Safarian will speak on “Global Study Experiences: Lessons from Observing Regional Variations” which is part of the “Clinical Projects: Faster and Smarter? It’s All in the Planning! session.

Date: June 15, 2:00PM – 3:30PM
Session #: 246
Room #: 140B

Novotech is the largest full-service Australian CRO with an extensive operations footprint across Asia, and has helped global customers conduct trials across a population base of more than 1.5 billion people in the Australasian region.

Headquartered in Sydney, Novotech works with biotechnology and pharmaceutical companies in North America and Europe to bring new products to the global market by offering a full range of ICH-compliant clinical services, from first human exposure through to completion of Phase III trials.

“Judging by the growth in number of new clinical trials starting in the region over the last few years, Asia provides a tremendous untapped opportunity to the drug development industry,” said Safarian.

The DIA Annual Meeting is the premier event for professionals involved in the discovery, development, and lifecycle management of pharmaceuticals, medical devices, and related products. There is no other industry meeting of its kind that can rival the breadth and depth of experience that this meeting delivers. With 25 content-area tracks, 330 sessions and 20 tutorials, presentations are geared to attendees at all disciplines, works settings, and experience levels.

About Novotech
Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in nine countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Since 2006, Novotech has been recognized as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

ABOUT THE DRUG INFORMATION ASSOCIATION (DIA)
DIA is a neutral, global, professional, member-driven association of nearly 18,000 industry, academia, and regulatory professionals involved in the discovery, development, and life cycle management of pharmaceuticals, medical devices, and related products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.

Media contact:
Susan Fitzpatrick
DatelineMedia Group
Australian office: +61 2 9006 1614
USA office: +1650 7985238
EMAIL: susan@datelinemedia.com

Atlanta, GA – July 1, 2007 — Novotech, the largest Australian owned contract research organization (CRO) with offices on the US east and west coasts, announced on the eve of DIA 2007 that the new tax breaks for research in Australia, which includes clinical trials, starts July 1, 2007.

Novotech CEO Alek Safarian said international firms can now take advantage of generous tax breaks for R&D including clinical trials as part of a bid by Australia to attract increased productive investment in areas including clinical trials.

The change to extend the beneficial ownership test for the 175% R&D Tax Concession will allow claims for R&D projects undertaken in Australia, regardless of where global biotech and pharma firms hold their intellectual property.

The change which comes into effect on 1 July 2007 supplements the R&D value proposition that Australia offers multinational R&D firms and partnering opportunities. Safarian said the new tax break is good news for Novotech clients as most are from the USA and Europe and so can take advantage of this further cost saving.

He said more than 90% of Novotech clients are international biotechs and pharma companies that chose Novotech for quality, speed and cost effective clinical trials, and regulatory consulting.

Novotech continues to win awards recognizing its performance and capabilities. Novotech is the recipient of the Frost & Sullivan Asian CRO of the Year 2006 – Australia Award and a winner of the Deloitte Fast 500 Asia Pacific 2006 program.

According to Frost & Sullivan Program Manager Shruti Dwivedi, Novotech demonstrated “exemplary growth and performance” and is well placed to benefit from the 15% per annum increase in trials conducted in Australia, much of which is coming from large pharmaceutical firms.

Novotech came out on top against its competitors after being evaluated on key criteria including “research capabilities, breadth and depth of services, geographical coverage, and alliances/partnerships that would enhance capabilities and the growth strategies adopted in pursuit of corporate objectives”, said Dwivedi.

“Novotech offers a broad spectrum of services in Australia and New Zealand, catered by a strong research team, experienced in diverse therapeutic fields. It has formed a subsidiary in UK as well as external partnerships/alliances in North America and other regions to widen its geographical reach.”

Novotech also won praise for its therapeutic experience with its special focus on Oncology, Ophthalmology and Cardiology trials. It conducts approximately 40 clinical trials every year, where nearly 80% are in Phase II & III, with remaining in Phase 1.

For meetings with Novotech at DIA 2007 please contact: Alek Safarian at 760-931-4841.

About Novotech
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company’s subsidiary in the United Kingdom and its US operations.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region.
Novotech’s US operations make it uniquely positioned to offer trials across the two countries, providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at
the same time take advantage of access to the much larger US market for rapid patient enrolment – a service that has to date only been available via large global CROs at higher overhead costs.

www.novotech-cro.com

The Australian Clinical Trials Advantage
Increasingly, US companies are turning to Australia to expedite the pace, and reduce the cost, of clinical trials, while maintaining the high standard of research that US authorities demand. Australia has been ranked the number one location to conduct pharmaceutical clinical trials in an international benchmarking study undertaken by the Economist Intelligence Unit (EIU). The EIU study ranked Australia against six countries – US, UK, Germany, Japan, Singapore and India. Other studies have found that clinical research costs may be as much as 30 percent lower in Australia than in the United States and Europe. In addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process. This compares favorably to usual timelines in major Western countries.

Novotech made the call on the eve of the Generic Conference [Sydney 15 & 16 May 2007] where key stakeholders in Australia’s pharmaceutical sector will come together to discuss the role generic medicine will play in the market over the next 5-10 years.

www.terrapinn.com/2007/gmed_au/index.stm

Novotech has been involved in the registration of more than 70 new generic drugs and 150 new dose forms in Australia and New Zealand over the past ten years and, while over the past few years, Novotech has been increasingly involved in managing studies intended for European and US registration.

Awarded as “Asian CRO of the Year – Australia” for 2006, Novotech is arguably the most experienced clinical CRO in the bioavailability/bioequivalence space in Australia and New Zealand, and one of a very few with ISO 9001:2000 quality accreditation.

“Our model for service delivery involves end to end management of the process from protocol writing to regulatory agency submission and negotiation to approval,” said Safarian.

With its origins as a regulatory consultancy, Novotech is staffed by some of the most experienced regulatory affairs professionals in the Australian industry. “This is a real edge for our business,” said Safarian. “It enables us to rapidly assess the requirements for a new generic drug, including design and costing of study/studies for local and international registration.”

“In addition, our validated WinNonlin® platform provides best-in-class technology for modeling and analysis of pharmacokinetic parameters, including analysis and presentation of results for steady-state kinetics as required for modified release preparations.”

With access to clinic beds in Australia and New Zealand, together with laboratory analytical services in Australia, New Zealand and South Africa, Novotech is able to custom-design the BA/BE requirements of clients’ generic formulation for maximum efficiency in terms of cost, quality and timelines.

About Novotech
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company’s subsidiary in the United Kingdom and its USA operations on the East and West Coast.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Novotech’s USA operations make it uniquely positioned to offer trials across the two countries, providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at the same time take advantage of access to the much larger US market for rapid patient enrolment -a service that has to date only been available via large global CROs at higher overhead costs.

www.novotech-cro.com

Novotech is the recipient of the Frost & Sullivan Asian CRO of the Year 2006 – Australia Award and a winner of the Deloitte Fast 500 Asia Pacific 2006 program.

Novotech CEO Alek Safarian said there were some considerable variations in opportunities and delivery in the Australian and Asian region for drug trials and research, and the updated checklist would help guide sponsors to weigh up their options to suit their needs.

Issues such as regulatory environment, clinical data management, approval timelines, cost saving opportunities, IP protection, reliable data issues, regional disparities, and availability of experienced staff, are all part of the decision making mix.

Safarian said one of the best indications that a CRO has the necessary experience in their market is that they also offer regulatory consulting services. However, he said “Still the most important decider, once a fit is established, is a site audit of the corporate headquarters and associated facilities to ensure they are at the standards required.”

Speed and cost savings are not enough on their own, he said. “Decision-makers really need to see for themselves that the CRO is offering exactly what they are promising to ensure quality and smooth operational progress.”

He said Novotech regularly hosts client audits of its Sydney, Melbourne, and Brisbane facilities prior to commencing trials with US firms. Novotech has worked with more than 50 U.S.-based and European pharmaceutical and biotech companies over the past 3 years.

He said a CRO also needs to demonstrate international expertise, a track record of trials with US and other pharma and biotech firms, have unparalleled knowledge of local regulatory procedures, and expertise in the requirements of international regulatory authorities. Ideally they are also referrals from other trusted sources.

According to Frost & Sullivan Program Manager Shruti Dwivedi, Novotech demonstrated “exemplary growth and performance” and is well placed to benefit from the 15% per annum increase in trials conducted in Australia, much of which is coming from large pharmaceutical firms.

Novotech came out on top against its competitors after being evaluated on key criteria including “research capabilities, breadth and depth of services, geographical coverage, and alliances/partnerships that would enhance capabilities and the growth strategies adopted in pursuit of corporate objectives”, said Dwivedi.

“Novotech offers a broad spectrum of services in Australia and New Zealand, catered by a strong research team, experienced in diverse therapeutic fields. It has formed a subsidiary in UK as well as external partnerships/alliances in North America and other regions to widen its geographical reach.”

Novotech also won praise for its therapeutic experience with its special focus on Oncology, Ophthalmology and Cardiology trials. It conducts approximately 40 clinical trials every year, where nearly 80% are in Phase II & III, with remaining in Phase 1.

For meetings with Novotech at BIO 2007 please contact: Alek Safarian at 760-931-4841.

For a copy of the new CRO Checklist please contact Susan Fitzpatrick 650 279 7771 susan@datelinemedia.com

About Novotech:
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company’s subsidiary in the United Kingdom and its US operations.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Novotech’s US operations make it uniquely positioned to offer trials across the two countries, providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at the same time take advantage of access to the much larger US market for rapid patient enrolment – a service that has to date only been available via large global CROs at higher overhead costs

www.novotech-cro.com

The Australian Clinical Trials Advantage:
Increasingly, US companies are turning to Australia to expedite the pace, and reduce the cost, of clinical trials, while maintaining the high standard of research that US authorities demand. Australia has been ranked the number one location to conduct pharmaceutical clinical trials in an international benchmarking study undertaken by the Economist Intelligence Unit (EIU). The EIU study ranked Australia against six countries – US, UK, Germany, Japan, Singapore and India. Other studies have found that clinical research costs may be as much as 30 percent lower in Australia than in the United States and Europe. In addition, Australian regulatory procedures often enable a trial to begin in as little as 2-3 months from the initiation of the approval process. This compares favorably to usual timelines in major Western countries.