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.