Tag: oncology

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 Peter Larson to Lead Hematology/Oncology

DURHAM, N.C., December 1, 2016 — Premier Research announces the appointment of Peter Larson, M.D., as Senior Medical Director for Hematology/Oncology. Dr. Larson will support the drug development work of the company’s innovative biotech customers, bringing to the role more than 17 years of clinical and medical affairs experience. With a background spanning the pharmaceutical,...

Premier Research Bolsters Rare Disease and Oncology Drug Development Expertise with New Hires

DURHAM, N.C., June 13, 2016 — Premier Research is expanding its international organization of experts in rare disease amid continued growth in the field — especially in rare oncology, which has surpassed one-third of the company’s rare disease work. “Development of novel compounds for treatment of unmet medical needs historically has been overlooked by big pharma,...

Consulting

Starting a Novel Oncology Trial? A Lot Is at Stake, So Attend this February 24 Webinar

PHILADELPHIA, FEBRUARY 24, 2016 — There’s a lot to consider when investigating a novel and targeted oncology compound, and decisions you make early on can have profound and lasting implications. At a webinar on Wednesday, February 24, Premier Research will show how making sound decisions from the outset can improve your odds of long-term success....

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...