Strategic Partnering Among CROs (Nov 2013)


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  • Strategic Partnering Among CROs (Nov 2013)

    1. 1. Discovery Chemistry Formulation Commercialization introducing DavosPharma A leading provider of discovery, chemistry and formulation services, offering solutions to both emerging biotech and established multinationals during drug development.
    2. 2. A Strategic Partnership Outsourcing Model Discovery Chemistry Formulation Commercialization DavosPharma has a unique model working with best in class suppliers to customize workable solutions DavosPharma
    3. 3. Our Value Proposition Davos has no labs/manufacturing facilities of our own. We match Client’s needs with Supplier’s Capabilities. We offer our Clients: • • • • • Carefully Vetted Supplier Base in US, EU, India, China & Japan Quality Suppliers audited by Davos Technical Staff Fixed Cost & Predictable Deliverable Timing Active Project Support & Coordination (“Bandwidth”) Expert Shipment and Delivery Services DavosPharma
    4. 4. Resume - Gifford Marzoni Education: BS Chemistry with Honors, Lafayette College MS Organic Chemistry, Purdue University Work Experience: Davos Chemical CA, Inc. (1998 - Present) Vice President, Global Pharmaceutical Development Agouron Pharmaceuticals (1987-1998): Director, Head of Pilot Plant Services Eli Lilly and Company (1978-1987): Corporate Headquarters, Process Research and Development Tippecanoe Laboratories, API Technical Services Patents and Publications: 17 US Patents, 15 Peer reviewed Journal Articles Regulatory Filings Participated in filing 7 INDs and 3 NDAs DavosPharma
    5. 5. DavosPharma Deliverables We offer a full palette of development and custom manufacturing services: o Discovery Chemistry and Biology o Organic Synthesis, Fermentation and Purification o Analytical Method Development o Non-GLP and GLP Toxicology (acute, chronic, reproductive, genotox) o Process Research, Development, and Industrialization  API  Dosage Form o Manufacturing under ISO and cGMP Quality Systems  Process development and scale-up  Commercial scale manufacture All Our Deliverables are Supplied by CRO Partners DavosPharma
    6. 6. Why Partner? • Expand internal business development (BD) function or partner? – Expansion of BD is expensive – Partnering only costs once there is business • Provides access to established business relationships. • Broadens sales footprint beyond established regions. • Mitigates business risk DavosPharma
    7. 7. Nature of Partnerships • Outright partnering – our standard business model representing suppliers • Cooperative partnering – managing multiple relationships we do not normally work with • Competitive partnering – supplying our competitors DavosPharma
    8. 8. How Does Our Supplier Pool Change? 1. Organic growth a) new directions – selling what the market is asking for 2. Pruning a) b) c) d) e) mismatch in cultures change in BD leadership changes in ownership changes in business practices no opportunities develop 3. New relationships formed DavosPharma
    9. 9. Nature of Partnering Agreements • Minimal formality – If you want to work together, you don’t need much paper. – If you don’t want to work together, it doesn’t matter how much paper you have. • DavosPharma uses two documents with suppliers: – a confidential disclosure agreement – a customer protection agreement. DavosPharma
    10. 10. When it Works Well 1. Supplier understands Davos represents supplemental sales to their own BD efforts. 2. Davos handles all business aspects and price negotiations. • • • • Davos takes the business risk. Supplier sells to Davos ex their dock. We pay in local currency by wire transfer. Davos participates in all communications 3. Supplier is responsible for technical aspects. 4. Nobody gets paid until delivery occurs, subject to: • • Credit worthiness Research based (FTE) programs DavosPharma
    11. 11. When It Doesn’t Work Well • Internal sales force considers Davos as competition. • Supplier expects to get paid for failure. • Supplier wants Davos’ involvement only during problems and crises. • Davos is expected to fill supplier’s facility. • Supplier doesn’t want a long term relationship. • Davos and Supplier have different business cultures – Ethics and business practices – Communication styles DavosPharma
    12. 12. How to Begin a Successful Relationship 1. Start small. 2. Recognize there will be problems (business and technical). 3. How the problems are resolved will determine if the partnering will be successful. 4. Play nicely with other people – if the partnership isn’t a match, don’t burn bridges. 5. Business relationships are like fruit trees. It takes awhile after planting for fruit to grow. DavosPharma
    13. 13. DavosPharma Offices o DavosPharma Corporate Headquarters  Upper Saddle River, NJ o DavosPharma Satellite Offices  Research Triangle Park, NC  Boston, MA  Pennsylvania Biotechnology Center, Doylestown, PA  San Francisco, CA  San Diego, CA o Davos Japan Limited  An independent sourcing company operating in Japan on behalf of Davos o Milano, Italy  Dr. Claudio Giordano (APIs Chem) DavosPharma
    14. 14. Contact Please visit our website at to learn more about DavosPharma. Contact Information Giff Marzoni Vice President, Global Pharmaceutical Development 619-429-0120 DavosPharma