Day :
- Biosimilars
Location: Webinar
Session Introduction
Abdel Qader Al Bawab
Al-Zaytoonah University of Jordan, Amman, Jordan.
Title: Pharmacodynamics model of the effect of gliclazide therapy on Hemoglobin A1C in response in patients with type 2 diabetes
Biography:
Abdel Qader has completed his PhD in Clinical Pharmacy and pharmacokinetics from Queen’s University Belfast and started working as ssistant at Al-Zaytoonah University of Jordan. Huring his career journey, Abdel did a one year Post-Doc at Queens University Belfast and got promoted to an Associate Professor. In terms of scientific research interest; Abdel is interested in Clinical pharmacokinetics and bioequivalence and therapeutics of diabetes.
Abstract:
Diabetes is a global health issue that affects more than 425 million people and is expected to affect over 690 million people by 2045. Because of its large propagation and related economic costs, diabetes is considered a main public health concern nationally and worldwide. Gliclazide (GLC) is a very commonly used oral hypoglycemic agent that is used in treatment of type 2 diabetes. As per the clinical treatment guidelines; GLC is considered as a second line treatment that is typically used concomitantly with metformin. Predictors to clinical outcome of using GLC (with metformin as a background therapy) is lacking. This study sheds the light of various predictors that are correlated to the effect of GLC on glycated hemoglobin (HbA1c) and facting plasma glucose (FPG).]
Anil Batta
Govt.medical college, amritsar
Title: Challenges With Successful Commercialization Of Biosimilars
Biography:
Prof. Dr. Anil Batta is presently professor & Head with senior consultant in Govt. Medical College, Amritsar. He did his M.B.B.S. and M.D. in Medical Biochemistry from Govt. Medical College, Patiala in 1984 and 1991, respectively. His research interest is mainly in clinical application especially cancer and drug de-addiction. He has supervised more than 25 M.D., M.Sc. and Doctorate researches and published more than 130 international research papers. He is the chief editor of America’s Journal of Biochemistry. He is also working as advisor to the editorial board of International Journal of Biological and Medical Research. He has been deputed member Editorial Board of numerous International & National Medical Journals of Biochemistry. He has also been attached as technical advisor to various national and international conferences in Biochemistry. He has been attached as hi-tech endocrinal, genetics and automated labs of Baba Farid Univ. of Health Sciences, Faridkot. He has chaired various sessions in the Biochemistry meets. He has been designated as member Editorial Board of various in US and other European Courtiers. He is also involved in various research projects at Govt. Medical, Amritsar. He has done superspecialisation in Drug-de-addiction from PGIMER, Chandigarh.
Abstract:
Commercialization rights for novel therapeutic products are protected for a finite period by patents and other measures. After expiration of patents and other exclusivity rights, other manufacturers are allowed to make copies of these products, referred to as generics in the case of small-molecule pharmaceuticals and biosimilars in the case of biopharmaceuticals (1). Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing approved reference product (1). They offer improved affordability and are thus expected to have major impact on accessibility of biotherapeutics, including in developing and emerging economies. The global market value of biosimilars is expected to reach $36 billion by 2020 (2). Biosimilars are defined by the European Medicines Agency (EMA) as biological medicines that are highly similar to another already approved biological medicine (the ‘reference medicine’) (3). They are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines. There are some key differences between the production of biosimilars and that of the traditional small-molecule generics. Capital investments, as well as operating costs associated with manufacturing of biosimilars, are significantly higher than that for small-molecule generics, along with the associated risk of failure. The heterogeneities are a result of the size and complexity of the molecules themselves, as well as activities in the host cell that is used to express the product, the bioreactor conditions under which the cells are grown, and the purification process utilized for generating the final product.
Kaiser J Aziz
Food and Drug Administration, Rockville, USA
Title: Biosimilar Drug Development and Approval Process
Biography:
Abstract:
Emphasis will be placed on a stepwise approach to provide analytical studies, biological characterization, preclinical and clinical testing of the proposed biosimilar product presented in the premarket applications.The sponsors of premarket applications must present analytical characterization, pharmacokinetic (PK), pharmacodynamic (PD) and comparative clinical studies to demonstrate that a proposed biosimilar product is highly similar to a licensed reference product.Discussions will be presented on Quality Systems approach to c-GMP’s for Biosimilar Applications (Design Controls, validation and verification studies, analytical similarity, manufacturing and effective total product life-cycle CMC strategy).Discussions will be presented on clinical aspects of proposed biosimilar product (Immunogenicity Assessment, Extrapolations & Interchangeability in conformance with specific recommendations described in the FDA’s guidance on biosimilar labeling) .Emphasis will be placed on Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the clinical use of the new biosimilar drug product by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use
Mohammed Hassoon Alwan Radhi
Al Nahrain University, Iraq.
Title: Applications and advantages of gold nanoparticles as X-ray contrast age
Biography:
Mohammed H. Alwan has completed his Bachelor degree from Baghdad University/ Iraq in 2004 then studied for M.Sc degree in Al-Nahrain University/ Iraq and graduated at2018. He spent ten years serving as Biomedical Engineer at the Ministry of Health institutes/ Iraq started at 2005 in Al-Karamaa general Hospital and in Ibn-Al-Bitar Center for Cardiac and Vascular Diseases and Al-Sadr General Hospital then at 2015 in the Middle Euphrates center for oncology at Al-Najaf health directorate.
Abstract:
X-ray medical imaging is one of the most important imaging techniques because its low cost and reachable technique. But it has poor ability of depict soft tissues and small details between soft tissues at the borders of interference. This limitation was overcome by using iodine-based contrast agent but this chemical compound has limitations for use due to its toxicity and side effects. Ten years ago, a new variant contrast agent of medical X-ray imaging was discovered, developed and understudy to date. The new variance factor is gold nanoparticles, which may overcome these limitations because of its excellent properties, where the biological distribution of these Nanoparticles is higher than iodine compounds, interference between bones and soft tissue is more apparent and these nanoparticles stay longer at the targeted site which allows for a longer imaging time. All of the above factors enhance the X-ray diagnostic ability. This study consists of the synthesis of gold nanoparticles, animal preparation (which includes a selection of animal type, housing, preparing the tumor and tumor implantation), intravenous administration of gold nanoparticles to tumor implanted mice then X-ray imaging was taken by conventional X-ray unit. The resulted X-ray images demonstrated that gold nanoparticles were attractive to move towards tumor site through the general circulation and spent more time at the tumor site (inverse the iodine contrast agent) which allows for a longer time of imaging, lower levels of toxicity and side effects. All of the mentioned factors leads to enhancement of X-ray diagnostic (i.e. obtained X-ray images contain the site of abnormality, two dimensions abnormality map, extra details of bone-soft tissue interference and high contrast level).