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Weird and wonderful case studies: Real-world solutions for unexpected bioanalytical challenges

Are you facing unsolvable bioanalytical issues with your existing provider that is impacting your nonclinical or clinical PK/PD study setup? Is there a lack of communication and support with your current CRO?

Weird happens. More often than you expect. Rescue studies are a particular point of strength at Agilex Biolabs, where the bioanalytical experts are driven to solve challenges presented by what we call “the weird and wonderful.”

Sometimes studies go awry, but through shared experience, you can avoid suffering the same pitfalls that others have already experienced. Pharmacokinetic (PK) and Pharmacodynamic (PD) data are critical to non-clinical and clinical safety studies, dose escalation, and decision-making. Delays in assay setup and ongoing bioanalytical challenges during the study can severely impact drug development timelines. When a study needs rescuing, it is critical to choose the appropriate intervention that will get your assay back on track. Having a partner that understands how to troubleshoot bioanalysis issues is critical for success.

What will you learn?
  • How to select the right partner for your bioanalysis.
  • How to salvage the problematic study – understanding the challenges and applying customized solutions.
  • Success stories from a China-based clinical-stage biotech developing first-in-class and best-in-class multi-specific biotherapeutics as well as a small Australian-based first-in-class clinical-stage biotech.
  • The benefits of working with an Australian bioanalytical lab.
Who should attend?

Bioanalytical, Biomarker, DMPK scientists, Clinical Operations and sponsors who are struggling with getting their assays setup, working with a tricky compound or who are experiencing communication issues with their current lab which is impacting their study, assay development or clinical timelines.

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Yongliang Fang

Yongliang Fang

Chief Operating Officer, Zhejiang Doer Biologics Co., Ltd

Dr. Yongliang Fang currently serves as the Chief Operating Officer for Zhejiang Doer Biologics Co., Ltd. He oversees the early R&D, translational research, clinical operation, and business development activities at Doer Biologics. Dr. Fang has deep knowledge of protein engineering, immunogenicity risk analysis, protein deimmunization, drug discovery, and clinical translation of biotherapeutics. He also has a proven track record of fundraising, in- and out-licensing, program management, and business development. Prior to joining Doer Biologic, Dr. Fang was the co-founder and Chief Operating Officer for Occulo Bio LLC and Lyticon LLC.

Dr. Yongliang Fang earned his Ph.D. degree in Bioengineering from the Thayer School of Engineering at Dartmouth College. He received his B.E. degree from China Pharmaceutical University.

Sharon Hanegraaf

Sharon Hanegraaf

Vice President, Drug Development, Kinoxis Therapeutics Pty Ltd

Sharon Hanegraaf has over 28 years of experience in the pharmaceutical and biotechnology industry. As Vice President of Drug Development, Sharon currently leads the drug development program with Kinoxis, an innovative NIH/NIDA backed biotechnology company developing novel therapies for the treatment of substance use disorders and social dysfunction associated with neuropsychiatric disorders. Her current role involves management of the preclinical ADME/toxicology programs, drug substance manufacturing, and regulatory submissions, as well as being closely involved in early-stage clinical programs. Having held various senior roles within Australian companies, Sharon specializes in managing all development and regulatory activities for pharmaceuticals transitioning from early-stage to late-stage development through to commercialization on the US market.

Yogesh Patel

Yogesh Patel

Senior Method Development Scientist, Agilex Biolabs

Yogesh Patel, engaged as Senior Method Development Scientist with Agilex Biolabs, is responsible for the design, strategic planning & execution of innovative techniques focused on the development of intricate ligand binding assays. His demonstrated experience with ELISA & ECL based immunoassay for the assessment of pharmacokinetic (PK) and multi-tiered immunogenicity enables him to facilitate, coordinate and liaise with sponsors to support multiple non-clinical and clinical studies in a regulated environment for advancing biologics programs across all therapeutic areas.

Kirsten Wilcox

Kirsten Wilcox

Analytical Services Manager, Agilex Biolabs

Kirsten Wilcox has over 10 years of experience working within the regulatory bioanalysis to GLP and GCP standards. She is skilled in working with EMA and FDA guidance to support the development of both clinical and nonclinical validations and sample analysis. With Agilex Biolabs, she is currently engaged as the Analytical Services Manager for the LC/MS-MS bioanalytical laboratory team. Kirsten has a Bachelor of Science in Forensic Science and a Bachelor of Laws in Law and History which has helped her in her role supporting a CAPA program to drive process improvements that help reduce risk and maintain regulatory compliance.

ArsalanArif
moderator

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.