Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 8th Asian Biologics and Biosimilars Congress Beijing, China.

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Scientific Program Day 1
Scientific Program Day 2
Scientific Program Day 3

Day 3 :

Keynote Forum

Hossein Pakdaman

President, Iranian Neurological Association, Iran

Keynote: Biosimilars in treatment of multiple sclerosis

Time : 10:05-10:55

Conference Series Asian Biosimilars 2017 International Conference Keynote Speaker Hossein Pakdaman photo
Biography:

Hossein Pakdaman graduated in Neurology from the Pennsylvania and Henry Ford University. He is Professor of Neurology affiliated to Shahid Beheshti University School of Medicine, President of Iranian Neurological Association, and Director of Iranian Neurological Board Examination. He has also published more than 40 papers in international journals and is Chairman of Iranian Journal of Neurology. 

Abstract:

 

The landscape of multiple sclerosis treatment has changed dramatically over the last decade. As of November 2014, 9 disease-modifying therapies (DMTs) for MS have been approved by the US Food and Drug Administration (FDA). Despite the availability of more treatment options, costs for all MS DMTs have increased sharply. First-generation DMTs, originally costing $8,000 to $11,000, now cost about $60,000 per year. Costs for these agents have increased annually at rates 5 to 7 times higher than prescription drug inflation. Newer DMTs commonly entered the market with a cost 25%–60% higher than existing DMTs.
It is predicted that biosimilars will lead to a $44.2 billion reduction in direct spending on biologic drugs from 2014 to 2024, or about 4 percent of total biologic spending over the same period, with a range of $13 billion to $66 billion in USA. While the EU biosimilars market is relatively new, studies suggest that biosimilars in some therapeutic areas are priced below reference biologics, often with discounts of 25 percent or more. At the present time, approximately 50% of patients with multiple sclerosis in Iran are on treatment in which 2/3 are on biosimilars. Of note, the efficacy and safety of such products were assessed and stablished in different experimental and clinical controlled studies.
Biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups.  The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.

  • Emerging Biosimilars in Therapeutics | Clinical Studies on Biosimilars
Location:
Speaker

Chair

Asif Mahmood

Disease Area Cluster Lead for Biosimilars, Pfizer, USA

Session Introduction

Zhaoyang Li

Director Clinical Pharmacology at Sanofi , USA

Title: Practical considerations in clinical strategy to support the development of biologics device combination products
Biography:

Dr. Li is Director of Translational Medicine & Clinical Pharmacology at Sanofi.  She received her B.S. in Chemistry from Peking University (China) and a Ph.D. in Pharmaceutics from the Ohio State University (USA).  She 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 1 clinical pharmacology studies, responsible for design, execution and reporting of the trials.  Dr. Li has accumulated extensive experience in regulatory interactions and submissions, and was the clinical pharmacology lead for the approvals of Kynamro (for a rare disease, HoFH), Lemtrada (for MS) and Dupixent (for atopic dermatitis).  Her interests have included traditional clinical pharmacology topics (e.g. PK/PD, metabolism, drug-drug interactions and special populations), patient focused medicines development and Biosimilar.  Dr. Li 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. 

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 form(s) 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.  

Divya Chadha Manek

Head of Commercial Business Development, NHR, UK

Title: Patients as partners - transforming the delivery of clinical research in the NHS
Speaker
Biography:

Divya Chadha Manek is the Head of Business Development (Commercial) for the NIHR Clinical Research Network (CRN). Divya’s role is to maintain strategic relationships with Global and UK life sciences companies. Divya facilitates key discussions between life sciences industry and the Clinical Research Network. Divya provides advice and works collaboratively with companies on how they are able to tap into the Clinical Research Network services to ensure clinical studies are set up quickly and effi ciently so that they recruit to time and target. Divya also leads on ensuring that the Clinical Research Network is abreast of new study delivery innovations to ensure that the organisation is evolving to service life sciences industry requirements. 

Abstract:

This presentation will focus on getting the conversation going by the initiatives to create a society that can enhance clinical research. Look into priority setting by answering the questions that matter most. And overcoming the challenges by making patient involvement work for the NHS, its patients and our commercial partners. So the overall aim is to transform the delivery of clinical research in the NHS. 

Frank Cheng

Founder and principle senior consultant, Alban Pharma, Hong Kong

Title: GMP Complliance: how critical to your success of biological product to the market
Speaker
Biography:

Frank Cheng is the Founder and Principle Senior Consultant of Alban Pharma, Hong Kong, which is a leading consulting company on biosimilar development and submission to EU and US. With his PhD from Canada and PDF experiences from JHU in USA, he is now directing and managing several biosimilar projects from GMP compliance to design and implementation of regulatory submission roadmaps. 

Abstract:

GMP represents a quality management system manufacturing and submission of biological products. For filing IND in biological products for clinical studies, GMP compliance is required at the different levels. The topic shall address GMP conditions and GMP compliances from Phase-I, Phase-2, Phase-3 clinical studies through commercialization with MA.