保诺推出新策略,满足分析服务市场千变万化的需求

激烈竞争伴随强势增长

在2015年的全球医疗保健分析测试服务市场中,生物分析服务占据了最大份额,这反映出制药行业大分子药物的比例不断上升,预计在未来这一趋势仍将继续。另一方面,据Markets and Markets预测,在未来五年,批放行测试增长将超过其它测试环节。

目前,凭借其优质的服务供应商和高质量的标准,以及该地区生物仿制药和生物制剂业务的快速增长,北美垄断了医药分析测试服务市场。然而,由于印度和中国公司在成本上占有优势,导致亚太地区外包分析服务市场增速迅猛,同时也充满挑战,尤其是在服务质量和知识产权保护方面。在中国,其食品药物管理局正在积极应对服务质量的问题,政府已发布更加严格的规定并开始取缔不合规的公司。预计这一系列措施将刺激中国的外包服务市场的发展。

制药分析测试服务市场的强势增长吸引了很多新兴企业进入该行业,直接加剧了对现有独立服务商的竞争。今天,很多有分析能力的外包服务商(CDMOs),不论是大型的还是小型的,除了支持自己的开发制作业务外,也开始向外提供分析服务和相关专业知识。专门提供分析服务的众多小型公司也进入市场,凭借其在价格和周转周期上的优势加入竞争。

 

外包允许资源重置

不仅只是新药,包括药品开发,药物制剂和药品生产过程的复杂程度都在持续递增。因此,生物制药企业不得不最大限度的利用项目资源。因此,选择将类别繁杂但又比不可少且对专业技术要求不高的分析业务外包出去成为一种行业常态。

 

分析方法的开发,包括优化和转移,分析方法验证,放行测试,稳定性研究和相关测试(例如,微观测试)以及原材料测试,是制药企业所必需的且最经常被外包出去的核心服务。通过外包,药企自身的资源得到解放并重置到更具有挑战性的研究和产品开发上,以及/或与特定药品相关的复杂程度较高的/专属的研究上。放行,稳定性和原材料测试是高度商品化的分析服务,将此类分析研究外包或可为药企节约成本。

 

当然,也不乏有些例外,企业为了追求研发技能及研发设备的专业性而选择外包服务。近年来,随着越来越普遍地大规模采纳单次使用技术,对萃取和溶出(E&L)测试的需求也有所增长。对API和药品描述的市场需求也直线上升。而E&L分析和描述研究都需要特定的仪器(质谱仪和核磁共振成像系统)来完成,大部分公司无法负担购买和维护这类仪器的费用,也不具备会操作这些仪器并能解读测试结果的专家。因此,这类仅发生在新药申请前的测试业务的外包量也随之增加。

 

质量、成本和周期时间都很重要

虽然节约成本是(生物)制药公司起初选择外包服务的主要原因,但现在,选择外包服务远不仅仅是为了减少项目费用。事实上,据2016年Nice Insight CDMO外包调研(n=587)显示,提高质量成为了选择外包服务的第一目的,其次是减少药品进入市场的时间,提高效率,最后是减少成本。

 

在寻找分析外包服务商时,制药企业看重的是技术性能的质量,例如数据的质量,工作绩效,以及有关合规方面的问题。特别关注服务商是否具有在项目早期辨认不合格(OOS)材料的能力以及是否具有积极处理该类型问题的能力;因为,如果不合格材料在项目后期被发现,很大程度上能克会导致项目进程受阻。

 

当然,成本仍然是选择外包服务的一大原因,尤其对于很多已经商品化的服务而言。然而,大部分客户在选择合作伙伴的时候并不会把成本单独列出来作为考虑因素。成本和价值比才是决策之道。大部分客户愿意为可量化的附加价值支付额外费用。

 

对于分析服务而言,快速的周转周期对于客户的成功至为关键,这或许同样适用于其他的外包服务

对于分析服务而言,快速的周转周期对于客户的成功至为关键,这或许同样适用于其他的外包服务。分析测试的结果是客户在药物开发过程中制定关键决策的必要条件。因此,分析服务供应商可对项目的各个阶段产生影响,包括制剂筛选、制造工艺的决策和临床试验材料的释放等,列举其中一二。

 

对于小型和新兴的(生物)制药公司而言,在其选择分析测试服务商时,是否具备有关监管方面的专业知识显得尤为重要。这类公司从最初提出新药申请和NDA申请到后期回答监管部门的问题通常需要服务商的协助。如果供应商对药品开发过程和政府监管要求有深入广泛的了解,并且可提供定制化的支持,该供应商将被视为能提供真正附加值。此外,如果外包合作伙伴——包括分析测试服务供应商——可提供创新合同选择,例如创新的风险共担模式,专属的资源(FTE模式)以及其他金融激励方案等,也受到了这类公司的青睐。

 

新策略撬动发现和开发的专业知识

作为针对一体化药物发现和开发、化学、DMPK、API合成和优化、制剂开发和cGMP生产提供终端对终端解决方案的供应商,凭借其全面专业的分析测试能力,保诺可对客户从药物发现到临床试验材料生产的整个药物开发过程进行全方位支持。目前,保诺推出一项新策略,通过撬动其分析能力潜能,引进独立的分析服务,满足制药行业对高质、快速的分析测试服务不断增长的需求。

 

凭借其在发现和开发方面相关的分析专长,保诺可在药物开发的全部环节对客户进行支持,包括发现和候选药物筛选的研究;临床前到临床的实验内容,包括API合成,筛选和描述;制剂前到制剂开发的实验内容;以及试产批(engineering batch)和临床试验材料生产。在CMC药品开发过程中,分析数据对几项关键决策起到推动作用。拥有一支在分析方面掌握正确的实操知识和工具的专家团队,缩短科学决策的时间,是每一个研发项目成功的关键。

 

通过提供独立服务,保诺可充分利用其分析方面的专长,从项目早期阶段一直到临床试验后期对客户进行支持。类似保诺这样的CRO或者CDMO公司所提供的分析服务,其优势之一就是这类公司对API和药品的物理、化学和生物属性以及对制剂和生产工艺所面临的挑战问题都有更充足的理解。这一优势使得保诺能够更有效地研发和优化分析方法。凭借该新策略,保诺移除了独立分析外包商在支持药物开发不同阶段时普遍面临的难题。

 

由于缺乏API和剂型开发工艺的背景知识及经验,在筛选最佳分析路径、解决非典型或非常规的分析数据等问题方面,独立的分析外包服务商经常会显得手足无措。保诺内部各部门之间开展广泛的合作,凭借其在化学、DMPK、加强溶解度和生物利用度方面的出色能力,协助客户快速找到问题解决方案,提前识别问题的严重程度, 使分析服务对整个项目周期、质量及成本方面的负面影响降至最低。

 

通过该独立分析服务,新客户可全方位评价保诺在制剂开发、生产及其他领域的服务能力。该新型的独立分析服务,充分调用了保诺的服务链条,预计将会为公司带来更多业务。另外,将分析部门从纯粹的支持性部门转变为公司内部其他业务的关键驱动,旨在增加公司所提供的服务的内在及外在价值。

 

作为一家在新兴领域拥有专长的小型CDMO公司,保诺有出色的敏捷度和反应能力,能够与追求卓越灵活性和反应能力的小型/新兴制药企业达成深度合作,并对其在研发技术和项目管理方面进行额外支持。凭借其对药物发现和CMC药物开发流程的深厚知识经验,保诺能够并愿意协助其合作伙伴补全不足,加快项目开发周期。

 

结论

目前,越来越多的生物制药公司选择将内部资源利用在高度复杂及专属性较强的研究活动上,因此,市场对分析测试服务的需求不断增加。提供分析服务解决方案的保诺科技,拥有发现和开发两个部门,可为客户提供有别于其他CDMO通常无法提供的专业分析服务,在项目早期建立分析策略、解决分析方法难题,为客户减少项目风险,节约成本。

 

参考

Healthcare Analytical Testing Services Market worth 4.13 Billion USD by 2021. Markets and Markets. 30 May 2016. Web.

The 2016 Nice Insight Contract Development & Manufacturing Survey. 2016.

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

San Diego - BioDuro-Sundia

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,China

Taiwan Sundia

Our site in Taiwan, China 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, China

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