1. 1 machan consulting www.machan.co.uk Commercialising the Supply Chain Ian Machan Machan Consulting

2. 2 machan consulting www.machan.co.uk Introduction Provide an overview of a number of topics Feedback session to identify those important to you Why consider how to Supply your product? –Can it be supplied in large quantities? –Can you and you investors make a profit with it? –“I’m going to sell the IP, why bother?”

3. 3 machan consulting www.machan.co.uk Scaling up from Lab to production Laboratory experiments to one tenth, and then full size processing. Is it scalable? Do you use the same process, but bigger? Advanced thinkers in the industry are viewing this as a key competitive advantage area. Crossing over ideas from other industries and using more science

4. 4 machan consulting www.machan.co.uk Deciding to make or buy A decision based on: –Fundamentals, such as science, technology or IP –Practicalities, such as the scale of the process –Fixed cost/variable cost implications –Location of your knowledge, market, raw materials Where in the world?

5. 5 machan consulting www.machan.co.uk Deciding on a facility A facility that allows scale up A facility that will meet Regulatory inspection A facility that is affordable, or acceptable to funding stakeholders A facility that can grow A facility where 50% + will be support!

6. 6 machan consulting www.machan.co.uk Regulatory and Quality Systems Regulatory Bodies: MHRA, EMEA, FDA, ICH, Japan What they require of your product What they require of your processes What they require of your Supply What they require of your people e.g. QPs

7. 7 machan consulting www.machan.co.uk Validation of processes and supplies Validation is about proving that processes, equipment, materials and supplies do what you say they should do Creating a Master Validation Plan Assistance from the ISPE Biopharmaceutical Baseline guide

8. 8 machan consulting www.machan.co.uk Production process understanding and optimisation Understanding your process on a large scale basis Optimising your process so that you succeed with goods right first time Inter and intra batch process consistency Using Process Analytical Technology (PAT) or final product testing

9. 9 machan consulting www.machan.co.uk Recruiting, managing and supervising a factory In a study of US Biopharma manufacturers, 90% of the people employed were in production compared with 7% in the R and D function* Frequent failures identified by Inspections are insufficient skills, experience, and supervision of production people Recent Employee legislation has intensified * Source : Windows on the workplace 1997

10. 10 machan consulting www.machan.co.uk Maintenance of process and utility equipment To provide a consistent process, the equipment must: –Remain in calibration –Operate as validated, with change controls –Be cleanable and cleaned Half of the equipment may be support/non- process kit

11. 11 machan consulting www.machan.co.uk Product formulation and pack design Why worry about it? Marketing people will want tablets Producing a Pack design that appeals to Physicians and/or the patient Distribution channels and marketing channels Conditions of transport and shelf life

12. 12 machan consulting www.machan.co.uk Business Resource Planning Planning how to align your Business resources to the Market demand Based around forecasting/collecting demand Based around planning your supply Matching the two, short and long term Reacting in a controlled way to changes in either demand or supply

13. 13 machan consulting www.machan.co.uk Non-Healthcare Regulations Health and Safety Executive Environmental Waste disposal and effluent control Packaging directives Working Time Directive

14. 14 machan consulting www.machan.co.uk Technology Transfer Moving a product from a manufacturing site is neither straightforward nor quick Forward planning by registering two sites is one option Crossing over methods, processes and systems requires planning, but can be lucrative Planning on transfer as a business strategy

15. 15 machan consulting www.machan.co.uk IT Systems Looking forward, paper based systems are dead Electronic signatures on Electronic Batch Records Electronic drug submissions through the CTD Statistical Process control on key processes Electronic support systems

16. 16 machan consulting www.machan.co.uk Contracting Supplies and production Buying the right materials Buying in the quantities you now need is different Ensuring quality of supplies Ensuring continuity of supply: single or dual sourcing Ensuring a competitive cost: Global sourcing

17. 17 machan consulting www.machan.co.uk Thank you Ian Machan Machan Consulting Contact:+44 (0) 7780 646142 E-mailian@machan.co.uk