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醫藥 - SAPANE年會6/17 中国在研药品的FDA法规注册之路

19th SAPA-NE Annual Conference


         June 17, 2017@MIT


        广  欢  阵  药


        积  迎  容  协


        人  参  强  年


        脉  加  大  会


Registration link:

http://www.sapa-neweb.org/AC2017.php

Registration to 19th SAPA-NE Annual Conference 2017


19th SAPA-NE Annual Conference 2017


Date: 9:00 am - 6:00 pm (Conference), Saturday, Jun 17th, 2017
Dinner Event: 6:30 pm - 9:30 pm, Saturday, Jun 17th, 2017
Location: MIT Sloan School of Management, Tang Center, Wong Auditorium, Cambridge, MA

Registration:
Free for all active SAPA-NE members and MIT students
$15 for students and postdoctoral fellows
$30 for all other participants
Thank you for your donation to SAPA-NE. Please fill in all the information.
This donation is not refundable.Thank you.

Confirmed Speakers:
Andrew “Andy” Plump, M.D., Ph.D., Chief Medical and Scientific Officer, Takeda 

Yong-Jun Liu, Ph.D., Head of Research, Global R&D, Sanofi

Richard Murray, Ph.D., Chief Executive Officer and President, Jounce Therapeutics 

Sven Ante “Bill” Lundberg, Ph.D., Chief Scientific Officer, CRISPR Therapeutics 

Yinxiang Wang, Ph.D., Chief Executive Officer, Jacobio Pharmaceuticals, Co-found of Betta Pharma 

Lijun Wu, Ph.D., Entrepreneur-in-Residence, Atlas Ventures, SVP at Delinia (now Celgene) 

Luhan Yang, Ph.D., Co-founder and Chief Scientific Officer, eGenesis 

James (Jianguo) Yang, Ph.D., President & CEO, Abpro-China Shidong Jia, Ph.D., Founder & CEO, Predicine Holdings Ltd


CABA美中生物医药协会2017年会暨十周年庆典召开在即

 2017-04-11 Jo Lee CABA

“Boston BioForum 2017”
CABA10th Annual Conference
Coming Soon!!!
🏨Boston Marriott Newton
📍2345 Commonwealth Ave, Newton, MA 02466
🕙10:00 AM to 6:00 PM on Saturday, May 6, 2017.

SPEAKERS

Gordon Freeman

Professor at Harvard University

Carmen Bozic, MD
Carmen Bozic MD is Senior Vice President of Global Development at Biogen, accountable for developing, obtaining and maintaining regulatory approval of therapies in Biogen’s therapeutic focus areas of Neurodegenerative and Rare Diseases. Dr. Bozic is an experienced drug development leader with 18 years of progressively increasing responsibilities in the biopharmaceutical industry.
Kenneth I Kaitin, Ph.D.
Dr. Kaitin is Professor of Medicine and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. Dr. Kaitin alsoholds appointments as Advisory Professor at Shanghai Medical College of Fudan University in China; Visiting Executive at the Tuck School of Business at Dartmouth College; and faculty of the European Center for Pharmaceutical Medicine at the University of Basel.
Ken LeClair, Ph.D.
Ken LeClair received his undergraduate degree from BowdoinCollege and a Ph.D. in Immunobiology from Yale University.
He did a postdoc at the MIT Center for Cancer Research andhad an academic appointment as Assistant Professor of Medicine in theImmunology Division of the Beth Israel Deaconess Medical Center at the Harvard Medical School.
He joined Editas Medicine late in 2016 and is working to help bring CRISPR-based therapies to the clinic and to market.
Samarth Kulkarni, Ph.D.
Samarth(Sam) Kulkarni is the Chief Business Officer of CRISPR Therapeutics since 2015.  At CRISPR, Sam is responsible for Corporate Strategy, Business Development, and Investor Relations. Sam has significant expertise in strategy and operations in biotech and a wide range of related cutting-edge therapeutic technologies. 
Xinyu Weng, Ph.D.
Weng, Xinyu, Ph.D, is First Secretary of the Embassy of the People’s Republic of China to the United States of America. As the primary point ofcontact 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.
Lynn Yang, MBA
Lynn Yang, focusing on healthcare investment. Prior to joining Sequoia Capital in May,2015, Lynn worked at Legend Capitalhealthcare team. Lynn accomplished investment deals in different area of healthcare industry. Before setting her foot in venture capital, Lynn worked as business development manager in Johnson & Johnson and product managerat GE Healthcare.  
Mrs. Yang holds a MBA from Duke University and Master of Clinical Science from Huazhong Technology University.
Jason Fisherman, MD, MBA
Jason is an investor in medical innovation, drug developer, and company founder. He has worked to build life science companies as a managing director at the global private equity firm Advent International and subsequently as co- founder of the venture spin-out Synthesis Capital. Jason has funded more than thirty companies that have brought over ten new products to market.
James (Jianguo) Yang, Ph.D.
Dr. James (Jianguo) Yang has over 20-year extensive experience in biopharma industry. Currently, Dr. Yang is President / CEO Abpro-China. Before joining Abpro, Dr. Yang was CSO / VP Biologics in Qilu Pharmaceuticals, and also had scientific leadership positions in Abbott Lab Pharma Division, MedImmune /Astra Zeneca, and Genzyme / Sanofi.

Junzhi (John) Yao, Ph.D.
Dr. Junzhi (John) Yao received his PhD degree in chemistry from Wuhan University. He joined Medicure Inc. in Winnipeg, Canada as a Research Scientist conducting drug discovery research for cardiovascular diseases and stroke.

In 2009, Dr. Yao co-founded TC Scientific Inc. in Edmonton, Alberta, Canada, which has become one of the top CROs in Canada.
Hui Cai, Ph.D.
Dr. Hui Cai joined WuXi AppTec in 2009 as Vice President of Business Development, and is currently Vice President of Corporate Alliances,and Head of PR and Corporate Communications.
Prior to WuXi, Dr. Cai spent 10 years at Johnson& Johnson Pharmaceutical Research and Development leading multiple drug discovery programs in the therapeutic areas of inflammation and autoimmunediseases.


Agenda

09:00 - 10:00 am      Registration / Social and Networking
10:00 - 10:05 am      Opening Remarks, Conference Chair
10:05 - 10:15 am      Introduction of CABA, President, CABA
Featured Speaker
10:15 - 11:00 am       Kenneth I. Kaitin,Ph.D., “The Global Landscape for Pharmaceutical R&D: Current Trends -Future Opportunities”
Session I -Immunotherapy: for the Cure ofCancer
11:00 - 11:35 am       Samarth Kulkarni,Ph.D. “CRISPR-based Therapeutics:  Making it a Reality in Asian Markets”
11:35 - 12:10 pm       Ken LéClair, “Development of Cell and Gene-edited Products”
LUNCH AND VENDOR SHOW: 12:10 - 1:30 pm (LunchProvided on Site)
LUNCHOEN PRESENTATION
12:45 - 1:15 pm  TC Scientific Presentation, John Yao, "A CRO's View of the Pharma Landscape"
SESSION II – Innovation,Investment, and Entrepreneurship
1:30 - 2:05 pm          Hui Cai, Ph.D. Wuxi (TBD ,)
2:05 - 2:40 pm          James Yang, Ph.D. “StrategicPartnership for Success in Biologics
2:40 - 3:15 pm           Lynn Yang, MBA, Sequoia Capital “Sequoia China HealthcareInvestment Strategy”
3:15 - 3:50 pm           COFFEE BREAK AND VENDOR SHOW
SESSION III - CFDA Regulatory reform and Innovation for the benefit ofPatients           
3:50 - 4:25 pm           Jason Fisherman, M.D.(TBD)
4:25 - 5:00 pm           XinYu Weng, Ph.D; MBA. “Overview onCFDA Drug Regulatory Reform”    
5:00 - 5:35 pm           Carmen Bozic, M.D. SVP GlobalDevelop. “Innovations in Intrathecal Antisense Oligonucleotide Therapy forNeurological Diseases”
5:35 - 6:00 pm          Closing Remarks and Networking
Registration:
Link: http://caba-annualmeeting-2017.eventdove.com
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同写意论坛第59期活动

中国在研药品的FDA法规注册之路

时   间
2017年6月3-4日
地   点
苏州·独墅湖世尊酒店
主   办
同写意新药英才俱乐部
承   办
北京梓潭管理咨询有限公司
协  办
复旦大学药学院
Humphries Pharmaceutical Consulting, LLC
博瑞生物医药(苏州)股份有限公司
新药创始人俱乐部
支持单位
海思科药业
杭州和泽医药科技有限公司
支持媒体

HPC药闻药事、米内网、新浪医药、GBI、药事纵横、健点子ihealth、汤森路透、药智网、药物简讯、苏比亚、易贸医疗、药渡、医药信息新药开发群、医药研发社交平台、药物临床试验网、投壶网、火石创造、贝壳社、汇聚南药、当代医生、中睿医药评论、中国医药报、医药经济报、Insight数据库、新药汇、药物一致性评价、药研、药研汇、洛施德GMP咨询

HKS Science + Innovation Diplomacy Symposium
The HKS Science + Innovation Diplomacy Symposium aims to put a spotlight on the intersection of Science and innovation with diplomacy and how these two elements act as drivers for solutions to foreign policy challenges.
The Science + Innovation Diplomacy Symposium will provide a space for a trilateral exchange between Academia, Policy makers and the Private Sector to discuss “common ground” where science and innovation can be used as a bridge between governments and people.
Saturday, April 15, 2017 | 9:00AM - 3:30PM
Starr Auditorium, 5th Floor, Belfer Building
79 John F. Kennedy Street
Cambridge, MA, 02138
This event is free and open to the public. As space is limited for this event, RSVPs will be accepted on a first come, first served basis.

At the Harvard T.H. Chan School of Public Health on Friday, April 7th for the 2017 Health Equity & Leadership Conference themed “Advocacy and Leadership for Health Equity.”

Closing keynote: Dr. Elisa Choi, Chairperson of the Commonwealth of MA Asian American Commission

Tickets are FREE and open to all. PLEASE REGISTER in advance through Eventbrite to ensure entry, as space is limited. Lunch and refreshments are included!

REGISTER HERE: http://bit.ly/2n5Raly

HEAL was formed in 2012 by a group of students at the Harvard T.H. Chan School of Public Health dedicated to generating discourse and action to resolve issues related to health inequities in the Boston and Cambridge communities. This year we aim to expand our scope to discuss how we can address health equity in a new administration from grassroots organizing to lobbying policymakers. We seek to foster a conversation between community members, students, and faculty about the causes of inequities, the role of community organizations in serving vulnerable populations, and innovative solutions for a more equitable future.

Featured speakers and panelists include:
* Thaddeus Miles, Director of Community Services at MassHousing)
* Dr. Benjamin Cook, Director of the Health Equity Research Lab and the Center for Multicultural Mental Health Research
* Eva Stahl, Director at Community Catalyst Children's Health Project
* Ashley Slay, Boston Area Rape Crisis Center
* Irvienne Goldson, Deputy Director of ABCD Health Services
* Dr. Nancy Oriol and Jennifer Bennet, Executive Director of The Family Van
and more to be announced!

See below for a tentative conference agenda:
*subject to changes*

8:30am - 9:30am- Registration & Breakfast
9:30am -10:20am- Opening Remarks
10:30am -12:20pm- Panels
- Panel #1 - Advocating for Health Equity: Translating Research & Policy into Action
- Panel #2 - Community-Based Approaches to Health Equity
12:30-1:30PM- Lunch
1:30pm-2:20pm- Workshops Session #1
- Grassroots Organizing
- Advocating for Health Equity in a Clinical Setting
- Negotiation and Conflict Resolution
2:30pm-3:20pm- Workshop Session 2:
- Negotiation and Conflict Resolution
- Public Speaking
- Social Entrepreneurship and Innovation
- Grassroots Organizing
3:30pm-4:30pm Closing Keynote


哈佛医学院中医药论坛
Traditional Chinese Medicine Forum-HMS

Time: 9:00am-5:00pm Sunday May 21, 2017
Place: McLean Hospital, Harvard Medical School, 115 Mill Street, Belmont, MA 02478 FRANCIS de MARNEFFE (cafeteria)
Parking: Free 

CEUs (Continue Education Credit): 9 credits
Fee (lunch included): 
Need 8 CEU Credits: $90 for MSCM members; $120 for non-members
No CEU, Free for Dr. Lee’s group, Harvard employee (reservation needed)
Sponsored: Massachusetts Society of Chinese Medicine (MSCM)
Alternative Medicine Center, McLean Hospital, HMS

Program

9:00-9:15am Registration
9:15-12:00pm Integration of Stretching motion and Tuina with Acupuncture
导引运动,推拿与针灸的整合应用
12:00-1:30pm Lunch & discussion
1:30pm-5:00pm Holistic approach in treating neuroendocrine disorders
神经内分泌系统功能紊乱的中医与自然疗法
Speaker: Dr. Jing Liu, PhD, L.Ac


Contact 
Call Dr. Li 617 323 7809 or 
Email:Johnzhang999@gmail.com






Allurion Repays Massachusetts Life Sciences Center
Natick company has commercialized a gastric balloon technology
to combat obesity

Natick, MA - The Massachusetts Life Sciences Center (MLSC) and Natick-based Allurion Technologies announced today that the company, which was awarded a $750,000 Accelerator loan from the MLSC in 2011, has repaid the loan with interest after a successful funding round from private investors. Allurion’s repayment to the MLSC totaled $1,115,824.

Allurion’s flagship product is the Elipse™ gastric balloon, a procedureless™ medical device for weight loss.  The Elipse device comprises a balloon made of thin polymer film that is delivered in a 15-minute outpatient visit without need for anesthesia or surgery.  It is filled with water and resides in the stomach for four months, enabling weight loss which averages between 10% and 15% of starting weight.  At the end of therapy, a patented opening mechanism is automatically activated, allowing the device to empty and pass naturally.

At the time of the MLSC loan Allurion had three employees and was still developing its technology.  The company now has more than 20 Massachusetts-based employees.  Its product, which has not yet been approved by the FDA, is currently available in select weight loss centers in France, Italy, Belgium, Greece, the U.K., Spain, Kuwait, Saudi Arabia and Qatar, with plans for a U.S. clinical trial commencing in 2017.

Allurion has also served as a host company for the MLSC's Internship Challenge Program, hosting seven interns to date for which it has or will receive salary reimbursement through the MLSC. 

Allurion’s Chairman and CEO Jonathan Wecker said “the Accelerator loan from the MLSC did exactly what we needed – it accelerated our development and allowed us to build a case for traditional private investment.  We are grateful to the MLSC for its early confidence in our potential and are proud to have returned the funds, with interest, to the Commonwealth.”

“Our Accelerator Loan Program seeks to derisk promising earlystage companies and make them more attractive to private investors,” said Massachusetts Life Sciences Center President & CEO Travis McCready.  “We were pleased to provide early financial and workforce support to Allurion, both through our Accelerator Program and our Internship Challenge Program, as they built their company and developed this promising technology.  We look forward to seeing the ongoing positive impact that their technology will have on patients around the world.”

“The biotech sector is thriving across the state, and Allurion is a terrific example of innovation and entrepreneurship here in MetroWest,” said Senator Karen E. Spilka (D-Ashland). “This is a MLSC success story of a targeted investment in the life sciences cluster creating jobs and advancing critical technology. I look forward to continuing the state’s partnership with Allurion and other innovative life sciences companies in our community.”


“It is great to see that the MetroWest continues to be a leader in the research and development of life sciences,” said Representative David Linsky (D-Natick). “I look forward to the future projects that will come out of Allurion.”

SAPA-NE Career Development Symposium Career in Biotech Start-up and Entrepreneurship 
– Translating Research into Business, Ideas/Technology into Pipelines/Products 
MIT Maclaurin Building 4-370 182 Memorial Drive (Rear), Cambridge, MA 02138 
Saturday 1-6 PM, March 18, 2017 

Welcome to attend the 19th SAPA-NE Career Development Symposium on Saturday, March 18th, 2017 at MIT Maclaurin Building. The biopharma industry entrepreneurs and the experts in legal and venture capital will share their experience and perspective in successfully founding, managing or investing in biotech start-up(s) and overall insight and visions on scientific innovation and biotech entrepreneurship. The meeting will also provide the attendees an excellent opportunity to network with biopharmaceutical professionals around Boston area and to access some new job openings posted onsite. The Plenary Session Speakers include: Yi Zhang, Ph.D., a HHMI Investigator and Professor of HMS and BCH, and a co-founder of Epizyme Joy Alamgir, Entrepreneur, Founder, EVP and CSO of Consilience Software, A Xerox Company Chong Xu, Ph.D., Associate, F-Prime Capital Partners, Boston Ruhong Jiang, Ph.D., a co-founder, president and CEO of Applied Stem Cell Fang Xie, Ph.D., Of Counsel, Greenberg Traurig, LLP, Boston Follow by a panel discussion with all speakers plus Wei Zhao, Ph.D., Associate, Wuxi Healthcare Venture Online registration: http://sapa-neweb.org/CDS2017.php This event is free for SAPA-NE members and MIT students; $30 for non-members; $15 for students. (coorganizer MIT-CHIEF) SAPA-NE Career Development Symposium Organizing Committee 

U.S. Department of Homeland Security to Keynote at Biosurveillance Integration,
part of Biodefense World Summit

The national strategy for biosurveillance calls for a coordinated approach for threats to public health and safety, bringing together federal, state and local governments; private sector, nongovernmental organizations and international partners to enhance existing biosurveillance capabilities and develop new ones that provide decision makers and responders with the essential information to manage these threats. This strategy recognizes that a well-integrated national biosurveillance enterprise can save lives by providing essential information for better decision making at all levels. The Sixth Annual Biosurveillance Integration conference will address implementation strategies for the national strategy for biosurveillance identified core functions.
Luther LindlerBiosurveillance to Protect the Homeland
Luther Lindler, Ph.D., Senior Scientist (ST), Biological Programs, Chemical and Biological Defense Division Science and Technology Directorate, U.S. Department of Homeland Security
One of the Department of Homeland Security's (DHS) responsibilities is to protect the U.S. from a biological attack. The Science and Technology Directorate, through the Chemical and Biological Defense Division (CBD), has developed a Real Time Threat Awareness biosurveillance program that integrates information data streams with new detection technologies. This presentation will discuss the interest areas and progress DHS CBD is making toward building a 21st century biosurveillance program.

Dr. Lindler joined the DHS Science and Technology Directorate in October 2003 as a Senior Science Advisor. Dr. Lindler currently serves the Senior Scientist for biological programs within the chemical and biological defense division where he provides expertise to both DOD as well as DHS about current infectious disease threats from a global perspective. He currently serves on the Joint Influenza Surveillance Working Group for DOD, is the DOD representative to the Interagency Influenza Diagnostics Working Group, as well as senior advisor to DOD Health Affairs on technical diagnostic issues that affect force health protection. He currently manages several projects related to infectious disease for the AFHSC. The most notable is to bring forward deployed rapid molecular diagnostics to DOD forward deployed forces. He also serves on the National Biodefense Analysis and Countermeasures Center review committee for DHS S&T and has participated in the national Material Threat Assessment and Biological Risk Assessment programs. His first position within DHS was as the Science Advisor for the NBACC. He helped plan the NBACC forensics and threat characterization programs as well as the first DHS laboratory building on the Fort Detrick National Biodefense Campus. Before joining DHS, Dr. Lindler was a leader in the US Army Biodefense program. He was a principle investigator at the Walter Reed Army Institute of Research leading a team of professionals studying the pathogenesis of the plague bacterium. He served on the Army’s plague vaccine steering committee and the emerging threats steering committee within the Biodefense program. The peak of his career with the Army culminated with his senior editorship of the well-acclaimed Biodefense book entitled, “Biological Weapons Defense; Infectious Diseases and Counterbioterrorism.” Dr. Lindler was a postdoctoral fellow in the laboratory of Dr. Susan Straley at the University of Kentucky in Lexington from 1987 until 1989. Dr. Lindler received his Ph.D. in Microbiology from the Medical College of Virginia in 1987, his Masters of Science in Microbiology from Clemson University in 1981 and his Bachelor’s of Science in Medical Technology from Lenoir Rhyne College in North Carolina in 1978.













WuXi NextCODE Appoints Hannes Smarason as CEO, John Long as CFO, and Alex Fowkes as COO

Appointments bolster global business expansion, operational integration and independent strategic development

NEWS PROVIDED BY
WuXi NextCODE 
Feb 28, 2017, 13:00 ET

SHANGHAICAMBRIDGE, Mass. and REYKJAVIK, IcelandFeb. 28, 2017 /PRNewswire/ -- WuXi NextCODE, a WuXi AppTec group company and the contract genomics organization enabling precision medicine worldwide, today announced that the company's chief operating officer Hannes Smarason has been appointed as the company's chief executive officer, and WuXi AppTec senior vice presidents John Long and Alex Fowkes have been named chief financial officer and chief operating officer, respectively.
"WuXi NextCODE is executing on its vision to enable anyone to use the genome to advance health and wellness worldwide," said Dr Ge Li, founder and chairman of WuXi AppTec group and chairman of WuXi NextCODE. "It is also positioning itself as the data management platform at the heart of the genomics revolution and what may become the world's largest data ecosystem. Hannes, John and Alex have the breadth of vision and proven executive capabilities to carry out this strategy and advance the company to the next level."














"This is an exciting time at WuXi NextCODE, as we work on leading projects in every facet of genomics and advance a global standard for the way genomic data is organized, mined and shared," said Mr Smarason. "John and Alex's leadership and experience in life sciences finance and operations, and in the recent independent listing of other WuXi AppTec companies, will be invaluable as we grow our business and forge our own strategic path. We are very pleased to have them join our team and offer them a warm welcome to WuXi NextCODE."
Hannes Smarason co-founded NextCODE Health in 2013 as a spinout from deCODE genetics. He oversaw NextCODE's acquisition by WuXi AppTec in 2015 and its merger with the WuXi Genome Center to create WuXi NextCODE. He served as COO until January 2017 and as CEO will lead the company's overall business and corporate strategy.
John Long has served as WuXi AppTec's senior vice president of finance since 2013. He was actively involved in WuXi AppTec's privatization from NYSE in 2015 and played important roles in WuXi AppTec's subsequent corporate restructuring, supporting WuXi Biologics's recent IPO filing process in Hong Kong as well as private placements in the China capital market. John has over twenty years' experience in financial management, investment and operations in the US, China and Singapore, and prior to joining WuXi AppTec served in senior roles at Willis Group, Tyco International and Lucent Technologies. In addition to finance and operations leadership, he will provide WuXi NextCODE with global expertise in governance, reporting, strategic planning, treasury and tax. John holds a bachelor's degree in economics from the University of International Business and Economics in Beijing and received his MBA from Wharton School of Business at University of Pennsylvania.
Alex Fowkes has twenty years experience in the life science industry in operations, business development, strategy and legal roles. He joined WuXi AppTec in 2012 initially to lead corporate development and then most recently serving as senior vice president of commercial operations. Prior to WuXi Alex served in a variety roles for Pfizer in the US, UK, Australia and China over 14 years.
About WuXi NextCODEWuXi NextCODE is a fully integrated global contract genomics organization. With offices in ShanghaiKendall Square in Cambridge, Massachusetts; and Reykjavik, Iceland, we offer comprehensive services that enable population, precision medicine, diagnostics and wellness initiatives and enterprises to use the genome to improve health around the world. Our capabilities span study design, sequencing, secondary analysis, storage, and interpretation and scalable analytics – all backed by the most proven and widely used technology for organizing, mining and sharing genome sequence data. We are also applying the same capabilities to advance a growing range of sequence-based tests and scans in China. WuXi NextCODE is a WuXi AppTec Group company. Visit us on the web at wuxinextcode.com.