Clinart MENA – Conducting Clinical Studies in the MENA Region for a Strategic Advantage

Dr Alaa Assem of Clinart MENA, a sponsor company at the marcus evans Evolution Summit 2012, on what clinical research capabilities and opportunities the MENA region offers.  Interview with: Dr Alaa Assem, Chief Executive Officer, Clinart MENA

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Meeting patient recruitment and enrolment targets is the number one problem in clinical research globally, Dr Alaa Assem, Chief Executive Officer of Clinart MENA points out. To speed up drug development, pharmaceutical companies should consider what the Middle East and North Africa (MENA) can offer – access to large patient pools, as well as local and international expertise. Getting a head start in the MENA markets, with a population of over 300 million and counting, could also prove to be a strategic advantage.

From a contract research organisation (CRO) at the upcoming marcus evans Evolution Summit 2012 Dr Assem discusses the case for conducting clinical trials in the MENA region.

Why do you consider the MENA region as the next destination for clinical trials?

With the right awareness and education, we believe that the region can become the next destination for clinical trials in emerging markets, for pharmaceutical companies that want to accelerate drug development.

Meeting patient recruitment and enrolment targets is the number one problem in clinical research globally, which is slowing down drug development. MENA has a predominantly young population compared to an ageing population in the West. It is one of the fastest growing regions in the world, and expected to grow in double digits in the next few years. It stretches from Iran to North Africa, offering a wide range of patients and specific disease areas.

How could conducting clinical research in the region be a strategic advantage?

Certain diseases, such as diabetes and its associated disorders, are more prevalent here. Conducting research in the area would give a company access to its market and patient group, and expertise in the therapeutic field. Going to the Middle East is not simply about cost efficiency. It is about being the first to gain access to the target patient population.

It is also important to note that the expertise in the Middle East is quite sophisticated and up to the Western standard. Many of the physicians here have trained in major centres in Europe and the US, which translates to international as well as local expertise. This cannot be found in other parts of the world.

Why do Western companies tend not to consider the CRO capabilities the region offers?

There is a lack of awareness of what the region can offer. People see the region as one when in fact it is diverse, with many countries at different stages of development. News on the political situation here concerns many, but it often does not reflect reality.

The CRO industry in the region is relatively young. Does this work in your favour?

We believe it does, as it allows us to grow the industry and learn from other emerging markets that started before us. We have an advantage, because this region is young and evolving. There is a lot of room for us to grow and for others to come into the market. We are very optimistic.

Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager
marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the Evolution Summit 2012

Offering much more than any conference, seminar or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on achieving quality and compliance, integrating HEOR and the migration of clinical trials to emerging markets.

For more information please send an email to info@marcusevanscy.com or visit the event website at www.evolution-summit.com 

marcus evans group – life sciences /pharma sector portal

Complementing our Summit format, the Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations.

Please note that the Summit is a closed business event and the number of participants strictly limited.

About Clinart MENA

Clinart MENA is a full service contract research organization CRO headquartered in UAE, providing services across the MENA Region. Services provided are Clinical Operations, Project Management, Clinical Data Management, Medical Writing, Biostatistics, Training, Regulatory Services and Safety reporting. Clinart is ISO 9001:2008 certified and Oracle Gold Partner capable of providing validated and audited clinical research data management services (OC/RDC).

www.clinart.net

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-to-one business meetings. For more information, please visit www.marcusevans.com

All rights reserved. The above content may be republished or reproduced – kindly inform us by sending an email to press@marcusevanscy.com

Truly Innovative Drug Discovery

Dr Youssef Bennani, a speaker at the marcus evans Discovery Summit 2012, on developing innovative drugs. Interview with: Dr Youssef Bennani, Vice President Research & Development, Vertex Pharmaceuticals (Canada)

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Pharmaceutical companies need to ask themselves whether they are truly innovating and adding value, or doing a lot of “Me Too” type of work, says Dr Youssef Bennani, Vice President Research & Development (R&D), Vertex Pharmaceuticals (Canada). The bloated cost of clinical development is largely due to the “Me Too” concept, he adds.

A speaker at the marcus evans Discovery Summit 2012, Bennani offers his expertise into drug discovery and adding value to R&D programmes.

How can pharmaceutical companies add value to R&D programmes?

Pharmaceutical companies need to focus on the real priorities – innovation in disease control and treatment, instead of endeavouring in a lot of “Me Too” work.  A focus on real patient needs, rather than meeting financial goals is mandatory.

Why is this an issue in this industry?

The pressure to bring in revenue is common in all businesses, but the pharmaceutical industry has gone to the extreme of absolutely matching marketing expectations to the detriment of what is necessary for the patient. Decisions are based on guarding market share and generating revenue, rather than on better disease treatments. Adjusting the thinking within the industry would lead to better, as well as, differentiated products.

How would this impact the cost of drug development?

The bloated cost of clinical development is largely due to the concept of repetition. For second or third generation products, regulators demand large trials to show differentiation or non-inferiority, making drug development costly. Trials of brand new drugs should cost less. Stratification with regards to genotyping patients (selecting who is more likely to respond) and personalised medicine would go a long way to reduce costs.

On the discovery front, if times were shortened, the cost of researching would obviously go down. However, the cost of drug discovery is far inferior to that of clinical development, on a programme basis. Efforts in saving from the larger part and speeding it up would make a bigger difference.
 
What are some of the scientific areas worth following?

A much greater investment and understanding of predictive toxicology on all fronts is needed. In the past, drugs failed due to our inability to predict pharmacokinetics and toxicology in human settings. We have come a long way in pharmacokinetics but not yet mastered the science of toxicology.

Predictive pharmacology is another area that has not yet panned out. Many molecules work in animal models of disease, but fail in the clinic. The link between discovery and clinical pharmacology should be further researched.

Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager
marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the Discovery Summit 2012

Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on ensuring successful drug discovery, stimulating innovation and creating partnerships.

For more information please send an email to info@marcusevanscy.com or visit the event website at www.discovery-summit.com 

marcus evans group – life sciences / pharma sector portal

The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations.

Please note that the Summit is a closed business event and the number of participants strictly limited.

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-to-one business meetings. For more information, please visit www.marcusevans.com 

All rights reserved. The above content may be republished or reproduced – kindly inform us by sending an email to press@marcusevanscy.com

The Key to Drug Discovery Success

Riccardo Isola of Accelera, a sponsor company attending the marcus evans Discovery Summit 2012, on adding value in drug discovery programmes. Interview with: Riccardo Isola, Chief Executive Officer, Accelera

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The combination of a highly innovative and well-validated target is the key to project success, says Riccardo Isola, Chief Executive Officer, Accelera. From a sponsor company at the upcoming marcus evans Discovery Summit 2012, Isola offers his insight into drug discovery, and how pharmaceutical and biotech companies can add value, reduce costs and innovate.

How can pharmaceutical companies add value to their R&D programmes? 

The key to value in a pipeline is that it be rich in high-quality, highly innovative programmes. Unfortunately, in an ever more competitive environment, this is no easy matter, especially for companies that do not have the resources to execute powerful in-licensing campaigns. For small-medium companies that rely on in-house products, it is of utmost importance to make firm and well-informed strategic decisions regarding innovative areas of research on which to focus, then to develop highly competitive programmes in those specific fields.
 
How can the overall cost of drug development be reduced?

The best means of reducing overall drug development costs is to start off with targets that are as fully validated as possible from a preclinical point of view, and to envisage development in selected patient subpopulations, if appropriate and feasible. This subsequently facilitates the design of early clinical trials that are able to accurately predict drug activity, minimising the possibility of failure due to inadequate activity at later development stages. This is a major problem today, especially in the cancer field. However, this requires a willingness to kill programmes that do not live up to expectations as early as possible. Therefore, intensive implementation of patient selection, pharmacodynamic and pharmacological biomarkers, and stringent clinical activity criteria are all important factors.

How could potential failures be identified sooner?

The combination of a highly innovative and well-validated target is the key to project success. Beyond this, the ability to select active compounds at early development stages that are optimal in terms of potential ADMET liabilities is what Accelera specialises in.

The best advice I can give is to be stringent and not yield to the temptation to carry forward sub-optimal compounds. Going back to the chemistry bench is almost always the best, if not the easiest, choice!

What are some of the scientific areas or technologies worth following? 

In the drug discovery field, kinase inhibitors will remain an important avenue to further exploit in the next few years. Four anticancer therapies that are kinase inhibitors were approved in 2011, for different cancer indications. Interestingly, this approach is also beginning to be explored in other therapeutic areas, including inflammation/arthritis.

Another therapeutic approach, monoclonal antibody therapy, is still holding up to its promise, and in particular antibody-drug conjugates are currently of much interest, with tens of molecules in clinical development.

Relatively new areas that have yet to be fully exploited include gene silencing technologies (e.g. siRNA, miRNA), which currently need to be optimised as therapeutic agents but that could benefit enormously from recent advances in drug delivery technologies.

What is your outlook for the future?

Pharmacological therapy, especially for but not limited to the field of cancer, is increasingly likely to be based on Patient-Tailored Therapy approaches, i.e. choosing or adjusting the most suitable course of therapy based on the molecular characteristics of the individual patient and of his or her disease. Therefore, increasingly sophisticated yet generally available diagnostic approaches (such as high-coverage DNA sequencing, analysis of circulating tumour cells, and so on) will continue to be developed and implemented at an ever greater pace.

Drug discovery scientists and organisations need to keep fully abreast of technological advances in these fields, judiciously choosing the right implementation policies, working closely with academia and regulatory authorities, to ensure that the development of new therapies and the implementation of appropriate and effective diagnostic approaches can result in maximum patient benefit, as well as optimise development costs.

Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager
marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the Discovery Summit 2012

Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on ensuring successful drug discovery, stimulating innovation and creating partnerships.

For more information please send an email to info@marcusevanscy.com or visit the event website at www.discovery-summit.com 

marcus evans group – life sciences / pharma sector portal

The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations.

Please note that the Summit is a closed business event and the number of participants strictly limited.

About Accelera

Accelera is a non-clinical CRO that operates as a drug development partner with biotech and pharmaceutical companies worldwide. We know by experience that the success of drug discovery is measured by the quality of the product candidates that are generated. Accelera’s integrated services include Attrition Reducing Technologies (ART) and Toxicology Screening for the selection of high-quality drug candidates.

www.accelera.info

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-to-one business meetings. For more information, please visit www.marcusevans.com 

All rights reserved. The above content may be republished or reproduced – kindly inform us by sending an email to press@marcusevanscy.com

Life sciences conferences will be buzzing with the news that chemists are saying phosphorus shortages are in the pipeline this century.

Major scientists in the US have warned that production of phosphorus, which is one of the main fertilisers used for food production, will peak and begin to decline later this century, leading to problems for fertilisation as the population expands.

A report by five major scientific bodies, entitled ‘A Sustainable Global Society’, suggests that the decline could lead to rocketing prices and food shortages.

The report also raises concerns over the supplies of other resources, such as lithium, which is used in the production of many modern gadgets including hybrid cars, computers and military weapons.

Bloomberg Business Week reported this week that some domestic fertilisers are now being produced without phosphorus, suggesting that it is possible to artificially recreate the effect of the natural mineral.

Marcus Evans presents life sciences conferences, created by experienced professionals and with information presented by industry experts.

The UK is a world leader in science and research, according to a new report which may be off interest to people attending life sciences business events.

According to the ‘International Comparative Performance of the UK Research Base 2011′ report, which was compiled by Elsevier and published by the Department for Business, Innovation and Skills, research in the UK attracts more citations per pound spent in overall research and development than any other country.

In fact 14 per cent of the world’s most highly–cited articles were down to UK research.

What’s more according to the report, which was unveiled by Universities and Science Minister David Willetts at a Science Council lecture,  UK research talent is highly valued across the world.

Marcus Evans presents life science business events, created by experienced professionals and with information presented by industry experts.
 

Job cuts announced by Swiss pharmaceutical company Novartis will no doubt give rise to discussion at pharmaceuticals and life sciences events in the coming months.

The company is the biggest single employer in the West Sussex town of Horsham, where most of the 950 jobs are likely to go.

Novartis has confirmed that it will retain its respiratory research unit at the Horsham plant, and will keep its operations in Liverpool, Grimsby and Dundee intact.

General manager for the UK and Ireland Sue Webb cited uncertainty about future NHS spending as one of the reasons behind the decision.

"With significant changes in healthcare systems aimed to contain or cut cost, this critical assessment and the subsequent potential changes to the Novartis UK organisation are key to maintain significant investment in innovative drugs and our research efforts in the UK," she said.

Marcus Evans presents life sciences events, created by experienced professionals and with information presented by industry experts.

Mergers and acquisitions will be the talk of life sciences business events after a busy 2010. And this year sees no sign of slowing after manufacturing giant Danaher purchased a major life sciences firm.

Danaher has offered $6.8 billion for Beckman Coulter, a biomedical testing company which makes instruments and chemicals used by hospitals and medical labs.
Beckman has over 12,000 workers worldwide, and previous history indicates that Danaher will allow the firm to keep its name.

Danaher has acquired Beckman in order to expand its growing healthcare business. The medical testing equipment market is becoming more competitive than ever, and Danaher will benefit from purchasing a company regarded as an industry leader.

Last year Danaher reported an 18 per cent increase in annual revenue to $13.2 billion dollars.

Marcus Evans presents life sciences business events, created by experienced professionals and with information presented by industry experts.

Edwards will be the talk of life sciences business events after shares rose nearly 5 per cent this week.

The Californian-based medical device manufacturer is a global player in developing products designed to treat cardiovascular disease.

And the rise in share prices is due to European regulators approving a new and larger version of a heart valve.

Edwards Life Sciences revealed the new Sapien XT will now be available in three sizes.

The device is inserted by a surgeon through a small incision made in the patient’s ribs.

Less-invasive valves such as the Sapien are considered at the forefront of replacement heart valves, where Edwards leads in innovation.

Edwards is currently in a race with rival firm Medtronic to be the first to get an aortic valve replacement onto the US market.

Marcus Evans presents life sciences business events, created by experienced professionals and with information presented by industry experts.

Sagentia: Thriving in the Complexity of the Medical Device Sector

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“One of the biggest challenges today is the increasingly complex regulatory framework that is delaying time to market”, says Brent Hudson, Chief Executive Officer, Sagentia. “This means that more than ever you need to get the design right and have the right team in place from the start. Medical device R&D executives must also feel comfortable with a new set of success criteria.”

As CEO of a solution provider company at the upcoming marcus evans Medical Device R&D Summit Fall 2011, in Amelia Island, Florida, November 13-15, Hudson discusses competing against emerging market competitors, increasing regulations and the need to get products out faster.

What are the opportunities available to medical device R&D executives?

Brent Hudson: There are quite a few opportunities out there, particularly from a technology perspective. There is an increasing demand for cord-free, mobile-driven, lower energy devices. This gives R&D executives the chance to produce point-of-care devices which are smaller and more cost effective. 

There is also the opportunity for more complex devices reliant on embedded software. This needs to be accompanied by rigorous control procedures around building and testing as FDA approval is required.

There are several others but I think the main point here is the innovative use of technology to serve more demanding requirements around cost, portability and usability. These are areas that Sagentia is well positioned to assist with given our 25 years of experience developing complex medical devices for clients.

What are the present challenges that medical device R&D executives are faced with?
 
Brent Hudson: The current regulatory framework is making design concepts more complex, therefore delaying time to market. This means that more than ever you need to get the design right and have the right team in place from the start. Medical device R&D executives must also feel comfortable with a new set of success criteria.

Equally, cost pressures in the Western markets are severe, while growth is low. To address this, medical device R&D executives need to understand new healthcare system constraints and come up with breakthrough concepts that address the core issues at a very low cost base.

Finally, the emerging markets are no longer optional markets; they are too big and too important. Western companies need to get in there now before local competitors out-innovate them. This requires an understanding of a completely different set of user needs and a frugal innovation approach to product development.

How is the convergence of home treatments changing medical devices?

Brent Hudson: The trend now is out of the hospital and into the home. Complex medical devices were historically used by fully trained physicians in a hospital and are now being used by Mr Smith aged 76 sitting in his home in Miami. This requires medical device companies to take a much more consumer and services based approach to development, sales and support.

What long-term strategies would you recommend?

Brent Hudson: Organizations must learn to balance the needs and opportunities of both developed and emerging markets. This needs to include in depth consideration about user requirements, materials costs, margins and brand. Long-term growth is really only obtainable if you succeed in markets such as Brazil, China and India. I think there is an opportunity for only a few players in the medical device sector to stake out massive long-term growth in these economies.

Another strategy is to continue investing in the understanding of regulatory pathways. This, as with user needs, will change from country to country.

Any final comments?

Brent Hudson: I think we are in the most exciting and challenging time for medical device development. The opportunities for companies who get things right the first time are immense.

Contact: Stacey Melvin, Journalist, marcus evans, Summits Division

Tel: + 357 22 849 400
Email: press@marcusevanscy.com

About the Medical Device R&D Summit Fall 2011

This unique forum will take place at The Ritz-Carlton, Amelia Island, Florida, November 13-15, 2011. Offering much more than any conference, exhibition or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on lowering the costs of medical device R&D, issues in medical device compliance and introducing remote and home therapy treatments. 

For more information please send an email to info@marcusevanscy.com or visit the event website

marcus evans group – manufacturing sector portal

Please note that the summit is a closed business event and the number of participants strictly limited.

About Sagentia

Sagentia is a global technology and product development company, providing outsourced R&D consultancy services to the medical, industrial and consumer sectors.

We work with clients from front end needs analysis to transfer to manufacture, delivering innovation around new technologies and new generation products and services that provide commercial value and market advantage.

Further information can be found at: www.sagentia.com

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-on-one business meetings. For more information, please visit www.marcusevans.com

Follow us on Twitter @meSummitsGlobal                

All rights reserved. The above content may be republished or reproduced – kindly inform us by sending an email to press@marcusevanscy.com

CMIC Co. Ltd – A Win-Win Outcome with CROs

Kazuo Nakamura from CMIC Co., Ltd., a sponsor company at the upcoming marcus evans Evolution Summit 2011 and Evolution Summit 2012, on maximising the CRO-pharmaceutical company relationship. Interview with: Kazuo Nakamura, Chief Executive Officer, CMIC Co., Ltd.

FOR IMMEDIATE RELEASE

“The Contract Research Organisation (CRO) is a key part of the development of orphan drugs,” says Kazuo Nakamura, Chief Executive Officer, CMIC Co., Ltd. When the profit margin is low, a CRO developing drugs for pharmaceutical companies results in a win-win outcome for both parties.

From a sponsor company at the upcoming marcus evans Evolution Summit 2011, in Montreux, Switzerland, 17 – 19 October and Evolution Summit 2012, in North America, Nakamura talks about maximising the CRO-pharmaceutical company partnership, and his expectations for the coming years.

What insights do you have into what is challenging Chief Medical Officers (CMOs) of pharmaceutical companies today?

Kazuo Nakamura: Some pharmaceutical companies want to enter the orphan drug development market, yet they do not have the know-how. Licensing out in the Japanese market is complicated and requires expertise and negotiating with local authorities. Many want to sell the drugs without heavily investing into the development themselves. 

The pharmaceutical market in Asia holds great potential, which is why many large companies from across the world are looking into taking advantage of the opportunities the region has to offer. However, they cannot necessarily do it alone. CROs play a key role in this.

Asia is also attractive when it comes to recruiting a vast number of patients for clinical trials; CROs can facilitate and speed up that process.

How can clinical trial safety and efficiency be enhanced?

Kazuo Nakamura: CMIC is challenging the process of innovation in drug development. Conducting clinical trials is at times too complicated, hindering innovation. The government is very conservative and in some cases we have a very big documentation backlog. CMIC is trying to re-engineer this process.

What would help pharmaceutical companies maximise return on investment?

Kazuo Nakamura: Pharmaceutical companies need to form strategic partnerships with their CROs. Old-fashioned type of outsourcing such as using them like one part of their company is no more productive. Developing the new process to facilitate the trial with their partnered CRO is essential to reduce the cost while maintaining the good level of trial quality and data integrity. From this point of view selecting the appropriate CRO and providing them with the information they need would be the key to success in developing the drug sooner. Close collaboration is necessary for a win-win situation.

What are your expectations for the coming years?

Kazuo Nakamura: Lately translational research programs are increasing at the academic centres strongly backed up by the governmental financial support in Japan. These programmes are expected to prove the concept of the programme for future contribution to the patients.

We, CROs, can play an important role to support their R&D in terms of pre-clinical studies and clinical studies for the targeted technologies in compliance with the necessary regulations. CMOs should carefully watch the result of these activities and not lose the opportunity to license-in their technologies.

Contact:
Sarin Kouyoumdjian-Gurunlian
Press Manager
marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com

For more information please send an email to info@marcusevanscy.com or visit the event websites below:

Evolution Summit 2011 – Europe: www.evolution-summit.com

Evolution Summit 2012 – North America: www.evolutionsummit.com

marcus evans group – life sciences /pharma sector portal

Complementing our summit format, the Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations. Lend an ear to fellow experts and live news from our events on our LinkedIn and Twitter accounts!

Please note that the summit is a closed business event and the number of participants strictly limited.

About CMIC Co., Ltd

The CMIC Group has been taking the lead in the industry since 1992 when it started the first ever CRO (Contract Research Organization) business in Japan.

Using its abundant experience, CMIC comprehensively supports pharmaceutical companies in carrying out their value chains of drug development, manufacturing and marketing & sales

www.cmic.co.jp/e

About marcus evans Summits

marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, think tanks, seminars and one-to-one business meetings. For more information, please visit www.marcusevans.com

All rights reserved. The above content may be republished or reproduced – kindly inform us by sending an email to press@marcusevanscy.com