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[Report] Innovation to Improve Human Health in the Pandemic2021 SAPA NE & CT Joint Annual Conference

Pharma and biotech companies have shown an incredible response to the COVID pandemic which has changed the world forever, and innovation is in the front and center like never before. To showcase the best effort in industry and academia, Sino-American Pharmaceutical Professionals Association-New England (SAPA-NE) and Sino-American Pharmaceutical Professionals Association-Connecticut (SAPA-CT) held this year’s annual conference jointly. October 15th and 16th 2021 marked the successful day and half of the joint conference.

Under the theme “Innovation to Improve Human Health in the Pandemic”, 14 distinguished leaders from world renowned academic institutes, leading startups, biotech and pharmaceutical companies shared their perspectives and insights on Innovative Research, R&D Global Trends and Genomic Medicine. This living streaming event has attracted registrants from around the world.

Dr. James Cao, President-Elect of SAPA-NE and Dr. Xiaoyong Yang, President of SAPA-CT kicked off the conference. They introduced to the audience the mission of SAPA-NE and SAPA-CT, as well as the leadership teams and recent activities.

Session I: Innovative Research (AI and Bioimaging)

Scientific leaders from leading companies and top universities including BMS, Moderna and Sanofi, as well as Harvard, Yale and Stony Brook shared exciting updates on the most recent innovative research in industry and academia.

Dr. Wei Zheng, Director of computational science at Moderna presented the hottest topic “Tracking, assessing and predicting SARS-COV-2 variants of concern”, in three sections: Closely monitor emerging Variants of Concern and waning immunity; Rapidly move to update vaccine for virus variants with breakthrough potential; Partner with governments to ensure access to the most up-to-date boosters. The evidence for vaccine protection is strong, but new epidemic waves are undoubtedly on the way. Lower neutralizing titers against key variants suggest a risk of reduced protection over time. In addition, increased transmissibility of variants could increase the exposure risks in high-risk populations. She shared Moderna’s current workflow that rapidly evaluates potential mRNA-1273 escape variants. Then Wei illustrated that the tracking prevalence over time at the country level and scoring mutations with the antibody contact map can predict antibody escape potential. Moreover, she highlighted the multiple strategies at Moderna to model viral escape. “We are working to integrate AI and machine learning to predict escape risk, and our learning in fighting SARS-COV-2 will improve future readiness for other rapidly evolving viruses”, Wei concluded.

Dr. Yu Qiu, Digital biologics leader at Sanofi, presented “Learning a language spoken by nature: protein language model, a useful tool for protein engineering”. Dr. Qiu covered challenges in protein engineering, protein language model (PLM), and PLM applications in protein engineering. Yu showed how the current protein sequence space for engineering is vastly under-explored. Machine Learning-guided directed evolution could significantly help the learning in human antibody sequence space. Using real experimental data, Yu showcased how protein language model can use unsupervised tasks to help understand protein structure. PLM shows great promise for protein engineering, especially with iterative workflow to reduce the number of variants needed in future protein engineering.

Dr. Shuyan Du, Executive Director at BMS, showcased how imaging could be valuable biomarkers in drug development, highlighting an imaging-based assessment in NASH, a multifaceted progressive liver disease. NASH, characterized by steatosis, chronic inflammation, and cell injury, is the fastest growing liver transplant cause in US. There has been no approved drugs for NASH and its current diagnosis requires a biopsy with histologic examination. Multiparametric MRI & MRE have great accuracy in NASH steatosis and fibrosis staging and are available worldwide. Shuyan discussed application of MR steatosis and fibrosis staging I and MRE for longitudinal disease monitoring and treatment response assessment in NASH clinical trials.

Next, Dr. Jason Cai, an Assistant professor at Yale University, highlighted his academic research on the topic of “Seeing is believing: PET ligands as biomarkers in CNS drug discovery”. He introduced the role of imaging in drug discovery and development. He also showcased recent translational small animal imaging systems, PET neuroimaging in the US, and how they are applied to diagnosis and research on Alzheimer’s disease. Prof. Cai then showed PET imaging of synaptic density, an exciting new tool for the investigation of neuropsychiatric diseases.

Professor Jerome Liang from the Department of Radiology, the Institute for AI of Stony Brook University, shared his perspectives on computed tomographic colonography (CTC): A potential screening method for not only early detection but also diagnosis of colorectal cancer. Prof. Liang first introduced known adenoma to carcinoma progression, and how removal of polyps reduces cancer incidence. Then he shared current colon screening procedures, both optical colonoscopy (fiber optic probe) and flexible sigmoidoscopy, and CTC or CT-based the virtual colonoscopy procedure. He showed the comparison of their modeling-driven computer-aided diagnosis (CADx) AI method vs. human experts by lesion dynamical feature. He pointed out that fully 3D processing with high quality navigation and computer aided detection and CADx can significantly shorten the examination time and improve diagnosis.

The scientific session was concluded by Professor Yung-Chi Cheng, Henry Bronson Professor of Pharmacology and Medicine at Yale University, Chairman and Consortium for Globalization of Chinese Medicine. His talk emphasized that the current reductionist approach is insufficient to treat heterogeneous and complicated diseases because target-oriented drugs disturb the body’s equilibrium thereby inducing toxicity. Instead, a paradigm taking into account systems biology could lead to breakthroughs. The convergence of western medicine and traditional Chinese medicine concepts could be a new direction for the future of medicine. To illustrate, Prof. Cheng explained that there are strong similarities between the mechanisms of botanicals and biologics and that both must fulfill strict drug regulatory requirements. Additionally, he discussed strategies for cancer drug development: improving the anti-cancer drugs’ selectivity and protocols with fewer toxicities, how to decrease the side effects of current cancer treatment modalities without compromising their anti-cancer activity. He discussed how the TCM-inspired drug in development, YIV-906, significantly reduced toxicities when combined with approved single-target therapies. Using this approach promising new treatments could be mined for treating different stages of COVID-19 progression, and ailments experienced by post-COVID-19 long haulers.

Session II: R&D Global Trends

Research and Development in the biotech industry has become a global game. Insights showcasing the global competition were shared by academic pioneers and business leaders shared.

Dr. Jingwu Zang, Founder and Chairman of I-Mab, presented “I-Mab’s Journey Towards Global Innovation”. I-Mab is a clinical-stage biotech company focuses on the discovery, development and commercialization of innovative biologics for immune-oncology. It has made significant progress in expanding its current pipeline through the next generation of novel antibody candidates enabled by transformative technologies. I-Mab’s pipeline is not only innovative and globally competitive but also advanced with several assets moving towards late-stage clinical trials and BLA. During the presentation, Dr. Zang shared the stories of the development of CD47 (lemzoparlimab) and CD73(uliledlimab), both are representative of I-Mab’s innovation by design.

Dr. ChangChun Xiao, Global Head of Sanofi Pathology, presented the topic of “Sanofi institute for biomedical Research: a new journey”. Dr. Xiao introduced the Sanofi institute for biomedical Research based in Suzhou, China, highlighting the advantage of building a research laboratory in China, including the talent and financial support from the government. Dr, Xiao then introduced the brand-new laboratory in Suzhou industrial park in detail showcasing the full capability. Dr. Xiao also discussed the limitation of innovation of the pharmaceutical industry in China, which could be achieved by recruiting more global talents to join Sanofi, a leader in industry.

Dr. Yun-Fu Hu, Former Deputy Division Director of FDA and current CMO of Genetron Health, presented the topic of “Demystifying COVID-19 Emergency Use Authorization (EUA)”. Dr Hu first introduced the process for EUA issuance and the development process of the diagnosis test for COVID-19. EUAs allow the public to access these products faster when they’re most needed. Further, he discussed the reference panel testing and validation requirement in detail and shared his advice for EUA application.

Professor Zhinan Yin from Jinan University focused on “Gamma delta T cells: From basic to the clinic”. He addressed the translation from basic research to industry using T cell therapy as an example. Amazing research by Prof Yin’s group on identifying the role of Vy4 T cells in anti-oncology therapy was discussed. Further, studies from his group indicated that there were subsets of T cells in different organs, which could contribute to a potentially more economic strategy for cell therapy. The patented formula developed by Prof Yin’s group, prolonged the survival of end-stage liver cancer. The therapy has the potential in treating infectious disease and anti-aging in the future.

This session was closed by Dr. Pearl Huang, the President and CEO of Cygnal Therapeutics, with the topic of “Platform approaches to Drug Discovery and Development”. Dr. Huang started her talk with the advantages of the platform, including insight of modality, biology, geography, and team. Dr. Huang then introduced Cygnal Therapeutics, a Flagship Pioneering Company, focusing on peripheral nerve signaling. The platform established anatomical, functional interaction to find druggable targets. Her group identified exoneurogenesis as a new hallmark of cancer.

Session III: Genomic Medicine

Genomic medicine is an interdisciplinary medical specialty involving the use of genomic information that has rapidly grown since the completion of the Human Genome Project (HGP). Genomic medicine is rapidly changing the future of medicine. Academic and business leaders shared their perspectives on the promises and challenges. It started off with Dr. Catherine O’Riordan’s presentation on “Gene Therapy for Genetic Diseases”. Dr. O’Riordan, Translational Head, Sanofi Genomic Medicine Unit and her team has focused on using AAV as a vector for gene therapy. She first compared different types of viruses commonly used as viral vectors for gene therapy, such as adenovirus, retrovirus, lentivirus and AAV and pointed out that AAV has great advantages, such as, low immune response and different serotypes available, though studied less. Then she discussed the status of AAV-mediated Gene Therapy, including the regulatory environment, clinical validation in multiple rare, genetic diseases and successes in treating multiple rare pediatric diseases. Furthermore, she dived into case studies to show how AAV Gene Therapy treated inherited retinal diseases, which overall showed significant progress and bright future on the horizon utilizing AAV as a delivery vehicle.

Dr. Dinesh Bangari, Global Head of Sanofi Discovery Pathology, presented the topic of “the Promises and Pitfalls of Animal Models for Genomic Drug Discovery”. Dr. Bangari first reviewed the utility and rationale of mouse models in genomic drug discovery with illustrative examples of transgenic, KI and KO mouse models. For example, humanized mouse models were designed to express the human Duchenne Muscular Dystrophy genes for critical preclinical evaluation of novel therapeutics that are now approved for human use. Dr. Bangari then addressed pitfalls of animal models, including limited fidelity to human pathophysiology and inherent variability of the model. The talk was concluded by Dr. Bangri giving perspectives for translational research. Although no model is perfect, it can help establish causations, interrogate mechanism and efficacy and predict human safety risks when we understand the diseases mechanisms and models.

The scientific session was closed by Professor Miles A Miller from Harvard and MGH, with a talk titled “Probing Spatial Pharmacology through Imaging the Tumor Microenvironment”. Dr. Miller reviewed the history and progress of nanomedicines in cancer therapy, as well as the challenge and major barriers of nanomedicine delivery to solid tumors. Dr. Miller’s research group is dedicated in high resolution and multiplexed imaging supports for in vivo pharmacology, where they were able to monitor the nanomedicine PK/PD at a single-cell level and the DNA damage response in tumor cells. Instead of finding of positive correlation between tumor associated macrophages (TAM) and therapy resistance, the nanoparticles accumulation in the TAM and IGF1R-targeted inhibition improved tumor uptake and efficacy.

Dr. Xiaodong Chen, SAPA president, share with the ‘One SAPA” vision and business plan going forward. The Annual Conference was concluded by Dr. Guiqing Liang, the President of SAPA-NE and Dr. Xiaoyong Yang, the President of SAPA-CT, announcing 2021 Outstanding Service Award and 2021-2022 president elect candidates. The organizing committee’s closing remarks highlighted the well-organized scientific program and highly engaged questions and discussions. Special thanks to all speakers, sponsors, volunteers, especially the excellent IT support to make the SAPA-NE and SAPA-CT joint annual conference a great success.

Dr. Guiqing Liang announcing 2021 Outstanding Service Award

Dr. Xiaoyong Yang acknowledging SAPA-CT volunteers

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