2022 SAPA Annual Conference: “Creating Platforms for Innovation & Growth in Pharma & Biotech” — Event Report 1
Plenary Sessions, SAPA Award and Election Announcement and Part of Parallel Sessions
Reporters: Menglin Chen, Guangyu Dong, Shanshan Guan, Shuo Huang, Jiaying Liu, Junchi Lu, Jingwen Song, Linxuan Yan, Charlotte Yang, Raymond Zhao, Eva Zhou
Photographers: Ellen Chen, Junqi Chen, Yan Ma, Dexi Yang, Tianyu Yuan, Song Yue
In the mid-autumn of New Jersey, the Sino-American Pharmaceutical Professionals Association (SAPA) held the 2022 SAPA Annual Conference both virtually and in-person on September 30th and October 1st. SAPA is the one of the most active Chinese American professional associations in the pharmaceutical and biotech industry in North America, promoting science and technology, entrepreneurship and investment, education, and career development. This year’s annual conference hosted over 70 leaders in the field to give talks and 30 companies to give presentations, share knowledge, and showcase their innovations. More than 500 life science professionals attended the session in person at the DoubleTree by Hilton, Somerset Hotel, with over 300 additional attendees participating virtually. Here are some notable highlights from the event:
Plenary Session 1: Riding the Wave of CGT and Collaborating to Transform
Dr. Yongmei Li, welcomed all attendees and guests back to SAPA Annual Conference.
Dr. Yongmei Li, SAPA President-Elect, extended a warm welcome to all in-person and online attendees and speakers at the 2022 SAPA Annual Conference. She highlighted the continued dynamics and fast growth of SAPA as a non-profit organization despite its challenges from the pandemic and market uncertainties. With the unwavering support of its sponsors and volunteers, SAPA will continue to live up to its core missions and keep on creating platforms for the innovation and advancement of the pharmaceutical and biotechnology industry.
The talks and discussion of plenary session on Friday focused on the latest advances in cell and gene therapies. Opportunities for collaboration to accelerate the research to commercialization process were also explored.
Dr. Guang Yang,partner at McKinsey & Company, discussed the recent development of the CGT.
Cell and gene therapy has grown to be a key pillar in therapeutic options today as a result of growing funding. Dr. Guang Yang reviewed the recent development of the Cell & Gene Therapy (CGT). Discussing the growing amount of funding directed to the development of platform technologies, the impact of CGT has reached a much broader population. Nevertheless, safety and manufacturing concerns continue to result in delays in the market approval of innovative CGTs. While these challenges may limit near-term market size, but the industry’s focus on CGTs will likely continue.
Dr. Yangzhou Wang discussed the innovation approaches to accelerate the development of cell and gene therapeutics.
Dr. Yangzhou Wang,CEO of Porton Advanced Solutions,gave a talk on the process innovation for CGTs. Many challenges to successful approval and commercialization for CGTs stem not from clinical efficacy but manufacturing/CMC quality. To address these barriers,Porton Advanced is committed to providing robust and cost-effective CMC services to CGT developers by process innovation. Dr. Wang noted that the innovation at a CDMO may involve several levels, including: (1) system adaptability,(2) platform & process improvement, (3) methods & standard development, and (4) quality systems.
IQ fireside chat panelists discussion. Panelists from left to right: Dr. Peter Wuelfing (Merck), Dr. Maureen Cruz (IQ), Dr. Yun Mao (BMS), Dr. Shubha Gargya (GSK), Dr. Heidi Einolf (Novartis).
Dr. Peter Wuelfing (Executive Director of Merck & Co.,Inc.) moderated a panel discussion focusing on IQ Consortium, a technically focused not-for-profit organization with a mission of advancing science and technology in the pharmaceutical industry. The panel discussed how the IQ Consortium builds community through organizing industry-wide efforts & collaborations to develop transformational solutions that benefit patients, regulators, and the broader R&D community.
Plenary Session 2 – From the Wonders of Chemistry to the Future of Cancer Care
Dr. Xiaodong Chen opened the plenary session on Saturday and welcomed the speakers and audience.
Dr. Xiaodong Chen, SAPA President, opened the plenary session on Saturday morning with a warm greeting. Despite challenges caused by the COVID, SAPA continued to host flagship events and provide a trusted platform for the community to interact with each other. Xiaodong introduced new initiatives such as establishing SAPA global task forces and launching SAPA Community Platform to unite members with a common interest and disciplines.
Michelle Weese shared insights on the impact of inclusion and diversity on innovation
Michelle Weese, EVP of Corporate Affairs at BMS, discussed three topics surrounding biopharma innovation, beginning with potential breakthroughs stemming from the use of AI, robust digital platforms, precision medicine, and telehealth. Secondly, she discussed how inclusion and diversity are not only moral imperatives, but scientific imperatives with a clear impact on successfully implementing innovation. Her personal story of growing up as an Asian child touched and inspired many audiences to speak up more in work and life in the future. Finally, Michelle discussed how technology and innovation can be leveraged as the cornerstone of the future of pharma.
Dr. David MacMillan gave a talk on Organocatalysis and Photoredox and the impact on pharmaceutical research
Next, Dr. Dexi Yang, session moderator, associate principal scientist in Merck, solemnly introduced SAPA Distinguished Achievement Awardee, the 2021 Nobel Chemistry Prize Laureate, Dr. David MacMillan, 2021 Nobel Chemistry Prize Laureate, presented on the impact of Organocalysis & Photoredox technologies on pharmaceutical research. Dr. MacMillan also introduced the concept of Asymmetric + Organo + Catalysis (biocatalysis + metal catalysis) and discussed the impact of the molecules. Some applications include Firmenich and telcagepant. His metaphor of the famous 30-yard bicycle kick of the football star Zlatan Ibrahimovic made it much easier to understand the tremendous joy of scientific discovery and breakthrough. Dr. MacMillan also highlighted how it was amazing to talk to and learn that high school students in Ukraine in the war were still trying their best to learn science. Dr. MacMillan’s Nobel Prize award established a foundation named after his parents,to support economically disadvantaged students to enter university study.
Dr. Kevin Campos presented how Merck’s strategy is realized through investments in talent,technology,and culture
Dr. Kevin Campos,VP and Head of Process R&D at Merck & Co,began the presentation with a personal story about how he and his six-year-old son succeeded through trial and error at many iterations to develop a transformer suit for Halloween,which not only won him a Youtube Influencer Award,but also told him to never say no to innovation. He then talked about how at Merck,they strive to design the most direct method to convert commodity chemicals into the target molecule with zero waste. By investing in a mindset of innovation,Merck has established a legacy of breathtaking yet practical solutions to vexing synthetic issues,providing countless benefits to how our medicines are manufactured,maximizing access to medicines for patients worldwide,and expediting the field of synthetic chemistry. How Merck’s strategy is realized through investments in talent,technology,and culture were also discussed.
Dr. Lai Wang,Global Head of R&D at BeiGene,gave a talk on how BeiGene determined to build the new generation of Global Biotech
Dr. Lai Wang,Global Head of R&D at BeiGene,believed that the biopharmaceutical industry is at its best era with tremendous advancement in our understanding of life science. More importantly,new biotechnologies are transforming the way we are making medicine. BeiGene is building fast global progression & expansion and is trying to build its commercial capability to help young companies and build the new generation biotech company.
The following fireside chat was a panel discussion moderated by Hong Tang focused on past,current and future state of health equity in cancer care.
Dr. Elizabeth Jaffee,Jennifer Rasing, Dr. Lin Zhu, Dr. Aiwu (Ruth) He opened the health equity discussion based on their personal stories
Hong Tang, Dr. Lin Zhu, Jennifer Rasing, Dr. Aiwu (Ruth) He (Left 2 to 5) discussed the historical achievement and future state of Health Equity in Cancer Care
Hong Tong,BMS PAN Co-Lead Health Equity,opened the second fireside chat panel discussion by defining health equity and talking about how it plays a role in cancer treatment for the past three decades.
Dr. Elizabeth Jaffee shared the cancer equity study that 25 million Americans are less likely to have access to the latest clinical trials and new treatment options. She also introduced the Cancer Moonshot 2.0 program by the White House as a very important first step. Dr. Lin Zhu shared her participation in outreach activities among community-based organizations,including churches,Buddhist temples,faith organizations and senior centers to address awareness and access. Dr. Aiwu (Ruth) He,shared a recent study showing significant health disparity based on the incidence and screening incidence in DC. In addition,a recent study on high incidence of liver cancer in DC,Maryland and Virginia showed a huge disparity gap among different ethnicity groups. The Q&A for the panel discussed how diagnostics and screening are important to build the awareness and access for people with all conditions and backgrounds. Healthcare equity is such an important topic. It takes a lot of time,resource,trust to increase access of healthcare to low income or undocumented patients. This panel discussion will help improve awareness among various stakeholder groups and benefit the patients in the long run.
SAPA Awards and Leadership Election Result Announcement
In the SAPA annual conference, the election result of the new president office and executive committee members in year of 2022-2023 was also announced. Dr. Jack Wu was elected to be the president-elect and Dr. Xiaodong Chen will pass the baton to Dr. Yongmei Li to lead SAPA forward in the coming year. The new president office and executive committee will continue to serve the entire SAPA community and pharmaceutical and biotech professionals with devotion, dedication and best effort.
Presidents. From Left to Right: Dr. Jack Wu, Dr. Yongmei Li, Dr. Xiaodong Chen, Dr. John Sun
For their contribution to science, education and leadership, this year’s SAPA Distinguished Achievement Awards were awarded to Dr. David McMillan, and Dr. Dean Li, the Executive Vice President and President of Merck Research Laboratories. The SAPA 2022 Scholarship & Excellence in Education for Life Sciences Award was given to June Yin, who is now a freshman at MIT, for her outstanding achievement in high school and to support her pursue of dream in healthcare field.
Dr. David McMillan received the SAPA Distinguished Achievement Awards
Dr. Dean Li received the SAPA Distinguished Achievement Award.
Parents of June Yin received the SAPA 2022 Scholarship & Excellence in Education for Life Sciences Award on behalf of June.
Parallel Session C: Emerging Treatment Modalities and Recent Advances in Cell and Gene Therapy
Speakers and panel discussion of session C provided snapshots of CGT at various stages from research & discovery,CMC & regulatory strategy development, Biomarker and Bioanalytical Strategy, clinical development for Gene Therapy, and market access considerations for cell therapy.
Dr. Zhijian Wu gave a talk on developing AAV vectors for ocular gene therapy.
Dr. Zhijian Wu,VP of PTC Therapeutics, introduced the inherited retinal dystrophy (IRD) disease, citing it as an example of a genetic disorder which could cause vision loss or blindness. With over 20 years experiences in AAV mediated gene therapies for IRD,Dr. Wu’s work has generated several gene therapy clinical trials. He pointed that AAV vector development needed to focus on improving efficiency,specificity, and safety for future better application in IRDs’ gene therapy. He also discussed the most updated lateral spreading AAV from Atsena Therapeutics which ensures gene delivery to large areas of the retina.
Dr. Jason Sher presented on the recent advances in cell and gene therapy and related global regulatory considerations
Dr. Jason Sher, principal consultant at Parexel International Regulatory & Access, discussed the recent advances in cell and gene therapy and related global regulatory considerations, such as the key challenges in CGT product development, recent advances to overcome these challenges with three thought-provoking cases, as well as comparisons of expedited programs in different countries which include China, US, EU, Japan, Korea, Australia. He stated how efficiently the program progresses toward licensure will largely affect the issues addressed in every research and development processes. Among the three cases he shared, the single arms assay by Novartis to treat rare disease represented the typical situation that most rare disease related clinical trials encountered.
Dr. Pedro A. Moura gave a presentation on the newest Spark Therapeutics cell culture platform for AAV gene therapies.
Dr. Pedro A. Moura, Senior Director and Head of Upstream Process Development from Spark Therapeutics, shared his insight of the current challenges of AAV gene therapy commercialization, and how within the 500 gene therapy clinical trials ongoing around the world, the dosage of AAV gene therapy required continues to increase. As such, the capacity and cost of AAV gene therapy manufacture significantly impact the process of successful industrialization. Spark Therapeutics is dedicated to developing a comprehensive HEK293 cell culture platform for AAV gene therapy to better facilitate the commercialization through delivering higher virus production titers, improving product quality, and reducing the cost with innovative approaches, good safety and fast FDA approval. Their goal is to make sure that no life is limited by genetic disease worldwide.
Dr. Yan Ni described the biomarker and bioanalytical strategy supporting gene therapy.
Dr. Yan Ni, Executive Director from Passage Bio, discussed the struggles and major considerations regarding the biomarkers identification and bioanalytical strategy for rare diseases when developing gene therapies. From the disease diagnostics, the detection of anti-capsid antibody and anti-transgene protein antibody to the pharmacodynamic response and efficacy as well as safety, the bioanalytical requirements are extremely difficult to fulfill when the patient population is limited. The lack of disease relevant animal models and patients for interventional and natural history studies also cause significant delay in the gene therapy development.
Dr. Haichen Yang introduced the challenges, opportunities and acceleration with the clinical development of AAV gene therapy
Dr. Haichen Yang, VP of Clinical Research from Amicus Therapeutics, shared her view regarding the ongoing and the future of AAV gene therapy. The latest 4 approved AAV gene therapies encouraged the whole AAV gene therapy industry. The startup financing for gene, cell and RNA therapy companies rose in Q2, 2022, especially in the anti-cancer and rare diseases fields. However, concern over oncogenicity and vector integration, hepatic toxicity, thrombotic microangiopathy upon the receive of AAV gene therapies in patients remain obstacles for the development of AAV gene therapy, which leads to more condensed clinical development requirement and regulations both from the US and the EU.
Session C moderator, speakers and panelists accepting plaques from SAPA. From left: Mr. Amit Agarwal, the managing director of NextGen Practice Lead Deloitte; Dr. Haichen Yang, VP of Clinical Research from Amicus Therapeutics; Mr. Richard Rahul Maria, Senior Manager, Deloitte Consulting; Mrs. Eileen Brett, VP of program leadership in the center of breakthrough medicines; Mrs. Annie Curti, director of Novartis Gene Therapies on leading disease strategies; Dr. Jie Jia, VP of Strategic and Operations and head of CMC at Carsgen therapeutics; Dr. Samuel Zhang, chief business officer at Gracell Biotechnologies.
The panel discussion was led and moderated by Mr. Amit Agarwal, the managing director of NextGen Practice Lead Deloitte. While R&D is an important operation that helps drive growth for companies and society,Mr. Agarwal noted that the finances and the reimbursement process are also undeniably important in sustaining businesses and long-term research funding.
Mr. Richard Maria from Deloitte strategy team, gave a brief talk about the new era of personalized medicine, CGT, the differences between the two, the motivations of CGT access, as well as the financial frictions that limit the sector in its future development, highlighting how the high treatment costs are due to the underrepresentation of patients in the population. Mr. Maria also lists the programs that companies are working on with the key stakeholders, including health planners, governmental agencies, corporate employers, and patients to provide solutions to financial frictions.
In the panel discussion Mrs. Curti explained the four crucial components for CGT: “patient identification” to determine who requires the treatment the most, “access and affordability” to ensure that the treatment can be creatively priced and affordably by patients, “data” to track and understand results, and finally “trust and engagement with the community” to maintain confidence and positive long-term relationships in business and pharmaceutical practices.
To answer how strategic decisions behind setting up manufacturing facilities were made, Mrs. Brett told us that whether to build a manufacturing facility or buy manufactured products from external sources falls mainly on time and talent in individual companies.
When asked about the uncertainties of handling global operations, Dr. Jia talked about how the most significant challenge was allocating resources to satisfy both internal stakeholders and external investors and emphasized that reaching milestones is important so that you can receive your next round of funding.
For the question on understanding company limits, Dr. Zhang, detailed his experiences on teams overestimating their own capabilities and underestimating obstacles. He gave an example of how his company dealt with tight timelines by having a dual targeting approach coupled with a fast CAR approach for their clinical trials.
The panel discussion ended with questions from the audience, where a room-wide discussion over gene therapy affordability provided a happy conclusion to the chain of talks.
Parallel Section E: Recent Advances in Drug Discovery
The speeches given in Session E highlighted the significance of recent advancement of platform technologies to drug discovery.
Dr. Haihong Zhou introduced the HDX-MS as an advanced technology to drug discovery.
Dr. Haihong Zhou, the leader of the biophysical mass spectroscopy group at Merck, introduced her pioneering work on unraveling the interaction between insulin receptor partial agonist (“IRPA”) and insulin receptor using hydrogen-deuterium exchange mass spectrometry (“HDX-MS”) and Cryo-EM. Compared with insulin, IRPA elicits a much milder dose response than insulin in a human body, thus representing a safer alternative to diabetic patients. Dr. Zhou’s work highlights the growing importance of HDX-MS as a structural biophysics tool to facilitate early drug discovery.
Dr.Li described the three advanced bioimaging platforms for the research of biomarker.
Dr. Zhuyin Li leads the high content screening center in the Leading Discovery & Optimization Department at Bristol Myers Squibb. Her talk covered the use of three advanced bioimaging platforms—Luminex-based high throughput cytokine profiling platform, high content screening-based tissue imaging platform, and Mass spec-based high multiplexed tissue imaging platform—to support the research of preclinical and clinical biomarkers, which allow biomarker-driven patient stratification and improved treatment outcome. Dr. Li stated that the future of tissue imaging calls for more antibody-independent biomarker qualification to improve the multiplexity of imaging.
Dr. Wang presented his team’s achievement on the antiviral drug discovery targeting the SARS-CoV-2 main protease.
Dr. Jun Wang,an associate professor of medicinal chemistry at Rutgers University introduced his team’s work on the antiviral drug discovery targeting the SARS-CoV-2 main protease (Mpro) and the comprehensive study of nirmatrelvir resistant Mpro mutants. Using structure-based design, Dr. Wang’s team identified both covalent and non-covalent Mpro inhibitors with increased target specificity. These inhibitors overcome the major issue of currently available covalent inhibits, i.e., the unwanted targeting of host proteases such as cathepsins L and K.
Dr. Josien introduced orally administrable PCSK9 inhibitors for the treatment of coronary artery disease.
Dr. Hubert Josien, a principal scientist at Merck discussed his team’s breakthrough work in developing orally administrable PCSK9 inhibitors for the treatment of coronary artery disease. Currently, all approved therapeutics targeting PCSK9 are injectables, and an oral agent would significantly improve patient access and medical impact. Using an mRNA display platform and structure-based design, his team developed a small peptide that has demonstrated efficacy in cynomolgus monkeys. With only around 1% of the molecular weight of an antibody, this small peptide exhibited similar potency with monoclonal antibodies for PCSK9.
Parallel Session F: Implementing Precision Medicine
The talks in session F covered a broad range of topics in precision medicine, from development of new diagnostic tools for cancer to the discussion of IVD testing regulations in clinical laboratories.
Dr. Yi introduced the testing and related regulations in clinical laboratories.
The first speaker, Dr. Xin Yi, an associate professor and the clinical chemistry laboratory director at Houston Methodist Hospital/Weill Cornell Medical College gave an extensive overview of the testing (especially IVD tests) and related regulations in clinical laboratories, or CLIA labs. She pointed out that the future of IVD tests lies in the advancement of technologies, which may lead to novel multiplex assays and wider use of digital tools.
Dr. Ye described the emerging role of circulating miRNAs as biomarkers for diagnosis and monitor of Germ Cell Tumors.
The second speaker was Dr. Fei Ye from Memorial Sloan Kettering Cancer Center. Her talk focused on the emerging role of circulating miRNAs as biomarkers for diagnosis and monitor of Germ Cell Tumors (“GCT”), as well as therapeutic targets for cancer. In particular, Dr. Ye explained how her team identified two specific miRNAs as biomarkers for GCT, which resulted in an LDT approved by the New York State Department of Health.
Dr. Zhou described AI-empowered platform for clinical interpretation of somatic mutations in cancer.
The third speaker was Dr. Yunyun Zhou, a principal investigator at Children’s Hospital of Philadelphia. Her team developed CancerVar, an AI-empowered platform for clinical interpretation of somatic mutations in cancer. Applying rule-based and deep-learning-based approaches, CancerVar is equipped with a score-based system for interpretation of cancer somatic variants and an AI-empowered web server for clinical interpretation of these variants. Dr. Zhou pointed out that CancerVar has brought promise to the standardization of clinical interpretations that may resolve inconsistent or even conflicting interpretations produced by currently available tools.
Panel discussion on implementing precision medicine.
A panel discussion moderated by Dr. Willie Wu followed. The three speakers had a lively discussion with the audience on the collection and interpretation of clinical data in the implementation of personalized medicine.
More news on parallel sessions, lunch and learn, job fair, vendor booths and networking sessions in the Event Report 2.