About 3D BioOptima About 3D BioOptima

About 3D BioOptima

Into 3D Milestones Founder's Profile Honors And Qualifications

Into 3D

Founded in 2008 in Suzhou, China, by a group of industrial veterans with extensive experience in drug discovery and development, 3D BioOptima strives to best serve our clients with value-added solutions for their drug R&D programs of chemical and biological therapeutics by conducting specialized preclinical services, such as absorption, distribution, metabolism and excretion (ADME) characterization, pharmacokinetic and pharmacodynamic evaluation, bioanalysis, high-throughput ADME screening, ADME-assisted lead optimization, biological/pharmacological screening, large molecule research, exploratory toxicity assessment, and regulatory consultation. 3D BioOptima has a 33,000-sq ft advanced preclinical facility that is equipped with state-of-the-art instruments and integrated with a 10,000-sq ft high-standard vivarium.

 

3D BioOptima has completed over 400 IND-enabling ADME package studies for our clients, with all the work passed regulatory inspections. Over 300 of them have been approved to enter into clinical trials by NMPA and over 200 of them by US FDA and Australian TGA.


  • 15 years
    +

    R&D and Analytical Experience

  • 400
    +

    Successfully Filed IND Projects

  • 400
    +

    Active Clients Worldwide

Milestones

2008

Company Settled in Suzhou 1st Industrial Park and DMPK Service Platform completed.

2011

Strategic collaborations with BeiGene for small molecule drug screenings in DMPK.

2012

“Suzhou PK/PD Engineering and Technical Research Center” Recognized by Suzhou Science and Technology Bureau.

2013

Pharmacology Research Platform Established.

2015

Immunogenic Bioanalysis Platform Establishment.

2018

GLP Bio-analytical Labs Completed, passing inspections of ISO/IEC17025 and CNCA.

2022

Over 400 IND-enabling ADME package studies completed, among which over 300 have been approved to enter into clinical trials by NMPA and over 200 approved by US FDA and Australian TGA.

2008
2011
2012
2013
2015
2018
2022

Founder's Profile

Haizhi Bu
Founder, Chairman and CEO

Experience

Dr. Bu has had 30 years of scientific and managerial experience in drug discovery and development in major pharmaceutical and CRO companies. At Covance, Dr. Bu deeply learned how a top CRO company would satisfy clients with premier services. At Pfizer, Dr. Bu participated in the discovery and development of a number of dug candidates and two anticancer drugs, Sunitinib (2006) and Axitinib (2011), and won two prestigious awards, the James R. Gillette Best Drug Metabolism Paper Award of 2005 (ASPET) and the W. E. Upjohn Award in Innovation of 2006 (Pfizer). In addition, Dr. Bu has published over 60 original papers and invited reviews in ADME and bioanalytical sciences.

In 2008, Dr. Bu resigned from Pfizer and immediately returned to Suzhou, China, to build up 3D BioOptima, providing  specialized services in DMPK, PKPD and bioanalytical sciences. With his extensive R&D experience, over the past ten years, Dr. Bu has been providing high value-added consulting activities for current and potential clients free of charge.

Expertise

DMPK and PKPD
Metabolite Profiling and ID
Bioanalytical Chemistry
ADME-Assisted Drug Screening
ADME-Assisted Lead Optimization
Drugability Evaluation
Founder's Profile

Honors

Dr. Bu received the James R. Gillette Award for Best Drug Metabolism Research from the American Society for Pharmacology and Experimental Therapeutics (ASPET) in 2005, the only recipient of the award globally, and was the sole recipient of the Wiliam E. Upjohn Award for Innovation in Science and Technology, Pfizer's highest award for an individual employee, in 2006 at the Pfizer San Diego office. In 2006, he was honored with the Wiliam E. Upjohn Technology Innovation Award, the highest individual employee award from Pfizer, and was the only recipient from Pfizer San Diego that year.

11-W.E. Upjohn Award for Innovation in Science and Technology (2006)

11-W.E. Upjohn Award for Innovation in Science and Technology (2006)

#4 - Gillette Award Certificate

#4 - Gillette Award Certificate

Gusu Innovation and Entrepreneurship Leaders

Gusu Innovation and Entrepreneurship Leaders

Honors And Qualifications

2022 High Enterprise Certificate
Engineering Technology Center
Jiangsu Science and Technology-based Small and Medium-sized Enterprises
Provincial Foreign Experts Workshop
Municipal Foreign Experts Workshops
Certificate of Specialization
SPF Animal House Use Permit
2023 General Class Animal Use Permit

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