2022 SAPA Annual Conference: “Creating Platforms for Innovation & Growth in Pharma & Biotech” -Event Report 2

PART OF PARALLEL SESSIONS, JOB FAIR AND VENDOR BOOTH AND EVENING GALA

Reporters: Ellen Chen, Shuo Huang, Jiajie Huo, Jerry Jia, Jiaying Liu, Junchi Lu, Yan Ma, Jingwen Song, Juechun (Cathy) Tang, Bobby Wei, Ruth Xiong, Linxuan Yan, Charlotte Yang, Yunwen Yang, Raymond Zhao

Photographers: Ellen Chen, Junqi Chen, Yan Ma, Dexi Yang, Tianyu Yuan, Song Yue

As a continuation from event report 1, here are highlights from the parallel sessions focused on entrepreneurship, business/market trend, new clinical strategy and tools, job fair, vendor booth and outlook for SAPA community

 

Parallel Session A: CEO Forum: Transcending the Challenges and Driving to Success

Session A was held on the first day of the Annual Conference. In this session, C-level executives shared their insights on the acceleration of innovation and drug development given the current macroeconomic condition and reflected on their personal journeys of building successful biotech companies.

In Panel Discussion I, Dr. Sean Zhang, CMO of InnoCare Pharma, stated that globalization and collaboration in the pharmaceutical industry is necessary no matter what business model one chooses. Dr. Joanne Jiang, Chairman and CEO of LeaderMed Health Group Ltd., remarked that the current market situation does not favor starting a research-based company that calls for considerable R&D spending, when cost reduction and revenue generation have become crucial for a drug development company. Dr. Jay Mei, Chairman and CEO of Antengene Corp., highlighted the emerging role of Asia (especially China and South Korea) as a warehouse in the global landscape of biotech innovation. Mr. Andrew Jiang, President of Aleon Pharma International, Inc., stated that orphan drug industry would likely gain more popularity in the coming years with US FDA providing incentives.

Panelists from the first panel discussion of Parallel Session A (from left to right): Mr. Andrew Jiang (Aleon Pharma International, Inc); Dr. Joanne Jiang (LeaderMed Health Group Ltd); Dr. Jay Mei (Antengene Corp.), and Dr. Sean Zhang (InnoCare Pharma).

In Panel Discussion II, the panelists shared their personal stories on becoming entrepreneurs. Mr. John Gregg, CEO of BalinBac Therapeutics, described his determination to be an entrepreneur starting with serious academic and practical preparations that he began at the age of 18. Dr. Xiaohui Wu, CEO of Hopkins MedTech Compliance, recounted his diversified prior academic and business experience in physics and finance, before his new venture into the medical device area that was “thrusted” upon him by the COVID pandemic. Mr. Steve Yang, CEO of Merit CRO, Inc., recaptured his transition from an office job at Wall Street to an entrepreneur in clinical trial services that is loaded with both excitement and huge rewards. Dr. Yanbin Pan, CEO of BirdoTech Lab US Co., emphasized the need of family support and backup plans for an entrepreneur, in addition to the strong belief in success.

Panelists and moderators from Panel Discussion II of Parallel Session A (from left to right): Dr. Yongmei Li (SAPA President); Mr. John Gregg (BalinBac Therapeutics); Dr. Yanbin Pan (BirdoTech Lab US Co.); Dr. Xiaohui (Homer) Wu (Hopkins MedTech Compliance); Mr. Steve Yang (MERIT CRO); Dr. Jack Wu (SAPA President-Elect).

 

Parallel Session B: Challenges and Opportunities in Pharma and Biotech Outsourcing

Parallel session B panelists (from left to right): Mr. Gui-Hua Qian (BeiGene USA); Dr. Shanming Kuang (J-Star Research); Mr. Jim Huang (Ascendia); Dr. Jim Shen (BMS); Dr. Firouz Asgarzadeh (BioDuro-Sundia); Dr. John R. White (GSK); Dr. Winston Wu (Proteovant).

The panelists offered insights into their motivations, challenges, as well as benefits of outsourcing in a panel discussion on the theme of “‘Challenges and opportunities in pharma and biotech outsourcing”. They provided insights both from a pharma and biotech perspective as well as CRO and CDMOs’ perspectives.

Jim Huang first pointed out that (1) companies gain capacities with outsourcing, (2) centralizing processes build specialization and expertise, and (3) outsourcing provides flexibility for companies and enables the allocation of resources. John White added that GSK, as a big pharma, often outsourced to CROs to produce the critical reagents that liberated internal capacity of developing new assays. Winston Wu also agreed that for small-size semi-virtual companies that cannot afford to set up a facility for manufacture, it is a necessity to outsource the development and manufacturing processes. Gui-Hua Qian mentioned that since BeiGene’s development and manufacturing center is currently located in China, it is preferable to outsource in order to launch the development and commercialization in the US. Jim Huang stated that CDMOs could also provide help on labor and provide direction on CMC strategies. For small virtual biotech companies, he mentioned that CDMOs can become a partner for pharmaceutical functions when developing new products. Shanming Kuang added that CRO & CDMO companies must be expertized in certain processes to make profit and their expertise will help accelerate the process of commercialization. Firouz Asgarzadeh shared his previous experience at Merck. When working on leading compounds, the big pharma internal process could be fast. However, when working on backup-line products, outsourcing to CRO and CDMO would quicken the timeline compared with internal processes.

Based on their experiences of various company sizes, the panelists also discussed in-depth their preferences for local or global CROs and CDMOs. Moreover, the panelists provided their insights on the most important factors when choosing CROs and CDMOs. John, Firouz, and Jim Huang all emphasized the quality of the product is the primary priority when choosing CROs. Other factors include size of the manufacturing facilities, capability to keep up with timelines, ability to handle toxic compounds, and etc.

The panel also reflected on the challenges and impacts of outsourcing brought by the COVID-19 pandemic. Shanming said clients now have high expectations and they look for one-stop shop experience that can provide a full line of service in drug development. Jim Shen and Winston both brought up that the pandemic had extended the timeline and part of the reason was due to labor shortage. Despite all the challenges, Firouz pointed out some positive impacts the pandemic has brought, including but not limited to the fast and flexible reaction to different situations, new solutions and policies to enable a timely progress of projects. Jim Huang suggested both parties of outsourcing business take proactive measurements and plan ahead of time to minimize the negative impacts from labor shortage, shipping delays or enrollment slowdown of clinical trial participants.

At the end of the discussion, the panelists provided many career development suggestions for fresh graduates. Shanming said that the first job is not going to determine the future. Rather, young graduates should focus on what they love. Jim Huang said visa sponsorship is important but long-term vision is also important. There are pros and cons of both large pharmas and CDMOs. However, continued learning from your work is essential. Firouz encouraged the newly graduates to build their career from where they enjoy the most.

Parallel Session D: Roadshow and Career Development Clinic

Parallel Session D group photo

The theme of Parallel Session D is investment and entrepreneurship. In this session, several companies shared their business plans to experienced investors and coaches, who shared the traits they believe are crucial for the success of a start-up.

Part A Investment Roadshow

Part A of the session was moderated by Dr. Xiaowen Wang and Dr. Jiajun Mei. The winners of the SAPA 5th Investment Forum and Roadshow– Vivacitas, AnHeart Therapeutics, Microvascular Therapeutics, and Yiviva, pitched their business plans. Among them, Vivacitas already owns a lead drug candidate in clinical stage with orphan drug designation that is anticipating promising Phase II data. Anheart Therapeutics showed the excellent safety profile and efficacy data of their ROS1 inhibitor in lung cancer. Microvascular Therapeutics has multiple theranostic products in its pipeline for significant unmet needs in cardiovascular diseases, oncology, and neurology and is looking at commercialization by EOY 2023 with 100 products and looking for partnership at both clinical development and commercialization phases. Yiviva is also a clinical stage biotech with a strong pipeline of first-in-class, systems biology medicines. Its product in development has shown great potential in many types of cancer and it is now raising funds for Series B to advance clinical opportunities, preparing commercial manufacturing, and developing STAR Discovery Platform. Besides the award winners, HanchorBio was also invited to showcase their business journey. It is a global biotechnology company focusing on immuno-oncology, with 8 assets in pipeline, at the phase of in-vitro and in-vivo research.

Part B Career Clinic Workshop

Part B was moderated by John Sun and featured an interactive and engaging entrepreneurship booster session that serves as a discussion platform for CEOs and leaders to learn from startups or VCs. Daniel Chai, the Founder and managing partner of Turret Capital Management, led and moderated this section.  Our attendees asked their questions that bothered them the most during their entrepreneur journey, encompassing what characteristics of entrepreneurs the investors are looking for, how the investors convince the entrepreneurs to work with them, why sometimes innovation or new drug programs are not leading us to success, and why some investors think 2022 is the best year for venture capitals and some think it is the worst. Daniel provided his personal insights based on his vast and well-rounded experience in both the medical and investment field, emphasizing that entrepreneurs should learn from failures and keep on innovating, and that being genuine and transparent are the most powerful tools to establish strong trust and collaboration relationship between the investors and the companies. He also emphasized that leadership, people, and culture are the three critical aspects in building a successful company and achieving the set goal. In between questions, John, Jamie and many other leaders in the room also shared their learnings over the years.

 

Parallel session G: Clinical Development, Data Sciences and Regulatory Affairs: Expediting Life-Saving Drugs to Patients

Session G showcased the critical role of rigorous design and analysis in clinical trials, emphasizing the importance of assessment of benefits and risk, maintenance of data integrity, as well as consistent evaluation of uncertainty while expediting the life-saving drugs to patients. Dr. Jerry J. Li, Director and TA Lead of Hematology Myeloid Diseases from Bristol Myers Squibb extended a warm welcome to all the speakers and attendees to start the session.

Dr. Jerry J. Li welcomed the speakers and audience to the session.

Dr. Esther De La Cuesta shared the successful clinical development of larotrectinib.

The first speaker, Dr. Esther De La Cuesta, Senior Director and Clinical Development Leader from Bayer Pharmaceuticals, shared the successful clinical development of Larotrectinib. Larotrectinib is an exclusively designed and highly selective TRK inhibitor. It was approved in 48 countries for the treatment in adult and pediatric patients with solid tumors including primary CNS tumors harboring a NTRK gene fusion, which accounts for less than 1% of all solid tumors. Dr. Cuesta discussed the Larotrectinib data from three multicenter, open-label, single-arm clinical trials, highlighting that the comprehensive testing for NTRK gene fusions is essential to identify the patients who can benefit from larotrectinib as well as the tremendous success of the trials. Towards the end, Dr. Cuesta also shared the challenges and tactics in conducting pediatric studies, providing informative insights to the audience who are interested in clinical trial design.

 

Dr. Ivan Chan discussed the challenges and opportunities in dose optimization for oncology drug development.

The second speaker Dr. Ivan Chan, Vice President and Head of Hematology Biostatistics from Bristol Myers Squibb, started his talk by pointing out that the traditional paradigm for dose selection based on cytotoxic drugs often does not apply for molecular targeted agents. To address this discrepancy, FDA initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development. By using the new class of drugs (e.g., CELMoDs, BCMA-targeted therapies, T-cell engager) for the treatment of multiple myeloma as a case example, Dr. Chan discussed the idea of evaluating multiple doses in an inferential adaptive seamless phase II/III design to address dose optimization in pivotal trials. He further illustrated a few key issues surrounding the use of biomarkers and quantitative measures of benefit and risk for selecting the optimal dose, the analysis of clinical outcomes based on combined data from both phase II and III, as well as blinding and trial integrity with interim adoption. Dr. Chan concluded the presentation by emphasizing that holistic assessment and adaptive designs are essential for dose optimization while enabling acceleration of drug development.

 

Dr. Jiang Liu elaborated FDA’s Project Optimus and the holistic approach for dose selection and optimization in oncology drug development.

Following the topic on Project Optimus, Dr. Jiang Liu, Associate Director for Therapeutic Review at FDA, provided a pragmatic and holistic approach for dose finding and optimization in oncology drug development from the regulatory perspective. Dr. Liu first reviewed the current paradigm of oncology drug dose finding and optimization, which is driven by toxicity and no longer appropriate for the new molecular targeted agents and immunotherapies. Therefore, the pressing need for an improved oncology drug dose finding and optimization strategy has been highlighted, as demonstrated by the recent Project Optimus from the FDA. In regard to the new strategy, Dr. Liu elaborated in details the factors (e.g., drug, subject, disease, trial) affecting dose selection and the holistic approach integrating the totality of evidence at different stages of drug development for dose selection and optimization. In the end, Dr. Liu concluded his talk with an emphasis on the model-informed drug development (MIDD) for dose optimization.

Dr. Flonza Isa presented the promising phase 3 trial data of casirivimab and imdevimab in preventing COVID-19.

After coffee break, Dr. Flonza Isa, Medical Director of Regeneron, introduced Regeneron’s proprietary technology, which brought the novel anti-spike mAb combination Casirivimab (CAS) and Imdevimab (IMD) to clinic within 5 months for the prevention of SARS-CoV-2 infection. It was reported that a single 1200 mg subcutaneous dose of CAS+IMD prevented symptomatic COVID-19 by 81.4% and prevented all SARS-CoV-2 infections (asymptomatic and symptomatic) by 66.4% in household contacts living with recently infected individuals over a 28-day period. This data supported the Emergency Use Authorization (EUA) of CAS+IMD for post-exposure prophylaxis. Dr. Isa presented additional results demonstrating the efficacy and safety of a single dose of CAS+IMD to prevent COVID-19 in a 7-month follow-up period of this study.

Dr. Mark Chunming Li discussed statistical methodology for clinical studies and regulatory considerations.

Lastly, Dr. Mark Chunming Li, Senior Vice President of Pharmaron Clinical, discussed the statistical methods for clinical studies dealing with outcomes such as categorical endpoints and count data. He also shared his thoughts on recent experiences and learnings in the context of regulatory interactions. In addition, Dr. Li presented some technical details and simulation results based on performance evaluation criteria and metrics. To conclude his talk, Dr. Li reaffirmed the importance of statistical and regulatory considerations in achieving successful clinical studies.

Group photo of panel discussion. From left to right: Dr. Mark Chunming Li (Pharmaron Clinical); Dr. Esther De La Cuesta (Bayer); Dr. Ivan Chan (BMS) with Dr. Jiang Liu (FDA) joining online

In the panel discussion, our panelists Dr. Esther De La Cuesta, Dr. Ivan Chan, Dr. Jiang Liu, Dr. Mark Chunming Li, and onsite and remote audience had an engaging and lively discussion on the topics including 1) operational challenges in clinical trials, 2) regulatory agency’s guideline on the benefit and risk ratio, 3) strategies for working with different size companies from a CRO perspective, 4) recommendation on subject number per arm for PK profile characterization, and 5) interim analysis. The conversation was meaningful, thought-provoking, and educational.

Group photo of session speakers, moderators, and volunteers.

 

Lunch and Learn

 Lunch and Learn session was moderated by May Huang (WWC CPA P.C.). This session focused on the investment and start-up landscape in the past year by successful entrepreneurs and investment consultants in the field. The discussion was started by Dr. Mark Tang (Partner, Good Health Capital), who shared his insights regarding the status of the financial market in the USA and Hong Kong. Nowadays the biotech companies are experiencing the deepest economic slump since 1991. He elucidated the cause of existing conditions from the environmental, economic, and political point of views. Bing Yuan, co-founder and CEO of OnCusp Therapeutics, continued to demonstrate the situation between biotech companies and the investors. With the rising concerns from investors and high cash burn rate, it is not only difficult for startup companies but also for large enterprises. Finally, Dr. Q.Y. Ma (Chairman and CEO, Time Medical Systems Inc.), elaborated the emerging and new trends of telehealth originated from this difficult time. With the combination of cutting-edge chemistry and physics technologies, patients would be able to get access to at-home imaging for diagnosis in the future.

Lunch and Learn group photo (from left to right: Q.Y.Ma, May Huang, Mark Tang, Bing Yuan)

Job fairs and Vendor Booths

Besides the plenary and parallel sessions, SAPA annual conference also offered a convenient and trusted platform for job seekers to have 1-on-1 communication with the recruiters from over 30 companies. They hosted booths outside of the ballrooms and showcased their products, which continuously drew large crowds of attendees during the one and half day conference and many established new networks and relationships for future collaborations.

Attendees having discussions at vendor booths and the job fair.

 

Evening Gala

Following the parallel sessions, SAPA hosted a grand dinner Gala on Saturday night. Dr. Xiaodong Chen, the SAPA President, started the gala by reviewing the achievements SAPA has made in the past year and expressed his gratitude to volunteers for their devotion and efforts that make all these happen. Xiaodong introduced the progress made towards SAPA’s 2022 goals, including the establishment of global task forces, launch of SAPA community platform, and over 40 successful events hosted by all SAPA chapters. He also thanked the sponsors for their continuous support and engagement with SAPA. The representatives from BMS and Beigene also expressed their appreciation of SAPA’s contribution to the field. The outstanding volunteers and leaders in SAPA were awarded special recognition awards and SAPA’s service excellence awards. The SAPA immediate-past president, John Sun, received the SAPA Presidential Service Excellence Award shared his moving story with SAPA in the past decades. SAPA was holding strongly together because of the dedication, friendship, and collaboration of members and friends. The SAPA President-elect, Jack Wu, officially announced the end of the SAPA 2022 Annual Conference with encouragement of more participation from the audience in future events. The Gala ended the enjoyable and memorable day with laughter, wine, and a good feast.

Outstanding SAPA volunteers received SAPA Service Excellence Awards and Special Recognition Awards

Attendees at the dinner gala were given a review of SAPA’s achievements, watched the award ceremony while enjoying dinner.