Word count: DESIGNER BABIES The world ́s genetically edited Babies Dang Thuy Ly Pham | 1072562 Managing Technology by Dr. Sandra L. Fisher|FH Münster, Summer Semester 2021
2 Table of Contents Glossary........................................................................................................................................................3 1Introduction.........................................................................................................................................4 2Designer Baby: Description and Evaluation of Current State..................................................................5 2.1 Overview of technologies being used............................................................................................................5 2.1.1 Preimplantation Genetic Diagnosis (PGD)..............................................................................................5 2.1.2 Transcription Activator-Like Effector (TALENs)......................................................................................5 2.1.3 Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9).........................................5 2.1 World ́s first gene-edited babies....................................................................................................................7 2.2.1 Benefits vs. unwanted risks....................................................................................................................7 3Application of Course Concepts.............................................................................................................8 3.1 Technology Adoption and Diffusion...............................................................................................................8 3.1.1 Technology Acceptance Model (TAM)...................................................................................................9 3.2 Types of Innovation........................................................................................................................................9 3.2.1 Architectural vs. Component Innovation.............................................................................................10 3.2.2 Product vs. Process Innovation............................................................................................................10 3.2.3 Radical vs. Continuous Innovation.......................................................................................................10 3.3 Gartner ́s Hype Cycle....................................................................................................................................11 3.4 S-Curves in technological improvement.......................................................................................................12 3.5Project Portfolio: Innovation Ambition Matrix (S.6, 27 May)..............................................................13 4Recommendations and Conclusion......................................................................................................13 Reference list...............................................................................................................................................17 Ehrentwörtliche Erklärung bei allen schriftlichen Arbeiten...........................................................................18
3 Glossary Clustered regularly interspaced short palindromic repeats - CRISPR-associated protein 9 (CRISPR-Cas 9) A new approach to genome editing allows scientists to modify any part of the human genome (Genetics Home Reference, 2020). Designer baby (aka genetically modified baby) The term “designer baby” refers to one whose genetic makeup has been modified or selected to provide the desired genome (Cambridge Advanced Learner ́s Dictionary & Thesaurus, n.d.). Genome editing (aka gene editing) A group of technologies that allow scientists to change the genetic code (DNA) (Genetic Home Reference, 2020). Human Germline Engineering The process by which the genome of a human being is edited (Cambridge Advanced Learner ́s Dictionary & Thesaurus, n.d.). In vitro fertilization (IVF) “IVF is a process of fertilization where an egg is combined with sperm outside the body, in vitro ("in glass")”(Wikipedia,2021). Off-target effects Undesired side effects that might occur when using CRISPR-Cas9 which additionally may lead to serious consequences.
4 1Introduction Humans are trying to take the genetic scepter into their own hands to shape themselves according to their own will. With the help of technology, people can shape not only their environment but increasingly themselves. Healthier, more intelligent, and more powerful people could be the result of gene modification. Nothing stands in the way of the 'mechanization' of the brain. Genome editing allows scientists the ability to change genetic material (DNA). These technologies give scientists the ability to add, remove or alter an organism's DNA at certain locations in the genome (Genetics Home Reference, 2020). Multiple editing techniques have been developed and in May 2012, a French microbiologist Emmanuelle Charpentier and her American colleague Jennifer Doudna had described their “invention” of CRISPR-Cas as a new approach to genome editing in a scientific publication. The two researchers have used a defense strategy of bacteria against phages to cut human DNA at certain locations, which enables targeted editing of (not only) the human genome. The new tool allows scientists to modify any part of the human genome and therefore, the reality of having designed babies is closer than ever (Leidford & Callaway, 2020). Designer babies, also known as genetically modified babies are the results of many years of Research and Development in in vitro fertilization (IVF) technology. One of the main goals of genetic research in humans is to combat previously incurable diseases, such as certain types of cancer or HIV. In addition, new techniques such as the gene scissors Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) can contain or completely avoid risks of diseases or damage at the embryonic development stage in the future. In addition, the CRISPR-Cas9 system offers possibilities for influencing characteristics, appearance, and intelligence. Although the idea of a designer baby sounds tempting, as with any technology there are some key issues involved. Human Germline Engineering is a controversial topic. Besides ethical concerns, there are also very practical problems. So far, researchers agree that the technology is still too error-prone and risky to be tried out on humans. The controversial discussion on the concept of designer babies has provoked several debates on the ethics of genetic manipulation and the future of genetics. The purpose of this paper is to evaluate the current situation of the creation of designer babies and analyze its technology by applying relevant concepts provided in the course “Managing Technology” by Professor Dr Sandy L. Fisher. In particular, it will discuss the costs and efficiency of the different techniques used in the creation of designer babies and what is unique about CRISPR. In detail, the paper sets CRISPR-Cas 9 in the context of the biotechnology and creation of designer babies while analyzing the applied class concepts to obtain insight into its innovation processes and to illustrate its potential for the future. It will also debate controversial opinions by assessing various risks and
5 benefits of the technology. Based on the research and analysis, a recommendation for how the creation of designer babies using CRISPR Cas9 can be moved forward in development, and the market will be made. 2Designer Baby: Description and Evaluation of Current State 2.1 Overview of technologies being used Multiple methods are being used in the creation of a Designer Baby. As of right now, three technologies have been developed to create designer babies. In all cases, fertilized eggs are manipulated before in-vitro fertilization. 2.1.1 Preimplantation Genetic Diagnosis (PGD) The first one is called Preimplantation Genetic Diagnosis. This is the simples and the only legal method of all three. It is not associated with gene editing. Instead, it involves choosing among viable eggs and decide for the one that best meets the parent ́s desire. It can be used, for example, to eliminate diseases or even to pre-determine gender (ivfcentreinindia, n.d.). 2.1.2 Transcription Activator-Like Effector (TALENs) The second technique is called TALENs which Stands for Transcription Activator-Like Effector Nucleases and is associated with gene editing. TALENs are enzymes that can be constructed to cut out specific sections of DNA strands. They then take over a certain part, so that edits can be made. In theory, TALENs can target any section of DNA (New England Biolabs, 2019). 2.1.3 Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR-Cas9) The third technology is also a gene-editing tool which is the CRISPR-Cas9 system. As mentioned before in Chapter 1, this is a new technology that allows scientists and other researchers in medical fields to modify, delete or correct specific areas of human DNA. It is a process that was found in the 1980s in the DNA sequence of certain bacteria. Their DNA involves snippets of DNA viruses that previously infected them which help them to recognize any threats in the future. The evolution of genetic technology is called CRISPR-Cas9. The technique has been replicated to support the modification of other DNA strands (Chen, 2017).
6 In particular, there are two methods how to use CRISPR-Cas 9 to create designer babies. Assuming that the egg is healthy while the sperm has a mutation in its DNA, scientists have now two options to use CRISPR-Cas 9 to edit the genes. The first technique involves editing genes after fertilization. Sometimes mutant genes escaped editing when eggs had already copied the DNA, leading to an embryo with edited and unedited cells, also known as patchwork or mosaic embryo. Today, scientists have learned to avoid mosaic embryos by adding the CRISPR-Cas9 gene editor during fertilization instead of after. The new technique involves injecting CRISPR-Cas 9 along with sperm which repairs the mutation before DNA replicates. That led to an embryo with all healthy cells. For the first time scientist have corrected a disease-causing mutation in early-stage human embryos with the CRISPR Cas9 system. This prevents the disease-causing mutation to pass on to future generations (vcmsht, 2017). Despite only one of these methods being legally used at the moment, many options are available for parents. Their eggs can be modified for gender, appearance, personality, intelligence, and disease (ivfcentreinindia, n.d.). 2.1 World ́s first gene-edited babies As of right now, it is still illegal to create designer babies using CRISPR-Cas9. Nevertheless, a Chinese biophysicist showed that it is possible. On 28 November 2018, the Chinese biophysicist He Jiankui announced at a symposium in Hong Kong that he had created human embryos through artificial insemination and had previously modified their genetic material with the help of the CRISPR-Cas9 gene scissors. He had the embryos implanted in the biological mothers, who then carried the babies to term. Two twin sisters had already been born when He Jiankui made his procedure public. He has already manipulated the genetic material before the sperm and egg cell are joined, to create a modified, new genetic material. If these children conceived in this way were to have children of their own, they would pass on the altered genetic material to them. As far as it is known, He Jiankui has thus created the world's first designer babies (He, 2018). 2.2.1 Benefits vs. unwanted risks Genome editing, especially CRISPR, reduces the problems that arise from the randomness of breeding. This means time and cost savings, but also more safety through greater precision. All breeding alters genes, but only the new genome editing methods know the details of these alterations, which makes them fundamentally different from conventional breeding, but also genetic engineering (Transparenz Gentechnik, 2021).
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