21% of new drugs approved from 1990-2007 involved PSRIs

It’s been about a year now since the New England Journal of Medicine published an article by AUTM President Ashley Stevens finding public-sector research had a more immediate effect on improving public health than was previously realized. (Stevens AJ, et al. N Engl J Med 2011;364:535-41)

Just about the same time, I was advising Bioscience Bridge on connections for university research from Boise State, Tulane, and Purdue.

This research article underscores the important role the universities play in improving healthcare.  And why Bioscience Bridge continues to create attention to commercialization of intellectual property.

In the introduction to the article, Stevens states that historically, “public-sector researchers have performed the upstream, basic research that elucidated the underlying mechanisms of disease and identified promising points of intervention.”

This is contrasted with corporate researchers who performed the downstream, applied research resulting in the discovery of drugs for the treatment of diseases – and who carried out development activities to bring them to market.

Today, however, the boundaries between the roles of the public and private sectors have shifted substantially since the dawn of the biotechnology era, and the public sector now has a much more direct role in the applied-research phase of drug discovery.

The authors (organized by Stevens, and including researchers from Boston University Schools of Medicine, Law and Management, the Radium Hospital, Oslo, along with collaborators from the National Institutes of Health led by Mark Rohrbaugh, Ph.D., J.D.) found that during the past 30 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in public sector research institutions (PSRIs). These drugs included 93 small-molecule drugs, 36 biologics, 15 vaccines, 8 in-vivo diagnostic materials, and one over-the-counter drug.

Their conclusion:

“We believe that our study supports the concept that the emergence of biotechnology in the mid-1970s, combined with policy changes implemented in the early 1980s regarding the ownership and management of the intellectual property of PSRIs, allowed these institutions to play an important role in the downstream, applied phase of drug discovery.”

Specifically, the data show that PSRIs have contributed to the discovery of 9.3 to 21.2% of all drugs involved in new-drug applications approved during the period from 1990 through 2007. It also suggests that PSRIs tend to discover drugs that are expected to have a disproportionately important clinical effect.

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

N-of-8 New Product Conception: Global R&D Leadership meeting

Several years ago, I was engaged for the Baxter Healthcare Global Senior R&D Leadership Meeting.

We were asked to support the free exchange of information at this forum. It was a terrific opportunity for us to interact with Baxter scientists, product developers, research consultants, and expert speakers – from every continent around the globe.

And it, of course, demanded the utmost in confidentiality. (Only recently did our secrecy agreement expire to allow me to even discuss our involvement in this important conference.)

 

This Global R&D Leadership meeting a two-day collaboration that brought together some 250 people to conceive health technologies for communities in the developing world. Norbert Riedel, Chief Scientific Officer, led the event.

 

It was a conference about innovation, and we shared the belief that innovation thrives in the intersections of disciplines that come from bringing together such an eclectic group. We applied our N-of-8 model and drew inspiration from other models of innovation, design, and community empowerment: co-creation, cross-disciplinary collaborations and crowd-sourcing.

 

Unlike a strictly academic conference, with papers and proceedings, the Global R&D Leadership meeting emphasized development of solutions, It capitalized on the revolution in product design that aims to create equity in the distribution of research and development resources by focusing on the needs of the world’s poor.

 

Specifically, here’s how N-of-8 contributed to the conference.

 

Working with our Baxter colleagues in the New Product Innovation department, a team of 12 Stinson “innovators” facilitated a series of breakout groups.

• Each group had a specific definition of a problem
• We gave a short description of our Action Shoes® activity
• The participants were assigned N-of-8 working tables and captured new product ideas on color-coded index cards
• Each N-of-8 table evaluated the ideas and added to their teammates notes
• All the idea cards were posted by color
• The full group did a “walk around” to comment and vote on most-promising ideas
• The Stinson and Baxter facilitators led a discussion of key success factors
• A team was selected to create a presentation to the general session
• A follow-up survey captured further thinking and feedback

$6.5 billion in global R&D contracts: Battelle an example of creative energy in Columbus

As we get into December, I start looking back over the year to appreciate some personal and professional highlights.

I've enjoyed getting to know Columbus better, including the chance to experience the creative energy of new people and world-class organizations.

One such group is Battelle.

Battelle is an 82-year-old organization that has grown into the world’s largest independent R&D conglomerate, offering services through four global business units: laboratory management; national security; energy, environment and materials sciences; and health and life sciences -- one of its key targets for growth.

At this point, Battelle’s global R&D contracts are worth about $6.5 billion annually.

Carmin Gade, PhD, Battelle’s chief marketing-communication officer, was interviewed earlier this year about the future of global R&D.  Here's what Dr. Gade told Mike Kallmeyer, host of ONN-TV’s Ohio Means Business program:

"In health and life sciences, 

we’re focusing on public health; drugs, devices and diagnostics; 

(and) agriculture and food science — and analyzing: 

'What are the needs of communities worldwide? 

Where can we help advance the science to meet those needs?'  

We have clients in the international markets that are looking for 

someone to partner with and offer solutions that can meet 

their needs and deliver the impact to 

humankind that they’re looking for."

You can watch the interview at onntv.com