Meeting the Needs of the Industry at Interphex USA

Entering its 29th year, Interphex 2008, the world's largest and most comprehensive pharmaceutical conference and exhibition, was held at Pennsylvania Convention Center from March 26-28, 2008, Philadelphia, PA, US. The show was co-located with PharmaMedDevice and Biotechnica.

Presented by Reed Life Sciences, a part of Reed Exhibitions, Interphex 2008 reached into another new industry segment with the co-location of BIOTECHNICA - Europe's number one biotechnology exhibition and conference. The additions of PharmaMedDevice and BIOTECHNICA have positioned the event as the most expansive gathering across the life sciences industry.

Pharmaceutical and biotechnology advances, and the latest in medical device and biomedical product technologies have broadened the appeal of Interphex helping a wide range of life sciences professionals gain competitive advantages in their respective fields.

In an attempt to gain some insight on professional sentiments on Asia with regards to issues such as talent availability, transparency and compliance with regulatory laws, Pharma Asia spoke with some exhibitors at the show.

Manufacturing is the Word
Anthony Sollazo, Industry Solutions Manager, Life Sciences, Asia Pacific. Rockwell Automation

We are clearly seeing a significant demand for resources and a lack of availability and talent to match the pharma manufacturing industry in Asia. As biomanufacturing establishes itself as a primary industry in Asia, the capacity for resources will grow. There are more university programs to cater to the industry, and governments are offering incentives to pharma companies. There are joint international programs being leveraged to facilitate knowledge transfer and resource readiness. It is critical to grow Asia's capacity as quickly as possible to meet the demand of the industry for today's period of significant growth and it establishing itself as a key industry.

In the CMO space, Intellectual Property (IP) protection is critical. Counterfeiting and unlicensed production pose significant business liabilities to major companies. There is more emphasis on supporting IP protection here. Unfortunately, there are unfavorable reputations in the industry and this has likely slowed the contract manufacturing capability of Asia. Good Manufacturing Practices (GMP) compliance is critical to ensure the quality and safety of drugs for the global market place. We have all seen the tragedies that could happen with poor manufacturing practices.
On having a successful relationship with our Asian counterparts, there needs to be a focus on adding value to the business and leveraging the relationships to create such value. Manufacturing can be a strategic advantage and the right investments in technology and infrastructure can make this a reality.


On the High-End Platform
Anurag Gupta, MD, Life Sciences, South Asia
GE Healthcare

Resource constraints are not specific to Asia but to growth in general. High growth and potential can lead to resource bottlenecks. The faster Asian firms can develop, the faster are we able to grow as a company.

We need to not only tap into the region's talented graduates, scientists and researchers but also help develop them. GE has built two of its four global research centers in Shanghai, China and Bangalore, India. Over 2,000 engineers work on fundamental early stage research in these two facilities. GE Healthcare's Life Sciences business has two dedicated FastTrak centers in Asia (with its global headquarters in Bangalore), focused on helping develop the region's biopharmaceutical industry. They provide technology training, engineering services and custom solutions to support our customers' biopharmaceutical development and manufacturing.

IP protection and its enforcement are keys to many things, including GMP. Countries with better IP protection not only attract investment, but also tend to be places where successful domestic and international champions come from. Without IP protection, small local firms would be forced to compete on price and not on quality. This hinders the development of a GMP culture. As a supplier of high quality research and bioprocessing products and services, we are dependent on companies that are successfully competing with high quality in a GMP environment.

Expanding Society with Quality People
Robert P. Best, President and CEO
ISPE

Our "partners" are known as our "affiliates". Currently, in Asia Pacific, we have affiliates in Japan, Singapore, India, Thailand, Australia and New Zealand. We are close to an official start-up in Indonesia, and we are well on our way to establishing affiliates in China and the Philippines. Society for Pharmaceutical Engineering (ISPE) is an individual membership, volunteer-led organization. It is essential for us to identify dedicated, passionate members in these countries to lead these initiatives.

We have been extremely fortunate to find people who understand how the mission of ISPE can benefit the industry and regulatory authorities in these countries that share the vision of ISPE, and are willing to make the commitment necessary to establish and maintain these affiliates. This commitment is what has enabled us to be global.

Looking ahead, we will be participating at Interphex India this year. India is certainly an important country for ISPE and we believe that the Interphex shows are excellent vehicles for introducing ourselves to the industry.

Asia Gears Towards Regulated Markets
Ron Martin, Vice President, Asia Pacific, Process Systems & Solutions, Emerson Process Management

Pharmaceutical companies in Asia and throughout the world must produce products of the highest standards in order to comply with global regulatory requirements. To do this, they need to be able to show that they adhere to GMP as well as Good Automated Manufacturing Practices (GAMP) with all stages of their manufacturing well documented.

GAMP ensures consistent quality, and generates verification that products have been manufactured according to intended specifications. Manufacturing, documentation, and quality management practices must be acceptable to regulatory agencies in Asia, Europe, and the US.

There is a rapidly growing consensus that IP rights need to be strictly enforced. Industry associations and several governments have recognized this need and are taking steps to resolve existing problems. We believe the enforcement of IP rights laws is improving, especially in countries such as China, India and Thailand.

Several countries have established key initiatives for the protection of IP and strict enforcement of corporate ethics and laws. For example, the Japan Pharmaceutical Manufacturers Association (JPMA) has established policies and procedures to meet the challenges involved in IP protection and GMP compliance, with an emphasis on data protection systems, patentability of research tools, and patentability of medical treatment methods.
In Singapore, the government has set forth clear-cut policies supported by laws on IP protection, and these are strictly enforced. There are also various life sciences forums/conferences conducted periodically in Asia Pacific to underscore the importance of IP protection and GMP compliance.
Growing with Asia
Christian Stark, Marketing Director, Christ Water Technology Group

Some of our core markets in Asia are in China and India where we maintain manufacturing, project engineering and sales facilities. We also have a sales and project execution office in Singapore. Our group has more than 130 employees in Asia. This structure was built-up due to the strategic importance of the Asian markets for our group of companies.

As far as we can see, many customers in Asia are concentrating on the fulfillment of the US standards (USP, FDA, etc.). Thus, documentation and validation are very important issues in project execution. Our group of companies is based in Switzerland and has a good reputation for high-quality products.