“We are delighted to have someone with Peter’s obvious talent and wealth of experience joining our company,” said Walsh. “His excellent leadership skills, proven track record of uniting and motivating operations and sales professionals to achieve top-line performance make him a great fit for Intelsius. As our infrastructure continues to grow to support our global business, Peter’s talents will be critical to our continuing growth.”

“I look forward to supporting the dynamic, ongoing strategic vision of Intelsius by cultivating stakeholder relationships and continuously evaluating Intelsius’ short and long-term strategic sales objectives while identifying ways to enhance critical business performance and create larger financial business opportunities,” said Amatulli.

Prior to joining Intelsius, Amatulli held various high-level sales and management positions in a variety of biotechnology and pharmaceutical industries. Most recently, he served Rules-Based Medicine, Inc., as Vice President Sales and Marketing.  Over his career he has held similar positions at MDS Pharma Services (Clearstone) and Covance.

Amatulli received his Bachelor of Science degree from Ohio University in Athens, Ohio.

About Intelsius
Incorporated in 1998, Intelsius is a subsidiary of DGP Life Science Ltd, which is headquartered in York, United Kingdom. Intelsius specializes in the design, manufacture and supply of temperature-controlled packaging and regulatory-compliant sample transport solutions. Intelsius serves a wide range of organizations, including government agencies, leading pharmaceutical, biopharmaceutical and clinical research industries to major laboratories and life science organizations. With a strong focus on developing environmentally sustainable products and procedures, the company offers eco-friendly ways to ensure the integrity of customers’ products and samples. Intelsius is a growing global presence, with manufacturing facilities, distribution hubs and local offices situated throughout the world, including North America, Europe and Asia. For more information, visit www.intelsius.com.

Media Contact:

Tammy Moran (Intelsius) – +1 317 536 9950 or tammy.moran@intelsius.com

Today we are launching not one, but two new product ranges. The announcement was made at IQPC Cool Chain Logistics Europe 2012 in Basel Switzerland by David Walsh, chief executive officer of Intelsius.

The first is the Xtremotherm™ product range, which protects the integrity of critical ambient patient samples when exposed to extreme climates. The most exciting part of this range is the Xtremotherm-5 utilizes patent pending PRA (Peak Ratio Algorithm) Technology™. Read more in our news release here!

Thermotrek™ is our second new product. This range is a discreet cold chain personal carry case for patients to transport their temperature sensitive medications. Thermotrek™ provides thermal control and patient safety for the “last mile”. Read more in our news release here!

Intelsius continues to lead the way in developing solutions that ensure patient safety. We are dedicated to protecting life’s most precious cargo™.

Thermotrek systems are a range of insulated, patient carry cases designed for movement of temperature sensitive medications either being tested in clinical trials or for approved and marketed medicines used by patients.  The success or failure of clinical trials often depends on crucial passive climate controls to ensure the efficacy of medicines. In commercially available temperature sensitive medicines the systems ensure the patient’s investment in treatment is not wasted while ensuring efficacy of the medicine.  Thermotrek systems are qualified to maintain contents at the required temperature for up to 24 hours and designed to give many months of use.

The first two Thermotrek solutions are constructed with proprietary materials which provide a high level of resistance to tears or abrasions while providing stain and water resistance.

Each case is ergonomically designed to have a minimum impact on the patient’s daily life and enable comfortable transportation of medicine.  In addition, its discreet design keeps the contents confidential.  With the Thermotrek range, Intelsius continues to lead the way in developing solutions that ensure patient safety.

“Keeping patients safe and helping ensure successful clinical trial outcomes are the primary reasons for creating the Thermotrek line of products,” said David Walsh, chief executive officer of Intelsius.  “We are proud to lead the way in the effort to provide easy to use, technically advanced solutions to the life science industry,” said Walsh.

About Intelsius
Incorporated in 1998, Intelsius is a subsidiary of DGP Life Science Ltd. Intelsius specializes in the design, manufacture and supply of temperature-controlled packaging and regulatory-compliant sample transport solutions. With a strong focus on developing environmentally sustainable products and procedures, the company offers eco-friendly ways to ensure the integrity of customers’ products and samples. Intelsius is a growing global presence, with manufacturing facilities, distribution hubs and local offices situated throughout the world, including North America, Europe and Asia. For more information, visit www.intelsius.com.

Media Contacts: 

Michael Clark (Miller Brooks) – 317.873.8100 or michael@millerbrooks.com

Tammy Moran (Intelsius) – 317.536.9950 or tammy.moran@intelsius.com

Xtremotherm™ Extreme Exposure Systems range of shipping solutions protects ambient patient samples in extreme climates.  Xtremotherm solutions are designed to protect critical patient sample payloads against degradation during periods of extreme temperature exposures that are common during shipment due to increasingly remote clinical sites.

“The time-sensitive nature of clinical research and extraordinary costs involved in getting a drug or treatment to market, make the Xtremotherm products an excellent choice for extreme temperature environments,” said David Walsh, chief executive officer of Intelsius.

“Xtremotherm products were created to protect the enormous investments made in research and development around the world including emerging markets such as Brazil, China, India and Russia,” Walsh said.  As ambient samples are typically not temperature monitored during transport, our Pharma clients can now deploy the best available protection to ensure the sample is viable despite being transported through periods of extreme temperature.  “The loss of a single sample is simply not acceptable from either an ethical or financial perspective. We owe it to the patients to ensure their samples are received at the labs in optimum condition,” said Walsh.

These Intelsius packaging solutions are certified for time ranges from four hours to 38 hours at constant external temperatures of -30°C to +40°C. In particular, Xtremotherm-5 is unique in that it utilizes proprietary patent pending PRA (Peak Ratio Algorithm) Technology™ that delivers the absolute optimal size for maximum performance. “With Phase III per patient clinical trial costs set to reach nearly $50,000, minimizing risk of sample deletion is paramount to study success and hitting deadlines,” said Walsh.

About Intelsius
Incorporated in 1998, Intelsius is a subsidiary of DGP Life Science Ltd. Intelsius specializes in the design, manufacture and supply of temperature-controlled packaging and regulatory-compliant sample transport solutions. With a strong focus on developing environmentally sustainable products and procedures, the company offers eco-friendly ways to ensure the integrity of customers’ products and samples. Intelsius is a growing global presence, with manufacturing facilities, distribution hubs and local offices situated throughout the world, including North America, Europe and Asia. For more information, visit www.intelsius.com.

Media Contacts: 

Michael Clark (Miller Brooks) – 317.873.8100 or michael@millerbrooks.com         \

Tammy Moran (Intelsius) – 317.536.9950 or tammy.moran@intelsius.com

Often the media seems to thrive on reporting bad news.  Unfortunately in the case of 2011 employment, they seem pretty close to the mark.  Indiana, and for that matter much of the rest of the United States, saw a reversal of the positive gains in employment during 2010.  2011 job growth has been essentially stagnant versus a gain of about 20,000 jobs created in 2010.  To put these numbers in perspective though, consider that prior to 2010 Indiana lost nearly 200,000 jobs since the recession “officially” began in 2007.  All these numbers beg the questions “are we headed back down” or is it the dreaded “double dip”?   Perhaps, but of course those questions can only be answered by time.

The one inescapable conclusion is that in Indiana and the rest of the country, the employment reality in which we have lived has changed drastically.  This certainly comes as no big surprise to anyone that has been job seeking during the last four years.  It’s also no great revelation that manufacturing is not a comfortable sector in which to be employed and Indiana still depends heavily on manufacturing.   All of these factors seem to indicate we are still in for some very tough times.

I’d like to be able to end this by saying we are through the worst of it and things will get back to “normal” fairly soon.  The truth I fear is quite different.  In the end, what matters is what people do with this new reality?  Most Hoosiers must and will adapt.  As is always the case in this country, the most creative and innovative will succeed and prosper.  What however is to become of those that are not quite as creative or as innovative?  I suppose that’s a subject for a future blog.

November 2011 saw some encouraging clinical developments, three drug approvals, two Initial Public Offerings (IPOs) and news that Gilead Sciences is to buy Pharmasset  for $11 billion, says the report, from life sciences financial services specialist Burrill & Co.

Between 2006 and 2010, drug shortages increased by more than 200%, according to a Government Accountability Office. Luckily, the White House announced that they will immediately begin requiring some drug manufacturers to report production interruptions to the FDA, in order to prevent shortages from occurring.

The NHS Confederation has joined forces with the Association of the British Pharmaceutical Industry (ABPI) and the Association of British Healthcare Industries (ABHI) to help the NHS move innovation forward.

There are now 700 targeted oncology drugs in the global clinical trial pipeline, many with companion diagnostics to guide patient selection. But, over the last six months, the average monthly cost of each of eight cancer drugs approved in the US was over $10,000.

Bali, Indonesia is taking steps to improve their animal cold chain and vaccine management. A yearlong report discovered poor vaccine logistics and management including: unsuitable refrigerators, incorrect storage and arrangement, use of solid ice cubes which can lead to accidental freezing when transporting, etc.

Two years ago, the day after New Year’s Day to be precise, I was asked a question by both the CEO and COO, in my opinion “which is best Kaizen, Lean, or Six Sigma?” Having thought about this and knowing full well that this very question has been debated for what appears to eons; my response was “all of them”.

Not being one to sit on the fence, I added that in my experience each philosophy has its own merits depending on the intended application or activity. Indeed, I had found that a fusion gave the appropriate and desired results.  This is due to each sharing fundamental process steps. Let me explain.

There were a number of opportunities available for Continuous Improvement Programs however one in particular needed to be transformational. This was the lay-out of the Plant and the method with which DGP Intelsius manufactured and assembled its products. As a transformational event, this took in almost every element involved in Lean with elements of Sigma and ultimately ongoing improvement steps of Kaizen.

Production was located such that personnel encouraged to enter via the warehouse caused problems. This included people and workplace transport conflicts, absence of visual management, bottle necks in process flow, no build / cycle accountability, high stock levels of finished goods (PUSH not PULL) – all leading to costly downtime and lengthy line change-over, etc.

Once the ‘Vision’ had been established, a strategy was identified to realise that vision. Intelsius needed a structured Plan and a Change Agent to create the need for change and deliver the plan. The need for change needs to be communicated and that involves one of the most pivotal criteria in this process, which is to engage people and motivate them in order to drive change forward.

Our vision is become a World Class Manufacturer employing Good Manufacturing Practices.

Our journey has started in using DMAIC techniques (Sigma), to measure and benchmark; establishing Takt time (LEAN), the time required to manufacture a product to meet demand; and monitoring 4M’s (Kaizen) Man, Machine, Movement and Materials.

Suffice to say production was moved to improve safety, and give visibility.

One Piece Flow was introduced which reduced labour, allowed for quicker build / cycle times reducing the amount of finished goods stock, and opened up capacity to meet the growth demand, eliminating over-production. These all were put into place addressing the 8 wastes. Continuous Improvement programs were employed in other areas of production, the warehouse and planning, realising significant gains.

Whilst I believe the journey will never be completed as there is always need for improvement and that there is no doubt whichever philosophy is adopted there is one thing that unites them all and that is…. the desire for wanting and making improvement!

Oh and the question that was asked by the CEO and COO, it was in my 3^rd stage interview.

Why do you work here? Intelsius is a dynamic, innovative company with strong environmental ethics.

Which Intelsius offices have you travelled to? Americas, Ireland & Holland.

Do you have a pet? Yes, a Kitten named Pickle.

When I was a kid I wanted to be… Working for NASA, at least somehow involved in the space program.

Favorite Quote? “Give a man a fish and he will eat for a day, teach a man to fish and he will eat for the rest of his life” Anon.

Favorite ice cream flavor? Crème di mascarpone.

Coffee or Tea? Tea.

Would you rather be hot or cold? Hot, because being cold is miserable just like winter.

Favorite food to eat? Mexican, I like the spicy kick to it!

Dangerous or Safe? Safe as it brings routine, rather than chaos.

Temperature controlled medicine last taken? Never taken any, I have the body of a fine tuned athlete…..(off season!!).

Alex Roskoss, Global Head of Technical Services

There are two major ways to move temperature controlled products or payloads, passive provision or active provision of temperature control.

Active systems are what you typically think of as temperature control; freezers, fridges and cold rooms. When it comes to shipments, these active systems are typically just mounted on trailers, vans or pallets. They provide thermal control which actively responds to the adverse temperatures outside.

Passive systems are less obvious and most people would know them from coolers or chilly bins, combining ice or cool-packs with insulation to provide a fixed amount of thermal protection. Its ability to protect a payload depends upon the design and preparation of the passive system.

The choice between actives and passives involves a large number of factors including

• Cost
• Level of protection required
• Need for power supply
• Availability for use
• Flexibility of your supply chain
• Extremities of external environment

When powered and handled correctly, active systems can provide a high level of thermal protection, advanced units being capable of both heating and cooling in response to low or high external temperatures. They typically consume fuel, use battery power, or require constant external power to operate. This imposes tight restrictions on handling and shipping. The scale of these systems is typically from single pallet to whole vehicles. For high utilisation of space on fixed shipping routes and with good handling agreements, active solutions provide a good level of protection. There are inefficiencies however when only small payloads need to be moved.  The high initial costs for the units also pose a barrier to use. To ameliorate the inefficiency, suppliers often lease units to reduce the costs to the single customers while increasing the utilisation of the units.

The passive systems in contrast can be scaled from single vials to multi-pallet and once assembled for shipping can be sealed and sent without the need for power supply and typically without temperature aware handling. They can travel through a wide range of carriers and integrators. The thermal performance occurs irrespective of the handling or external environment so re-routing and flexible supply chains can be accommodated. The performance is determined by initial design and preparation, in contrast to active solutions, the duration of the thermal protection is finite. They are comparatively low unit cost and so can be held in stock to allow flexibility of supply. Not requiring special handling and being size versatile, if there are a large number of destinations for payloads, in differing quantities, the passive solutions can provide a very economic solution.

The choice between the active and passive solution, given an acceptable quality level, is best approached on a total cost of ownership model where the flexibility of provision, the security of supply to the market, the replacement and quality costs along with the shipping costs and thermal solution costs are all evaluated.

The UK Health Secretary announced that outcomes for patients in 11 new areas of medicine will be audited, monitored and published. Results will be published from 2013 and on a regular basis thereafter (PharmaTimes 01-Nov-11).

The European diabetes market earned revenues of $8.6 billion in 2010 and estimates it to reach $13.97 billion in 2017, a compound annual growth of 7.2% (PharmaTimes 03-Oct-11).

A signed executive order instructs the FDA to do three things to reduce drug shortages:

• Broaden reporting of potential shortages of certain prescription drugs;
• Speed reviews of applications to begin or alter production of these drugs;
• Provide more information to the Justice Department about possible instances of collusion or price gouging.