Steve Holmes, PhD Director, Therapeutic Targets Kymab Limited I am in the Biotechnology industry DNA A code Organised into genes >30,000 in each of us Each gene Can be translated Into a specific protein Proteins are large and complex and carry out the body’s functions Most biological medicines are PROTEINS 1 Biologics : Some of the Molecules used in Medicine Biologics. Some of the Molecules MW ca. 18,500 -Interferon Aspirin MW 180 Insulin MW ca. 6,000 IgG Monoclonal Antibody MW ca. 160,000 Pharmaceutical Product Sales Total Sales $Billion Top 10 - Sales $Billion 600 70 60 500 50 400 40 Biologic Drugs Conventional Drugs 300 30 200 20 100 10 0 0 2000 2008 2014 2000 2008 2014 • 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 Mechanism of Action of Monoclonal Antibodies Unique binding function Effector function Monoclonal Antibody Clinical use of Monoclonal Antibodies Rheumatoid Arthritis – Disease Reversal Clinically Approved anti-TNF Monoclonal Antibodies for RA Remicade Humira A day in the life of Steve Holmes ►Research ideas for monoclonal antibody therapy for Amyotrophic lateral sclerosis IP, literature and competition searches Review 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 Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development Early clinical Late clinical trials trials Approval What is my job in the cycle? What skills are required to do my job? • Ideas • Immunology, biochemistry, molecular biology • Research • Antibody generation, antibody engineering, cell line development and manufacturing • Development • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development Early clinical Late clinical trials trials Approval What skills are required to do my job? How did I gain the skills? • Immunology, biochemistry, molecular biology 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 Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development What skills are required to do my job? Early clinical Late clinical trials trials Approval How did I gain the skills? • Immunology, biochemistry, molecular biology • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record Academia Biotech. and Pharma. industry Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development What skills are required to do my job? Early clinical Late clinical trials trials Approval How did I gain the skills? • Immunology, biochemistry, molecular biology • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record Academia Biotech. and Pharma. industry 30+ Patents 60+ Publications Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development What skills are required to do my job? Early clinical Late clinical trials trials Approval How did I gain the skills? • Immunology, biochemistry, molecular biology • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record Pharma and Biotech industry Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development What skills are required to do my job? Early clinical Late clinical trials trials Approval How did I gain the skills? • Immunology, biochemistry, molecular biology • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record Biotech industry 30+ Patents, 60+ publications Kymab: Therapeutic monoclonal antibody company Life cycle: idea to clinic ~8 years Ideas Research Development Early clinical Late clinical trials trials 4 mAbs What skills are required to do my job? Approval Bosatria How did I gain the skills? • Immunology, biochemistry, molecular biology • Antibody generation, engineering, cell line development and manufacturing • Disease biology expertise • Clinical trials • IP, Fund raising, Bus. Dev. • Years of experience • Track record 30+ years Monoclonal antibodies in clinical trials Domantis – sold to GSK for £230M Biotechnology Industry Salary, Career path and career progression/promotion opportunities BSc PhD 0 – 4 years experience 0 – 4 years experience ~£18K - £35K ~£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