Publications and Presentations

A changing regulatory environment and difficult targets present significant challenges for biopharmaceutical companies seeking a balanced approach to risk management.
Risk management for prescription pharmaceuticals is both a high priority and a significant challenge for the biopharmaceutical industry today.

The many regulatory differences and their evolution implied by the spectrum of clinical trial emerging markets in which to conduct clinical trials clearly emphasizes the need for growing clinical logistics expertise as those regions of the world themselves grow in importance.

On September 28, 2007, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) released a new guideline for the biopharmaceutical industry entitled "Basic Concept for International Joint Clinical Trials." The PMDA issued the guideline in response to growing concern about the "drug-lag" challenge facing Japan. The new guideline on trial data provides opportunities for Japanese biopharmaceutical companies and global contract research organizations to work together to speed up drug development in Japan.

The differences between traditional generics and biosimilars are really quite fundamental. Biologicals are orders of magnitude more complex both in structure and in terms of impurity profile compared to small molecules. As a consequence of this increased complexity, it is more challenging to convince the regulatory authorities that the "biosimilar" is similar to the innovator product. Therefore, biologicals will not be treated as standard generics.

A survey produced by health industry insights, an IDC company and sponsored by PAREXEL reported that the top three most important companies in working with performance metrics for biopharmaceutical companies in working with clinical research organizations (CROs) on clinical studies are meeting milestones, keeping the project on time, and keeping the project on budget. These conclusions are reinforced in a Tufts Center for the Study of Drug Development survey conducted for the Association of Clinical Research Organizations (ACRO).

The industry is buzzing with today’s hot topics in outsourcing – performance metrics, diversity and clinical trials. Throughout the past decade increasing pressure to reduce costs and time to market has led to rapid expansion of the global CRO market. Specialty Pharma has asked some of the foremost CROs how they are addressing important issues of today and what they are doing to distinguish themselves from the rest of the crowd.

The development of new medicinal products is guided by internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategies starting from drug discovery, lead identification, and preclinical testing all the way through the clinical phases of development and drug approval. The major aim of this highly regulated process is to prove efficacy of new medicines and ensure patient safety throughout development and commercialization.

Web-based forums allow ongoing contact with key opion leaders-on their schedule

For most pharma companies, key opinion leaders (KOLs) have become an increasingly important part of the team, throughout the entire lifecycle of product development. And at each stage, there are electronic tools to help companies get the most out of their KOLs.

Structuring the knowledge and expertise within the organization is key to a project plan that works.

The number of new clinical trials worldwide has increased significantly, forcing the biopharmaceutical industry to look for new markets to conduct studies. Double-digit growth in the number of clinical trials conducted over the past five years in regions like Central Eastern Europe, Asia, and Latin America is a clear indication of this trend.

Since the 1950s, global pharmaceutical companies have invested billions of dollars in safety and monitoring systems to improve pharmacovigilance. Despite the tremendous expenditure of time and resources, the industry continues to experience unforeseen safety issues with compounds that have advanced to costly Phase III clinical trials or have reached the market.

Risk management considerations for conducting clinical trials outside ICH regions.

The first generation of eClinical technologies, such as Electronic Data Collection (EDC), Interactive Voice Response Systems (IVRS) and Clinical Trial Management Systems (CTMS), has been in use for a number of years; in some cases, a decade or more. These technological advances have helped the pharmaceutical industry realize significant improvements in efficiency and data quality in clinical trials and other aspects of drug development. Despite the important benefits delivered by eClinical systems, however, the industry continues to be relatively slow in embracing new technologies. As a result, the rate of technological advancement for clinical trials has not kept pace with the radical changes that have swept through the industry in recent years.

This article charts the rise of the contract service provider with global capacities and diverse services. The author outlines how contract service providers have been recognized for increasing capacity and expanding expertise and reviews the advantages of using contract service providers. The article discusses how a maturing contract services sector continues to deliver expertise, value and innovation to the bio/pharmaceutical industry.

Pharmaceutical companies’ regulatory affairs units are more vital than ever, but traditionally, they have not been known for flexibility. The author explains why this image is outdated and how working more cooperatively with the regulatory department will help maximize a company’s success in the marketplace.

Business needs and the processes built to support them are the driving force behind sound technological decisions. This article explores the notion that the best decisions about technology are driven by business reasons for a proposed study and the business processes built to support those reasons --- not the other way around. In other words, the medical needs of the protocol and the development program should be the driving force, with technology playing a supporting role.

The problems frequently associated with ramping up processes from pilot plant stage to full-scale production may be tempered with foresight and planning. This article provides elements that need to be considered from technical and business perspectives and keys to success to guide the ramp up process.

Conducting an analysis of the 4Ms – man, machine, methods and materials – enables companies to identify the true root causes of deviations. This article explores unintended consequences of automatically using operator error as the root cause of performance deviations. The article describes how to conduct a route-cause analysis of training events.

Phase II clinical trials play a pivotal role in determining whether a drug candidate moves forward to Phase III trials or licensing. The article reviews how anticipating and planning for Phase II requirements beginning in the pre-clinical process biopharmaceutical companies can produce the rigorous results necessary to make informed decisions and avoid costly missteps.

Imaging of bone serves as a well-recognized surrogate endpoint for monitoring the response to therapy of bone diseases, particularly the bone loss associated with osteoporosis. The author discusses the range of diagnostic imaging modalities available to clinical researchers.

Medical imaging in oncology trials is already well documented. Techniques such as CT, MRI and conventional radiology can provide insights into drug safety and efficacy faster than traditional clinical endpoints. Adopting an imaging strategy, however, introduces challenges, particularly around the potential variability of imaging data collected in multi-center trials and interpretation of that data. This article reviews how centralized independent review of imaging can reduce the variability and bias inherent in these types of trials.

High-quality clinical data will result in fast approval and clearance times. Such data will also help stakeholders in the clinical research process maintain their confidence in the industry’s procedures and products. To generate data that are credible in the eyes of regulators and the public, sponsors of medical device clinical research must take a strategic approach to clinical studies compliance so they can meet scientific, regulatory, and business objectives and demonstrate to the public their firm commitment to their product’s safety.

Leveraging technology is key to fulfilling the promise of automation and streamlining clinical trials. Simplifying, streamlining and integrating technology used in the clinical trial process will help make it less costly and time consuming, thus removing a major obstacle to new research incentives. Improving how technology is used and opening up communication across technology platforms will also enhance the process, creating greater efficiencies and fewer errors.

Biomarkers and surrogate endpoints are becoming an important part of regulatory submissions and this is driving the development of medical imaging in clinical trials. The author discusses the main imaging technologies and their value in assessing new treatments.

Combination products are highly diverse. The development process and life cycle for devices and drugs are quite different. Manufacturers of combination products will face challenges to meld drug and device processes so that safe, effective and profitable products are created, while regulators develop mechanisms to efficiently evaluate them.

The author addresses several aspects of compliance, including the FDA’s priorities for its bioresearch monitoring program, CDER’s initiative to study the pharmaceutical industry’s monitoring practices, and the implications for the FDA’s GCP compliance programs given the conduct of clinical research in developing markets.

A high-quality medical infrastructure and low costs make South Africa – largely an untapped opportunity – an attractive alternative for conducting clinical trials. By selecting the right local partner and understanding the specific challenges of the South Africa regulatory process, global bio/pharmaceutical companies can reap the benefits of the many advantages offered by the clinical research environment in South Africa and successfully conduct cost-efficient, high quality trials with the potential to reduce the time and cost of bringing new products to market.

Managers of FDA-regulated firms must be proactive in how they manage their company’s compliance with good manufacturing practices (GMP) regulations. This article examines how a system of management controls can serve to support and maintain a company’s GMP compliance status. The establishment of management controls is a concept that is embodied in FDA guidance.

The information needed to make decisions about clinical studies often already exists but is held in disparate places. By combining CTM and IVR clinical trial systems, sponsors can make their data available almost immediately.

In the past, there have been some fairly extreme under-estimates of the inventiveness of mankind and the usefulness of some of its inventions. The internet, on the other hand, has been almost universally hailed as one of the greatest of all inventions. I believe it is important to recognise the internet as a means to an end (albeit a very powerful one), but not the answer to life, the universe and everything. It is already having an impact on the way we run clinical trials and we should be using it more.