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DIA CONFERENCE
DIA=Drug Information Association
47th ANNUAL MEETING took place June 19-23, 2011 at McCormick Place in Chicago.
Theme: “Convergence”: The convergence of science, medicine, and health; of scientific and operating functions and technology solutions; of internal and contract personnel; of research professionals, health care providers, patients and public.
The DIA conference is a multidisciplinary event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products
This was an international conference with speakers, attendees and exhibitors from different countries. There were 18 tracks which were offered over the 5 day conference with many sessions running in parallel. The tracks included: Clinical Operations, Development Planning, Outsourcing Strategies and Innovative Partnering Models, Nonclinical and Early Clinical Translational Development, Product Advertising and Communications, IT Methods and Technologies, Research Data and Content Management, Regulatory Affairs and Science, Quality and GXP Compliance, Public Policy/Health Care Compliance, Clinical Safety and Pharmacovigilance, Statistics, Health Economics and Outcomes (HEO)/Comparative Effectiveness Research (CER)/Health Technology Assessment (HTA), Medical Devices, Professional Development, Global Agency, SIAC Showcase and there were some Late-breaking Topics as well.
FOCUS ON PEDIATRIC DRUG DEVELOPMENT
It is mandatory that before any drug registration there should be a Pediatric Investigation Plan (PIP) where applicable and regulations vary between Europe and America. A Pediatric Investigation Plan means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorized to treat the peadiatric population. The PIP Includes details of the timing and the measures proposed to demonstrate quality, safety and efficacy. It also includes development of an appropriate formulation for pediatric use if necessary and it is binding to the pharmaceutical company. In Europe the PIP or the application of a waiver should be submitted with a request for agreement not later than upon completion of the human pharmaco-kinetic studies (Phase 1) in adults.
As an advocate for pediatric drug development I actually found this very interesting that pharmaceutical companies are actually mandated to develop drugs for children. There are benefits of submitting a PIP and actually following it through and this includes:
• 6 months extension of Supplementary Protection Certificate (SPC)*
• 2 additional years exclusivity (for orphan products)
• Peadiatric Use Marketing Authorization (PUMA)
*SPC = is an intellectual property right, extending the protection a patent offers beyond the validity of the patent. From the moment a patent expires, the SPC starts its protection.
In the United States, the Pediatric Research Equity Act (PREA) of 2003 gives guidance to PIPs. The WHO Pediatric Regulators Network and CIOMS guidelines are also used.
There was an interesting discussion on whether clinical trials are always needed in pediatric drug development or extrapolation from adult studies. The discussion recognized that while this may be happening in reality there is always caution in extrapolating safety of drugs used in adults. Indication and efficacy issues may be ok to extrapolate in pediatrics but there is always concern on safety especially on dosing.
GLOBAL CLINICAL TRIALS
Globalization will affect both art and science of clinical research. Long a reality, the gradual shift of clinical trials from developed countries to emerging markets continues to be steeped in assumptions, misunderstandings, outdated facts and inaccurate data. Clearly more and more clinical trials sites are being indentified in the developing world. Many pharmaceutical companies for various reasons now use sites in Asia, China, India and Africa. One of the main reasons being that it is becoming more difficult to find research subjects in the developed world especially for infectious diseases. The other reason is that it may be cheaper for the pharmaceutical company to conduct clinical trials in these areas. I would however look forward to these developing countries benefiting when the drug comes into the market. Hopefully.
STATISTICS
There was a focus on Comparative Effectiveness research that the pharmaceutical world is trying to follow. Comparative effectiveness research (CER) is thought to identify what works and does not work in health care. CER infuses evidence on product quality into markets, shifting the relative demand for products in CER studies.
Adaptive Research Designs are being used more and more. These combine phase II and III studies by establishing a number of dosing arms and pruning those down to a manageable two or three (including a comparator) for a confirmatory stage. Once the final doses get confirmed, the study is then expanded assuming a second pivotal study is warranted. Simulations can be used to model possible outcomes and their ramifications. The methodologies and infrastructure for the adaptive approach should be in place and running well and that includes quick and accurate data capture, rapid data validation, prompt generation of meaningful information, and readiness for continuous decision making. This kind of approach can easily reduce development time by a year or more and save many millions of development dollars. However the question is always on the pros and cons of this approach and who benefits the most.
SITE SELECTION
There was an interesting discussion on how sponsors chose their research sites. There is a lot of outsourcing now and many pharmaceutical companies now use Clinical Research Organizations (CROs) to manage trials on their behalf. The CROs therefore will select the investigators’ sites. Site selection normal starts with a feasibility assessment of all potential sites with the use of a questionnaire. Upon identification of potential sites then a pre-study visit is done by the CRO or sponsor before the final selection is done.
FDA INSPECTION/AUDIT
I am based at a site that where I conducted a pharmacokinetic trial and we were the highest recruiters in Botswana. We may potentially be audited by the Food And Drug Authority (FDA). This session was very relevant because an investigator from a site that was audited was sharing experiences on an audit done on their site. You will never know whether your site will be audited and when you get to know it is not going to be for more than 24-48 hours for you to prepare.
CONCLUSION
This was a big welcome for me to the pharmaceutical industry and there is a lot that goes on behind the scenes and there are many renowned professionals behind as well. The next DIA conference is in Philadelphia in 2012.
DR TAFIREYI MARUKUTIRA
RESEARCH MEDICAL OFFICER (BOTSWANA-BAYLOR CHILDREN’S CLINICAL CENTRE OF EXCELLENCE)
WHO/TDR Clinical R&D Fellow
Astellas Pharma US. Inc.
3 Parkway North, Deerfield, IL60015