Premier Perspectives Blog

Insider Insights in Clinical Development

The FDA has released a new draft guidance for sponsors of drug and biological products for the treatment of rare diseases in early development and in the planning of and participation in formal pre-investigational new drug application (pre-IND) meetings. Read the full guidance here or click the image to download.

The FDA has released a new draft guidance for sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for the treatment of specific hematologic malignancies. Read the full guidance here or clickRead more

Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning processRead more

While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed. Here are a few of the key differences: Requirement for a clinical trial When studyingRead more

While clinical investigations of medical devices and investigational drugs have their differences, what they do have in common is the goal of safeguarding the rights and welfare of study participants while bringing safe and effective products to market as quickly and efficiently as possible. Not all medical devices require a clinical trial, depending on theirRead more

It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER)Read more

Experts describing recent advances in drug development often drift into hyperbole — but really, can you blame them? Gene therapies and drugs that weaponize the immune system against tumor cells are among recent breakthroughs that were unthinkable even a decade ago. But therapies for central nervous system disorders have been a stubborn exception. “We recognizeRead more

Rare disease and orphan drug research has a long history of serious challenges, thanks to both intrinsic factors—fewer patients means less available data; less available data means a less complete picture—and market forces—it’s more difficult to find investors when a smaller pool of patients may mean a more uncertain potential return on investment. Luckily, recent changesRead more

Want to know how to build strong strategic sponsor-CRO partnerships? Commit to the three Ds: Start with a dialogue that establishes the project’s direction, ultimately making a difference in the relationship. In these relationships, a CRO must bring to the table the supplemental expertise a sponsor doesn’t know they don’t have, but needs for success. 1. Foster a Dialogue Bidirectional communication is probably theRead more

Acne is a common chronic inflammatory skin condition with a complex pathophysiology involving multiple factors. Effective types of treatment involve both prescription and over-the-counter remedies that may be topical or systemic. While many popular therapies have been available for decades, today’s patients and physicians have more options for acne management. Additionally, new research and novelRead more

Adaptive design is a type of clinical trial methodology that incorporates prospectively planned opportunities for modification of one or more aspects of a study’s design or its hypotheses based on interim analysis of study data. Explicitly planning these pre-specified changes helps to maintain scientific integrity while also introducing greater flexibility in the clinical research environment. The majorRead more

When it comes to pediatric analgesic clinical trials, protocols cannot be simply “cut and paste” from adult trials. Likewise, extrapolation of efficacy and risks from adult studies is not always reliable due to developmental and physiological differences. Researchers engaged in pediatric trial design must consider the specific physiology, pharmacology, and normal daily activities for each group beingRead more

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