Strategic Outsourcing for Success

Transcription

1 Strategic Outsourcing for Success Improving Speed to Clinic using External Sourcing Massachusetts Biotechnology Council Meeting November 16, 2012 Cambridge, MA BioProcess Technology Consultants

2 BioProcess Technology Consultants World leader in providing strategic, technical, regulatory, and business consulting services to biopharmaceutical industry Founded in 1994; 18+ year proven track record Team of 12 consultants who have successfully executed over 500 client projects across six continents Process Development Quality & Regulatory Manufacturing Strategy Supply Chain Program Management Due Diligence

3 The Challenge Only seven in ten thousand compounds that enter pre clinical testing make it to human testing. Of the seven that enter clinical trials, only one eventually gets approved Pharmaceutical Manufacturer s Association Assume potential revenue for new drug of $250 Million/year $685,000 lost revenue for each day market launch is delayed Assume development costs of $20 Million/year $55,000 extra expense for each additional day of development time Manage new product development to get products into and out of the clinic faster Time is a competitive weapon

4 Path to First in Human Clinical Trials PD and Mfg define critical path! Initiate Pharm/Tox as quickly as possible File IND!

5 How to Do More with Less? Pharmacology Timelines Assay Validation QA/QC Phase I/II Clinical Protocol FDA Previous Human Experience Investigator vs.sponsor IND Sub-contractors Contractors Manufacturing Pre-IND Meetings Orphan Drug Status Clinical Trials Agreements Drug Formulation Toxicology Process Development Drug Stability What the is CMC? CEO CMC Record Keeping Fast Track Drug Vialing Regulatory Issues Investigator Brochure Investors THE REALITY OF BEING VIRTUAL

6 Outsource or Perform In-House? Coordination of all development activities essential for uninterrupted product supply and phase appropriate compliance In house Production Capital for design, land, structure, equipment Utilize existing equipment & facilities Staffing & operating costs fixed regardless of utilization Validation cgmp infrastructure & regulatory compliance Impact on existing operations Outsourcing Access new or different technology Provide maximum flexibility during development Controlled cash flow Maintain low overhead and minimize cash flow Reduce development time Access qualified trained staff Flexible production schedule Minimize risk Outsourcing development and manufacturing activities for early development can accelerate timelines and reduce technical risk

7 Integrated Program Strategy Determine Product Fit New technology vs. existing Select Project Team Set Goals and Priorities Define the Complete Plan Define deliverables and due dates Establish buy in for the goals and project timeline Track progress and tasks relentlessly Plan time to do practice runs at pilot or full scale Plan time for troubleshooting the process Develop Communications Strategy PLAN FOR CHANGE Don t forget plan B and plan C, D, and E

8 Finding the Right Match is the Key to Success Each relationship is unique No ideal contractor for any one customer No ideal customer for any one contractor Relationship is more like a partnership Not a traditional customer contractor relationship Typically not a one shot deal Customer is not always right!

9 Selecting a Contractor The single most important decision to be made Make a detailed list of your requirements Prioritize and weight the requirements Rank each of your needs for each contractor Cost not always the #1 priority Decision Factor Weight Factor Contractor 1 Weighted Score Contractor 2 Weighted Score Experience with required technology Large scale capacity Manufacturing history with product General cgmp manufacturing experien Commercial manufacturing experience Multiple facility capability Customer input over manufacturing Project cost Scheduling flexibility Project management time required Cooperation QA/QC support Regulatory support Location Technology transfer time required Success Rate Total Score

10 Keys to Success Prepare to manage the project closely Your project manager should have a technical background Contractor project leader should be technical Know your contractor s strengths and weaknesses and address them proactively Insist on an open dialog Have clear expectations about deliverables and timelines Prioritize your needs Allow adequate time to accomplish your goals On site supervision is strongly recommended

11 Dos and Don ts of Successful Outsourcing Relationships 1. Don t say it s urgent unless it really is stick to your deadlines 2. Share your objectives don t assume things will happen just because you want them to 3. Don t assume you are the Contractor s only client 4. Investigate significant differences before making decisions 5. Treat your contractor the way you would like them to treat you 6. If at first you don t succeed

12 One final view of outsourcing

13 Thank You! Howard L. Levine, Ph.D BioProcess Technology Consultants, Inc. 12 Gill Street, Suite 5450 Woburn, MA 01801