alexa Clinical Trials Of Biosimilars In Developing Nations: Obstacles And Opportunities | 22441
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)

3rd International Conference and Exhibition on Biowaivers, Biologics & Biosimilars

N Srinivas
ScientificTracks Abstracts: J Bioanal Biomed
DOI: 10.4172/1948-593X.S1.013
Abstract
Biopharmaceuticals are a cornerstone of therapy for a wide spectrum of disorders, from cancer to autoimmune diseases. Currently, the patents for several well-established biopharmaceuticals have expired or are approaching expiration. The development of biosimilars creates several opportunities and challenges. The cost advantage of biosimilars is incontrovertible albeit lack of physician or public acceptance could delay, if not derail, their use. The clinical trials concern is a thorn that will have to be dealt with somehow. Patients may be very reluctant to participate in a clinical trial of biosimilars for various reasons. Clinical trials will need to be indication-specific to establish interchangeability must be proven in all indications to satisfy the ?any given patient? standard. The obstacles include reduced speed of clinical trial completion owing to time for regulatory approval and recruitment of clinical trial patients. The site cost per patient will increase, as the investigator has to devote more time and effort per recruited patient for ensuring data quality & regulatory compliance. Increase in the number and duration of EC meetings, and additional work for the EC members and support staff. This could result in increase in EC fees. The cost of medical management, compensation for clinical trial related SAE, and exhaustive monitoring and audit will have a big impact on the trial budget. The challenge of meeting regulatory expectations of compliance and ensuring quality would require a change in mindset of all the stakeholders. This would require harmonization between research and practice and make documentation into effective vital practice for clinical trial conduct. The focus should lie on making biosimilars with interchangeability, accessible to a broader number of patients in less privileged areas of our planet.
Biography
N Srinivas has completed his PhD from JNT University Hyderabad in the area of bioanalysis & clinical pharmacokinetics. He is the Professor and Principal of Malla Reddy Institute of Pharmaceutical Sciences, Secunderabad and has a blend of 18 years teaching and 4 years industrial experience. His prior experience includes training of clinical research to life science students and industry professionals. He has 10 papers in reputed journals and has guided 20 post graduate projects. He is serving as Member in institutional ethics committees (IEC) of couple of reputed hospitals.
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

engineerin[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
Leave Your Message 24x7