Don Tracy, Associate Editor 

Preparing for Federal Regulations: Q&A with John Stanford

, John Stanford, executive director at Incubate, emphasized the importance of sustained investment in early-stage biotech to drive long-term innovation and ensure a robust drug development pipeline.

Funding Cuts Threaten Diversity in Clinical Research

, Kyle McAllister, co-founder and CEO of Trially, warned that funding cuts to clinical research threaten diversity by undermining support for studies focused on underrepresented populations and stressed that technologies such as artificial intelligence and telemedicine are vital to mitigating these challenges.

Help Patients Prevent and Treat Dry Mouth

Health care professionals can help patients prevent and manage dry mouth by identifying potential medication-related causes, recommending lifestyle changes and over-the-counter products with ingredients like xylitol, and emphasizing good oral hygiene practices to reduce the risk of dental complications.

Q&A: Expert Discusses the Critical Role of Clinical Pharmacists in Diabetes Management

Nathan Ramsbacher, PharmD, emphasized the vital role of clinical pharmacists in diabetes management by improving medication access through manufacturer-sponsored patient assistance programs, resulting in significant cost savings and better health outcomes for patients.

Supreme Court Preserves Key Part of Obamacare Coverage Requirements

The Supreme Court upheld a key provision of the Affordable Care Act requiring private insurers to cover preventive health services, rejecting a constitutional challenge and preserving access to no-cost care—such as cancer screenings and HIV prevention—for roughly 150 million Americans.

Articles

Pharma Pulse 6/30/25: Preparing for Federal Regulations; Funding Cuts Threaten Diversity in Clinical Research

2025 DIA Annual Meeting: How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials

, Brian Ongioni, chief product officer at uMotif, explained how the company integrates patient and site feedback early in the development process to improve the usability and regulatory strength of digital health tools, and shared how AI and machine learning could further enhance patient-reported outcomes by amplifying patient voices and streamlining trial workflows.

The Role of Patient Advocacy in Shaping AbbVie's Cancer Therapies

, Pedro Valencia, VP of asset strategy leadership, oncology, at AbbVie, emphasized the company’s commitment to incorporating patient advocacy into early development decisions—particularly in solid tumors—highlighting how feedback from advocacy groups helps shape AbbVie’s oncology pipeline and advance therapies that address both clinical outcomes and meaningful quality-of-life benefits.

Sticking With It: A Meta-Review of Anti-Dementia Medication Use and Adherence

A recent meta-analysis of nearly 700,000 patients found that persistence with anti-dementia drugs drops significantly over time, with only about half of patients remaining on treatment at 12 months, highlighting the need for standardized reporting and targeted interventions to improve long-term adherence and patient outcomes.

Q&A: Creating a Pharmacy Where Technicians Can Thrive

, Taylor Watterson, PharmD, PhD, emphasized that creating a pharmacy where technicians can thrive starts with recognizing their critical role in operations, offering career advancement, fair compensation, and involving them in decision-making—especially in independent pharmacies where their contributions are already deeply valued.

BRAF-Mutant and HER2+ mCRC Management Strategies Are Becoming Increasingly Tailored: With Chandler Park, MD, and Midhun Malla, MD

, Chandler Park and Midhun Malla explored how treatment for metastatic colorectal cancer is becoming increasingly personalized, emphasizing the importance of early molecular profiling and tailoring therapies for BRAF V600E–mutant and HER2-positive tumors based on emerging trial data, tumor sidedness, and evolving real-world practices.

Pharma Pulse 6/27/25: How AI and Machine Learning Can Improve Patient Reported Outcomes in Clinical Trials; The Role of Patient Advocacy in Shaping AbbVie's Cancer Therapies

How CRO Partnerships Are Evolving to Meet Changing Industry Demands

, Judith Ng-Cashin, MD, chief medical officer, Novotech, emphasized the need for CRO partnerships to become more collaborative, cost-efficient, and insight-driven in response to evolving regulatory and funding challenges, highlighting Novotech’s award-winning collaboration with Tune Therapeutics as a model for success.

Don’t Fall for the Call of Placebo-Controlled Vaccine Trials

 article, Spreeha Choudhury of Epstein Becker Green warns that calls for placebo-controlled vaccine trials—championed by HHS Secretary Robert F. Kennedy Jr.—are ethically dangerous, medically unnecessary when effective vaccines already exist, and risk repeating the dark history of withholding proven treatments in the name of research.

The decades-long debate over fluoridated public water has intensified following new toxicology data linking high fluoride levels to lower IQ in children, prompting statewide bans in Utah and Florida, pending legislation in several others, and an FDA move to remove certain fluoride products from the market—all while oral health experts prepare to push back against these sweeping policy changes.

Novel Targeted, Chemo-Free, and Cellular Therapies Are Poised to Transform Treatment Paradigms in B-Cell Malignancies

Alexey Danilov discusses how novel chemotherapy-free regimens, targeted therapies, and CAR T-cell approaches are beginning to transform treatment paradigms in B-cell malignancies such as mantle cell lymphoma and CLL, with a growing emphasis on individualized care, clinical trial participation for high-risk patients, and evolving strategies for sequencing therapies to improve efficacy and safety.

Introducing the Borderline Personality Disorder Inventory

A new psychodynamically-informed screening tool—the Borderline Personality Disorder Inventory—has been introduced to help clinicians more accurately identify core features of borderline pathology, offering a brief, 25-item questionnaire designed to capture deeper personality dynamics often missed by traditional symptom-based assessments.

Pharma Pulse 6/26/25: How CRO Partnerships Are Evolving to Meet Changing Industry Demands; Don’t Fall for the Call of Placebo-Controlled Vaccine Trials

2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development

 at the 2025 DIA Annual Meeting, Brian Ongioni, chief product officer, uMotif, emphasized the importance of incorporating early patient and site feedback into the digital health product lifecycle to ensure digital endpoints are accessible, intuitive, and regulatory-ready.

Developing FP&A Strategies in Today’s Environment: Q&A with Jennifer Kyle

, Jennifer Kyle, CEO, founder, Condor, discussed how the pharmaceutical industry is evolving its FP&A strategies by embracing cloud-native platforms, real-time risk modeling, and cross-functional collaboration to overcome fragmented data workflows and adapt to today’s increasingly unpredictable clinical and financial environment.

Q&A: PBM Unbundling, New Pricing Models Create More Transparency

, Scott Halperin, PharmD, and Morgan Lee, PhD, MPH, of the Pharmaceutical Strategies Group discussed how PBM unbundling and alternative pricing models such as cost-plus, pass-through, and PMPM guarantees are gaining traction as health plans and employers seek greater transparency, flexibility, and regulatory compliance in drug benefit design.

Wheat Germ May Boost Immunotherapy in Cancer Patients

A UC Davis clinical trial led by oncologist Joseph Tuscano is exploring how fermented wheat germ extract may enhance the effectiveness of immunotherapy in cancer patients by boosting immune response, reducing toxicity, and potentially offering a low-cost alternative to traditional chemotherapy.

FDA GenAI Reviews Hinge on Clarity of Dossiers

The FDA’s newly launched generative AI tool, Elsa, is accelerating NDA and BLA reviews by automating repetitive tasks and highlighting dossier discrepancies—prompting sponsors to submit clear, structured, and compliant documents from the outset to benefit from faster assessments and reduce regulatory back-and-forth.