Category Archives: licensing

EMA Publish Q&A on Post Approval Change Mangement Protocols

Posted on January 14, 2011 by admin| Leave a comment

EMA Publish Q&A on Post Approval Change Management Protocols.

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The concept of post approval change management protocols has been introduced in EU through the Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products that supports Variations Regulation EC (1234/2008).
This Questions and Answers document sets some general principles about the content and future use of these protocols and will be updated in the light of more experience.

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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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Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs

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

Drug Regulators, FDA- CDER, Publish Guidance on the Assessment of Abuse Potential of Drugs.

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This guidance is intended to assist sponsors who are developing drug products with the potential for abuse that may need to be scheduled under the Controlled Substances Act (21 U.S.C. 811(b), 811(c)). Examples of products that are addressed in this guidance include new molecular entities and new dosage forms of drug substances already controlled under the Controlled Substances Act (21 U.S.C. 812(c)). Drugs with abuse potential generally include drugs that affect the central nervous system, drugs that are chemically or pharmacologically similar to other drugs with known abuse potential, and drugs that produce psychoactive effects such as sedation, euphoria, or mood change.2

Specifically, the guidance discusses the following:

• The definition of abuse potential

• Information on submitting an abuse potential assessment, including a proposal for scheduling

• A description of what constitutes an adequate abuse potential assessment

• Information for sponsors performing an assessment, including (1) the design and conduct of appropriate studies and investigations and (2) general administrative recommendations for submitting a proposal for scheduling

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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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 regulattions, rules and initiatives each month, and summarise 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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Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

Posted on December 29, 2009 by admin| Leave a comment

Drug Regulators, FDA, CDER, Publish Guidance on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims

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This guidance describes how the Food and Drug Administration (FDA) reviews and evaluates existing, modified, or newly created patient-reported outcome (PRO) instruments used to support claims in approved medical product labeling. A PRO instrument (i.e., a questionnaire plus the information and documentation that support its use) is a means to capture PRO data used to measure treatment benefit or risk in medical product clinical trials. This guidance does not address the use of PRO instruments for purposes beyond evaluation of claims made about a medical product in labeling. This guidance also does not address disease-specific issues. Guidance on clinical trial endpoints for specific diseases can be found on various FDA Web sites.
By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their discussions with the FDA during the medical product development process, streamline the FDA’s review of PRO instrument adequacy and resultant PRO data collected during a clinical trial, and provide optimal information about the patient perspective for use in making conclusions about treatment effect at the time of medical product approval. PRO instrument development is an iterative process and we recognize there is no single correct way to develop a PRO instrument. Different strategies and methods can be used to address FDA review issues.
The Glossary defines many of the terms used in this guidance. Words or phrases found in the Glossary appear in bold italics at first mention. Specifically, we encourage sponsors to familiarize themselves with the terms conceptual framework of a PRO instrument, endpoint model, and content validity.
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 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.

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

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Medical Device Classification not Centrally Stored

Posted on December 11, 2009 by admin| Leave a comment

Medical Device Classification not Centrally Stored

A recent discussion with the MHRA has provided enlightening:

At present no single organisation holds details of all medical devices – there are plans for the creation of a European Database, however these are not yet in place.

The medical device regulations differ from the medicines regulations in that no ‘licence’ is issued by any EU Competent Authority as is the case for medicinal products. A medical device may be CE marked in one Member State and then freely placed on the market in any other Member State. The requirements under the medical device directives are for the manufacturer to demonstrate the products conformity to the requirements and to CE mark the product. The Directives require that Class I medical devices and in vitro diagnostic medical devices are registered with the Competent Authority in which the manufacturer or his authorised representative is based, however all other classes of medical device are CE marked via a duly designated Notified Body, who again may be located in any EU Member State. The Notified Bodies are responsible for confirming that the devices meet the requirements of the regulations and once this has been done by issuing a CE certificate to the manufacturer for the devices concerned.

All manufacturers of medical devices will provide details of their products classification and CE marking conformity route to each EU Competent Authority for medical devices upon request,  however this information may only be requested when there is reason to believe that the product concerned is not in conformity with the requirements of the medical device directives. Manufacturers are not obliged to provide this information to other third parties, although some are happy to do so or provide details on their websites.

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.
ida consultants freestrategyconsultation 515x64 Medical Device Classification not Centrally Stored

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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 Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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

Drug Regulators, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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The Center for Biologics Evaluation and Research (CBER), FDA, are recommending ways that would allow the manufacturer, generally a cord blood bank, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for specified indications. This guidance document is intended to assist you in obtaining a biologics license. It contains information about the manufacture of minimally manipulated, unrelated, allogeneic placental/umbilical cord blood and how to comply with applicable regulatory requirements.
This guidance finalizes the draft guidance entitled “Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies,” dated December 2006.

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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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, FDA, Publish Guidance for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoiteic Reconstitution for Specific Indications

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Regulators Publish Draft Guidance for industry on Risk Evaluation and Mitigation Strategies (REMS)

Posted on November 4, 2009 by admin| Leave a comment

Regulators, FDA CDER Publish Draft Guidance for industry on Risk Evaluation and Mitigation Strategies (REMS)

full text here

This document provides guidance to industry on:

  • The format and content of a proposed risk evaluation and mitigation strategy (REMS), including REMS supporting documentation;
  • The content of assessments and proposed modifications of approved REMS;
  • What identifiers to use on REMS documents; and
  • How to communicate with FDA about a REMS.

The information on the content of a proposed REMS submission (section III of this document) also applies to proposed REMS that are voluntarily submitted by applicants or holders of approved applications (see section II.A of this document).

This guidance will address REMS elements and provisions that are broadly applicable to proposed REMS and to assessments and modifications of approved REMS. Other provisions,  such as those that pertain only to abbreviated new drug applications (ANDAs), or expanded information about REMS assessments and proposed modifications, will not be fully addressed, but will be the subject of future guidance.

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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recombinant vaccines for the prevention and treatment of infectious disease, and provides guidance on quality, non-clinical and clinical aspects.
ida consultants freestrategyconsultation 515x64 Regulators Publish Draft Guidance for industry on Risk Evaluation and Mitigation Strategies (REMS)

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Access to Finance – New Yorkshire Forward Initative

Posted on March 4, 2009 by admin| Leave a comment

Just a breif note on a new Yorkshire Forward initiative, Access to Finance for Healthcare.

It is a programme designed to assist healthcare technology companies prepare for and go out on fund raising programmes, right up to being introduced to investors.

The programme is being run by Grant Thornton in Leeds and is on the back of a successful programme that was run by Grant Thornton in London called Gateway to Finance. Access to the programme is via application http://www.investinginhealth.co.uk/ , it gives guidance and mentoring for the individuals running the companies / project seeking finance and helps with market assessments and business planning. it also introduces these companies / projects to investors.

It looks like a great programme and I will be introducing a number of the companies that I work with to the programme.

As consultants working in the area of drug development, regulatory strategy and development strategy we are often involved in these kinds of document development processes and good housekeeping is vital. eCTD is coming to us all so its best we get up to speed as early as possible.

If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

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Drug R&D Licensing Economy was US$340bn in 2007

Posted on October 14, 2008 by admin| Leave a comment

Most drug discovery and development companies rely on licensing to fund their technology development programmes, either directly or as an exit for investors. We have complied a report that represents an attempt to put a figure on the amount of money that is circulating in the drug discovery and development economy. (full report available see bottom of article)

Our research led us to believe that:

The appetite for deals appears to have grown over the past 10 years but stabilised in recent years and this trend is followed by most of the individual indication groups.

The amount of money circulating in the drug discover and development economy in 2007 was roughly US$340bn, the level is pretty much the same as 2006, but an increase from 2005.

chart1 Drug R&D Licensing Economy was US$340bn in 2007

Get the full report!

This report makes interesting reading and should you wish to view the report in full, just drop a message in the contact form below with your e-mail and I will send you a password so you access the pdf from the reports section of the site (see top link). The report contains comparisons by indication group on deal volume and deal values with a brief outline of how we came to the global figure.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a 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 using the contact form or email Damien at damien.bove@idaconsultants.com

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