Johns Hopkins Courses this Academic Year

Innovation Management, Technology Transfer and Legal Aspects of Biotechnology

With appreciation to the masters degree program in biotechnology at JHU for providing a forum for online teaching — these topics are among the “core” competencies for managing innovation strategically and effectively! This semester (Spring 2017), my course in “legal aspects” focuses on managing legal (and business) risk in both for-profit and not-for-profit biotechnology enterprises. I’ve been using VoiceThread as a presentation/sharing tool on the Blackboard platform this year, and it’s been popular with students after getting past the interface training. Despite my initial misgivings, this is not just for high school students. It’s truly an effective way for grad students to develop a sense of community because commenting in context on presentations by voice or text is so easy to do and to review!

 

Report on Managing Global Health Risks

The Neglected Dimension of Global Security: A Framework to Counter Infectious Disease Crises (2016)

The National Academy of Medicine has just released a report by its Commission on a Global Health Risk Framework for the Future. It was my privilege to speak about innovation management as a component of this framework at one of the Commission’s workshops in Hong Kong last August.

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The report appropriately encourages the use of mechanisms to manage intellectual property and the pre-approval of clinical designs (Recommendation D.3). And it expounds on the IP recommendation to note the importance of having mechanisms for sharing data and reagents (page 76), but mentions material transfer agreements (MTAs) in the context of agreements involving manufacturers (vaccines, therapeutics and diagnostics). I would like to have seen something about pre-approval of MTAs and data sharing agreements focused on the research community, which is a topic that addressed in my slides at the workshop in August. However, the report addresses a much broader, overarching set of recommendations that urge a global response to pandemic infectious diseases and every implementation detail couldn’t possibly have been included.

You can download a free pdf here — the report is very important and quite interesting!

Related posts:

Video available online for the the National Academy of Medicine’s “Global Health Risk Framework” workshops

More About The National Academy of Medicine’s “Global Health Risk Framework”

Global Health Risk Framework: A Workshop on Research and Development of Medical Products

Ask and listen thoughtfully

Useful for managing innovation and most other things!

Shut up and listen! (linked above) is one of my favorite TED talks. I’ve blogged about this talk before (last August), but I recently watched part of it again preparing for a class session, and decided to re-post in case any of my subscribers haven’t see the video yet. It was presented in 2012 by Ernesto Sirolli, whose career started in international development and now involves a fascinating institute that makes “enterprise facilitation” a vital process in the development of diverse communities.This talk describes the importance of listening to a community’s aspirations and needs before trying to address their challenges. For me, the message underscores the value of asking open-ended questions and listening carefully to the answers. I apply this regularly, e.g., when negotiating agreements and thinking about customer-satisfaction surveys for my clients and students. Asking and listening are also hugely important to understanding customer needs when developing new products in the innovation space. Dr. Sirolli’s description of hippos scarfing down tomato plants in a Zambian river flood plain makes the point extremely well (at about 2:30). Enjoy the video!

Managing Risk in Material Transfers

Questions and concerns to address upfront!

Here is a superb questionnaire posted by the Office of Research Services at the University of Manitoba.

Manitoba mta questionnaire

It’s intended to identify several issues that need to be managed before a research institution accepts tangible, biological materials. In my own experience, it’s easy for busy people who submit or process material transfer agreements (MTAs) to overlook an question like whether the material will be described in a student’s thesis or what other third party materials — and from which sources — might be part of the contemplated research. This approach is just as important and useful at for-profit enterprises as well as academic institutions.

Viva questionnaires like this and also checklists for helping to manage innovation risk and ensure a high quality transaction!

Related posts:
1 Why asking questions is essential to success
2 Two Essential Questions to Ask BEFORE You Start a Negotiation!

Video available online for the the National Academy of Medicine’s “Global Health Risk Framework” workshops

Here’s a link to the video of my panel about “Sharing of Data and Reagents, Intellectual Property and Liability” at the August 19-21 Hong Kong Workshop on Research and Development of Medical Products. (My presentation slides are available in the first related post below.)

Dr Yamada summary remarks

I was particularly fascinated by one of the closing presentations made by the Co-Chair, Dr. Tachi Yamada, presently at Frazier Life Sciences. He constructed a matrix to show challenges and priorities needed to prepare for the next global pandemic. Surely and sadly, Ebola won’t be the last of these. Dr. Yamada’s platform looked at potential diseases, incentives for humanitarian and therapeutic responses, discovery and development of treatments and their manufacturing and distribution. This was a masterful and very pragmatic yet granular overview. I’m keen to see the final report made later this year to the National Academy of Medicine and the World Health Organization!

It will take a planet to manage the complexities of on-site response and data generation as well as the pharmaceutical innovation and the delivery of the health care and humanitarian response that will be required. May we rise to the challenge!

And the videos from other sessions of this workshop (including Dr. Yamada’s concluding remarks) are all very interesting and available through the link above, as well as video from other workshops in the overall “Framework” workshops.

Related posts:

  1. More About The National Academy of Medicine’s “Global Health Risk Framework”
  2. Global Health Risk Framework: A Workshop on Research and Development of Medical Products

The part of competitive assessment about finding patents on pharmaceutical products

Let’s say you’ve heard about a product or a patent infringement lawsuit and want to know about the relevant patents. Or you’re developing a similar product in an academic research department and want to scope out the competition or potential funders. Here are a couple of efficient ways to go about that.

And this is something that I do several times a week for clients who need to about the competition years before they anticipate their own product approval or who want an independent opinion about their own current patent position. With the right search tools, these kinds of projects are manageable, useful and often fascinating. Moreover, there are some great, no-cost approaches to getting the lay of the competitive landscape!

Here’s one that’s really simple but has limitations, so I often use it first to hit the target — Google Patent Search — and then switch to another tool.

Somewhat arbitrarily, I’ll start with the first new molecular entity (NME) approved by FDA in 2015, a drug called Savaysa that reduces the risk of stroke in patients with atrial fibrillation. That’s its “brand” name as marketed by Daiichi Sankyo, Inc., and the active ingredient’s name is “edoxaban” (or more precisely, edoxaban tosylate monohydrate). I looked for this on the FDA’s list of “New Molecular Entity and New Therapeutic Biological Product Approvals for 2015”.

No hits on Google Patent Search, however, with the name “Savaysa.” We would have better luck searching the product name, finding 322 hits. There’s also a tongue twister of a chemical name that you can find with a link from the product’s website under the tab called “Prescribing Information,” N-(5-Chloropyridin-2-yl)-N’-[(1S,2R,4S)-4- (N,N-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c] pyridine-2-carboxamido)cyclohexyl] oxamide mono (4-methylbenzene- sulfonate) monohydrate. And even though Google didn’t search this full name, because it was longer in length than the permitted search query of 32 characters, we still got another 51 hits.

So which of these records is important and how to begin finding them? Either with a double shot of something caffeinated or with a cheat! Sticking to one place where I can add value to your search, look at this FDA webpage — called the “Orange Book,” so named when there was a physical report with an orange cover — and then search by the product name or its active ingredient. Once you find the product, you’ll also see a list of the three approved formulations. Click on the FDA application number for any of the them, which takes you to a page that for each of the formulations has a list with the last entry being “Patent and Exclusivity Info for this product: View”.

More About The National Academy of Medicine’s “Global Health Risk Framework”

My July 18 event post talked about The National Academy of Medicine’s “Global Health Risk Framework” program, just held in Hong Kong from August 19-21, one of four related sessions this summer. I had the privilege of participating in the “Workshop on Research and Development of Medical Products.” The world’s response to Ebola was discussed frequently, particularly lessons learned and potential improvements in many dimensions to get out in front of the next potential epidemic.

(The following video, recently posted by the Centers for Disease Control, may be a helpful introduction to the topic of “Getting to Zero” for further outbreaks. You can find many more videos and photos at the Ebola information at CDC website and other health organizations.)

This program took a fascinating and multidisciplinary look at impediments and potential improvements in preparedness in how the world responds to global health threats posed by infectious diseases. Clearly, we can do a much better job responding to epidemic and pandemic disease threats. I’m keen to see the Commission’s synthesis and report, which will be released by the Academy later this year. Key recommendations from the report also will be provided to the World Health Organization in time for high level meetings in November.

My own panel session dealt with impediments to sharing of research materials and data, including material transfer agreements, liability and patents. And my remarks focused on the exchange of materials and data, which include not only viral isolates from infected patients, but genomic sequences of suspected pathogens and clinical data about safety and efficacy of candidate therapeutics, vaccines and diagnostics. These items are transferred between various researchers and institutions over extended periods of time as a threat is recognized and addressed.

I’ve blogged before about the importance of asking questions in the context of material transfer agreements and also developing a vision of what outcomes are possible. That’s still very much part of the solution in this global context. My slides expand upon some points to consider that would facilitate the exchange of research materials and data. You can download them here.

The Part of Competitive Assessment About Clinical Trials

If you’re interested in evaluating a therapeutic product, your own or a potential competitor’s, and are new to why we do clinical trials and how they are organized, have a look at clinical trials at NIH and follow a few links for a high level overview. In particular, check out this page with a host of disease-related registries, through which patients and their families can find and share additional information and think about participating in clinical trials.

Thoughtful, Thinking

When I’m undertaking a competitive assessment for a client, I usually spend some time on another website operated by NIH, which catalogs all of the clinical trials in the US. It’s called “clinicaltrials.gov.” You’ll find it helpful to look at the guide to searching and do some of the sample searches further down on this page. For practice, I suggest that you choose a disease like “malaria” or a disease and a population, for instance “hepatitis” AND “children”. Or search the term “genomic” with any second medical term of interest. Then click through a few of the clinical trials that pop up, and get a sense for the kind of information that is available about the trials, particularly who is sponsoring the study and what “active pharmaceutical ingredient (“API”) is being evaluated.

To get more proficient with this data gathering tool, try searching for any other API or disease that is relevant to your own research or other interests! Then when you need to evaluate the competitive landscape for a disease of company or product, you’ll have have some “muscle memory.” These sites are some of the best sources of information about potential products in clinical development.

Why asking questions is essential to success

particularly when you think you already know the answers!

Active listening (also know as reflective listening) is a fundamental approach to understanding another person’s concerns in any conversation, whether it’s a negotiation about material transfer agreements or research partnerships or hear-to-heart about daily relationships. It extends beyond just asking questions and notably includes repeating what you’ve heard. The speaker knows they’ve been heard and can correct or fine-tune their message. Another great technique called appreciative inquiry is a communications technique that envisions possibilities and works toward best outcomes. Together, these techniques go beyond trying just to find what’s wrong and then fix it. Combined, such techniques are important to successful innovation management and are also powerful productivity tools.

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One of my favorite TED talks is by Ernesto Sirolli, a compelling advocate and consultant of economic and community development. He talks about his experiences in international development. And shares a very funny story about hippos who like to eat tomatoes. His experience is a great reminder to ask questions, listen actively and don’t presume to know the answers.

Innovation Strategy — It’s More Than Moving A Product From Point A to Point B

An effective strategy takes you from where you are now to a predetermined goal. The planning process requires a candid assessment of what’s at both ends of the path so you know where you’re starting, where you’re going, and how to get there! In business, the assessment is usually fairly detailed and iterative.

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In contrast, when your objective is part of a personal strategy for achieving self improvement, for instance, working mindfulness meditation into your daily life, success is mostly under your control as long as the universe cooperates.For instance, finding the time to make something a new habit is often a mission critical component of implementing a “personal” strategic plan. Yet even this can be a challenge, and we all know that. My most recent success was actually doing 108 days in a row of yoga, with inspiration fromTravis Elliott, the ultimate yogi (available on DVD), and thanks to my cat, Raven, for keeping me company on some late night workouts! There are plenty of great self-help guides. One of my current favorites is “Better Than Before: Mastering the Habits of Our Everyday Lives” by Gretchen Rubin (2015).

In the technology innovation context, however, simply being intentional about getting from “point A” to “point B” isn’t enough. For instance, a competitor might get there first. Witness the epic patent infringement battles between Apple and Samsung. Or if the goal is developing an effective pharmaceutical product, it may not be worth the effort (and cost) involved if the therapeutic space is too crowded when you arrive. Your product has to be better enough than the alternatives so that the health care system will pay for it. Here’s a news story about states that won’t pay for a blockbuster drug to treat hepatitis C.And that’s just the developed countries’ perspective — how to make a given product available globally often adds a seemingly confounding layer of strategic and financial complexity to the process.

Successful strategic planning thus requires knowing way more than just the location of “point B” and heading in that general. One also needs to evaluate the lay of the land at “point A” and to understand the hurdles likely to be encountered and plan for them — including obtaining financing, hiring and retaining the right people with the right intellectual capital and effective teamwork skills, gathering research materials, securing patents, avoiding the infringement of patents owned by others, navigating the regulatory system and qualifying for reimbursement by third-party payers.

This integrated kind of evaluation is referred to variously as landscape analysis, competitive assessment, due diligence and is also known by a few other labels. It can be quite complex, and is done best with a multidisciplinary approach and team.

This is one if a series of posts that will dig into various aspects of that “competitive assessment” process. It’s intended to be provide some basic “how-to” guidance in evaluating the translational potential of a given research product and offer some useful tools in assessing the commercial potential of a developmental product.