The new age in strategic outsourcing lies in the mature portofio
Companies must safeguard their mature portfolios while continuously innovating and developing new products. But in-house resources are stretched and often lack the broader knowledge needed to ensure best practices for ongoing maintenance activities. As a result, traditional models of outsourcing – the low-cost, “lift and shift” approach of the past – are giving way to a more nuanced, strategic approach. One that leverages external expertise globally and delivers more efficient methods for supporting the product lifecycle. Dr. Constanze Burkhardt, Vice President, Head of Program Management at Pharmalex, explores why outsourcing the mature portfolio has become an industry priority.
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ReadHow an integrated product development strategy can drive speed and innovation across biopharma
Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board.
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ReadAnnex 1 – Final Implementation of the final draft
Pages 12-13. Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971 and forms part of EudraLex Volume 41 that interprets the basic principles of GMP as detailed in European Directive 2003/94/ EEC.2 Annex 1 provides guidance on the minimum controls that are required to protect sterile medicinal products during manufacturing.
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ReadKey Take Aways from the PDA Europe Workshop on Annex 1
Pages 10 to 11. The Pharmaceutical world, in particular those involved with the manufacture of sterile products, is anxiously looking out for the publication of the final approved revision of EudraLex Annex 1 “Manufacture of Sterile Products”.
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ReadThe New Age is Strategic Outsourcing Lies in the Mature Portfolio
Pages 22 to 24. Companies must safeguard their mature portfolios while continuously innovating and developing new products. But inhouse resources are stretched and often
lack the broader knowledge needed to ensure best practice for ongoing maintenance activities.
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ReadEstimate your probability of success with Bayesian statistics
Don’t settle for approximations, make smart, risk-based economic decisions. Bruno Boulanger explains how the application of Bayesian statistics can assist with decision making when data samples are small but pre-existing information is available.
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ReadABPI Code feedback
It has long been communicated to the UK pharmaceutical industry that the Prescription Medicines Code of Practice Authority (PMCPA) welcomes all input and feedback on the ABPI Code of Practice. But what does this actually mean, what does the PMCPA do with such feedback, and what motivates feedback or prevents it from being given?
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ReadThe use of LinkedIn and the ABPI Code of Practice
The Prescription Medicines Code of Practice Authority (PMCPA) has received at least nine complaints to-date about the use of LinkedIn, indicating that its use, which is not specifically addressed in the ABPI Code of Practice (Code), may benefit from guidance on how to adhere to existing principles whilst also respecting the purpose of LinkedIn. This should help ensure the LinkedIn accounts and activities of pharmaceutical companies and pharmaceutical/agency employees, comply with the Code.
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ReadAgencies and the ABPI code of practice
Rina Newton shares her top tips for ensuring agencies comply with the ABPI Code of Practice. Agencies are engaged by pharmaceutical companies because the expertise they offer may not be available in-house or because there is insufficient resource or time for in-house creation and development.
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ReadHow does the ABPI Code apply to congresses?
How does the ABPI Code apply to congresses? Mitigating the risks of breaching the Code. The ABPI Code of Practice provides guidance for pharmaceutical industry meetings and third-party meetings that the industry supports, covering meeting content and arrangements.
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ReadWhy you never really validate your analytical method unless you use the total error approach (part II: Producer and Consumer risks)
This is a second article in series of articles on the total error approach within the context of analytical method validation. If you missed the first article, I encourage you to read it to get familiar with the total error concept and what we are going to discuss below: https://www.linkedin.com/pulse/why-you-never-really-validate-your-analytical-method-use-de-marchin
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ReadWhy you never really validate your analytical method unless you use the total error approach (part I: concept)
Consistent and efficient use of any analytical procedure requires the knowledge of its reliability prior to its use. It is therefore necessary for each laboratory to validate their analytical methods. Validation is not only required by regulatory authorities [ICH, FDA, GxP] or in order to access accreditation [ISO 17025] but is also the essential step prior to the routine use of the method. The role of analytical method validation is to provide confidence in laboratory generated results that will later be used to make critical decisions.
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ReadNew SAS solutions for Population PK Model
Population pharmacokinetic (PK) models describe the drug concentration-time course in body fluids resulting from administration of a certain drug dose. Compartment models are typically used to conceptualize the mechanisms that take place in the interaction between an organism and a drug product.
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ReadBayesian Power, Assurance and Probability of Success: Reproducibility Issues
In this current document, we will try to analyze the effects that a misunderstanding of these concepts may lead to and more specifically the effects on reproducibility.
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ReadBayesian Power, Assurance and Probability of success: A quick who’s who
Bayesian power and Assurance allows accounting for the uncertainty on the parameters. These metrics give estimates closer to a probability of success that the trial will indeed be a success. Uncertainty must be accounted for in order to ensure that the appropriate sample size is selected in order to maximize the success of the clinical trial. Read the full article here
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ReadProposal for a Single Arm Clinical Study in Rare Disease using Bayesian Statistics
This short article aims to briefly introduce a methodology to address the challenge of rare clinical trials relying on Bayesian statistical methods, and the use of natural history data to determine the control group and inform the analytical model. You can read the full article here
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ReadIPI publication: Non-clinical safety evaluation of vaccines accelerating clinical development
International Pharmaceutical Industry: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadChemistry Today publication: Non-clinical safety evaluation of vaccines accelerating clinical development
Chemistry Today: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadSupporting M&As in the pharmaceutical/biopharmaceutical industry
Manufacturing Chemist: At PharmaLex, we believe we have a unique understanding of the cultural challenges experienced during M&As. Having merged ourselves in 2017 into PharmaLex, we have insight in how to overcome the challenges of maintaining agility while benefiting from working in a bigger corporate environment, having economies of scale with an increased resource pool.
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ReadNon-clinical safety evaluation of vaccines part II
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadNon-clinical safety evaluation of vaccines part I
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
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ReadCan a robust QMS help you achieve customer satisfaction?
PharmaLex.pert Limaris Alvarado discusses the part quality management systems (QMS) play in ensuring companies continually enhance customers’ experience and satisfaction?
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ReadProduct Launch
PharmaLex.pert Limaris Alvarado discusses the complexities of product launch and the importance of effective planning, efficient manufacturing process, technical capability, regulatory strategy, and committed launch date strategy.
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ReadLearning Lessons from Nitrosamine Impurities
PharmaLex.pert Diego Martinez discusses why industry must never become complacent about the safety of drug products and should seek to continually perform surveillance even if the drug is well-established.
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ReadDrug Development Decisions
Zeb Younes & Zaklina Buljovcic will give you insightful information about new approaches to Drug Development. This article is taken from the European Biopharmaceutical Review October 2019, pages 58-64. © Samedan Ltd.
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ReadEMA simplifies the process for internal transfer of MAs
PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.
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ReadAI in drug development|Pharmacovigilance
PharmaLex CEO, Tilo Netzer looks at the opportunities for AI in drug development, examining the use cases in relation to pharmacovigilance
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ReadMoving From Artificial Trials To Smarter Regulatory Process
PharmaLex’s Bruno Boulanger discusses the impact big data will have on how the pharmaceutical industry gathers and delivers data in the future. *subscription required*
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