​Innovation Management and Business Turnaround Case Study.

Problem:  A Global Contract Research Organization (CRO) was sick and on the verge of being sold out. The management wanted to give a final shot for its revival prior to potential sell off.

All projects were running late. Not a single project milestone was achieved hence, clients had stopped payment. Company’s cash-flow had come to standstill. Many employees were laid off. As the company had no funds to pay vendors, they had stopped supplying raw materials, hence work stopped too. It was turning into a vicious catch 22 situation. No funds- so no project work was happening and clients paid no funds- because no project milestone was delivered.

Due Diligence: Financial and Technical Audits, RCA, Pareto and Ishikawa studies were conducted to evaluate CRO’s financial health, site, systems, products, problems, processes, human capital, customer complaints etc. The objective was to review the CRO and bring back its glory.

Solution: Business process redesign/ re-engineering was undertaken alongside strategic portfolio management. Hoshin, QbD and DOE were installed for strategic innovation management. Lean and Just-in-time methodologies were installed to help cash-flow and prompt project deliveries. 8D and Kaizen models were executed to turnaround the business.

Result Dashboard:

• The CRO was reviewed in just 9 months! Balance sheet showed first signs of positive growth within 5 months of ‘process change’ implementation.
• An effective customer relationship management process was introduced which provided repeat business from existing clients.
• New clients were added. New contract research projects of over $ 35 million was received.  

​Innovation Management, Just-in-time and Kaizen Case Study

Problem:  An multi-national pharmaceutical company had an ambitious goal of new product introductions into several developed markets including US (20 products ANDA para III and IV), Brazil (36 products) , Canada (5 products) and Australia (3 products) to be accomplished over a period of 2 years. All the products were new to the company and they wanted to be 2nd or 3rd player in the market.

All the products had to be developed first, followed by regulatory submissions for getting  marketing approvals in US, Canada, Brazil and Australia. The company also wanted to know the LCM for each of the products in order to create appropriate yearly budgets.

Solution:  The Innovation portfolio was strategically designed. Potential value stream maps were designed for each new product and all concerned standard operating processes were put in place. Product development, regulatory, IP, manufacturing, testing, pricing and logistic strategies were developed along with their respective plan for implementation. LCM protocols were submitted to the company’s management board.

Design Thinking, QbD and DOE were employed to succeed with the innovation portfolio. Kaizen and Just-in-time methodologies were applied to bring about a culture of innovation within the organization.

Result Dashboard:  

• Product approvals for all products was received in time as per schedule.
• Profit margins further improved as Lean methodology was employed to operations which saved overheads by 18- 20%.

​Innovation Management Case Study:

Problem:   A Global Pharmaceutical Contract Research Organization (CRO) wanted to start a new division that could develop products via the 505 (b)(2) pathway. They had three main requirements- Create appropriate team, Identify 505 (b) (2) product development opportunities and develop the identified products within best possible time line.

Due Diligence:  A due diligence of CRO’s capabilities such as human capital, machinery, facility engineering, marketing plans, logistics, budget etc. was done. It was decided that existing scientific talent (rather than new recruits) shall be trained for this venture. A team Director shall be recruited who could provide leadership to the innovation program.

Solution: Innovation strategy was designed for team building and training of existing employees to prepare them for this new initiative, allocate space for conducting research work, set up budget etc . Appropriate product Life Cycle Management (LCM) opportunities were identified via Brainstorming, mind-mapping and Pareto tools.

Results Dashboard:

• LCM opportunities were identified for 10 products which would be developed using the 505 (b) (2) pathway.
• The management decided to select 3 out of the total 10 opportunities, to initiate the program. Balance 7 opportunities would be worked upon in a tiered fashion once funds accrue.
• The team building campaign was a super success. Output from this campaign fetched the CRO immense intellectual property which they would capitalize in due course.

Following three patent inventions involve 505 (b) (2) pathway product development-

1. Modified release mucoadhesive formulation of Clopidogrel bisulphate (Appl 2162/ MUM/2012)
2. Novel pharmaceutical composition of Argatroban (Appl 2713/ MUM/ 2011).
3. Novel formulations of Tetrabenazine (Appl 2716/ MUM/ 2011).

​QbD, Innovation Management and Training Case Study

Problem: A multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) and Canada markets. Their employees weren’t trained in QbD methodology, hence needed both direction for product development as well as training in QbD.

Due Diligence:  A due diligence of product development work conducted so far, machinery,  manufacturing site, testing equipment etc. was conducted. A report comprising the QbD design thru implementation strategies and training programs was presented to the company’s management.

Solution: Appropriate training on QbD was given to the organization’s scientific team in R&D and operations. Training was provided as classroom coaching as well as online courses.

In addition to QbD implementation at design and development phase, a Risk Assessment protocol was developed for procurement of drugs and critical excipients, such that, the company can have the flexibility to choose vendors as needed.

Results Dashboard:

• All 3 product were developed with QbD compliance and launched on time.
• Additionally, QbD implementation reduced 10% cost on product analysis in its very first year of implementation.