Co-development Of Drug Research Articles

Targeted drugs and diagnostic assays: Companions in the race to combat ethnic disparity.

African Americans (AAs) are more likely than European Americans to develop aggressive breast cancer subtypes, and have higher recurrence and mortality rates; this results in a stark breast-cancer related ethnic disparity in clinical outcomes. In this era of personalized oncology, companion diagnostics (CDx) are transforming the cancer treatment narrative slowly but steadily, by enabling the use of safety and/or efficacy biomarkers to stratify patient populations, and thus ensuring more effective deployment of targeted therapeutics. This parallel co-development of drugs and in vitro diagnostic assays is turning out to be the cornerstone of individualized cancer treatment. In this review, we assert that development of drugs and CDx targeted towards molecular and centrosomal aberrations that occur more frequently in AAs could yield next generation precision medicine tools better informed and inspired by, and more finely attuned to the unique tumor biology of AAs. By understanding more deeply ancestry-associated differences among breast tumors of different ethnicities, and gearing our drug and CDx development efforts to target these distinctions, we might be able to significantly alleviate racial health disparity.

EYE ON CHINA

Chinese Researchers Demonstrate that Icotinib Creates Better Progression-Free Survival with Fewer Side Effects than Whole Brain Radiation in Non-Small Cell Lung Cancer Patients with Brain Metastases. Depressed Patients Are Less Responsive to Chemotherapy. Sanofi and JHL Biotech Announced Strategic Biologics Alliance in China. Chinese Scientists Developed Cancer Breath Test. BGI Opens Seattle Office for North America Expansion. Mederi’s Stretta Therapy for GERD Approved in China. HONG KONG NEWS – Experts Call for Urgent Multi-Stakeholders Collaboration in the Development of an Integrated Cancer Strategy to Safeguard the Sustainability of Hong Kong's Health Care System. HONG KONG NEWS – Uni-Bio Science in Multiple Drug Co-Development Deal with Beijing Sun-Novo. HONG KONG NEWS – Immunotherapy with Pembrolizumab Deemed Cost-Effective for Advanced Melanoma Patients in Hong Kong.

Development of Novel Combination Therapies

Successful development of future targeted therapies will require the flexibility to rapidly evaluate combination regimens involving new targeted agents in a single development program. The FDA has therefore developed draft guidance on drug co-development.

Generating and Weighing Evidence in Drug Development and Regulatory Decision Making: 5th US FDA–DIA Workshop on Pharmacogenomics

The 5th US FDA-Drug Industry Association (DIA) workshop in a series on pharmacogenomics entitled: 'Generating and Weighing Evidence in Drug Development and Regulatory Decision Making', contained four major topics (tracks): 'Learning from Labels and Label Changes: How to Build Pharmacogenomics into Drug Development Programs'; 'Enabling Pharmacogenomic Clinical Trials Through Sampling'; 'Designing Pharmacogenomics Studies to be Fit for Purpose'; and 'Co-Development of Drugs and Diagnostics'. The meeting was attended by approximately 200 professionals, primarily involved in drug development and healthcare delivery. Several critical elements drove the success of the meeting: it was recognized that the enriched conversation at this workshop between regulators and drug developers was driven with less inhibition than before and with a greater scientific focus on the issues. Multiple examples in the field and broader collective experience helped more in-depth thinking of the pros and cons of implementing pharmacogenetic/genetic approaches during drug development, in the current environment. It was also noted that this field is still developing and nascent as illustrated by the paucity of actual diagnostic-drug co-development examples. Furthermore, the complexities of conducting pharmacogenetic research in global drug-development programs was acknowledged as was the need for rigorous research designs and methodologies despite these challenges.

Companion diagnostic development and commercialization: The good, the bad, and the ugly

Abstract QIAGEN (formerly DxS Ltd) has established itself as the market leader in the successful co-development of drug-diagnostic solutions with pharmaceutical partners. QIAGEN has a considerable portfolio of over 15 ongoing collaborations with drug giants such as Amgen, AstraZeneca, Bristol-Myers Squibb and ImClone Systems, Pfizer and Boehringer Ingelheim. This presentation will outline the current state of companion diagnostics as a driver of personalized healthcare; investigate the regulatory and commercial hurdles involved in bringing a companion diagnostic to market and the importance of pharma partnering during clinical development as a way to overcome these hurdles, as well as discuss some of the challenges inherent to companion diagnostic partnerships. Focusing on two of QIAGEN's key experiences with companion diagnostic development for cancer, the presentation will look first at the KRAS story and the challenge of producing the first companion diagnostic of its kind — the TheraScreen®: K-RAS Mutation Kit to predict patient response to metastatic colorectal cancer therapies Vectibix® (Amgen) and Erbitux® (BMS/Imclone Systems) based on the mutation status of the KRAS oncogene. Next, it will examine the importance of another companion diagnostic, the TheraScreen: EGFR29 Mutation Test Kit and its role in facilitating the marketing approval of AstraZeneca's non-small cell lung cancer drug IRESSA® in Europe for EGFR mutation positive patients. With the global perspective on personalized healthcare shifting and pharma recognizing the importance of independent partners for the co-development of drug and diagnostic, the obstacles to bringing companion diagnostic tests to market have shifted. While victories have been won winning the hearts and minds of drug companies, regulators and physicians in key markets like oncology, we are now fighting for value-based reimbursement so that predictive tests can be made available patients and expand the utility of companion diagnostics to new therapeutic areas. The personalized healthcare landscape is set to continue its rapid evolution to meet these new challenges.

Approval of novel biomarkers: FDA's perspective and major requests

FDA has been regulating diagnostic tests (including biomarkers) since passage of the Medical Device Amendments of 1976. Although always of interest as diagnostic tools, biomarkers (particularly genetic/genomic) have become of increased interest because of their potential impact on the development and personalized use of drugs. Unfortunately, there seem to be uncertainties among translational researchers as to the specific analytical and clinical measurement criteria needed for the approval of these novel biomarkers. This meeting presentation describes the current FDA perspective and major requirements and data for the validation/approval of an in vitro diagnostic device (IVD) based on a biomarker. The approval process for an IVD based on a biomarker used in the identification of a disease or condition (diagnosing, screening, monitoring) is well established, and is essentially identical to the process to generate sufficient analytical and clinical data for the approval of regular diagnostic devices. On the contrary, approvals for IVDs based on biomarker which may be designed to evaluate the efficacy or answer safety questions for new drug entities are less streamlined. The clinical studies are more complex, resulting in higher ethical standards, increased costs and requiring complex statistical evaluation. There is a small but growing literature on new models for co-development of drugs and diagnostics which will be discussed. Regulators like the FDA develop and bring a flexible regulatory toolbox to the table and are committed to assuring that scientific and regulatory thresholds are tempered to assure rapid access to new technologies while protecting public health.

Drug–Diagnostic Codevelopment Strategies: FDA and Industry Dialog at the 4th FDA/DIA/PhRMA/PWG/BIO Pharmacogenomics Workshop

The 4th US FDA/Industry Workshop on Pharmacogenomics in Drug Development and Regulatory Decision Making, was held in MD, USA, on December 10-12, 2007. One of the breakout sessions of the workshop focused on the regulatory issues around codevelopment of drugs and companion diagnostics. This session used hypothetical case studies as focal points for discussion of current thought and critical issues for both industry and the FDA in this evolving field. The panel and the audience discussed the evolution of the FDA's thinking on the regulatory path for companion diagnostics since the release of the April 2005 draft Drug Test Codevelopment Concept Paper and the issues faced by industry in attempting codevelopment efforts. This session provided an opportunity to allow an exchange of ideas between the FDA and industry and to identify critical issues that need further discussion in this important and evolving field.