Archive - augusti 2011

Rechon signs Exclusive License and Distribution Agreement with NovaDel

Rechon Signs Exclusive License and Distribution Agreement to Manufacture and Commercialize Zolpimist® outside the US and Canada
 
Rechon Life Science AB announces its entry into an exclusive license and distribution agreement with NovaDel Pharma Inc., where Rechon is to manufacture and commercialize Zolpimist® outside the United States and Canada. 
 
Zolpimist is the oral spray formulation of zolpidem tartrate for the treatment of insomnia, approved by the FDA in December of 2008, developed by NovaDel and manufactured by Rechon.
 
Insomnia is a sleep disorder whose sufferers experience inadequate or poor quality sleep and report one or more of the following: difficulty initiating sleep, difficulty maintaining sleep, and waking up too early.
 
Zolpimist oral spray offers the benefit of a faster rise in drug blood levels potentially leading to a faster onset of action, without having to take water.
 
Roland Holmqvist, CEO of Rechon Life Science AB expressed that, “This license and distribution agreement is offering a great opportunity for a successful introduction of Zolpimist outside the United States and Canada. We look forward to this extended partnership with NovaDel and we are impressed with NovaDel’s efficient oral spray drug delivery technology as used in Zolpimist.”
 
Steven B. Ratoff, Chairman and CEO of NovaDel Pharma Inc. said, “This agreement expands the market opportunity for Zolpimist to the world outside the U.S. We believe that Rechon, with its relationships with pharmaceutical marketers around the globe, has the ability to build a solid position for Zolpimist in the market for prescription sleep aids.” 
 
Contacts

To find out more about Rechon Life Science AB please visit our website at www.rechon.com or be in contact with Roland Holmqvist, CEO of Rechon, roland.holmqvist@rechon.se, +46 709 48 24 24 if you are intrested in Zolpimist.
 
  
About Rechon Life Science AB
Rechon Life Science is a complete pharmaceutical company providing manufacturing services for pharmaceutical and life sciences companies, of non-sterile, sterile and aseptic liquids from small scale batches for clinical trials up to full-scale manufacturing. Our facility operates under cGMP and we are regularly inspected by the Swedish Medical Products Agency, US FDA and other Health Authorities and can supply the commercial markets worldwide including US, Japan and Europe. Rechon assists with analytical, microbiological and stability testing, clinical services, QP release and regulatory filing support.
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Rechon Project Management at a glance

Maria Wingren, Rechons most skilled and experienced Project Manager, gives her story about Rechon Project Management.
 

Project Process

Rechon’s Project Management approach is based on the principle that every project is unique, with clear objectives, a defined schedule and full cost allocation. Projects are managed via a structured process that helps to accelerate completion and reduce costs while enhancing the end product and fulfilling project objectives. The Management is responsible for all strategic project decisions, including stop-or-go decisions. The Management evaluates project ideas, reviews progress, identifies problem areas and makes resource assessments throughout the project process. 

 
Extensive Experience
Several years of experience with different kinds of Technology Transfer projects, both from and into the site, has made us gain a lot of know how regarding these types of projects. It has also given us the possibility to focus on critical items and optimise the project plan already in the early planning phase of the project and thus minimise the risk of delays. Risk Management is included as a tool throughout the entire project.
 
The Rechon Project Management System is developed in such a way to have complete follow up on all activities as well as batches, material and stability.
 
Risk Management
The project group is gathered infrequently during the projects different phases in order to list and evaluate possible GMP and project risks and if necessary perform risk reducing measures in good time.
 
Open Communication
It is incredibly important to have an open communication and problem solving atmosphere between the Contract Giver and Rechon as well as within Rechon.
When called for, specialist from different departments are in direct contact with the Contract Giver to give the best solution to a concern. Besides the scheduled meetings, all critical questions are addressed as soon as they are observed in order not to let the project face a delay.
 
Focused Project Meetings
The aim is to have short Project Meetings were the Project Group and Contract Giver is informed about the main activities and to follow up on timelines and project progress. Discussions regarding specific activities in-house are preferably held in smaller groups with only specialist involved to optimise the recourses. This gives the possibility to have QC personnel involved in projects without steeling too much time from laboratory work. Each Project Member is responsible for the communication in the department and also to split the workload within the group.
 
Project Manager Responsibilities
The task for the Project Manager is to closely follow up on timelines and activities and to support the Project Group in discussions and communication both internally and with the Contract Giver.
 
Typical Project Set Up
Typical standard set ups are available for different kinds of projects; Clinical Trial supply, Technology Transfer, Large scale manufacturing etc. and are adapted to fit the specific project. A project plan is set and a project document file is established. This file is used throughout the entire project and includes at a minimum:
* Activity list with on-going and completed items
* Meeting minutes
* Change control
* Batch data (batch size, aim of batch, stability follow up etc)
* Material info (lot no, supplier etc for all raw material, API, primary and secondary packaging material)
* Contact information for Contract Giver and Rechon
  
Project Follow Up
One very important task for the Project Manager and the team is the follow up and “lessons learned” after the completion of a project and the following questions are answered:
* Which are the lessons learned that can be used in projects to follow?
* Did we have the right competences on the project?
* Did we make the right recourse estimations compared with the outcome?
* How can we plan the next project in order to optimise even more?
 
In larger projects the entire Project Group is gathered during a half day after project completion to follow up on the initial risk analyses and to have opinions regarding optimisation and follow up activities.
 
Read about a case study in Project Management at Rechon from a previous blog in May 2011 or be in contact with Maria.Wingren@rechon.se.
 
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