WEBINAR SPEAKERS

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WEBINAR SPEAKERS

Dr. Ketan Patel

St. John’s University – Assistant Professor of Pharmaceutical Sciences

Presentation: Development of self-medicated formulations of Remdesivir for COVID-19: Extended release in-situ depot and pulmonary liposome

Date: April 6th

Dr. Patel is working as an assistant professor of pharmaceutical sciences at St. John’s University, NY. He holds a Ph.D. in Pharmaceutics from the Institute of Chemical Technology, Mumbai, India. The major focus of his research group at St. John’s University is to develop a translational drug delivery system/formulations for improving the efficacy and/or patient compliance. Dr. Patel has authored more than 50 research publications in prestigious, peer-reviewed journals in the area of pharmaceutics, 3D printing, opioid abuse deterrent formulation, pre-exposure prophylaxis of HIV, investigating novel class of anticancer molecules and development of tumor targeted nanoparticles. He has five US patents on innovative formulation technologies. Dr. Patel received a Melanoma Research Scholar Award from Outrun the Sun, Inc. and a National Institutes of Health grant for his research on development of nanomedicine of Proteolysis Targeting Chimera (PROTAC) for the treatment of metastatic melanoma.

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Dr. Sean McMahon

Ashland – Business and Technical Manager

Presentation: Extended Release Injectables: ViatelTM Bioresorbable Polymer Design for Success

Date: Feb 23rd, 2021

Dr. Seán McMahon is the Business and Technical Manager for the ViatelTM bioresorbable polymer portfolio at Ashland, supporting customers with key excipients/materials and technical solutions in the development of extended release parenteral drug delivery formulations, medical devices, tissue engineering scaffolds and cosmetics.

He joined Ashland as part of the Vornia Ltd. acquisition in 2018 where he previously held responsibility for the company’s major business functions in his role as CEO. During his time at Vornia Ltd., he led development of the company’s major intellectual property platform for production of bioresorbable polymers. He has extensive knowledge of bioresorbable polymer design, chemistry and processing technologies used in medical applications. This experience comes from working on large research and commercial projects delivering bioresorbable polymer-based solutions for orthopedic, cardiovascular, neurological, oncology, wound-care, dental, ophthalmic, regenerative medicine and wider drug delivery technologies.

Dr. McMahon has published several research/review papers on polymer design for medical applications. He obtained his B.Eng. and M.Sc. from the National University of Ireland, Galway (NUIG) and his Ph.D. from the School of Medicine and Medical Sciences at the University College Dublin (UCD), Ireland.

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Tim Smith

Freund-Vector Corporation – Senior Process Development Scientist

Presentation: Bottom Spray (Wurster) Coating: Understanding the Challenges, Processing & Scale-Up Considerations

Date: March 16th

Tim has been involved in the design and development of equipment and processes for the pharmaceutical, food, and confectionary industries for over 35 years. Currently serving as a Senior Process Development Scientist with Freund-Vector Corporation. Previously served as a Research Associate, Application Engineer, R&D engineer, R&D project manager, and Laboratory Manager.

Presentations have included seminars at University of Tennessee, University of Mississippi, University of Maryland, Colorcon, E&G, Evonik, FDA, Interphex, Lubrizol, TechSource, AAPS annual meetings, Freund-Vector’s technical courses and numerous domestic/international customer facilities.

Lead author of “Development, Scale-up, and Optimization of Process Parameters: Roller Compaction”, Chapter 31 in Developing Solid Oral Dosage Forms edited by Yihong Qiu, Yisheng Chen, Geoff G.Z. Zhang, Lirong Liu, and William R. Porter, 2008.

Educational background is in Chemical Engineering (B.S.) and Food Science (M.S.) – Iowa State University.

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Charles Vesey

Colorcon, Inc. – Formulation Technology Manager

Presentation: Formulation Strategies and Tools for Accelerated Development of Solid Oral Dosage Forms

Date: March 9th

Charles Vesey has more than 20 years of experience in solid oral dosage form development and is currently a Formulation Technology Manager in the Market Development group at Colorcon, Inc., located in Harleysville, Pennsylvania. Charles received both his Bachelors in Pharmacy and Masters in Pharmaceutics from the Philadelphia College of Pharmacy at the University of the Sciences in Philadelphia. Charles began his career at Colorcon as a Research Associate in the Global Technology Development group where he focused on film-coating formulation, raw material qualification, process optimization, and scale-up. His current work is in the area of drug product design to make better tasting medicines for pediatric and geriatric populations to help positively impact patient compliance. More broadly, Charles interests include formulation and process troubleshooting of solid oral dosage forms with emphasis on multiparticulate controlled-release products. Charles has contributed numerous research publications and conference presentations in the area of modified release technologies. He is a member of the American Pharmacists Association (APhA), a licensed pharmacist in the Commonwealth of Pennsylvania, and a United States Pharmacopeia (USP) Expert Committee Member (volunteer).

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Dr. Larry Ereshefsky

Hassman Research Institute and CNS Research – CSO, Early Phase Development

Presentation: Optimizing Formulations in Early Phase Development: The view from the ‘clinical’ side

Date: April 27th

Dr. Ereshefsky is an internationally recognized thought leader in clinical translational central nervous system research with a proven track record in designing Phase I/IIA and clinical pharmacology studies. He is a leader in the application of translational drug development tools, and in the use of signal detection strategies to minimize placebo response. He is a retired Regents Professor of Pharmacy, Psychiatry, and Pharmacology from The University of Texas/UT Health Science Center. Subsequently, he was the VP, Principal Clinical Pharmacologist, and Global CNS Leader for Early Phase at PAREXEL.

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Dr. Changquan Calvin Sun

University of Minnesota (UMN) – Professor of Pharmaceutics and Director of Graduate Studies

Presentation: Material-sparing and expedited development of tablets for early clinical testing

Date: April 13th

Dr. Sun is Professor of Pharmaceutics and Director of Graduate Studies at the Department of Pharmaceutics, University of Minnesota (UMN). After receiving his Ph.D. in Pharmaceutics from UMN, he worked in the pharmaceutical industry for 8 years before joining the UMN in 2008. Dr. Sun’s research focuses on formulation development of tablet products through appropriate application of materials science and engineering principles, including 1) crystal and particle engineering for superior powder flow and compaction properties; 2) solid state chemistry and engineering, and 3) pharmaceutical unit operations, e.g., blending, granulation, and tableting.
Dr. Sun is an expert in the areas of solid-state science, tablet formulation design, and powder technology. He has published over 200 peer-reviewed papers in these areas with more than 7,800 citations (H-index of 46). Dr. Sun currently serves on the editorial advisory boards for J. Pharm. Sci., Int. J. Pharm., Mol. Pharmaceutics, and Pharm. Res. He has served on the Expert Committee in Physical Analysis of the United States Pharmacopeia since 2010. Dr. Sun is an AAPS Fellow and a Fellow of Royal Society of Chemistry. He has received a number of awards, including the 2019 Ralph Shangraw Memorial Award by International Pharmaceutical Excipient Council (IPEC) for his outstanding research contributions in the study of excipients or excipient-related technology over a number of years.

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Dr. Tom Tice

Evonik Corporation – Senior Director, Technical Global Marketing

Presentation: Lactide/Glycolide Parenteral Excipients for Successful Drug Delivery Solutions

Date: March 23rd, 2021

Thomas R. Tice, PhD, Senior Director, Technical Global Marketing, Evonik Corporation, provides scientific support to Evonik’s product development, sales, M&A, and intellectual property teams. Dr. Tice is internationally recognized for research in drug delivery and has lectured on the topic throughout the world. His specialties include complex parenteral dosage forms and bioabsorbable polymers. He has over 40 years’ experience developing injectable, extended-release microparticles and implants made with bioabsorbable lactide/glycolide polymers. He led the team and is one of the inventors that developed the first commercial, injectable, extended-release microparticle product. This product is Decapeptyl® SR, a one-month LHRH formulation indicated for the treatment of prostate cancer. Dr. Tice earned his PhD in Biophysics from Syracuse University, New York. He holds 48 US patents with many foreign equivalents and has more than 180 publications, presentations and invited lectures to his credit. He currently serves on the Board of McWhorter School of Pharmacy at Samford University. He has served on United States Pharmacopeia expert committees for 15 years dedicated to improving global health through setting pharmaceutical standards; presently serving on the General Chapters-Dosage Forms Expert Committee and Excipient Joint Committee.

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Abu Serajuddin

St. John’s University – Professor of Industrial Pharmacy

Presentation: Title to be announced

Date: March 2nd, 2021

Abu Serajuddin, PhD, is Professor of Industrial Pharmacy at St. John’s University, Queens, New York, USA. Prior to joining academia in 2008, he worked in the pharmaceutical industry for 32 years in scientific and managerial positions. In his latest positions in the industry, he served as Executive Director and the US Head of Pharmaceutical R&D at Novartis Pharmaceutical Corp. Currently, at St. John’s University, he has built a world-class teaching and research program dedicated to the development of drug delivery systems and pharmaceutical processing technologies, including melt extrusion. He has published over 120 papers and book chapters, and he is a coinventor in 13 patents. He also made 145 invited presentations in national and international conferences. In recognition of his scientific and professional achievements, he was elected Fellow of American Pharmacists Association (APhA) and American Association of Pharmaceutical Scientists (AAPS). AAPS also recognized him with 3 of its highest awards, namely, AAPS Research Achievement Award in Formulation Design and Development in 2010, AAPS Research Achievement Award in Manufacturing Science & Engineering in 2014, and the AAPS Lipid-based Drug Delivery Outstanding Research Award in 2015. For his academic and research excellence as a member of the faculty, St. John’s University bestowed him the University Medal for Outstanding Achievement in 2019.

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Dr. Dave A. Miller

Vice President  – Research and Development at DisperSol Technologies

Presentation: The Importance of Particle Properties on the Biopharmaceutical Performance of Amorphous Solid Dispersions

Date: March 30th, 2021

Dave A. Miller, Ph.D. has served as Vice President of Research and Development at DisperSol Technologies since 2011. Prior to joining DisperSol, he was a Senior Principal Scientist at Hoffmann-La Roche, Inc. in Nutley, NJ. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through various stages of development from early discovery to commercial-ready stages. Dr. Miller was an original inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a primary innovative driver for application and expansion of the platform. He has published 35 research articles in peer-reviewed journals, authored 7 book chapters, and is co-editor of the First and Second Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He has 8 granted patents in the United State and numerous pending applications. Dr. Miller holds a B.S. in Chemical Engineering and a Ph.D. in Pharmaceutics from the University of Texas at Austin.

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Dr. Dana E. Moseson

Purdue University – Postdoctoral Research Scientist

Presentation: Crystallinity: A Complex Critical Quality Attribute of Amorphous Solid Dispersion

Date: May 11th, 2021

Dana Moseson joined the Department of Industrial and Physical Pharmacy in the fall of 2016. Prior to coming to Purdue, she received her bachelors from Penn State University and then spent 10 years at Emerson Resources in Norristown, PA specializing in formulation development and clinical supplies manufacturing. Under the direction of Professor Lynne Taylor, Dana’s dissertation work has investigated the processing and performance of hot melt extruded amorphous solid dispersions, in particular seeking mechanistic insight into the performance impacts of residual crystallinity. Her research has won several prestigious awards, including the National Science Foundation Graduate Research Fellowship (NSF GRFP 2018-2021), International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) Graduate Student Award (2019), and National Institute for Pharmaceutical Technology and Education (NIPTE) Outstanding Student Research Scholarship (2020). She is currently a postdoctoral researcher at Purdue University.

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Dr. Mark A. Tracy

Tracy BioConsulting, LLC. – Founder and President

Presentation: Lessons Learned in Advancing Sustained Release Polymer Microparticle Products into the Clinic

Date: May 4th, 2021

Dr. Tracy is Founder and President, Tracy BioConsulting, LLC. Tracy BioConsulting (www.tracybioconsulting.com) is a specialty biopharmaceutical consulting firm dedicated to helping clients successfully advance their scientific research into and through the clinic. Dr. Tracy is known internationally for developing innovative first-in class complex injectable and nucleic acid therapeutics. Dr. Tracy played a key role in developing Onpattro®, the first RNAi therapeutic approved by the FDA, EMA and other regulatory agencies worldwide. He also developed several complex injectable sustained release products that have been commercialized including Vivitrol®, Bydureon®, and Nutropin® Depot, which was the first long acting protein product approved by the FDA. Dr. Tracy has extensive experience in the development of nano and microparticle-based products and other sterile injectable formulations from research through IND filing and commercialization. He has been recognized by peers internationally for accomplishments and leadership in the pharmaceutical product development, bioengineering, and delivery fields. Dr. Tracy is a Past-President and Fellow of the Controlled Release Society (CRS) and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).

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Wenzhan Yang

AstraZeneca – Associated Principal Scientist

Presentation: Small Molecule Drug Delivery Approaches to Modulate Target Engagement in Drug Discovery

Date: TBD

Wenzhan Yang is an associated principal scientist in the department of Advanced Drug Delivery in Pharmaceutical Sciences at AstraZeneca. She has extensive experience in clinical drug candidate selection, development risk assessment and formulation development for preclinical and clinical studies. She also had six years of teaching experience at Shenyang Pharmaceutical University in China. She has authored and coauthored over 30 peer-reviewed publications and several book chapters and patent applications.

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Dr. Jeffrey Leyton

Université de Sherbrooke – Associate Professor

Presentation: Journey to the Center of the Cell: Reprogramming Intracellular Transport to the Nucleus Enhances Tumor Killing for Antibodies Conjugated to Nuclear-Active Payloads

Date: TBD

Dr. Leyton is a scientist in the field of antibody-based medicines with a focus on the improvement of tumor targeting and accumulation. His successful projects range from the development of methods and algorithms to discover novel transport pathways and signal sequences to improve nuclear localization, the development of novel antibody-drug conjugates with nuclear-active payloads, antibody engineering.  Dr. Leyton earned his PhD in Molecular and Medical Pharmacology from the University of California, Los Angeles and trained as a postdoctoral fellow in the department of pharmaceutical sciences at the University of Toronto prior to joining the Université de Sherbrooke.

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Dr. Uriel Moreno

Stanford Universit – Scientist

Presentation: Plasticity of Human Natural Killer Cells in the Tumor Microenvironment

Date: March 17th, 2021

Uriel Moreno-Nieves is a Scientist at Stanford University. His research focuses on the study of human intratumoral NK cells and ILCs in head & neck squamous cell carcinoma (HNSCC), and on the development of protocols to increase the anti-tumor function of NK cells. Uriel Moreno-Nieves obtained his PhD from the Pasteur Institute, in France, where he studied the anti-HIV response of NK cells in the laboratory of Dr. Françoise Barré-Sinoussi, Nobel Laureate.

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David Preston
David Preston

Chairman

David Preston has had 38 years of healthcare experience with publicly – Traded and Private companies in the fields of Pharmaceutical’s, Animal Health and Biotechnology as a Board Member. The last 30 years of his experience has been in China, Taiwan and Hong Kong building successful high growth businesses. David Has been Chairman 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 businesses in China through diversified strategies in Innovative Pharmaceuticals, branded Generics, Biotechnology, and Animal Healthcare.


Key highlights in this period included building of the first Western Multinational Biotechnology C.M.O. facility as well as obtaining the first Test C.M.O.[ MAH] 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 Pharmaceutical’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 Government and the City of Shanghai. In 2013 he was awarded the Silver Magnolia followed 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
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 photo - 2.4.21 black and white
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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Jeffery
Jeffery Blazevich

Chief Financial Officer

Jeff brings over 30 years of professional experience working for publicly traded, venture-backed, and private equity companies in the technology, health care and medical device industries. Prior to joining BioDuro, Jeff was the CFO for Zest Dental Solutions, a private-equity-owned manufacturer of a diverse portfolio of dental products.  From 2008 to 2013, he served as Senior Vice President and Corporate Controller for DJO Global, formerly a Blackstone-owned manufacturer of orthopedic products.

Jeff is a Certified Public Accountant and started his career at Ernst & Young LLP after receiving his bachelor’s degree in Accounting from the University of San Diego.

Achievements

 

  • Jeff held CFO positions at Vativ Technologies Inc. Staccato Communications, and Applied Micro Circuits Corporation, a publicly listed semiconductor company.

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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
Kent M. Payne, PhD

President, Global CMC Solutions

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, South America in addition to the United States.

He also currently serves as a board member for Goodwin Biotechnologies (a biological contract manufacturer), and board advisor for Vitruvias Therapeutics (a specialty generic pharmaceutical business)

Achievements

  • CEO Socorro Pharmaceuticals, a generic pharmaceutical company
  • President Americas, Qualicaps Inc.
  • 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 Board Positions:
  • Board Advisor, Corporate Strategy Office, Life Science Institute Inc. (a wholly-owned subsidiary of Mitsubishi Chemical Holdings.
  • Board member for Technophar, Inc.; Qualicaps, Inc.
  • Non-executive Chair and Board Member PDS Biotechnology (PDS

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Tommy
Tommy Broudy, PhD

Executive Vice President, Marketing

Tommy Broudy joined BioDuro as Executive Vice President, Translational Sciences in 2018 following the acquisition of Molecular Response, a patient-derived tumor modeling company he cofounded in 2010. Tommy is now leading BioDuro’s translational oncology group, with focus on in vivo and in vitro oncology testing services that help more efficiently translate novel anti-cancer medicines into the clinic. Tommy previously served as General Manager of Crown Bioscience San Diego, where he led the US preclinical operation. Prior to that, Tommy served as Director at AltheaDx, working closely with the Business Development and R&D teams to establish gene expression-based companion diagnostics for oncology therapeutics. He also spent six years at Affymetrix, where he managed the company’s pharmacogenomic and toxicogenomic solutions in support of pharmaceutical R&D.

Achievements

 

  • Earned his PhD at Rockefeller University in the Laboratory of Bacterial Pathogenesis and Immunology
  • Held postdoctoral appointments at Rockefeller and Stanford University studying host/microbial genomics

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Roy
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/圣地亚哥

BioDuro- San Diego Facility

Our San Diego site is our corporate headquarters. The facility is home to BioDuro’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/北京

BioDuro Beijing
Operating since 2006, our Beijing site is home to BioDuro’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/上海-外高桥

BioDuro- Shanghai Facility

Established in 2012, BioDuro’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
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/无锡

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/河北

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/台湾

Taiwan - Sundia (1)
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/蚌埠

Bengbu - Sundia
Scheduled to open in fall of 2020, this site is designed to handle API manufacturing and additional expertise in intermediates, GMP starting material upto IND enabling sttudies

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

Mohekou Industrial Park,

Huaishang District, Bengbu, 

Anhui province
P.R. China

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Shanghai-Changli/上海-长利园区

Shanghai-changli - Sundia-min (1)
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/上海哈雷园区

Shanghai-halei - Sundia
Opened recently in 2018, BioDuro-Sundia’s Shanghai-Halei contains facilities that supports 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/上海-克伦

Shanghai-kelun - Sundia-min (1)
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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Jim-Li
Jim Li PhD