• Do you have too many mandatory projects, such that the remaining discretionary budget is too limited to be able to funnel it towards investments that will help you achieve your goals?
• Are there enough reliability-focused projects selected for funding to allow you to meet your targets? Or, for that matter, even enough proposed for funding?
• Do you have so many high-risk investments that you can’t fund them all within the budget constraints?

If you find yourself answering ‘yes’ to any of the above questions, you might be interested in the solution UMS Group has to offer.

For most companies in asset intensive industries, difficult investment planning decisions are made each budgeting cycle. Following asset management best practices, company strategies and objectives should be aligned to the investment decision-making process and a rigorous process for investment analysis and optimization of the proposed portfolio of investments should take place. With the large capital and O&M budgets and the numerous investments that are proposed each budget year, an investment optimization tool is usually required to best analyze the complex trade-offs that occur when deciding to fund or not fund each proposed investment. The struggle is that most companies either don’t have a unified tool suite in place to support all phases of the process OR the processes are not well enough established to support the consistent use of existing tools/applications.
UMS Group’s Spend Optimization Suite (SOS) application and process is fully aligned with current asset management philosophy and can provide solutions to these difficult risk and investment planning problems. The application is divided into 4 linked modules which provide decision support for the strategic planning, risk management, and investment planning and optimization processes.

Strategic Alignment (SA) Module: The SA Module is the starting point for the SOS Application. Company Strategy is defined and the relative priority of each objective is assigned. This strategy is incorporated into all decision making stages in the subsequent modules.

Risk Identification and Opportunities (RIO) Module: A detailed needs assessment phase, aligned withcompany strategy, should take place via a Risk Register and Analysis tool. Our application uses the RIO module to capture, score, and prioritize business level risks and opportunities that can be mitigated or addressed via proposed investment solutions.

Investment Definition and Scoring (IDS) Module: After the risk management/ needs assessment phase, proposed investment solutions and comprehensive investment scoring of each solution need to be captured. The IDS module of the SOS application captures proposed investment information and scores investments across all success criteria elements of company strategy across two different dimensions, value and risk of deferral. As each investment is analyzed during the investment planning process, there is a key decision to be made: fund the investment or defer the investment for one (or more) budget cycles.

Investment Optimizer (IO) Module: Investment Optimization is critical to analyzing the trade-offs of investment funding decisions. UMS Group’s SOS application utilizes the IO Module to perform these optimization functions.

Back to our questions…Too Much Mandatory Investments, Reliability Goals are Not Achieved, and High Risk Investments Not Funded? If you struggle with these issues and do not have the necessary decision support tools in place to provide adequate investment analysis and solutions, a portfolio evaluation and optimization tool might be a worthwhile investment.

Our Spend Optimization Suite (SOS) application is a web-based solution offered to the asset intensive industry that can help you solve these problems. Interested? Register for our webinar here

 

Q: How does continuous monitoring of Cerebral Blood Flow at the bedside help to improve outcomes for your Neurocritical Care patients and reduce cost to your institution?  

 

A: Real-time monitoring provides the earliest possible detection of critical flow thus enabling the earliest possible intervention and opportunity to reduce the severity and extent of damage. Early, successful intervention improves patient outcomes and reduces costs associated with complications.

 

Compromised blood flow is a critical condition leading to organ dysfunction, infarction and often death. In the absence of continuous monitoring, critically low flow can occur unknowingly and cause injury prior to manifesting clinical signs. Frequently this injury is irreversible when it occurs in comatose, sedated or anesthetized patients who, being unconscious, do not complain of symptoms of ischemia (e.g.,  pain) and do not exhibit clinical signs (e.g.,  changes in cognitive function, speech, or movement) that clinicians would otherwise be able to detect in an awake patient.

 

Continuous perfusion monitoring in absolute physiological units enhances clinical management by providing real-time assessments of blood flow to detect critically low flow, and to assess patient responses to treatment interventions.   The Bowman Perfusion Monitor (BPM) is the only technology that continuously measures blood flow (tissue perfusion) in absolute physiologic units at the bedside (Hemedex, Inc., Cambridge, MA). 

 

Q: How does continuous monitoring of CBF with the BPM improve Clinical Insight, Work Flow, and Patient Care?

 

A: By providing information about critical parameters and allowing insight into administered therapies, all in real-time at the bedside.

 

By quantifying flow in absolute physiological units, the BPM accurately measures CBF for comparison with known thresholds for detecting critically low flow (i.e., Vasospasm: 15ml/100gm-min, Ischemia: 10ml/100gm-min)[i] or hyperemia . By monitoring flow in real-time at the bedside, the BPM provides continual vigilance so clinicians can Know the Flow ™ and have assurance when flow is adequate or have actionable information for treatment decisions if the flow is critical.

 

Q: How does continuous monitoring of CBF with the BPM provide an opportunity for better outcomes?

 

A: By providing the clinician with real-time information and alerting the clinician to changes in physiology sooner rather than later when damage associated with such changes may be irreversible.

 

Early detection of compromised blood flow enables early intervention and the opportunity to improve patient outcomes. Real-time assessment of the effectiveness of therapeutic interventions enhances clinical decision making. [ii]

 

Example applications include:

 

• early detection of vasospasm in SAH patients[iii];
• monitoring for changes in CBF with changes in ICP or brain swelling in TBI patients;
• minimize re-bleeds by avoiding unnecessary therapeutic hypertension in SAH and TBI patients
• measure the impact of arterial clamping on flow during aneurysm or bypass surgery[iv] ;
• predict the maximal safe duration of Temporary Arterial Occlusion (TAO)[v]

 

Q: How could continuous monitoring of CBF with the BPM reduce health care costs at your institution?

 

1. Reduce the use of an expensive alternative technology:  BPM monitoring is less expensive, more accurate, and easier to use than intermittent velocity assessments made by technicians using Transcranial Dopper (TCD) to detect vasospasm in SAH patients[vi]
2. Improve selective use of more expensive assessments: Continuous bedside monitoring of CBF indicates when brain scans may be needed thus reducing the number of (cost of) unnecessary scans and improving the clinical utility of selected scans
3. Reduce expenses associated with false detection of vasospam: Qualifying an elevated TCD in SAH patients by a quantitative CBF measurement reduces the risk and cost associated with mistakenly treating hyperemic patients with angiography (~$10K) and angioplasty (~$3-10K)
4. Reduce risk of complications and their associated expenses: Early detection of compromised blood flow enables early intervention and the opportunity to avoid or mitigate complications
5. Shortened ICU stays: Knowing when the flow is adequate reduces tendency for unnecessary therapeutic hypertension thus reducing re-bleeds and associated prolonged length of stay in SAH and TBI patients

 

In summary, BPM monitoring of CBF provides opportunity for a number of clinical and economical benefits. Please contact Hemedex (http://hemedex.com/contact/sales/) for additional information or to set up a clinical trial. To sign up for this webinar register here

Everyone talks about the need to do trials differently but very few actually achieve it.  Unless, of course, it is to make things more intricate and expensive! Against a background of spiralling costs, struggling recruitment and every increasing complexity, the recently reported TASTE trial was a breath of fresh air.  For those of you that didn’t spot this study published in the New England Journal of Medicine a couple of months ago, it was a large-scale randomised trial examining the effect of thrombus aspiration in acute myocardial infraction.  Needless to say the neutral trial result wasn’t the headline, with all-cause mortality and a string of secondary outcomes unchanged by the intervention.

The real interest was in the way that the trial was done, and the incredibly low cost it was achieved at – by piggybacking on the Swedish registry system this study was reported by one commentator to have cost just $300,000 in incremental expenditure.  Not bad for a 7,000 patient study.  As an academic researcher based at the George Institute for Global Health in Sydney this really got me interested.  I’m used to stretching limited resources.  And over the years have been involved in a number of ‘’large-simple trials’’ evaluating cardiovascular outcomes.  But this sort of economy sets a new benchmark for us all.

In addition to my George Institute role, I am also the Scientific Director of George Clinical, a Contract Research Organisation wholly owned by the Institute. Our point of difference from the traditional CRO model derives from our scientific and operational leadership. The goal of George Clinicalis to provide clinical research services to the pharmaceutical industry but to do it in a way that the traditional CRO can’t. At George Clinical, we leverage academic expertise to develop and incorporate innovations like those in TASTE, while maintaining the operational excellence expected by industry.

While George Clinical is willing to provide just the usual fee for service functions that a traditional CRO provides, it is the integration of the academics that makes us different. By leveraging the skills, insights and connections of our researchers, we bring dimensions that can translate to both time and cost savings for our customers.  For now, perhaps not a 7000 patient trial for $300,000! But clever design, streamlined operations and efficient analyses on a lesser scale can still make a world of difference.

My role spanning George Clinical and George Institute is to provide scientific leadership to studies in my therapeutic areas but also to drive innovations in methodology.  Diabetes is a primary focus at the moment and builds upon our ADVANCE trial experience.  We completed ADVANCE some years ago but as one of the first large scale outcome trials in diabetes it cemented our role as a leader in the field.  Having randomised more than 11,000 patients into ADVANCE we have been able to work with sponsors to offer global reach and extensive content area expertise.  This has resulted in scientific and leadership roles in three more large diabetes trials since, with several others now in the pipeline.  The Asia-Pacific has been a particular asset for us because of our operational bases in the region, but also because of our strong academic linkages to the key opinion leaders and their networks.

Two fields of methodology we are currently working on are endpoint adjudication and trial monitoring.  In both we have identified significant opportunities for centralization and simplification of trial processes.  Already we are rolling out these new methodologies in our academic research program.  Persuading our commercial customers to take up these opportunities in full is going to take a while longer, but already we are starting to see this trickle down.  As with so much in health research, there’s not going to be a magic bullet and things aren’t going to change overnight.  But it’s not going to stand still either and our goal at George Clinical is to make sure we are at the front of the pack.

To learn more about how you can do things differently in your clinical trials register for our upcoming webinar on the 19th February here

Remy Wattiaux, Managing Director of Powder Systems Limited (PSL):

Rémy Wattiaux is the Managing Director of PSL, a worldwide manufacturer of advanced process equipment. He has a master’s degree in Medicine and a master’s degree in Engineering and Project Management. Rémy has years of expertise including R&D in medicine and Project Management in Aeronautics. Over the last 6 years, he has completed various projects around the world in the fields of high potent, complex powder handling and sterile manufacturing and established new business units in France, India and Australia. Rémy has been heavily involved in 15 microsphere formulation projects from R&D feasibility studies to production scale.

15 years ago, PSL developed the first sterile filtration unit for microsphere formulation with a leading process development organisation in the US and since then their process experts have designed and installed over 20 projects all around the world.

What does the term Microsphere mean in the Pharma Industry?

The IUPAC definition for microspheres is:
Microparticle of spherical shape without membrane or any distinct outer layer.

Note: The absence of outer layer forming a distinct phase is important to distinguish microspheres from microcapsules because it leads to first-order diffusion phenomena, whereas diffusion is zero order in the case of microcapsules.
Microspheres vary widely in quality, sphericity, uniformity, particle size and particle size distribution. The appropriate microsphere needs to be chosen for each unique application.

How can new technology improve the productivity of your microsphere formulation process?

PSL is an international manufacturer of filtration, drying and complete containment solutions from small scale production to full process systems. We have been supporting pharmaceutical, biopharmaceutical, chemical, speciality chemical and laboratory industries since 1989.
Our solutions enable clients to bring new generation drugs into the market place faster, using the latest technology in process equipment.

Our long experience in sterile production has led us to develop unique filtration solutions for microsphere formulation. We are now offering a full range of solutions to resolve any process difficulties when filtering, washing, classifying and drying micro-particles. Our technology allows easy and straightforward harvesting of the microspheres while maintaining sterility.
We are proud to have developed a unique technology that no other process equipment manufacturer is able to supply globally. Our service team has been recognized for the quality of their work and fast response to help with installation and qualification of new equipment, but also maintenance and re-validation of any existing installations.

Are you currently facing challenges with microsphere drugs formulation process or planning to start manufacturing such products?

The webinar will review the different manufacturing processes and new technologies recently developed for microsphere formulation from the upstream stage of the microsphere creation (emulsification, droplet formation…) to the downstream operations of harvesting the microspheres in a sterile manner with control size distribution.

This Case Study will give a practical insight to the product and process. The webinar will then be concluded by an interactive Q&A session where attendees will have the opportunity to receive advice on their current process challenges.

Our achievements – Powder Systems recognised with two manufacturing awards:
WINNER of Best Manufacturing Business
Award winning business for Asian Manufacturing

To read about our new technologies: Microsphere Formulation with the Sterile Microsphere Refiner from PSL click here. 

To read about our clients feedback click here. 

PSL will be celebrating 25 years of business in 2014 and as part of our continuous expansion we will be opening our 6th overseas office. The new office will be based in Perth, Australia to better serve our South East Asia customer base. We are also establishing a growing distribution network to provide a more efficient service to local markets such as South American and European countries.

PSL is a renowned manufacturer of high quality containment and filter dryers starting 25 years ago as a pioneer in this field. Today the company offers many other solutions and technologies, our full product range not always being known to customers. Since establishing the business PSL have manufactured and installed over 1,200 installations around the world, our work in sterile filtration applications is unfortunately not always recognized. We are now innovating with small scale sterile microsphere filtration solutions, unique in the industry, and we aim to spread the word more actively in 2014!

Powder Systems Limited’s webinar entitled ‘A refined solution for microsphere formulation’ will take place on 13th February at 3pm London/10am New York. Register for the webinar here.

In addition PSL believe that working with Business Review Webinars is the best way to approach the right people and share our knowledge in an effective manner. The webinar format supplied by Business Review allows drug manufacturers around the world to come together and gain an understanding for their process and freely ask questions they have difficulties to getting answers to.