FDA Unveils Database of Drug Side Effects, Procedural Changes

It could be argued that the pharmaceutical and medical products industry—with its high-value, high-regulation product lines—could have the most at stake for achieving operational excellence. Regulatory requirements have risen for this industry struggling to hold down cost.

Today, the Food and Drug Administration unveiled a new effort to bolster its oversight of drugs after they're on the market, in the agency's latest response to years of criticism about its handling of medication safety issues. Ultimately, the FDA is supposed to implement a second phase to the plan, called Safe Use, that will focus on ensuring that drugs are used safely in the real world. But the agency official said there were few details available yet about the plan.

Among other changes, the plan, dubbed "Safety First," involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions, particularly those based on emerging safety worries, though the new moves don't go as far as some critics have advocated. The FDA plans to grant some new powers to the office that focuses largely on the safety of marketed drugs, known as the Office of Surveillance and Epidemiology. Republican Sen. Chuck Grassley of Iowa, among others, has raised concerns about the agency's current decision-making process, because regulatory power over drugs once they are approved rests primarily with the same drug-review divisions that decided to approve them for marketing in the first place. The plan was announced to FDA staff in an email today, and the agency is expected to testify about it tomorrow on Capitol Hill.

The new moves stop short of divorcing the two functions. The safety office will not get the ultimate power to sign off on label changes or recommendations to remove a drug from the market.

The agency will have multidisciplinary groups, including the pre-market review division and the safety office, come together to make decisions. If one office disagrees, it can appeal to higher-level officials. Currently, while this may often occur, it is more ad-hoc. Also, the pre-market drug-review divisions will each get their own new, dedicated officials whose responsibilities focus on safety.

The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drug makers to do such studies -- a power the FDA gained under a new law passed last year -- or contracting with outside sources.

We help your organization keep compliance standards at their highest, while holding costs in check. Our services help companies achieve world-class regulatory compliance and drive operational excellence throughout their organizations.

No World Borders has developed several service offerings by combining our deep industry experience with pioneering technology and capabilities. We work with our clients to achieve sustainable, long-term, integrated solutions at lower cost aligning strategy with people, processes and technology. We aim for speed to value through extensive experience, pre-packaged materials and fast implementation. Our Health & Life Sciences industry group works with clients to ensure that patient need is at the center of everything they do. Within pharmaceutical and medical products, providers, payers and public service health we are transforming global health care by connecting information, insights and technology to improve the quality of the patient experience. Process improvement is at the forefront of No World Border's competencies, which are critical in highly regulated industries.

Microsoft & Yahoo Stalled but not Over – News Corp Enters the Fray: What it Means for Software, Advertising, & Innovation

With Yahoo shares down nearly 50%, Microsoft decided to prove the rumors true and make an unsolicited offer for Yahoo. The incredible $45 billion offer for Yahoo was designed to blunt Google's advertising momentum, and stall Google with its recent entry in to core Microsoft businesses such as word processing.

At last year's Wall Street Journal "All Things Digital" conference, Steve Ballmer said, "The world-wide advertising market is a $520 Billion industry, yet only a small fraction of it is online." Their acquisition of an ad server / ad network form last year was telling, but now Microsoft wants to expand its distribution channels. But that's not all. No World Borders believes Microsoft's dominance of Windows platform based applications won't be enough to sustain the growth of the company going forward. Software as a service (Saas) is the new opportunity Microsoft sees, and Google has the lead.

News Corp would have a different angle - expanding the search channel with social networking in MySpace, and leveraging its well-respected newspaper brands such as The Wall Street Journal.

• Global spending on Internet advertising rose to nearly $20 billion in 2007, according to PriceWaterhouseCoopers and eMarketer.

• Open source "free" software (nothing is free - you pay at least for support) means that more and more companies will innovate and move toward the relatively open playing field of Saas.   The distribution channels are harder to control.  Just as song artists who may have been unknowns have used MySpace for visibility and iTunes for distribution, a new "Ubiquitous Web" linked by Semantics (see our posts on the Semantic web and applications of semantics) will enable a renaissance of Saas innovation.

• Saas promises to cut licensing cost and make use of software universal, rather than tying it to a particular PC or server. No World Borders believes that as Saas permeates web sites, this development will help improve collaboration, collective intelligence, empowerful sharing of information tools with global populations. Even traditional enterprise software will have to compete with Saas, with new market entrants such as Coghead, providing asset management and other tools via Saas. This will mean more competition for Oracle, SAP and other firms who will either innovate toward more Saas or acquire companies such as Coghead in the future. Big companies like SAP have launched DNA, and Oracle is pushing OnDemand. For big companies, they have to move carefully so as not to blow up their multi-billion traditional software businesses.
  

• Those economies and demographics that have not had access to expensive Windows based systems will increasingly have access to faster internet connectivity, thus giving them access to Saas. It will lower the barriers to new products and services being viable. Analytical tools, communication techniques, and the ability to publish blogs and web sites reach more people, it will further the proliferation of empowerful individuals and small groups publishing information to the web. A renaissance of creativity and innovation will emerge with the best ideas coming from the best minds, rather than the largest corporations.
  

  
  

• Social networking usage has recently dropped. News Corp, fundamentally driven by an advertising model, would be challenged with the combination which assumes even more advertising revenue. The amount of time the average person spends on a social-networking site has dropped 14% over the last four months, according to Internet research company comScore. The reason: they're turned off by too much advertising on social-networking sites.
  

Microsoft's attempted acquisition of Yahoo, a key gateway to finding new ideas on the web, is a mixed development for innovation and advertising. As a gateway to innovation, Yahoo will be molded into something to protect Microsoft's core business, rather than be a free-thinking destination for innovation. Fortunately, Google has enough market share that Microsoft and Yahoo plus MSN do not pose a complete monopoly for the marketplace.
As a fierce competitor to Google, Microsoft and Yahoo's competition will likely cause price erosion in paid search advertising and ad placement.

News Corp (also parent of the Wall Street Journal) may actually have a more innovative plan between its well-known content assets in news, and the social network momentum of MySpace, but it will have to be careful in the rapidly maturing market about how advertising Is presented to users.

From Red Herring: Yahoo to Buy Blue Lithium

“Yahoo on Tuesday said it agreed to acquire ad network BlueLithium for about $300 million in cash, a move that will help the Internet giant sell advertising across a greater number of web sites. The acquisition was expected to help boost Yahoo’s effort to develop a third-party advertising network, helping the Internet company better compete with rivals such as Google and Microsoft.”

The continued consolidation in ad networks and the portals to those networks underscores the importance of developing and continuously reviewing your online presence and strategy. www.noworldborders.com can help. Contact us for more thoughts on this subject.

Coaching sales teams - avoiding Murphy's Law

Today we helped facilitate a teleconference between one of our clients and a potential customer.  The client has breakthrough process approaches that help their customers improve their ROI.   The prospect was looking for ways to scale their business.   Two days before the call, we held a “pre-call” to test our messaging, review prospect objections and very importantly, test internet connections, web conferencing connections, which example web sites we would use.  On the day of the meeting I called 15 minutes early to make sure everything was ready.   We tested each one of these things again.   The sales manager bought freshly made tacos for the delivery team to entice them to leave their day-to-day work so that we could present the best possible capabilities to the prospect.  Everything for a major client presentation is important.  Our client company was not accustomed to bringing in the entire delivery team on call as well as the sales team.    

 

You might have heard the old story about having an extra projector bulb for important presentations.   Today, the equivalent check list might look something like this:

 

1. Test the teleconference connection and pass code from different locations in the country
2. Test the web conferencing system from different networks, locations, and firewalls.  Practice, when relevant, passing control between different presenters smoothly using the conferencing software.
3. Determine who will speak first, who will do introductions, who will present web sites and PowerPoint, where relevant.
4. Create a list of FAQs and rehearse your answers to them. 
5. Encourage team participation on the call, rather than letting one person from your firm do all the talking.  Sometimes it might be better to have technical staff deliver the answer – even though they may not be the polished sales person, coach them on listening skills, empathizing with the customer requirements and concerns, and help them be participants in the call.  Your customer will appreciate this because after the sales person gets the contract signed, it is the delivery team they need to work with day-to day on the project.
6. Multiple reviews and quality checks.  Have more than one person review the presentation for accuracy, spelling mistakes etc.
7. Determine what you will do if your prospect asks for an unplanned demo of a technology or solution capability.  Will you accept the challenge on short notice?  If so who will show it and who will speak to the solution.?  DO NOT show unrehearsed customer solutions where confidentiality or unexpected results might cause you to be embarrassed and risk the sale in front of a new prospect.
8. Make sure you understand the goal for the meeting or expected outcome.  Is the team getting past an initial meeting?  If so, do we want to ask for a follow up meeting or on-site visit to continue the discussion at a deeper level and build the relationship?  If so, state this to the team in the pre-call so everyone knows what outcome you are intending.
9. Think about chemistry issues.  Will  the decision maker at the prospect company relate better to a senior female executive?  Are there common interests, sports, hobbies, etc. that mean that the young technician will have a better dialogue on the requirements document with the prospect?  Be ready to be a facilitator but to take a back seat and let the team members bond in a way that builds a relationship that will have lasting positive impact with the client.
10. Send a thank you note.  Email is ok but a personal letter and phone call is better.

 

When you are doing client presentations prepare, rehearse, and prepare again.  www.noworldborders.com  sales, marketing, business development expertise has helped many growing companies.  We can coach your delivery and sales team on the things that might require only slight adjustments in their approach that can help yield major gains with clients or shorten the sales cycle.

With $50 Billion in Cash, is Buffett Preparing to Dine on Mortgage Industry?

"The bond market has seized up, stocks are in turmoil, private-equity funds are sidelined and hedge-fund managers and lenders are hosting fire sales.

These are happy days for Warren Buffett." - WSJ, 8/21/07

Warren Buffet held back on buying financial services companies as the private equity firms drove up prices. Now with the credit crunch hitting even the largest lenders, Buffett is rumored to be considering buying even parts of Countrywide. Countrywide's assets, including its debt-servicing business and its portfolio of high-quality mortgages and mortgage-backed securities, could be attractive to Berkshire.

Due diligence firms that value portfolios of loans could help with this process, such as First American's Second Loan Outsourcing unit for home equity loans, and other firms that specialize in determining the health of mortgage loan pools.

Another one of the implications here is that purchased assets must be integrated in a complex, highly regulated business.  This requires industry knowledge, experience with process innovation, data normalization, compliance, analytics, and other methods and technologies.  Process flows, mortgage technology, and complex regulations must be mastered to improve the value of these ailing companies. Lean manufacturing techniques are just one of the areas where No World Borders provides value.