Blood, plasma, serum, bile, urine, feces, cerebrospinal fluid (CSF), bone marrow, tissue (liver, brain, kidney, etc.) or tumor specimen
Mouse PK: Serial bleeding
5-10 working days for small molecules
5-10 working days of bioanalysis for large molecules (the entire study turn-around time is dependent on in-life sampling period)
Large Animal PK/TK
In-house dog colony: 48 Beagle dogs
Administration Routes: PO and IV (bolus, infusion), SC, IM
Crossover or non-crossover; fast/fed (food effect); excretion pathways, PK/PD evaluation
In-house and partner NHP colonies: 60 Cynomolgus monkeys (Rhesus monkeys also available)
Partner: dosing, sampling, and clinical observation
BioDuro-Sundia: study design, vehicle selection and formulation preparation, monitoring for dosing and sampling, bioanalytical method development and sample analysis, and report writing
Crossover or non-crossover; fast or fed (food effect); cassette-dosing; excretion pathways; excretion pathways, PK/PD evaluation
10 working days for non-naive dogs & monkeys
5-10 working days of bioanalysis for large molecules (the entire study turn-around time is dependent on in-life sampling period)
Excretion pathways: biliary vs urinary
Blood Brain Barrier (BBB)
Drug-drug inhibitory interaction
75 IV/PO PK Studies/Week
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
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.
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.
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.
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.
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
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.
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
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.
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.
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.
Developed the extractable/leachable capabilities at PPD
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).
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)
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.
25 years of healthcare industry experience including Eli Lily and Boehringer Ingelheim.
Former Director of Corporate Business & Enabling Strategy at oehringer Ingelheim in Germany.
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
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
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
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.
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
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