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Innovation with Versatility: Exploring New Approaches from Benchtop to Bedside
- 2024 SAPA Scientific Symposium Meeting Report

SAPA communication team, April 24, 2024

On April 20, 2024, the highly anticipated 2024 Sino-American Pharmaceutical Professionals Association (SAPA) Scientific Symposium took place at the Rutgers University’s Robert Wood Johnson Medical School at Piscataway, New Jersey.  This year’s symposium, themed “Innovation with Versatility: New Approaches from Benchtop to Bedside”, featured presentations by distinguished scientists and thought leaders focusing on transformative platforms and technologies that have reshaped the pharmaceutical landscape. The event drew approximately 200 attendees, including pharma and biotech leaders, researchers, academic professors, and students from diverse sectors, fostering an exciting atmosphere conducive to intellectual exchange of science advancements in the Pharma and Biotech industries. 

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Notably, SAPA for the first time introduced a workshop on Generative AI, which was the subject of the afternoon Parallel Session III.  To accommodate the networking needs of attendees, SAPA also arranged on-site meeting rooms, facilitating pre-scheduled one-on-one meetings between attendees.

Dr. Zheng Chen, SAPA’s Chief of Staff and Co-Chair of the Symposium, kicked off the event with opening remarks highlighting the significance of pharmaceutical innovation in the post-pandemic context.  Subsequently, Dr. Jack Wu, President of SAPA, took the stage introducing the organization’s mission and outlining the agenda for the upcoming SAPA events.

The morning Plenary Session started with a keynote speech from  Dr. Xiaorong He, Senior Vice President, Site Head of Non-clinical Development US, and Head of Global Development Sciences at Boehringer Ingelheim Pharmaceutical Inc,

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During her talk  “Exploring New Frontiers: Transforming Non-clinical Safety Assessment with Innovative Approaches”, Dr. He emphasized the critical importance of early detection of drug safety issues with novel approaches, which led to substantial cost savings for pharmaceutical companies. Under the guidance of FDA Modernization Act 2.0/ 3.0 and utilizing alternative approach technologies (NAMs) such as the comprehensive In vitro Proarrhythmia Assay (CiPA) and Single Cell/ Spatial Sequencing, companies will be equipped to bridge translational gaps, proactively address early safety concerns, inform compound design, and enhance the probability of success (PoS), integrating the latest AI innovations.

 

Following Dr. He’s presentation, Dr. Yang Qiu, the Chief Scientific Officer of Duality Biologics, addressed the audience on the topic of "Challenges and Opportunities in Antibody Drug Conjugates Development." Dr. Yang provided an extensive overview of ADC development, covering its history, recent approvals, and market value, as well as the mechanism of action and evolution of ADC payloads, with a particular emphasis on off-tumor toxicity and payload generations. She highlighted the importance of dose optimization, indication selection, and combination strategies for successful ADC development, while also addressing challenges such as dose and patient selection, resistance mechanisms, translational research, #biomarker identification, and patient stratification.

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Dr. Manisha Desai, Vice President of Drug Product Development at Bristol Myers Squibb then delved deeper into the critical considerations behind linker design, payload selection, and conjugation. Her talk expanded on the development of ADC, particularly from CMC perspectives regarding the formulation approaches, manufacturing technologies, and key players in the market. She left the audience several key takeaways including how to explore ADC’s potential beyond cancer, citing Aristotle’s words: “The whole is greater than the sum of its parts”.  

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Dr. Malaz Abutarif, Vice President and Global Head of the Quantitative Clinical Pharmacology Department at Daiichi Sankyo Inc, outlined the rigorous methods used to determine dose selection during ADC development.  Using Daiichi's renowned ADC compound Enhertu (Trastuzumab Deruxtecan, T-DXd) as an example for HER2 positive breast cancer patients, Dr. Abutarif explained how the Population Pharmacokinetic (PK) modeling and Exposure-Response (ER) Analysis could address the complexities of optimal dose selection for patients, while ensuring efficacy and safety. 

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Thereafter, all the keynote speakers took part in a panel discussion moderated by Dr. David Cragin, SAPA’s Chief of Staff and Co-Chair of the Symposium. The speakers had a lively discussion with the audience on topics relating to their keynote speeches.

The morning Plenary Session was concluded by Dr. David Cragin, who encouraged the audience to engage in  SAPA communities, currently being established, comprising of individuals from diverse backgrounds sharing common interests. The Symposium ended with lively networking and discussions among attendees.

 

The afternoon’s Parallel Section I, “New and Advanced Modalities: Discovery and CMC” was chaired by Dr. Jianming Kang and Dr. Yu Tian. The session offered valuable perspectives on cutting-edge developments in biotechnology and gene therapy.

 

Dr. Yujia Jing, VP R&D at Xsome Biotech Inc., discussed the therapeutic potential of Inhalable Lung-derived Exosomes for treating Respiratory & Cardiovascular Metabolism Diseases. He covered topics such as the nature of exosomes, therapeutic applications, and the potential of nebulized exosomes for various conditions.

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Dr. Kaiyuan Jiang, Associate Director at Johnson & Johnson Innovative Medicine, delivered an overview and progress update on autologous CAR-T cell therapy manufacturing. He addressed challenges, solutions, and new technologies in the field.

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Dr. Renping Zhou, Professor and Associate Dean of Research at Ernest Mario School of Pharmacy, Rutgers University, presented on AAV-Mediated Gene Therapy and Genome Editing for Neurodegenerative diseases.  He discussed considerations, challenges, and promising approaches in treating these disorders.

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Dr. Haichen Nie, Associate Director at Teva Pharmaceuticals and an adjunct Associate Professor at Purdue Industrial and Molecular Pharmaceutics Department, brings a wealth of experience from his previous roles at Merck and AbbVie, where he focused on formulation and process development. He delivered a presentation highlighting the pivotal role of amino acids as excipients in the development of protein-based drug products. He elucidated how amino acids can serve as excipients, stabilizers, and viscosity reducers. Moreover, he thoroughly examined the challenges and risks of utilizing various amino acids as excipients in developing biologic drug products. Additionally, Dr, Nie provided insights into a potential molecular mechanism for utilizing amino acids to stabilize protein molecules, further enriching the discussion. 

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Parallel Session II, titled “Emerging Platforms and Novel Technology in Clinical and Medical Development,” was moderated by Dr. Xiaowei Sun from Bristol Myers Squibb and Dr. Llorente Bonaga from Merck & Co.

Dr. Jin Zhou, Director of Clinical Pharmacology Sciences at Gilead Sciences, covered clinical pharmacology considerations in the development of rheumatoid arthritis drugs, including pharmacokinetic and disease-drug interactions issues, as well as using the modeling approach to guide dose selection in clinical trials.

Dr. Jiajun Liu, Senior Pharmacokinetitcist at the U.S. FDA, taking the development of anti-infective drugs as an example, discussed how to use PK modeling and simulation for dose selection and optimization in clinical trials for particular patient populations (those with renal impairment or obesity), as well as for the selection of proper PK/PD targets.

Additionally, Rachel Tam, Senior Principal Clinical Biomarker Scientist at BMS, elaborated on the significant potential of circulating tumor DNA as a biomarker that could inform patient treatment decisions and expedite the screening of clinical drug candidates. Circulating tumor DNA holds huge promise for the detection and helping treatment decision of minimal residual diseases, and may serve as a major clinical endpoint.

Dr. Jian Wang, a senior Director of Bioanalytical and Biomarkers at Crinetics Pharmaceuticals, delivered a presentation on the regulations governing biomarker analysis and clinical diagnostic testing and how these two are bridged for drug development and clinical diagnosis in the US and globally. Quantitative biomarkers data are routinely included in regulation submissions in drug development. Dr. Wang elucidated bioanalysis and clinical diagnostic testing covering their application, regulatory environment guidance, standard operating procedures (SOPs), regulation bodies, and regulatory inspections.  Additionally, he detailed the guidelines governing bioanalytical method validation and sample analysis, emphasizing the establishment and verification of performance specifications to determine standards.  Concluding his presentation, Dr. Wang demonstrated the Clinical and Laboratory Standards Institute (CLSI) Guidance for Clinical Laboratory Improvement Amendments (CLIA) assays and biomarker assays extending beyond First-in-Human studies. Finally, he offered insights into the European In Vitro Diagnostic Regulation (IVDR).  

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Dr. Jian Wang, a senior Director of Bioanalytical and Biomarkers at Crinetics Pharmaceuticals, delivered a presentation on the regulations governing biomarker analysis and clinical diagnostic testing and how these two are bridged for drug development and clinical diagnosis in the US and globally. Quantitative biomarkers data are routinely included in regulation submissions in drug development. Dr. Wang elucidated bioanalysis and clinical diagnostic testing covering their application, regulatory environment guidance, standard operating procedures (SOPs), regulation bodies, and regulatory inspections.  Additionally, he detailed the guidelines governing bioanalytical method validation and sample analysis, emphasizing the establishment and verification of performance specifications to determine standards.  Concluding his presentation, Dr. Wang demonstrated the Clinical and Laboratory Standards Institute (CLSI) Guidance for Clinical Laboratory Improvement Amendments (CLIA) assays and biomarker assays extending beyond First-in-Human studies. Finally, he offered insights into the European In Vitro Diagnostic Regulation (IVDR).  

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This section’s last presentation was delivered by Dr. Weifeng Xu, a Senior Principal Scientist at Merck & Co. Dr. Xu addressed a critical concern regarding ADCs, which results from drug-mediated immunity.  The formation of ADCs poses a significant risk to the efficacy of the drug and may potentially cause serum sickness or other immunological complications. Dr. Xu discussed a novel assay named “killing neutralizing antibody (Nab) assay” designed to evaluate the clinical immunogenicity resulting in the formation of ADCs. Through his research, he demonstrated the assay capability to assess target-binding and internalization of ADCs by measuring dying cells, even in the presence of complicated factors such as payload and unspecific binding.

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The afternoon session of Parallel Session III gathered over 40 enthusiastic participants for the GenAI Workshop titled "Unlocking Generative AI: A Practical Guide for Non-Techies."  It offered a practical learning opportunity for attendees to gain hands-on prompt engineering experience using generative AI models like ChatGPT to improve the efficiency of their daily tasks.

 

Brian Jiang, Senior Manager of Digital R&D Creation Center at Pfizer, initiated the session by emphasizing the transition to a new era of AI and the importance of mastering LLMs. Dr. Lixia Yao, President and CEO of Polygon Health Analytics LLC, delved into the foundational theories of Artificial Intelligence (AI) and provided insights into the concepts of Large Language Models (LLM), highlighting both the challenges and opportunities associated with their utilization in critical tasks. 

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The afternoon session of Parallel Session III gathered over 40 enthusiastic participants for the GenAI Workshop titled "Unlocking Generative AI: A Practical Guide for Non-Techies."  It offered a practical learning opportunity for attendees to gain hands-on prompt engineering experience using generative AI models like ChatGPT to improve the efficiency of their daily tasks.

 

Brian Jiang, Senior Manager of Digital R&D Creation Center at Pfizer, initiated the session by emphasizing the transition to a new era of AI and the importance of mastering LLMs. Dr. Lixia Yao, President and CEO of Polygon Health Analytics LLC, delved into the foundational theories of Artificial Intelligence (AI) and provided insights into the concepts of Large Language Models (LLM), highlighting both the challenges and opportunities associated with their utilization in critical tasks. 

This year’s SAPA Scientific Symposium received strong support from many sponsoring companies, including Bristol Myers Squibb, Merck, {please insert other company names}. Attendees were engaged with productive discussions about potential opportunities for cooperation and employment.  Medicilon and Crystal Pharmatech, two prominent sponsors of the symposium, also delivered sponsor presentations giving an overview of their respective work and capabilities.

SAPA remains committed to its mission of fostering connections within the pharmaceutical industry, encouraging global innovation, and facilitating business development. We welcome everyone to stay engaged and take part in SAPA’s upcoming events throughout the year.

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