From Phase-Driven to Hypothesis-Driven R&D The traditional mindset of drug development – advancing candidates from phase to phase – often prevents companies from investing resources wisely. Scientists, managers and investors focus their energy on meeting milestones, distracting them from the real question: have we advanced knowledge on how to deliver value to patients? Rather than […]
https://dev.kummerconsulting.com/wp-content/uploads/2018/01/Knowledge-Focused-Decision-StepsSM.png318400bkdesignhttps://dev.kummerconsulting.com/wp-content/uploads/2017/11/KummerConsultingLogoFinal@3x-1-300x223.pngbkdesign2018-09-28 22:43:312018-09-28 22:50:31A New Model for Drug Discovery and Development
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 […]
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 […]
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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, […]
Do you watch different functions blame each other for problems? You’re not alone. Problem: A recent client was bringing its first compound to Phase Two after decades of research on a new class of therapeutic agents. An investor deadline loomed for starting the dose-finding study. Development was pushing to finalize the study but Research continued […]
https://dev.kummerconsulting.com/wp-content/uploads/2017/11/blog-align-RandD.png251515merlekummerhttps://dev.kummerconsulting.com/wp-content/uploads/2017/11/KummerConsultingLogoFinal@3x-1-300x223.pngmerlekummer2017-01-11 19:28:342020-11-04 05:14:38Using Powerful Questions to Align Research and Development
Can’t get people out of their silos? You’re not alone. Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design. My client Peter, the Program Executive, vented his frustration to me: “Dr. C [the Clinical Director] withdraws, withholds information, […]
https://dev.kummerconsulting.com/wp-content/uploads/2016/12/clincialstudydesign-small.jpg300498merlekummerhttps://dev.kummerconsulting.com/wp-content/uploads/2017/11/KummerConsultingLogoFinal@3x-1-300x223.pngmerlekummer2016-12-19 18:46:592020-11-04 05:14:38Finding the Best Path to a Clinical Protocol Design
Find it hard to innovate in the strictly regulated environment of drug development? You’re not alone. Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed […]
A New Model for Drug Discovery and Development
in Organizational Politics, Strategic Planning, UncategorizedFrom Phase-Driven to Hypothesis-Driven R&D The traditional mindset of drug development – advancing candidates from phase to phase – often prevents companies from investing resources wisely. Scientists, managers and investors focus their energy on meeting milestones, distracting them from the real question: have we advanced knowledge on how to deliver value to patients? Rather than […]
Innovation Mechanism 2: Collective Creativity
in Innovation CultureWant 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 […]
Follow my New Blog, Merle Kummer Insights
in Innovation CultureI’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 […]
Innovation Mechanism 1: Individual Scientific Creativity
in Innovation CultureDaunted 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, […]
Using Powerful Questions to Align Research and Development
in Cross-Functional Leadership, Difficult Conversations, Managing Conflict, Protocol DevelopmentDo you watch different functions blame each other for problems? You’re not alone. Problem: A recent client was bringing its first compound to Phase Two after decades of research on a new class of therapeutic agents. An investor deadline loomed for starting the dose-finding study. Development was pushing to finalize the study but Research continued […]
Finding the Best Path to a Clinical Protocol Design
in Innovation Culture, Organizational Politics, Protocol DevelopmentCan’t get people out of their silos? You’re not alone. Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design. My client Peter, the Program Executive, vented his frustration to me: “Dr. C [the Clinical Director] withdraws, withholds information, […]
Innovating In Highly Regulated Settings
in Decision-Making, Experiment Design, Innovation CultureFind it hard to innovate in the strictly regulated environment of drug development? You’re not alone. Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed […]