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Over the years, Lindsay Rosenwald has been a key leader and innovator in the area of biotechnology financing, helping drug development companies grow and bring their products to market.Lindsay Rosenwald has spent the past two decades building his career as a trusted partner for investors and pharmaceutical developers alike, with a long list of achievements to his credit. Among his recent accomplishments, Dr. Rosenwald steered Cougar Biotechnology, developer of abiraterone acetate, toward a nearly $1 billion purchase by Johnson & Johnson in 2009, a major coup for a product still in phase 3 clinical trials. Lindsay Rosenwald has earned widespread recognition for his work and was previously ranked number one on Genetic Engineering & Biotechnology News’ list of Molecular Millionaires. Active in philanthropy as well, Dr. Rosenwald serves on the Board of Visitors of Penn State University’s Smeal College of Business and has donated millions of dollars through the Rosenwald Foundation for a variety of charitable causes. With a background in medicine, Dr. Rosenwald practiced as an internist before moving to Wall Street to work as a physician/financial analyst in the mid 1980s. He holds a Doctor of Medicine from the Temple University School of Medicine and a Bachelor of Science in Finance from Penn State.

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Australian Team Posits New Theory of Bowel Cancer

A team of researchers in Australia has come up with a controversial new theory on how bowel cancer develops. The bowel lining contains structures known as “crypts,” or wells, in the bowel walls that look like pockets and serve a number of functions. Some scientists believe that stem cells maintain them, while others deny the stem cells’ existence. The research team found evidence suggesting that the stem cells not only exist, but that they also play a role in bowel cancer. By using three-dimensional imaging, the research team showed that crypts are generated through a budding process and that their cells undergo a constant process of death and regeneration. They also showed that in bowels that were cancerous or precancerous, the budding process had gotten out of control, with multiple buds appearing where there should have been only one. The researchers posited that bowel cancer caused by the stem cells likely developed due to the loss of a gene that regulates their function. An understanding of that gene, and the process by which it contributes to stem cells going haywire in the bowel, may be an important part of figuring out how to treat bowel cancer.                            

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New Finding May Make MicroRNA Cancer Treatments Feasible

Short molecules of RNA known as microRNA may now be feasible as a treatment for cancer following the discovery of a new delivery platform. MicroRNA molecules, which have an important job in regulating disease in humans, have long been the subject of speculation. Researchers have hoped that they could be used as cancer treatments, but a number of barriers in the body have kept potential microRNA therapies from getting to the tumor cells they were meant to impact. Now, a new molecule may provide a way to leverage them for treatment. A multidisciplinary team of researchers at Yale University found that in a mouse model, they could hamper the function of a microRNA molecule that leads to diffuse large B-cell lymphoma when it gets out of control. The researchers discovered that a molecule designed to be a mirror image of the microRNA molecule could bind to the malfunctioning microRNA and shut it down. The theory behind such a treatment has been in place for some time, but the Yale team was able to find an effective delivery method for it via a particular peptide. In the team’s mouse models, the peptide successfully delivered the treatment to cancerous cells, leading to smaller tumors and better survival rates.                            

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Testosterone Could Be Associated with Colon Tumor Growth

The male hormone testosterone may contribute to the growth of colon cancer tumors, according to a new study. Previously, research showed that women were less likely than men to develop non-gender specific cancers, such as stomach, pancreas, and colon cancer. Scientists believed that this was due to the protective properties of female hormones, such as estrogen, that prevented tumor formation. Recently, researchers at the University of Missouri tested their theory about testosterone on male rats. They observed that the removal of testosterone from the rats drastically decreased their susceptibility to colon cancer. The researchers said that the findings demonstrate that there could be a relationship between testosterone and the growth of tumors in the colon, rather than female hormones serving as protection against tumors. Moreover, the researchers said the theory that testosterone could contribute to the growth of tumors may be supported by the fact that women experience a steep increase in colon cancer in the years following menopause. After menopause, women’s estrogen levels decrease while their testosterone levels become much higher. At the same time, they also show higher rates of colon cancer.                            

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Researchers to Study Link Between Protein and Lung Cancer Development

Researchers at the Rutgers Cancer Institute of New Jersey plan to further study a protein called Sox9, which has been linked to low survival rates in lung cancer patients. Their work will be made possible by a $1.8 million grant that the National Institutes of Health awarded to Sharon Pine, a researcher at the Cancer Institute of New Jersey. She and her colleagues hope to gain a better understanding of the protein’s effect on lung cancer development and to build upon their prior research. At the 2014 American Association for Cancer Research Annual Meeting, Dr. Pine and her colleagues presented research showing that the Sox9 protein has a key role in gene transcription, affecting which genes are activated and deactivated. The influence on gene activation has the potential to spur lung cancer metastasis. Physicians previously observed the overproduction of Sox9 in several cancers. Dr. Pine and her team concluded that the excess is caused by Notch and TGF-β, two specific cell communication pathways that regulate Sox9. Dr. Pine and her colleagues intend to further explore the effect of Sox9 on gene regulation and, as a result, the progression of cancerous tumors. Additionally, the team aims to develop a treatment method to curb the overproduction of Sox9 and its impact on lung cancer cells.

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Established Cancer Drug Shows New Promise for Other Treatments

Arsenic trioxide achieves good outcomes for patients with low- or intermediate-risk acute promyelocytic leukemia (APL) when  combined with all-trans-retinoic acid (ATRA), according to an article published in the October 2014 edition of the Journal of Clinical Oncology. Fabio Efficace, a member of the Italian Group for Adult Hematologic Diseases, mentioned in the article that the therapy shows promise as a first-line treatment because it does not have a detrimental effect on patients’ quality of life. In the trial, outcomes were compared between patients treated with arsenic trioxide and chemotherapy, the standard protocol for patients with low-level leukemia, and those treated with arsenic trioxide and ATRA. The results showed that the arsenic trioxide/ATRA treatment was “non-inferior” to the drug and chemotherapy therapy. More than a decade ago, Lindsay Rosenwald started a small company to develop arsenic trioxide with a small staff of experts dedicated to it. The drug was developed and approved for market only 29 months after the first patient was treated with it in a clinical trial.                            

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Computers vs. Cancer - New Research Crunches Cancer Treatment Numbers

Radiation therapy has long been an important part of the oncologist’s tool kit, but it has many limitations, the most apparent being the unwanted damage to healthy tissue in the cancer’s vicinity. Currently, state-of-the-art radiation therapy technology uses a linear accelerator, or “linac” for short, targeted with help from images from a CT (computed tomography) scan. However, these scans cannot track moving targets like tumors found in the lungs, creating a situation where radiation cannot be focused on the cancer alone. Scientists at Houston’s MD Anderson Cancer Center and the Texas Advanced Computing Center (TACC) at the University of Texas at Austin have partnered to find a solution to this problem. One promising line of research involves the creation of an MRI-linac, which pairs the real-time view of magnetic resonance imaging with radiation therapy to allow for finely targeted treatments. However, MRI machines’ powerful magnetic fields interfere with the ionization chambers that measure the amount of radiation produced by the linac. Instead of building numerous expensive prototypes, the team in Texas has created models of the complicated reactions on TACC’s Lonestar supercomputer. Simulations will allow the team to test 16 ionization chamber prototypes, which should enable the future MRI-linac machines to incorporate rigorously tested dosage mechanisms.

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FDA Creates Process to Expedite Approval of Revolutionary Drugs

On average, a new drug brought to market in the United States requires $1 billion spent over 10 years in order to meet the stringent standards of the U.S. Food and Drug Administration (FDA). In 2012, however, the FDA sought out ways to ameliorate these high costs and lengthy delays of bringing breakthrough drugs to pharmacies across the country, creating a new program that expedites the process for medicines that show evidence of having major benefits for people with serious injuries and illnesses. Since then, more than 50 drugs have been admitted to the program, including new treatments for blood cancers, cystic fibrosis, and hepatitis C. For pharmaceutical companies and patients alike, this has been a major boon in many cases. One drug spent only six years between its initial trials and ultimate approval after inclusion in the new FDA program. Some observers have criticized the degree to which the FDA’s new process has complicated both pricing considerations and marketing concerns, but the FDA itself has declared the program an unqualified success. Industry experts consider it likely that in the coming years, the effects of the FDA’s new rules will make it much easier for promising drug candidates to reach American hospitals.                            

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The Phases of Clinical Drug Research

In the field of pharmaceutical research, clinical trials represent one of the most important stages in a drug’s life cycle. Conducted in a series of phases and carefully monitored by the United States Food and Drug Administration, clinical trials answer important research questions surrounding the safety and efficacy of pharmaceutical drugs. Typically, clinical trials encompass four phases. In the first phase, or Phase I, researchers administer a drug to a small group of people to gain an understanding of safe dosage and possible side effects. In Phase II, scientists expand the research group from several hundred people to several thousand to further test the drug's safety and efficacy. In Phase III, researchers again increase the scope of the trial and begin learning about the potential therapeutic effects of the treatment. Phase IV—the final phase of the clinical research process, commonly referred to as post-marketing surveillance—involves careful monitoring of patients to determine the effects of the drug in the long term.

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Pharmaceutical Investment vs. Biotechnology Investment

For prospective investors in the health care sector, pharmacy and biotechnology represent two of the most popular areas of interest. Each possesses its own advantages and disadvantages in terms of risk tolerance. Here is a quick look at the two types of stocks. Biotechnology: In general, biotechnology stocks carry a significant amount of risk, due to the possibility of regulatory obstacles, competition, and failed clinical trials. If a technology falls short of its objectives, the project often folds within days and the stock loses the majority of its value. However, if a drug or technology succeeds in all clinical trials, stocks can experience rapid growth in a relatively short period of time. Pharmaceuticals: Compared to biotechnology, the pharmaceutical sector requires investors to assume a relatively small amount of risk. The factors determining the price of pharmaceutical stocks typically include reimbursement charges, new drug pipelines, strategic alliances, and prescription data. Many of these are fairly easy to predict, which results in less volatility.

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Treatment Options for Acute Promyelocytic Leukemia

Acute promyelocytic leukemia (APL) is a cancer of the white blood cells that affects individuals of a wide range of ages. Unlike many other leukemias, APL is a relatively treatable condition, which features a 12-year, progression-free, survival rate of 70 percent. 

Treatment for APL usually begins with the administration of the non-chemotherapy drug known as all-trans-retinoic acid (ATRA), which possesses a structure closely related to vitamin A. Used in conjunction with an anthracycline chemotherapy drug such as idarubicin or daunorubicin, ATRA produces results in a considerable number of patients. Alternatively, physicians may choose to prescribe the drug arsenic trioxide, particularly for patients with an intolerance to anthracycline drugs.

After undergoing initial treatment, many patients receive post-remission treatment with combinations of several drugs and begin a maintenance therapy regimen that involves ATRA administration for at least one year. In some cases, doctors may also prescribe low doses of the chemotherapy drugs 6-MP and methotrexate.                                 

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The Importance of Lead Optimization in Drug Discovery

In the drug discovery process, finding a lead compound represents one of the most important tasks for researchers. Once scientists find a compound that affects the target molecule and passes a series of rigorous safety tests, they begin altering the structure of the compound to enhance certain biological and chemical properties. Often referred to as lead optimization, the alteration process results in safer and more effective compounds. Researchers often begin the lead optimization process by identifying interactions with other biological systems in the body and making the drug less likely to interact with them. By testing hundreds or even thousands of analogues, scientists can greatly decrease the likelihood of side effects. Lead optimization typically involves a significant back-and-forth between biologists, who test the compounds on living systems, and chemists, who make the desired alterations to the drug. At this stage, chemists also begin to consider logistics such as the delivery mechanism, inactive binding agents, and large-scale manufacturing.                            

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Three Ways Drug Researchers Find Lead Compounds

In the field of drug discovery, researchers typically begin the process by identifying a target molecule and validating it as a major cause of disease. Once they find a suitable target, researchers must then begin the search for a promising drug molecule, often referred to as a “lead compound.” Following are three ways scientists find lead compounds: - Nature: One of the oldest sources of medicinal compounds, nature plays host to a wide range of bioactive substances. While the large majority of nature-based research has focused on the medicinal properties of plants, researchers have discovered promising compounds in bacteria and mold. - Biotechnology: Over the past few decades, scientists have discovered many ways to genetically engineer living systems and cause them to produce specific biological molecules. - High-throughput screening: One of the most common drug discovery methods, high-throughput screening can test a large volume of compounds against the target molecule in a relatively short period of time.                            

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Zytiga, Johnson and Johnson on the Rise

As Johnson & Johnson's sales in the consumer and medical devices/diagnostics sectors have dipped, the company has experienced significant increases in its pharmaceutical sales. Johnson & Johnson maintains a strong portfolio of high-performing drugs, including immunology drugs like Simponi and Stelara, the hepatitis C treatment Olysio, and two oncology drugs, Velcade and Zytiga. Analysts predict that these five drugs will help drive Johnson & Johnson's estimated 5 percent growth in overall revenue for the next year. Zytiga will make an especially critical contribution to this growth rate. The blockbuster prostate cancer drug surpassed Velcade as Johnson & Johnson's top-selling oncology drug, and it experienced a 48.8 percent revenue increase in its quarter-one revenues. In the first quarter, Zytiga generated $512 million, over $100 million more than Velcade. Additionally, sales of Zytiga jumped 77 percent from 2012 to 2013, resulting in $1.7 billion for the pharmaceutical giant. The drug does face upcoming competition, however, from such therapies as Medivation and Astellas' Xtandi. Investors will be watching closely as the companies report on these drugs' quarterly sales.

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Three Factors That Contribute to Schizophrenia

One of the most studied and least-understood psychiatric disorders, schizophrenia manifests itself in a variety of ways, and researchers have yet to identify a single underlying cause. Researchers have, however, identified three factors that correlate with the onset of schizophrenia. Family history: One of the most reliable risk factors of schizophrenia, family history has been shown to correlate strongly with schizophrenia diagnoses. A child of a parent with schizophrenia has a 10 percent chance of developing the disorder, while an individual whose identical twin has been diagnosed with schizophrenia has a 40 percent to 65 percent chance. Chemical factors: In recent years, schizophrenia research has focused on the role of neurotransmitters. In particular, research has shown that schizophrenia may be related to imbalances in compounds such as glutamate and dopamine. Physical abnormality: With the arrival of advanced neuroimaging techniques, researchers have discovered that people with schizophrenia often have abnormal brain structures, such as larger ventricles, less gray matter, and abnormal activity in certain areas.

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A Few Simple Practices to Prevent the Spread of Flu

Seasonal influenza, which is especially prevalent during the fall and winter months, affects millions of people, infecting as much as one-fifth of the American population annually. According to the Centers for Disease Control and Prevention, the most common way for flu germs to spread is via respiratory secretions: the droplets of fluid expelled when someone coughs or sneezes. Contact with these droplets can result in infection from as far as 6 feet away. In some cases, an individual can contract the flu virus by touching an object handled by a contagious person and then touching his or her own mouth or nose. Individuals with flu should make every attempt to avoid spreading it to others by staying home while they are ill. A generally healthy adult is able to transmit the virus to others a full day before displaying any symptoms. In addition, he or she may continue to be contagious for as much as one week afterward. To prevent the spread of flu, remember to disinfect surfaces that an infected person has touched. Thoroughly wash dishes used by anyone who is sick with flu, and launder linens and towels before another person uses them. To avoid contracting flu, children and adults should wash their hands often and avoid touching their mouths and noses, especially when they are in well-frequented public places. Furthermore, the CDC advises the influenza vaccine, targeted to the current season’s strain of the virus, for everyone 6 months of age and older, unless an individual’s physician recommends otherwise.

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Multiple Theories about the Cause of Fibromyalgia

Fibromyalgia, a musculoskeletal condition characterized by increased sensitivity to pain throughout the body, is often associated with sleep disorders, lowered energy levels, and difficulty remembering. Experts believe the condition affects some 5 million American adults, women more frequently than men. Though patients living with fibromyalgia can often find pain relief with analgesic medications, the condition can become a chronic problem. While no researcher has yet posited a definitive cause for fibromyalgia, several theories have developed. Some experts believe that the condition results from a chemical or endocrine problem affecting the brain’s neurotransmitting system, from nerve cells made overly sensitive to pain, or from an emotionally traumatic event. Decreased levels of the calm-inducing neurotransmitter serotonin may result in heightened sensitivity to painful stimuli, as may an excess amount of substance P, which boosts the body’s amplification of painful sensations. In addition, some theorists have pointed to lower levels of human growth hormone as a contributor to the development of fibromyalgia. In addition, certain infections may be at the root of the condition, or may initiate flare-ups. Many researchers have proposed that fibromyalgia has a genetic component, as the condition does tend to occur in family members. However, most agree that the likeliest scenario involves several factors in combination.

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Some Basic Information on Overactive Bladder

Overactive bladder, often called “urge incontinence,” results from spasms of the urinary tract muscles. The risk of developing OAB increases with pregnancy and excess weight gain. It can be associated with certain neurological conditions, lowered kidney function, and tumors, or it can occur as a side effect of particular medications. There may additionally be a genetic component involved.

People with overactive bladder experience sudden urges to void urine, and over time, the condition can lead to issues with incontinence. Sometimes, the urge to urinate immediately results in an episode of incontinence. People with OAB tend to urinate frequently, often eight or more times in the course of a day. They may experience nocturia, which causes them to awaken several times during sleep in order to urinate. Overactive bladder should not be viewed as an inescapable part of growing older. Effective treatments exist that can cause symptoms to lessen or disappear. Your physician may recommend Kegel exercises to strengthen the muscles of the pelvic floor.

After instruction from a medical professional, it may take a month or two to achieve results. Losing weight, and learning to time and schedule fluid intake and urination, may also help. Intermittent catheterization may be an option, or a doctor may recommend a regimen of bladder training. In addition, a wide variety of medications is available to relax the bladder and reduce the urge that leads to incontinence.