Mission3: Changing the Game

Is The Economy Affecting Your Business?

"The perfect storm" has caused a rough global economic environment. Steven Burrill announced today that biotech is facing a long downturn. What are life science companies to do? Hunker down and learn to outlast the downturn? Partnerships and m&a? Anything they can to survive.
One important thing to do now is to build in efficiency. Getting from here to past the downturn with less going to be an important strategy.
Mission3 customers understand this. Investing in SaaS means less investment in IT resources and less capital expeditures. Integrative software means more efficiency both in daily operations and through the entire product development process. Collaborative software enables the outsourcing pardigm which fostering efficient operation while keeping everything in control.
Immuneregen, an Arizona based therapeutic company, who's core team manages 29 ongoing studies has realized 30% increase in daily efficiency for their scientific team.
Now, it is more critical than ever to seek out capabilities to make your company more streamlined and the tools are out there to do so. You might say the perfect storm has emerged to fight this current economic downturn.

Commercializing personalized medicine

Phyllis Whiteley from Mohr Davidow Ventures spoke at today's Commercializing Arizona Life Sciences. The theme of the impacts of personalized medicine focused on impacts on patients, payors and healthcare economics. One interesting point from the VC's perspective was that the true benefit and success factor is combination of diagnostic, data, and therapeutic. From our perspective this means an interesting challenge for product development and regulatory. Mission3 OnDemand's ability to simultaneously handle combination and adhoc submissions makes it a great choice for personalized mediciine companies.
As medicine changes - the investment in Mission3 OnDemand is not only secure but critical.

Your Clinical Process is on Trial

When we asked the question about what other applications can be built upon the robust Mission3 OnDemand platform – Joe Jenkins of InPharmatics Solutions Group had an answer. Mr Jenkins’ in-depth experience with regulated content and leadership roles in the life-sciences lead him to believe that Mission3 OnDemand is the perfect platform for Trial Master File management. Built upon Mission3 OnDemand 3.0, the ClinTrialDocs solution deploys all of the project and document configurations needed to manage a Trial Master File.
“Now is the ideal time for this application” says Mr. Jenkins.   "With more and more emerging biotechnology and pharma companies running geographically dispersed trials, coupled with the need to have better control and access to their TMF while managing costs, ClinTrialDocs provides companies full visibility into all of their required clinical documents through a cost-effective, rapid deployment model. Sponsors can track all of the various CRO’s input while restricting access to other information, and the ubiquitous availability and cost effectiveness of Software as a Service makes this a must have application for all companies running trials.”
What sold Mission3 on this collaboration is that it is a perfect showcase of our technology. If you are visited for an audit and you can simply sit an inspector in front of your laptop to show them your TMF documents rather than having them wait for days while you locate and compile the necessary information – which do you think the inspector would prefer? This is the difference between significant delays and efficiently sailing through your trials. Reducing travel to sites and knowing exactly where every task and document is at any time is leaps and bounds better than the status quo.
As one of our customers put it - "Mission3 helps us get from A to B with significantly less manual effort. Our investors love that." We can’t say it better ourselves.
ClinTrialDocs eliminates the “I don’t know what I don’t have” problem while letting you focus your time and money on the R&D process rather than spending it on expensive enterprise systems. With the functionality and configurability of Mission3 OnDemand and the pre-packaged ClinTrialDocs application from InPharmatics Solutions Group, clinical sites can be connected to one web-based system.
We are seeing a massive uptake in Software as a Service as attested to by the other posts on our Blog and we feel this is the next major milestone in the Electronic Document Management / Software as a Service revolution for Life Sciences.

It's too early.

We are often told by our prospects that it's too early for them to think about implementing a Program Delivery solution. Of course, we understand and sympathize with that sentiment. In early stage companies the growth is so fast-paced and dynamic that trying to formalize the process seems impossible.
However, most of the time when we engage with our customers it is at a point where there is enough legacy data that sustaining the manual organization and process becomes impossible. It's critical to implement Program Delivery early enough to avoid this growing pain. We feel that the right time to implement Program Delivery is at non-clinical for biopharmaceutical companies. This is a natural time where a product candidate can be "projectized".This is still a very dynamic time in the process and it may feel too early but it is the right time. Implementing a system to organize early will help avoid the regret of waiting too long.

Is there a place for us to go green?

Is going green a concern for the Life Science industry? I think, being less consumer focused means that we do not put the marketing behind being green. Obviously, in our personal and work life we want to be conscientious. No one wants to print of 2 pallets worth of paper, right. So maybe electronic submissions, electronic data capture and all of the other paper reducing tools have a benefit besides quality.
On the other hand, all of these electronic tools use power. That is a drain on resources too.
We at Mission3 like to think that by providing electronic tools to make Life Sciences work more efficient we also reduce paper consumption. Of course, this means we can improve security, quality, and collaboration as well, but paper reduction is a nice side benefit.
To the energy use issue, our production servers run within CSC's robust and secure data center but our public website and other supporting applications are housed at RackSpace. Rackspace has created the Greenspace initiative in order to reduce carbon emissions. Have a look. Maybe we can all take a lesson here. Additionally, many of Mission3's employees embrace this philosophy; two of us drive hybrids while others carpool to work. Sometimes, when the weather is right - I ride my bicycle to work.

A model for next generation pharma & biotech program delivery

Among the radically changing technology landscape in the Life Sciences lies promise of safer, faster, and more efficient development of products. Biomarkers, personalized medicine and computer models are all showing signs of success. In conjunction with new operational strategies, the process of commercializing life altering therapies will radically evolve in the coming years.
Two of these operational strategies are the collaborative virtual model and the unencumbered flow of data from discipline and system to discipline and system. The problem is - how do you get these to approaches to work in harmony. The virtualized model requires outsourcing many if not most of the development functions. Outsourcing has the potential to create silos that interupt the flow of data and the interaction of people. These silos also blur the visibility of key decision makers.
Clearly the benefit of outsourcing is there. You get the expertise in the disciplines that you need when you need it and only when you need it. So how do you kill the silo effect?
The way have approached this problem is by opening up a common Program Delivery system that can be accessed by all contributors on the program or project. The sponsor doesn't worry about the incremental cost of external user licenses. Data is secure and access is controlled. No matter the phase or discipline whether clinical, stats, regulatory, legal, or any other contributor their content is stored centrally and their days can flow or me used for subsequent needs, like submissions.

When it comes to collaborative authoring for Life Science work, is Word the right choice?

When it comes time to author anything from protocols to regulatory submissions, the Life Sciences turns to Microsoft Word. Is this the right choice? The reason we tend to use Word is, well, everyone has it and we all know how to use it. We all do tend to have it, that is a fact, but we don't all know how to use it.

Word is a good tool for many things, like writing letters to Mom, creating labels, doing a "mail merge". But it is not really great for writing the content that is critical to us. Here is a brief overview of why.

The Life Sciences by nature are a collaborative group. We need to be because expertise lies in many different people but all of this expertise needs to be assemble into one cohesive and consist place (in the submission example). Microsoft Word really allows for authors to do what they want. They can change fonts, sizes, layouts, etc. Of course you can lock down styles but most authors will just get around this with the File>New function.

Also, Word just doesn't do well with long documents. I will say this again, Word just doesn't do well with long documents. Isn't this what we do? Write long documents? Last time I checked, most of the real documents created by Life Science companies are pretty complex and long. What tends to happen is that layouts, numbering, headers and footers - they all lose their place after a document in Word gets too long. That simply isn't acceptable. Authors spend their time trying A) fix problems with their documents or B) make things look the way they want, when their precious time should be spent putting the important information into the document.

What is the alternative? Well the ideal alternative needs a few main things. It needs to be something that all contributing authors have access to. It needs to limit what they can do as far as formatting and "playing" with the way a document looks. It needs to be good with long documents.

When we at Mission3 were thinking about this problem, we decided the solution needed to be web-based. This means everyone can have access to it. More people have a web-browser than have Word. It also means that there is no need for external resources to install software or have their IT departments (if they have such a thing) support it. This also means that there are no documents to download or email, giving precise control over access and versions.

We thought, let's set specific document constructs like heading levels, table headings, figures, equations, and make them fixed so their styles cannot be altered by the author. Then we said, to support collaboration we should allow comments like Word but they should be threaded meaning you can have a discussion over a specific item directly in the document. Also, it should support templates. Now, since we are specific to Life Sciences, maybe those templates can have guidance tracablity, instructions, and referential integrity to other documents.

We are happy to announce we have done all of that. We call it SciAuth and it is part of Mission3 OnDemand 3.0.
 

Scalability

Scalability is a notion that software products must be able to grow as your company grows. You can learn more here but this is something that Life Science companies are forced to think about. This is especially critical for emerging companies. You want something that works for your needs today but will "scale" as your company continues to reach milestones. Scalability can relate to many areas including features and functionality, price, storage, and number of users. Sometimes this can become overly complex but you want scalability and you want it to be easy. You want to know going in that your system is technically scalable. You should also know going in what this scale up is going to cost you. In addition, you should be aware of the time and complexity of taking your software to the next level.
This is where OnDemand solutions can really shine. Smoothly scaling without having to worry about the cost or IT burden. The last thing you want to do as you become more successful is worry about how your infrastructure can support this success. It should just happen.

New website, new product, same great team

Mission3 would like to introduce our new website. We talk a lot about program delivery in this update and program delivery is what we do. With our upcoming 3.0 release of Mission3 OnDemand we take Program Delivery for Life Sciences to the next level. New features include regulatory templates, web-based authoring, paper publishing and a slew of new features to our existing offerings.
In addition to new offerings our site now gives you everything you need to know about Mission3 OnDemand. We've include a pricing calculator (so you always know what you will pay), an ROI calculator so you can calculate and print the enormous savings you will experience with Mission3 OnDemand. Also, we've added an RFP self responder so that you can get a head start on creating a Program Delivery RFP and we've  added our response to make it that much easier.
We'll be spending more time here on the blog in the future and look forward to continuing the conversation with you.

The relevance of everything

Welcome all to the first "Changing the Game" post. The reason we are here, writing this post, is to give context to everything that Mission3 is doing. We want to let you know what we are doing and why we think the way we are doing it provides the most value to you.
Mission3 has it's beginning in 2005 in a time real enterprise class technology was beginning to find it's way to the web. We built an integrated set of functionality that was available to all life sciences companies via a web-browser. We thought this was a great way for companies to get the best of class technology without the significant cost and loss of time related to licensing and implementing legacy technology. Further, we built our model in a friendly monthly fee and eliminated licensing on a per user basis. All of this to make it easy to use and provide the greatest benefit to our customers.
Another great advantage to the way we do things is that Software as a Service reduces the cost and burden of software validation. We have written a white paper about this but even better John Edwards at CFO.com has written a great short article about these benefits.
Thanks for looking in and we will see you again soon.