Regulatory Reform to

Support Sustainable Growth

SAPA-DC 2016

Founding Conference

September 17, 2016 (Saturday)

8:00 am – 5:00 pm

Hogan Lovells Law Firm

Columbia Square

555 Thirteenth Street, NW

Washington, D.C. 20004

Sino-American Pharmaceutical

Professionals Association

Scan to REGISTER

Conference Time and Location

September 17, 2016 (Saturday) 8:00 am – 5:00 pm

Hogan Lovells Law Firm, 13th Floor

Columbia Square, 555 Thirteenth Street, NW, Washington DC, 20004

Banquet starts at 6:00 pm

Recommended transportation: Metro RD, OR, SV and BL line to Metro Center Station and

take exit at 12th and F Streets

Parking: limited street parking and nearby garages

Our distinguished speakers include senior staff from FDA and CFDA, law firm

partners with expertise in pharmaceutical product regulation, licensing and M&A,

and senior managers from pharmaceutical companies in the US and China!

Conference Highlights

Pharmaceutical Innovation: Challenges and Opportunities FDA/CFDA Regulatory Enforcement Trends

Licensing and M&A in the US Precision Medicine, Cell therapy and Diagnostics

Introduction

Nowadays the US and China are the most important pharmaceutical markets for drug development and manufacturing. During the year of 2015, the U.S. Food and Drug Administration (FDA) has approved 45 novel drugs, hitting a 19-year record high, which is extremely encouraging for the pharmaceutical industry worldwide. In the meantime, the China Food and Drug Administration (CFDA) has started a reform aiming to solve backlogs of review and approval process for drugs and medical devices. This extensive reform has brought many critical challenges for every multinational pharmaceutical company. How can you and your company benefit most from the US and China markets when facing the new changes and challenges? Do you have concerns about selling your products in the US market? What are the new opportunities for generic drugs in the US? What are the registration expectations from FDA? Do you plan to acquire US biopharma assets? No matter who you are -- entrepreneurs, pharmaceutical industry professionals, or academic researchers -- as long as you are interested in the pharmaceutical industry, you can find all the answers at our SAPA-DC Founding Conference & 1st Annual Meeting on September 17th, 2016 in DC -- the center of the US legal and regulatory administration. We will offer you the latest legal and regulatory information, provide face-to-face opportunities with directors from both FDA and CFDA, and bring the top regulatory professionals to help you tap into these new situations. You will learn and network with keynote speakers from FDA and famed law firms with rich industry

experience. We promise you -- all conference attendees, speakers and exhibitors, this event will be a highly

valuable, stimulating, inspiring and enjoyable experience.

2016 SAPA-DC

Founding Conference

Regulatory Reform to Support Sustainable Growth

Conference Topics

The Future of Pharmaceutical Innovation: New Challenges

and Opportunities Sustainability of the current pharmaceutical R&D model and ideas of “smart regulation”: to foster

regulatory regimes favoring the emergent novel technologies and therapies that may potentially transform the standards in patient healthcare and pharmaceutical innovation

Strategies to overcome challenges in the current pharmaceutical innovation model in order to ensure that continued medical benefits are delivered to patients

FDA/CFDA Enforcement Trends and Strategy for Compliance FDA’s focus on data integrity and supply chain oversight in the global pharmaceutical industry

Understanding FDA’s inspectional, compliance, and enforcement operations regarding pharmaceuticals and biotechnology, and who the key players are

FDA medical device inspections – what FDA looks for and recent trends in FDA enforcement

Drug Supply Chain Security under the Drug Supply Chain Security Act

Things You Want to Know Before Entering the U.S. Market Marketing of Dietary Supplements and Medical Foods in the U.S. : A Regulatory Primer

Cell, Tissue, and Gene Therapies: Regulatory pathways and considerations for selling regenerative medicine products in the U.S.

Precision Medicine: Targeted therapeutics and companion diagnostics

Asset Acquisition and Licensing in the U.S. Pharmaceutical

and Device Industry So you acquired a 510(k) or PMA – Now what you can expect…

Asset Acquisition and Licensing in the U.S. by Oversea Companies: a Corporate Lawyer’s Perspective

Conference Agenda

8:00 – 9:00 am Registration (On-site Registration Not Accepted)

Breakfast and Networking

9:00 – 9:05 am Opening Remarks

Meng Fu, MD, MBA, President of SAPA-DC; Senior Clinical Research Manager at MedImmune

9:05 – 9:15 am Announcing the Founding of SAPA-DC

Weiguo Dai, PhD, President of SAPA, Scientific Director/Janssen Fellow in Drug Product Development at J&J

9:15 – 9:20 am Congratulatory Remarks for the Founding of SAPA-DC

Xin Li, Counselor, Embassy of the People's Republic of China in the United States of America

9:20 – 9:35 am The State of the Biohealth Industry in Maryland

Brad E. Fackler, MBA, Senior Director, Office of BioHealth and Life Science; State of Maryland Department of Commerce

SESSION I: China Updates: CFDA Regulatory Reforms and Enforcement Trends

Session moderator: Qiang (Patrick) Hu, MD, Senior Safety Physician, AstraZeneca

9:35 – 9:50 am The Status of CFDA Regulatory Reform and Collaboration with FDA

Xinyu Weng, PhD, First Secretary of the Embassy of the People’s Republic of China to the United States of America; Former Division Director in the Department of Drug Safety and Supervision, China Food and Drug Administration (CFDA)

9:50 – 10:05 am The Status of Generic Drug Therapeutic Equivalence Evaluation in China as Well as China Strategy Proposal for Generic Companies

Zengjiang Cheng, PhD, President of PharmaSea Biotechnology (科贝源（北京）生物医药

科技有限公司); Founder of Tongxieyi (同写意) Forum, Director of Tongxieyi New Drug Elite Club; Editor of The Pharmaceutical Index

10:05 – 10:20 am Through Artemisinin We Connected

Xia Jiang, Executive Vice President at Kunming Pharmaceutical Corporation (昆药集团)

10:20 – 10:35 am Coffee Break

SESSION II: Bring Novel Products to the Market

Session moderator: Yujian Zhang, PhD, Group Lead, Otsuka Pharmaceutical

10:35 – 10:50 am Cell, Tissue, Gene Therapies and Precision Medicines: Regulatory Pathways in the U.S.

Michael N. Druckman, JD, Partner, Hogan Lovells US LLP

10:50 – 11:05 am Marketing of Traditional Chinese Medicine in the U.S.: Botanical Drugs, Dietary Supplements, and Beyond

Xin Tao, JD, Associate, Hogan Lovells US LLP

11:05 – 11:20 am Data and Analysis Considerations in the Submissions to FDA for Regulatory Approvals

Lihan Yan, PhD, Team Leader, Office of Biostatistics and Epidemiology, Center of Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)

11:20 – 11:35 am Regulatory Challenges and Opportunities for Next Generation Sequencing-Based Diagnostics

Yunfu Hu, PhD, Deputy Division Director, Division of Molecular Genetics and Pathology, U.S. Food and Drug Administration (FDA)

11:35 – 11:50 am Abpro – Innovative antibody drug discovery platform

Jianguo (James) Yang, PhD, CEO (Abpro-China) and VP (Abpro-US) at Abpro Biotech/Biopharma

11:50 – 12:05 am Regulatory Consideration for Cell Based Therapy

Xin Du, PhD, Executive Director of Regulatory Affairs at Advaxis Inc

12:05 – 1:00 pm Lunch

SESSION III: Generic Drugs, FDA Inspections and Enforcement Actions ― Trends and Strategy for Compliance

Session moderator: Peng Sun, PhD, JD, Associate, Foley & Lardner LLP

1:00 – 1:15 pm Generic Drugs: A Primer and Prospective from FDA

Markham Luke, MD, PhD, Director (Acting), Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

1:15 – 1:30 pm Generic Drugs ANDA Refuse-To-Receive (RTR) Letters – Addressing The Issues

Nathan A. Beaver, JD, Partner, Foley & Lardner LLP

1:30 – 1:45 pm An Overview of FDA’s Abbreviated New Drug Application (ANDA) Requirements

Frederick A. Stearns, JD, Partner, Keller and Heckman LLP

1:45 – 2:00 pm FDA’s Focus on Data Integrity and Supply Chain Oversight in the Global Pharmaceutical Industry

James R. “Jim” Johnson, JD, Partner, Hogan Lovells US LLP

2:00 – 2:15 pm FDA Medical Device Inspections – What FDA Looks for and Recent Trends in FDA Enforcement

Danielle C. Humphrey, JD, Senior Associate, Hogan Lovells US LLP

2:15 – 2:30 pm FDA Inspection Issues for Clinical Investigations – Protecting Study Subjects

David L. Rosen, JD, Partner, Foley & Lardner LLP

SESSION IV: Asset Acquisition in the U.S. Pharmaceutical and Device Industry by Chinese Companies

Session moderator: Changhui Li, MBA, Business Development Manager, Poochon Scientific LLC

2:30 – 2:45 pm Cross-border Mergers and Acquisitions 101

Liang Xu, LLM, LLB , Partner, Hogan Lovells International LLP

2:45 – 3:00 pm Chinese Investment in the United States and CFIUS Review

Brian Curran, JD, Partner, Hogan Lovells US LLP

3:00 – 3:15 pm Coffee Break

Breakout Session Discussion

Group A: Novel Drugs and Medical Devices

3:15 – 4:45 pm Moderators: Jason Ma, MD, LLM, LLB, Principal, Law Office of Jason Ma PLLC Peng Sun, PhD, JD, Associate, Foley & Lardner LLP

Group B: Asset Acquisition and Licensing

3:15 – 4:45 pm Moderator: Xin Tao, JD, Associate, Hogan Lovells US LLP

Partners and Sponsors

Speaker Bios Listed in Alphabetical Order

Nathan A. Beaver, J.D. Partner, Foley & Lardner LLP

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval process and patent and exclusivity issues related to the Hatch-Waxman Act. Mr. Beaver is a member of the firm’s Government & Public Policy and FDA Practices, and the Food & Beverage Industry and Life Sciences Industry Teams. Mr. Beaver also has significant experience in FDA and Hatch-Waxman cases involving drug approvals, withdrawals and other types of litigation involving FDA regulated products. Mr. Beaver was named a 2012 BTI Client Service All-Star, one of only 272 attorneys so honored throughout the United States, as a result of unprompted positive feedback from BTI’s interviews with nearly 300 corporate counsel from Fortune 1000 companies. He was also selected for inclusion in The Best Lawyers in America© (2015 and 2016) for his work in food and beverage law. In 2015, Mr. Beaver was recognized by The Legal 500 for his work in health care – life sciences.

Zengjiang Cheng, Ph.D. President of PharmaSea Biotechnology (科贝源（北京）生物医药科技有限公司)

Founder of Tongxieyi (同写意) Forum, Director of Tongxieyi New Drug Elite Club Editor of The Pharmaceutical Index

Dr. Cheng founded the Tongxieyi Forum in 2004, the platform designed to host the exchange of ideas among top minds in the global pharmaceutical industry. For over a decade, Dr. Cheng and his friends in Tongxieyi have devoted extensive efforts to bringing in high-level discussions on topics including new drug R&D and healthcare reform; together they have successfully organized over 50 forums and seminars nationwide. With a goal of introducing creative thinking into the medical/pharmaceutical industry in China and a focus on technology innovation, regulation and healthcare, Tongxieyi has now become one of the most influential medical/pharmaceutical forums in China. As an experienced pharmaceutical professional, he has worked in multiple biopharma companies including JOINN Laboratories (昭衍新药) and Sihuan Pharmaceutical (四环医药) as

R&D directors. In 2007, Dr. Cheng founded PharmaSea Biotechnology in Beijing with a focus on the research and development of generics and innovative drugs. So far, the company has successfully completed filing of multiple generic and innovative drug products to CFDA. Dr. Cheng earned his PhD degree from The Academy of Military Medical Sciences in China in 1997.

Brian P. Curran, J.D. Partner, Hogan Lovells US LLP

Brian helps clients navigate the export control implications of cyber attacks and cloud computing and assists clients with investment survey filings mandated by the Commerce Department's Bureau of Economic Analysis (BEA), including the BE-10, BE-13, and BE-180 surveys. He can also assist clients with internal investigations, M&A due diligence, and licensing matters related to the EAR, ITAR, and U.S. economic sanctions. His CFIUS clients have included companies in the aerospace and defense, telecommunications, energy, biotech, information technology, 3D printing, transportation, physical security, and real estate industries. Brian also represents a diverse group of foreign and U.S. clients on export controls and economic sanctions matters before the Commerce Department's Bureau of Industry and Security (BIS), the State Department's Directorate of Defense Trade Controls (DDTC), and the Treasury Department's Office of Foreign Assets Control (OFAC). These clients are involved in the private equity, defense, satellite, pharmaceutical, information technology, aircraft, oil and gas, automotive, consulting, and education sectors.

Michael N. Druckman, J.D. Partner, Hogan Lovells US LLP

Mike Druckman leverages his prior experience at the FDA — and what he has learned since then while extricating companies from regulatory problems — to anticipate and prevent life science clients from getting into trouble in the first place. Mike understands the business challenges that companies face in a highly regulated environment. He actively works with other Hogan Lovells lawyers experienced with government reimbursement, anti-kickback limits, product liability, and a full range of other regulatory areas to craft approaches that will maximize clients' opportunities and minimize their risks. Mike formed and now chairs the firm's Stem Cell and Regenerative Medicine Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular products to help people with serious health problems.

Xin Du, Ph.D. Executive Director of Regulatory Affairs at Advaxis Inc

Dr. Xin Du is a regulatory professional with unique combination of FDA and industry regulatory experience as well as international regulation knowledge and experience. He obtained his PhD degree from the University of Florida and completed his post-doctoral training at the National Institute of Health (NIH). He worked for US FDA, and pharmaceutical companies of Aventis-Pasteur, Wyeth, Novartis, BMS NPS and Actinium Pharma. Currently, he is the Executive Director of Regulatory Affairs at Advaxis Inc. Prior to coming to USA, he worked at Southwest University in Chongqing and the Agricultural Ministry of China in Beijing.

Brad E. Fackler, MBA Senior Director, Office of BioHealth and Life Science at State of Maryland Department of Commerce

Brad Fackler has over 30 years of commercial and corporate experience in the pharmaceutical and biotech industries. He is currently the Sr. Director BioHealth and Life Sciences for the State of Maryland within the Department of Commerce. In that role, he leads the team responsible for increasing the biotech presence within the state. Formerly he served as CEO for Cellona Therapeutics, a company developing a treatment for metastatic melanoma. In addition, he operated Kinect Point LLC, a biotech consulting agency where he coached NIH scientists transitioning from academia to industry positions. Prior to that, he served as Executive Vice President, Commercial Operations at Sucampo Pharmaceuticals, Inc. In that role he was responsible for creating and operating the marketing and sales functions for the company. In addition, he shared responsibility for completing an IPO in 2007 and building the operations to support the newly public company. He has also held executive management positions in 25 years at Novartis Pharmaceuticals. Key among these roles, he built and managed a series of specialty organizations, served in an international marketing capacity and had responsibility for the overall integration of operations for the Sandoz/CIBA-Geigy merger. Mr. Fackler holds a BA degree in Biology from Otterbein University and an MBA degree in Management from the New York University, Leonard Stern School of Business.

Yunfu Hu, Ph.D. Deputy Division Director, Division of Molecular Genetics and Pathology, U.S. Food and Drug Administration (FDA)

Dr. Hu is currently the Deputy Director of the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. He completed his undergraduate studies in China, and received his M.S. and Ph.D. degrees from the Ohio State University. After 5 years of studies on the cellular and molecular mechanisms of breast cancer development at Fox Chase Cancer Center initially as a postdoctoral fellow, then research associate and eventually a Staff Fellow for the last 2 years there, he joined Becton Dickson as a Project Scientist leading the development of a molecular diagnostic test for melanoma. He led biomarker discovery and test development at GSK as an Investigator and then Group Manager for more than 6 years before joining Metabolon as the Director of Diagnostics Development to oversee the diagnostics research and development programs. He joined FDA as a Scientific Reviewer in 2009 and was promoted to Associate Director in 2011. He became the Chief of the Molecular Pathology and Cytology Branch of the Division of Molecular Genetics and Pathology in 2012, and was promoted to his current position last year providing oversight of regulatory reviews of genetic tests, oncology companion diagnostics, and anatomical / molecular pathology and cytology devices.

Danielle C. Humphrey Senior Associate, Hogan Lovells US LLP

Danielle C. Humphrey understands the pressures businesses face in the highly regulated life science industry. A former Assistant General Counsel of Wal-Mart Stores, Inc., she uses her experience in the industry and firm grasp of medical device law and regulation to help yield innovative and practical solutions for her clients.

Danielle focuses on matters related to advertising and promotion, regulatory compliance, and premarket clearance and approval of new medical devices and combination products. She advises clients on the U.S. Food and Drug Administration's (FDA) regulation of medical devices and combination products. She analyses complex legal challenges and regulatory strategy for innovative products, prepares regulatory submissions, reviews print and web-based promotional and educational materials, reviews company-wide regulatory audits, and reviews and drafts standard operating procedures. Danielle also reviews and negotiates contracts. She assists in the defense of criminal investigations by the U.S. Department of Justice, responding to FDA Warning Letters and Form 483s. She conducts regulatory due diligence and assists in negotiating corporate mergers and acquisitions and initial public offerings. While in law school, Danielle was a member of the Duke Law Mock Trial Board and editor for Law and Contemporary Problems, an interdisciplinary journal published by Duke Law School that focuses on the intersection of science, social sciences, humanities, and law.

Xia Jiang Executive Vice President, Kunming Pharmaceutical Corporation

Ms. Xia Jiang is the current executive vice president of Kunming Pharmaceutical Group, the director of KPC Enterprise University, and a Level I (highest level) Certified Human Resource Manager in China. Xia has been focusing on HR management in pharmaceutical industry for 20 years including 10 years of HR management experience in foreign invested enterprises and 10 years of listed company HR management practice. Ms. Jiang specializes in human resource planning, HR system construction, organizational development and talent development projects, and strategic planning of HR solutions in corporate mergers and acquisitions in which she has accomplished a series of successful cases.

James R. “Jim” Johnson, J.D. Partner, Hogan Lovells US LLP

Positioned at the forefront of FDA compliance and regulatory issues critical to the business of life science companies, Jim Johnson excels at knowing what's ahead. He works with life science clients on U.S. Food and Drug Administration (FDA) compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, data integrity responsibilities, import and export issues, and pharmacovigilance obligations. He helps clients around the world identify compliance risks early, prevent problems from happening, efficiently resolve issues with minimal corporate pain, and improve agency relationships. Jim knows the FDA well. Prior to joining Hogan Lovells, he served as Associate Chief Counsel for Enforcement in the FDA's Office of the Chief Counsel. He handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA's Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research's (CDER) Office of Compliance.

Markham C. Luke, M.D., Ph.D. Director (Acting), Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

Markham Luke, MD PhD currently serves as the acting director of the ORS Division of

Therapeutic Performance, OGD. Markham is a dermatologist and regulatory scientist, with over 18 years of experience at FDA. He most recently served as the Deputy Director and Chief Medical Officer for the Office of Device Evaluation (ODE) at CDRH. His main work focused on managing the quality of clinical reviews for medical devices, the CDRH advisory committee process, and efficient interfacing of the various CDRH Offices with ODE. Specific tasks that he championed included reclassification of indoor tanning, rare disease policy, clinical study design and endpoints development, and new reviewer training initiatives. In addition to serving 8 years at CDRH, Markham has served as a Lead Medical Officer for Dermatology at CDER/OND until 2008 and as the Acting Director for Cosmetics in CFSAN in 2013. Markham was born and raised in New York City, went to Stuyvesant High School and New York University. He earned his MD degree and PhD in Pharmacology from Johns Hopkins University School of Medicine in 1994. His dermatology residency was at Washington University in St. Louis and a fellowship at NIH, NCI. Markham continues to see patients and teach residents and medical students at NIH, Walter Reed Medical Center and the Uniformed Services University for the Health Sciences in Bethesda.

Jason Ma, M.D., LL.M., LL.B. Principal, Law Office of Jason Ma, PLLC

Jason Ma’s practice focuses on complex food and drug regulatory compliance matters, as well as prosecution, licensing, and enforcement of intellectual property rights and dispute resolution. Before starting his legal career in 1992, Jason Ma practiced as a medical doctor for four years in a city hospital. Jason Ma was formerly a partner of a law firm in Guangzhou and worked as a senior attorney of leading international law firms in Hong Kong, San Francisco and Washington, D.C. before he started his own law office in 2015.

Steven N. Robinson Partner, Hogan Lovells US LLP

During Steve's career, he has thrived in the face of new challenges, whether in his role representing the government-in-exile of Kuwait following the invasion of Iraq, or working with the Russian state enterprise on the launch of the International Space Station, or developing a market-leading education practice in China. Steve's comprehensive international experience advising clients on their most important projects around the world enables him to serve as a trusted advisor, assisting clients in achieving their objectives. From considering structures and strategies for entry into China's markets to working with clients on expanding their activity or achieving an exit, Steve's strong experience across a range of disciplines provides an experienced sounding board for clients. Steve's core activities are advising corporate clients on capital raising, M&A and ongoing operational issues. He applies his considerable deal-making skills to work with clients in the technology, education and real estate sectors and he has developed a reputation for successfully advising clients in all these sectors. Steve is recognized as the leading education lawyer in China and has worked with more than 70 education clients on their projects in China. He writes and speaks extensively about the Chinese legal environment and its impact on foreign participants.

David L. Rosen, J.D. Partner, Foley & Lardner LLP

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams. Mr. Rosen was formerly a partner with two other law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process, combination products, jurisdictional issues and related compliance activities. Mr. Rosen is a member of the University of Connecticut School of Pharmacy Advisory Board.

Frederick A. Stearns, J.D. Partner, Keller and Heckman LLP

Frederick Stearns' practice involves a wide range of issues affecting manufacturing of prescription and over-the-counter drugs, medical devices, dietary supplements, and cosmetics. Mr. Stearns helps product manufacturers evaluate the need for marketing approval from FDA, to pursue appropriate clearance when necessary, and address regulatory compliance issues with marketed products (including OTC drug monographs, product labeling and promotion, and current good manufacturing practices). He also works with clients to respond to FDA enforcement activities, navigate the interrelationship of the patent laws and the FDA drug approval process, communicate with Agency officials, and develop innovative strategies to deal with evolving FDA regulatory requirements. In addition, Mr. Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions. Mr. Stearns is a frequent speaker at conferences on the legal issues involving the regulation of drugs, medical devices, and dietary supplements.

Peng Sun, J.D., Ph.D. Associate, Foley & Lardner LLP

Peng Sun is an associate and intellectual property lawyer with Foley & Lardner LLP. He focuses his practice on patent prosecution and client counseling for biotechnology, chemistry, and biochemistry-related innovation. During his graduate and postdoctoral work, Dr. Sun gained considerable experience in cancer therapies, stem cells, pharmaceuticals, and medical devices. He is a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice. Prior to joining Foley, Dr. Sun was an associate attorney with a law firm in the D.C. metropolitan area, where he counseled domestic and international clients on patent, trademark, and comprehensive FDA regulatory matters regarding marketing or distributing FDA regulated products in the U.S. He also was a postdoctoral fellow at Johns Hopkins University School of Medicine. During law school, Dr. Sun was a summer associate with Foley, as well as a judicial intern to the Honorable Susan Braden and the Honorable Dania Zane, both of the U.S. Court of Federal Claims. His experience also includes working as a patent agent at a reputable IP law firm.

Xin Tao, J.D. Associate, Hogan Lovells US LLP

With a working knowledge of regulatory requirements and a strong understanding of life science, Xin Tao works closely with clients in the food and drug industry to navigate the evolving federal and state regulatory environments and also communicate with agency officials and develop innovative regulatory strategies. Xin's background in life science (biochemistry and molecular genetics) assists him in his science-based food and drug law practices. Xin advises clients on food and drug law with a particular focus on food ingredients, dietary supplements, and food and pharmaceutical packaging materials. Xin has helped numerous food, dietary supplement, and pharmaceutical companies evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). He also pursues clearance or pre-market approval when necessary and responds to FDA enforcement activities. Xin has advised numerous companies on issues relating to the advertising and promoting of products including the Federal Trade Commission (FTC)'s claim substantiation standards. Xin also has vast experience with FDA and USDA due diligence investigations for companies subject to takeover or merger activity. He assists with finalizing deals and identifies regulatory deficiencies. He is increasingly expanding his knowledge of California's Proposition 65 as it pertains to his clients.

Cullen G. Taylor, J.D. Partner, Hogan Lovells US LLP

Cullen Taylor helps companies structure and negotiate their most complex commercial transactions, particularly those involving the development, acquisition, and commercialization of intellectual property and technology. Cullen takes a practical, results-oriented approach to getting deals done, drawing on his broad experience across multiple industries to anticipate and address problems before they arise. Trained as an intellectual property lawyer, Cullen understands the technical and business issues that arise as parties enter, live under, and exit long-term commercial arrangements. Cullen is skilled at structuring and drawing contracts that address these concerns while keeping the client's business goals at front and center. Given his versatility, Cullen practices across a variety of industries, including life sciences, communications, sports, information technology, and media. In the life sciences industries, Cullen handles a variety of transactions, including product acquisition, licensing, development, collaboration, manufacture, supply, and co-promotion agreements. In the cable and communications fields, Cullen advises clients in connection with network, transport, interconnection, cell tower backhaul, hosting, co-location, and other communications service agreements. Cullen regularly collaborates with his colleagues in the firm's Corporate practice to address intellectual property and technology-related issues that arise in mergers, acquisitions, and other corporate transactions.

Xinyu Weng, Ph.D. First Secretary of the Embassy of the People’s Republic of China to the United States of America Former Division Director in the Department of Drug Safety and Supervision, China Food and Drug Administration (CFDA)

As the primary point of contact for China Food and Drug Administration (CFDA) in the U.S., Dr. Weng is committed to strengthening bilateral food and drug regulatory cooperation between China and the U.S., and reaching out to the U.S. food and drug industry. Before being transferred to the Chinese Embassy in Washington DC, Dr. Weng served as a Division Director in the Department of International Cooperation, CFDA since May 2013. In this capacity, he was responsible for bilateral cooperation with foreign food and drug regulatory authorities, non-governmental organizations, as well as foreign food and drug manufacturers. Dr. Weng was essential in the negotiations of the Implementing Arrangement between CFDA and US FDA regarding the cooperative mechanism of regulatory staff in 2014. Prior to that, he served as Division Director in the Department of Drug Safety and Supervision, State Food and Drug Administration (SFDA). In that capacity, he coordinated implementation of the 2010 Edition Chinese Good Manufacturing Practices (GMP) for pharmaceutical products, and was an active participant in the International Conference of Drug Regulatory Authorities (ICDRA) organized by the World Health Organization. Dr. Weng joined State Drug Administration (SDA) in 1998, holding various positions including Deputy Division Director in the Department of Drug Registration, and the Department of Drug Safety and Supervision. He was involved in carrying out traditional medicine registration and Good Clinical Practices (GCP) inspection, and in drafting Good Agricultural Practices (GAP) for herbal medicines. Dr. Weng got his PhD from Shenyang Pharmaceutical University. He completed his MBA degree at the Birmingham University of the United Kingdom.

Liang Xu, LL.M., LL.B. Partner, Hogan Lovells International LLP

Working as a bilingual lawyer, Liang Xu has advised on many cross-border M&A transactions, both for Western corporations doing business in China, as well as Chinese enterprises (including SOEs and private companies) looking to expand and invest in global markets. His practice encompasses a variety of industries, with a focus on life science and technology sectors, including advising several acquisition and disposal transactions for global pharmaceutical companies. He has vast experience working with Chinese companies both as clients and as opponents, and is skilled in bringing the two sides of a dispute/transaction to a negotiated deal. Prior to joining Hogan Lovells in 2004, Liang was an in-house counsel with China Eastern Airlines Corporation Limited based in Shanghai. Liang initially focused his practice on joint ventures, private equity and direct foreign investment matters for multinational clients. In recent years, with more and more Chinese companies going global, he has developed skills in advising and guiding Chinese companies through the Western style deal process, which is complicated for players from China who typically have insufficient global experience. Liang Xu is qualified in China and the New York State in the U.S., and is nominated as one of the Chambers Global leaders in the field of Corporate/M&A in China.

Lihan Yan, Ph.D. Team Leader, Office of Biostatistics and Epidemiology, Center of Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA)

Dr. Lihan Yan is a team leader in the Office of Biostatistics and Epidemiology at the Center of Biologics Evaluation and Research (CBER) at FDA. She has over 20 years of experience in the statistical analyses of epidemiological and clinical trial data as well as the reviews and researches for developing new medical products in both the industrial and regulatory settings. She holds a M.S. degree in Statistics from Virginia Tech and a Ph.D. in Biostatistics from the George Washington University.

Jianguo (James) Yang, Ph.D. CEO (Abpro-China) and VP (Abpro-US) at Abpro Biotech/Biopharma

Dr. Jianguo (James) Yang has over 20 years of experience in biopharma industry (from biologics R&D to manufacturing process). Currently, Dr. Yang is CEO of Abpro-China and VP of Abpro-US. Prior to Abpro, Dr. Yang was CSO/VP of Biologics R&D at Qilu Pharmaceuticals. Before Qilu, he held scientific leadership positions in several global 500 pharmaceutical companies, including Genzyme/Sanofi, MedImmune/AstraZeneca and AbbVie. As an internationally recognized scientist, Dr. Yang achieved world record of high cell line productivity and published numerous patents and papers. He is an editor of Bioprocess International (Journal), the Executive Director of Sino-America Pharmaceutical Association-NE (2012-2014), a reviewer for several scientific journals, and is frequently an invited speaker at international conferences. Dr. Yang got his Ph.D. in cell/molecular biology from Illinois Institute of Technology, USA.

Liang Zhao, Ph.D. Director of the Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS) at Office of Generic Drugs (OGD), U.S. Food and Drug Administration (FDA)

Dr. Zhao has a wealth of scientific and management experience from consulting, industrial R&D, and FDA. Through his 12-year professional career, he has demonstrated leadership in clinical pharmacology, pharmacometrics, industrial R&D for small molecules and biologics, novel quantitative methodology development, and model based strategic decision makings in regulatory and industrial settings. Liang joined FDA as a clinical pharmacology reviewer in the Office of Clinical Pharmacology in 2009 and has been a team leader at the Division of Pharmacometrics since 2013. In the agency, Liang worked in therapeutic areas of Oncology, Pulmonary, Allergy, and Rheumatology, and on product specific biosimilar guidance development. Prior to joining FDA, Liang worked at MedImmune as an Associate Director. He was a key contributor to establishing the clinical pharmacology function. Prior to joining MedImmune, Liang started his professional career as an Associate Consultant at the Strategic Consulting Service, Pharsight and a Research Investigator at Clinical Discovery, Bristol Myers Squibb. Dr. Zhao has a diversified educational background from four universities, a PhD degree in Pharmaceutical Sciences and a master degree in Statistics from the Ohio State University, a master degree in Pharmaceutics from Shanghai Medical University, a bachelor degree in Pharmaceutics from China Pharmaceutical University, and a MBA degree for executives from University of Cambridge at UK.

About SAPA-DC

Founded in 1993, the Sino-American Pharmaceutical Professionals Association (SAPA) grew rapidly and has become one of the most active and well-recognized Chinese-heritage enduring professional organizations in the United States. SAPA is an independent, nonprofit and professional organization with over 5,000 members in USA, China, Hong Kong, Taiwan and Japan. Its headquarters is based in the tri-state area (NY-NJ-CT) with three regional chapters in New England, Greater Philadelphia and California bay area, Mid-West, Washington DC/Baltimore area, and one chapter in Zhengzhou, China. SAPA is united by a commitment to promoting pharmaceutical science and technology and its essential roles in fostering member's career development. In service to science, SAPA facilitates communication among scientists, policy makers, government officers, educators, and journalists from both the United States and China through its interdisciplinary conferences, symposia, section meetings, seminars, workshops and diverse publications. In service to association, SAPA Programs draw upon the foremost experts and the most current information about advances in drug discovery and development to inform analysis and discussion of public health issues, to promote scientific exchanges and networking opportunities. SAPA-DC resides in the Washington DC/Baltimore area which features numerous government agencies and research institutions (FDA, NIH, NIST, HHMI, USP, USDA, DOD, etc.), top-tier universities including Johns Hopkins University, University of Maryland, George Washington University, Georgetown University and over 300 pharmaceutical/biotech companies (large international corporations like AstraZeneca, GlaxoSmithKline, Novavax, etc). The Washington DC/Baltimore area is especially recognized as the center of global vaccine research and development, as well as a global talent pool where the most experienced and innovative biotech/pharmaceutical professionals are gathered. Sitting in this particularly favorable location, SAPA-DC aims to connect local pharmaceutical professionals through a variety of events such as annual conferences, scientific symposiums, career development workshops and other social networking opportunities.

Conference Co-Chairs

Meng Fu Xin Tao

Planning Committee

Renkui Bai Long Chen Ru Chen Fenghao Chen Ruby Gao Di Gao Wei Gao Patrick Hu Changhui Li Jason Ma Peng Sun Leiyun Weng Cong Xu Yujian Zhang Chen Zhao

Notes

Sino-American Pharmaceutical Professionals Association –

Washington D.C./Baltimore

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