The Bright Line: Understanding the Scope and Limitations of Bioscience

by David Dyer Ph.D.

In his 2007 letter titled “Our Biotech Future,” physicist and futurist Freeman Dyson envisioned a world where biotechnology infiltrates all aspects of human existence. From trees that generate power for homes to designer plants, animals, and people, Dyson believed the trend of biotechnology would lean toward commercialization and decentralization, much as computers have moved away from large centralized systems toward PCs and other personal electronics. Then, the idea that biotechnology applications should follow such a trend may have seemed like pure science fiction. Not now.

In July 2017, U.S. researchers successfully edited the genes of 167 human embryos to remove a mutation coding for a hereditary heart condition known as hypertrophic cardiomyopathy. This application of the gene-editing technology known as CRISPR-Cas9 stunned the world’s medical communities, not only for its successful outcome, but also for crossing the ethical “bright line” of applying gene-editing technology to humans. We now live in an age where biotechnology affects practically every aspect of our lives, including food supply, medical therapeutics, energy production, and environmental remediation. Diseases such as Hepatitis C can now actually be cured (a term not taken lightly in the medical science community), and other viral diseases, including HIV and HSV, are moving down the same path. Top innovations for 2016 included smart contact lenses for detection of glaucoma, diabetes, and hypertension; prosthetics that provide sensory feedback; autonomous wheelchairs; and affordable, personalized genome sequencing.

This flurry of innovation has triggered a steady expansion of companies and jobs in biopharma, medical devices, medical testing and research, high-tech manufacturing, and agriculture—the five industry sectors of the bioscience business community. According to the 2017 California Life Sciences Industry annual report, our state is home to 3,040 life sciences companies (192 more than last year) that employ more than 287,000 people. This highly trained workforce has developed novel drugs (1,269 currently in the FDA approval pipeline), devices and diagnostics (264 devices approved in 2015-16), and applications of biotechnology to produce sustainable energy. These companies produced more than $147 billion in revenue, received $4.4 billion in venture capital funding, and drove $22 billion in exports. The counties of Los Angeles and Orange boast approximately one-third of the total California-based bioscience companies, making it the second-largest bioscience business cluster in the United States, and analysts expect this trend of productivity and growth in local and national businesses to continue.

Many factors must work in tandem to support this rapid expansion, with academic excellence leading the way. A well-trained, highly educated workforce is essential to virtually all operations in this sector. Effective leaders in this area require training in the science underpinning the sector and in critical business-related skills, such as project management, scientific communication, teamwork, and regulatory affairs.

The new Master of Science in Biotechnology at Azusa Pacific does just that. The program trains future leaders in the biopharmaceutics and medical device business sectors and provides knowledge and skills in key aspects of biopharmaceutical drug development from early discovery to clinical application, focusing on informatics and biostatistics, clinical trials, project management, and regulatory affairs.

Above all, APU’s program integrates faith-based, business-related bioethics into the curriculum. Further, the applied-learning approach enables students to gain practical experience through internships and master’s degree projects with APU’s industrial partners, working among teams of professionals. Such partner companies include Gilead Sciences, Grifols Biologicals Inc., Shire Pharmaceuticals, Johnson & Johnson Biopharma, and Covidien Medtronic. In this mutually beneficial arrangement, students receive practical experience and greatly expand their professional contacts, the university builds relationships that can lead to productive collaborations on other projects, and partner companies benefit from graduate student work on problems and projects that might otherwise remain incomplete due to time and staffing limitations—and also gain a conduit for future employees.

As this emerging field continues its expansion into unknown areas of science, medicine, and ethics, Azusa Pacific stands at the forefront, producing leaders prepared to make scientifically sound, ethically informed decisions that will help apply a God-honoring framework to the rapidly expanding field of clinical biotechnology.

This rapidly advancing field of biotechnology has yielded some of the world’s greatest innovations. A few highlights include:

  1. CRISPR-Cas9 gene editing for precise selection and replacement of individual genes
  2. Gilead Sciences’ hepatitis C virus (HCV)cure Harvoni™
  3. Personal genomics with affordable high-throughput DNA sequencing (e.g., Veritas Genomics and others)
  4. Medtronic’s creation of the world’s first artificial pancreas
  5. Glaucoma-detectingcontact lenses (SENSIMED Triggerfish)