Tag: hematology/oncology

Clinical Research: Phase 1 - Phase 4

Why Have Cancer Treatment Vaccines Fallen Short?

Vaccines were once thought to have great potential for combating some types of cancer, but reality has failed to match those expectations. To date, vaccines have failed to play a major role in the pursuit of immune response for oncology patients. There have been two notable successes — sipuleucel-T (marketed as Provenge) is approved to...

Clinical Research: Phase 1 - Phase 4

Considering iRECIST Guidance in Evaluating Solid Tumors

In evaluating patient response to treatment of solid tumors, the nearly decade-old RECIST 1.1 guideline remains the gold standard. But the implementation earlier this year of the iRECIST guidance is focusing attention on how the many wide-ranging approaches to tumor assessment interrelate, and how they rank in relevance — today and looking forward. It all...

Consulting

Webinar Explores Expanding Role of Immuno-Oncology Drugs

DURHAM, N.C., MAY 23, 2017 — Interleukin-2, interferon, and other immune-modulating agents have long been used to treat some solid malignancies, but their efficacy is generally limited to immunogenic cancers such as melanoma and kidney cancer. Until now. Today, multiple immuno-oncology pathways are under development, and we’ll explore this promising trend in a webinar on...

Consulting

5 Endpoints for Rare Oncology Trials

In general, greater certainty about the clinical benefit of a drug correlates with an increased time to achieve needed results — the best evidence can take years of careful follow-up. But an unnecessarily long time to market isn’t good for sponsors and patients alike. This is especially true for patients battling rare cancers: With many of these conditions lacking standard treatments,...

Consulting

Adaptive Design Strategies in Rare Oncology

Traditional trial design use only a priori inputs to obtain final trial results. From first patient in to last patient out, trial execution proceeds without change, following a black box approach. While a standard for clinical research, this strategy doesn’t always suit rare oncology research, which must contend with very small patient populations that are often difficult to treat....

Consulting

From Lab to Bedside: February 28 Webinar Examines Treatment of Rare Cancers

DURHAM, N.C., FEBRUARY 22, 2017 — Premier Research will share new insights on rare oncology drug development at a webinar on Tuesday, February 28. From Laboratory to Bedside: Expediting Development of Novel Rare Cancer Treatments (11 a.m. EST / 4 p.m. GMT / 5 p.m. CET) will examine how new processes and regulatory pathways are...

Patient and Stakeholder Engagement

Rare Cancer Research from the Patient’s POV

The purpose of clinical research is ultimately to help patients. That may sound obvious, but all too often we forget the human side when it comes to clinical trials. For patients with rare cancers, taking their perspectives into consideration is invaluable to quality research. But what specific unmet needs do rare oncology patients have? What...

Medical and Regulatory Affairs

8 Programs That Get Rare Cancer Treatments to Patients Faster

A variety of factors can make it difficult to conduct traditional full-scale clinical trials for new treatments of rare cancers. Consequently, because so little information is available, treatments for rare oncology patients are inadequate or nonexistent. Luckily for both patients and researchers, the FDA and the European Medicines Agency (EMA) have introduced regulations that expedite review and approval of certain investigative drugs. Expedited FDA...

Clinical Research: Phase 1 - Phase 4

Innovations in Rare Oncology Trial Design

A rare cancer is often defined as one with an incidence of less than 15 per 100,000. The patient populations of these conditions are so small that traditional clinical trial design strategies can be unfeasible. But, with such a low incidence, just why is rare oncology research so important? Why Rare Oncology Needs Innovation Keep in mind...

Premier Research Names Paul Hallenbeck Executive Director for Oncology

PHILADELPHIA, December 17, 2015 — Premier Research announces the appointment of Paul Hallenbeck as Executive Director for Oncology. Dr. Hallenbeck has more than 20 years of experience in the biotech industry and expertise in all phases of oncology drug discovery, development, and commercialization, including work in complex, targeted biologics. Dr. Hallenbeck most recently served as...