Day 2 :
Sr. Director Quintiles IMS, Canada
Oxana Iliach is a PhD in Pharmaceutical Science from St. Petersburg Chemical and Pharmaceutical Academy, Russia and the Senior Director Global Regulatory Strategy and CMC at the Biosimilar Center of Excellence, QuintilesIMS, Canada. She has more than 15 years’ experience in healthcare industry, including the last 10 years in regulatory affairs. Her expertise lies in the development of global regulatory strategy for biosimilars with the focus on overall quality and CMC compliance. She has a particular focus and expertise in regulatory and CMC requirements for biosimilars and regularly presents and writes on the topic. Presently, she is a Professor at Seneca College of Applied Arts and Technology, Toronto, Canada and a Member of CAPRA (Canadian Association of Professionals in Regulatory Affairs) and RAPS.
Growing numbers of companies are pursuing a global development of biosimilars for multiple markets. This global approach presents multiple challenges from selecting a reference product for biosimilar development to designing and conducting a clinical trials including a marketing strategy development and pharmacovigilance program. How to ensure that the global development results in successful marketing authorization in each jurisdiction? How to incorporate specific country requirements for biosimilar development at the early stages of biosimilar program? The strategic approach to the alignment of product development, regulatory activities and clinical program provides an answer to these questions. This presentation will discuss strategy of the biosimilar product development through earlier development to regulatory approval and provide some practical examples.
Senior Medical Director Quintiles IMS, India
Charu Manaktala is an MD in Pediatric Medicine, the Senior Director, Strategic Drug Development (Asia) and Head of Asia Pacific Biosimilars Centre of Excellence at QuintilesIMS, Canada. She has over 20 years of work experience in the healthcare and pharmaceutical industry and has worked in all stages of clinical drug development from Phase-I through commercialization. Her experience spans a variety of disciplines including drug development, medical writing and pharmacovigilance. She has comprehensive experience in clinical development of pharmaceutical/biopharmaceutical products and advises biotechnology companies on region specific and/or global clinical strategies for the development of biopharmaceutical products with a special focus on biosimilars.
Clinical development of biosimilars is an expensive and time consuming undertaking. The biosimilars space continues to evolve rapidly and presents a number of unique challenges and fierce competition. There are as many as 20 biosimilars in development for some of the top-selling biologicals creating an intense race for the sponsors, especially those wishing to enter the western markets. To avoid any delays, biotech companies need solid clinical development plans built on the latest regulatory guidance with intimate knowledge of the clinical trial landscape. This presentation will discuss how companies could design their clinical development plans to meet the western regulators expectations. It will share insights on determining the extent of clinical data requirements, design of clinical studies, considerations on the study population/indication, endpoints, evaluation of risk of immunogenicity and designing global development programs. Further, the presentation will share insights on efficient operational delivery of the safety and efficacy studies and outline best practices for accessing and retaining patients in biosimilars clinical studies.
- Globalization of Biosimilars | Biosimilars Market Challenges & Prospects | Pharmacovigilance of Biosimilars
President and Founder at Biosimilars Solutions and BioSciencesCorp, USA
President of Iranian Neurological Association, Iran
CEO Founder at appliedstrategic, London, UK
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
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.
Head of Commercial Business Development, NHR, UK
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.
The Biosimilars market is going to heat up considerably over the next three years - but is the NHS ready for the biosimilars boom? The NIHR Clinical Research Network (NIHR CRN) - the research delivery arm of the NHS - offers a unique insight into the biosimilars clinical trial landscape in the UK. The NHS deals with over 1 million patients every 36 hours. It is one of the largest single users and purchasers of all categories of medicines. In this context, biosimilars are a no-brainer. With the promise of a smaller price tag than original biologics, they have the potential to deliver NHS cost-savings and help ensure the sustainability of public healthcare systems, whilst also broadening access to healthcare so that greater numbers of patients can be treated with cutting edge biologic medicines. What’s not to like? But as with anything new, there are always early adopters and skeptics. The NIHR CRN is an independent, government-funded organisation. As a data rich organisation it has oversight of the majority of clinical research happening in England and with that comes unique insight into the clinical trial landscape. (We currently support over 80% of all clinical research in England commercial and non-commercial). The NIHR CRN can report that despite some challenges, the tide has turned and attitudes, appetites and acceptance in relation to biosimilars in the UK are changing.
Sharpening the competitive edge
The UK (and Europe) are approximately ten years ahead of the US our approach and acceptance of biosimilar drugs and therefore offer a more permissive market for the developers of biosimilar drugs. At a joint presentation on biosimilars at American Society of Clinical Oncology (ASCO) in June 2016, the EMA presented information on the large numbers of biosimilars approved (20 approved marketing authorisations) compared to the FDA (which is currently just four authorisations). Despite this, it came to light, some of our life science industry partners were overlooking the UK as a destination for biosimilar trials claiming that the appetite for delivering these types of trials was low. The National Institute for Health Research Clinical Research Network was drafted to sharpen the UK’s competitive edge. In this presentation we can reveal why life science companies were overlooking the UK to deliver their trial and how these challenges are being overcome using the Clinical Research Network structure which is unique to the NHS in England. Companies can now continue to place their biosimilar trial in the UK with confidence and get ahead of the game when it comes to study set-up, feasibility, and patient recruitment.
A range of perspectives
Within this presentation we can also bring you a range of perspectives (via video clips) which illustrates how the UK’s appetite, capacity and capabilities to deliver biosimilar clinical trials have developed in parallel with the expansion of the biosimilars market - which is forecast to be worth $25 billion by 2020. You will hear from those involved in conducting biosimilar trials - the clinicians, investigators and nurses at the coal face of research delivery in the NHS. We’ve also captured the NHS Trust R&D viewpoint, along with some thoughts from the NHS pharmacy team. The British Biosimilar Association offers up some interesting ideas, but probably the most memorable perspective is that of the patient.
Founder and principle senior consultant, Alban Pharma, Hong Kong
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.
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.
- Special Session
Disease Area Cluster Lead for Biosimilars Pfizer, USA
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.
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.