保诺科技推出人体肿瘤微环境3D药物筛选和源自患者的异种移植物验证平台:h TME-3DX筛选和验证™

圣地亚哥,3月29日,2017 /PR Newswire/——保诺科技今日宣布正式推出hTME-3DX筛选和验证平台,这个平台以300个具有代表性的癌症患者的肿瘤样本为基础, 是世界上第一个以模拟人体肿瘤微环境的三维肿瘤培养进行体外筛选, 以及拥有与其匹配的患者来源的异种移植瘤(PDX)库来进行体内验证的抗肿瘤药物的研发平台。


该基础肿瘤标本库和三维细胞培养基技术,由Molecular Response开发,目前独家授权保诺科技提供相关外包服务。

 

从发现到临床使用,癌症药物漫长而昂贵的交付过程仍旧是一个挑战,这一点从化合物获得监管批准的低通过率就可见一斑。导致一期药物90-95%的临床失败率的部分原因在于目前所使用的临床前模型对转化预测较差,这其中就包括2D细胞株和肿瘤异种移植物模型。近期,提高转化成功率的研究都集中在对代表性更好、更加有效且与人体肿瘤生物学更相关的模型的开发和使用上。

 

传统的细胞株模型对体内有效性预测差,而动物体内实验成本高昂且耗费时间。hTME-3D筛选和验证平台通过利用患者早期的肿瘤样本来处理人体肿瘤细胞在环境上和生理学方面所呈现的复杂性,该早期肿瘤样本在专门的培养基中三维生长,保留了人体肿瘤微环境核心的病理生理属性。

 

作为不同于2D细胞培养基模型的另一个选择,体内患者来源的异种移植瘤(PDX)模型保留了肿瘤结构,将肿瘤从患者体内直接移植到小鼠体内,能更好地反映出肿瘤遗传多样性和生物相关性,是更具有临床转化意义的模型。作为体外测定方法,hTMD-3D筛选和验证平台能减少临床前阶段的动物测试;保持筛选通量的同时提高成本时间效益,并增加整体数据包的相关性。“癌症药物在临床试验阶段的高失败率以及将此类药物推进到临床试验阶段的巨大成本费用对更好的临床前模型呼之欲出,以实现快速辨认低转化值的化合物,并加快那些选择性和效能出众的化合物的研发进度,”保诺主席兼CEO Cyrus K. Mirsaidi说。“hTME-3DX筛选和验证平台是针对新药和药物组合的一个高级筛选平台,该平台可减少肿瘤药物发现的总成本,通过与之匹配的体内模型的验证,为其临床相关性给予额外保证。”

 

hTME-3DX筛选和验证平台的开发主要基于一个获得专利的基础肿瘤标本库和Molecular Response公司所开发的3D药物筛选平台,集合了过去十年大量的学术和商业研究,以及关于体外细胞培养基和人体肿瘤样本保存的内部专业知识。“为了对癌症药物效能有更好的理解,我们需要与实际更接近的筛选环境,而hTME-3DX筛选和验证平台可提供了优化为人体肿瘤微环境的模型,”Molecular Response的CEO Brett Hall博士说道。“与其他测定相比,hTME-3DX筛选和验证平台可更加有效地模拟人体肿瘤的核心病理生理条件。”

 

如果想获得更多关于hTME-3DX筛选和验证平台或者想要了解更多关于保诺科技肿瘤学的服务,请通过邮件联系保诺或者浏览www.bioduro.com。 保诺科技将参加在美国华盛顿举行的2017年美国癌症研究学会(AACR)年会。您可以在4月2-5号期间到保诺科技的展台1358与他们的专家进行面对面交流,了解保诺可如何支持您的肿瘤学项目。

 

关于保诺科技

 

保诺科技是一家领先的全球性生命科学研发公司,专业为生物制药客户提供从靶标识别到新药临床试验申请,再到临床试验用药GMP生产的综合的整合性药物研发服务。保诺科技在大小分子发现、研发和放大方面拥有深厚而丰富的治疗专业知识,结合其独一无二的技术平台,例如3D药物筛选平台和针对不溶解化合物生物利用度增强平台,在大幅度加快客户先导化合物发现项目的进度、降低研发项目风险获取高价值成功方面拥有得天独厚的条件。详情请见www.bioduro.com

 

保诺科技隶属Bridgewest集团,该集团是一家在全球范围内专注于高新技术和无线技术、生物医药科技、房地产、金融和资本市场的投资公司。详情请见http://bridgewestgroup.com/

 

关于Molecular Response

Molecular Response拥有最先进的生物样本库设备,使用智能设计的肿瘤模型,发现创新肿瘤药物。我们的目标是利用先进的、有临床相关的分子应答和生物标记数据的人体生物平台加速创新或改良的治疗药物的开发进程和项目。如想了解更多相关信息请登录我们的网站: www.molecularresponse.com

 

David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicky Traded and Private companies in the fields of Phammaceuticals, Animal Health and Biotechnology as a Board Member. The last 30 years of his xperience has been in China, Taiwan and Hong Kong building successful igh growth businesses. David Has been Chaiman and CEO for Greater China for Sanofi and Boehringer – Ingelheim as well as the Janssen Corporation since 1991 in China. During this time he build high Growth ousinesses in China through diversified strategies in Innovative Pharmaceuticals. branded Generics. Biotechnology. and Animal Healthcare.

Key highlights in this period indluded building of the first Westem Multinational Biotechnoloqy C.M.O. facility as well as obtaining the first Test CM.OJ MAHI license. Establishment of a number of High tech Vaccine Plants, and R and D facilities in in the field of Animal Health. Signing and development of numerous JV’s as well as Wholly owned Subsidiaries. Mergers and Acquisitions across Phamaceutical’s. Animal Health. and Biotechnology industries

David’s achievement’s in the Healthcare industry and it Growth and development in China is widely recognized By the Chinese Govemnment and the City of Shanghai In 2013 he was awarded the Silver Magnolia ollowed in 2015 the Gold Magnolia award. This was then followed by being awarded in 2017 the Honorary Citizen of Shanghai by 40th People’s Municipal Congress of Shanghai. David Holds a Business Science Degree

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Filippo
Filippo de Vecchi

Director, Advent Partner

Filippo de Vecchi joined Advent in February 2000. He started in the Advent São Paulo office, then moved to Milan in 2002, in 2012 set up the Advent office in Shanghai and in 2016 set up the Hong Kong office. Before joining Advent, he was a senior consultant with Value Partners, in São Paulo and Milan, focusing on strategy and organization in the automotive, energy, cable and media sectors. He began his career at Wasserstein Perella & Co., working as an analyst in the Mergers and Acquisitions department in London and New York. Filippo holds an undergraduate degree cum laude in Economics, with a major in Business Administration, from the LUISS University and an MBA from Columbia Business School, where he currently serves as a member of the Board of Overseers.

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Andrew Li
Andrew Li

Director, Advent Partner

Andrew Li joined Advent in 2012. He previously worked at Warburg Pincus, HSBC PE, Solera Capital and Credit Suisse where he focused on the retail and consumer, healthcare, industrial, and energy sectors. Andrew has worked in finance and private equity throughout the U.S. and China since 1999. Andrew holds a BA from Middlebury College and an MBA from Harvard Business School.    

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Michael Miltenberger
Michael Miltenberger

Director, Advent Partner

Michael Miltenberger  joined Advent in 2011 as an associate on the healthcare team. Following business school, he rejoined Advent’s Boston office, focusing on healthcare investments. Prior to Advent, Michael was a consultant at McKinsey & Company in their Washington DC office, serving a range of healthcare and private equity clients. Michael earned a BA, cum laude, from Harvard College and an MBA from Harvard Business School, graduating with High Distinction as a Baker Scholar and a Harvey Fellow.

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Masood Tayebi
Masood Tayebi, PhD

Director, Operating Partner

Dr. Masood Tayebi is the Founder of BioDuro. He currently serves as CEO of a nationwide real estate portfolio and is a Partner and Chief Executive Officer of the Bridgewest Group. Prior to BioDuro, Dr. Tayebi was Co-Founder and Chairman of Wireless Facilities, Inc. (NASDAQ: WFI), a global leader in telecommunications outsourcing.

Achievements
  • Co-Founder of Wireless Facilities, Inc.

  • Co-Founder of BioAtla, LLC

  • Recipient of the Ernst and Young 2000 Entrepreneur of the Year award in San Diego

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Kewen Jin
Kewen Jin, PhD

Director, Operating Partner

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Amit patel
Amit Patel

Director, Operating Partner

Amit Patel has twenty years of healthcare industry experience with publicly-traded, private equity-backed, and start-up companies in the capacity of executive, board member, advisor, and investor.  He is currently Executive Chairman of Azurity Pharmaceuticals (a NovaQuest Capital Management portfolio company) and a board member at BioDuro (Advent International portfolio company), Tergus Pharma (Great Point Partners portfolio company) and Calyptus Pharma.  Recently, Amit was SVP & President of Dosage Form Solutions at Capsugel, a KKR portfolio company (purchased from Pfizer in 2011 and sold to Lonza in 2017).   

Prior to Capsugel, he worked at Dr. Reddy’s Laboratories, Inc. as EVP & Head of North America, and SVP & Head of Global Corporate Development & Strategic Planning. Earlier, Amit was VP of Corporate Development at CTIS, Inc., and Co-founder & CEO of MedOnTime, Inc. (acquired by CTIS).  He started his career as a strategy consultant with Marakon Associates. Amit holds an M.B.A. degree from Harvard Business School, a B.S. degree in Economics from the Wharton School of Business, University of Pennsylvania, and a B.A.S. degree in Systems Engineering from the Moore School of Engineering, University of Pennsylvania.

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Haijun Dong
Haijun Dong

Chief Executive Officer

Dr. Haijun Dong currently serves as global CEO of BioDuro-Sundia. He previously was CEO for over 5 years at PharmaBlock Sciences Inc., a public company listed in the Shenzhen Stock Exchange (300725.SZ). The positions he held prior to PharmaBlock includes, among others, Senior Scientist at Boehringer Ingelheim Pharmaceuticals in Ridgefield, Connecticut; Senior Principal Scientist at Roche in Nutley, New Jersey; Head of DMPK and Drug Safety at Roche China R&D Company in Shanghai; Chief Operating Officer of Eli Lilly China R&D Center in Shanghai.

Dr. Dong received his PhD in organic chemistry from the University of Washington in Seattle, Washington, and MBA from China Europe International Business School in Shanghai. 

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Teo Nee Chuan
Teo Nee Chuan

Chief Financial Officer

Teo Nee Chuan joined us in May 2021 as chief financial officer. Prior to joining us, he was chief financial officer of Huazhu Group from November 2015 to May 2021, and was the chief financial officer for Rnomac International Limited, from November 2011 to August 2015. Mr. Teo worked in DDB Greater China Group, was appointed as the chief financial officer in September 2009, and was additionally appointed as the director of operations in January 2011. He previously served in Focus Media Group and was appointed as the financial deputy director in June 2007. Prior to that, from September 1994 to May 2007, Mr. Teo worked at Ernst & Young and Ernst & Young Business Services Ltd. in various positions in Kuala Lumpur and Toronto, including as a senior manager in the Transaction Advisory Services. Mr. Teo has been an independent director of 111, Inc. (a company listed on the NASDAQ, ticker symbol: YI) since September 2018. Mr. Teo received his Bachelor of Science in Accounting and Financial Analysis degree from The University of Warwick in the United Kingdom in July 1994. He is a Chartered Certified Accountant in the United Kingdom, who has obtained his qualification in July 1998 from The Association of Chartered Certified Accountants, and is a Certified Public Accountant in the United States and Hong Kong, who has obtained his qualification from American Institute of Certified Public Accountants in May 2002 and Hong Kong Society of Accountants in October 2003, respectively.

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TJ
TJ Deng, PhD

President, Discovery

Dr TJ Deng joined BioDuro in the initial stages of the company and helped BioDuro grow to an industry leading discovery services organization. He established and managed several scientific departments, including DMPK, before transitioning to a leader of the business and operations functions. Prior to joining BioDuro, Dr. Deng spent six years at PPD, in positions with increasing responsibilities from scientist to scientific manager.

Achievements

 

 

  • Developed the extractable/leachable capabilities at PPD
  • 18 years industry experience

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Kent Payne
Kent M. Payne, PhD

Chief Executive Officer

Kent is distinguished as a business operator and leader in areas of sales, commercial manufacturing and product development. He has extensive executive experience in M&A as well as successfully running, start up, growth and turn around businesses. This includes both Fortune 500 and Private Equity environments. He combines strong business leadership, successful P&L track record, and technical background to strategically lead and grow enterprise value across Biotechnology and Pharmaceutical market segments. He has successfully led the geographic expansion of businesses into Europe, Asia, and South America in addition to the United States.  He currently serves as CEO for BioDuro-Sundia, LLC (an Advent International company). He also currently serves as a board member for Goodwin Biotechnologies (a Signet Healthcare company). 

Prior Roles

  • President, Global CMC Solutions BioDuro-Sundia, a global
    CRDMO
  • CEO Socorro Pharmaceuticals, LLC, a generic pharmaceutical
    company
  • President Americas, Qualicaps Inc.(a Mitsubishi Chemical Holdings subsidiary)
  • Principal Consultant and Partner at CoreFactor LLC, providing executive strategic, licensing and operational advisory services to clients.
  • Vice President/General Manager Catalent Pharma Solutions, Inc. (a Blackstone Group company formed in 2007, formerly part of Cardinal Health)
  • Progressive leadership responsibility at: Novartis, Monsanto and G.D. Searle.  

Prior Brand Position

  • Board Advisor Vitruvias Therapeutics
  • Board Member Qualicaps, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board member Technophar, Inc. (a wholly owned subsidiary of
    Mitsubishi Chemical Holdings)
  • Board Advisor, Corporate Strategy Office, Life Science Institute
    Inc. (a wholly owned subsidiary of Mitsubishi Chemical Holdings)
  • Non-executive Chair and Board Member PDS Biotechnology·        (PDSB: NASDAQ)

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John Phillips
John Phillips

Vice President, Business Development (US & EU)

Coming soon…

Achievements

 

  • Coming soon…

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Roy Xu
Roy Xu

Chief Strategy Officer

Roy has over 25 years of healthcare industry experience.  He started his career as an orthopedic surgeon.  Roy joined Eli Lilly as a sales rep in 1997.  Since then he has had various roles in market research, business intelligence, BU head, strategy, regional general management, business development etc., both at Eli Lilly and Boehringer Ingelheim (BI).  Roy also spent more than two years in Germany where he was BI’s Director of Corporate Business and Enabling Strategy.

Roy obtained a bachelor’s degree in Clinical Medicine at Zhejiang Traditional Chinese Medicine University, and an MBA from Zhejiang University.

Achievements

 

  • 25 years of healthcare industry experience including Eli Lily and Boehringer Ingelheim. 
  • Former Director of Corporate Business & Enabling Strategy at oehringer Ingelheim in Germany.

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San Diego

BioDuro- San Diego Facility

Our San Diego site is our corporate headquarters. The facility is home to BioDuro-Sundia’s drug product development technologies and has 9 GMP clean rooms. Development and manufacturing operations are conducted for projects up to Phase III clinical trials.

Size: 44,000 sq. ft.
Featured capabilites: Tableting, Coating, Hot Melt Extrusion, Spray Dried Dispersion

11011 Torreyana Rd.
San Diego
CA 92121
United States

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Beijing

BioDuro Beijing

Operating since 2006, our Beijing site is home to BioDuro-Sundia’s first wet chemistry operations. With 300 regular fume hoods and 18 scale-up chemistry hoods the Beijing facility houses most of BioDuro’s chemistry operations, while also hosting labs for biology and monoclonal antibody discovery.

Size: 100,000 sq. ft. 
Featured capabilities: Radioactivity Lab, Monoclonal Antibody Discovery, Medicinal Chemistry

No. 29 Life Science Park Road
Changping District Beijing,
102206
P.R. China

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Shanghai-Waigaoqiao

BioDuro- Shanghai Facility

Established in 2012, BioDuro-Sundia’s Shanghai facility has been growing with its departments. The cutting edge facility contains labs for ADME, bioanalysis, in vitro assays and translational research. The site includes a 18,000 sq. ft vivarium and 20,000 sq. ft of office space.

Size: 92,000 sq. ft.
Featured capabilities: Scale-up Chemistry, Discovery Biology, DMPK, In Vivo Pharmacology

No. 233 North Fu Te Road
Waigaoqiao Free Trade Zone
Shanghai, 200131
P.R. China

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Cathy Yen
Cathy Yen

Director, Operating Partner

Cathy joined the Board of Directors of BioDuro-Sundia in 2020, with the Advent-led acquisition of Sundia and creation of BioDuro-Sundia. Prior to that, she was Chairman of the Board at Sundia Meditech Group, where she was the key architect of Sundia’s strategic vision and growth. Under her leadership, Sundia solidified its position as one of the leading pre-clinical CROs in China.

Prior to Sundia, Cathy had a distinguished career as a seasoned venture capitalist, having led numerous investments in high-growth companies in Asia. Cathy served as a Partner of AsiaVest Partners, TCW/YFY Ltd., a global venture capital firm, for over a decade, Vice President at Global Financial Services, Vice President at Crimson Ventures/Chinatrust Bank and Senior Manager at Fortune Capital. She brings over 20 years of experience in corporate finance, accounting, strategic planning and private equity investments. 

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Wuxi

Wuxi - BioDuro

Established in 2019, BioDuro-Sundia’s fully integrated discovery facility located at the heart of Jiangsu Wuxi Life Science & Technology Industrial Park with plans of growing staff to 1000+ scientists.

Size: 300,000 sq. ft.
Featured capabilities:
Discovery Chemistry & Biologics, Biology, DMPK, Pharmacology, CMC Services

no.1699,Huishan avenue
Huishan Economic 
Development Zone,Wuxi
P.R. China

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Hebei

Hebei - Sundia

Established in 2011, this pilot plant this handles mg to kg scale up.

Size: 45,208 sq. ft.

Featured capabilities: SFFS Chemistry: mg to kg scale up
(150 hood)

238 Changjiang Road
Shijiazhuang,
Hebei province
P.R. China

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Taiwan

Taiwan Sundia

Our site in Taiwan supports Discovery Biology and Chemistry.

Size: 3,352sq.ft.
Featured capabilities: Chemistry;Biology

7F, No. 107, Sec. 4
Ren Ai Road,
Da-an District,
Taipei, Taiwan

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Bengbu

Bengbu - Sundia

Scheduled to open in fall of 2021, this site is designed to handle non-GMP manufacturing, advanced intermediates, GMP starting material(RSM) for IND enabling sttudies as well as clinical and commercial use. 

Size: 43,056 sq. ft.
Featured capabilities: Intermediates, GMP starting materials

Mohekou Industrial Park,
Huaishang District, Bengbu, 
Anhui province
P.R. China

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Shanghai-Changli

Shanghai Changli

Our Shanghai-Changli site supports FTE cheimistry and advanced Discovery Chemistry processes.

Size: 71,844 sq. ft.
Featured capabilities: Chiral Analytical Lab, Analytical and Purification Lab, NMR Lab, Synthetic Lab, Parallel Synthesis Lab, Flash Chromatography Lab..(380 hoods)

法拉第路251号8号楼;
Building 8, 251 Faladi Road,
Zhangjiang Hi-Tech Park,
Shanghai, China
P.R. China

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Shanghai-Halei

Shanghai Halei

Opened in 2018, BioDuro-Sundia’s Shanghai-Halei contains facilities that support both Discovery and CMC parts of the drug development & manufacturing process. Facilities include amorphous dispersion techniques like SDD & Discovery Biology.

Size: 31,043 sq. ft.

Featured capabilities: Formulation : Preformulation, Wet Granulation, Compression, Tablet Coating, Fluid Bed Room, Spray Dryer, Hot Melt Extrusion, Dry Granulation Biology: Kinase selectivity, Cellular Assay, Compound Screen, Immune oncology service

哈雷路917弄1号;
Building 1, 917 Halei Road,
Zhangjiang Hi-Tech Park,
Shanghai, China

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Shanghai-Kelun

Shanghai Kelun

Established in 2008, our Shangahi-Kelun site is desgined to handle advanced process and analytical chemistry including process GMP and non-GMP kilo lab.

Size: 98,503 sq. ft.

Featured capabilities: general chemistry; Process: GMP & non-GMP kilo lab, Process analytical, Column Purification , Flow Chemistry. Analytical: 22 HPLC/UPLC. 8 Stability Chambers . DMPK: animal PK, Bioanlysis Metabolite ID, In Vitro Studies, In- Life studies

Building 8, 388 Jialilue Road,
Zhangjiang Hi-Tech Park,
Shanghai China, 201203

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