2019 chinese biomaterials congress...

2019 Chinese Biomaterials Congress th5 China-US Joint Forum on Regulation,

Standards and Innovation of Biomaterials

Organizers: Chinese Society for Biomaterials

Society For Biomaterials (US)

August 23, 2019

Dalian • Liaoning • China

WELCOME

Welcome to the 2019 Chinese Biomaterials Congress and the 5th China-US Joint Forum on

Regulation, Standards and Innovation of Biomaterials!

This is the 5th joint Forum organized by the Chinese Society for Biomaterials (CSBM) and the

US Society for Biomaterials (SFB). Following three forums successfully hosted in the US and

one in China, it is the second time that the forum will be hosted in China.

This serial forums were initially proposed by Professor Xingdong Zhang, president of the CSBM

at a joint business meeting between the CSBM and SFB during the 9th World Biomaterials

Congress in June 2012, Chengdu, China. Professor Zhang’s idea was then echoed onsite and

strongly supported by the former presidents of the US SFB including Professors Joel

Bumgardner, Karen Burg, Arthur Coury, Jeremy Gilbert, Lynne Jones, Antonios Mikos, Nicholas

Peppas and other SFB participants in that meeting. The first four joint forums were held

successfully during the SFB and CSBM Annual Meetings in Boston (2013), Denver (2014),

Haikou (2015), and Minneapolis (2017). With the subtitle of “Scientific advances for assuring

safety and effectiveness of regulated medical products”, the goals of the forums are to promote

the international collaboration in the biomaterials field, and to create favorable opportunities for

products and companies to enter the market of partner country. The discussion topics will cover

regulatory, standards, academic and clinical perspectives, regulatory science and industrial

innovations.

This forum will be composed of presentations and panel discussion. The former will be given by

the invited speakers from regulatory agencies, leading Chinese and global companies, clinical

research institutes, and academia. The invited speakers will present their experience and

lessons learned with case studies. The latter will address the questions from the audience.

Welcome friends and colleagues from China and US as well as other countries to the Forum!



ORGANIZATION

◆

◆ EXECUTIVE CO-CHAIRS

◆ ORGANIZERS

◆ ORGANIZING COMMITTEE

DIRECTORS:

MEMBERS:

SECRETARIES:

CO-CHAIRS

Xingdong Zhang Xiaobing Fu Art Coury Andres Garcia

Yingjun Wang Len Pinchuk

Chinese Society for Biomaterials

Society For Biomaterials (US)

Kai Zhang Tim Topoleski

Hua Ai Changsheng Liu Lei Sun Deyuan Jiang

Liisa Kuhn Horst von Recum Bill Sutton Ed Margerrison

Wanlu Zhao / +86-28-85415030 Email: [email protected]

Yilei Wang / +86-28-85412757 Email: [email protected]

01

TOPICS1. Regulatory perspectives

2. Standards perspectives

3. Academic and clinical perspectives

4. Regulatory Science

5. Industrial innovations

TENTATIVE SCHEDULE

02

ndLocation：Multifunction Hall, 2 Floor

rdLocation：No.1 Meeting Room, 3 Floor

10:15-12:10 Moderators: Yingjun Wang, Cato Laurencin

13:30-16:25 Moderators: Liu Changsheng, Nicholas Peppas

10:15-10:30 Opening Remarks

Speakers: Xingdong Zhang, Art Coury, Xiaobing Fu, Andres Garcia

10:30-10:55 Lecture 1: The Ambulatory Kidney to Increase Vitality (AKTIV): The Intersection

of Biomaterials, Medical Devices, Translation, Regulation and

Commercialization

Speaker: Buddy Ratner, Professor, University of Washington

10:55-11:20 Lecture 2: Progresses on the Reform of Medical Device Evaluation System in China

Speaker: Lei Sun, Director, Center for Medical Device Evaluation,

National Medical Products Administration

11:20-11:45 Lecture 3: New Perspectives on ISO 10993-1 VS FDA (2016) and ISO 10093-23

Speaker: James Anderson, Professor, Case Western Reserve University

11:45-12:10 Lecture 4: Progress of China Medical Device Standardization Administration

Speaker: Zhijun Zhang, Vice Director, National Institutes for Food and Drug Control

12:10-13:30 Lunch

13:30-13:55 Lecture 5: The Immune Response to Biomaterials and Development of

Regenerative Immunotherapies

Speaker: Jennifer Elisseeff, Professor, Johns Hopkins University



03

rdLocation：No.1 Meeting Room, 3 Floor

13:55-14:20 Lecture 6: Milestones During the Commercialization of Biomaterial Products

Speaker: Hongxin Nie, Founder, Sunland Capital

14:20-14:45 Lecture 7: Development of Gliadel Wafers and Future Approaches for Treating

Glioblastoma

Speaker: Howard Rosen, Independent Consultant

14:45-15:10 Lecture 8: The Use of the Ultra-biocompatible SIBS Polymer in Implantable

Medical Devices

Speaker: Len Pinchuk, Founder, Innovia LLC

15:10-15:35 Lecture 9: Advancing the Construction of Regulatory Science System for the

Medical Devices and Personnel Training Based on the Guangdong-Hong

Kong-Macao Greater Bay Area

Speaker: Xinrong Xu, Vice Director, Medical Devices Research and Testing Center,

South China University of Technology

15:35-16:00 Lecture 10: Biosynthetic Materials for Islet Encapsulation and Transplantation

Speaker: Andres Garcia, Professor, Georgia Institute of Technology

16:00-16:25 Lecture 11: Evidence-based Regulatory Science

Speaker: Kai Zhang, Professor, Sichuan University

16:25-16:40 Tea Break

Panel Discussion

All Speakers

16:40-18:00 Moderators: Hua Ai, Horst Von Recum

04

GENERAL INFORMATION

Registration

Official language

Visa

Weather

Registration fee of the Forum is included in that of the 2019 Chinese Biomaterials Congress. Please

register via the website of the 2019 Chinese Biomaterials Congress (http://2019.csbm.org.cn) or at the

Registration Desk on site.

English

Foreign citizens need visa to enter China. Please contact the secretary of the forum to obtain official

invitation letter for visa application.

The climate of Dalian in August is mild and humid. The average temperature is around 22-27°C (71-80°F).



CO-CHAIRS, MODERATORS AND SPEAKERS

Xingdong ZhangProfessor, Sichuan University

President, International Union of Societies for Biomaterials Science and

Engineering

Academician, CAE

Foreign Member, NAE

Email: [email protected]

Xingdong Zhang is a professor of Sichuan University, a Member of the Chinese Academy of Engineering, a Foreign

Member of the US National Academy of Engineering, President of the International Union of Societies for

Biomaterials Science and Engineering (IUSBSE), Honorary President of the Chinese Society for Biomaterials

(CSBM). He is also an honorary doctor of both Macau University of Science and Technology and University

Polytechnica of Bucharest and a Distinguished Professor of Northeastern University in US, dean of advisory board of

the Research Base of Regulatory Science for Medical Devices. He was the president of International Bioceramics, the

advisor of Science and Technology of Japanese National Materials Institute.

His research focuses on biomaterials and implantable medical devices for musculoskeletal system. In the 1980s, he

was the first in China to research and develop hydroxyapatite bioactive ceramics and coatings to design and develop

titanium dental implants and total hip replacements with plasma-sprayed hydroxyapatite coatings. He was one of the

pioneers in the world to find and confirm that porous biomaterials can induce bone formation. To date, he has

obtained six Registration Certificates for Medical Devices issued by the China Food and Drug Administration. 20

series of products have been commercialized and applied to dozens of thousand cases in near 1000 Chinese hospitals.

He has obtained more than 20 national and international awards in biomaterials research.



05

06

Xiaobing FuProfessor and President, College of Life Science, the PLA General Hospital

and PLA Medical College

Director, Key Laboratory of Wound Repair and Regeneration of PLA

President, Chinese Society for Biomaterials

Academician, CAE


Professor Xiaobing Fu, M.D. PhD, Academician (Chinese Academy of Engineering, Division of Medicine and Health),

Foreign Academician of France Academy of Medicine, President of the College of Life Science, the PLA General

Hospital and PLA Medical College, Director of the Key Laboratory of Wound Repair and Regeneration of PLA.

He has made great contributions on trauma, especially in the fields of growth factors and stem cell biology,

biomaterial research and its use in chronic skin wound management, tissue repair and regenerative medicine. His

works were supported in part by the National Basic Science and Development Programme (973 Programme),

National High-Technique Programme (863 Programme), Grant for National Distinguished Young Scientists and Grant

for National Natural Science Foundation of China. He has published more than 600 scientific papers, including papers

published in the Lancet (1998, 2001), Science Translational Medicine and Biomaterials, etc. He has published 26 books

as the editor in chief and won the 25 international and national prizes of Sci-Tech Progress from 1989 to 2018.

He was the members of the Scientific Committee of the Third Joint Meeting of the European Tissue Repair Society

and the Wound Healing Society (USA) held in Boudreaux in 1999, the Scientific Committee Member, Advisor or

Member of the International Faculty from the First World Union of Wound Healing Societies (WUWHS) Congress to

5th WUWHS Congress, held in Melbourne in 2000, Toronto in Canada in 2008, Yokohama in Japan in 2012 and

Florence in Italy in 2016.

Now he is the Chairman of the Asian Wound Care Association (AWCA), the President of Chinese Society for

Biomaterials, the President of the Chinese Tissue Repair Society (CTRS), the President of the Chinese Tissue Repair

and Regeneration Society (CTRRS) and the member of National Natural Science Foundation of China. He was the

Chairman of Chinese Trauma Society from 2010 to 2013.

Professor Fu was awarded the International Lifetime Achievement Award in Wound Repair and Regeneration in

2008. He was selected as the Academician (Chinese Academy of Engineering, Division of Medicine and Health) in

2009 and the Foreign Academician of France Academy of Medicine in 2018 and the Fellow of American Institute for

Medical and Biological Engineering (AIMBE) College in 2018.

Arthur J. CouryUniversity Distinguished Professor, Northeastern University

NAE


Member,

Art Coury holds a B.S. degree in chemistry from the University of Delaware (1962), a Ph.D. in organic chemistry

(1965) and an M.B.A. (1980) from the University of Minnesota. His industrial career included positions as: Senior

Research Chemist at General Mills, Inc. (1965-1976), Director, Polymer Technology and Research Fellow at

Medtronic, Inc. (1976-1993), Vice President, Research and Chief Scientific Officer at Focal, Inc. (1993-2000), and

Vice President, Biomaterials Research at Genzyme Corporation (2000-June, 2008). He currently is a consultant and

academic professor. His career focus has been polymeric biomaterials for medical products such as implantable

electronic devices, hydrogel-based devices and drug delivery systems. He holds over fifty five distinct patents

and has published and presented widely in his field. His prior or current academic service has included

adjunct or affiliate appointments at the University of Minnesota, the Harvard-MIT Graduate Program in

Health Sciences and Technology, the University of Cape Town, South Africa, the University of Trento, Italy, Sichuan

University, China and Northeastern University. His professional service has included: Chair, Minnesota Section,

American Chemical Society (1989-1990); President, Society for Biomaterials, USA (1999-2000); President,

American Institute for Medical and Biological Engineering (AIMBE) (2003-2004) and membership on a number

of university, professional society and corporate advisory boards. His recent recognitions have included the

delivery of distinguished lectureships, receipt of the 2007 Innovation and Technology Development Award of the

Society for Biomaterials, being named as one of “100 Notable People in the Medical Device Industry” by MD&DI

magazine, 2008, induction into the National Academy of Engineering, USA, 2009, recognition on the

University of Delaware alumni “Wall of Fame,” 2010, “The Man, the Myth, the Materials,” a symposium in honor

of Art Coury’s 70th birthday, 2010, induction as an American Chemical Society Fellow, 2011, recipient of

the Society for Biomaterials Founders’ Award, 2012 and its C. William Hall Award, 2013 , of the AIMBE Pierre

Galletti award for 2012, of the University of Minnesota Outstanding Alumni Award for 2013, appointment as

Honorary Professor, Sichuan University, Chengdu, China (2013), and University Distinguished Professor,

Northeastern University (2014), and recognition with the Directors’ Award of the Harvard/MIT Joint Program in

Health Sciences and Technology (2016).



07

08

Andrés J. GarcíaExecutive Director, Parker H. Petit Institute for Bioengineering

and Bioscience

Petit Director’s Chair in Bioengineering and Bioscience

Regents’ Professor, George W. Woodruff School of Mechanical E ngineering

Georgia Institute of Technology


Andrés J. García is the Executive Director of the Petit Institute for Bioengineering and Bioscience and Regents’

Professor at the Georgia Institute of Technology. He earned a B.S. in Mechanical Engineering with Honors from

Cornell University (1991), and M.S.E. (1992) and Ph.D. (1996) degrees in Bioengineering from the University of

Pennsylvania. He completed a post-doctoral fellowship in cell and molecular biology at the School of Medicine of

the University of Pennsylvania and then joined the faculty at Georgia Tech in 1998. Dr. García’s research program

integrates innovative engineering, materials science, and cell biology concepts and technologies to create cell-

instructive biomaterials for regenerative medicine and generate new knowledge in mechanobiology. This cross-

disciplinary effort has resulted in new biomaterial platforms that elicit targeted cellular responses and tissue repair in

various biomedical applications, innovative technologies to study and exploit cell adhesive interactions, and new

mechanistic insights into the interplay of mechanics and cell biology. In addition, his research has generated

intellectual property and licensing agreements with start-up and multi-national companies, demonstrating the

translational potential and impact of this work. He has received several distinctions, including the NSF CAREER

Award, Arthritis Investigator Award, Young Investigator Award from the Society for Biomaterials, Georgia Tech’s

Outstanding Interdisciplinary Activities Award, the Clemson Award for Basic Science from the Society for

Biomaterials, and the International Award from the European Society for Biomaterials. He has been recognized as a

top Latino educator by the Society of Hispanic Professional Engineers. He is an elected Fellow of Biomaterials

Science and Engineering (by the International Union of Societies of Biomaterials Science and Engineering), Fellow

of the American Association for the Advancement of Science, Fellow of the American Society of Mechanical

Engineers, and Fellow of the American Institute for Medical and Biological Engineering. He served as President for

the Society for Biomaterials in 2018-2019.

Title: Biosynthetic Materials for Islet Encapsulation and Transplantation



09

Yingjun WangProfessor, Biomaterials at South China University of Technology (SCUT)

Academician, CAE

Former President and President-Elect, Chinese Society for Biomaterials

Founding Director, National Engineering Research Center for Tissue

Restoration and Reconstruction

Fellow, International Union of Societies for Biomaterials Science and Engineering


Prof. Wang has worked in the area of biomedical materials for more than 40 years. She obtained multiple original

achievements in tissue engineering, regenerative biomedical materials, antibacterial nano-materials, biomaterial

surface and interface, biomimetic techniques of materials, etc. She also has promoted these biomaterials

commercialization and 21 items has been awarded of Approvals of CFDA(6 Class III). She holds 57 patents and has

published more than 200 peer-reviewed journal articles in leading journals. She is on the editor boards of journals

including ACS Biomaterials Science and Engineering, Regenerative Biomaterials, Bio-Design and Manufacturing.

Her greatly contributions on biomaterial industry in China has earned the government and society support. She has

set up an Education-Research-Industry collaborative innovation center which is composed of 34 top hospitals and 48

enterprises of biomaterials and medical devices. Her full chain developing model with ‘Biomedical Materials

Research- Industrialization- Clinical Application’ accelerated the transition from bench to clinic.

Prof. Wang has undertaken more than 60 competitive grants (totally more than 1 billion). Her interdisciplinary

research and distinguished contributions in biomaterials has been recognized by over 30 major national and

international awards including the State Technological Invention Award from the State Council, Natural Science

Award from Ministry of Education of China, and European Federation for Pharmaceutical Sciences. Prof. Wang is

highly committed to cultivating students for which she received the SCUT's outstanding mentor. Over 80 graduate

students her mentored have gone to academia as faculty or gone to biomedical industry as mangers or engineers.

10

Cato LaurencinUniversity Professor University of Connecticut

NAE and NAM


,

Member,

Foreign Member, CAE

Professor Cato T. Laurencin is internationally renowned and recognized in Biomaterials Science. He is the University

Professor at the University of Connecticut, the 8th named in the school’s long history. Professor Laurencin is an

Academician of the Chinese Academy of Engineering, a Fellow of the Indian National Academy of Engineering, a

Fellow of the National Academy of Sciences, India, a Fellow of the African Academy of Sciences and a Fellow of

The World Academy of Sciences.

He earned his B.S.E. in Chemical Engineering from Princeton University, then earned his Ph.D. in Biochemical

Engineering/Biotechnology from the Massachusetts Institute of Technology where he graduated with a 4.9/5.0 grade

point average and was designated a Hugh Hampton Young Fellow. At the same time he earned his M.D., from the

Harvard Medical School where he graduated Magna Cum Laude, the highest honors given in his class year, and

received the Robinson Award for surgery.

In Biomaterials, Professor Laurencin received the Founders Award, the Clemson Award for Contributions to the

Biomaterials Literature, and the Technology Innovation and Development Award from the Society for Biomaterials.

The Society for Biomaterials created the Cato T. Laurencin Travelling Fellow Award in his honor. He was named one

of the 100 Engineers of the Modern Era by the American Institute of Chemical Engineers for his work in

Biomaterials, and he received the first Biomaterials Global Leadership Award from the Chinese Association of

Biomaterials.

Professor Laurencin is the pioneer of the field of Regenerative Engineering. He is the first to receive both the

National Institutes of Health (NIH) Director’s Pioneer Award, and the National Science Foundation (NSF) Emerging

Frontiers in Research and Innovation Award for this field. For his work, the American Association for the

Advancement of Science awarded Dr. Laurencin the Philip Hauge Abelson Prize given ‘for signal contributions to the

advancement of science in the United States’. He received the National Medal of Technology and Innovation,

America’s highest honor for technological achievement, given to him by President Barack Obama in ceremonies at

the White House.

Professor Laurencin is an elected member of the National Academy of Engineering, an elected member of the

National Academy of Medicine, and an elected member of the American Academy of Arts and Sciences.

Buddy RatnerDirector University Washington Engineered Biomaterials (UWEB)

Co-director, Center for Dialysis Innovation (CDI)

University of Washington

NAE


, of

Member,

Dr. Buddy D. Ratner is the Director of University of Washington Engineered Biomaterials (UWEB21) Engineering

Research Center, co-director of the Center for Dialysis Innovation (CDI) and the Darland Endowed Chair in

Technology Commercialization. He is Professor of Bioengineering and Chemical Engineering, University of

Washington. Ratner received his Ph.D. (1972) in polymer chemistry from the Polytechnic Institute of Brooklyn.

Ratner is a fellow of the American Institute of Medical and Biological Engineering (AIMBE), AVS, AAAS, ACS,

POLY and the International College of Fellows Biomaterials Science and Engineering. In 2002 Ratner was elected a

member of the National Academy of Engineering, USA. He has been involved in the launch of seven companies and

won numerous awards including the AVS Welch Award (2002), Society for Biomaterials Founders Award (2004), the

BMES Pritzker Distinguished Lecturer Award (2008), the Acta Biomaterialia Gold Medal (2009), the Galletti Award

(2011) the George Winter Award of the European Society for Biomaterials (2012) and the University of Washington

School of Medicine Lifetime Innovator and Inventor Award (2014). He served as President of Society For

Biomaterials in 1998 and AIMBE in 2002. His research interests include biomaterials, tissue engineering,

regenerative medicine, polymers, biocompatibility, surface analysis and plasma thin film deposition.

Title: The Ambulatory Kidney to Increase Vitality (AKTIV): The Intersection of Biomaterials, Medical

Devices, Translation, Regulation and Commercialization



11

12

Lei SunDirector, Center for Medical Device Evaluation,

National Medical Products Administration (NMPA)

Mr. Sun, Lei is the Director of Center for Medical Device Evaluation, National Medical Products Administration

(NMPA). Mr. Sun has been working for NMPA at various positions including the deputy director of Drug Testing

Department in National Institutes for Food and Drug Control, director of the Second Department of Inspection

Bureau in former China Food and Drug Administration (CFDA), where he was responsible for the investigation of

important legal cases related to drugs and medical devices. He was also the deputy Director of Department of

Medical Device Supervision in former CFDA, where he took overall responsibilities in terms of supervision of

medical device production and marketing.

Title: Progresses on the Reform of Medical Device Evaluation System in China

James M. AndersonDistinguished University Professor

Professor of Pathology, Macromolecular Science and Biomedical Engineering

Case Western Reserve University

NAE and NAM


Member,

James M. Anderson, M.D., Ph.D., is a Distinguished University Professor, a member of two national academies:

National Academy of Medicine and National Academy of Engineering, and Chair of the Case Western Reserve

University School of Medicine Dean’s Honors Committee. Since 1990, Dr. Anderson has been the Chair of ISO

10993-1, Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management

Process. This Standard involves biocompatibility/safety evaluation of biomaterials, medical devices and prostheses.

Currently, this Standard is undergoing the required five-year revision. Dr. Anderson’s research and clinical activities

involve the evaluation of tissue responses, i.e., biological response evaluation, with a focus on the identification of

the inflammatory, wound healing and foreign body responses to biomaterials, medical devices and prostheses. In

particular, Dr. Anderson’s activities involve biodegradation and biodegradable polymers, bacterial/blood/material

interactions, biocompatibility of biomedical polymers and drug delivery systems, biodegradation and biodegradable

polymers, and biological mechanisms of macrophages and foreign body giant cells with biomaterial surfaces.

Title: New Perspectives on ISO 10993-1 VS FDA (2016) and ISO 10093-23



13

14

Zhijun ZhangDeputy director-general, National Institutes for Food and Drug Control

Deputy director, National General Institute for Drug Control

Deputy director, Center for Medical Device Standardization

Administration, NMPA

Zhijun ZHANG, deputy director-general of National Institutes for Food and Drug Control, deputy director of

National General Institute for Drug Control, and deputy director of Center for Medical Device Standardization

Administration, NMPA. He is the chairman of National standardization Technical Committee for medical electrical

equipment(SAC/TC10) , National Standardization Technical Committee for Quality Management and General

Requirements of Medical Devices(SAC/TC210). He was graduated from the Department of Pharmacy, Peking

University Health Science Center with a Bachelor's degree in pharmacy and School of Public Health, Columbia

University with a Master degree in public health. Currently, he is in charge of the inspection and testing of drugs,

biological products, medical devices, and the administration of medical device standards. He was formerly Deputy

Director of Drug Registration Department and Director of Center for Medical Device Evaluation of former National

Food and Drug Administration.

Title: Progress of China Medical Device Standardization Administration

Changsheng LiuCheung Kong Scholar Professor and President, Shanghai University

Director, Engineering Research Center for Biomedical Materials

of Ministry of Education

Academician, CAS


Prof. Changsheng Liu is the Cheung Kong Scholar Professor of Shanghai University, the academician of Chinese

Academy of Sciences, winner of the National Natural Science Foundation of China for Distinguished Young

Scholars. He is now president of Shanghai University and director of the Engineering Research Center for

Biomedical Materials of Ministry of Education. He is the International Fellow of Biomaterials Science and

Engineering and AIBME Fellow. Prof. Liu received his Ph.D. in Chemical Engineering from East China University

of Science and Technology in 1996. He has been engaged in biomedical materials for a long time and developed

raised novel concept of materiobiolgy. He has developed various biomaterials including calcium phosphate cement

(CPC) formulations and growth factor-loaded calcium phosphate artificial bone, which were approved by SFDA and

used in more than 500 hospitals in China for over 20 years. He has published more than 220 refereed journal articles,

60 patents and invention disclosures, 4 edited books and 3 book chapters to his name, including the authorative

journals such as Biomaterials, Chemical Reviews, Advanced Functional Materials, etc. Owing to these distinguished

work, he achieved the second-prize of National Natural Science Award in 2014 and National Award for Science and

Technology Progress in 2004, as well as the Ho Leung Ho Lee Foundation Scientific and Technological Innovation

Award in 2007.



15

16

Nicholas A. PeppasCockrell Family Regents Chaired Professor, Departments of Chemical,

Biomedical Engineering, Surgery and Pediatrics, and Pharmacy

Director, Institute of Biomaterials, Drug Delivery and Regenerative Medicine

University of Texas at Austin


Member, NAE and NAM

Foreign Member, CAE

Nicholas A. Peppas is the Cockrell Family Regents Chaired Professor in the Departments of Chemical, Biomedical

Engineering, Surgery and Pediatrics, and Pharmacy, and Director of the Institute of Biomaterials, Drug Delivery and

Regenerative Medicine of the University of Texas at Austin. Member of the National Academy of Engineering,

National Academy of Medicine, American Academy of Arts and Sciences, Chinese Academy of Engineering,

European Academy, Canadian Academy of Engineering, Greek Academy, National Academy of France, Royal

Academy of Spain, International Academy of Biomedical Engineering. Work on multidisciplinary approach by

blending modern molecular and cellular biology with engineering principles to design the next-generation of

biomaterials, medical systems and devices for patient treatment.

Jennifer ElisseeffProfessor and Director, Translational Tissue Engineering Center

Wilmer Eye Institute and Departments of Biomedical Engineering,

Orthopedic Surgery, Chemical and Biological Engineering,

and Materials Science and Engineering at Johns Hopkins University

NAE


Member,

Dr. Elisseeff is the Morton Goldberg Professor and Director of the Translational Tissue Engineering Center at Johns

Hopkins Department of Biomedical Engineering and the Wilmer Eye Institute with appointments in Chemical and

Biological Engineering, Materials Science and Orthopedic Surgery. She was elected a Fellow of the American Institute

of Medical and Biological Engineering, the National Academy of Inventors, a Young Global Leader by World Economic

Forum. In 2018, she was elected to the National Academy of Engineering and National Academy of Medicine.

Jennifer received a bachelor’s degree in chemistry from Carnegie Mellon University and a PhD in Medical

Engineering from the Harvard–MIT Division of Health Sciences and Technology. Later she was a Fellow at the

National Institute of General Medical Sciences, Pharmacology Research Associate Program, where she worked in the

National Institute of Dental and Craniofacial Research. She has published over 200 papers, book chapters, and

patent applications and received a number of awards including the Carnegie Young Alumni Award and in 2002 she

was named by MIT Technology Review as a top innovator under 35. She is committed to the translation of

regenerative biomaterials and has founded several companies and participates in several industry advisory boards

including the State of Maryland’s Technology Development Corporation (TEDCO).

Jennifer’s initial research efforts focused on the development of biomaterials for studying stem cells and designing

regenerative medicine technologies for application in orthopedics, plastic and reconstructive surgery, and

ophthalmology. In clinical translation of these technologies, the group recognized the importance of the immune

response in regenerative medicine responses. This led to a significant shift in research efforts to biomaterials-directed

regenerative immunology and leveraging the adaptive immune system to promote tissue repair. The group is now

characterizing the immune and stromal environments of healing versus non-healing wounds and tumors. Biomaterials

are now being applied to model and manipulate tissue environments and studying the impact of systemic and

environmental factors such as aging and senescent cells, gender and infection/microbiome on tissue repair and

homeostasis.

Title: The Immune Response to Biomaterials and Development of Regenerative Immunotherapies



17

18

Hongxin NieFounder, Sunland Venture Capital Fund


Hongxin Nie, J.D. is a managing partner at Sunland Venture Capital Fund with more than 15 years of medical device

industry experience. Dr. Nie has extensive experience in healthcare startups, operations, mergers and acquisitions.

She is also a frequent speaker for the Chinese medical device industry, with topics including, but not limited to,

regulatory policy and healthcare investment.

Prior to joining Sunland Capital, Dr. Nie was the general manager of Libeier Medical Device Company, where she

was in charge of sales and marketing, mergers & acquisitions. She has served as an Executive Council Member of

Chinese Society for Biomaterials (CSBM) since 2012. She also chaired Surgical Implants Committee of China

Medical Device Association (CAMDI) from 2011 to 2016. Dr. Nie earned her Juris Doctor degree from US and

admitted in New York and New Jersey Bar.

Title: Milestones During the Commercialization of Biomaterial Products



19

Howard RosenIndependent Consultant

NAE


Member,

Mr. Rosen received a B.S. degree in chemical engineering with distinction from Stanford University in 1980, an S.M.

degree in chemical engineering from the Massachusetts Institute of Technology in1982, and an MBA degree from

Stanford University in 1987.

Mr. Rosen is an independent consultant and serves on the board of directors of: AcelRx Pharmaceuticals, Inc., where

he served as CEO from 2015-17; Entrega, Inc.; Hammerton, Inc.; Metera Pharmaceuticals, Inc.; and, Kala

Pharmaceuticals, Inc. Mr. Rosen also is a Lecturer in the Department of Chemical Engineering at Stanford and a

Lecturer in Management at the Stanford Graduate School of Business. From 2004 to 2008, he was Vice President,

Commercial Strategy at Gilead Sciences, Inc. where his responsibilities included strategic marketing, global brand

management, health economics, competitive intelligence, market research and Gilead’s overall portfolio and business

planning. Prior to joining Gilead, Mr. Rosen was President of ALZA Corporation where he was responsible for all

aspects of managing ALZA as an independent 1000-person operating company within the Johnson & Johnson Family

of Companies. Previously at ALZA as Vice President, Product Development, he was responsible for product

development activities, portfolio management and corporate and new product planning. Over his 10 years at ALZA,

Mr. Rosen also had responsibilities for mergers and acquisitions, R&D planning, and technology ventures. Prior to

joining ALZA, Mr. Rosen managed the west coast practice of Integral, Inc., was Director, Corporate Development at

GenPharm International, Inc. and was a consultant in the San Francisco office of McKinsey & Co.

Mr. Rosen was elected to the NAE in 2005 for the invention of bioerodible polymers and leadership in the

development of drug-delivery systems and also is a Fellow of the American Institute for Medical and Biological

Engineering (AIMBE). He is a member of the Biomedical Engineering Advisory Board at City College of New York

and the Industrial Advisory Board for the University of North Carolina/North Carolina State Joint Biomedical

Engineering Department. Mr. Rosen is a past member of the Stanford University Advisory Council on

Interdisciplinary Biosciences and the Stanford School of Engineering Advisory Council.

Mr. Rosen is an Arjay Miller Scholar and Henry Ford II Scholar for graduating first in his MBA class at Stanford. He

is a past member of Tau Beta Pi and Sigma Xi honor societies. Mr. Rosen is co-inventor on 7 US patents.

Title: Development of Gliadel Wafers and Future Approaches for Treating Glioblastoma

20

Len PinchukFounder and Chief Scientific Officer, InnFocus, Inc., a Santen Company

Distinguished Research Professor, Biomedical Engineering,

University of Miami, Miami FL

Founder/President/CEO Innovia, LLC

NAE


Member,

Dr. Pinchuk has 129 U.S. patents, 90 publications and founded 10 companies. His major accomplishments include the

invention of the Nylon 12 angioplasty balloon, the helical wire stent, the modular stent-graft, a drug-eluting stent

(TAXUS®), several biomaterials (Bionate® and SIBS), a novel glaucoma tube (the InnFocus MicroShunt®) and the

next generation intraocular lens. His inventions are used in hundreds of millions of patients with a financial impact

well over $100 billion. He was inducted into the National Academy of Engineering in 2012, was awarded the 2017

Society for Biomaterials Innovation and Technology Award, San Antonio’s BIOMED SA Award (2017) and the

National Academy of Engineering 2019 Fritz J. and Dolores H. Russ Prize. He received a B.Sc. in chemistry from

McGill University (Montreal, Canada, 1976) and a Ph.D. interdisciplinary in Engineering and Chemistry from the

University of Miami (Miami, Florida, 1984). Dr. Pinchuk co-founded Corvita Corporation (1987) which went public

in 1994, was acquired by Pfizer, Inc. (1996) and then sold to Boston Scientific (1998). He then founded Innovia LLC

(2002), which spun-out InnFocus, Inc. (2004) which was acquired by Santen Pharmaceuticals in 2016. Dr. Pinchuk

also enjoys an appointment as Distinguished Research Professor of Biomedical Engineering at the University of

Miami.

Title: The use of the Ultra-biocompatible SIBS Polymer in Implantable Medical Devices



21

Xinrong XuDeputy Director, Medical Devices Research and Testing Center

South China University of Technology, Guangzhou

Research and practice are focused on biomaterials characterization and evaluation, standard development, medical

devices safety evaluation as well as research on scientific strategy of supervision and regulation.

Committee Member, the Advisory Committee of the Medical Device Technical Review Expert of the State Drug

Administration.

Committee member, Implants for Surgery and Orthopedic Devices of China.

Committee member, National Dental Materials, Instruments & Equipments Standardization Technical Committee of

China.

Committee member, Chinese Society for Biomaterials, Bone Repair Material and Devices Branch.

Committee Expert, 3D Printing Medical Devices Professional Committee Group Standardization Technical

Committee of China Association For Medical Devices Industry

National Assessor, China Inspection Body and Laboratory Mandatory Approval.

Secretary, General Administration Quality Supervision Inspection and Quarantine of China, High-tech Analytical

Instruments Working Group.

Title: Advancing the construction of regulatory science system for the medical devices and personnel

training based on the Guangdong-Hong Kong-Macao Greater Bay Area

22

Kai ZhangProfessor,

National Medical Products Administration

Professor, Institute of Regulatory Science for Medical Devices,

Engineering Research Center for Biomaterials, Sichuan University

Email：[email protected]

Research Base of Regulatory Science for Medical Devices,

Kai Zhang, Ph.D. is a professor and Deputy Director of the Institute of Regulatory Science for Medical Devices at

Sichuan University, which is also the Research Base of Regulatory Science for Medical Devices of National Medical

Products Administration (NMPA). Professor Kai Zhang is a Fellow of American Institute for Medical and Biological

Engineering (AIMBE), an Executive Council Member of the Chinese Society for Biomaterials, a member of the

National Standardization Technical Committee on Surgical Implants and Prosthetic Devices, a member of the

National Standardization Technical Committee on Additive Manufacturing, a member of NMPA Technical Review

Advisory Committee, a member of NMPA Technical Advisory Committee for Classification of Medical Devices, a

member of the Liaison Committee of the US Society for Biomaterials. Professor Zhang’s research focuses on

bioactive and regenerative materials and devices for tissue repair and regeneration, as well as new methods, standards

and tools to evaluate the safety, efficacy, performance and properties of such materials and devices. His

representative work include books, peer-reviewed journal articles and issued Chinese, US and EU patents. Professor

Zhang serves as an Editorial Board Member for “Journal of Biomedical Materials Research: Part B, Applied

Biomaterials” and “Bioactive Materials”.

Title: Evidence-based Regulatory Science



23

Hua AiProfessor, National Engineering Research Center for Biomaterials

Adjunct Professor, Radiology, West China Hospital

Sichuan University

Email:[email protected]

Hua Ai, PhD, Professor of Biomaterials, National Engineering Research Center for Biomaterials, Sichuan University;

Adjunct Professor of Radiology, West China Hospital, Sichuan University. He is the Secretary General of Chinese

Society for Biomaterials. Dr. Ai is focusing on design and application of magnetic nanobiomaterials for molecular

imaging and drug delivery. He developed sensitive magnetic resonance imaging probes based on superparamagnetic

iron oxide nanoparticles and paramagnetic molecules. Most of his work was carried out under clinical magnetic

resonance imaging scanners and published on academic journals including Biomaterials, Acc Chem Res, Adv Drug

Deliv Rev, Pharm Res, etc. He currently serves on a few journal editorial boards including Biomaterials,

Regenerative Biomaterials, Journal of Pharmaceutical Sciences, JBMR– A, etc. Besides, he also serves on the Board

of Governors of Acta Materialia, Inc. Dr. Ai is a Fellow of Biomaterials Science and Engineering (FBSE), and also a

Fellow of American Institute for Medical and Biological Engineering (AIMBE).

24

Horst von RecumProfessor, Case Western Reserve University


Horst von Recum began his training in Chemical Engineering and in Biochemistry at Rice University, where he

worked with Tony Mikos. For his PhD, Dr. von Recum attended the University of Utah where he studied under Sun

Wan Kim on drug delivery and tissue engineering. Following that he had two different postdoctoral fellowships, first

at MIT in Bob Langer’s lab, then at the University of Washington in Suzie Pun’s lab; studying stem cells and gene

therapy. Since arriving at Case Western Reserve University in 2004, Dr. von Recum has been working on a range of

projects delivering proteins and small molecule drugs for a number of therapeutic applications from tissue

engineering, to cardiovascular disease to cancer. He has over 40 peer-reviewed papers, including Biomaterials “Most

Cited Article 2006-2010”, with over 1285 citations; as well as 6 book chapters, 60 conference proceedings, and 37

invited presentations. He is Principal Investigator for >20 funded projects, including an NSF CAREER award in

2010; and an NIH RC1 “Challenge Grant” in 2009; all together totally $4.5 million since 2005, and Co-Investigator

on 7 additional funded projects ($8.9 million total costs). In 2012 he and colleague Dr. Julius Korley founded Affinity

Therapeutics, LLC to bring some of their basic science discoveries closer to commercial and clinical application.

2019 chinese biomaterials congress...

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