—Sino-American Pharmaceutical Professionals Association-Greater Philadelphia (SAPA-GP) 15th Annual Conference
The Sino-American Pharmaceutical Professionals Association-Greater Philadelphia (SAPA-GP) 15th Annual Conference was successfully held at Sheraton Valley Forge Hotel on June 23rd and 24th, 2017, with nearly 1,100 people attended. The theme of this conference was “Winning for Patients: Building Global Pharmaceutical Ecosystems & Delivering Breakthrough Medicines.” The meeting highlighted the need and significance of China–US collaboration, innovative Research & Development landscape in China and the US, breakthrough medicines, regulatory strategies of drug development, big data and artificial intelligence in drug discovery and healthcare, and the importance of emotional intelligence in professional development.
Featured presentation by Joseph Tarnowski, Senior Vice President, GlaxoSmithKline
Growth and Progress
Tremendous Growth of The Pharmaceutical Industry And Opportunities in China
Many speakers discussed the tremendous growth of the pharmaceutical industry and opportunities in China. Mr. Mingde Yu, Honorary President and Chair of Expert Committee, China Pharmaceutical Enterprise, gave a presentation on Situation and Present Policies of China’s Pharmaceutical Industry. He expressed his strong confidence in China’s pharmaceutical industry, “It will achieve sustainable, stable, and high-speed growth.” Yu also acknowledged that the growth of science and pharma in China is largely driven by scientists who went back China after studying overseas.
In the CEO Forum on Innovative Drug R&D in China, 15 CEOs from startup, CRO, domestic, and multi-national companies discussed how globalization and recent policy reform had brought Chinese pharmaceutical companies bountiful opportunities and challenges. Dr. Dan Zhang, CEO of Fountain Medical Development Ltd, pointed out that China is the second largest and fast-growing market and its large population facilitates exploring and testing new drugs. Dr. Mingjiu Chen, President and CEO of BioSynergics Inc. stated that China had made incredible scientific progress and drug discovery advancement, and the key to the global success is to position and market domestic pharmaceutical companies appropriately. All CEOs emphasized the importance of national and international collaboration to drive innovative drug development in China.
CEO Forum: Innovative Drug R&D in China
Good examples of the fast growth of Chinese pharmaceutical industry and expansion of American pharma to China are Kelun, Hengrui, and Amgen. Dr. Jingyi Wang, the President of Kelun Pharmaceutical Research Institute, shared drug discovery and development progress in Kelun. Kelun is rapidly expanding its R&D and markets in both US and China and is actively seeking talents to join the company. Dr. Weikang Tao, CEO of R&D Centers, Vice President, Jiangsu Hengrui Medicine Co. shared Hengrui’s perspectives in innovative drug R&D. Hengrui aims to transform into a global player of innovative drugs with a current focus on cancer immunotherapy. Hengrui’s representative products include PD-1 antibody (SHR-1210), c-Met-ADC (SHR-A1403), and IL-15 mimicking agents. Dr. Ming-Qiang Zhang, Vice President of R&D, Head of Amgen Asia R&D Center, shared goals and strategies of Amgen and its close collaboration with China. Amgen aims not only to bring breakthrough medicines to China but also to get China involved in the global collaboration of drug development.
Featured Presentaion by Jingyi Wang, President of Kelun Pharmaceutical Research Institute
A Bridge Connecting Philadelphia and China
In the US-China Public Private Partnership Session, Mrs. Lauren Swartz, Director of International Business Investment of Philadelphia, shared her recent trips and efforts to introduce Philadelphia to China. Swartz mentioned that building this connection is not only to attract investments but also to bridge the collaboration of biotech research and commercialization between Philadelphia and China. Dr. John Xu, Senior Vice President of AbPro, pointed out that Philadelphia needs more incentives for start-ups and venture capitals, which provide the oxygen for the biotech–research ecosystem.
VIP Session by Miss Lauren Swartz, Senior Director, Deptartment of Commerce, City of Philadelphia
Scientific Progress and Breakthroughs in Medicine
Scientists from both academia and industry shared scientific advances and breakthroughs in medicine. Dr. Gary Wu, Ferdinand G. Weisbrod Professor at the University of Pennsylvania School of Medicine, discussed the potential of engineering the gut environment to treat inflammatory bowel disease. Dr. Li Mao, Vice President and Head of the Johnson & Johnson China Lung Cancer Center, highlighted the significant unmet medical needs to treat lung cancer. He discussed that innovative sensors and detection technologies might facilitate interventions for early-stage lung cancer, and multidisciplinary solutions may address treatment challenges at advanced stages. In a featured presentation, Joseph Tarnowski, Senior Vice President, GlaxoSmithKline (GSK), presented GSK’s breakthrough innovative medicine through cell and gene therapy: Strimvelis for Severe Combined Immuno-Deficiency (SCID), known as the ‘bubble boy disease,’ with patients extremely vulnerable to infectious diseases. The treatment takes only one infusion of the gene-corrected cells, in contrast to other options, such as life-long enzyme replacements once a month. However, Strimvelis is among the most expensive therapies: the cost is about $665,000.
Clinical Research and Regulatory Strategies
International and National Guidelines
Another hot topic was the regulatory process of drug development. Dr. William (Bill) Wang, Executive Director, Clinical Safety Statistics, Biostatistics and Research Decision Sciences, Merck Research Laboratories presented the history of International Council for Harmonization (ICH) and how it could develop towards the goal of “one drug, one submission, global approval.” Bill pointed out that CFDA’s recent joining of ICH is a milestone and described how opportunities and challenges would come along. Dr. Kim Gilchrist, Senior Director, Value Evidence & Outcomes, GSK, introduced the evolving healthcare systems and drug access. She mentioned the guideline and pricing strategy in China, stating that Pharmacoeconomic guidelines published in 2011 provide the basis for drug pricing and reimbursement policy making in China.
Paul Savidge, Senior Regulatory Counsel, Spark Therapeutics, Inc. discussed how to build access consideration into drug development and emphasized the importance of communicating the value of investigational products throughout the development process.
Regulatory Strategies for Generics, Biosimilars, and Orphan Drugs
Thomas Parker, Partner, and Stephen Yang, Senior Associate, from Alston & Bird LLP discussed opportunities for obtaining generic exclusivity. Stephen provided some patent certification strategies for generics. Thomas highlighted the importance of generic exclusivity and its strategies. In the highly competitive landscape of pharma, one-day exclusivity could have tremendous economic value.
Bioavailability and bioequivalence (BA/BE) are critical assessments during the development of generics. Bangqian Xu, Chief Operating Officer, Oryza Pharmaceuticals Inc. gave an overview on bioavailability and bioequivalence. Daniel Du, Vice President of Clinical Services at Frontage Clinical Services, Inc., introduced the application of bioequivalence study in the pharmaceutical industry. Jason Luo, Patent Attorney from Duane Morris LLP, discussed Abbreviated New Drug Application (ANDA) filing for generics, the Hatch-Waxman Act, and post grant patent challenges including inter parte reviews. Jason provided an overview on how generic drug companies can challenge patents owned by brand name pharmaceutical companies.
Compared to generics, the development of biosimilars is more complicated and requires large clinical trials in patients. Patrick Liu, Vice President of Biologics R&D and Head of Global Bioassays and Technology of Teva Pharmaceuticals, discussed approaches and challenges in the process of biosimilar assessment, as well as opportunities for biosimilar development. Xin Tao, Senior Associate from Hogan Lovells US LLP. introduced legal framework and license application for biosimilars, and described the complexity of the biosimilar patent exchange process (“patent dance”). Audrey Jia, Senior Consultant from DataRevive LLC., elucidated the development of biosimilars in the US from regulatory and quality perspectives.
Due to huge generic competition, the development of orphan drugs is trending as it may provide recovery and stability for pharma within the market. Jim Wang, Head of Regulatory Affairs Strategy, Spark Therapeutics, Inc. introduced the challenges and strategies for orphan drug development and its regulatory process in the US and EU.
Huabin Sun, Medical Safety Officer/Director, Global Medical Safety, Janssen R&D illustrated medical safety issues in clinical trials and regulatory process. Sun also discussed strategies for a quick approval and the importance of the pharmacovigilance system.
Contract Research Organization (CRO)
Dr. Henry Lu, Vice President of WuXi AppTec, stressed that academia, pharmaceutical companies, and CRO companies should work together to build a thriving ecosystem. Dr. Karen Chu, Vice President of Parexel International, pointed out that China's strong market and drug regulatory reform will promote the development of Chinese CRO companies.
Dr. Simon Li, Chief Medical Officer, Vice President of CSPC Pharma, shared his professional experience working in a small Chinese company, especially on outsourcing and internal management. Simon elaborated on how to choose and collaborate with CRO from both technical and financial perspectives.
Budding from Seed
The job fair attracted more than 20 international and Chinese pharmaceutical companies, including Amgen, Merck, Teva, BGI, Bristol-Myers Squibb (BMS), and Klus Pharma. Opening positions include scientists, senior directors, and vice president of business development, in multiple locations across the US and China. The recruiters from BMS said that they value the opportunity at SAPA-GP Annual Conference because they would like to be recognized as part of the pharma network. Julianna, a conference attendee, commented that she found great opportunities and submitted several resumes.
Crowd in Job fair
Dr. Dennis Gross, CEO & Treasurer of Pennsylvania Drug Discovery Institute, gave a talk on biotechnology entrepreneurship, with discussions on starting a biotech company, protecting the intellectual property, and making deals. Gross emphasized the importance of getting legal advice; “Don’t rely on Mr. Google,” commented Dennis. Dennis also shared tips for business pitch and elevator speech: state the opportunity, the uniqueness of the solution, why your team, and why now.
Executive Development Program: A Pathway to Leadership Excellence
At the 15th anniversary of the SAPA-GP, Mr. Michael Malefakis, Associate Vice-Dean, and Ms. Gaëlle Beltran-Grémaud, Senior Director, at Aresty Institute of Executive Education, Wharton School, University of Pennsylvania, introduced executive development programs. Wharton offers executives and organizations three different types of programs that enhance leadership skills and advance business acumen in key areas such as finance, marketing, and strategy. Ms. Beltran-Grémaud provided customized examples involving strategic leadership and functional programs. Through a cooperation between the Wharton School and pharmaceutical companies, the programs focus on enhancing leadership skills rapidly. Mr. Malefakis emphasized the strong faculty and comprehensive training facilities at Wharton. He concluded that “the two countries (US and China) working together are going to create the global economy of the 21st Century. We are honored to be here with SAPA-GP. The more connectivity we have, the better it will be not only for our professions but also for the globe.”
Emotional intelligence and career advancement
During this SAPA-GP and Ascend co-organized session, three speakers were invited to share their experience in career development and self-positioning plan. Jen Groover, a human potential and business expert, discussed how emotional intelligence (EI) promotes innovation and collaboration throughout the career path. Jen believes EI is an essential ingredient for success. Sue Crimmin, Vice President, GSK, recommends analyzing the self-behavior and practicing different leadership styles to become effective leaders. Carolyn Buser-Doepner, Vice President of GSK, added, “Plan, prepare, be persistent and flexible.” She encouraged the audience to explore challenging goals and demonstrate agility. “Meanwhile, keep learning, and share learning.”
Workshop Presentation by Miss Jen Groover, Human Potential & Bussiness Expert
Big Data and Artificial Intelligence (AI)
Big data and AI in drug discovery and healthcare
Three experts discussed the role of big data and new data analytics technologies in drug discovery, and the breakthroughs, challenges and opportunities of AI in healthcare. Big data and AI have become the emerging focus of pharmaceutical and healthcare industries. However, both industries face several challenges in integrating big data and AI. The first challenge is to integrate and interpret large and complex data sets to provide meaningful insights into drug discovery and disease risk prediction. According to Sean Zhou, Senior Director, Head of Computer Aided Detection and Diagnosis, Siemens Healthineers, another challenge is the reliability of AI and deep learning to perform automated tasks, such as medical image analysis. The third challenge is the informatics infrastructure built for data engineering and AI. “Are we building a highway only for flocks of sheep to pass?” Commented by Gunaretnam (Guna) Rajagopal, Global Head of Computational Sciences within Discovery Sciences, Janssen R&D. Gang (Gilbert) Feng, Executive Director of Shanghai Jiaotong Unversity (SJTU)-Yale Joint Center for Biostatistics also shared the big data platforms his team built for SJTU and Children’s Hospital of Shanghai. In addition to functioning as an image repository for research and teaching, these platforms can also perform genomic analysis.
Deals and Investment
Pharma/healthcare global deal dynamics
Patrick Deng, Finance Director at Johnson & Johnson, and Michael Tang, Tax Associate at Ernst & Young (EY) co-chaired a VIP session on “Pharma/Healthcare Global Deal Dynamics Forum,” with the focus on global merger and acquisition (M&A) in pharma/healthcare industry, especially by Chinese companies. The speakers included Jie Liu, Managing Director at Torreya Partners, Liang Xu, Partner at Hogan Lovells International, Yudan Zhang, Senior Manager at EY, and Yong Chen, Partner at Liu, Zheng, Chen & Hoffman LLP. There are growing cross-border M&A activities for Chinese companies in recent years, with 123 deals since 2011. Most M&A focused on oncology and infectious diseases. However, several obstacles have led to unsuccessful deals and will continue to pose risks to future transactions, such as foreign exchange control from the Chinese government, lack of acquisition experience, cultural and language barrier, and legal challenges.
SAPA-Hopkins venture forum
The SAPA-Hopkins Venture Forum, co-organized by SAPA-GP and Hopkins Club from Baltimore, has brought together pharma and biotech leaders, emerging fast-growing companies, technology innovators, and investment community to discuss biotech innovation and assets. DaVinci HealthX Inc is currently developing a smartphone application to track healthcare information. This company expects to collaborate with hospitals to create a system for online paperwork, which will reduce patients’ wait time in the hospital and improve clinical operations. Other interesting innovations include patent GM-GPS like DNA testing system, new oncolytic viral therapy for cancer, and Carboxyamidotriazole Orotate for the treatment of Glioma.
Plan for Retirement
Six key retirement strategies
Harry Keller, Founder/CEO of Financial Independence Planning, LLC., explained the difference between investment and financial planning. He listed 6 key retirement strategies: 1) understand how allocation and diversification affects investments, 2) understand corporate benefit plans and maximize lump sum and annuity options, 3) maximize 401k and IRA contributions, rollovers and distributions, 4) optimize social security benefits, 5) address life expectancy and market volatility, and 6) minimize your taxes on your retirement distributions.
Connect, Continue, and Promise
In addition to presenting breakthroughs in biotech and sharing opportunities, SAPA is also proud to continue to build connections for and with other organizations. At this annual conference, Dengxi Wang, Mayor of Xinxiang Municipal People’s Government signed a strategic cooperation agreement with Bin Shi, President of SAPA-GP.
This meeting marked the leadership transition between Bin Shi and the next President of SAPA-GP, Zhenhua Wu. Han Dai also joined the board as President-elect. Zhenhua and Han will work together to create more opportunities and build more connections starting from SAPA members, to China, the US, and the world.
Finally, SAPA-GP would like to acknowledge all volunteers for their contribution to the annual conference. SAPA-GP is proud to bring together professionals at different stages of their careers and aims to build strong connections for all. SAPA-GP hopes the volunteering experience has connected us all.
Editor: Yue Liu and Pengbo Guo
Reporters: Huixi (Violet) Zhang, Hangfei Fu, Mingkun Wang, Chun Shao, Chen Qu, Kexin Shi, Mingkun Wang, Malana Li, Yayi Feng, Dan He, Xin Shu, Jia Nong, Minyi Nie, Zhuxuan Xu, Haoyu Wang, Di Wu, Kehua Yin, Hong Zhang, Xianhua Li
Photographers: Menglan Jiang, Jiahao Li, Jianting Shi, Aimin Tang, Hao Wu, Jennifer Yuan, Jingyi Zhang, Xinjun Zhang, Songmao Zheng, Shu Zhu
SAPA-GP would like to thank all editors, reporters, photographers, and Han Dai, Xue Liang, Hui Wang for their feedback on this article.