"21st century...the century of biomedicine" - Lilly CEO Lechleiter

"Wealth follows health, and it ain't the other way around," said John Lechleiter, the CEO and chairman of the drug maker Eli Lilly & Co.

Mr. Lechleiter explains, "There's no better investment that we can make than in biomedical research and in our health.  I believe this will be the biomedical century.  We'll look back a hundred years from now and say the 20th century was the century of chemistry and physics, and the 21st century was the century of biomedicine."

"The challenge or the opportunity we have is that never before has the science and our knowledge base been riper for exploitation," Mr. Lechleiter adds during his interview with The Wall Street Journal.

Read the complete story by clicking to http://online.wsj.com 

Is the FDA promoting or precluding medical innovation?

I have been working with a number of medical device clients lately, and I've been struck by the frustrating delays in bringing new innovative products to market.

"U.S. investment in medical devices is falling...yet the FDA is demanding more drug-like trials for devices, causing many of the delays in getting new products to U.S. consumers," says Dr. Scott Gottlieb, a leading physician and deputy commissioner of the FDA from 2005-2007.

In a recent opinion piece in The Wall Street Journal, Gottleib refers to data from PricewaterhouseCoopers and the National Venture Capital Association showing the number of newly started, venture-backed medical-device companies fell to 60 in 2010 from 118 in 2008. "The magnitude of these declines dwarfs those seen in other entrepreneurial sectors. It can't reasonably be ascribed to the struggling economy alone," he asserts.

Gottleib references a 2011 study by the Boston Consulting Group of European device approvals that suggests that Europe's more expedited process is just as rigorous and safe as the FDA's. 

"Devices are also tools in the hands of physicians. The benefits of a device are ultimately dependent on how it is used by a physician," writes Gottleib. "A stethoscope, for example, only needs to show that it can enable a doctor to hear heart sounds. A stethoscope should not have to prove that using it can reduce the complications from heart failure."

He concludes, "This is no way to run a regulatory process if the FDA is serious about promoting medical innovation and advancing the public health."

Click here to read his entire article at http://online.wsj.com

3 ideas how “recommendation algorithms” could have a role in pharma marketing

Recommendation algorithms are best known for their use on e-commerce Web sites, where they generate a list of recommended items based on input about a customer’s interests.

When you compare two important measures of Web-based and email advertising effectiveness – click-through and conversion rates – these personalized suggestions perform vastly better compared to untargeted content (such as banner ads and top-seller lists).
 

From our pharma marketing viewpoint, I’ve been pondering the health, medical, and wellness applications of such recommendations:

1. If you have this condition, you should pay attention to these associated risk factors.
2. If you’re taking this prescription, you might consider this companion product/food to make it more tolerable.
3. If you are seeing this kind of doctor, you could also benefit from these supportive healthcare services. 

Read more about these CRM-enabled Web messages on my Brand Liberator blog post at www.gsw-w.com/blog

9 best practices in technology licensing -- and the effects of patents in drug repositioning

This is the last of five posts this weekend on drug positioning -- trying to get a new drug genie out of the bottle.

And remember why it's of such interest:

Drug development is a long, complex, costly, and high-risk business. According to the Tufts Center for the Study of Drug Development, drug development from discovery to U.S. approval takes about 15 years on average and costs over $1 billion, and only 3 in 10 drugs on average make enough revenue to sustain R&D.

In order to get a return on investment, companies need to ensure that their repositioned drug will have at least some patent protection. 

Drug repositioning candidates that are still in development may have composition of matter patents, depending on how far into development they are and how long they have been on hold. Companies developing off patent drugs or drugs with patents close to expiry have to rely on data protection, method of use patents, or patents related to formulation technologies. 

Manufacturers launching drugs have some protection against generic competition through data exclusivity, which provides 3 to 11 years of data protection after launch, depending on the market.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

I’m working now with a small nanotechnology company in this area of Technology Licensing.

We work at ensuring best practices for success are being followed by both parties in the licensing process. This may include identifying target application areas, drafting communication documents, promoting technologies on-line and through direct personal contacts, and providing assistance in deal facilitation and in the negotiation process.

1. Non-disclosure agreements
2. Needs and objectives
3. Key elements of the term sheet
4. Positions on relevant issues
5. Negotiating schedule and deadlines
6. Progress reports
7. Documentation
8. Draft agreements
9. Legal counsel

The challenges in drug repositioning -- and application of B.E.A.M.S

In my weekend series of posts on drug repositioning, let's look at a number of challenges for companies repositioning drugs.  Some are unique to this process and others common to any form of drug development. 

In the development of a drug for a completely new indication, drug repositioning cannot avoid the potential risk that the drug will not be effective in late-stage clinical trials -- especially if it has not previously moved further forward than preclinical development.

Drug repositioning can be based on marketed drugs that are off patent. This means that the active ingredients are easily available. However, if the dose required is similar to the dose used for an existing indication, physicians may simply choose to use the generic form, which is likely to be cheaper than the newly available, and possibly higher cost, branded repositioned drug.

“Because of this, it is important for a repositioned drug to have a difference in presentation. This may be a difference in delivery system or formulation, or a significant difference in dose — for example, Merck & Co launched the 5-alpha reductase inhibitor finasteride as Proscar for benign prostatic hyperplasia and then relaunched it as Propecia, at a significantly reduced dose and under a new patent, for male pattern baldness,” says one major company executive.

Access to data can have an impact on drug repositioning timelines. Companies that are developing a compound that they have not originated will need access to a competitor’s data or will have to rely on public domain data. This dependence on publicly available data can have its pitfalls. “If the company relies wholly on using public databases for their in silico screening, then there is a risk that their discovery may be found simultaneously by others,” adds another industry expert.

It may be harder for drug repositioning companies to get funding, as some investors have been burned by project failures, and others may be more familiar with traditional drug development and so are unsure how to value repositioning projects, especially as existing financial models don’t work.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

When I have consulted with Bioscience Bridge, LLC, we worked with clients to classify and prioritize existing technology assets through the use of our proven process in the evaluation of a university’s bioscience IP portfolio.

The B.E.A.M.S. Evaluation Tool measures a technology’s:

• Breakthrough potential
• Ease of development
• Advantages over competitive technologies
• Marketability
• Sampling or prototyping for evaluation

3 benefits of drug repositioning – and the application of Strategic GPS®

A number of studies have shown that in the last 10 to 15 years, while R&D spending has steadily increased, the number of drugs making it to the market has not followed pace.  That’s why the advantages of drug positioning hold such allure.

The key advantage of the drug repositioning approach is that it reduces the time, cost, and risk compared with de novo development. As well as providing an advantage to companies, it also provides an advantage to patients, because it reduces the overall cost by rescuing the investment in failed drugs and makes safer and more effective drugs available. 

“Drug repositioning is a means of obtaining better health outcomes without the massive investments and long time frames associated with traditional drug development. As such, it is both commercially and socially attractive,” says Steven Flostrand, business development director, at Marco Polo Pharmaceuticals.

Take a closer look at 4 benefits of drug repositioning:

1. Recouping existing investments
Many pharma companies have drug libraries of well-characterized compounds that are gathering dust and losing value as assets, whether it’s through failures in development or a change in therapeutic focus.

2. Saving time and money
Drug repositioning is generally a faster process than de novo development because it can rely on existing data, including efficacy and toxicity studies. Developing an NCE (new chemical entity) can take 10 to 17 years, depending on indication. For a drug repositioning company, the development process from compound identification to launch can be around 3 to 12 years.  What’s more, development of a single compound to enter clinical trials will cost around $10 to $20 million. The cost of identifying a repositioning candidate that already has phase 1 data varies but could be as low as $2 to $3 million.

3. Reducing risk
Drug repositioning is a significantly lower risk than de novo development, certainly from a scientific or clinical perspective. Because it deals with compounds whose safety profiles are already known, it significantly reduces this risk of drug development.

For the improvements to existing marketed drugs, we know what needs to be changed and generally, how to make these improvements. Very few 505[b][2] projects fail due to a science issue — most are due to money or markets.

In classical drug development, everyone is chasing ‘first-in-class,’ which does provide a high reward, but is very high risk. It’s still possible to get a ‘first-in-class’ with drug repositioning, even with an old drug, because it may represent a new mechanism applied to a new indication.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

When working with early-stage technologies, I have used a proven process designed to configure the technologies’ “road map” called Strategic GPS^® Navigation Process. This process: 

• Identifies the key targets 
• Articulates the current situation (Where we are)
• Defines the desired objective (Where we want to be)
• Conveys the over-arching strategy
• Delineates the milestones 
• Outlines the key tactics 
• Bridges the science and the business in a comfortable atmosphere

2 experts answer "What are the opportunities for drug repositioning?"

Drug repositioning is a growing field, with many companies looking to exploit its potential.  

In today’s blog, we hear from two industry executives:

1. Ken Phelps, president and CEO, Camargo Pharmaceutical Services. Phelps founded Camargo in 2003 as a strategic partner in drug development, including drug repositioning.
   
   
2. Steven Flostrand, MBA, business development director, Marco Polo Pharmaceuticals. “From a commercial perspective, with the era of ‘easy’ discoveries seemingly over, it makes sense to revisit existing drugs to ensure that we are making the best possible use of them.” Marco Polo Pharmaceuticals, founded in 2008, specializes in geographic repositioning — developing existing drugs for new markets.

Phelps says, “Generic companies are aware that as pharma pipelines decline, there will be a fall in the number of molecules coming off patent, so they are using drug repositioning to create new markets. Pharmaceutical companies are using drug repositioning to extend the life cycles of marketed products, creating new patents and defending themselves against generic competition, and to salvage the investment in failed or failing drug candidates. Finally, entrepreneurs are creating new drug repositioning companies to provide a service.”

Flostrand comments, “Many older drugs and drug candidates in development have never been fully explored. These can be looked on as resources, as they already have stores of valuable preclinical and clinical data on toxicity, safety, and dosing.”

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

4 kinds of candidates for drug repositioning

Because of the decline in drug launches, drug development companies are under increasing pressure to reduce costs and shorten development timelines through a range of different approaches.

These approaches include improving processes and protocols, moving more toward collaboration, and licensing and drug repositioning.

This weekend, I'll be posting a series of blogs on "drug repositioning.”  Also known as drug repurposing, drug reprofiling, or therapeutic switching, is the process of developing existing molecules for new indications.

Candidates for repositioning fall into four key groups, explains David Cavalla, Ph.D., founder of Numedicus:

1. marketed drugs that are still under patent or patents that have expired,
2. drugs that have moved through development and fallen at clinical or regulatory hurdles, and
3. stereoisomers or metabolites of existing compounds.
4. small change in the molecular structure — this provides stronger patent protection but still reduces the risk of failure.

Cavalla founded Numedicus in 2008 to provide collaborative services to companies seeking novel uses for existing drugs.

Read more in “Getting The Drug Repositioning Genie Out Of The Bottle” at www.lifescienceleader.com

8 notable projects presented by Elizabeth Diller at Ohio State lecture last night

Last night, I attended a special lecture by architect Elizabeth Diller, a founding member of innovative and highly respected interdisciplinary design studio Diller Scofidio + Renfro.

Her studio’s work spans the fields of architecture, urban planning, visual arts, and the performing arts. 

She showed us eight notable projects including High Line park in New York (built on an abandoned elevated rail line), the Lincoln Center expansion and renovation, and the Institute of Contemporary Art in Boston—all of which have received rave reviews.She also shared plans for museums in Rio, Los Angeles, and Washington, DC.

In her talk, Diller discussed the creative rationale behind these high profile projects.

Wexner Center director Sherri Geldin introduced Diller and said, “Having followed the work of Diller and Scofidio over two decades now, it’s beyond exhilarating to see the remarkable trajectory of their practice. Diller’s essentially performative and socially integrated approach to architecture and design has dramatically influenced the field and stunningly transformed the public realm with such widely acclaimed projects as New York’s High Line park and a completely re-imagined Lincoln Center complex. We’re thrilled to bring her to the Wex and to Ohio State.”

You can see more on the DSR website, www.dsrny.com

10 examples of US healthcare going viral with social networks

US innovators are finding ways to use social networks to improve healthcare, despite a variety of challenges.  

Writer Danny Bradbury of the UK newspaper, The Guardian, offers a number of familiar examples -- along with a few I was did not know.

Social media offers a focused channel for special interest groups to communicate – and those in the healthcare sector are among them. "Health is social," says Phil Baumann, founder of a US consulting firm with the same name that advises healthcare institutions on the use of social networks. He argues that healthcare is better when people can connect to share information and experiences. "Any media, any technologies that enable those connections and encourage collaboration will only lead to a better healthcare system."

Unfortunately, healthcare facilities could be using social media a lot more. A report by consultancy Deloitte on social networks in healthcare found that the sector ranked third last in terms of social network use, beating only pharmaceutical makers and that bastion of collaborative digital media petroleum refining. Although half of the healthcare companies in the Fortune 100 are on Twitter, none are official users of Facebook or blogs, according to Deloitte.  The article lists some of the challenges faced.  Read it at http://www.guardian.co.uk/healthcare-network

Here’s a list of 10 social networks in US healthcare:

1.     Sermo - an online network exclusive to physicians.

2.     PatientsLikeMe - a social network enabling patients to share experiences and advice.

3.     CureTogether - millions of ratings comparing the real-world performance of treatments for hundreds of conditions.

4.     DailyStrength - social network of support groups for various ailments, from alcoholism to infertility.

5.     FacetoFace Health - this social network connects patients with similar ailments, enabling them to share their experiences.

6.     MedHelp - health management network and online support community.

7.     Ozmosis - social network for physicians, including a cloud-based social collaboration and clinical content management platform.

8.     RadRounds - a professional network for radiologists that also includes the ability to share and discuss interesting medical imaging cases.

9.     WebMD - part social network, part portal, this site provides insights and information about health issues.

10.  WEGO Health - a social network which aims to empower health activists and leaders.

2012 and its layers of objectives

The central challenge for business leaders looking over the horizon to 2012 is:  how to address many layers of objectives at the same time.

It’s not enough to just find new revenue growth or to create more profitability; the problem is to do both at the same time.

It isn’t just the need to produce better brand performance in the short term that makes our jobs hard, but also the need to produce results today and build for tomorrow at the same time.

Every leader and every company I know in health, science, and technology faces these seemingly impossible and simultaneous objectives.

That’s why the companies which are winning are those that not only strengthen individual brands, but also increase the innovation ability of the whole portfolio. That means new products contributing profitably sooner. Sales at launch that endure through the entire lifecycle. And high-performing brands within a valuable whole.

In my book, N-of-8, I offer a look at some obstacles that managers can fall into that can break up a brand team rather than lead to breakout innovation.

Specifically, I present details of each of the four primary ways to apply the N-of-8 methods. For each, I identify what can make N-of-8 compatible the objectives of the team.

Contact me for a personal preview.

3 years retrospective: 3 points from my interview on Fox Business

Three years ago this week, I was interviewed on Fox Business News.  Looking back, some things have changed (the prices of stocks and gas have gone down), but many things have not.



Some key points from my interview:

1. It's important not abandon your brand in this economy. Those companies who keep spending money on their brand will survive.

2. To get results remember to stay customer focused. Think about what the customer wants to hear and you will be more successful in the long run.

3. Make quality improvements to core products, invest in R&D, and attribute an experience with your product.

Overall, don’t hit the “stop” button. Instead find the opportunity to go forward…fast.


Watch it again on our YouTube/StinsonBrand channel.

Living in an X-problem world

As more companies looked to “innovation” to be the key to their growth and success, those same companies were caught off guard by the multifaceted problems that came with innovation, ultimately squashing innovation efforts. 

Adam Richardson, creative director at frog design, inc, has labeled those problems X-problems.

In his book, “Innovation X”, Richardson takes you through several detailed case studies and points out where disruptive competition, demanding customers, the need to deliver integrated systems of offerings, or ambiguous goals have stalled companies innovations.

After defining the X-problems, Richardson shows you how to use a framework to diagnose real problems and uncover more insights. The advanced thinking in this simply presented methodology doesn’t swallow you up, but offers up one “Aha!’ moment after another.

Innovation X breaks down and redefines overused words, uses real life cases you’ll recognize, and suggests how an innovation strategy can be implemented, how you can get real results, and make real impact in your organization and in your customer’s world.

With a hefty notes, bibliography, and index section, Richardson demonstrates the need to understand the context and connectedness of all the cases presented.

I continue to get share ideas by following frog on Twitter.

As my daughter and former business partner, Melanie, said about Innovation X, “You’ll feel smarter after you read this book.”

186 design professionals share advice on what makes a great portfolio in “Flaunt”

The portfolio — it is all about branding yourself or your company, and it is ever-changing and evolving. 

The objective is simple: Create a delivery mechanism to showcase your work and depth of experience in an accessible and attractive matter. The intricacies of the different outcomes are as diverse as the owner.

A few months back, my long-time creative partner Katie Pendlay shared a book-about-books with me:  “Flaunt: Designing effective, compelling and memorable portfolios of creative work,” by Bryony Gomez-Palacio and Armin Vit.

Here is Katie's review of Flaunt.

The book is a collection of 41 case studies of diverse portfolios. The case studies feature close-up photographs; detailed breakdowns of the materials used, techniques, and resources it took to create them; and interviews with each designer.

Under the heading of “speaking from experience”, sprinkled throughout the book are reports from emailed interviews with 186 professionals in the design field such as Steve Liska and Michael Bierut. They share the most common mistakes people make in their portfolios, and offer great advice.

Another survey targeting the interviewee (designer) was conducted and those results are charted throughout the book under the heading of “census of portfolio etiquette.” They answer common concerns like how many pieces to include, method of first contact with potential interviewers, and how to present your work in an interview.

This book is a useful resource for everyone from young designers looking for their first job, to seasoned consultants in search to increase their client base.

(Thanks for the review, Katie. I owe so much of what's in my book to you.)

N-of-8® resource: “The Mirrored Window,” by Judith Langer

I’ve been facilitating a lot of N-of-8® groups latterly, as well as updating the use of this valuable insight tool.  

This has led me back to review some good resources, including “The Mirrored Window,” by Judith Langer.   

Langer draws insights from her experience and expertise to clearly explain the role of focus groups in the overall marketing process. It is a comprehensive how-to guide wherein Langer shares case studies filled with tips and tricks on effective moderation of focus groups.

In this book, Judith Langer explains why focus groups are an important method for learning about your customers and how to effectively conduct focus groups. If you’re involved with focus groups in any way, look no further for expert advice. Whether you are using focus groups for the first time or looking for ways to make your focus groups more productive, “The Mirrored Window” offers practical advice from an expert moderator.

Qualitative research, Langer explains, is more than just words. It is about listening to the non-verbal cues such as body language, tone of voice, and facial expressions to put context to the words. To illicit the best responses, creating an environment of comfort starts from the first interaction with the respondents during recruitment. The room should be tailored to suit the tone of discussion, so in some cases a living room style is appropriate whereas in some cases a conference room style is more suitable.

The moderator’s discussion guide is a critical tool for focus groups. Guides should be written as a conversational flowchart and not as a script. The moderator should be allowed to decide when to probe based on the dynamic of the respondents and flow of discussion. An experienced moderator is also prepared to handle rogue focus groups, when discussions go out of control. Langer suggests ways to deal with such situations in a professional manner to bring the group together again and refocus on the topic of discussion. 

In the book, Langer shares actual phrases and signals you can use to keep a focus group on track; how to get the focus group talking, how to ask focus group questions without biasing responses, how to control group dynamics, when to probe and when to use a firm hand.  In a full chapter dedicated to writing useful reports on focus group research, she shares sound advice about how to present qualitative analyses and strategic implications. 

Overall, the book is a great how-to guide for anyone planning qualitative research using focus groups. Langer shares a broad range of tips and tricks from her own experiences and includes a couple case studies as well. “The Mirrored Window” is a good read for anyone aspiring to be a moderator or learning to engage in market research.

3 new meanings for DTC -- from Bruce Rooke

"DTC is due for some big Invention," writes Bruce Rooke, Chief Creative Officer of GSW Worldwide.

On our agency's Brand Liberators blog, Bruce says, "It'd be a shame if we just stood there and kept putting out the same Beauty and the Beast formula of disease-stricken patient magically transformed into a walking grin, interrupted by 32 seconds of fake doctor-patient interaction while fair balance is read. We have the chance– and responsibility– to respond to the changing landscape with a whole new vocabulary of action."

Direct to Consumer says what it is and where it plays. But effective brands today are built on what they do than what they are. So imagine if DTC stood for:

 

D = Do.

T = Teach.

C = Connect.

 

Read more about what Bruce thinks DTC could mean on the Brand Liberators blog:

www.gsw-w.com/blog

 

5 actions steps for radiology to respond to the strategic shift of Hospital as Customer

This summer, I had the privilege of moderating an N-of-8® group during the AHRA conference for medical imaging in Dallas.

In the conference bulletin, Jim Sutton CRA, FAHRA published this viewpoint on the dramatic shift in the business environment between radiology practices and hospitals.

 "An increased number of radiology practices are being terminated from long- standing contractual relationships with their hospitals.

The evolution of teleradiology has changed the rules between radiology practices and hospitals. It has raised the bar for service expectations, such as rapid report turnaround times, the use of technology (e.g., physicians and ER can review images and reports), improved accessibility, and the availability of the radiologist for consults. And teleradiology companies specialize in high service levels. So unless your practice’s service levels meet or exceed those of the outsourced company, you may have introduced the hospital to a new level of service expectations and possibly your replacement. Thus, remote reads introduces a new business dynamic to the practice/hospital relationship.

There is also the quality of the hospital setting to consider.

For example, do your radiologists provide reports dictated promptly and results of significant findings? Are their reports signed promptly? Is there consistent participation in QA? In hospital settings, techs aren’t turned away, and there is cooperation in technology initiatives, such as voice recognition, and participation of hospital and medical staff committees.

For many radiology groups, hospital can represent more than 80% of revenue. So the hospital will roll the dice on its relationship with the practice. Remember, medical staff and community loyalty is not a lock. Hospitals expect quality in terms of service levels and participation. So the question is, if hospitals have shown they are willing to pull the trigger to end an agreement, is your radiology practice willing to risk playing hardball?

Radiology practices need to shift their view of the hospitals, and see them as customers. So how would a vendor treat its largest customer? Would the customer get special attention? Could the customer expect higher service levels? Would the vendor strive to partner with the customer for long-term success?

To save the relationship, group leaders need to recognize and lay out the reality of the relationship to the practice. They must review the professional service agreement (PSA) for areas that need to be addressed. Leaders must consider the hospital’s financial condition in terms of radiology. Where is it losing income/ cases? Are you asking for financial support from the hospital? Where does the group participate (or not)?

Make the first move.

The hospital is a valued customer. As in life, both sides must be committed to making a relationship work.

1.    Consider requesting a meeting with hospital administration and express your willingness to partner with them.

2.    Suggest a joint operating committee concept involving practice leadership, hospital administration, and departments like IT, medical records, and QA.

3.    Set goals and projects for the committee for items such as strategic planning, process improvement, communication, turnaround times, etc.

4.    Going forward, follow up on promises and projects, market to the hospital, and pay attention to details in your PSA.

5.    And definitely make sure your service levels surpass those of the telerad company!

To survive and thrive in the future, practices must learn to view life from the hospital’s perspective and move to a collaborative role/partnership with hospitals."