Category Archives: business

Doncaster Solicitor Service Launched

Posted on April 19, 2011 by admin| Leave a comment

Doncaster Solicitor Service Launched

how to find a solicitor in doncaster – click here

this exciting new website has been launched, its a tool to help you find a Local solicitor for people in the Doncaster area.

It Covers the following areas of Law

Divorce Law

Administrative / Public Law

Advocacy

Children Law

Civil Liberties and Human Rights

Clinical Negligence

Commercial Litigation

Property Law

Common Law

Consumer Problems

Criminal Law

Education Law

Family Law

Fraud

Immigration

Insolvency and Bankruptcy

Landlord / Tenet – Residential

Licensing

Mental Health and Incapacity

Neighbour Disputes

Pensions

Personal Injury

Professional Negligence

Trust Law

Wills & Probate

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New Oxford Fund to Bridge Innovation Gap

Posted on July 14, 2010 by admin| Leave a comment

New Oxford Fund to Bridge Innovation Gap

A new Fund launched today by Oxford University will enable donors to support proof of concept and prototyping work to turn more research ideas into commercially-viable technologies, products and services.

The Oxford Invention Fund, which will be managed by Oxford University’s technology transfer company Isis Innovation, is part of Oxford Thinking, the Campaign to raise a minimum of £1.25bn for the collegiate University.

It is widely recognised that there is an ‘innovation gap’ between the early stages of an invention or idea and the point when it is mature enough to be commercialised through a license or spin-out company. The new initiative aims to raise up to £5m to create a self-sustaining fund to help develop Oxford inventions to the point when they can attract commercial investment.

‘Many university-based inventions lack well-developed product prototypes and vital experimental data to help them succeed, and obtaining funds for such work from venture capital providers or research funders is still a problem,’ said Tom Hockaday, Managing Director of Isis Innovation. ‘The aim of this Fund is to support the work needed to make even more Oxford inventions attractive propositions for licensing or investment.’

‘The Oxford Invention Fund provides the opportunity for donors to the University to see their donations used to support innovation and enterprise in Oxford, and to see a return to the University from successful new business ventures,’ said Bernard Taylor, Chairman of Isis Innovation.

Isis Innovation has a long track-record of success in exploiting research discoveries and ideas from Oxford University. In the last ten years Isis has set up 54 new technology spin-out companies, over 90% of which are still in business, and concluded 500 technology licensing transactions. Isis currently manages over 750 technology projects and files on average more than one new patent application each week.

Isis Innovation has managed the highly successful Oxford University Challenge Seed Fund (UCSF) which, since it was first launched in 1999, has awarded £5.7m, financing 102 projects and prompting the formation of 31 spin-out companies and the completion of 51 commercial deals.

The Oxford Invention Fund is modelled after the UCSF, with returns from its investments re-invested in further projects so that it can continue to support innovation at Oxford for many years to come. It is hoped that one day money generated from the Fund could be used to subsidise scholarships and bursaries to help the next generation of inventors and scientists.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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BIA – Fund Map Useful Tool for Finding Funding For Your Technology Development

Posted on June 14, 2010 by admin| Leave a comment

BIA – Fund Map Useful Tool for Finding Funding For Your Technology Development

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The BIA Fundmap provides easy navigation to the grants and funding available to businesses in the UK bioscience sector.

Click Here for Drug Development Services

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, FDA, Publish Guidance for Public, FDA Advisory Committee Members and FDA Staff, on Public Availability of Advisory Committee Members Financial Interest Information and Waivers

Posted on May 23, 2010 by admin| Leave a comment

Drug Regulators, FDA, Publish Guidance for Public, FDA Advisory Committee Members and FDA Staff, on Public Availability of Advisory Committee Members Financial Interest Information and Waivers.

Full Text Here

This guidance is intended to help the public, Food and Drug Administration (FDA) advisory committee members, and FDA staff to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers granted by FDA to permit individuals to participate in advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2). This guidance describes the basis and provides a format for public disclosure of certain financial interests by special Government employees (SGEs) and regular Government employees participating in these advisory committee meetings, and provides a format for FDA waivers allowing participation in these meetings. This guidance also explains how and when these documents will be made publicly available by FDA.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

Posted on May 7, 2010 by admin| Leave a comment

Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

Full Text Here

There are consulting with you on whether to bring all nicotine containing products (NCPs) – with the exception of tobacco and tobacco products – within the medicines licensing regime, which would require all currently unlicensed NCPs on the market, such as electronic cigarettes containing nicotine and nicotine gels, to apply to the Medicines and Healthcare products Regulatory Agency (MHRA) for a medicines marketing authorisation (MA).

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

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ida consultants freestrategyconsultation 515x64 Drug Regulators, MHRA, extend deadline on Nicotine Containing Products Review to 2nd June

Free Strategy Consultation - Biotech Pharma Regualtory

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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£70 million Boost for UK manufacturing (including Regenerative medicines)

Posted on January 22, 2010 by admin| Leave a comment

£70 million Boost for UK manufacturing (including Regenerative medicines)

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The first three state of the art manufacturing research centres funded under a new £70M Government investment will be based at Southampton, Loughborough and Brunel universities, to help UK businesses develop the technology products of the future and underpin manufacturing growth, Business Secretary Lord Mandelson announced today.

The three new Engineering and Physical Sciences Research Council (EPSRC) centres will focus research efforts in the fields of:

  • Photonics (the science and application of light using optical fibres to revolutionise the internet and telecommunications) at Southampton;
  • Regenerative Medicine (therapies to enable damaged, diseased or defective tissues to work normally again) at Loughborough; and
  • Liquid Metals (developing innovative technologies for the reuse and recycling of metal) at Brunel

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulatory Guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.

Posted on January 12, 2010 by admin| Leave a comment

Drug Regulatory Guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.

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This guidance is intended to encourage manufacturers of medically necessary drug products (MNPs) and any components of those products to develop contingency production plans to use during emergencies that result in high absenteeism at production facilities. In CDER’s Manual of Policies and Procedures (MAPP) 6003. “Drug Shortage Management,” a medically necessary drug product is defined as: Any drug product that is used to treat or prevent a serious disease or medical condition for which there is no other adequately available drug product that is judged by medical staff to be an appropriate substitute. The guidance provides considerations for the development and implementation of a contingency production plan that will ensure the highest possible quality MNP under the circumstances, including specific elements that should be included in the plan. The guidance also discusses the Center for Drug Evaluation and Research’s (CDER’s) intended approach to helping to avoid drug product shortages that could have a negative impact on the national public health during such emergencies. The guidance is intended for manufacturers of drug and therapeutic biological products regulated  by CDER and manufacturers of raw materials and components used in those products. FDA encourages drug product manufacturers to show this guidance to all suppliers and contractors associated with the manufacture of MNPs and to discuss the guidance with them to stimulate planning to avoid or mitigate disruptions in supply.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulatory Guidance, Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A

Posted on December 26, 2009 by admin| 1 Comment

Drug Regulators, EMEA, Publish ICH M2, Common Technical Document, Updated Q&A

Full text is an excell spreadsheet, its available from me on request. damien.bove@idaconsultants.com or on the EMEA website.

This question and answer document is a summary of questions reviewed by the eCTD Implementation Working Group (IWG) on the eCTD Specification.  The questions answered here relate to common questions that relate to the eCTD in all three ICH regions.  Many of the questions received on the Step 2 specification were addressed in Step 4 and do not appear in the list.   Questions concerning the timeframe for implementation of region-specific application types, module 1 implementation, lifecycle management and those questions that relate to items in the specification that direct the reader to each region are answered in guidance documents published for each region.

Questions related to the table of contents for the Common Technical Document (CTD) should be directed to the CTD question and answer section of the ICH Website.

Some of the questions posed so far address change requests to the eCTD Specification.  The change request section of this document addresses all those items received by the eCTD IWG and indicates their status.

This document will be updated as the specification undergoes change control or as new questions are submitted to the eCTD IWG.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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Drug Regulators Publish, ICH M2, Business Requirements Guidance

Posted on December 25, 2009 by admin| Leave a comment

Drug Regulators Publish, ICH M2, Business Requirements Guidance.

Full Text Here

ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs), the eCTD NMV will be developed jointly with the HL7 RPS project. M2 has developed the following list of requirements as input into the HL7 RPS Project.
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Drug Regulators Publish, ICH M2, Business Requirements Guidance

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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FDA Convenes Meeting Regarding Online Advertising

Posted on December 12, 2009 by admin| 1 Comment

FDA Convenes Meeting Regarding Online Advertising

Article From First Word

At a two-day meeting convened Thursday by the FDA, representatives from the pharmaceutical and other industries are gathering to give their opinions on how the US regulator should regulate advertising for drug products through the Internet and social media. The FDA agreed to consider formulating guidelines for online advertisements based on companies’ concerns that regulations for traditional media, particularly those involving the disclosure of side effects, may not be appropriate for the Internet.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 FDA Convenes Meeting Regarding Online Advertising

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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New 10% Tax Rate for Patent Income

Posted on December 10, 2009 by admin| Leave a comment

New 10% Tax Rate for Patent Income

Taken From RMS Bentley Jennison Pre-Budget Report Review

A new tax rate of 10% for income derived from patients s to be introduced, compared to the current corporation tax rte of 28%. The details reveal that the new regime is set to apply to patents granted after April 2013, i.e. in more than 3 years time, with the legislation only to be included in the Finance Bill 2011, following consultation on the design of the scheme. Whilst this measure may appear to be aimed far into the future, the development of patented products can take time and the intention is clearly to encourage future R&D in the UK.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free.

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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ida consultants freestrategyconsultation 515x64 New 10% Tax Rate for Patent Income

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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EMEA – SME Scheme Reminder

Posted on December 10, 2009 by admin| Leave a comment

EMEA – SME Scheme Reminder

Guide Here

This guide has been prepared for micro, small and medium-sized enterprises (SMEs) operating in the pharmaceutical sector. Its aim is to facilitate understanding of the main aspects of medicinal product legislation. The guide is structured to follow the chronological stages of developing a medicinal product. An overview of the scientific data requirements for obtaining a marketing authorisation in the European Union (EU) is provided. The regulatory procedures in place to optimise development and obtain an EU marketing authorisation are also summarised.

The guide focuses primarily on the requirements for authorising innovative medicinal products for human or veterinary use. The guide is not intended to be an exhaustive document but rather to raise SMEs’ awareness of the various more detailed sources of information available, with links throughout the text to additional information.

In December 2005, Commission Regulation (EC) No 2049/20051 introduced provisions aimed at promoting innovation and the development of new medicinal products for human and veterinary use by SMEs. This guide is intended to fulfil the obligation laid down in Article 12 of that Regulation, which calls for a ‘User Guide’ on the administrative and procedural aspects of medicines legislation that are of particular relevance to smaller companies to be published by the European Medicines Agency (EMEA).

Pursuant to the SME regulation, companies can access financial assistance (in the form of fee reductions and fee deferrals) and administrative assistance from the agency, details of which are outlined in Section 2 of this guide. To facilitate contact with the agency, an ‘SME Office’ was launched in December 2005 and is dedicated to addressing the particular needs of smaller companies.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Free Regulatory Watch Service

As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 EMEA SME Scheme Reminder

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“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

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New Fund Available for Industry / Uni Tie ups

Posted on December 9, 2009 by admin| Leave a comment

3rd Call for applications

i4i Funding Streams 3a (FPD3a) and 3b (FPD3b)

The NIHR’s Invention for Innovation (i4i) programme would like to invite submissions of applications to funding streams 3a and 3b (FPD3a and FPD3b).

Stream 3a applications must include collaboration between at least one industry and one research (academic or clinical) partner aiming to determine the commercial viability of a proposed device or technology, with the development of a robust route to market and a strong, appropriate consortia serving as key deliverables.  Primarily expected to be the first stage of a full collaborative applied research project, total project costs can be no more than £100K in total, of which 75% funding is available.

Stream 3b applications should build on the results of a completed assessment of feasibility and must also have collaboration between at least one industry and one research partner (academic or clinical). This will provide further evidence of the capability to deliver improved healthcare outcomes and commercial opportunity, delivering an advanced prototype along with plans for commercial and intellectual property exploitation. Lasting no longer than 3 years, successful projects will be funded to a maximum of 50% of the total project costs, with £100K-£300K per year in funding available.

All applications must show innovation and must have relevance, impact and potential to contribute to future health gain for patients and the general population.  This programme is open to research providers in the academic, NHS communities and industry across the UK.

For further information on eligibility and to submit an application please visit http://www.nihr-ccf.org.uk/site/programmes/i4i/ or email any questions that you may have to i4i.enquiries@quotec.co.uk.

Applications must be submitted via the NIHR CCF website no later than 5.00pm on Friday 29th January 2010. Applicants will be notified of the outcome of their application by late March 2010.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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How much does the tax man owe you?

Posted on November 19, 2009 by admin| Leave a comment

You can now  get  tax free CASH BACK! – R&D tax credit rules have changed so even more companies can claim money from the Tax Man

There is an R&D Tax Credit for you if you are;-  Developing  new products,new science, New Services,New Software, or Large Engineering projects? , SO don’t miss out.

Get in touch NOW ! IDA has been working closely with Armstrong Watsons R&D Tax credit expert and frankly we are BLOWN AWAY by the size and scope of the new opportunities. contact  Nigel Holmes, if you’re a Limited company doing R&D or new product development, Nigel will tell you quickly how much cash you are due.

Even if you receive a grant towards R&D you can get the R&D tax relief too!

Fill in the form below and get our free guide, or if you can’t wait pick up the phone –  01228 690200 and Nigel will educate you as well.

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Merck & Co Great Strategy for Tropical Disease Voucher Production

Posted on November 1, 2009 by admin| Leave a comment

Merck & Co Great Strategy for Tropical Disease Voucher Production

I have read a great story in First Word (Click here)

Merck & Co. and the UK charity Wellcome Trust announced Thursday the creation of a joint venture that will focus on developing affordable vaccines against diseases that commonly affect low-income countries. I don’t doubt that Merck are keen to be do good but there is a great upside that I am sure will not be lost on Merck – Priority Review Vouchers. Its a topic that we have covered a few times on this site, but if you get a technology approved for a neglected tropical disease the FDA will award you a Priority Review Voucher that you can use or sell as you see fit. The estimated value of these vouchers is put at between US$50 million and US$300 million. It looks like Merck have developed a system of producing these vouchers as quickly as possible and getting charities involved to share the cost too, somebody at Merck needs a huge bonus for this one, and think of the huge global health benefits its going to deliver.

for more article on this topic try – Click Here1 and Click Here2

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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METRC Announce Short Term Project Funding

Posted on October 16, 2009 by admin| Leave a comment

METRC Announce Short Term Project Funding £3000 going to £7000.

Short Term Project Funding is designed to support small research projects to explore the feasibility of innovative new products and processes. In the first stage, funds of up to £3,000 are available to support collaborative projects between METRC’s academic members and industry partners. The funding can be used flexibly at the METRC academic  institutions on a range of activities such as project consumables, paying for researchers or some limited consultancy work. For the most successful projects, funding can be extended into a second stage worth up to an additional £7,000 providing there is a matching contribution from an industrial partner.

he call will open on 16th October 2009 and funding will be available on a first-come first-served basis. We will be accepting applications for stage 2 funding from 1st January 2010 and there is funding available to support up to 10 stage 2 projects. We expect that a second tranche of Short Term Project Funding will be made available during 2010.

The Contacts Are:

Richard France – r.m.france@sheffield.ac.uk, 0114 222 9563
Simon Butler – simon.butler@sheffield.ac.uk, 0114 222 9450
Sam Whitehouse – S.P.Whitehouse@sheffield.ac.uk, 0114 222 9493

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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US Senate Votes to Improve Drug Trial Access

Posted on September 30, 2009 by admin| Leave a comment

Clinical Trial Access Improved by US Senate

just read an interesting article on www.Pharmaceutical-Technology.com

Four members of the US senate have introduced legislation to improve access to clinical trials for patients with rare diseases.

The “Improving Access to Clinical Trials Act” will allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare.

At present patients are prevented from accepting research compensation from clinical trials as it would make them ineligible to receive government medical benefits.

The move would also benefit researchers who often struggle to recruit patients with rare diseases such as cystic fibrosis due to limited patient populations and patient unwillingness to risk losing government support.

US Senator Ron Wyden said that for many suffering from rare diseases, access to clinical trials is their best hope for treatment.

“This legislation will make sure the small financial incentives these people receive will not be counted against them,” Wyden said.

The Improving Access to Clinical Trials Act is co-sponsored by Senators Ron Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby (R-AL).

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Increased Biotech Market Protection – USA

Posted on August 3, 2009 by admin| Leave a comment

US senate moves to protect biotech products from Generic Competition

I have just read an interesting news article on pharmaceutical-technology.com that says the US senate is moving to protect biotech products from Generic Competition for a period of 12 years

A 16-7 vote in the Senate Health, Education, Labor and Pensions Committee approved the amendment to award the biotechnology industry with 12 years of exclusivity before generics can be launched.

Biotech medicines, or biologics, are manufactured from living cells. Despite being more complicated and expensive to produce than conventional drugs they represent a growing segment of the industry.

Generic drug makers backed proposals limiting the exclusivity of the period from five to seven years.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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As you know this website is a great resource for keeping up to date with developments and regulations, why not get our FREE monthly regulatory and market round up. You can un-subscribe at any time and we do not share your details with anybody.

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Drug/Biotech Development Fund, UK government announces GB£150m fund

Posted on July 24, 2009 by admin| Leave a comment

Drug/Biotech Development Funding, UK Government Announces a GB£150 million fund.

UK government press release: 29th June 2009

The Prime Minister has today announced the creation of the UK Innovation Investment Fund to invest in technology-based businesses with high growth potential. The new fund will focus on investing in growing small businesses, start-ups and spin-outs, in digital and life sciences, clean technology and advanced manufacturing.

The Department for Business, Innovation and Skills, with the Department of Energy and Climate Change and the Department of Health, will invest £150 million alongside private sector investment on an equal basis known as pari-passu.

It is the Government’s belief that this could leverage enough private investment to build a fund of up to £1 billion over the next 10 years. The UK Innovation Investment Fund forms part of the Government’s strategy for Building Britain’s Future.

The UK Innovation Investment Fund will operate on a Fund of Funds structure which means it will not invest directly in companies, but rather invest in a small number of specialist technology funds that have the expertise and track record to invest directly in companies. The fund will provide a cost effective solution that provides a market return to both private sector investors and HM Government.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Markets – USA Regulators Go After Deals That Slow Generic Competition

Posted on July 21, 2009 by admin| Leave a comment

Drug Markets, Out of Court Settlements for Generics in Firing Line

This issue of settling Generic Drug Patent issues out of court was on the site last week, and this week more activity in generic drug deals slowing competition, an article on Frist Word, this time its more obviously illegal but watch this space.

The appeals court had invited the DOJ to submit comments on such deals as the court considers whether to allow a challenge to a $398-million patent settlement between Bayer and Teva’s Barr unit over the antibiotic Cipro (ciprofloxacin).

The head of the department’s antitrust division, Christine Varney, stated in the brief that agreements involving payments by the drug manufacturer to the patent challenger to delay a generic launch “requires the defendant to offer justifications in order to avoid antitrust liability.” In addition, the DOJ remarked that the resulting decrease in drug costs after a generic product is introduced, as well as the terms of federal drug law, “create unique incentives and opportunities for settlements that threaten the public interest, incentives and opportunities apparently not found elsewhere.” The DOJ declined to take a position on the litigation launched by drug purchasers against Bayer and Barr over the drugmakers’ 1997 settlement to delay the introduction of a generic version of Cipro

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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This guideline ap
recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.

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