Biopharma Leadership for a Changing World

As the distance between colleagues increases, the need for leadership skill skyrockets. As it becomes clearer that every aspect of the R&D enterprise is interconnected, people at all levels of the organization are being forced to think more cross-functionally, more globally, and more collaboratively.

Critical lessons emerged from a knowledge exchange with leaders across the industry who convened on July 21, 2020:

  • Communicate clearly and widely
  • Expect the unexpected
  • Look beneath the surface
  • Face change with collaborative re-thinking
  • Focus on your priorities

Learning from Leading through Upheaval

On June 23, 2020, a group of biopharma leaders met for a virtual knowledge exchange on how to emerge from this tumultuous time stronger, smarter, and more resilient. We’d like to share some stories from the front lines and critical lessons for the future.

For coming back stronger

  • Build new relationships across organizational boundaries.
  • Don’t be afraid to take ownership.

For coming back more resilient

  • Solicit ideas from outside your own circle.
  • Open yourselves to help from all your stakeholders.

For coming back smarter

  • Focus on what’s most important to accomplish.
  • Experiment with new ways to communicate.

Hypothesis-Driven R&D: An idea whose time has come

Six years ago I worked with a group of biopharma managers who wanted to reduce the risk of late-stage failures. It’s time to share again what we learned, in light of the recent Phase 3 failure of aducanumad, an Alzheimer’s drug based on a clinical hypothesis that years of data had already eroded.

The article From Phase-Driven to Hypothesis-Driven R&D shows R&D leaders that rigorous work on human biology in early development reduces the risk of clinical failure.

Rather than focusing R&D programs on advancing a compound, groups can focus on advancing knowledge about how to deliver health benefits through improving human biological function. Advancing drug candidates would be the by-product of successful work, not the product.

They can visualize R&D as a series of experimental cycles:

  • Build hypotheses about chances that treatment will succeed
  • Design sound experiments
  • Execute experiments with tools fit-for-purpose
  • Generate robust, interpretable data
  • Rigorous quantitative analysis to reduce risk
  • Boost certainty about chances treatment will succeed
  • Apply knowledge to decisions.

Many of the managers I worked with then are now leading their own R&D groups, and I have the privilege of introducing these ideas to innovative startups.  To learn how you can benefit, drop me a line at mkummer@kummerconsulting.com.

Innovation Mechanism 6: Innovation Ecosystem

Want to keep innovation flowing?  Don’t think of it as a pipeline, think of it as an ecosystem.

It’s the connections that matter.

Value creation takes place in continuous, iterative conversations between scientists, clinicians, patients, and investors. These conversations form a complex, adaptive system – a social network.  Like an ecosystem, a company’s innovation network evolves over time as relationships multiply and grow deeper.

Recommendation: Invest in the relationships that work.

From the beginning, foster deep learning relationships between scientists and investors.

It takes constant conversation to learn what will work.  Only a social network can create value.

Retain relationships, not just individuals.

Trace the interactions between people to learn how they created successful results.  Use these maps to guide future projects.

When integrating an existing group into a new R&D organization, learn which relationships were key to delivering high-quality work.  Engage those people to determine the best way to preserve the relationships.

Don’t imagine that a high valuation means you can forget about maintaining your value-creation engine.

Too many companies find that they can’t realize the potential of assets without the deep knowledge embodied in the relationships of the people who developed them.  Engage the original team in detailed planning on how to organize a transition that doesn’t leave the tacit knowledge behind.

Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Innovation Mechanism 5: Product Development

Want to deliver successful products?  Don’t keep people in their comfort zones.

Synthesize knowledge across disciplines every day.

Successful innovators describe habitual mechanisms that synthesize knowledge from different functional groups:

“No big distinction between Research and Development.”

“We understand that Research and Early Development are really a continuum.”

This everyday dynamic enables companies to find opportunities and pursue them more efficiently than firms with segregated functional organizations.

Recommendation: Stop isolating Development from Research.

Train Clinical and Commercial to listen for possibilities, not problems.

Too many Development people think, “Research is impractical,” which leads Research to think, “I won’t show this to Development because they’ll just tell us it won’t work.”

Train Research to explain the science clearly to Clinical and Commercial.

Too many Research people think, “Development won’t understand it so I won’t bother to explain,” which leads Development to think, “They must be hiding something.”  When scientists listen to questions from people outside their disciplines, they discover gaps in their reasoning and learn better ways to describe what they’ve found.

Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Innovation Mechanism 4: Proof of Concept

Do you scramble to meet milestones?  You might be missing the mark.

Focus on designing the right experiments, not moving to the next phase.

Champion innovators don’t plan for a compound’s success – they plan for knowledge. They want to discover whether a treatment will help patients – not discover a signal to justify moving their program forward.

Starting with a well-formulated hypothesis, teams plan a sequence of experiments that would progressively reduce the uncertainty of whether the treatment will work in the real world.  Research investments enable the company to avoid costly clinical studies when the likelihood of success is minimal.

Unlike the norm in science-based organizations, where negative results are black marks, smart R&D groups synthesize knowledge from experiments that both proved and disproved their therapeutic hypotheses.  This growing knowledge base improves the group’s ability to assess the value of opportunities and make sound investment decisions.

Recommendation: Reverse perverse incentives

Don’t reward starting new phases unless you want late-phase disappointments.

Moving to a new phase isn’t a value-creation event.  It’s a commitment to spend money.

Don’t push teams to shorten timelines – push them to find more elegant ways to get the data you need.

Talk about the decisions you must make before arguing about the schedule.

Educate executives that faster isn’t better.

We know of a financial executive who genuinely believes that if you get to Phase 1 faster, your chance of approval is higher.  Don’t let beliefs like that choke your team.

See what really drives innovation success.  Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Innovation Mechanism 3: Scientific Collaboration

Want to help your ideas turn into products?  Let them out into the innovation community to find unexpected routes to value.

Broaden the boundaries of collaboration.

Technical and scientific work requires rich information flow between people across social networks.  Holding inventions closely or restricting publication blocks knowledge flow, preventing social networks from growing in both breadth and depth.

Recommendations: Don’t over-value your ideas

Educate academic collaborators on the realities of the market

Be honest about the high failure rate of promising ideas and the high costs of bringing drugs to market.  Help researchers understand that pots of gold are only found at the end of the rainbow.

Stop fearing someone will steal your ideas

Many entrepreneurs believe that others are waiting to pounce on every new idea, so they hide in stealth mode.  What they lose is the opportunity to learn how their ideas might be used.

Assemble a creative legal team early

Find attorneys who are interested in new business models rather than telling you how “it has to be done.”

Explore the use of Materials Transfer Agreements that enable researchers to use your compounds in return for data and appropriate commercial rights.

Lose “not invented here”

You’re not as smart as you think.

Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Innovation Mechanism 2: Collective Creativity

Want to bring out the best ideas from your organization? Follow my blog series on the innovation mechanisms that enable new ideas to become great products.

Successful innovators seek to learn – not to convince.

A group of creative individuals can generate collective creativity.  Innovation is the process of newly applying ideas to problems, generating novel solutions.  When people interact, they gain access to each other’s experience, and activate associations across far-flung bodies of knowledge.

Recommendations: Build a culture of learning, not telling

Unlearn the habits of academia.

Admitting you don’t know is a sign of integrity, not a source of shame.

A presentation is not a dissertation defense.

When presenting, your job is enabling others to learn, not defending.

When watching, your job is learning, not grading.

Proving which idea belongs to whom interferes with problem-solving.

Questioning someone senior is a knowledge-building move, not a career-limiting move.

Reduce dependence on PowerPoint.

Writing PowerPoint slides suppresses the cognitive activity of synthesizing knowledge because it encourages people to divide information into discrete, sequential pieces organized in rigid outlines.

Innovation, in contrast, connects information in associative networks.  Full sentences in prose paragraphs better express the integration of different strands of thought that result in new solutions.

Model high-quality conversation at the top.

Train and coach senior executives on the disciplines of collaborative leadership:

Skillful reflection on the different perspectives underlying technical and business decisions.

Building solid understanding of the critical data and reasoning for taking action.

Bringing out the whole range of concerns and ideas that bear on the issues at hand.

 

Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Innovation Mechanism 1: Individual Scientific Creativity

Daunted by the challenge of keeping your organization innovative? Follow my new series on mechanisms that drive sustainable performance.

Creativity fuels the innovation organization.

Research on creativity shows that long incubation, broad investigation, and wide experience enable scientists to synthesize knowledge from disparate sources to create new ideas.

Recommendation: Find creative individuals

Value broad thinking, not just subject-matter expertise.

Biopharma organizations typically look for employees, advisors, and collaborators with experience in precise technical and scientific domains. This can filter out people who can assemble novel solutions from a variety of sources.

Look far beyond your own network.

People that you already know tend to know what you already know. Don’t let your own experience limit your ability to access domains of knowledge that can increase the value of your ideas.

Seek people with deep interests outside their professional domains.

Passionate engagement in a pursuit beyond one’s specialty is a strong clue to a creative mind.

Require curiosity.

Anyone who doesn’t ask questions won’t learn enough to provide better answers.

Click here for a free download of the Kummer Consulting case study, Mechanisms of Innovation.

For a free consultation on how to improve your organization’s effectiveness contact Merle at mkummer@kummerconsulting.com

Follow my New Blog, Merle Kummer Insights

I’m delighted to begin sharing the insights that emerge from the deeply satisfying work of helping biopharma leaders innovate.  Every day, I have the privilege of reflecting on problems at the edge of innovation with committed scientists and leaders.  Every time we succeed with a new approach, I think of a dozen people who could use the ideas, and wish I could call every one of you. That being impossible, I’ll post what we learn and hope to inspire you.  If you try something out, call me at 617-489-9964 any time!

I’ll begin 2018 with a 6-part biweekly series on the mechanisms of innovation that drive sustainable performance for R&D organizations.   These are drawn from the White Paper Designing a New Engine for Life Science Innovation, a practical case study showing the mechanisms at work.