Category Archives: Pharmaceuticals

Drug Pricing in New Jersey Made More Transparent

Pharmaceutical executive John Klein serves as the chairman of Cambridge Therapeutics in New Jersey. In this capacity, he leverages more than two decades of experience in the pharmaceutical industry to set Cambridge Therapeutics’ strategic direction. To enhance his experience, John Klein stays abreast of state news that relate to the field.

A bill sponsored by Senator Troy Singleton was recently approved by the New Jersey Senate health committee that would bring more transparency to pharmaceuticals marketed and sold in the state, thus helping Garden State residents reduce their medication expenses.

Over the last several years, the rising costs of medication has become a major concern for many Americans. Reports from the New Jersey Health Care Quality Institute stated that drug prices rose 27 percent between 2012 and 2016, while overall healthcare spending only rose 18 percent in the state and 15 percent nationwide. Subsequently, Garden State hospitals have had to double budgets for pharmaceuticals between 2008 and 2017, as well as increase per-patient costs by an average of 132 percent.

Under the proposed bill, a public website would be created that listed specific drugs, along with information about their generic status, brand, and dosage. The per-unit wholesale cost of the medication would also be included on the website. Furthermore, pharmaceutical manufacturers and marketing agencies will be required to submit quarterly updates on pricing details to the State Board of Pharmacy. Companies that fail to do so will be fined between $200 and $20,000.

HMH Center for Discovery and Innovation Focuses on Future of Medicine

 Hackensack Meridian Health Hospitals pic
Hackensack Meridian Health Hospitals
Image: hackensackmeridianhealth.org

At Cambridge Therapeutics, based in Teaneck, New Jersey, chairman John Klein directs the work of teams dedicated to innovation in medical products and pharmaceutical packaging. In keeping with his professional focus on helping to deliver high-quality medical care, Cambridge Therapeutics founder John Klein additionally serves on the board of trustees of Hackensack Meridian Health Hospitals.

Affiliated with Hackensack University Medical Center, HMH has developed the Center for Discovery and Innovation, which works to take pioneering techniques in biomedicine and harness them as a means of improving outcomes for patients with debilitating or life-threatening diseases, and as a way to prevent major diseases entirely. The center’s founders believed that the technological innovations of the 21st century can and should inform medical treatment more thoroughly for the benefit of patients and communities.

The center makes use of advances in the fields of genetics and genomics, bioengineering, immunology, and cellular and stem-cell biology, particularly in the treatment of cancer. The regenerative medical programs at the center also aim to discover the best ways of restoring tissues or entire organs damaged through injury or disease.

Among the individual units of the center are the Institute for Cancer and Infectious Diseases, and another institute dedicated to exploring best treatments for multiple myeloma.

Novel Drug Delivery Systems Are the New Frontier in Drug Treatments

Possessing three decades of experience in the pharmaceutical industry, John Klein serves as the chairman of Teaneck, New Jersey-based Cambridge Therapeutics. John Klein is responsible for guiding Cambridge Therapeutics in the development of combination therapies and novel drug delivery systems.

Novel drug delivery systems involve innovative approaches to the delivery of drugs. The process used to deliver drugs to patients can significantly impact their effectiveness and safety. For instance, many pharmaceuticals have an optimum concentration range that provides a maximum amount of therapeutic benefit, while higher amounts can be toxic and lower amounts may result in no benefit.

To maximize the health benefits of pharmaceutical therapies and reduce harmful side effects, researchers are developing new drug delivery systems that are based on interdisciplinary research in fields such as bioconjugate chemistry, polymer science, molecular biology, and pharmaceutics. Some of the techniques used in novel drug delivery systems include cell ghosts, microparticles comprised of biodegradable or insoluble polymers, microcapsules, lipoproteins, soluble polymers, and other delivery techniques.

The Role of the New Drug Application in FDA Approval

 

FDA pic
FDA
Image: FDA.gov

The founder and chairman of Cambridge Therapeutics, John Klein draws on more than two decades of experience as a senior executive with companies such as Zenith Laboratories, Ivax, and NovaDel Pharma. During his career, Cambridge Therapeutics founder John Klein has gained a deep understanding of the U.S. Food and Drug Administration’s (FDA) approval process.

Before applying for FDA approval to market a new drug, sponsors must file a New Drug Application (NDA), in which they are required to detail data and analyses regarding the drug’s manufacturing process, pharmacology, dosage, and toxicology, as well as any human and animal studies. Upon the submission of an NDA, the FDA can take as long as 60 days to decide if it is going to file it for further review or reject it on the basis that it requires additional information.

If filed for review, the NDA is then evaluated by the FDA’s Center for Drug Evaluation and Research (CDER), which can take up to 6 months to act on priority drugs and 10 months for all other drugs. The CDER can then either approve or reject the drug, or issue an approvable letter regarding the drug which states minor deficiencies that need to be corrected before ultimate approval. The NDA process has served as the basis for regulating new drugs in the United States since 1938.