The Three Clinical Phases of Drug Discovery

Clinical trials represent some of the most important and widely recognized stages of the drug discovery process. Here is a quick look at the three primary stages of clinical trials.

Phase 1: Phase 1 clinical trials involve the first human testing in the entire life cycle of a potential drug. The trials occur in a small group of healthy volunteers and typically address questions involving absorption into the body, metabolism of the substance, and the presence of side effects.

Phase 2: After a drug passes through Phase 1, researchers expand clinical trials to include a small group of patients with the disease or condition in question. In Phase 2 clinical trials, scientists gather valuable data on the efficacy of the drug, the mechanism by which it proceeds, and the optimal dosage and scheduling.

Phase 3: In the final stage of clinical trials, researchers again expand the study to include anywhere between 1,000 and 5,000 patients. In Phase 3 trials, researchers conduct further investigation of safety and efficacy and hone in on appropriate labeling for the compound.

An Overview of Rheumatoid Arthritis

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Rheumatoid arthritis affects approximately one out of every 100 people in the United States, occurring more frequently in older women than in other population groups. The autoimmune disorder develops when the body’s immune system wrongly targets its own joints, creating an inflammatory response and often severe pain, which is usually localized in the small joints. Different from osteoarthritis, RA affects the joints’ inner lining. This causes swelling that can wear down the supporting bone structure and create malformations in the joints.

Researchers have not yet identified a definitive cause for rheumatoid arthritis, although a combination of environmental and genetic factors is likely responsible. They have pinpointed certain genetic markers associated with chronic inflammation and an overly active engagement of the immune system as exhibiting a tenfold potential to lead to the development of RA. Yet the presence of these genes does not necessarily mean that a person will display symptoms, and their absence cannot give assurance that he or she will never develop the condition.

In addition to its focus on attacking the joints, RA can occasionally affect other areas of the body, such as the eyes, skin, blood vessels, and respiratory system. Treatments for RA concentrate on alleviating pain and lessening the potential for permanent damage to the joints.

Smeal College of Business Researches Recalls and Brand Loyalty

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Consumers with high brand commitment, defined as people who are “attached to brands, form close relationships with them, and have a general desire to maintain this close relationship,” may take a dimmer view of product recalls than consumers with low brand commitment, according to research published by Smeal College of Business professors in 2013. The findings contradict the prevailing opinion that high brand loyalty helps companies weather periods of negative publicity.

The Smeal researchers investigated consumer reactions to recalls in cases where the products being called back could cause death or serious injury. They discovered that high brand commitment was a liability in those situations. Researchers speculated that consumers might feel more disappointed than usual when a company they particularly like lets them down in such a way. The findings did not hold in cases of low-severity recalls, in which the researchers confirmed previous studies stating that brand loyalty tended to mitigate the negative effects.

Charlie Rose Honored for Contributions to Medical Knowledge

A member of the Columbia-Presbyterian Hospital Health Sciences Advisory Council, Dr. Lindsay Rosenwald has assisted in bestowing the Council’s annual Award for Distinguished Service to individuals who have significantly contributed to the health and well-being of society. A physician and investor, Dr. Lindsay Rosenwald has spent much of his career as the founder and backer of biotechnology companies that have developed medicines that have greatly improved the health of many patients.

Numerous well-known individuals have received the Advisory Council’s Award for Distinguished Service, including Christopher Reeve, Mike Wallace, Anna Wintour, and Sanjay Gupta. In 2012, the award was given to Charlie Rose, a television personality and anchor. Rose, who co-anchors the TV shows Charlie Rose on PBS and CBS This Morning, worked with Nobel Prize winner Eric Kandel on PBS’ The Brain Series. The series, which focused on the study of the human brain, addressed topics such as aging, creativity, and social interaction. The Brain Series also has examined the most current research into mental illness, including Alzheimer’s disease and schizophrenia.

Abington Health Expands Services, Facilities

A physician and investor in the biotechnology field, Dr. Lindsay Rosenwald began his medical training at the Temple University School of Medicine. While starting his private medical practice, Dr. Lindsay Rosenwald completed an internship at Abington Memorial Hospital in Pennsylvania.

The hospital is now the flagship facility of Abington Health, a not-for-profit regional health care provider that consistently offers innovative and advanced care to its patients. Abington Health’s providers assist more than 700,000 patients annually, and the health care system employs in excess of 1,200 physicians. Abington Health has earned Comprehensive Stroke Center certification from the Joint Commission and the American Heart Association/American Stroke Association.

Recently, the provider installed the latest-generation MR system, which offers patients a better MR scan experience and produces high-resolution images that help physicians to make more accurate diagnoses. Furthermore, the health care system added a fourth outpatient center. The new 48,000-square-foot facility houses outpatient services and several doctors’ practices that provide care for a wide range of patients, ranging from newborns to senior citizens. The center encompasses a laboratory draw site and an imaging center.

Early Biotechnology IPOs Led to Greater Growth

As one of the first physician analysts on Wall Street, Dr. Lindsay Rosenwald came to the biotechnology marketplace with a strong understanding of what would benefit medicine in general and secure profits at the same time. Entering the world of biotechnology investment in the mid-1980s, Dr. Lindsay Rosenwald built upon a precedent largely set by Genentech, SmithKline, and other innovative biotech firms 10 years earlier.

With SmithKline’s development of Tagamet (the first-ever “blockbuster drug” with $1 billion in annual revenue) and Genentech’s advances in rDNA technology, the mid-1970s proved a fertile ground for the nascent biotech sector. When Genentech launched a highly successful initial public offering in 1980, opening itself to investment on Wall Street became the next logical step for innovators in the life sciences, followed by other, early IPOs Cetus, Applied Biosystems, and Amgen. At the same time, much larger pharmaceutical companies began acquiring promising biotech firms that had yet to go public, creating multiple pathways for these new drug developers to grow and expand.

Pharmas Report Initial Successes with New Heart Disease Biotherapy

A physician and biotechnology investor, Lindsay Rosenwald has helped to fund drugs for leukemia and prostate cancer. Today, Lindsay Rosenwald co-manages a New York City asset management firm that focuses on medical innovation.

Over the last decade, researchers have made a series of major discoveries that have given pharmaceutical and biotechnology firms a better understanding of the biological causes of high cholesterol. Due to this extraordinary research, which showed that various mutations of a gene called PCSK9 dramatically affect low-density lipoprotein (LDL) cholesterol levels, drug developers have begun a race for what could be a cure for heart disease.

Currently, pharmaceutical giants Amgen Inc., Pfizer Inc., and Sanofi each have drugs in clinical trials. Comprised of monoclonal antibodies derived from living cells, these new therapies mimic the effects of the mutated PCSK9 gene. Patients currently participating in the clinical trials have responded well to the injected drug, demonstrating drastically lower LDL levels. Although the drugs will not likely receive approval from the U.S. Food and Drug Administration for several years, Amgen has already built three facilities to produce its cholesterol drug once it is ready for market.

Two Basic Differences between Biotech and Pharmaceutical Firms

A New York City-based investment professional, Dr. Lindsay Rosenwald co-heads an asset management hedge fund dedicated primarily to the biotechnology sector. Over the course of his career, Dr. Lindsay Rosenwald has played a role in developing drugs to treat prostate cancer, influenza, and rheumatoid arthritis.

Although the work of biotechnology and pharmaceutical companies often overlaps, several major differences actually exist between the sectors. This article will discuss two such distinctions.

Firstly, biotechnology firms typically work with complex proteins, genetic material, and microorganisms. Rather than using chemical-based synthetic processes to develop small-molecule drugs, as pharmaceutical companies do, biotechnology firms focus their research on the discovery of novel compounds that can be applied to various therapies.

Secondly, biotechnology companies often operate at a loss during their extensive research and development phases; however, by taking this risk in R&D, they are often responsible for creating the most innovative drugs on the market. On the other hand, pharmaceutical companies generally invest more in marketing and sales, and can use the funds from current drugs on the market to subsidize new research or to license new drugs from organizations like biotechnology firms. Upon creating a successful drug or therapy, many biotechnology firms collaborate with larger pharmaceutical companies that have a marketing and sales infrastructure in place, licensing the drug to or even merging with the larger firm.

From Wall Street to Biotech

A biotechnology and life-sciences investor with numerous achievements in his field, Lindsay Rosenwald serves as one of two founding partners of Opus Point Partners, an asset management firm in the healthcare sector. Raised in Pennsylvania, Dr. Rosenwald graduated from Abington Senior High School before enrolling at Penn State University, where he pursued studies in finance and economics. An outstanding student and member of the Beta Gamma Sigma honor society, Lindsay Rosenwald graduated from Penn State with a Bachelor of Science in 1976 and subsequently became an independent management consultant for the burgeoning healthcare industry. From there, he gained admission to the Temple University School of Medicine, earned his Doctor of Medicine in 1983, and completed his clinical training in internal medicine at Abington Memorial Hospital. After a period in private practice, Lindsay Rosenwald returned to the business world and began a prolific career in the investment and management of promising drug development companies.

Having worked on Wall Street in the mid-1980s, Lindsay Rosenwald became a hugely successful venture capitalist in the Biotech space. To date, Dr. Rosenwald and his companies have licensed and further developed over one hundred drug candidates. More information on Lindsay Rosenwald and his work can be found at www.linkedin.com/in/lindsayrosenwald.