Mike Hennessy Jr.

Mike Hennessy Jr, President and CEO, MJH Life Sciences

Nothing says “end of summer” like high school football practice, apple cider, and Halloween decorations. Everyone packs up their sand chairs and boogie boards and heads back to the classroom, or workplace, whichever is most applicable. Here at MJH Life Sciences

, where education and events go hand-in-hand, our studios have been polished up all summer to bring a series of medical education programs for our physician audience. Titles such as NSCLC Insights, CKD Stakeholder Summit, and Medical Crossfire

: Expert Insights in Anti-VEGF Dosing for nAMD and DME, are all intended to help physicians improve their patients’ outcomes.

On the Industry Sciences side, MJH strives to contribute to these efforts in a different way. We inform and educate those professionals who research new compounds, investigate potential therapies in clinical trials, manufacture and distribute these drugs, and who also inform patients and healthcare professionals (HCPs) on the most appropriate ways to take advantage of
innovative drugs.

Here, in addition to events, Industry Sciences offers webcasts, digitally-enhanced “books” and magazines, videos, podcasts, and other forms of educational material for our audiences.

Some current topics that may have relevance to clinical trial professionals when peeking ahead to potential commercial viability, especially those developing hopeful advanced and curative treatments, include:

 that overall health spending was 18.3% of GDP in 2021 compared with 19.7% of GDP in 2020. That figure was down a bit, but still represents a hefty piece of the pie. Of this, 31.1% went to hospital care, 14.9% to physician services, and 8.9% to prescription drugs.

Of course with any large enterprise, complexities abound. This complexity—a constantly evolving and moving target—ensures that learning new information must take precedence for all decision-makers. Please take advantage of our many resources as you head back to work and educate yourself on all the latest issues, challenges, and strategic guidance impacting your decisions.

is the president and CEO of Applied Clinical Trials' parent company, MJH Life Sciences

Articles

MJH Life Sciences, parent company of Applied Clinical Trials, continues to offer many forms of educational content to healthcare professionals. 

Staying Ahead of the Game

, it’s back to school for clinical trials professionals! We are focusing on good clinical practice (GCP) and how to “audit-proof” your clinical trials. While keeping tabs on GCP has always been important, the task has only gotten more complex in recent years. The increased adoption of decentralized clinical trials (DCTs) and technological solutions are among the reasons for this. It is crucial to remain compliant in an area that is highly regulated.

This is also our first issue since our editors attended the 2023 DIA Global Annual Meeting in Boston, MA, in late June. A number of themes emerged through the sessions and interviews, including patient data, regulatory compliance, and diversity. You can visit our 

 to check out our latest event show coverage in its entirety.

, regular contributor and freelance writer Christine Bahls gives an overview of how the industry can raise the bar in GCP adherence. Key industry leaders provide insights on improving training and real-time application, as the list of GCP items is only proliferating amid the rise of digitalization. The end goal is avoiding compliance pitfalls in conducting clinical studies.

 focuses on the International Council for Harmonization’s (ICH) Good Clinical Practice (GCP) E6 guidance. Through the COVID-19 pandemic, drug developers learned a lot from the spike in DCTs—the practical challenges and benefits. However, at the time, ICH’s GCP E6 R2 guidance was out of date and did not address DCT elements. With the draft R3 version being issued in May, there are a new set of principles when it comes to DCTs that sponsors must support their investigators and sites in carrying out.

This issue’s trio of feature articles concludes with a 

 on eSource interoperability in the transfer of data from electronic health records (EHRs) to electronic data capture (EDC). Through a live pilot study, embedded within a Phase III cancer trial, experts were able to conclude that the industry is indeed taking steps toward establishing EHR-to-EDC as a highly effective option for clinical trial data requirements.

 is the president and CEO of Applied Clinical Trials' parent company, MJH Life Sciences

Increased adoption of decentralized trials and new advancements in technology among reasons for evolving regulatory landscape.

'Audit-proofing'  Your Trials

As I write this, it is three days before the ASCO Annual Meeting, the first in a series of conferences that arrive in rapid succession, such as CMSC, ASMS, ACR, and the many more conferences that the healthcare brands under MJH Life Sciences® cover. For the 

 audience, we also look forward to attending the Drug Information Association (DIA) Global Annual Meeting at the end of June in Boston.

However, it is ASCO that holds a special place at the heart of MJH. Our flagship iconic oncology brands include 

™, CancerNetwork®, and CURE®. We also offer academic and community oncologists, nurses, patients, and all involved with the cancer care journey with an unmatched selection of resources. These include our live educational events, along with digital and print solutions that deliver the peer-to-peer education needed for improving patient outcomes. From video editorials to conference coverage, we independently produce content that combines objective facts and expert insights for the cancer care community.

 mission isn’t to report the clinical trial results, it is the results from the actual conduct of these oncology clinical trials that are reported. Where would oncology trials be without a team of investigators, clinical research coordinators, data managers, lab providers, medical writers, and many more? That is where 

comes in, on the operations side of drug development.

Clinical trials represent the research side of the clinical care continuum in oncology. Of all the therapies in development, oncology is the largest in the pipeline. That is representative of the true need for cancer treatments. While many patients can participate in clinical trials, many more do not or are not given access due to lack of knowledge or overly strict exclusion criteria.

On both sides of our business—healthcare and industry sciences—we continuously hear about those who have entered the field of oncology in a variety of roles to make an impact on those suffering from cancer. Whether it is an investigator, a pharma CEO, CRO project manager, or clinical research nurse, many are on the front lines with their stories that touch a tremendous amount of people with their compassion. We would like to thank them all for bringing us one step closer to a world without cancer.

A look at the clinical trials side of oncology.

Mike Hennessy Jr.

Articles

Staying Ahead of the Game

'Audit-proofing' Your Trials

ASCO, Clinical Trials for Life