Continue reading »]]> Attended the eMarketing and Digital conference hosted in Barcelona by eyeforpharma on 27-29 March 2012, it was a rich experience with presentations and case studies from Pharmaceutical and Medical Devices companies.
With several Pharmaceutical and Medical Devices companies moving to mobile devices such as iPads and Tablets, eMarketing is a cost effective and a meaningful way to engage with Physicians and consumers. There are regulatory and legal challenges, which warrant a closer interaction and cross functional collaboration.
The overall trend is that in 2012, over 55% of digital marketers expect more resources to be available to them. While iPad is a clear winner for e-detailing, branded websites are not often visited by physicians. Due to trust issue, 85% of the physicians in the UK do not visit branded websites.
Physician Portals/networks supported by the industry on the other hand are popular. Physician Portals therefore offer the best ROI of any digital channel.
Patient Portals serve as an effective digital channel, with industry partnering more and more with patient networks for data collection, clinical trial recruitment opportunities, gaining knowledge of patient sentiment and early adverse events.
Electronic Continuing Medical Education (eCME) is growing in importance with tightening budgets. A key opportunity for the industry is to provide unbranded eCME to help Physicians keep up-to- date and maintain educations requirements. Co-ordination between CME and eCME is often poor resulting in wasted time and money for companies.
I will cover specific insights on eMarketing, Digital and Mobile in subsequent posts.

Continue reading »]]> Attended the 2012 Medicines Australia Parliamentary Dinner on Feb 29^th. The keynote address was from the Australian Prime Minister – Julia Gillard and the global CEO of Glaxo Smith Kline- Andrew Witty .

The key takeaways from the evening were:

• The Pharmaceutical Industry has played a significant role in increasing life expectancy and quality of life. 
•  The main challenge globally is the rising healthcare costs and pressure on payers private and public alike to fund these rising costs  each year in the wake of ageing population. 
• In order to address this challenge the industry and the payers need to take a co-operative rather than a confrontational approach.
• The pharmaceutical industry needs to become more efficient at drug development and proactively look for ways to reduce the cost of innovation from the current costs which is over $1B to bring a drug successfully to market. The industry needs to reduce cost of failure.
• The payers in turn need to provide a stable and predictable reimbursement regime in recognition of the long lead times in developing drugs and preparing the HTA evidence.

For example, when a payer changes the basis for HTA on drugs that are ready for launch, it is not possible to gather the necessary clinical evidence without losing another 2-3 years.

The pharmaceutical industry also needs to embrace transparency both in terms of Clinical Trials results and payments to HCPs as a way forward to build trust and long term relationship with Payers, Prescribers and Patients.

Continue reading »]]> Attended the CEO Summit 2012 held in Sydney last week. It was a stimulating day with insightful presentations, great networking and entertainment.  A few interesting points from the conference:

1. Scientific studies show that the brains of the Millennials are wired very differently to the previous generation as they grew up playing Video games.

2. I realized how prescient the book cluetrain manifesto written back in 2000 was about consumer behaviour on the Internet based on some of the facts shared by the futurist Craig Rispin.

3. Talking about the future also interesting to see Craig Venter: On the verge of creating synthetic life. To see more on this: http://www.youtube.com/watch?v=nKZ-GjSaqgo

4. While the US national debt is very high right now at over 100% of GDP, it is not the highest it has been in the last 100 years. The US debt was as high as 120% of GDP back in 1945 after World War II.

5. IBIS world findings on happy and unhappy countries based on Index of Consumer Sentiment over the last 30+ years.  US happy 48% of the time, Australia happy 73% of the time while the UK happy only 11% of the time.

Continue reading »]]> In his recent NVCA blog post Mark Heesen points to several alarming signs in the venture capital ecosystem indicated by three major funds walking away from the healthcare sector! The reasons?

To quote Scale Venture Partners’ Kate Mitchell in her blog post, even though companies within the Scale portfolio recently had five NDAs approved by the FDA, it “took longer and used more capital than planned from the start”.

Prospect Venture Partners’ Managing Director Alexander Barkas announced the decision not to deploy the $150 million they had raised in their fourth $250 million health-care fund. They do not believe “$150 million would enable them to build a sufficiently diverse portfolio of biotechnology and medical-device companies with adequate reserves” reports Dow Jones Venturewire.

Morganthaler Ventures and Advanced Technology Ventures on the other hand lost their health care teams who will soon launch their own medically focused healthcare firm. While the Wall Street Journal Venture Capital Dispatch does not point to a change in the firms’ strategy, Mark Heesen concludes that the funds are spinning their healthcare investment practices off.

Perhaps the most concern is raised in the Vital Signs Report from the NVCA’s MedIC coalition. Dr. Jonathan Root, general partner at U.S. Venture Partners and MedIC Steering Committee member, states that “While many factors are at work in driving away investment from U.S. medical innovation, it is the FDA approval process – and the cost, time, and unpredictability that it adds to the development of innovative products – that weighs most heavily on investors. The FDA and the Administration are already taking significant actions to reverse these trends, but we need the support of Congress to make sure these reforms are effective and lasting.”

So while we wait for these actions to wind their way through the political gridlock in the Beltway, what is industry to do other than collective hand wringing?

I totally agree with Lisa Suennen when she says in her blog post on the subject, “As the Age Wave crashes over our country, we will need the next generation of drugs, devices, services and technologies that can effectively serve the needs of our population. Those who are there with innovations that grease the wheels of progress will be tomorrow’s Charlie Ledleys.”

What specifically does innovation in the bio-pharma space look like? Here are a few avenues for action. Some of these have been on the FDA Critical Path Initiative since 2006 however their adoption across the industry is still evolving.

1. Innovative clinical trial approaches to reduce time to filing

There are several approaches that promise to reduce the time taken to move from Proof of Concept to an NDA/BLA through newer clinical trial designs. Two in particular have attracted a lot of interest.

First, Adaptive Clinical Trials offer potential to reduce timelines and increase chances of meeting the FDA’s efficacy criteria. Setting these trials up is not straight forward and may not apply to all situations but adaptive designs must be considered as one of the ways to speed up the path to a successful NDA/BLA for the new therapeutic product.

Second, Bayesian approaches to clinical trials may also make it possible to shorten timelines and be more cost effective. The great advantage here is that unlike traditional clinical trials, Bayesian statistics leverages information available prior to the trial being conducted thus building on the evidence base that already exists.

These approaches may not  be applicable in all instances. In addition they require a change to business as usual in clinical trial design as they are more complex to setup and require significant cross functional collaboration. However success in gaining competency not only promises to reduce development timelines, but also to bring new sources of competitive advantage.

2. New biomarkers to help reduce cost of development

Many of the biomarkers currently in use have been around for decades and are not up to the task of dealing with newer therapeutic agents.  In the Critical Path initiative, the FDA highlighted this to be another area of development. Many new biomarkers have been proposed but actually confirming their value in clinical development still requires work. Qualifying newer biomarkers along with new drug development will most certainly deliver shorter development timelines.

At least four areas have been highlighted starting with powerful new biomarkers that arise from genomic, proteomic and metabolomic technologies. FDA has already approved several “omic” based biomarkers and there is the potential to develop many new ones that can revolutionize diagnostics and drug development.

The second area is a range of safety biomarkers which could improve effectiveness of safety screening prior to First in Human trials all the way to clinical trial safety and thus improve the overall development effectiveness.

Another key area is to qualify additional surrogate endpoints. This is very exciting as every new surrogate endpoint that is qualified can significantly cut the development timeframes short. In spite of the amount of work required to establish the confidence that changes in such endpoints indeed reliably point to clinically meaningful outcomes.

Of course the most exciting area is personalized medicines. Whether it is more precise disease classification, directing new agents at molecular targets or developing dosing protocols based on genetic profiles, this has to be an area with the greatest impact on drug development. The possibilities of shorter paths to highly effective and profitable co-dependent technologies surely offer the best opportunities in which to invest.

3. Upgrade Market Access competency

Even big pharma does not always get this one right. An excessive focus on getting past the regulatory approval hurdle often prevents healthcare product development teams from paying adequate attention to developing the evidence base for payers early enough. The result? Knock backs from payers for prices that could have been justified if the evidence for cost effectiveness was developed during clinical development. Better market access will surely mean better returns for investors. Specific areas for action:

From Proof of Concept,  market access  professionals must be part of the cross-functional team that guides the development program. Whether it is choosing the right endpoints, patient reported outcome measures or comparators, this is where it starts and yet products still reach P&T meetings with inadequate evidence. A Value Demonstration Plan must be in place as the Phase II/III trial plans are developed.

Approaching launch, the teams could get so much better prepared to hit the ground running to ensure that when the request for submission comes from a payer, a quality value dossier is ready. Once the much awaited marketing approval is received, tracking those formulary submissions and ensuring they get reviewed in the very first P&T meeting would get the return on investment flowing a lot faster from investors!

4. Focus on Launch Excellence

Many opportunities to get the product launched on time and with the best possible marketing program are lost because teams are not supported with best practices for managing launches.

Activities to help establish the brand in the market such as   developing and executing communication material, medical education events or patient familiarization programs all can be executed so much better if the teams are not forced to reinvent the wheel.

Using simple but highly effective launch execution kits can make the launch team’s jobs significantly easier and deliver high physician awareness and opportunities to try the product in a clinical setting soon after FDA approval. The result – improved ROI on the development and launch investment.

5. Target unmet medical needs

So yes this is motherhood and apple pie! Clearly, cutting out the “me three”  analogues and targeting truly unmet medical needs with first-in-class agents has to be the best way to get to market faster and with greater success.  The opportunity to take advantage of the FDA’s priority review is perhaps the best way to achieve superior returns for investors.

Witness the recent priority review designations for the March 2012 action date . Roche’s new skin cancer drug vismodegib and Chelsea’s Northera are excellent examples of therapies that target genuine unmet needs.  Roche’s drug promises to address advanced basal cell carcinoma for which there is no effective treatment. Northera, which targets a much smaller area for dizziness in Parkinson’s patients. Both are clearly unique offerings and will bring excellent returns to investors.

BMS/Pfizer’s Eliquis is an interesting case in that it is actually the third entry competing with  Boehringer Ingelheim’s Pradaxa and the Bayer/Johnson & Johnson drug Xarelto for a slice of the $9 billion anti-clotting market. However superior early trial results gave sufficient reason for the FDA to grant the product a priority review.

Unmet medical needs are surely one of the best ways to improve ROI on healthcare investments. Perhaps the exit of some of the possibly excess venture capital money from the healthcare sector will refocus investments on genuine innovation.

I remain optimistic that these approaches offer investors in healthcare the promise of superior returns. Let us not forget that with an aging population and better understanding of genetic drivers of chronic disease, the market opportunity is still huge. This is not a sector with market risk. Sure there are technical risks in implementing cutting edge approaches such as adaptive clinical trials and qualifying new biomarkers. Isn’t  this what venture capital’s all about?

Continue reading »]]> Did you ever assemble a jigsaw puzzle without the picture on the box lid to guide you? Talk about frustration. You’d stand a chance if it’s your four-year-old’s Big Bird puzzle, but once you get past the 100-piece threshold, good luck. You might be there for a while – or it might get tossed across the room. You literally can’t see the forest for the trees, the sea for the seashells, the cornfield for the individual stalks.

Continue reading »]]> Who among us hasn’t turned a blind eye to an annoying situation or event, at one time or another? A missing button from an occasionally worn sweater? A slow leaky faucet? The dreaded check engine light? Most of us eventually see to the repair – after all, a stitch in time does save nine.

But while ignoring a missing button is one thing, behaving the same way with operational inefficiencies is quite another. When a dealy in execution could result in millions of dollars in cost or lost benefit realization letting this continue, we would all agree, is inexcusable.

Have you ever considered why anyone would let this happen? We thought an April 3^rd NY times article captured some of the essence around this topic.

Margaret Heffernan has. The author of Willful Blindness (Walker Publishing 2011), Heffernan says that “love, ideology, fear and the impulse to obey and conform all play important roles in rendering us blind to the makings of personal tragedies and corporate collapses.”

She’s also found that information overload, physical exhaustion and the pursuit of financial gain contribute to people intentionally barring their head-in-the-sand.

We’ve no intentions of playing amateur psychologist (despite how much fun that might be) but we can suggest that technology has been shown to help eliminate this problem. Their is technology that can let you accomplish seamless business operations and allow for information to be cross-functionally viewed, all stakeholders know what is going on at the same time and achieve Execution Excellence. This avoids the problem of information being shared via email attachments and multiple versions of documents being sent around via email. How novel is that?

Technology will permit you to take the blinders off. But don’t feel bad about past behavior; it will be a learning experience. And that, in our opinion, is always an asset.

(To read some of the book, type in Willful Blindness Heffernan in Google; the second listing should be a Google books result.)

Continue reading »]]> I wanted to share some insights from Pharmaceutical and Regulatory Compliance Congress held in Washington DC on Nov 2-4, 2011. The conference was rich with information about the current and upcoming compliance requirements. Of particular interest was the FDA presentation by Thomas Abrams, Director FDA – Office of Prescription Drug Promotion – OPDP (formerly DDMAC).  He touched on Social Media and the challenges in monitoring what is discussed on these sites.

In the Q&A, I asked Tom, how does the FDA – OPDP control what is discussed on the Social Media sites since it is a forum with comments from the community. He mentioned that their technical team monitors Social Media content however given the vast nature of Social Media it is a challenge.

It appears that there is no clear way to control the discussions that occur on the Social Media sites. From a risk mitigation perspective, voluntary compliance is probably the best way forward.A formal guideline document from the FDA on Social Media is expected to be released soon. In the meanwhile, additional information on Social Media can be found on DDMAC Part 15 Web site: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm184250.htm and Part 15 docket www.regulations.gov  Search docket “FDA-2009-N-0441-0001” to view comments.

I will share more insights as we research this topic further.

Continue reading »]]> Despite the high rate of growth for content management systems like SharePoint, the most widely used system for managing documents is the venerable Shared Drive. Organizations large and small commonly use them to share important business documents and files. This is likely because it’s very quick and easy for IT to implement and they are initially very user friendly.

However unfortunately, (as I am sure everyone who is reading this is thinking) Shared Drives impose quite an array of limitations in terms of how documents are organized, managed, shared and can mostly importantly, be found!

Shared Drives are incapable of the much needed functionality to support business users to effectively manage and control their documents. Put bluntly Shared Folders have no real capability to support:

• Powerful Document Search.
• Automated version control.
• Comprehensive audit trail of who has accessed or edited a document.
• Easy collaboration, review and approval for important documents.
• Enabling users to be notified when certain types of documents are created or changed.
• Restrict duplication of documents.
• Ability to check out a document from editing, to avoid multiple versions.

With all of the above restrictions shared drives after relatively short periods become real bottle necks and sources of frustration for users. How often have you spent 15 minutes just looking for one document? Even worse, finally found your document to only discover later that it was not the most up to date version of the document and what you really wanted was in another folder buried somewhere else on the drive!

So how do we remove the frustration and bottlenecks? The most commonly offered answer is a content management system like Microsoft’s SharePoint but it’s not a complete solution. There are some serious deficiencies with most Content Management System out there as you will see in our next installment is our document management series next week…

Continue reading »]]> Janaki Joshi, CEO of Iris Interactive, was featured recently in the profile section of eHealthSpace.org. In the article, called “Joshi chases global pharma dream,” she discusses the challenges that pharmaceutical, biotech, medical device and consumer companies face in launching their new products.

“I realized that the teams there had no software to help cross-functional teams to collaborate and co-ordinate all the activities involved in developing and launching drugs. While there were islands of information managed by each function, these were essentially silos. I thought that I could do something about it,” she says.
Through the Iris Pharma platform which is web based, her company helps bring cross-functional teams and stakeholders together, improving communications to deliver value through higher product sales, faster time to market and increased brand equity.

The need for companies to improve their business processes is a critical success factor in today’s cost-constrained environment. Iris Pharma is the only product commercialization software solution tailored for the bio-pharmaceutical industry. Data entry and regulatory submission are very costly: Entering information only once and then easily leveraging it through a global company across all stakeholders can save millions of dollars.

Want to learn more about Iris Interactive? Then please visit its web page and look at what some of its customers have said about its products. If you would care to see a demonstration, Iris can arrange for that too.

eHealthSpace.org is an online community for health professionals who are committed to clinical reform and its enablers, including health technologies and change management practices. ]]> http://blog.irisinteractive.com/2011/03/19/ceo-of-iris-interactive-featured-on-ehealthspace-org/feed/ 0 http://blog.irisinteractive.com/2011/03/19/ceo-of-iris-interactive-featured-on-ehealthspace-org/?utm_source=rss&utm_medium=rss&utm_campaign=ceo-of-iris-interactive-featured-on-ehealthspace-org http://feedproxy.google.com/~r/IrisInteractive/~3/BIC6muiMCPY/ http://blog.irisinteractive.com/2011/03/16/the-serverside-conference-all-about-scalability-and-performance/#comments Wed, 16 Mar 2011 09:05:00 +0000 Jayant Joshi http://blog.irisinteractive.com/?p=10

Continue reading »]]> This conference is very interesting from many perspectives. For starters, the opening key note from James Gosling, father of the Java platform, opened up several topics, one of which I found particularly worth noting – to achieve massively scalable systems, Relational Databases are no longer adequate. Starting with Google’s “Big Table” database through to HADOOP, all databases that scale to vast numbers – billions of rows! But they are not relational! So to achieve the levels of connectivity we are looking for, connecting large numbers of health care innovators with big pharma, we will have to look at taking these No-SQL databases into account.