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16 April 2012
By Diane R. Whitworth, MLS
Alliances between the pharmaceutical industry and contract research organizations (CROs) have evolved over the past three decades from transaction-based relationships to truly collaborative strategic partnerships. Although the traditional fee-for-service outsourcing model still exists, an increasing number of pharmaceutical companies and CROs have formed enduring partnerships. [
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16 April 2012
By Marc Dunoyer
The recent dramatic increase in the number of orphan drug designations has prompted patient groups, pharmaceutical companies, legislators and many other stakeholders to look for ways to accelerate the delivery of innovative new medicines to people with rare diseases. In particular, patients suffering from illnesses for which there are no adequate licensed therapies want access to promising new products earlier in the drug development cycle. [
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26 March 2012
By John Geigert, PhD, RAC
This article explores Prions--“adventitious agents” that are microorganisms (including bacteria, fungi, mycoplasma/spiroplasma, mycobacteria, rickettsia, viruses, protozoa, parasites, TSE agent) that are inadvertently introduced into the production of a biological product. Three adventitious agents of primary concern for biologics are addressed in this article: prions, viruses and mycoplasmas.
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6 February 2012
By John Geigert, PhD, RAC
Note: Demystifying, according to Merriam-Webster’s dictionary, is “to remove the mystery or mystique; to make rational or comprehensive.” This is the third part of a series on demystifying CMC regulatory strategy for biologics. Part 1 covered the complexity of biologic CMC regulation; Part 2 examined the major differences between biologics and chemical drugs; and Part 4 will examine the challenge of adventitious agent contamination control for biologics.
Failures in the chemistry, manufacturing and controls (CMC) regulatory strategy for biologics abound: a recombinant enzyme is delayed in gaining market approval because the US Food and Drug Administration (FDA) concludes that "the commercial process is not representative of the Phase 3 material used to establish the safety and efficacy profile; "a recombinant protein is rejected by the European Medicines Agency (EMA) because "with regard to Quality a large number of outstanding issues remained" (e.g., lack of product comparability, insufficient stability data, manufacturing process not adequately validated); a recombinant protein is withdrawn from the US market because a "minor change in the formulation" leads to spontaneous syncope (fainting). [
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1 December 2011
By Grant Ramaley
One of the things that never really changes in the field of medical device compliance is how we look at solving our trade problems. For decades, we heard, “Accepted once, accepted everywhere. Harmonization is the answer.”
But the collapse of the Global Harmonization Task Force (GHTF) and much food fight-style banter at the World Trade Organization (WTO) mean too little progress has been achieved in serving up solutions that genuinely improve medical device trade.
The main problem with harmonization within the public health protection sphere stems from the sincere obligations of regulators to protect their own people. As a result, what happened at GHTF can be seen as a movement away from harmonization, as each nation creates a custom version of the harmonized guidance.
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1 December 2011
By Joy L. Frestedt, PhD, RAC, CCTI, Jane Wright-Mitchell, PharmD, JD, Kim Fonda, Pierre Kiami, Rosanne Savol, Flora S. Siami and Frank Navran
The Regulatory Affairs Professionals Society (RAPS)
Code of Ethics was initially developed based on discussions between executive director Sherry Keramidas and the RAPS Board of Directors with support from Frank Navran in the Ethics Resource Center. Members and focus groups were consulted, and those discussions revealed that regulatory professionals would be best supported by a strong professional group with a clear code of ethical conduct.
The code has endured for the past decade by using the following eight simple words to outline ways to consider the right things to do in just about any situation: [
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1 November 2011
By Raymond A. Huml, MS, DVM, RAC
Regulatory Affairs Certification (RAC) is the badge that proves the person carrying it has done the legwork to speak authoritatively in matters that are vital to the drug and medical device industry. But why is that so important?
The RAC denotes regulatory competency as measured by the Regulatory Affairs Certification Board in the form of an initial exam and must be renewed every three years. Of the four certifications available, three are regional (US, EU and Canada) and require knowledge of the regulations in those areas; the fourth (General Scope) focuses on the knowledge and critical thinking skills related to the general scope of the practices of regulatory professionals throughout the product lifecycle, regardless of the region in which they work. It references global standards from the International Conference on Harmonisation, Global Harmonization Task Force,
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1 November 2011
By Pierre Kiami, MPH, RAC
Continuing from last month’s review of leadership ethics, this third article continues the discussion on organizational ethics with a focus on the individual as decision maker. In particular, attention is paid to the tools and methods available to regulatory professionals to enable ethical awareness, uphold industry-wide values and improve public trust.
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1 November 2011
By John Geigert, PhD, RAC
Senior managers, especially if they have recently moved from the chemical drug side of the business into biologics, may raise the question of whether biologics are really different from chemical drugs or if this is just a perception. As clearly stated by the regulatory authorities, biologics are not chemical drugs and similar biologics are not biogenerics.
A glance at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites clearly shows the agencies view biologics and their manufacturing processes as different from chemical drugs.
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