Understanding Bioscience
 |
Description
Book Introduction
In 2017, 『Understanding Bioscience - Focusing on Korea's New Drug Development Biotechnology』 was published.
It was the first book by Biospectator, a specialized media outlet for the biopharmaceutical industry, primarily composed of reporters who majored in life sciences.
To mark the first anniversary of its launch, we set a goal of interpreting the Korean new drug development scene from a scientific perspective based on information analyzed over the past year, and attempted to explain it in a way that even non-specialist readers could understand.
Since its publication, the book has received an unexpected response, not only from industry and academia surrounding the biopharmaceutical industry, but also from non-specialist general readers interested in the field, and even being used as a supplementary textbook for high school life sciences.
However, in 2019, just two years later, it was decided to go out of print after the 9th edition.
Although only two years have passed, the science behind new drug development has rapidly evolved, and it was decided that a longer-term plan was needed to prepare the book.
After four years of preparation, planning, writing, and editing, the revised second edition was published in 2023.
The original 368 pages were quite a lot, but in the revised second edition, they increased to 648 pages.
It covers the trends and developments in new drug development research around the world and the proof of concept for 74 drugs that have successfully obtained marketing approval from regulatory agencies.
We also analyzed data from clinical trials currently underway or scheduled to be conducted as of the second half of 2023.
During this process, we reviewed over 380 data sets, including papers, and went through the process of re-verifying and organizing the contents of countless articles published in Biospectator.
If the first edition was a book introducing and explaining Korean pharmaceutical companies and biotechnology, the revised second edition is a book that analyzes and understands Korean pharmaceutical companies and biotechnology, which have overcome the frustrations and failures that occurred during that time and are continuing to take on challenges.
This is how 『Understanding Bioscience - Focusing on Korea's New Drug Development Biotechnology』 was published.
It was the first book by Biospectator, a specialized media outlet for the biopharmaceutical industry, primarily composed of reporters who majored in life sciences.
To mark the first anniversary of its launch, we set a goal of interpreting the Korean new drug development scene from a scientific perspective based on information analyzed over the past year, and attempted to explain it in a way that even non-specialist readers could understand.
Since its publication, the book has received an unexpected response, not only from industry and academia surrounding the biopharmaceutical industry, but also from non-specialist general readers interested in the field, and even being used as a supplementary textbook for high school life sciences.
However, in 2019, just two years later, it was decided to go out of print after the 9th edition.
Although only two years have passed, the science behind new drug development has rapidly evolved, and it was decided that a longer-term plan was needed to prepare the book.
After four years of preparation, planning, writing, and editing, the revised second edition was published in 2023.
The original 368 pages were quite a lot, but in the revised second edition, they increased to 648 pages.
It covers the trends and developments in new drug development research around the world and the proof of concept for 74 drugs that have successfully obtained marketing approval from regulatory agencies.
We also analyzed data from clinical trials currently underway or scheduled to be conducted as of the second half of 2023.
During this process, we reviewed over 380 data sets, including papers, and went through the process of re-verifying and organizing the contents of countless articles published in Biospectator.
If the first edition was a book introducing and explaining Korean pharmaceutical companies and biotechnology, the revised second edition is a book that analyzes and understands Korean pharmaceutical companies and biotechnology, which have overcome the frustrations and failures that occurred during that time and are continuing to take on challenges.
This is how 『Understanding Bioscience - Focusing on Korea's New Drug Development Biotechnology』 was published.
- You can preview some of the book's contents.
Preview
index
Introduction 005
Part 1 Artificial Intelligence (AI)
01.
Artificial Intelligence in Medical Diagnosis (AI) 019
02. AI Drug Discovery (Artificial Intelligence Drug Discovery) 063
Part 2 antibody treatment
03.
Bispecific Antibody 091
04.
Antibody-Drug Conjugate 121
05.
Biosimilar 159
Part 3 Immunotherapy
06.
Immune Checkpoint Inhibitor 191
07. CAR-T cell therapy (Chimeric Antigen Receptor T cellTherapy) 237
Part 4 RNA therapeutics
08.
mRNA(messenger RNA) 291
09. RNAi & ASO (RNA interference & Antisense Oligonucleotide) 323
Part 5 Gene Therapy
10.
Adeno-associated virus & lentivirus
(AAV[adeno-associated virus] & Lentivirus) 371
11.
Gene Editing 411
Part 6: Concepts made possible
12.
Obesity Treatment 449
13.
Non-alcoholic Steatohepatitis Treatment 483
14.
Alzheimer's Disease Treatment 523
Part 7 and Exploration
15.
Targeted Protein Degradation 573
16.
Microbiome 609
17.
Digital Therapeutics (DTx) 631
Part 1 Artificial Intelligence (AI)
01.
Artificial Intelligence in Medical Diagnosis (AI) 019
02. AI Drug Discovery (Artificial Intelligence Drug Discovery) 063
Part 2 antibody treatment
03.
Bispecific Antibody 091
04.
Antibody-Drug Conjugate 121
05.
Biosimilar 159
Part 3 Immunotherapy
06.
Immune Checkpoint Inhibitor 191
07. CAR-T cell therapy (Chimeric Antigen Receptor T cellTherapy) 237
Part 4 RNA therapeutics
08.
mRNA(messenger RNA) 291
09. RNAi & ASO (RNA interference & Antisense Oligonucleotide) 323
Part 5 Gene Therapy
10.
Adeno-associated virus & lentivirus
(AAV[adeno-associated virus] & Lentivirus) 371
11.
Gene Editing 411
Part 6: Concepts made possible
12.
Obesity Treatment 449
13.
Non-alcoholic Steatohepatitis Treatment 483
14.
Alzheimer's Disease Treatment 523
Part 7 and Exploration
15.
Targeted Protein Degradation 573
16.
Microbiome 609
17.
Digital Therapeutics (DTx) 631
Into the book
The use of AI is also very helpful in diagnosing lung cancer.
Chest X-rays are used to diagnose lung cancer.
Chest X-ray images are often the first thing used when lung cancer is suspected, and are known to be useful in determining the overall extent of the disease or observing changes.
Runit conducted joint research with the University of Edinburgh.
This was a study to detect lung cancer using video images using a total of 1,960 chest X-ray data in which 10 major lung diseases, including pneumonia, pulmonary fibrosis, and pneumothorax, were observed.
The results of Lunit INSIGHT CXR, Lunit's AI solution, were compared with the results of radiologists, and the reading level of Lunit INSIGHT CXR was found to be similar to the reading accuracy of radiologists with more than 20 years of experience who participated in the study.
--- p.25~26
However, dual antibodies can simplify the complexity of CAR-T cell therapy.
If one side of the bispecific antibody captures T cells in a cancer patient's body, and the other side captures cancer cells and allows the T cells to eliminate the cancer cells, then simply administering the bispecific antibody to the patient could achieve the results that CAR-T cell therapy is aiming for.
However, there is no need to spend as much money on production as CAR-T cell therapy.
Although the process of making dual antibody therapies is not simple, they can be produced more quickly and at a lower cost than CAR-T cell therapies, allowing them to be administered to patients.
Dual antibody treatments can be prescribed to patients for approximately $355,500 to $395,000.
It is possible to administer drugs directly in the form of pharmaceuticals without going through the costs and processes that burden medical staff, patients, and companies.
Additionally, bispecific antibodies can be a realistic treatment alternative in cases where it is difficult to obtain sufficient immune cells to serve as raw materials for CAR-T cell therapy from the blood of cancer patients with rapidly weakened immune systems.
--- p.103~104
The conjugate of the antibody and the chemotherapy drug is absorbed into the cancer cell (internalization).
Antibodies are absorbed into the cell while bound to cell membrane receptors, which is how cells accept foreign substances.
The combination of antibodies and chemotherapy drugs encounters lysosomes, which act as trash cans inside cells.
The linker that connects the antibody and the chemotherapy drug has a peptide structure. When the proteolytic enzyme (proteasome) in the lysosome decomposes the peptide linker, the chemotherapy drug attached to the antibody, i.e. the toxic substance (toxin), is released.
And this toxic substance destroys cancer cells. ADCs treat cancer.
--- p.126
As PD-1 immune checkpoint inhibitors become a part of the treatment of metastatic cancer, there is now a movement to treat earlier-stage cancers.
When we say early stage cancer, we are talking about the time before or after the patient has had the cancer removed through surgery.
Trials testing the efficacy of PD-1 and PD-L1 immune checkpoint inhibitors in early-stage cancer began in the mid-2010s, but only a few dozen have been conducted.
The number of cases has been rapidly increasing, reaching 179 in 2019 and 249 in 2020.
It is mainly tested in non-small cell lung cancer, breast cancer, esophageal cancer, and melanoma, and has also shown benefits in clinical settings.
This is because administering immune checkpoint inhibitors can reduce the size of the tumor before surgery, increase T cells that recognize a wider variety of cancer antigens, prevent the cancer from metastasizing to other sites, and create long-term memory immunity, thereby reducing the risk of recurrence.
That is, to some extent, it includes the concept of preventing cancer.
However, in the case of early-stage cancer, surgery alone can be sufficient to remove the cancer, so there is a problem of deciding whether it is better to postpone the most effective surgery and administer medication.
This is because side effects from drug administration must also be considered.
--- p.210
CAR-T cell therapy is fundamentally changing the treatment of blood cancers. This novel treatment concept has demonstrated complete remission (CR) rates approaching 80-90%.
And it is increasing patient survival (OS) to an unprecedented level in the history of cancer treatment development.
What matters to patients is not just the immediate removal of the cancer mass, but also how long they can survive after treatment. While CAR-T cell therapy is difficult to produce and expensive, medical professionals have no choice but to administer it to patients.
--- p.249
In a practical sense, the mRNA vaccines developed by Moderna and BioNTech were the first to succeed in developing a COVID-19 vaccine.
Moderna and BioNTech's vaccine consists of mRNA that expresses the protein antigen of the COVID-19 virus and lipid nanoparticles (LNPs) that can deliver the mRNA into human cells.
Drug stability has been a challenge in the development of mRNA drugs.
Since mRNA can only function when it enters cells, the mRNA drug administered into the body must be safely delivered into the cells.
The medium that transports the necessary substances to the destination is called a carrier.
The reason Robert Malone of the Salk Institute chose liposomes as carriers in 1978 was that liposomes were
This is because it was made up of a phospholipid bilayer that mimics the human cell membrane.
And LNPs, which have a more advanced form than liposomes and have high stability, have been developed.
Originally, LNPs were developed to deliver another type of RNA drug, small interfering RNA (siRNA).
--- p.300
In 2021, semaglutide began to be prescribed under the name WEGOVY®, and within five weeks of its introduction, it surpassed Saxenda in terms of prescriptions. While obesity treatments utilizing the GLP-1 mechanism have shown significant results, this alone is not enough.
Obesity is a chronic disease that occurs when the homeostasis that maintains body weight is disrupted.
And the treatment for chronic diseases does not restore homeostasis itself, but administers drugs that can maintain homeostasis.
In other words, it must be taken for a long time, like blood pressure medication or diabetes medication, and there should be no side effects or problems caused by it.
The reason most existing obesity treatments were phased out was because of side effects.
For example, if you lose weight, problems such as worsening blood vessels may occur.
In the case of obese patients, most patients die from cardiovascular disease.
Therefore, it must be proven that losing weight can reduce risk factors such as heart attack and stroke.
Otherwise, it will end up being just a weight loss drug.
--- p.468
Novo Nordisk is developing a NASH treatment using a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a hormone secreted by enteroendocrine L cells when food enters the intestines. GLP-1 stimulates insulin secretion, which in turn promotes energy storage in the body.
When insulin is released from the beta cells of the pancreas, glucose and fatty acids are stored in muscles, liver, and fat cells, lowering blood sugar levels.
GLP-1 also suppresses the secretion of glucagon (GCG), which has an opposing effect to insulin. GCG increases blood sugar levels by breaking down stored glycogen into glucose.
For this reason, the development of diabetes treatments that utilize the GLP-1 mechanism is active.
And GLP-1 receptor (GLP-1R) agonists that activate the action of GLP-1 are prescribed as treatments for type 2 diabetes and obesity.
--- p.497~498
Protofibrils (75–5,000 kDa) are the precursors of amyloid beta plaques.
When amyloid beta proteins, which are sticky monomers, clump together, they form toxic small oligomeric aggregates (9–75 kDa).
As these oligomers combine, they form protofibrils.
Up to this stage, it is soluble in blood.
If they clump together further, they form insoluble fibrils and then amyloid beta plaques.
Aducadumab does not recognize monomers, but is selective from the toxic oligomeric phase to plaque forms.
That is, it prevents toxic amyloid beta proteins from clumping together to form plaques.
But rather than trying to bind to all the different forms, wouldn't it be possible to develop more effective treatments if we could better recognize the specific amyloids associated with Alzheimer's disease?
Chest X-rays are used to diagnose lung cancer.
Chest X-ray images are often the first thing used when lung cancer is suspected, and are known to be useful in determining the overall extent of the disease or observing changes.
Runit conducted joint research with the University of Edinburgh.
This was a study to detect lung cancer using video images using a total of 1,960 chest X-ray data in which 10 major lung diseases, including pneumonia, pulmonary fibrosis, and pneumothorax, were observed.
The results of Lunit INSIGHT CXR, Lunit's AI solution, were compared with the results of radiologists, and the reading level of Lunit INSIGHT CXR was found to be similar to the reading accuracy of radiologists with more than 20 years of experience who participated in the study.
--- p.25~26
However, dual antibodies can simplify the complexity of CAR-T cell therapy.
If one side of the bispecific antibody captures T cells in a cancer patient's body, and the other side captures cancer cells and allows the T cells to eliminate the cancer cells, then simply administering the bispecific antibody to the patient could achieve the results that CAR-T cell therapy is aiming for.
However, there is no need to spend as much money on production as CAR-T cell therapy.
Although the process of making dual antibody therapies is not simple, they can be produced more quickly and at a lower cost than CAR-T cell therapies, allowing them to be administered to patients.
Dual antibody treatments can be prescribed to patients for approximately $355,500 to $395,000.
It is possible to administer drugs directly in the form of pharmaceuticals without going through the costs and processes that burden medical staff, patients, and companies.
Additionally, bispecific antibodies can be a realistic treatment alternative in cases where it is difficult to obtain sufficient immune cells to serve as raw materials for CAR-T cell therapy from the blood of cancer patients with rapidly weakened immune systems.
--- p.103~104
The conjugate of the antibody and the chemotherapy drug is absorbed into the cancer cell (internalization).
Antibodies are absorbed into the cell while bound to cell membrane receptors, which is how cells accept foreign substances.
The combination of antibodies and chemotherapy drugs encounters lysosomes, which act as trash cans inside cells.
The linker that connects the antibody and the chemotherapy drug has a peptide structure. When the proteolytic enzyme (proteasome) in the lysosome decomposes the peptide linker, the chemotherapy drug attached to the antibody, i.e. the toxic substance (toxin), is released.
And this toxic substance destroys cancer cells. ADCs treat cancer.
--- p.126
As PD-1 immune checkpoint inhibitors become a part of the treatment of metastatic cancer, there is now a movement to treat earlier-stage cancers.
When we say early stage cancer, we are talking about the time before or after the patient has had the cancer removed through surgery.
Trials testing the efficacy of PD-1 and PD-L1 immune checkpoint inhibitors in early-stage cancer began in the mid-2010s, but only a few dozen have been conducted.
The number of cases has been rapidly increasing, reaching 179 in 2019 and 249 in 2020.
It is mainly tested in non-small cell lung cancer, breast cancer, esophageal cancer, and melanoma, and has also shown benefits in clinical settings.
This is because administering immune checkpoint inhibitors can reduce the size of the tumor before surgery, increase T cells that recognize a wider variety of cancer antigens, prevent the cancer from metastasizing to other sites, and create long-term memory immunity, thereby reducing the risk of recurrence.
That is, to some extent, it includes the concept of preventing cancer.
However, in the case of early-stage cancer, surgery alone can be sufficient to remove the cancer, so there is a problem of deciding whether it is better to postpone the most effective surgery and administer medication.
This is because side effects from drug administration must also be considered.
--- p.210
CAR-T cell therapy is fundamentally changing the treatment of blood cancers. This novel treatment concept has demonstrated complete remission (CR) rates approaching 80-90%.
And it is increasing patient survival (OS) to an unprecedented level in the history of cancer treatment development.
What matters to patients is not just the immediate removal of the cancer mass, but also how long they can survive after treatment. While CAR-T cell therapy is difficult to produce and expensive, medical professionals have no choice but to administer it to patients.
--- p.249
In a practical sense, the mRNA vaccines developed by Moderna and BioNTech were the first to succeed in developing a COVID-19 vaccine.
Moderna and BioNTech's vaccine consists of mRNA that expresses the protein antigen of the COVID-19 virus and lipid nanoparticles (LNPs) that can deliver the mRNA into human cells.
Drug stability has been a challenge in the development of mRNA drugs.
Since mRNA can only function when it enters cells, the mRNA drug administered into the body must be safely delivered into the cells.
The medium that transports the necessary substances to the destination is called a carrier.
The reason Robert Malone of the Salk Institute chose liposomes as carriers in 1978 was that liposomes were
This is because it was made up of a phospholipid bilayer that mimics the human cell membrane.
And LNPs, which have a more advanced form than liposomes and have high stability, have been developed.
Originally, LNPs were developed to deliver another type of RNA drug, small interfering RNA (siRNA).
--- p.300
In 2021, semaglutide began to be prescribed under the name WEGOVY®, and within five weeks of its introduction, it surpassed Saxenda in terms of prescriptions. While obesity treatments utilizing the GLP-1 mechanism have shown significant results, this alone is not enough.
Obesity is a chronic disease that occurs when the homeostasis that maintains body weight is disrupted.
And the treatment for chronic diseases does not restore homeostasis itself, but administers drugs that can maintain homeostasis.
In other words, it must be taken for a long time, like blood pressure medication or diabetes medication, and there should be no side effects or problems caused by it.
The reason most existing obesity treatments were phased out was because of side effects.
For example, if you lose weight, problems such as worsening blood vessels may occur.
In the case of obese patients, most patients die from cardiovascular disease.
Therefore, it must be proven that losing weight can reduce risk factors such as heart attack and stroke.
Otherwise, it will end up being just a weight loss drug.
--- p.468
Novo Nordisk is developing a NASH treatment using a glucagon-like peptide-1 (GLP-1) receptor agonist. GLP-1 is a hormone secreted by enteroendocrine L cells when food enters the intestines. GLP-1 stimulates insulin secretion, which in turn promotes energy storage in the body.
When insulin is released from the beta cells of the pancreas, glucose and fatty acids are stored in muscles, liver, and fat cells, lowering blood sugar levels.
GLP-1 also suppresses the secretion of glucagon (GCG), which has an opposing effect to insulin. GCG increases blood sugar levels by breaking down stored glycogen into glucose.
For this reason, the development of diabetes treatments that utilize the GLP-1 mechanism is active.
And GLP-1 receptor (GLP-1R) agonists that activate the action of GLP-1 are prescribed as treatments for type 2 diabetes and obesity.
--- p.497~498
Protofibrils (75–5,000 kDa) are the precursors of amyloid beta plaques.
When amyloid beta proteins, which are sticky monomers, clump together, they form toxic small oligomeric aggregates (9–75 kDa).
As these oligomers combine, they form protofibrils.
Up to this stage, it is soluble in blood.
If they clump together further, they form insoluble fibrils and then amyloid beta plaques.
Aducadumab does not recognize monomers, but is selective from the toxic oligomeric phase to plaque forms.
That is, it prevents toxic amyloid beta proteins from clumping together to form plaques.
But rather than trying to bind to all the different forms, wouldn't it be possible to develop more effective treatments if we could better recognize the specific amyloids associated with Alzheimer's disease?
--- p.540
Publisher's Review
This book is divided into seven major topics: 'Artificial Intelligence (AI),' 'Antibody Therapy,' 'Immuno-Oncology,' 'RNA Therapy,' 'Gene Therapy,' 'Possible Concepts,' and 'Exploration,' and covers Artificial Intelligence in Medical Diagnosis, Artificial Intelligence Drug Discovery, Bispecific Antibody, Antibody-Drug Conjugate, Biosimilar, Immune Checkpoint Inhibitor, Chimeric Antigen Receptor T Cell Therapy, mRNA (messenger RNA), RNAi & ASO (RNA interference & Antisense Oligonucleotide), AAV [adeno-associated virus] & Lentivirus, Gene Editing, Obesity Treatment, Non-alcoholic Steatohepatitis (Non-alcoholic Steatohepatitis). It consists of 17 subtopics, including Steatohepatitis treatment, Alzheimer's disease treatment, Targeted Protein Degradation, Microbiome, and Digital Therapeutics (DTx).
All of these topics have passed the proof-of-concept stage for new drug development as of 2023, or are expected to do so soon.
Hottest topic
Medical AI, antibody therapeutics, and immuno-oncology drugs
In Part 1, we examined medical AI in the current context, where the challenges of new drug development—growing medical demand, a shortage of medical personnel, and increasing costs and time—overlap with the opportunities of finding and accurately treating more patients quickly.
We introduce a case where medical AI was used to change the work of two radiologists into one that can be done by one doctor, a medical AI that helps to prescribe cutting-edge new drugs to more patients by more clearly dividing patient groups where the judgment of prescribing cutting-edge new drugs was mixed, and an attempt to reduce the astronomical development costs and long development periods required for new drug development using medical AI.
In this process, we will see what value AI, which is becoming a reality in every aspect of life, can have in saving human lives.
In Part 2, we look at the next steps for antibody therapeutics, which have moved beyond the title of cutting-edge new drugs and become tangible treatments.
Bispecific antibodies were an old idea, but it took a long time to prove the concept.
The technological development process required to prove the concept, and the potential as a new drug that began to open up once the concept was proven, are now being realized in dual antibodies.
The same goes for antibody-drug conjugates.
Antibody-drug conjugates, which combine the advantages of antibody drugs that bind precisely to the site of treatment with the advantages of chemical drugs that can effectively treat with strong toxicity, also took a long time to prove their concept.
However, many antibody-drug conjugate drug development researchers have found a way forward in drug development, not antibody development as they had anticipated, demonstrating that unbiased science is key to proof-of-concept.
Meanwhile, biosimilars were a successful Korean new drug development model that proved the concept, pioneered the market, and established the field.
We take a look at biotechs that are challenging new proof-of-concepts to advance to the next level in the increasingly competitive biosimilar field.
Immunotherapy is becoming increasingly important in cancer treatment.
As understanding of the human immune system increases, Merck & Co.'s Keytruda, which successfully demonstrated its concept based on this, is changing the concept of anticancer drugs.
The same goes for CAR-T cell therapy, which is treating patients with blood cancer who were once thought to have no other alternatives.
Part 3, Immuno-Oncology, explores how global pharmaceutical companies and biotechs have successfully demonstrated the concepts of immune checkpoint inhibitors and CAR-T cell therapies.
And in the field of developing new immune anticancer drugs, which was once considered a challenge that Korea could not dare to undertake, we explore how Korean pharmaceutical companies and biotech companies can further prove their concepts.
The most cutting-edge field
RNA therapeutics, gene therapeutics
Part 4: RNA Therapeutics: The Story Begins with the COVID-19 Pandemic
COVID-19, which had gripped the world with fear, has been slowed down by the development of a vaccine based on RNA mechanisms.
Until the development of the COVID-19 vaccine, RNA therapeutics had not achieved proof of concept.
In some ways, it may seem like we achieved proof of concept all of a sudden thanks to COVID-19, but in fact, we were able to successfully prove the concept because we had been conducting research and investing in the development of new drugs based on RNA mechanisms.
Following the COVID-19 vaccine, mRNA therapeutics are expanding their proof-of-concept to include cancer vaccines, and RNAi & ASO therapeutics are accelerating the hurdles of new drug development. We examine the scientific focus and efforts being made to achieve proof-of-concept.
If the disease is caused by a problem in the genes, the patient may be cured by correcting the genes.
Gene therapy is an intuitive and powerful idea, but if it fails to prove its concept, it will remain in the lab and cannot be deployed in the field.
Part 5 examines proof-of-concept cases related to gene therapy.
A treatment must go exactly where it needs to go to treat the disease, not cause serious side effects along the way, and work as intended at the treatment site it arrives at.
Adeno-associated viruses and lentiviruses are currently responsible for this part of gene therapy, but they still have limitations.
We examine adeno-associated viruses and lentiviruses, which are essential for gene therapy to become viable pharmaceuticals, and examine proof-of-concept efforts to overcome their limitations.
And in gene editing, we look at concepts such as gene scissors and base editing that are necessary for actual gene therapy, and similarly, we examine what is needed for the next step of proof of concept.
Concepts made possible
And the search
When the first edition of "Understanding Bioscience" was published, the concept of therapeutics for obesity, non-alcoholic steatohepatitis, and Alzheimer's disease had not yet been established.
However, as we enter the 2020s, the possibility of proof of concept required for new drug development is being demonstrated.
Part 6 examines concepts that have made new drug development more feasible, including obesity treatments that are opening up new avenues for the development of new drugs for metabolic diseases including diabetes, non-alcoholic steatohepatitis, for which there was no clear cause or suitable treatment, and Alzheimer's disease treatments that experienced ups and downs throughout the development process.
If there are concepts that are now possible, there are also concepts that will become possible in the fairly near future.
Rather than finding a specific site that suppresses the activity of a pathological protein and finding a substance that acts at that site, targeted protein degradation that binds to any site of the pathological protein and degrades the protein itself is a task that new drug development researchers are engrossed in.
Part 7 explores the potential of proving the concept of the microbiome, which treats diseases by regulating the intestinal microbial environment, and digital therapeutics, which treat diseases by utilizing digital devices and the IT environment.
Proof of concept
Proof of concept is the first and most difficult hurdle science must overcome to move from science to industry.
It's one thing to prove a scientific hypothesis in a laboratory where many things can be controlled, but it's another thing to see science actually work in the field where many things are uncontrolled.
Even if a substance is proven to eliminate cancer cells in a controlled experimental environment in a life sciences laboratory, there is little guarantee that it will cure cancer patients in a medical setting where multiple variables occur simultaneously.
Rather, it may cause side effects that are harmful to the patient.
Proof of concept goes beyond the laboratory scientific stage and demonstrates that concrete results can be expected in the field.
Proof of concept in new drug development is therefore important and weighty, and it signals that we can now move on to the tangible stage.
For this reason, the revised second edition of "Understanding Bioscience" focuses on proof-of-concept (PoC) for new drug development.
Above all, we covered cutting-edge science for new drug development, but we selected specific, tangible things.
We also looked into the various scientific fields related to new drug development, and examined the journey of global pharmaceutical companies, biotechs, and Korean biotechs that have taken their ideas and hypotheses to the proof-of-concept stage.
Their journey involved constantly examining their own research and that of others, never hesitating to confront what was happening in the medical field without remaining confined to the laboratory, and, above all, persuading investors, the market, and themselves with their belief in science.
This process was a journey of people who were overly honest, straightforward, and upright in front of science.
Thanks to this, it also provides an opportunity to reconsider what strategy really is in new drug development.
This book is divided into seven major topics: 'Artificial Intelligence (AI),' 'Antibody Therapy,' 'Immuno-Oncology,' 'RNA Therapy,' 'Gene Therapy,' 'Possible Concepts,' and 'Exploration,' and covers Artificial Intelligence in Medical Diagnosis, Artificial Intelligence Drug Discovery, Bispecific Antibody, Antibody-Drug Conjugate, Biosimilar, Immune Checkpoint Inhibitor, Chimeric Antigen Receptor T Cell Therapy, mRNA (messenger RNA), RNAi & ASO (RNA interference & Antisense Oligonucleotide), AAV [adeno-associated virus] & Lentivirus, Gene Editing, Obesity Treatment, Non-alcoholic Steatohepatitis (Non-alcoholic Steatohepatitis). It consists of 17 subtopics, including Steatohepatitis treatment, Alzheimer's disease treatment, Targeted Protein Degradation, Microbiome, and Digital Therapeutics (DTx).
All of these topics have passed the proof-of-concept stage for new drug development as of 2023, or are expected to do so soon.
All of these topics have passed the proof-of-concept stage for new drug development as of 2023, or are expected to do so soon.
Hottest topic
Medical AI, antibody therapeutics, and immuno-oncology drugs
In Part 1, we examined medical AI in the current context, where the challenges of new drug development—growing medical demand, a shortage of medical personnel, and increasing costs and time—overlap with the opportunities of finding and accurately treating more patients quickly.
We introduce a case where medical AI was used to change the work of two radiologists into one that can be done by one doctor, a medical AI that helps to prescribe cutting-edge new drugs to more patients by more clearly dividing patient groups where the judgment of prescribing cutting-edge new drugs was mixed, and an attempt to reduce the astronomical development costs and long development periods required for new drug development using medical AI.
In this process, we will see what value AI, which is becoming a reality in every aspect of life, can have in saving human lives.
In Part 2, we look at the next steps for antibody therapeutics, which have moved beyond the title of cutting-edge new drugs and become tangible treatments.
Bispecific antibodies were an old idea, but it took a long time to prove the concept.
The technological development process required to prove the concept, and the potential as a new drug that began to open up once the concept was proven, are now being realized in dual antibodies.
The same goes for antibody-drug conjugates.
Antibody-drug conjugates, which combine the advantages of antibody drugs that bind precisely to the site of treatment with the advantages of chemical drugs that can effectively treat with strong toxicity, also took a long time to prove their concept.
However, many antibody-drug conjugate drug development researchers have found a way forward in drug development, not antibody development as they had anticipated, demonstrating that unbiased science is key to proof-of-concept.
Meanwhile, biosimilars were a successful Korean new drug development model that proved the concept, pioneered the market, and established the field.
We take a look at biotechs that are challenging new proof-of-concepts to advance to the next level in the increasingly competitive biosimilar field.
Immunotherapy is becoming increasingly important in cancer treatment.
As understanding of the human immune system increases, Merck & Co.'s Keytruda, which successfully demonstrated its concept based on this, is changing the concept of anticancer drugs.
The same goes for CAR-T cell therapy, which is treating patients with blood cancer who were once thought to have no other alternatives.
Part 3, Immuno-Oncology, explores how global pharmaceutical companies and biotechs have successfully demonstrated the concepts of immune checkpoint inhibitors and CAR-T cell therapies.
And in the field of developing new immune anticancer drugs, which was once considered a challenge that Korea could not dare to undertake, we explore how Korean pharmaceutical companies and biotech companies can further prove their concepts.
The most cutting-edge field
RNA therapeutics, gene therapeutics
Part 4: RNA Therapeutics: The Story Begins with the COVID-19 Pandemic
COVID-19, which had gripped the world with fear, has been slowed down by the development of a vaccine based on RNA mechanisms.
Until the development of the COVID-19 vaccine, RNA therapeutics had not achieved proof of concept.
In some ways, it may seem like we achieved proof of concept all of a sudden thanks to COVID-19, but in fact, we were able to successfully prove the concept because we had been conducting research and investing in the development of new drugs based on RNA mechanisms.
Following the COVID-19 vaccine, mRNA therapeutics are expanding their proof-of-concept to include cancer vaccines, and RNAi & ASO therapeutics are accelerating the hurdles of new drug development. We examine the scientific focus and efforts being made to achieve proof-of-concept.
If the disease is caused by a problem in the genes, the patient may be cured by correcting the genes.
Gene therapy is an intuitive and powerful idea, but if it fails to prove its concept, it will remain in the lab and cannot be deployed in the field.
Part 5 examines proof-of-concept cases related to gene therapy.
A treatment must go exactly where it needs to go to treat the disease, not cause serious side effects along the way, and work as intended at the treatment site it arrives at.
Adeno-associated viruses and lentiviruses are currently responsible for this part of gene therapy, but they still have limitations.
We examine adeno-associated viruses and lentiviruses, which are essential for gene therapy to become viable pharmaceuticals, and examine proof-of-concept efforts to overcome their limitations.
And in gene editing, we look at concepts such as gene scissors and base editing that are necessary for actual gene therapy, and similarly, we examine what is needed for the next step of proof of concept.
Concepts made possible
And the search
When the first edition of "Understanding Bioscience" was published, the concept of therapeutics for obesity, non-alcoholic steatohepatitis, and Alzheimer's disease had not yet been established.
However, as we enter the 2020s, the possibility of proof of concept required for new drug development is being demonstrated.
Part 6 examines concepts that have made new drug development more feasible, including obesity treatments that are opening up new avenues for the development of new drugs for metabolic diseases including diabetes, non-alcoholic steatohepatitis, for which there was no clear cause or suitable treatment, and Alzheimer's disease treatments that experienced ups and downs throughout the development process.
If there are concepts that are now possible, there are also concepts that will become possible in the fairly near future.
Rather than finding a specific site that suppresses the activity of a pathological protein and finding a substance that acts at that site, targeted protein degradation that binds to any site of the pathological protein and degrades the protein itself is a task that new drug development researchers are engrossed in.
Part 7 explores the potential of proving the concept of the microbiome, which treats diseases by regulating the intestinal microbial environment, and digital therapeutics, which treat diseases by utilizing digital devices and the IT environment.
Proof of concept
Proof of concept is the first and most difficult hurdle science must overcome to move from science to industry.
It's one thing to prove a scientific hypothesis in a laboratory where many things can be controlled, but it's another thing to see science actually work in the field where many things are uncontrolled.
Even if a substance is proven to eliminate cancer cells in a controlled experimental environment in a life sciences laboratory, there is little guarantee that it will cure cancer patients in a medical setting where multiple variables occur simultaneously.
Rather, it may cause side effects that are harmful to the patient.
Proof of concept goes beyond the laboratory scientific stage and demonstrates that concrete results can be expected in the field.
Proof of concept in new drug development is therefore important and weighty, and it signals that we can now move on to the tangible stage.
For this reason, the revised second edition of "Understanding Bioscience" focuses on proof-of-concept (PoC) for new drug development.
Above all, we covered cutting-edge science for new drug development, but we selected specific, tangible things.
We also looked into the various scientific fields related to new drug development, and examined the journey of global pharmaceutical companies, biotechs, and Korean biotechs that have taken their ideas and hypotheses to the proof-of-concept stage.
Their journey involved constantly examining their own research and that of others, never hesitating to confront what was happening in the medical field without remaining confined to the laboratory, and, above all, persuading investors, the market, and themselves with their belief in science.
This process was a journey of people who were overly honest, straightforward, and upright in front of science.
Thanks to this, it also provides an opportunity to reconsider what strategy really is in new drug development.
This book is divided into seven major topics: 'Artificial Intelligence (AI),' 'Antibody Therapy,' 'Immuno-Oncology,' 'RNA Therapy,' 'Gene Therapy,' 'Possible Concepts,' and 'Exploration,' and covers Artificial Intelligence in Medical Diagnosis, Artificial Intelligence Drug Discovery, Bispecific Antibody, Antibody-Drug Conjugate, Biosimilar, Immune Checkpoint Inhibitor, Chimeric Antigen Receptor T Cell Therapy, mRNA (messenger RNA), RNAi & ASO (RNA interference & Antisense Oligonucleotide), AAV [adeno-associated virus] & Lentivirus, Gene Editing, Obesity Treatment, Non-alcoholic Steatohepatitis (Non-alcoholic Steatohepatitis). It consists of 17 subtopics, including Steatohepatitis treatment, Alzheimer's disease treatment, Targeted Protein Degradation, Microbiome, and Digital Therapeutics (DTx).
All of these topics have passed the proof-of-concept stage for new drug development as of 2023, or are expected to do so soon.
GOODS SPECIFICS
- Date of issue: October 27, 2023
- Page count, weight, size: 648 pages | 867g | 140*215*35mm
- ISBN13: 9791191768060
- ISBN10: 1191768066
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