A practical learning to help create an efficient and targeted approach towards clinical supply. TA exciting event and one particularly captivating presentation came from Gelesis's Chief Technology Officer, Eyal Ron. The vastly experienced Dr. Ron succinctly showcased manufacturing management strategies and examined selection processes to help provide the ideal manufacturing partner for your company.
Analytical Profile of Coleus Forskohlii | Forskolin .pptx
Establishing manufacturing management strategies
1. Establishing manufacturing
management strategies
Clinical Trials Supply New England 2016
Eyal S. Ron, Ph.D.
Chief Technology Officer
501 Boylston Street; Suite 6102
Boston, Massachusetts 02116
Tel: +1 617.308.8200
Email: eron@gelesis.com / Eyal@MADASH.com
Web: www.gelesis.com
Twitter: @EyalSRon
2. Establishing manufacturing management
strategies and examining selection
processes to ensure the best manufacturer
is selected for your company
Outline:
Introduction
Manufacturing Management Strategies
Requests for proposals (RFPs)
• The organization's culture and needs
• Project Requirements
• Timeline / Milestones / Deadlines
• “Killer” criteria
• Decision / Evaluation
3. What is a Manufacturing Management
Strategy?
A pattern of decision making with certain consistency
Steady buildup of small decisions that gradually formed as action pattern for
the company (all stake holders)
Strategy as plan (vision)
• Strategy as "what top management says“
or
• Strategy as pattern (action pattern)
Strategy and implementation are inseparable (and are a vital force
in overcoming resistance to change)
4. Manufacturing Management Strategies
Business Strategy
Competitive priorities
(e.g., cost)
Decision categories
(e.g., performance)
Manufacturing Strategy
Two major constituents of manufacturing strategy:
competitive priorities and decision categories
5. Request for Proposal (RfP)
A request for proposal (RfP) is a solicitation, often made
through a bidding process, by an agency or company
interested in procurement of a commodity, service or
valuable asset, to potential suppliers to submit business
proposals. It is submitted early in the procurement cycle,
either at the preliminary study, or procurement stage
https://en.wikipedia.org/wiki/Request_for_proposal
6. What's the Purpose of the RfP Process, and
When Do You Need One?
Finding the site/vendor/OM that best suits the needs of the
organization
an opportunity to interview key stakeholders and bridge the gap
between the vague aspirations that launch a project and the
concrete, measurable requirements that guide it to successful
conclusion
Accountability and good governance (encourages fairness and
transparency while minimizing the likelihood of favoritism)
7. Steps in the RfP Process
Establish the project's boundaries
Identify key stakeholders and advisors
Define your project needs
Draft the RFP
• Create a draft of the scoring criteria
• Review with the team (stakeholders and advisors)
Select 3 – 5 Regions / vendors / OM
Submit the RfP
Q & A
Review proposals
8. What Information Should be Included in
the RfP?
Organizational background
Project Description / objectives
Product Description
Project Requirements / acitivites
Timeline (create a reasonable timeline)
• Milestones / Deadlines
Questions and required information
• A “Killer” criteria
• Questions based on past experiences
• MSDS, Product specifics (such as physical properties)
• Fee structure
Contact information and deadline for submissions
9. RfP Specifications
Examples of quantitative measures that will be evaluated in the vendor's
response
Product drawings
Engineering tolerances
Service levels
Technical or Business Requirements
Functionality
Hardware requirements
10. RfP’s “Do Nots”
Misleading information
Different verbal and written communication
Ask for “Freebies”
Champion receiving lowest prices
12. RfP Challenges
Not all vendors with the appropriate capabilities will be interested in the
amount of business that are offered
Forecasts of future needs are uncertain, but they set the foundation for
credibility with the vendor
Rushing through the process can lead to costs inaccuracies and mistakes
Product’s quality must be inline with the competitive priorities and the
decision categories
With frequent product changes, establishing a single point of communication
Managing the end of a relationship is often viewed as adversarial and
therefore not addressed until a crisis occurs
The vendor’s team that wins often isn’t the team that services the business
relationships
Ensuring compliance with regulatory directives
13. Evaluation Criteria
Quality
Timeline
Cost
Quality of communication
Project leader
Do they “get us”?
Contract
Cost True Cost
Quality Defects/ # of lot failures
Delivery Lead time
Innovation Number of ideas / improvements from the vendor
15. Evaluate RfP - do not judge a vendor
solely on the proposal
Meet the vendor
• Management
• Team
• Project leader
• Communication style
Optionally, audit the vendor
References
Does the vendor really wants to win the proposal?
18. Summary
A pattern of decision making with certain consistency
Steady buildup of small decisions that gradually formed as action pattern for
the company
Manufacturing strategy as pattern (action pattern)
Strategy and implementation are inseparable
Exploited through the RfP process
19. Make Manufacturing a Competitive
Advantage
Thank you!
Eyal S. Ron, Ph.D.
Eyal@madash.com
+1 617-308-8200