DNA Vaccines Explained

Emily BurkeBiotech Basics, Clinical Trials, Cocktail Fodder, The WEEKLY, Vaccine

MORE ON THE POWERFUL, ELEGANT SIMPLICITY OF VACCINES Last week, we overviewed vaccine development and manufacture, focusing on those that use whole pathogens to protect us from a disease. This week, we examine subunit and polysaccharide vaccines, which use different strategies to fight infection. We also take a brief look at the US Food and Drug Administration (FDA)’s vaccine approval … Read More

Picturing Disease

Emily BurkeBiotech Basics, Cancer, Clinical Trials, Diagnostics, Term of the Week, The WEEKLY

USING MEDICAL IMAGING TO INVESTIGATE DISEASE Medical imaging — using various modalities to take a snapshot of the body’s interior structure — has been around since 1895, with the discovery of X-rays by Wilhelm Roentgen. X-rays are a type of electromagnetic radiation (more on that later!) that are able to pass through soft tissues such as skin, fat, and muscle … Read More

Eye Of The Cytokine Storm

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs, The WEEKLY

THE FLASH OF THE FIRST CAR-T Last week’s much anticipated FDA approval of the first chimeric antigen receptor T-cell (CAR-T) therapy for acute lymphocytic leukemia hails as the first gene therapy on the US  market. Classified as a “cell-based gene therapy,” Novartis’ (Basel, Switzerland) Kymriah works by removing patients’ T-cells, using a viral vector to introduce a gene that will allow the … Read More

Vaccines: Schooling The Herd

Emily BurkeBiologics, Biotech Basics, Clinical Trials, Drug Development, Mechanism of Action, The WEEKLY

VACCINATION NATION Back to school means shopping for new school supplies, adjusting to a new schedule, and making sure all required vaccinations are up to date. Every state requires school-age children to be vaccinated against certain infectious diseases including tetanus, hepatitis B, measles, mumps, rubella, polio, pertussis (whooping cough), and chicken pox. Vaccination policies are highly effective at eliminating many … Read More

The Microbiome Magnified

Emily BurkeBiologics, Biotech Basics, Drug Development, Drug Targets

DECODING THE GUT-BRAIN AXIS There is no shortage of microbiome-focused startups in biotech right now. The link between the gut microbiome — the entire collection of microbes living in the gut — and diseases such as inflammatory bowel disease are well-established. New research has made it clear, however, that the gut microbiome also impacts neurological health, leading to the phrase “the gut-brain … Read More

Breast Cancer Subtypes

Emily BurkeBiotech Basics, Cancer, Genetics, Mechanism of Action

FOUR MOLECULAR VARIANTS EXPLAINED Hearing your doctor utter the words HER2-positive, HR-positive, triple-negative, or BRCA mutation can be devastating — even for the most resilient person. Simply put, breast cancer is a complex disease. A diagnosis can be derived from any combination of the factors listed above — or, none at all. The National Cancer Institute (Bethesda, MD) has outlined four molecular subtypes of the disease. … Read More

Cell Signaling Explained

Emily BurkeBiotech Basics, Cancer, Deoxyribonucleic Acid (DNA), The WEEKLY

UNDERSTANDING THE DISEASE PROCESS Greetings from BIO 2017! It’s been a busy week here at the BIO International Convention here in San Diego, CA. At our convention booth, this year’s giveaway was our book written especially for non-scientists: The Biotech Primer: An insider’s guide to the biotech and pharma industry. If you weren’t at the convention to stop by and … Read More

The Biotech Primer BIO 2017 Preview

Emily BurkeBiotech Basics, Business of Biotech, The WEEKLY

Biotech Primer At BIO 2017 Biotech Primer will be headlining a few events at the BIO 2017 Annual International Convention in San Diego, CA next week. Will you be there? If so, please join us! Learn the fundamentals of biotechnology in our all-day class BioBriefing: Biotech for the Non-Scientist on Monday, June 19th. SOLD OUT What are the most popular topics in the WEEKLY? Attend Readers’ … Read More

Nanobodies: These Are Not Your Mother’s mAbs

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Orphan Disease, Orphan Drugs

The Drug Kingpins Monoclonal antibodies (mAbs) are the undisputed drug kingpins. In 2013, the mAb market raked in $75 billion in combined sales, covering a whole range of indications from cancer and infectious disease, to autoimmune disorders, and even high cholesterol. Despite the success, mAbs have one chink in their armor: they cannot enter cells due to their large size, hampering their range … Read More

Decoding Your Genes

Emily BurkeBiotech Basics, Deoxyribonucleic Acid (DNA), Diagnostics, Drug Approvals, Easily Confused, FDA, Genetics, Genomics, Orphan Disease, Term of the Week, The WEEKLY

The Skinny On DNA Testing 23andMe (Mountain View, CA) recently found itself back in the limelight after the disease risk section of its mail-in DNA kit received an OK from the FDA. The Silicon Valley biotech had to halt sales of its direct-to-consumer genetics testing back in 2013 after regulatory officials grew concerned over marketing claims and the possibility of consumers misinterpreting the test results. 23andMe rebooted a limited part of … Read More

RNA Therapeutics March Onward

Emily BurkeAntisense, Biotech Basics, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Orphan Disease, Orphan Drugs, Ribonucleic Acid (RNA), The WEEKLY

Taking Steps With Antisense With their high specificity and relative low manufacturing cost, RNA therapeutics may be tomorrow’s biotech sweetheart. In fact, chances are good that previously “undruggable” targets that cannot be accessed by small or large molecule drugs, are now within reach. However, the main roadblock continues to be delivery—getting the RNA drug where it needs to be, in high enough concentrations, to … Read More

Putting The NA in DNA

Emily BurkeBiologics, Biotech Basics, Cancer, Cardiovascular Disease, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Ribonucleic Acid (RNA), Small Molecule Drugs, The WEEKLY

Nucleic Acid Therapeutics Small molecule, peptide, and biologic drugs aren’t the only players in the game of drug development. A fourth class of therapeutics differs from all three of these: nucleic acid-based drugs. These drugs are rising in prominence due to their potential to specifically target a wide range of diseases, including various types of cancer, autoimmune, and infectious diseases. Companies … Read More

The Mechanics Of Melanoma

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

Spectrum Of Therapies Melanoma accounts for less than 1% of skin cancer cases yet causes the vast majority of skin cancer deaths. If detected early enough, melanoma is almost always curable. If not, its ability to metastasize makes it difficult to treat. Melanoma is more common in young adults than many other types of cancer, with 25% of new cases occurring in people under age … Read More

Therapeutic Antibody Primer

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs

Basics & Innovations Monoclonal antibody (mAb) therapeutics burst onto the healthcare scene 20 years ago, and today they remain one of the most versatile and effective therapeutics available. The tried and true mAbs are still in high demand, and we suspect this first wave of derivative products clamoring their way through the pipeline will be equally as successful. In this WEEKLY, we’ll … Read More

Swallowing A Biologic Drug?

Emily BurkeBiologics, Biotech Basics, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs

Surviving The Stomach Is Key Over the past two decades, biologic drugs — drugs composed of proteins produced by living cells — have become the safest, most effective top sellers within the pharmaceutical industry. Approved to treat a variety of diseases including rheumatoid arthritis, diabetes, multiple sclerosis, Crohn’s disease, and a whole range of cancers, these drugs include monoclonal antibody … Read More

Eye Of The Cytokine Storm

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs

Understanding CAR-T Safety Chimeric antigen receptor therapy (CAR-T) is our top technology pick of 2016, blazing trails in drug development with its innovative approach of using engineered immune cells to fight cancer. Despite its success in clinical trials, safety concerns remain. Serious adverse events, including death, have occurred as a result of “cytokine storms” during CAR-T treatments. We reviewed the basics of CAR-T in last week’s … Read More