Study Design

Pharmaceutical Outsourcing – Using Science to Drive Successful Study Strategy in Hematological Malignancies

Advances in our understanding of the genetic drivers of cancer and the immune system’s complex response to cancer have led to significant breakthroughs in the treatment of hematological malignancies. While gene therapy technologies are addressing unmet needs in hemato-oncology, the design and execution of clinical trials of these therapies can be challenging. Obstacles in researching...

Medical and Regulatory Affairs

Medical Design & Outsourcing – What you need to know about growing cyber threats to medtech

Medical devices are an especially rich cybersecurity target for malicious activity by those seeking commercial gain or just trying to wreak havoc. And while data theft is a serious threat, the risks posed by hacks that involve the expanding universe of networked medical devices can be especially menacing. In 2015, the FDA warned that a...

Clinical Research: Phase 1 - Phase 4

Outsourcing-Pharma – Trials suggest long-acting antipsychotics use should be expanded

Outsourcing-Pharma – Trials suggest long-acting antipsychotics use should be expandedQ&A with Andreas Schreiner, M.D., Executive Director, Medical Affairs Neuroscience & Analgesia

Clinical Research: Phase 1 - Phase 4

Outsourcing-Pharma – Clinical trial logistics for the schizophrenic patient

Outsourcing-Pharma – Clinical trial logistics for the schizophrenic patientQ&A with Andreas Schreiner, M.D., Executive Director, Medical Affairs Neuroscience & Analgesia

EE Times – Medical Devices Battle Cyber Threats

For five days in July 2018, someone hacked the email account of an employee at cancer-testing startup Guardant Health and stole information that included names, Social Security numbers, birthdates, and medical diagnosis codes. The breach, involving about 1,100 patients, came to light when the company filed for its initial public offering with the Securities and...

Applied Clinical Trials – Improved Understanding of Psoriasis Buoys Treatment Hopes for Patients

Of all the stunning advances medical science has made over the past few decades, perhaps few are more pronounced than the treatment of psoriasis. In the 1950s, common remedies included arsenic, ammoniated mercury, and coal tar. In the ‘60s and ‘70s, heavy advertising promoted a “new healing discovery” called Tegrin, a coal tar product promising...

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Complex, Puzzling, Ill-Defined: Challenges in Assessing PTSD

A recurring challenge in assessing and treating Post-Traumatic Stress Disorder or PTSD is the inherently complex, ill-defined, and sometimes downright puzzling nature of its symptoms. The condition has had many names over the years. Among them: shell shock, combat exhaustion, irritable heart, and even nostalgia. The affliction, now widely know as post-traumatic stress disorder, was...

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Alzheimer’s Clinical Trials: Obstacles and Opportunities

Dementia is a global epidemic, affecting nearly 50 million people worldwide. By 2050, it’s estimated that 115 million people will suffer from some form of dementia. Alzheimer’s disease (AD) is the most common type of dementia occurring late in life. AD is also the only condition among the leading causes of death that cannot currently be...

Clinical Research: Phase 1 - Phase 4

Pharmaceutical Executive – Small Biotechs Gain As the Span of Clinical Trial Outsourcing Grows

A customer approached me recently for advice on hiring a chief medical officer. My answer: “Don’t.” The last thing his two-person company needed was to spend a lot of money increasing its staff by 50% and still not achieving its real objective. Not that there’s anything wrong with CMOs—I am one, after all—but tiny, virtual...

Clinical Research: Phase 1 - Phase 4

PM360 – Maximizing the Probability of Trial Success for CAR-T Cell Therapies

CAR-T cells are complex products, and translating them from basic and preclinical research to clinical trials and commercialization can be challenging. Understanding the regulations and developing a protocol that puts safety first—at every stage of development—are important first steps in bringing promising CAR-T cell therapies to the patients who need them most. CAR-T Cell Therapies:...