Scientific Program

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

Day 1 :

Keynote Forum

Kamali Chance

Vice President, Quintiles, IMS, USA

Keynote: FDA/EMA current thinking on totality of evidence for development of biosimilars
Asian Biosimilars International Conference Keynote Speaker Kamali Chance photo
Biography:

Dr. Chance has over 25+ years of work experience in the healthcare industry, including over 18 years in regulatory affairs at CRO, CMO, and pharmaceutical/biotechnology companies. She has spearheaded strategic global development for number of biosimilar products and has authored and/or co-authored number of articles on biosimilars. Dr. Chance has provided global regulatory strategy for number of biosimilar products currently in development including biosimilars of Enbrel, Remicade, Herceptin, Rituxin/Mabthera, Humira, Avastin, Aranesp, Epogen, Recombinant Insulins, Forteo and Neupogen/Neulasta. Dr. Chance has authored/co-authored number of articles on biosimilars: • Investment Decisions Based on Biosimilar Programs, Part 1 • An Integrated Approach to Biosimilar Development & Commercialization • Elucidating Biosimilars Characterization • The Biosimilar Landscape: A Systematic Review of Its Current Status • Operational Challenges Associated with Biosimilar Drug Development • A Model for Expeditious Progress to a Phase 3 Trial • Biosimilars in rheumatology: understanding the rigor of their development… & many more…

Abstract:

The regulatory landscape for the development of biosimilars in the US and EU is dynamic as many of the guidance issued by European Medicines Agency (EMA) have recently undergone revisions and the FDA has issued number of revised guidelines for quality and scientific considerations as well as updated questions and answers documents that lend much needed clarity. FDA has also issued final guidelines for nonproprietary naming of biological products as well as draft interchangeability guidance. This session is designed to provide current status of biosimilar guidelines in the US and EU. The focus will be to identify major updates in order to help sponsors navigate through the complex requirements for the regulatory approval of biosimilars in the US and EU.

Keynote Forum

Jianguo Yang

President / CEO, Abpro China, USA

Keynote: Strategic partnership for China biologics
Asian Biosimilars International Conference Keynote Speaker Jianguo Yang photo
Biography:

Dr. Jianguo Yang, is the Vice President of Abpro, USA and the CEO of Abpro, China. He was the principal scientist , leads late stage biologics commercial projects at Genzyme/ Sanofi. Prior to Genzyme, he worked on early, late stage and commercial biologic drug development in MedImmune /Astrazeneca and Abbott labs , respectively . With over 16-year bio-pharm industry experience, and achieved world record high mammalian cell line productivity, he is an international recognized expert in biologics development, and frequently invited keynote speaker / chairperson / scientific advisor for international conferences, a member of Editor and Advisor Board for Bioprocess International Journal, reviewer for scientific and professional Journals, and authored numerous publications and patent applications. He holds both M.S. and Ph.D. degrees in molecular cell biology and biotechnology from Illinois Institute of Technology.

Abstract:

Biologic drugs on the market now have been results of some partnership from RD to commercialization. Increasing complexity of biologic drug development requires more collaborations or partnerships in biopharma industry. This presentation will review current status of biologic drugs market and articulate landscape and importance of strategic partnerships in biologic research and development, and future trends.

Keynote Forum

Raymond Huml

Vice Precident, Quintiles IMS, USA

Keynote: Biosimilars: Accelerating early clinical development
Asian Biosimilars International Conference Keynote Speaker Raymond Huml photo
Biography:

Raymond A. Huml, MS, DVM, RAC is Vice President, Strategic Drug Development and Head, Global Biosimilars Strategic Planning, at QuintilesIMS. Dr. Huml has written over 60 articles on a variety of subjects and three books. He has more than 27 years of experience in the biopharmaceutical and healthcare industries and holds an MS in biology from East Stroudsburg University, a DVM from the North Carolina State University College of Veterinary Medicine, and has earned the RAC (US) certification.

Abstract:

This presentation will discuss how early clinical development with biosimilars is paramount to later development and registration success. It will provide an overview of ECD services successfully used for implementing Phase-I biosimilar trials in Asia Pacific as well as the West (e.g., US and EU) for global registrations. It will present an overview of site selection and feasibility data using a Next Generation approach driven by IMS legacy data to aid recruitment especially in tough areas to recruit patients for biosimilar trials such as the US and Europe. Finally, a model to accelerated biosimilar development will be presented that has been successfully used by one of the world’s largest providers of pharmaceutical services.

  • Challenges in Developing Biosimilars | Cost Analysis of Biosimilars | Emerging Trends in Biosimilars | Emerging Biosimilars in Therapeutics
Speaker

Chair

Darius Panaligan

Vice President, Global Head of Commercial at Merck Group, Switzerland

Speaker

Co-Chair

Hossein Pakdaman

President of Iranian Neurological Association, Iran

Session Introduction

Beat Fluehmann

Director Vifor Pharma Ltd, Switzerland

Title: Challenges in assessing therapeutic equivalence of nano-similars
Speaker
Biography:

Beat Flühmann is a Pharmacist, completed MBA and PhD in Molecular Biology. Presently, he is the Director of Vifor Pharma and Steering Committee Member of the Non-Biological Complex Drugs Working Group hosted at Lygature (a non for profit organization). Previously, he had worked for Hoffman La Roche R&D in the area of diabetes and lipid metabolism. His current interest is in regulatory science aspects of nanomedicines.

Abstract:

Showing therapeutic equivalence of nanomedicine follow on products to a reference drug is like for biosimilars more challenging than for low molecular weight drugs. The pharmacokinetics and especially the bio-distribution can be among other parameters which depend on the size/size distribution and composition of the nanoparticle, having implications on the efficacy and safety of the drug. Today, the interaction of these nanoparticles with the body is not fully understood and the clinically meaningful physicochemical parameters are only partially identified. In two clinical studies of chronic kidney disease patients depending on hemodialysis, a lack of therapeutic equivalence was demonstrated for the first time for a nanomedicine, namely Venofer® (iron sucrose), a nano particulate iron preparation for i.v use and it follows on products or better called iron sucrose similars (ISS)-approved on a generic pathway in Europe. Upon switching from the originator iron sucrose to the ISS, a rapid drop in Hb level and iron parameters was observed and higher doses of i.v iron as well as ESA was required to stabilize the patient’s Hb levels. Further clinical reports also showed different safety outcomes such as increased levels of inflammation markers in hemodialysis patients and a significantly higher number of adverse events in gynecology patients. The generic paradigm, lacks the clinical and non-clinical safety and efficacy requirements, is therefore not appropriate to assess nanomedicine follow-ons. Although ISS share the international nonproprietary name with the originator, they can exhibit clinically meaningful differences. Alarmed by these findings, the FDA and EMA have issued draft guidelines and reflection papers that propose a multi-step in vitro, non-clinical and clinical testing to evaluate the extent of similarity as a pre-requisite to define the therapeutic position and the interchangeability or switchability of such nanomedicines.

Darius Panaligan

Vice President, Global Head of Commercial at Merck Group, Merck Biosimilars, Switzerland

Title: Challenges and opportunities in biosimilar commercialization
Speaker
Biography:

Darius Panaligan is currently the Vice President and Global Head of Commercial for Merck Biosimilars. In addition to developing commercial and go-to-market strategy, he has been focusing on organizational readiness for Biosimilars within Merck. Prior to this he was with Novartis Group for 15 years in multiple global and country roles in both pharma and generics division including 3 years with Sandoz Biopharmaceuticals Global HQ. One of his key projects at Sandoz is the launch of the first biosimilar in the US (Zarxio) and Lead for global G-CSF biosimilar portfolio. His earlier roles within Novartis include Business Head, Marketing, BD&L and Development in both Specialty and Primary Care. He holds a Bachelor of Science and an MBA from the University of British Columbia and Simon Fraser University in Canada, where he also worked in research for a biotechnology start up early in his professional career.

Abstract:

The biosimilar market holds significant potential and benefit for all stakeholders. The experience with first wave of Biosimilar launches provide interesting and in some cases exciting references for the next wave of more complex biosimilars. What does experience in Europe and US could show us so far about the evolving opportunity in Biosimilars? In this talk the challenges and opportunities with commercialization of biosimilars will also be covered.

Robert Salcedo

President and Founder at Biosimilars Solutions and BioSciencesCorp, USA

Title: Convergence of regulatory expectations
Speaker
Biography:

Robert Salcedo has over 25 years of experience in biotechnology. He has worked for both Amgen and Genentech. He also leads a start-up biosimilar company. He is the Co-Founder of Biosciences Corp and Biosimilar Solutions which are dedicated in helping both biotech and biosimilar companies to develop their strategy and bring products to commercialization.

 

Abstract:

As biosimilar regulatory environment evolve, there is a trend for a convergence on regulatory expectations. This trend is driven by economic forces and is forcing companies that have local quality systems and local regulatory practices to change very rapidly. This trend is affecting how R&D is conducted, how clones and cell lines are acquired, the building of talent and the leveraging of external expertise and resources. The regulatory convergence is creating an internal dynamic that is introducing the need to have one quality system from R&D through commercialization. Biosciences Founder Robert Salcedo will explain how this trends are affecting the ways company are evolving.

Luis Ulloa

Professor of Surgery, Rutgers University- New Jersey Medical School, USA

Title: From neuromodulation to drug discovery and treatment
Speaker
Biography:

Ulloa L is a Professor of Surgery at New Jersey Medical School at Rutgers, The State University of New Jersey, USA. He has completed his Post-doctoral training at the Memorial Sloan Kettering Cancer Center, New York. He is an expert in neuro-immune modulation and its translational research for treating infectious and inflammatory disorders such as in sepsis. He has published more than 76 articles in prestigious peer-review journals and is currently serving as an Editorial Board Member of reputed journals.

Abstract:

Polymicrobial sepsis is a leading cause of death in the ICU characterized by detrimental systemic inflammatory response leading to multiple organ failure. We reported that electrical vagal stimulation controls systemic inflammation and prevents multiple organ failure in severe sepsis. We recently reported that transdermal neuronal stimulation attenuates the innate immune response to bacterial infection and prevents multiple organ failure during experimental sepsis. These effects were mediated by the induction of dopamine from the adrenal medulla. However, recent studies indicate that most of the septic patients have adrenal insufficiency and neuronal stimulation failed to control inflammation in adrenolectomized animals. Thus, transdermal neuronal stimulation will fail to induce dopamine and to control inflammation in these patients. Our pharmacological studies indicated that dopamine controls inflammation and improves survival in experimental sepsis by activating dopaminergic receptors type-1 (DR1). DR1-agonists such Fenoldopam was more efficient than Dopamine at inhibiting LPS-induced TNF production in macrophages and also inhibiting serum TNF levels in experimental endotoxemia. In vivo, DR1-agonists inhibit the production of inflammatory factors including TNF, IL1, IL6 and INF-γ even in adrenolectomized animals that mimic adrenal insufficiency in septic patients. These results indicate that pharmacological translation of neuromodulation can provide new insights for treating sepsis.

Speaker
Biography:

Gustavo H Marin is the Head Professor in Pharmacology Department of National University of La Plata. He belongs to CONICET research system. He is a Doctorate in Medicine, Master in Public Health, Master in Health Economics and in Political Science. He was a Former Medical Doctor in Public Health Assistance of Paris and Post-Doctoral Foreigner Assistant in University Paris, Diderot, France. He is the main author of more than 150 papers and was the Director of Science Policies of Buenos Aires State in Argentina and Director in health care Ministry of Health. Also, he is the Specialist in Hematology and in Public Management. 

Abstract:

Biosimilars are medicines that are not original products subject to patents; greatly reduce the cost of treatments. However, if they are subject to the processes of guarantee of efficacy and safety that are requested to the original biotechnological medicines, the costs remarkably increase. This point force countries to face a dilemma, provide access to their population to innovative treatments or avoid the potential adverse effects associated with their use. Biosimilars are increasingly attractive niche to several countries around the world. They are drugs of biotechnological origin, which has proven to be comparable to the innovative drug of reference once its patent has expired, since they are considered therapeutic equivalents in terms of safety and efficacy. However, these data come from very expensive studies such as randomized clinical trials. It is thus that underdeveloped countries like those of Latin America are in a permanent dilemma of either guaranteeing the access to these new products (generally for catastrophic diseases) or taking care of the population of its potential adverse effects. Latin American governments developed different strategies to face biosimilars market. Abbreviated regulatory pathways, alliance between public and private sector, promotion of science agencies benefits to finance part of local industry to develop new biosimilars and transfer of human resources from the academic to the business are some of those strategies. Brazil, Cuba and Argentina are interesting examples to study because their way chose to develop the industry. While Brazil and Cuba has led policies to increase the development of biosimilar drugs based on local public manufacturing capabilities and on relaxed standards regulation and became one of the majors world producers; in Argentina, exists three majors biotechnology private pharmaceutical enterprises that managed the market, articulating with local science and technology infrastructure and receiving governments’ benefits in order to enter into the biosimilars segment. In this last country the Regulatory Administration (ANMAT) did not accompany the promoting policies relaxing the regulatory standards. Through these experiences, it would seem that in order to be successful in the development of the local biosimilars market, it would be necessary to accompany the market’s efforts with flexibilities in regulatory, registration and production standards.