alexa Practical Considerations In Clinical Strategy To Support The Development Of Biologics Device Combination Products | 70782
ISSN: 1948-593X

Journal of Bioanalysis & Biomedicine
Open Access

Like us on:

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations
700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

8th Asian Biologics and Biosimilars Congress

Zhaoyang Li
Sanofi, USA
ScientificTracks Abstracts: J Bioanal Biomed
DOI: 10.4172/1948-593X-C1-032
Abstract
Over the past thirty years, biotechnology products have grown enormously, becoming the main stream of targeted therapeutic agents and promising to bolster the future treatment options for challenging and rare diseases. This increasing trend of developing biologics has boosted intensive efforts in developing various types of biologics-device combination (BDC) products, in which the primary mode of action (PMOA) is from the biological agent. The development of a BDC product is an intricate and evolving process from the drug substance to the final delivery system and can take multiple iterations at any of the steps. These iterations could involve changes in cell line, manufacturing site, formulation, primary container or safety features. Moreover, because of the complexity of the work involved and the high investment required, the commercial target dosage forms may not be available by the time the pivotal trials commence. These changes, occurring at different stages of a BDC product development, can present substantial challenges and often require a scientifically sound and robust clinical bridging strategy before they can be introduced into the clinic safely and efficiently. The development of BDC products is now a strategic imperative across the pharmaceutical industry. A successful clinical strategy to address changes in manufacturing processes for drug substance as well as for BDC presentations needs to be risk-based and scientifically sound. An analysis of common issues, as well as review of current regulatory requirements and industry trend have shown that the rigor of a bridging package depends on the risk associated with the changes and clinical studies are required when important changes that could consequently affect PK and/or PD, efficacy and safety profiles in a clinically relevant manner and occur at a relative late stage of clinical development.
Biography

Zhaoyang Li is the Director of Translational Medicine and Clinical Pharmacology at Sanofi. She has received her BS in Chemistry from Peking University, China and PhD in Pharmaceutics from the Ohio State University, USA and has over 17 years of industry experiences in clinical pharmacology and drug development of both small molecules, RNA based therapies and monoclonal antibodies. She is also a Clinical Study Director for Phase-I clinical pharmacology studies, responsible for design, execution and reporting of the trials. Her research interest includes traditional clinical pharmacology topics (e.g., PK/PD, metabolism, drug-drug interactions and special populations), patient focused medicines development and biosimilar. She also serves as a Member on a variety of working groups and councils in Sanofi, including Immunogenicity Council, PK Working Group, Patient-Centered Integrated System Design Working Group and Patient Engagement Task Force.

Email: [email protected]

image PDF   |   image HTML
 

Relevant Topics

Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2018-19
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

Agri & Aquaculture Journals

Dr. Krish

[email protected]

+1-702-714-7001Extn: 9040

Biochemistry Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Business & Management Journals

Ronald

[email protected]

1-702-714-7001Extn: 9042

Chemistry Journals

Gabriel Shaw

[email protected]

1-702-714-7001Extn: 9040

Clinical Journals

Datta A

[email protected]

1-702-714-7001Extn: 9037

Engineering Journals

James Franklin

[email protected]

1-702-714-7001Extn: 9042

Food & Nutrition Journals

Katie Wilson

[email protected]

1-702-714-7001Extn: 9042

General Science

Andrea Jason

[email protected]

1-702-714-7001Extn: 9043

Genetics & Molecular Biology Journals

Anna Melissa

[email protected]

1-702-714-7001Extn: 9006

Immunology & Microbiology Journals

David Gorantl

[email protected]

1-702-714-7001Extn: 9014

Materials Science Journals

Rachle Green

[email protected]

1-702-714-7001Extn: 9039

Nursing & Health Care Journals

Stephanie Skinner

[email protected]

1-702-714-7001Extn: 9039

Medical Journals

Nimmi Anna

[email protected]

1-702-714-7001Extn: 9038

Neuroscience & Psychology Journals

Nathan T

[email protected]

1-702-714-7001Extn: 9041

Pharmaceutical Sciences Journals

Ann Jose

[email protected]

1-702-714-7001Extn: 9007

Social & Political Science Journals

Steve Harry

[email protected]

1-702-714-7001Extn: 9042

 
© 2008- 2018 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version