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.

Amgen Moves into Cancer Treatment with Purchase of Onyx

New York City-based biotech financier Lindsay Rosenwald, MD, possesses over 20 years of experience in investing in health care and life sciences companies. In 2008, Lindsay Rosenwald co-founded Opus Point Partners to create a premier investment fund focused on biotechnology.

After several months of discussion, Amgen Inc. agreed to buy Onyx Pharmaceuticals Inc. in a transaction valued at $10.4 billion. The deal will bolster Amgen's product line with Onyx's slate of cancer-fighting drugs, including Kyprolis, a treatment for a form of blood cancer. Until this acquisition, Amgen had mainly produced drugs aimed at supporting rather than treating cancer patients. Because the population is aging and the oncology market is expected to grow as a result, Amgen's purchase of Onyx is widely considered a sound, forward-looking move.

This buyout is the latest in a pharmaceuticals industry in which numerous established firms have sufficient cash on hand to acquire smaller companies. From an investment perspective, this market environment offers many opportunities for investors in small, innovative companies to see their stakes rise dramatically in value as larger firms seek to enhance their product portfolios.