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

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

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

Harnessing Your Immune System For Good

Emily BurkeBiologics, Biotech Basics, Cancer, Drug Targets, Mechanism of Action, Monoclonal Antibodies

YOUR INNER IMMUNE WORKINGS What do monoclonal antibodies, CAR-T therapy, and checkpoint inhibitor treatments all have in common? They are immunotherapies, or therapies that activate the immune system to fight or prevent a disease. While an activated immune system can help save a life, an overactive immune system can attack the body it is charged with protecting. This over-activity is the … Read More

Post-translational Modifications In Biotech

Emily BurkeBiologics, Biomanufacturing, Biotech Basics, Cancer, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Mechanism of Action, Monoclonal Antibodies

Basic Science Meets Application “Post-translational modification” may not be a term you hear every day, but it is critically important to the biotech industry—from understanding how cancer develops to producing biologics. Breaking the term down, we know that: “post” means “after.” “translation” is “the cellular process of making proteins.” “modification” means “change.” So, a post-translational modification (PTM) simply means that … Read More

The Long And Short Of AMD

Emily BurkeBiologics, Clinical Trials, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Genetics, Mechanism of Action, Monoclonal Antibodies, Term of the Week, The WEEKLY

A Spotlight On One Of The Most Prevalent Eye Diseases It’s easy to take our ability to see for granted. On a day-to-day basis, we rely on vision to process information and to navigate the world without giving it a second thought. For the millions of people affected by eye disease, vision loss, and blindness, impaired vision is a daily reality … Read More

Next-Generation CAR-T

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Drug Development, Drug Targets, Genomics, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

The Race Is On Our last WEEKLY—Hacking the Immune Response—unveiled the science behind CAR-T and TCR, two immunotherapies under the microscope of the mainstream press. The well-deserved media attention highlights the ability of these “living drugs” to recognize and obliterate cancers. With all of the early phase clinical success, a few challenges have popped up: • Safety: CAR-T and TCR can … Read More

Two Monoclonal Antibodies Walk Into The Market

Emily BurkeBiologics, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, Term of the Week, The WEEKLY

Attacking Asthma & Pushing Out Psoriasis Two new monoclonal antibodies debuted on the market thanks to FDA approvals last month. Both treat chronic inflammatory conditions: Lilly’s (Indianapolis, IN) Taltz for psoriasis and Teva’s (Petah Tikva, Israel) drug Cinqair for severe asthma. Interestingly enough, having psoriasis is associated with an increased risk of developing asthma according to a study in the British Journal of Dermatology. While these two conditions … Read More

The Emerging Proteomics Market

Emily BurkeBusiness of Biotech, Cancer, Deoxyribonucleic Acid (DNA), Diabetes, Diagnostics, Drug Targets, Genomics, Term of the Week, The WEEKLY

Picking Apart The Protein Genomics continues to be all the rage in biotech circles—with special kudos to Illumina’s (San Diego, CA) recent ability to obtain an entire human genome sequence in 24-hours for a mere thousand dollars. Our overall understanding of human DNA combined with our ability to determine individual genomes leads to better disease insight, more powerful diagnostics, and a … Read More

Inching Across The Blood-Brain Barrier

Emily BurkeBiologics, Biotech Basics, Cocktail Fodder, Drug Development, Drug Targets, Monoclonal Antibodies, Term of the Week

A Constant Hurdle in Drug Delivery When it comes to achieving success in drug development, picking the right drug target and developing an effective inhibitor (or activator) is only half the battle. A drug candidate may appear promising in cell-based testing—and even in preclinical testing—but still fail to work in humans. It simply does not get to where it needs to be … Read More

Packing A Punch With The Immune System

Emily BurkeBiologics, Biotech Basics, Drug Targets, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

THE INNER WORKINGS OF YOUR IMMUNE SYSTEM What do monoclonal antibodies, CAR-T therapy, and 3D vaccines all have in common? They are immunotherapies, or therapies that activate a patient’s own immune system to fight or prevent a disease. While immune system activation can help save a life, an overactive immune system can potentially attack the body it is charged with … Read More

Targeting Breast Cancer

Emily BurkeCancer, Drug Approvals, Drug Development, Drug Targets, FDA, Genetics, Monoclonal Antibodies, Small Molecule Drugs, The WEEKLY

The Subtypes of Breast Cancer 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, all are linked to breast cancer. Breast cancer is complex and a diagnosis can be caused by all, some, or even none of the factors listed above. In fact, the National Cancer Institute’s (Bethesda, … Read More

Longevity In Biotech

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Drug Development, Drug Targets, Genomics, The WEEKLY

Longevity has fascinated mankind for centuries, from ancient myths about fountains of youth to current speculation around caloric restriction. With our increased scientific understanding of aging, clinical validation and commercialization of treatments are near. The goal is to extend lifespan as well as health span, and we may be looking at a future where the norm is to remain mentally and physically active at age 90, or even … Read More

The FDA’s Decidedly Average Year

Emily BurkeThe WEEKLY

2013 DECIDEDLY AVERAGE FOR THE FDA The FDA approved 27 new drugs in 2013, down from the 15-year high of 2012 with its 39 approvals. This should not be cause for alarm since 2013 numbers fall in line with the average of 28 over the last five years (FDA.gov). The FDA attributes the drop to fewer applications received: 32 for … Read More