the past year.

Dr. Xiuling Lu, Secretary of SAPA-CT, and Associate Professor of University of Connecticut School of Pharmacology Department then announced the SAPA-CT election results. Dr. Li Wang, Professor of University of Connecticut, Department of Physiology and Neurobiology was elected as the next SAPA-CT president (2018-2019). Dr. Wang thanked everyone for the support and shared her plan for the organization in the coming year.

Ms. Wenyan Zhong, Counselor for Science and Technology, Chinese Consulate General in New York, spoke at the conference. She congratulated SAPA-CT for successfully organizing the 5th Annual Conference, and applauded the organization for making the contributions to the local community.  

After that, Dr. Peter Farina, Executive in Residence, Canaan Partners gave an honorable opening speech on the theme topic. He vividly talked about the current landscape of pharma/healthcare in the digital era and shared a few examples of digital companies, in which Canaan Partners had invested. He also shared his own career path and gave valuable career advice to young professionals. 

Plenary Session I: Executives’ Insights 

Shirley Zhao, MD, MBA, General Manager & President of China Mainland & HK, Bristol-Myers Squibb gave a presentation, entitled “We Care, We Pioneer, For all Possibilities”.  She described the healthcare landscape in China, provided insights on challenges and opportunities that global pharmaceutical companies have with the China healthcare reform,  and shared BMS’ strategies in China, which includes patient-centric direction, innovation mapping, accessibility acceleration, compliance-first culture, and value-based healthcare.

Dr. Lan Huang, Co-founder, Chairman & Chief Executive Officer, Beyond Spring, Inc. was the second speaker in this session. The title of her presentation was” Opportunities and Challenges of Biotech Companies with Cross-Border Business Model”.  Dr. Huang explained why Beyond Spring chose the US-China cross border business model. She said this model was valuable in saving drug development cost and shortening development timeline. Take cancer for example. As China has 1/3 of the world’s cancer patients, and medical care for cancer patients in China is also centralized in big cities (Beijing, Shanghai, Guangzhou, etc.), patients enrollment for cancer clinical trials is therefore much faster than in Western countries. Additionally, the cost of a patient in China in a clinical trial is only 1/3 of the cost in US. 

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.