A Common Quality Language for Better Biomedical Research Results

Ulo Palm, a speaker at the marcus evans Evolution Summit 2012, on the necessity of common quality standards in unregulated biomedical research. Interview with: Ulo Palm, Senior Vice President – Clinical Operations & Biometrics, Forest Research Institute

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The lack of a common language on the quality of non-regulated biomedical research is resulting in the poor reproducibility of findings, says Ulo Palm, Senior Vice President – Clinical Operations & Biometrics, Forest Research Institute. This is wasting valuable resources and hindering innovation, as the majority of the work is having to be repeated by different laboratories, he adds.

A speaker at the upcoming marcus evans Evolution Summit 2012, in Wheeling, Illinois, April 30 – May 2, Palm discusses how common standards for non-regulated biomedical research would create synergies that could lead to drug development breakthroughs.

From your perspective, why is there poor reproducibility of biomedical research findings?

There are no common quality standards or methods, therefore laboratories are producing different results that others are then unsuccessfully trying to validate. The majority of the efforts put into biomedical research are going into replicating work, instead of building on each other’s work and creating synergies. If you take into account that USD 100 billion a year is spent on mostly non-reproducible biomedical research, this has major implications from a productivity perspective.

Besides not spending our money efficiently, we seem to be unable to turn the promises of modern biology into new effective drugs for patients worldwide.

What should these standards include? How would compliance be monitored?

They must cover the process from the concept of an idea to the publishing of research results. This is about creating a common language in biomedical research.

These standards should be voluntary; we still have to continue to trust people. Scientists would state whether they followed the standards and over time, there would be methods developed to verify that they did. To start with, if labs were requested to provide a statement that they did follow the standards, it would go a long way.

Would such standards nurture or hinder innovation and creativity?

They would increase creativity significantly. There is a misconception of what creativity is. People often think that in order to be creative, there should not be any rules, but if you want to be productive with your creativity, you need to use tools in the way they were designed for.

For example, you cannot be a very creative musician without knowing how to play any instruments. Only when you know and follow the basic rules can your mind free up for creativity. You do not want to be creative in how you conduct your research, but in the concept of research. If the technical aspects of biomedical research were standardized, scientists would really be able to focus on the science.

We need a common quality language to create synergies in biomedical research that could lead to breakthroughs for patients who are desperately waiting for new research outcomes.

Contact: Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division

Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the Evolution Summit 2012

This unique forum will take place at the Westin Chicago North Shore, Wheeling, Illinois, April 30 – May 2, 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 the future of drug development, developing a culture of safety and maximizing return on investment.

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

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-on-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

Pharmaceutical Marketing Driven by Science

Josh Schafer, a speaker at the marcus evans PharmaMarketing Summit 2012, on more effective pharmaceutical marketing.� Interview with: Josh Schafer, Vice President, Global Oncology Strategy, Astellas Pharma

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“Pharmaceutical marketeers need to find a balance between science and commercialization,” says Josh Schafer, Vice President, Global Oncology Strategy, Astellas Pharma. It is the innovative science that drives our business, so marketeers must have a fundamental understanding of the science and how it can be translated into commercial and patient value, he adds.

A speaker at the upcoming marcus evans PharmaMarketing Summit 2012 in Wheeling, Illinois, April 30 – May 2, Schafer talks about pharmaceutical marketing and why science should be driving marketing decisions. 

How is the pharmaceutical marketplace changing?

The industry is undergoing a transformation. The days of blockbuster drugs are behind us. Pharmaceutical companies need to find opportunities in smaller drug categories and patient segments. The ability to understand those and having a more intimate relationship with patients and other customers is the way of the future.

Would you say that the traditional methods for marketing pharmaceutical products are no longer effective?

They have worked up to this point, in a marketplace that was receptive to that. Now the marketplace and customer expectations are shifting, and the industry needs to shift with it. We need to be much more dynamic, flexible and creative in how we market in the future.

Marketing executives need to find a balance between science and commercialization. They must have a fundamental understanding of the science and how it can be translated into commercial and patient value. Science should be driving marketing decisions.

In the future, we need to ensure that innovative new products with clinical benefits reach patients. And as marketeers we need to do this in a way that goes beyond the traditional methods of promotional activity.

How is Astellas Pharma planning to reach its goal of becoming a global cancer treatment leader by 2015?

There are several elements to reaching our goal of becoming a Global Category Leader in Oncology. First, we are making sure that we are developing the right products to bring to the market and patients, and secondly we have built the infrastructure to bring new therapies to patients around the world.

Finally, it is important to have strong corporate support and commitment to the therapeutic area, as complex and dynamic areas require significant resources to be successful.

We have been able to put all of these pieces in place over the last three years and position ourselves as a category leader in oncology within that timeframe.

What is the best way of maintaining brand loyalty in this industry?

To maintain brand loyalty, pharmaceutical companies must demonstrate a commitment to patient care and ongoing innovation to bring new therapies that benefit patients. At the same time, companies have to understand the complexities of managing patients in a clinical practice and provide the support their customers need to better engage with patients.

Ultimately it is the commitment to innovation and advancing the science that helps drive loyalty.

Contact: Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division

Tel: + 357 22 849 313
Email: press@marcusevanscy.com

About the PharmaMarketing Summit 2012

This unique forum will take place at the Westin Chicago North Shore, Wheeling, Illinois, April 30 – May 2, 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 social media, healthcare reform and how to approach emerging markets.

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

marcus evans group – marketing/sales sector portal

The Marketing 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-on-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

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

FOR IMMEDIATE RELEASE

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

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

FOR IMMEDIATE RELEASE

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

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.