Digital Transformation in Pharma managing content and assets across the digital supply chain

| June 10, 2019

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Pulse, a specialist healthcare organisation, review how digital transformation has impacted how global life sciences and pharmaceutical organisations, and the way they reach and engage with healthcare professionals (HCP's). The change, empowered by digital and its associated technologies, is being driven both by patients and HCP's.

Spotlight

Biorad Medisys Pvt Ltd

Biorad Medisys is a leading global specialty manufacturer of a large portfolio of implants and surgical devices . Full-fledged integrated manufacturing facilities in Pune and Bengaluru, adhering to strict GMP are set up, starting its operations almost a decade ago the company operates under stringent guidelines and certified by ISO 13485/IS0 9001-2008. The facilities boast of state of the art machinery imported from UK, Germany & Japan. The company develops and markets innovative technologies and medical products through its two divisions; Orthovasive and Indovasive which are CE certified and partners with healthcare professionals in enhancing patient care.

OTHER ARTICLES
PHARMACY MARKET

A pharma outsourcing mission

Article | August 18, 2021

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand. The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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Top Pharmaceutical Firms Urge FDA to Adopt Blockchain for Drug Tracking

Article | August 18, 2021

Leading market participants in the United States pharmaceutical industry, logistics firms, distributors and other stakeholders in the pharma supply chain have come together to publish a report buttressing the need for industry players to adopt blockchain for tracking prescription drugs, following the successful completion of a DLT pilot project with the Food and Drug Administration (FDA), according to reports on February 24, 2020. Though nascent, blockchain technology, the building blocks of Bitcoin (BTC) and other cryptocurrencies are fast gaining ground across various ecosystems, due to its immutability, security, privacy, and other intricate properties. In the latest development, 25 leading manufacturers of pharmaceutical products, logistics partners and other market participants in the pharma supply chain, have published a report that highlights the importance of blockchain technology in drug traceability.

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VIEWS AND ANALYSIS

New Dimensions of Clinical Trial Optimization

Article | August 18, 2021

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Enabling Active Pharma Ingredients for Batch Balancing and Integration to SAP EWM

Article | August 18, 2021

Batch and its Classification system are two most potent weapons used in Chemical, Pharma or Medical life science industry to record the potency of a batch or technically called as Active Pharma Ingredients(API). These material consist of one or more active ingredients, concentrates, carrier materials, or impurities, and so on. The potency of the active ingredients varies from batch to batch. The active ingredient is the substance of greatest interest in the bill of materials, the proportion of which may vary from batch to batch. Therefore, during creation of a process order, the system must be able to select and adjust the batches needed to obtain the required amount of active ingredient. Take an example of a drug hydroxychloroquine which is used as potent weapon to fight COVID-19. This drug is manufactured by using API, however, the Potency of this API material vary from batch to batch. To map this kind of requirement in SAP ERP, SAP calls it as Material Quantity Calculation.

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Spotlight

Biorad Medisys Pvt Ltd

Biorad Medisys is a leading global specialty manufacturer of a large portfolio of implants and surgical devices . Full-fledged integrated manufacturing facilities in Pune and Bengaluru, adhering to strict GMP are set up, starting its operations almost a decade ago the company operates under stringent guidelines and certified by ISO 13485/IS0 9001-2008. The facilities boast of state of the art machinery imported from UK, Germany & Japan. The company develops and markets innovative technologies and medical products through its two divisions; Orthovasive and Indovasive which are CE certified and partners with healthcare professionals in enhancing patient care.

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