4 pillars of successful drug development from Ross Weaver

Earlier this year, the Philadelphia Inquirer interviewed my business friend Ross Weaver about some challenges in clinical trials. 

Here’s what Ross had to say in “A Neglected Part Drug Development Gets New Attention”:

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At Goldman-Sachs' health care conference, Merck CEO Ken Frazier said that his company would stock a higher proportion of its late-stage pipeline with in-licensed and purchased compounds.

A business professor from the University of Michigan was moved by Frazier's remarks to comment, "Looking for late-stage deals is not a sign of confidence in the internal late-stage pipeline...Nothing is more expensive than a late-stage deal."

Frazier's comment and the reactions to it provide a capsule view of pharma's current condition. More than patent expirations, stingy, third-party payers or illegal and unethical promotions, the drug industry's current down cycle results from its reduced productivity at developing new drugs.

Signs are emerging, however, that the industry's leaders are at least starting to pay attention to this shortcoming. Analyst Tim Anderson at Sanford Bernstein finds it encouraging that pipelines may "improve as a result of the conscious effort by drug company management teams to try and fix” the complex  problems affecting drug development.

Ross Weaver makes the point that successful drug development rests on four pillars.

1. assessing the prospects that a particular compound will demonstrate sufficient efficacy and safety for inclusion in the standard of care.
2. new compounds must meet regulatory criteria for approval.
3. pharmas must demonstrate that their compounds provide a sufficient advantage over alternatives to permit the market access needed for commercial success. Specialists that work in this area, for example, try to forecast a compound's potential sales.
4. drug companies must successfully manage the "operational feasibility" of clinical trials to permit the adequate, timely enrollment of patients into clinical trials.

Weaver claims that, historically, pharmas have rigorously assessed and coordinated the first three elements while the challenges of recruiting patients have been shorted at the planning table. Clinical operations groups at pharma companies do assess the factors affecting recruitment and they typically model the approaches used by previously approved compounds in the pertinent classes. 

Nevertheless, Weaver claims that the heavy lifting of trial planning involves the first three pillars. Only after progress of a study has been delayed well beyond projections, typically as a result of slow recruitment, does attention turn obsessively to that factor. Too often, by then the stalled trials cause financial pressures that compromise one or more of the other three factors as companies scramble to enroll patients.

To prevent such "fire drill trial amendments," Weaver suggests a more rigorous effort at assessing feasibility and recruitment early in the planning process, taking into account the unique characteristics of the trial at hand. This involves such tasks as working collaboratively with nurse coordinators at appropriately selected trial sites to discern how patient candidates and referring physicians will react to a particular compound, its projected profile and overall trial design.

Factors that can hinder recruitment include things such as the number of times a patient must visit the clinic during the several weeks or months of a trial. Other influences can include the frequency of drawing blood samples from patients, the nature and severity of side effects, and the extent to which patients feel the test drug relieves their condition. The list of things that can affect recruitment remains quite long and can include considerations that are not easily predictable in advance.

Companies must then use this assessment of operational feasibility to modify the risk assessment, regulatory relations and commercial projections for each mid-to-late stage compound.

"The operational assessment," according to Weaver, "should receive the same strategic emphasis as the other three factors."

By his calculation, the money required to do this appears quite modest, compared to the costs for planning and carrying out the other functions. As a typical example, he claims it would mean, "spending $250,000 to inform an investment of $50 million."

Industries with long development times show a wide range of efficiencies at developing new products. Some of them, such as aerospace, have been notorious for getting away with cost overruns because they maintain captive customer markets, consisting of a few nations or airlines. By contrast pharma finds itself in a period where the incremental value of its new products fails to compel purchasing. Until such time as the science can restore pharma's growth prospects by creating new products that people want to buy, the industry must do a better job of managing the timing and costs of developing its drugs.

The fact that at least a few suppliers are proposing tactics for achieving this efficiency represents an encouraging sign.

(Ross Weaver is now partner of Clinical Trial Recovery Specialists, and president of DDI)

UIC study is examining direct-to-consumer drug ads on TV

There are three types of pharmaceutical ads, which are subject to different levels of regulation by the FDA:

1. product claim ads, which include the drug name, an FDA-approved use, and the most significant risks; 
2. reminder ads, which give the name of the drug but not its uses, which do not have to contain risk information; and 
3. help-seeking ads, which describe a disease or condition but do not recommend a specific treatment.

A team at University of Illinois at Chicago is asking, “Do pharmaceutical ads educate patients and improve health -- or merely spur drug sales?”

Researchers at the University of Illinois at Chicago's Institute for Health Research and Policy are conducting the first comprehensive study of televised drug commercials using Nielsen Media Research and health care utilization data.

The research is funded by a $3 million, four-year grant from the National Heart, Lung, and Blood Institute.

The U.S. is the only country that allows televised ads for prescription drugs. Direct-to-consumer drug commercials are the fourth most common category of television advertising.

The increase in the amount of advertising has coincided with huge increases in health care costs, said Sherry Emery, principal investigator of the project at UIC, who notes that advertising has not likely caused the entire rise in health care costs.

On the one hand, the pharmaceutical industry claims that these advertisements provide a public service by educating consumers and giving people information to take to their doctors that might improve their health and ultimately result in lower health care costs, Emery said. But there are a lot of economists who would suggest that you don't advertise a product unless you expect to make money from it -- and these ads might be driving excess demand.

Previous research has not demonstrated either effect conclusively, said Emery, a senior research scientist at the UIC institute, perhaps because such studies have focused on single categories of drugs. Several studies have examined the effect of direct-to-consumer advertising on consumers' behavior and health outcomes, but most have used aggregate spending rather than more refined measures of ad exposure.

It seems reasonable that an advertisement for a cholesterol medication that treats a non-symptomatic condition might be different than an advertisement for an asthma medication, where if you don't adhere to the medication, you may end up in the hospital with a flare-up of your asthma, she said.

Emery and colleagues will use the Nielsen data to examine direct-to-consumer advertising on health care utilization and pharmaceutical sales of eight therapeutic classes of drugs promoted in the top 75 U.S. media markets from 2005-2009. The drugs include those for allergies, asthma, arthritis, depression, erectile dysfunction, hyperlipidemia, sleep disorder, and smoking cessation. Data from millions of patients will be examined for doctor visits, hospitalizations, new prescriptions, and prescription refills. The study will take into account different patient characteristics and regional differences in access to physicians.

The researchers will also evaluate the content of the ads to see how they vary among drug classes -- and whether these differences affect their impact.

There are three types of pharmaceutical ads, which are subject to different levels of regulation by the FDA: product claim ads, which include the drug name, an FDA-approved use, and the most significant risks; reminder ads, which give the name of the drug but not its uses, which do not have to contain risk information; and help-seeking ads, which describe a disease or condition but do not recommend a specific treatment.

It's conceivable that the different types of advertising are used differently by drug class and that they might affect the way people respond to the advertisement in terms of their health-seeking behavior and their demand for the medication, said Emery.

5 C’s of "discover" -- and how social media monitoring is applied

On Monday, I posted an article on my agency blog on tools to analyze the social media environment.

I shared some details on the social insights listening methods we can use in each of the 5C’s:

1.  Category – Document the language used by customers to describe the class, mechanisms of disease, modes of action, and the dynamics of care.  Capture both the words and visuals found throughout social media.  Analyze the frequency of use, as well as the context.
2.  Competition – Audit competitive online promotions.  Moreover, verify customers’ positives responses or negative reactions (using social media monitoring tools, such as Atlerian SM2 and Scoutlabs).
3.  Clinical – Compare and contrast how audiences are talking on social platforms.  Uncover opportunities for message clarity about the disease and treatment options.  Monitor products in the pipeline through social reaction to press releases, clinical trial updates, and investor communication.
4.  Customer – Evaluate forums where like-minded physicians are gathering or patients with similar conditions are interacting.  Identify channels for community management, content planning, and media engagement. Target the diverse stakeholders who are potentially impacting information and decisions of the customers.
5.  Culture – Assess social exchanges in broader cultural contexts, such as payer environments, practice settings, legal controversies, or patient advocacy positions.

Read more about this, along with a recent example of this kind of listening, on the "Brand Liberator" blog at GSW Worldwide.

6 research tools we’ve used lately to leverage social media in Discover stage

 Earlier this week, I posted a blog for my agency on ways to use social media to LISTEN, not just share.

At the heart of an account planner’s role is the ability to listen to what customers knows about a brand, how they feel about it, and how they use it.

That’s why we always have looked for new and better techniques to understand what they like, what they say to their friends, what they associate the brand with, and how they experience the brand – all in hopes of moving toward brand loyalty.

No wonder social media insight is proving such a powerful qualitative research modality.

Today, account planners can observe and learn from online communities by following the real-world conversations that take place there. Through networks (LinkedIn, Facebook), blogs, forums (WebMD, PatientsLikeMe), bookmarking (StumbleUpon, del.icio.us), podcasts, visual content communities (Flickr, Pinterest, YouTube), and micro-blogs (Twitter), we can construct a more complete picture of how a brand fits into a customer’s life.

In addition social conversations already taking place, we can use social media platforms to create our own source of customer research. Here are just a few tools we’ve used lately in our Discover stage with clients:

1. Online focus groups
2. Webcam one-on-one interviews
3. Content monitoring services and text analysis software
4. Keyword search analysis
5. SEO and linking research
6. Brand story and concept evaluation surveys

Read more by clicking on the "Brand Liberator" blog post at GSW Worldwide

2 pronged approach to DTC: ULORIC campaign

This is an excerpt from a campaign profile by Matthew Arnold, in Medical Marketing & Media.

As the first new product for gout on the market in four decades, the Uloric team had some work to do in educating patients about how the disease works and available treatments.

“Our campaign was really focused on targeting patients who were on treatment but were still experiencing flares,” says Heidi Gillmore, marketing director for Uloric. “There was a big awareness gap because of the fact that there's been no new innovation in the category for decades, and therefore no promotion happening. There was really a lack of credible resources on the Internet.”

While the disease is most often treated by primary care physicians, the market for gout drugs is a niche one, with around eight million adults diagnosed in the US, and just short of three million treated chronically.

Because there's a lot of co-morbidity, the topic often fails to come up during doctor visits, as more immediate health concerns predominate. Around half of those on treatment are still experiencing flares, according to Takeda's research, which also found poor patient understanding of the role of hyperuricemia, the underlying metabolic condition treated by Uloric, in gout.

“So that fed into our strategy behind doing a really broad-based, multichannel, branded and unbranded campaign to both educate on the disease state and introduce the brand as an option to these patients,” says Gillmore. 

Takeda took a two-pronged approach:

1. Unbranded ads that featured a real doctor talking about the role that uric acid plays in gout along with the tagline “Gout can attack silently even between flares.” 
2. Branded ads feature patients lugging around a large flask of liquid that serves as a metaphor for uric acid reduction. 

Both efforts drive viewers to goutinfo.com. The brand is now moving to put more emphasis on relationship marketing.

“Now that we've built this awareness level, we're really trying to drive more dialogue between patients and physicians,” says Gillmore. “So we're starting to step away from the awareness-building vehicles like the TV ads and center more on the action vehicles—online and in-office media.”

Gout is one of the most-searched conditions, says Gillmore, and Takeda research has shown that four out of five patients searching for gout info online are currently suffering a gout attack.

“They're having pain and they're trying to seek out solutions at that time, so we really try and leverage that as much as possible, because that was something we identified at our launch that, because of the lack of innovation in the category, there was a lack of credible resources on the Internet for patients to turn to. So you search on ‘gout' and you're getting a lot of home remedies and those types of things.”

Takeda's Gout.com is the destination for its unbranded efforts, while its Gout Smart program offers interactive discussion guides and other features aimed at getting patients into treatment.

6 steps of ForwardFast model: listen to feature on Sky Radio

It was 4 years ago this week that I was interviewed by the Sky Radio Network for an in-flight audio  segment for broadcast on US Airways.

Dennis Michael of Sky Radio showcased ForwardFast, my first book (and one of the first books of its kind), which presents the principles of brand innovation for health, science, and technology products.

If you’re driven to accelerate the adoption of new medical treatments, then this book will show you how to move with urgency to learn fast. track fast, think fast, respond fast, and create fast, then ForwardFast will help you become more creatively prepared and focused to reach the scientists, medical researchers, physicians, nurses, clinics, and the millions of patients who use your brands.

Other topics covered include:
• putting brand innovation to work with the 6 steps of the ForwardFast model;
• defining both a quality offering and a quality experience; and
• understanding what positive brand associations you can create

You can listen to the full interview here:

Clinical Trial Insights: a different way to identify evaluate new pharma brand experience

I'd like to share a note I received from my friend, Ross Weaver, President and CEO at DDI.



Are you absolutely positive -- not just somewhat positive, but absolutely positive -- there is nothing else that can be done to identify benefits that new products offer? That is a question we asked our R&D folks.

They said 'oh sure', we are positive. We weren't so sure, and had them think about it more.

To the windowless room they went.

To the white boards, pizza and cramped space.

After two weeks, they came back with some newfangled analytical methodology to identify another benefit. Nope. That wouldn't help. What they recommended was simply a re-crunching of the same old data. We told them to re-consider the whole process. Every step of the way.

Back to the white boards, pizza and cramped space. Naturally, with some more assertive stimuli (think 'Slumdog Millionaire'), they had an insight. Instead of a new way to look at old data, they said 'what we need is new data'!

Here is what they came up with:

• They said, you know, the typical approach is to have the clinical team summarize the findings from the clinical trials.
• Then, we conduct market research by having physicians who treat patients with the condition review the findings and asking them a bunch of questions.
• We conduct market research with patients whohave the condition and ask them a bunch of questions

What is missing?

Follow me here. Did anyone actually just ask the people who actually took your new product a bunch of questions about their experience with it? Did anyone just ask the study coordinators (i.e., the nurses at each investigator site who have day-to-day management responsibilities of the study) about their experience with it?

It was one of those 'well, duh' moments! Of course, let's get insights from those who have real experience with the product. Not just those for whom it is all make believe.

We planned to name it the 'unifying theory'. But, someone told us that name was taken. After a few beers and more pizza, we came up with name 'CTI'. CTI stands for clinical trial insights. 'Clinical trial insights' is too many letters, plus it just doesn't sound as cool as 'CTI'.

We started doing CTI studies and, as we had hoped, it did identify some terrific benefits previously uncovered.

For all of you in new products, I'd love to tell you more about CTI.

You will like what you hear.

Contact Ross to schedule a teleconference, web-meeting, or in-person presentation.

Ross H. Weaver, PharmD at ddinsights.com

7 steps for pharma in the years leading to 2020

The choices for pharma companies are two:

Change now and control your destiny

- or -

pursue business as usual and allow your fate to be controlled by others.

Executives and board members at pharmaceutical companies need to ask themselves: Which path will we take?

The global pharmaceutical industry is facing an unprecedented opportunity. Over the next decade, the market for pharmaceutical products will nearly double in size, reaching $1.3 trillion by 2020 to meet the medical needs of the aging global population and a surge in demand from emerging countries.

Yet, according to PricewaterhouseCoopers LLP in its “Pharma 2020” vision series, some pharma companies will never capture a share of this enormous market – because they continue to bank the future of their business on a model that will no longer exist.

The PwC reports says that anticipating and adapting to the changing dynamics in health care is the great challenge for the pharmaceutical industry. “It is becoming abundantly clear that maintaining the current course is no longer an option. Pharmaceutical companies are fast approaching a fork in the road, and they must choose a path: Will they focus on innovation and offer value in the form of more targeted drugs, with proven outcomes and a suite of value-added services around them? Or will they go after the commoditized mass market, driving revenue with volume?,” asks PwC.

Along the way, there will be winners and there will be losers. The winners will be those who have the courage to pick the right path and begin making changes in their business models now.

Here are seven major steps that PricewaterhouseCoopers believes that pharma companies can take in the years leading up to 2020.

1. Look Beyond the Blockbuster Model
2. Increase R&D Productivity
3. Focus on Prevention, Not Just Treatment
4. Make the Regulatory Process More Flexible
5. Personalize the Distribution Chain
6. Go Global
7. Choose a Path

Read the details on each of these recommended steps in the full report at PwC Pharma-2020

If pharmaceutical companies undertake these steps, they will be better positioned to manage the seismic shifts that not only pharma, but all of the health industries will undergo by 2020. The changes will enable them to benefit from the opportunities that will emerge from globalization, new technologies and new business models.

Although these changes need to be implemented over a period of years, companies must start now.

5 B-to-B Brand Ads – and 4 Stinson Brands Ads – That Point in the Right Direction (To The Web)

Blog entry submitted by Nancy Burgess, one of our Verbal Brand CHEMists.

When we use our C.H.E.M. tool to create ads for our clients, we not only Connect with our audience, provide Honest information, and make content Easy to follow, but we also ensure that we Motivate our targets to take action.

In today’s environment, a clear call to action drives customers and potential customers to a website. Unique URLs for each ad can help track the promotional efforts and be a measure of ROI.

In a recent issue of B-to-B Magazine, five campaigns were reviewed specifically on their ability to drive visits to the web site:

• Energy concern Petrobras had only a scant reference to its Web site, as a standalone element in the bottom left-hand corner of the ad.
• Deutsche Bank gives readers no incentive to visit its web site.
• Sun Microsystems and technology services provider Computer Sciences Corp. offer to help companies with their identity and access management programs – with a reason to visit the web to “watch a compelling video on the importance of identity management. ...” Now that's more like it.  (There's one big problem: the URL is 50 characters long.)
• Adobe Systems offers a URL better look at its product in action and a free trial of the system.
• IBM Corp’s ad “Leaner. Meaner. Greener” ends on an effective note inviting readers to see a webcast.  The landing page has a talking owl that picks up where the ad leaves off. That's the kind of print/Web synergy that more advertisers need.

Click here to read more about these brand campaigns.

As we at Stinson Brand Innovation are creating campaigns, we also want to point readers in right direction – to the web.

• Fujirebio Diagnostics is building web traffic from European physicians through an ad we developed for Italian medical journals. The unique URL helps track ROI by associating the specific URL directly to the ad placement.
• Vivaglobin^® ads in a consumer journal urge patients to consult with their doctors about therapy and also encourage them to visit our branded website for more information.
• Privigen^® has an attention-grabbing, die-cut physician ad – a rarity in medical journals, driving physicians and pharmacists to the branded website.

Click here to see more of Stinson’s brand work.

3 Trends in Pharma Branding Over the Next Five Years -- STINSON Brand Innovation, Inc. Releases White Paper

We are releasing our latest white paper titled, "A Look in the Crystal Ball: 3 Trends in Pharma Branding that will Impact the Industry Over the Next Five Years." This white paper is available for immediate free download on our website. Click here for your free download.

When considering the constant development of technology and the advancements of communication that is affecting every industry today, we wondered how it is affecting the pharma industry.

The three ideas we focus on in this white paper include:

1. Mobile branding: Due to the explosion of mobile communications, brand media must now offer healthcare professionals highly personalized and relevant information when and where they need it.
2. Growth of patient content: Health 2.0 (a subset of Web 2.0) has become a driving force in the further evolution towards customer-centric care--collaboration between patients, as well as between patients and their caregivers.
3. The experience of the brand and marketing as a service: The relationship between doctors and drug reps has changed—and it may never be the same again.

Staying ahead of the game is a challenge for every brand innovator. "A Look in the Crystal Ball" is a white paper to stir advanced thinking into the future of pharma branding and highlight various ways to communicate a brand through popular social media sites, such as Facebook, LinkedIn, and Twitter.

This is our ninth white paper to be published by STINSON Brand Innovation on topics ranging from brand strategy to brand experiences. They are all available for free download on our website. Click here for free downloads of any of our white papers.

Roche drops PhRMA; moves to BIO -- are they a "maverick?"

I noted with interest on Tuesday that Hoffman-La Roche plans to drop its membership in the Pharmaceutical Research and Manufacturers Association (PhRMA), the leading US industry association lobbying for pharma interests in Washington and beyond. Likewise, the Financial Times is reporting the company also has plans to drop its membership in the Association of the British Pharmaceutical Industry (ABPI).

Instead, as part of its take-over of Genentech, Roche says in the US it will join the Biotech Industry Organization (BIO).

“Genentech and Roche believe BIO’s purpose is closely aligned with the direction of the new company and, therefore, can represent the company’s interest in Washington,” spokeswoman Darian Wilson said in a company statement released last week.

The New Jersey newspaper Star-Ledger quite rightly painted the move as an effort by Roche to sever its ties to Big Pharma.

It is a defection whose importance is made clear by the efforts put forth by PhRMA to keep Roche onboard. Billy Tauzin, president and CEO of PhRMA, told the Star-Ledger that the group sent it chairman, AstraZeneca CEO David Brennan, to Roche’s headquarters in Basel to make a personal appeal to Severin Schwan, Roche’s chief. But in the end, Tauzin says, the Genentech forces, who “feel they are different,” won out.

But attempting to be different than the rest of Big Pharma may make sense if you’re Roche – or any other company looking to survive and thrive in the reality that is today’s pharma marketplace. Let’s face it; the industry’s not terribly popular (deserved or not) with consumers, governments, activists groups… and the list goes on.

In her "Eye for Pharma" blog, Lisa Roner liken Roche’s move to the strategies Southwest Airlines has employed over the years to set itself apart from the rest of the US airline industry. Southwest, arguably the most successful US airline now or ever, has built its business on being different, bucking the “group think,” stick-together-as-we-push-ourselves-over-a-cliff mentality embraced by all the other airlines.

Roner points out that when everyone else in the US airline industry rushes to raise fares and tries to one-up each other on who can charge more, Southwest lowers theirs. When the industry suddenly decided that charging exorbitant fees for carrying checked passenger baggage somehow made for smart strategy, Southwest said not us. They fly out of alternate airports, run local “shuttle” type flights and do a whole host of other things the rest of the US airline industry would tell you amount to flirting with certain death.

But Southwest remains the most profitable, stable and highly respected airline in the country – precisely because they are not like the others.

Roche’s move to distance itself from the Big Pharma pack is, in some industry watchers' opinions, is an incredibly smart one if they leverage it well. It’s a unique opportunity for Roche to paint its newly merged company as a different breed of pharma, with different priorities and commitments to its stakeholders. It’s the ultimate opportunity to pull a “Southwest” and break free from the lemming mentality that so often seems to rule pharma.

New Ideas for Growth

I love walking into my office and hearing the conversation of brainstorming employees. It means ideas and energy are flowing and innovation is at work. That’s why I really liked this story I came across in BusinessWeek.

Last year, Best Buy picked four groups of salespeople in their early 20s and 30s and asked the strangers to room together for 10 weeks in an L.A. apartment complex. They were to come up with business ideas that Best Buy could roll out quickly and cheaply. The result: A service called Best Buy Studio, which provides Web-design consulting for small businesses.

It’s the Real World of business-extreme brainstorming. As participant Jermey Sevush says, “Living together and knowing we only had 10 weeks sped up our team-building process. We voluntarily worked longer hours, talking about business models while making spaghetti.”

Other companies have caught on. Whirlpool sends eight sales reps to Benton Harbor, Michigan, to test out products in a program called Real Whirled. The more experience each rep has with the products, the better marketers they become.

I wonder -- how could this idea be applied to Pharma branding and connecting with the patient and their experiences?

11 views on the question: “Which Biotech and Pharma companies would you say are growing the best during the economic down turn?”

Recently, Jonah Manning of BeAspired Inc. in Tallahassee, Florida asked “Which Biotech and Pharma companies would you say are growing the best during the economic down turn?”

Here are some the answers you might find interesting, plus a view from STINSON Brand Innovation.


Miguel Vilaplana, MD, MBA -- Biogen Idec, Amgen, Novo Nordisk, Pharmamar (Spanish), Life Technologies (for sure, Stem cells and anything related to cell culture etc. as Advancell; Spanish too...), Lonza (Stem cell department). However, how many of the medium-sized biotechs will survive after 2009? I do not know. Pfizer/Wyeth movement and Roche/Genentech hostile approach are telling us that M&A are just starting. Who is not able to stay without movement? Novartis, BMS (buy or be bought?), GSK, Merck ... We are going to see several movements there and some of the medium-sized pharma will have to buy or might be bought, and you can bet according to this parameters: total revenues, pipeline, sales force and manufacturing (being the first two, the most important I guess).


Chris Pounds -- Myriad Genetics just announced our Q4 2008 numbers and saw ~50% annual revenue growth over 2007.


Belkis Castro & Mary Jo Miller -- I would have to add Novartis to the list of growing companies. I just read their press release today and they are showing growth and actually hiring. They have over 80+ openings just in the US. For a large Pharma company they seem to be adding value without having to cut personnel.


Lin Chen -- I'd say more globalized company will more likely to survive this wave of economic downturn. Those who focus their business in the U.S. will suffer more for sure.

Guido Tomás Rozenblum -- For sure those companies that doesn't need fundings from investment institutions. Interests are going high, therefore, companies with cash such as Novartis, Invitrogen, Pfizer or Roche they may go for a trip buying small start-ups at ridiculous prices to fill up their pipelines.


Thomas Beattie -- Genentech will continue to lead in innovation over next 10+ years if Roche tender is unsuccessful. Watch the data released over next 30+ days (DNA).


Karen Strauss -- I believe that the Contract Research Organizations (CRO) that work for the Biotech and Pharma Industry are doing well. With mergers there is a chance that a particular contract could be cancelled but they usually have a wide range of clients and are able to keep revenues up.


Mike L -- The companies that benefit most from the down turn are the medium to large Pharma companies with a lot of cash. Biotech and Pharma companies are going for fire sale prices. Secondly, since Pharma and Biotech are shedding RD staff left and right, CROs are gaining huge market share.


Amy Clausen -- MD Biosciences is also experiencing good growth. We are a contract research organization and drug development company. We are continually adding staff, new services as well as searching for drug development partners.


Mohankumar Sowlay -- In the current global macroenvironment, small but innovative biotechnology companies which do not have to go to the market in the immediate future for financing needs have a good chance to survive the economic downturn. The present cost structure of big pharmaceutical companies dictated by the conventional drug development model is unsustainably high leading to a wave of cost optimization strategies. On the other hand, shareholders and employees may benefit from those companies that invest in targeted biotherapeutics, molecular diagnostics and regenerative medicine as successful product candidates from these companies become attractive acquisition targets by Big pharma. The attraction of these products to big pharma is due to the prospect of high reimbursement rates from the payers and the urgency to buffet their dwindling product pipeline. In my opinion, look for signs of prudent management of research dollars through the enlistment of global partnership in clinical development and for eventual market cultivation in emerging markets. I regularly analyze these and other company and industry strategies both from a business development and M&A perspective.




At STINSON Brand Innovation, we’re admiring two companies: CSL Behring and BioMarin.

CSL Behring
Commenting on CSL’s outlook, Dr Brian McNamee, CEO, said in February, “To-date there has been little to no impact on our sales arising from the global financial crisis. This is consistent with a product portfolio of life saving therapies and essential vaccines. However, we remain vigilant as the situation develops. Potential risks to our outlook include pressures on healthcare spend, debtors risk, foreign exchange volatility and ongoing access to long term debt. However, in this difficult economic environment, we anticipate broadly stable market conditions for CSL’s group of businesses. Research and Development spend of $153 million in the first half is expected to be similar in the second half with total spend for the year between $300 million to $310 million on a reported currency basis. Vivaglobin® (subcutaneous Immunoglobulin), a product which provides the convenience of immunoglobulin self administration, attracted significant patient growth. We have met key milestones in the approval process for increasing Privigen® manufacturing capacity. Specialty products, particularly Beriplex® P/N and Berinert® P, made a strong contribution.”



BioMarin

"All three of our commercial products are independently profitable, which helps fund the advancement of several promising programs including PEG-PAL for PKU and GALNS for MPS IVA. We are strategically developing earlier stage programs and looking for attractive later stage in-licensing or acquisition opportunities to ensure continued growth," said Jean-Jacques Bienaime, Chief Executive Officer of BioMarin. "We feel confident in meeting our overall top and bottom line financial objectives for 2009.”

One BioMarin growth brand, for example, is KUVAN® (sapropterin dihydrochloride) Tablets, a product for the treatment of phenylketonuria (PKU). Net product revenue was $15.5 million for the first quarter of 2009, compared to $5.8 million for the first quarter of 2008. The quantity of commercial tablets dispensed to patients, the best metric to track true patient demand, increased 9.5 percent in the first quarter of 2009 compared to the fourth quarter of 2008.