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.

Bullish Biotech a Boon to Health Sector Investors

As the co-founder of Opus Point Partners, Lindsay Rosenwald, MD, devotes his considerable expertise as a physician and entrepreneur to managing one of Wall Street's top biotechnology-focused investment funds. Top investors like Lindsay Rosenwald have taken serious notice of the very bullish biotechnology sector this year.

A number of biotechnology acquisitions have been announced in the past few months, including:

- Valeant Pharmaceuticals International agreed to buy Bausch + Lomb for $8.7 billion, greatly expanding Valeant's eye care business.

- Actavis Inc., which manufactures generic drugs, announced the purchase of Warner Chilcott in an $8.5 billion transaction.

- Thermo Fisher Scientific, a maker of scientific instruments, acquired another instrument manufacturer, Life Technologies, for $13.6 billion.

- Amgen announced a deal worth $10.4 billion to buy Onyx and its line of cancer treatments.

Typically, a buyout forces the purchasing company's stock price to drop and the acquired company's price to spike. In recent biotech acquisitions, however, both parties' stock prices have risen, suggesting strong investor confidence in the sector. This attitude is further reflected in the recent positive performance of many biotechnology exchange traded funds (ETFs), which track along with sector-wide trends.

Many analysts believe this positive trend will continue as large firms seek to buy out small, agile companies with innovative new products. Given the aging trends in the populations of developed nations, investing in life sciences today would appear to be a good bet for the long term.

Biotechs Experience Success after Initial Public Offering

The co-founder of the New York City asset management firm Opus Point Partners, Lindsay Rosenwald has built a career around biotechnology investment. Since the 1980s, Lindsay Rosenwald has identified investment opportunities in the medical sector, having served as one of Wall Street's first physician analysts.

As of July 2013, 16 biotechnology companies have gone public this year, with more than half a dozen companies completing initial public offerings in June alone. Share prices for these firms are now at an average of 48 percent higher than their offering prices. This jump is due in part to Onyx Pharmaceuticals' recent refusal of a $120 per share buyout offer from international giant Amgen. Onyx's demand for a higher price launched a wave of stock increases for biotechs across the country. In mid-July, the New York Times reported that "four of the top 10 performing companies on the Nasdaq year-to-date were biotechs."

In addition, larger companies have acquired venture-capital-backed biotechs. In the second quarter alone, industry leaders bought out five such firms. Moreover, pharmaceutical companies often target small biotechs as licensing partners, saving themselves the upfront investment in research and development.

Pharmaceutical and Biotech Sectors Experience Surge in China

Over the last two decades, Lindsay Rosenwald has funded an array of small biotechnology firms, and he has sold several of these companies to large pharmaceutical corporations. Today, Lindsay Rosenwald draws on this experience in his work as co-manager of the asset management firm Opus Point Partners in New York City.

In recent years, health care spending has increased dramatically in China. In 2006, only 43 percent of the Chinese population had health insurance, and the average health care spending per person was $119. Five years later, 95 percent of the population had health insurance, and spending had jumped to $261 per person.

In response to the country’s increasing commitment to health care, pharmaceutical companies have started making inroads in the Chinese market. Major firms such as Sanofi, Novo Nordisk A/S, and Eli Lilly and Company have helped grow the pharmaceutical market size to more than $71 billion. Additionally, these corporations are collaborating with and investing in an array of local partners.

China also boasts a burgeoning biotechnology industry; thanks to more than $160 billion in investments, the sector has developed 12 new drugs. Presently, the country is focused primarily on producing therapies to treat cancer, and it places a significant emphasis on biologics rather than small molecule drugs. By 2020, officials hope to bring 100 new therapies to market.

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.

Smeal College of Business on Final Stretch of Five-Year Strategic Plan

Dr. Lindsay Rosenwald co-leads a New York City asset management firm focused primarily on biotechnology investment. A graduate of The Pennsylvania State University and the Temple University School of Medicine, Dr. Lindsay Rosenwald holds a seat on the Board of Visitors of Penn State's Smeal College of Business.

In 2008, the Smeal College of Business at The Pennsylvania State University introduced a five-year strategic plan that focused in on four core principles: extraordinary education, research with impact, dialogue with society, and community with distinction. Within each of these categories, officials identified an array of measurable goals, ranging from creating a new major to increasing research endowments to boosting mentorship programs. The Smeal College of Business developed these strategic goals with the ultimate objective of becoming one of the top five business schools in the nation.

Over the last five years, the Smeal College of Business has demonstrated its commitment to continued success and improvement. As the plan comes to an end with the close of 2013, officials will analyze the overall effectiveness of the initiative and its goals. To learn more about this school's educational programming for undergraduate, graduate, and executive students, please visit Smeal.PSU.edu.

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.