A. Potential energy
B. Light energy
C. Sound energy
D. Heat energy
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A. Business partner (buyers and suppliers) and Labour related issues
B. Customer related issues
C. Environment related issues
D. Culture, country, and community related issues
E. All of the above
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A. Make their invention
B. Commercialize their invention
C. Keep others from making their invention
D. Publish the results of tests using the invention
E. Collect a monetary award from the government
F. 1 and 2
G. All of the above
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Daniel Galbraith founded BioOutsource in 2007 with a team which included some former colleagues from Q-One Biotech, Europe’s leading CRO biosafety provider. Initially he worked as Head of Operations and more recently has taken the role as Chief Scientist where he has developed a successful team which is now seen as one of the leading providers for bioanalytical services globally and has gained a reputation for successful contract research in the biosimilar industry.
Prior to founding BioOutsource Daniel headed up the Biotechnology Service for Covance Laboratories Europe where he was in charge of their Biosafety Team. It was during his time in Covance that he first became involved with the bioanalysis of complex biologic molecules and eventually went on to develop services for Biosimilar molecules. He has also held senior positions in the fields of contract research (BioReliance Europe) and manufacturing (MedImmune) for some of the largest players within the Biotechnology industry. Daniel has a keen interest in Biosimilars and from his time with MedImmune working on the FluMist project he has retained an interest in virus vaccines and their testing to meet regulatory guidelines.
1. Why did you decide to do a webinar with Business Review Webinars?
We have been thinking of using webinars as a sales & marketing tool to complement our existing activities for a while and BRW offered the most comprehensive package that met all our needs.
2. What is one thing that’s key to BioOutsource’s success that somebody from outside the company wouldn’t know about?
The key to the company’s success is our unrivalled expertise in the field of Biosimilar Monoclonal Antibody characterisation. Due to our internal investment into this field, we have created a niche in the industry and offer the most comprehensive range of ‘off-the-shelf’ bioassays in the market, to meet the regulatory and quality requirements for Biosimilar products, reducing clients’ timelines and costs.
3.What is the most informative fact and what do you wish to achieve from the webinar?
Biological characterization is a complex, expensive and timely process, often fraught with costly errors that can ultimately lead to the failure of a development project. We seek to show our audience the importance of biological characterization in reducing the risk of development failure of Biosimilar Monoclonal Antibodies.
4. What do you most enjoy about your role?
The role of Chief Scientist allows me to work closely with a large number of companies to understand their products and where BioOutsource can partner with them to support the development of their projects. Key to the role is the challenge of understanding the mechanism of how these very complex drugs work and how we can provide assays which will characterize the drugs in a timely and cost effective manner.
5. What is your favourite movie or any you recommend to watch and why?
Favourite movie is 12 Angry Men, which is a very intense movie where one man stands against the rest of the jury as he doubts the verdict and finally triumphs through careful analysis to show the innocence of the accused. I think I like this movie as it shows where careful analysis of the facts points us to conclusions rather than the emotions which we are all guilty of.
Simon heads up the Business Review Webinars Energy team, leading the Business Development and Operational activities within this sector. Having worked within sales & marketing for the last 12 years, he has a good understanding of how to help clients reach their target audiences and deliver the right brand message to the market. He lives in London, is a father of 2 boys and enjoys watching and playing sports.
1. What do you most enjoy about your role?
One of the most rewarding things is being able to help my team develop their own skills and I also enjoy learning about the ever changing energy market.
2. What is the biggest advantage of hosting a webinar with Business Review Webinars?
I think Business Review Webinars takes a very proactive approach to delivering great presentations and reaching the right audiences for our clients. We make this an easy and effective process for our clients and really help them build their own brands.
3. Who or what inspires you?
My kids, they make me want to do better every day.
4. In your experience, what makes a successful webinar?
An interesting topic, an engaging presenter and interaction with the audience.
5. Where is your favourite place in the world and why?
York, as that’s where I was born and it will always be home. (Although I live in London)
Richard Mullan graduated from Queens University Belfast with a BMedSc (Hons) in BioMedical Science and has over 15 years experience in the Pharmaceutical industry. Beginning his career in the manufacture of Veterinary products, he subsequently moved to Clinical Research at Bio-Kinetic Europe and specialised in data management, protocol writing and project management of Phase I and IIa clinical trials. Since joining Almac in 2007 he has worked with Pharma and Biotech companies to manage supply chains across the full range of sponsors and trial designs.
1. Why did you decide to do a webinar with Business Review Webinars?
Webinars are a fantastic tool which enable us to communicate with a global audience. Business Review offers a great platform from which can share industry experience.
2. What was the most informative fact of the webinar?
That’s a great question and one that’s very difficult to answer, however I would say it’s the message underpinning the webinar: an experienced Supply Chain Manager has a significant impact on the successful financial and clinical outcome by building visibility in the supply chain through demand management, then integrating this into real time production/distribution strategy through tools like Supplywise and IRT. Our case studies help to demonstrate this by putting the theory into practice with what happened in real trials.
3. What do you wish other people knew about ALMAC?
What our customers have come to recognise in Almac is our total commitment to providing exceptional customer service, this is demonstrated through some of the examples given in the webinar. Our team thrives on the challenges given to us by our customers, as this is how our service offering develops in line with our customer’s needs.
4. What do you most enjoy about your role?
I thoroughly enjoy the constantly changing environment in which the Supply Chain Managers work in Almac. Each trial (even when inside a program) brings its own unique requirements/success criteria and being able to work with the multidisciplinary teams to develop effective solutions is very rewarding.
5. What has been your best holiday and where would you recommend visiting?
I’ve been very lucky as this job has taken me all over the world, however my favourite place is a little quiet fishing village called Portballintrea which sits on the North Antrim Coast of NI, near the famous town of Bushmills. It’s a fantastic place where time stops and you can just relax with family and friends. A walk along the beach towards the Giants Causeway in winter is simply brilliant.
6. What might someone be surprised to know about you?
What could I say that won’t get me in trouble! I have been a competitive strength athlete for 20 years and in that time I have been successful in Highland Games, Strongman and Powerlifting events, winning 2 world powerlifting championships! There’s nothing like the feeling of pulling a truck or tossing a caber to keep things in perspective (and help you stress a priority in the office)!
Learn how plant electrical efficiency can be optimized using residual or waste heat. Watch’s Triogen’s video exploring their facility in The Netherlands. http://www.youtube.com/watch?v=jg09yUrsDXQ 
Quite often a label remains the wrong point of focus in the manufacturing process. A broader view is required. Although it is a vital component in the production process, the actual label is one of many – a final output that is intrinsically linked, and indeed the product of, all the other variable aspects. Label design and delivery cannot, therefore, sit in isolation. It is only one aspect in a 360° process – and to meet the highest standards of accuracy, it needs to be built upon a 360° view of all the variable data components that influence its content. In the highly regulated medical device and pharmaceutical environment, these variables can include product specifications, country and product-specific regulations, market destination, local language requirements, batch number and expiry dates. And the regulatory landscape, rather like companies’ product portfolios, is evolving all the time. Systems and processes must therefore evolve with it.
With the continual tightening of labelling regulations and audits, understanding and future proofing your global labelling processes is a challenge that should be met head on. You need to make sure you know how to:
PRISYM ID is a leading provider of turn-key labelling solutions for organisations that require integrated in-house printing solutions with life cycle trace-ability for the medical device, life sciences and manufacturing industries. We aim to empower our clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labelling issues.
Our upcoming Business Review Webinar is designed to raise awareness of the many areas that must be considered within the medical device & pharmaceutical labelling industry, including the new FDA UDI regulatory requirements, and to bring to attention how label life cycle management solutions can centrally manage and transform companies’global labelling processes in the supply chain.
Please join us for the ‘Mind Your Language; Controlling Labelling on a Global Scale’ webinar on 23rd January 2014 3pm GMT/10am EST. Register here.
Business Review Webinars, a thought portal leader for business professionals in the pharmaceutical, healthcare, energy, supply chain, packaging and food & beverage, today announced their collaboration with BioOutsource, to promote a series of webinars in
2014.
BioOutsource is a global provider of biotesting solutions and the leading expert in the biological analysis of Biosimilar Monoclonal Antibodies for the biopharmaceutical industry. The series of webinars will discuss Biosimilar characterisation and highlight solutions to help speed Biosimilar products to market as well as review regulatory issues and future techniques and molecules.
To request further information and to sign up for any upcoming webinars, please contact [email protected]
Business Review Webinars allows individuals throughout the world to learn and to communicate. Particularly in the past two years, webinars have rapidly gained prominence as an important component of many marketing strategies. No longer considered an afterthought, a well-crafted and successful webinar can greatly enhance a company’s reputation, sales and benefit the audience as a progressive learning tool. Business Review Webinars deliver high level thought leadership presentations on intriguing and current topics, which appeal to a live audience. Ultimately, the key to
designing a good, relevant webinar is in understanding what an audience is looking for.
“We’re looking forward to working with BioOutsource and are pleased that we have been chosen to leverage promotional aspects of webinars”- Jake Sharp, Head of Business Review, Progressive Digital Media PLC.
For more information on our upcoming webinars, please visit the following link: http://www.business-review-webinars.com/webinars?chan=pharma
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About BioOutsource
BioOutsource is one of the world’s leading providers of contract testing services to the Biopharmaceutical Industry, offering a comprehensive range of testing services to support a range of products throughout development and manufacturing. BioOutsource have a created a niche in the market and have consolidated a leading position in the biological analysis of Biosimilar Monoclonal Antibodies.
The updated FDA Guidance for Industry on Process Validation encourages an in-depth level of process understanding and ongoing life cycle continuous verification. The guidance explains that process validation consists of three stages: process design (process development studies), process qualification (evaluation of the process design) and continued process verification (life cycle monitoring, control and improvement of the post licensure product). Thus in a nutshell the regulators emphasise two central themes; process understanding and use of this understanding to develop systems to ensure that the process remains in a state of control throughout its lifecycle.
This regulatory emphasis on increasing levels of process understanding can sometimes cause confusion. This is mainly due to the fact that the developers and manufacturers of biopharmaceuticals are often unsure of what is required – what type of studies should be taken (one factor studies or multivariate experimental design approaches), how to qualify scale down models, how and when to perform risk assessment, how to utilise statistical techniques and learning from risk assessment, how to set acceptance validation criteria, etc. Thus the difficulty faced by the developers and manufacturers of biopharmaceuticals is how to answer these questions within limited resources and demonstrate to the regulators an increase level of process understanding to support their licensing application i.e. how to get the biggest bang for their buck?
As one of the world’s leading providers of contract process development and manufacturing services for the biopharmaceutical industry, Fujifilm Diosynth Biotechnologies have extensive experience in QbD approaches applied to both microbial and mammalian derived biologics. Our experience includes delivery of multiple process characterisation and process validation projects in addition to Continued Process Verification for our commercial products.
Fujifilm Diosynth has a variety of tools and approaches to facilitate the use of QbD principles, expertise in statistical analysis to support process understanding for effective delivery of robust manufacturing processes. In the upcoming webinar on 30th January, Process Development studies for Product Commercialisation, we will share our experience with some examples and tools we have developed to assist our customers in their journey. In this webinar we will answer some of the above questions raised, interactively take questions from the audience and allow the participants to gain an insight into how process development studies can be leveraged into a successful process validation.
Mahesh Shivhare & Graham McCreath