Hawaii Biotech, Inc.

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1 Hawaii Biotech, Inc. Biotechnology in Hawaii and the Workforce Requirements National Association for Workforce Improvement Slide 1

2 Education David Clements - Director of Vaccine Research UH Hilo BA Chemistry/Biology UH Manoa MS Biochemistry Slide 2

3 3 Career Path 30 years at Hawaii Biotech Research Assistant Research Associate Research Associate/Lab Manager Scientist Director of Molecular Biology and Cell Culture Director of Vaccine Research Slide 3

4 4 Slide 4

5 5 What is Biotechnology? Biotechnology is not a distinct discipline, it is a multidisciplinary field In biotechnology there are many different fields of study, such as: Animal Sciences Biochemical and Chemical Engineering Biochemistry Botany and Plant Sciences Cell Biology Genetics Immunology Microbiology Molecular biology Slide 5

6 6 The Original Biotechnology Selective breeding of crops and livestock One of the earliest activities of modern man Plant hybrids Cross breeding of select varieties or species Bread, cheese, and beer Earliest application of microbiology to improve products Slide 6

7 7 Biotechnology Industry Today More than $100 billion a year industry more than 200 drugs and vaccines already developed. More than 300 new biotech drugs and vaccines in development Treatments for cancer, Alzheimer s, heart disease, diabetes, AIDS, arthritis and many more Diagnostic tests keeps the blood supply safe from the AIDS virus, Hepatitis B and C viruses, Zika virus and West Nile virus Genetically engineered crops 10 million farmers in 18 countries grow genetically engineered crops Approximately 20 million acres plated each year Slide 7

8 8 Application of Biotechnology Environmental technology - pollution-eating bacteria used to clean up hazardous waste and oil spills Industrial technology enzymes (proteins) Used to make paper and textiles Used in food production Used in laundry detergents Forensic medicine DNA fingerprinting has dramatically improved criminal investigations like in CSI Archeology and anthropology Slide 8

9 9 Application of Biotechnology Recombinant DNA application to drugs Bacteria used for production Slide 9

10 10 Application of Biotechnology Recombinant DNA application to vaccines Yeast used for production Slide 10

11 11 Hawaii Biotech Privately held company Founded in 1982 by group of UH professors In business for 35 years Laboratories were in Aiea for 33 years, now located at Dole Cannery Hawaii Biotech s focus is on vaccines and small molecule drugs Vaccines under development West Nile, dengue, tick-borne encephalitis, Zika, malaria, Ebola, and Crimean-Congo hemorrhagic fever Drugs under development Anthrax and Botulinum toxin inhibitors, and flavivirus inhibitors Slide 11

12 Emerging Infectious Disease Dengue, Zika, and Chikungunya have spread globally in recent years Significant health and economic burden All spread by Aedes mosquitos Any State/Country with these mosquitos, such as Hawaii are at risk The Hawaii State Department of Health is taking proactive measures to keep Hawaii free of mosquitoborne diseases like Zika, dengue, and chikungunya Slide 12

13 13 Hawaii Biotech Most vaccines that we work on target human diseases that are carried by insects Slide 13

14 Hawaii Biotech - Vaccines 50 times more money spent treating disease than on finding ways to cure or prevent disease Development of vaccines offer a means of protection The World Health Organization estimates that immunizations prevent between 2-3 million deaths every year Hawaii Biotech provides years of experience in the subunit vaccine field A piece of protein from the virus surface used for vaccine Slide 14 Subunit Vaccine

15 15 Hawaii Biotech - Vaccines How do we do it? Resource Based Management Molecular Biology and Cell Culture Protein Biochemistry and Purification Immunology Clinical Trials Multiple disciplines (fields of study) required Slide 15

16 Hawaii Biotech - Vaccines Molecular Biology and Cell Culture Drosophila S2 Expression System DNA goes into cells Drosophila S2 Cells Drosophila Expression Vector phh-202 Protein Slide 16 Gene of protein subunit Cloned DNA Protein comes out of cells DENV WNV ZIKV TBEV OHFV AHFV KFDV CHIKV EBOV CCHFV RFV NIPV SFTSV SARS MERS

17 Hawaii Biotech - Vaccines Molecular Biology and Cell Culture Drosophila S2 Expression System Scaling up cells in the lab Frozen cells 1 ml 10 ml 5 days 50 ml 5 days 1000 ml 5 days 1 ml to 1000 ml in 15 days Slide 17 17

18 Hawaii Biotech - Vaccines Molecular Biology and Cell Culture Growth and Expression of S2 Cells Density (cells/ml) 4.0E E E E E E E E E+00 Wave Run 24 Den2.3.3 Growth Curve D2.3.3 Induction C C Day of culture Slide 18

19 Hawaii Biotech - Vaccines Protein Biochemistry and Purification Purified Target Protein A series of steps are required to arrive at a purified product Slide 19

20 Hawaii Biotech - Vaccines Slide 20

21 21 Product Development What does it take to move an idea from concept to the market? Time, Money and a lots of hard work What is the typical path taken? Research Optimization and Proof of Concept Preclinical Development Phase 1 Clinical Phase 2 Clinical Phase 3 Clinical Slide 21

22 22 Product Development How long does it take to bring a product to the market? Research Optimization and Proof of Concept Preclinical Development Phase 1 Clinical Phase 2 Clinical Phase 3 Clinical 2-3 years 2-3 years 2-3 years 1 year 1-2 years 1-3 years Total time 9 to 14 years! If not longer! Slide 22

23 Product Development How much does it cost to bring a product to the market? Research Optimization and Proof of Concept Preclinical Development Phase 1 Clinical Phase 2 Clinical Phase 3 Clinical 2-5 million 2-5 million 5-10 million 3-5 million 5-20 million million Total cost $ 37 to 145 Million! Slide 23

24 24 Product Development Development of a West Nile Vaccine Research Optimization and Proof of Concept Preclinical Development Phase 1 Clinical Phase 2 Clinical Phase 3 Clinical IND 2007 First Patient Enrolled 2009 Next Major study??? Slide 24

25 25 Product Development West Nile Vaccine IND (Investigational New Drug Application) 18 volumes Approximately 8,000 pages Slide 25

26 26 Jobs in Biotechnology Animal Caretaker Animal Technician Bioinformatics Specialist Clinical Research Associate Documentation Coordinator Forensic DNA Analyst Greenhouse and Field Technician Greenhouse and Field Worker Health and Safety Specialist Instrumentation Technician Statistician Laboratory Assistant Laboratory Automation Specialist Laboratory Support Worker Laboratory Technician Manufacturing Assistant Manufacturing Technician Material Handler Quality Assurance Specialist Quality Control Technician Research Associate Sales Representative Scientist Technical Service Representative This is only a sampling there are many more job types Slide 26

27 27 Jobs in Biotechnology Biotechnology covers a large number of disciplines (fields of study) These disciplines offer a wide variety of possible career paths allowing the opportunity to explore many scientific areas There are some entry level positions that require only a high school education. On the job training. As the field is science based, a Bachelor's Degree, Master s Degree or Ph.D. Degree is generally required. Slide 27

28 28 Jobs in Biotechnology Most jobs areas have 4 step grades Research Associate level 1 - $35,000 to $45,000 level 2 - $40,000 to $55,000 level 3 - $50,000 to $70,000 level 4 - $65,000 to $85,000 Scientist level 1 - $70,000 to $80,000 level 2 - $80,000 to $100,000 level 3 - $95,000 to $125,000 level 4 - $105,000 to $150,000 For more details check out salary.com Slide 28

29 29 Jobs in Biotechnology Typical Job Description Research Associate Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Requires a bachelor's degree and 0-2 years of direct experience in the field. Familiar with a variety of the field's concepts, practices, and procedures. Relies on limited experience and judgment to plan and accomplish goals. Performs a variety of tasks. A certain degree of creativity and latitude is expected. Typically reports to a supervisor or manager. Slide 29

30 30 Jobs in Biotechnology HBI in Employees Title Title 1 RA I 31 ROS VP 2 RA II 32 RA I 3 S1 33 RA II 4 COO 34 RA I 5 Purchasing Mgr. 35 RA II 6 ROS RA I 36 Director, lead Discovery 7 RA I 37 Receptionist 8 Project Mgr. I 38 ROS S II 9 Group Leader 39 Director, Protein Biochem 10 Sr. Project Mgr. 40 S III 11 Sr. RA 41 Part-time 12 Project Mgr. II 42 RA II 13 Sr. RA 43 RA II 14 RA II 44 S II 15 ROS S I 45 RA II 16 Controller 46 General Counsel (PT) 17 Research Planner 47 Part-time 18 Sr. Director Admin 48 RA III 19 Accounts Payable Admin 2 49 IT Manager 20 Accounting Mgr Sr. RA 21 ROS S1 51 Sr. RA 22 S1 52 S I 23 Chemistry Direcor 53 CEO/President 24 Facilities Assistant 54 Project Manager I 25 ROS Director 55 Sr. VP 26 S1 56 RA II 27 S1 57 RA III 28 Group Leader 29 Audit Manager 30 RA II Slide 30 HBI in Employees Current Goal is to add 10 new positons by 2020

31 Jobs in Biotechnology Last science hire in 2016 RA 4 or Sci 1 Posted job on February 22 nd Total of 55 qualified applicants 1 st cut down to 15 3 selected for follow up interviews, end of April Senior management had concerns about fit Random application from local candidate, mid-may Local candidate hired, started July 7 th Slide 31

32 Jobs in Biotechnology The High Technology Development Corporation (HTDC) announced 80/80 plan Goal is to create 80,000 new technology and creative industry jobs earning $80,000 in Hawaii by 2030 Currently 50% of HBI employees are >$80,000 Slide 32

33 Jobs in Biotechnology Hawaii Biotech participates in science education efforts to promote awareness of science and technology jobs UH Honors Biology Program HPU and 2011 Science Tech Day Pearl City HS Career Day Moanalua HS STEM program UH MHIRT program Slide 33

34 Jobs in Biotechnology Kapiolani Community College has a Biotechnician Certificate of Achievement program Prepares students for entry-level employment in the biotechnology Students learn basic laboratory skills, equipment operation and maintenance, quality control, safety and good manufacturing practices Meets the needs of Hawai i and the Nation for a trained workforce in the biotechnology industry Also serves as the core pathway to other 2 and 4 year degrees in the sciences Slide 34

35 THANK YOU Vaccines