Life sciences expert Rena Roseberg, Ph.D., warns that research and commercial efforts cannot operate within a vacuum. Here, she shares best practices on developing a therapeutic product with solid understanding of its commercial viability.
- Is It Time To Replace RECIST — Or Just Add AI?
- India Opens The Fast Lane For Drug Development
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
- What Really Moves The Needle In Primary Immunodeficiency Research And Treatment
- Clinical Trials Have A Native American Problem
- First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success
GUEST COLUMNISTS
-
![Young female scientist works at work bench in laboratory-GettyImages-899074182]( "What Really Moves The Needle In Primary Immunodeficiency Research And Treatment")
What Really Moves The Needle In Primary Immunodeficiency Research And TreatmentKedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access SuccesseGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![MRI scanning in control room-GettyImages-2176245578]( "There's A Gap In Brain Tumor Research — Here's How We Fix It")
There's A Gap In Brain Tumor Research — Here's How We Fix ItBrain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.
-
![Glioblastoma in Left Frontal Lobe with Midline Shift-GettyImages-2226756753]( "Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic")
Lessons Learned While Taking Glioblastoma Drug From Bench To ClinicMimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection.
-
![pharmaceutical inspection identifies pills-GettyImages-2154549420]( "The Much-Feared FDA Form 483, Part 3")
The Much-Feared FDA Form 483, Part 3This final installment in this three-part series offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs.
-
![Seasonal allergies-GettyImages-2208079266]( "Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze At")
Considerations For Allergic Rhinitis Trials Are Nothing To Sneeze AtInimmune CEO David Burkhart explains how a GSK layoff led to the formation of a new company focused on treating allergic rhinitis. Here, he shares success from the company's approach to site selection, trial design, and timing.
CLINICAL TRIAL WHITE PAPERS
-
![GettyImages-2024666721-meeting-table-office-business-man-doctors]( "De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital")
De-Risking Early-Stage Biotech: Turning Vision Into Venture CapitalFor early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
-
Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
-
Best Practices In Rare Disease Patient Recruitment3/9/2026
Recruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.
-
AI in Pharma: Benefits, Risks, And The Road Ahead10/23/2024
How could leveraging AI technologies, including machine learning (ML) and generative AI (GenAI), enable your company to streamline processes from drug discovery to post-launch?
-
Decentralized And Community-Based Solutions Driving Women's Healthcare9/24/2025
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
-
Outlook Good For 7 Drugs Up For Q3 Review8/15/2024
A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
-
Use Case: How Consulting & Analytics Can Guide Clinical Strategy7/10/2025
A large European pharmaceutical company sought to benchmark a CRO’s suggestions involving a Phase III trial for a newly acquired asset.
-
How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives6/5/2024
Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
-
U.S. Renal Care Achieves 75% Site Adoption Of eConsent5/1/2024
By dispelling prevalent misconceptions regarding participant age, cost, and complexity, see how this platform emerged as a versatile, rapid, and effective solution tailored to the unique needs of the elderly renal care population.
-
Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
-
Cracking The Code: Strategies For Success In Complex Trials8/27/2024
Navigating the complexities of modern clinical trials requires advanced technology and strategic planning. Learn what goes into managing a challenging, decentralized rare disease trial.
NEWSLETTER ARCHIVE
- 04.17.26 -- Continue To Choose New AI-Related Projects
- 04.16.26 -- Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic
- 04.15.26 -- Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
- 04.15.26 -- STREAM Edition: Continue To Choose New AI-Related Projects
- 04.14.26 -- Manipulating Costs And Technology Prices In Clinical Research
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
FOCUS ON PATIENTS
-
![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
-
![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
