Innovation in technologies and globalization are the keys to quality and affordable healthcare
The Shimadzu Global Pharma Summit 2012, held in Singapore, looked at emerging healthcare models and new analytical technologies and discussed what role innovation and generic pharma will play over the next few years in achieving cost-effective healthcare
Panelists discussing innovative performance between the U.S., Europe and Asia
Singapore, 6 November 2012: Traditional business models in the pharmaceutical industry are slowly dying. European and U.S. decision-makers in the pharmaceutical sector no longer regard traditional strategies as viable for affordable healthcare. The challenge for drug makers is to discover new approaches to cushion the shrinking margins, expiring patents and growing regulatory pressures while simultaneously delivering cost-effective healthcare solutions.
The Shimadzu Global Pharma Summit 2012 – a multinational melting pot of ideas for the pharmaceutical industry – was held from October 31 to November 1, 2012 at Marina Bay Sands in Singapore. The summit, the first of its kind organized by an analytical instrument manufacturer, demonstrated emerging healthcare models and new analytical technologies and discussed what part innovation and generic pharma will play over the next few years.
Over 180 healthcare industry experts from 15 countries in Asia, the U.S. and Europe, including decision makers from the sector and research heads, shared their ideas and strategies and sounded out new approaches for affordable healthcare. Key speakers included – Dr Bianca Avramovitch, Senior Director and Head of Analytical Technologies, Global Generic R&D – Teva Pharmaceutical, Israel; Ms. Ashwini Sathaye, Head-Analytical, Novartis Healthcare Private Limited Technical R&D, India; Dr. Akiko Koga, Deputy Manager, CMC Development Department, Chugai Pharmaceutical Co., Ltd (Roche Group), Japan; Dr. Parizad Elchidana, Managing Director, Apotex Research Pvt. Ltd, India; Dr. Chunlin Chen, CEO, Shanghai Medicilon Inc. China; Dr. Michael Entzeroth, Deputy Director, Global Alliance and Preclinical Development, Experimental Therapeutics Centre (ETC), A*STAR, Singapore; Dr. Mingqiang Zhang, General Manager, VP & Head of Asia Pacific R&D, MSD R&D (China) Co. Ltd., China; Mr. Narayanan Suresh, Chief Editor, Biospectrum and Technology Review India, India; Ms. Rhenu Bhuller, Global Vice President, Pharmaceuticals & Biotechnology, Frost & Sullivan, Singapore and Mr. Gerhard Klement, CEO, CD2.
Generics versus innovation for cost-effective healthcare
A high-quality drug is developed through technological innovation. Dr. Bianca Avramovitch, SeniorDirector of Global Generics R&D, Analytical Technologies, Teva Pharmaceutical Industries, emphasized that technologies play a key role in making or breaking the successful venture of a new drug profile. "Any drug application has two sides; one is clinical and the other is technical. Even for a generic drug manufacturer, FDA approval requires quality standards from manufacturing to product launch. It is the new technologies that will bring faster development of drugs, and minimize the chance of errors."
She also mentioned that speed and excellence bring balance in drug development. "Sophisticated technologies at development and manufacturing stages speed up the market launch of a drug. Inadequate product development results in a slow response to regulatory queries and leads to multiple review cycles, delaying the product deadline."
Affirming the above views, Dr. Ashwini Sathaye, Head, Analytical Division, Novartis, remarked that the question of the hour is how to achieve faster and more efficient drug development. She opined: "It can be achieved through merging deeper scientific understanding with cost efficiency and effectiveness. The drug discovery process involves high multi-phase, complex and dynamic processes and, hence, needs significant investment and strong focus."
Therapeutic monoclonal antibodies are being developed globally at an accelerating rate. Compared to cytokine biopharmaceuticals, they require a higher dose and have a higher molecular weight and more complicated structures. In addition to the issues of manufacturing cost, these attributes increase the importance of appropriate quality control in commercial manufacturing.
Dr. Akiko Koga, Deputy Manager, CMC Development Department, Chugai Pharmaceutical Co., Ltd (Roche Group), explained the Japanese regulatory perspectives on new drug development and presented an overview of the flow of characterization, quality design and quality control. In addition, she presented cases from her experience with the development of various therapeutic monoclonal antibodies, including the analytical development of RoACTEMRA/ACTEMRA, the first therapeutic antibody originating in Japan.
Cost pressures, the need to tap global talent, and growth opportunities in emerging markets have prompted western pharmaceutical companies to shift substantial work to India. Sharing a broad perspective on the essence of globalization, Dr. Parizad Elchidana, Managing Director of Apotex Research Pvt. Ltd, said: “Multinational corporations are searching for means to broaden their capacity for drug development while decreasing costs. Pharmaceutical firms in the U.S. and Europe are increasingly forging partnerships with companies in emerging nations to gain revenue and to develop their own expertise.” She added that globalization increases the availability of technologies and provides access to capabilities that are not available in-house, thus improving speed of development and better disaster management.
China represents a unique opportunity to reverse the divergent industrial trends of higher investment in research and early development (RED) and lower productivity. Over 30% of total R&D spend is in RED where products have a less than 10% probability of reaching the market. The Chinese government has made huge investments in R&D infrastructure, talents and technology platforms. However, to fully capitalize on this initial investment and turn China into a RED hub of global MNCs, several hurdles need to be overcome, especially in the area of early clinical development.
Sharing useful insights on China’s Pharma R&D trends and challenges, Dr. Mingqiang Zhang, General Manager, VP & Head of Asia Pacific R&D, MSD R&D (China) Co. Ltd., said: “Many of the newest patented medicines are not licensed in China as ‘drug lag’ and ‘strategic decisions’ by MNCs as well as the quality of domestically produced generics lag behind Western and Indian companies because drugs from different manufacturers show different efficacy.” He also shared experiences and explored better methods of administrating within the sector.
The highlight of the event was the panel discussion in which speakers discussed and argued innovative performance in pharmaceuticals between the U.S., Europe and Asia. Giving an analytical perspective on innovation for successful drug stories, Ms. Rhenu Bhuller, global VP, Frost and Sullivan, stated that “partnerships are still isolated and there needs to be more global ventures. For instance, 90 percent of the research in vaccine is coming from Europe; however, it is predicted that in the years to come, this percentage will drop to 78 percent and the countries that increase their vaccine development will be Asian countries, such as India, China, Taiwan and Korea, and not the U.S." She added that innovation is not about solving a disease but preventing it. Dr. Bianca also shared strategies for successful research and development using innovative approaches.
In addition, speakers shared insights on how the rate of scientific advancement in analytical science influenced the composition, productivity and organization of pharmaceutical R&D. The potential impact of new technologies on reducing the time and cost of the clinical drug development process, improving data quality and throughput, regulatory compliance, and pipeline productivity was discussed.
A two-way discussion between a speaker and an audience member
Audience listening in rapt attention