8^th Asian Biologics and Biosimilars Congress August 10-12, 2017 Beijing, China

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.

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.

Biography:

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.

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.

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.

Biography:

Dr Richard Littlewood is the CEO Founder at appliedstrategic. He is a physician with clinical practice experience in hospital medicine, combined with excellent management consulting experience at Bain & Company and extensive senior pharmaceutical industry experience.

Entrepreneurial success forming a medical device start-up company

Abstract:

Biosimilars uptake in Asia has been historically low. Recent evolutions in regional regulations are preparing the market for a step change. Countries like Japan and South Korea have developed their own regulatory pathways. India and China both recently finalized national biosimilar guidelines. Rapidly increasing research efforts in the region with more than 300 candidates in development indicate a huge potential for change. The Asia-Pacific Biosimilars market is expected to grow from $0.8 billion in 2016 to over $4 billion by 2021, India and China are estimated to grow the fastest. There is an opportunity to leverage local knowledge and learning’s from experience to succeed in competition. The pioneering launches in Europe were the departure point for the fast moving industry. The early pathway in the development of biosimilars was based on advances in protein characterization with the ability to define and prove similarity. As biosimilar medicines are becoming common, success is built on efficient partnerships between specialists in development and companies with commercial power. Small molecule generic medicines manufacturers dominated success in the first phase of biosimilars. This pioneer phase was centered on the manufacture of 3 main products; EPO, GH and GCSF. Market leaders were highly capable in skills of protein characterization and invested in the iterative processes to achieve comparability. The early competitors worked with regulators to make biosimilars work. The first phase was built on capabilities in development including mastering the science of comparability. Recent events in the biosimilar global market place provide insights into drivers of future success. Major development players are pulling back on development of biosimilars; leading biosimilar commercial players are increasingly dominating the decisions in the global market. Core skills scarce in the early days of the industry are now common place and development skills are available from a great range of providers. Future success is built on market reach and commercial power. Competitors must be fast to market and able to deploy leading resources in commercializing their products. The blueprint for success is based on important factors including the capability to deploy global sales power along with access to efficient, smart, fast development in part secured with partnerships. Execution of development partnerships will be the key for future winners. It is not clear if the early runners from the first 10 years can match the giants. The markets in Asia will be key in the future to the global uptake of biosimilars, likely new approaches sensitive to local customer and patient needs will be key to success.

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:

 

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:

When a Bio-Pharma plans to develop biosimilar for global market, it is important to understand the regulatory requirements from different destination of the markets. While FDA requires tremendous biological, analytical and clinical trials data on the tier basis, EMA requires clear quality, non-clinical and clinical data on the head-to-head comparison basis. However, US is a single market where as EU is multinational market, this has important impact on the selection of RMPs, which sometimes are critical to the success of biosimilar development and submission. 

Biography:

Asif Mahmood has diverse leadership experience as a health services professional with significant accomplishments in all aspects of pharmacovigilance, clinical development, medical affairs, regulatory affairs, primary health care, project management and international health programs. He has vast experience of working in diverse therapeutic areas including rare diseases, novel preventive and therapeutic vaccines, monoclonal antibodies, cardiovascular, oncology, neurology, nosocomial diseases, generic and OTC medicines. He is currently working as Disease Area Cluster Lead for Biosimilars and Drug Delivery Devices at Pfizer. His past experience includes working as Associate Vice-president PV and Therapeutic Area Head (Rare Diseases) for Sanofi Genzyme, working as Senior Director and Director for Vaccines PV at Sanofi Pasteur, working as Medical Consultant for Apotex Inc., Canada. Prior to joining industry, he had worked as Joint Executive Director for Pakistan Institute of Medical Sciences (PIMS), Registrar of the Post-graduate Medical Institute PIMS and as Deputy Director General, Ministry of Health Pakistan.

Abstract:

Advances in biotechnology have ensured a world of opportunities for biosimilars to enter the market and serve the needs of patients in a cost-effective manner. However, Pharmacovigilance and risk management for biosimilars present a significant challenge that arise from their unique characteristics as biologics as well as from their differences with the reference innovator products. Traditional PV processes may not incorporate sufficient provisions to meet the particular requirements for biosimilars. While a biosimilar and its reference drug can show similar efficacy, it can exhibit a different safety profile with respect to the nature, seriousness or incidence of reported adverse events (AEs). Therefore, there is a need to clearly identify the specific product associated with the AE. Hence, product naming is an important consideration for biosimilars traceability. The potential for immunogenicity represents an important safety concern with all biologics, including biosimilars. The nature and severity of immunogenic reactions may differ from those observed for the reference innovator and immunogenicity data from the reference product may not be directly extrapolated to the biosimilar. Given the relatively small number/size of clinical trials required for regulatory approval of biosimilars, full characterization of the immunogenicity profile of a biosimilar may not be established at the time of regulatory approval. Continued post-marketing surveillance of biosimilars is critical for effective risk management. Also, the unique nature of biosimilars requires a labeling approach that combines data on the reference product with data specific to the biosimilar due to differences in their source materials, manufacturing processes and impurities. Finally, the safety specifications in the RMP of a biosimilar should include the identified and potential risks of the reference innovator product as well as risks identified from studies on the specific biosimilar product.

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.  

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. 

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.