An 8-Step Transformational Process

1. Determine Corporate Vulnerabilities and Driving Forces for Change
   1. Financial-product liability, lost product, Consumer confidence (lost sales)
   2. Reputation and Public Confidence
   3. Legal and Social
   4. Competitiveness
   5. Agency Relationships
2. Establish an Executive Commitment
   1. Urgency
   2. Priority and Sustainability
3. Create a vision and strategic alignment of systems, staffing, values and behaviors that form the basis of operating principles
4. Infiltrate with new leadership
5. Prioritize key initiatives and assign staffing
6. Align measurements, accountabilities, rewards, and consequences
7. Communicate, Educate, Participate, Celebrate
8. Repeat step 5 and 7

 If you are about to enter the world of strategy and structure, the following questions may assist with the organizational design.

·      How and under what conditions should a firm bring new technologies in house? 

• What are the prerequisites for a successful integration? 

·      When should a firm primarily focus on life cycle management or new product development and under what conditions?

·      What are examples of equivalent product platform in biopharm or how should the industry consider positioning platforms ?

·      Is biopharm different than other industries when applying lessons learned to generate product families? 

·      Are there different types of organizational structures whichimprove productivity in biopharm R&D? 

·      Have present novel organizational structures improved R&D productivity?

·      Should biopharm create a Sematech-style pre-competitive consortium to address R&D issues such as Personalized Medicine, pathophysiology, Modeling, DMPK/Toxicology  or IT issues? 

·      What would create a dramatic paradigm shift in new product development e.g diagnostics and population segmentation? 

·      Where in biopharm and device R&D could one apply ‘lean’ principles?

·      What lessons on the management of common resources in other contexts are relevant to biopharm R&D?

·      How could one change the IP approach to improve productivity in R&D  or is a vulnerability ?

·      What are the areas in biopharm R&D where ‘contact’   (frequency and geography) is critical for innovation and productivity?

·      How does decision making influence biopharm R&D  and  where is coordination   crucial for innovation and productivity? 

·      How would you measure productivity and innovation strategically?  How would this contrast with the investment community? 

·      Can Systems Biology change the way we do R&D? What impact will this have on organizational structures?

·      How can we use web based tools to transform the way we do R&D?