Steve Holmes, PhD Director, Therapeutic Targets Kymab Limited

1. Steve Holmes, PhDDirector, Therapeutic TargetsKymab Limited

2. I am in the Biotechnology industry Each gene Can be translated Into a specific protein DNA Proteins are large and complex and carry out the body’s functions A code Organised into genes >30,000 in each of us Most biological medicines are PROTEINS 1

3. -Interferon Biologics : Some of the Molecules used in Medicine Biologics. Some of the Molecules MW ca. 18,500 Aspirin MW 180 IgG Monoclonal Antibody MW ca. 160,000 Insulin MW ca. 6,000

4. Pharmaceutical Product Sales Total Sales $Billion Top 10 - Sales $Billion • By 2014 Biologics are expected to account for 75% ($50Bn) of the revenues from the top 10 best selling drugs • Five of the Top 10 are predicted to be monoclonal antibodies

5. Monoclonal Antibody Mechanism of Action of Monoclonal Antibodies Unique binding function Effector function

6. Clinically Approved anti-TNF Monoclonal Antibodies for RA Remicade Humira Clinical use of Monoclonal Antibodies Rheumatoid Arthritis – Disease Reversal

7. A day in the life of Steve Holmes • Research ideas for monoclonal antibody therapy for Amyotrophic lateral sclerosisIP, literature and competition searchesReview list of experts in field • Prepare for meeting with Contract Manufacturing Organisation • Attend antibody research group meeting • Attend management meeting • Telecon with Wellcome Trust • Prepare project plan for new monoclonal

8. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What is my job in the cycle? • Ideas • Research • Development • What skills are required to do my job? • Immunology, biochemistry, molecular biology • Antibody generation, antibody engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record

9. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? Post-Doc (3 years)Assistant Professor (4 years)On job training • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record

10. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? • Antibody generation, engineering, cell line development and manufacturing AcademiaBiotech. and Pharma. industry • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record

11. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? • Antibody generation, engineering, cell line development and manufacturing AcademiaBiotech. and Pharma. industry • Disease biology expertise • Clinical trials 30+ Patents 60+ Publications • IP, Fund raising, Bus. Dev. • Years of experience • Track record

12. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials Pharma and Biotech industry • IP, Fund raising, Bus. Dev. • Years of experience • Track record

13. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. Biotech industry 30+ Patents, 60+ publications • Years of experience • Track record

14. Ideas Research Development Early clinical trials Late clinical trials Approval Kymab: Therapeutic monoclonal antibody companyLife cycle: idea to clinic ~8 years 4 mAbs Bosatria • What skills are required to do my job? • Immunology, biochemistry, molecular biology How did I gain the skills? • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience 30+ years Monoclonal antibodies in clinical trialsDomantis – sold to GSK for £230M • Track record

15. Biotechnology IndustrySalary, Career path and career progression/promotion opportunities BSc 0 – 4 years experience ~£18K - £35KPhD 0 – 4 years experience ~£20K - £50K Career Path Science Career Career Opportunities Research Associate Marketing/Sales Scientist Patent attorney Senior Scientist Business Dev./CBO Director CEO CSO Consultant Found own company