Why Life Sciences Companies Should Be Aware Of Its Benefits

RACHEL BEAVINS TRACY | June 21, 2019 | 88 views

Compliance with regulatory standards does not mean that life sciences companies should ignore ISO standards. We all know that implementing a management system or operational excellence program into a life science company’s workflow isn’t without its costs.

Spotlight

Intercept Pharmaceuticals

We are a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. We are committed to improving patients’ lives as we partner with leaders in the liver community to provide support and educational resources that help address unmet needs.

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PHARMA TECH

Why Is Diversity of Thought Essential for Developing a Winning Strategy?

Article | May 25, 2021

In developing or evolving a strategy, there are key decision moments. Those are the moments where you are deciding where you need to focus, what you need to excel at to win there, and where and how to allocate resources to get to a point in the future. At these moments, it is the contest of ideas that matters. Having choices matters. Having a cross-functional team participating in the development of strategy is one way of ensuring that you are going to be more successful at generating choices before you start making choices. What Is a Cross-functional Team? A cross-functional team is a collection of individuals with varied skillsets from different areas of a business collaborating to achieve a common goal. Why Are Cross-functional Teams Essential for Business Success? Having this diverse set of minds analysing the situation, considering the big picture and the organisation’s capabilities, and the needs of all stakeholders, inspires teams to think about the choices they have differently and more creatively. For example, in a pharmaceutical setting, the medical affairs team brings knowledge of the data, unmet needs, and insight into clinical practice. Access and reimbursement teams identify the right data and take the lead in building that value story to accelerate market access and product uptake. It is incumbent upon commercial to hear their ideas, obtain their perspective and secure their alignment to all strategy decisions. Cross-functional collaboration can help break down silos. Research suggests that working in silos and not sharing data with team members from other departments can cost a company close to $8,000 per day in wasteful expenses. Time is widely recognised as a scarce resource: we need quick access to accurate and real-time insights to make effective business decisions. Real time insight will come from those closest to the customer, so it is important for cross-functional members from different geographies to participate in the development of strategy. Improved insight is a source of sustainable competitive advantage. One single version of the truth is what is required for the right narrative to take place. The right narrative will lead to the right decisions. One single version of the truth is more easily achieved by cross-functional team members working closely together. Better Innovation & Creativity: Individuals with diverse skillsets often explore a problem in different ways. When different people working in different capacities come together, they think outside the box to significantly improve outcomes. It is a great way to come up with concepts that distinguish companies from their competitors. Achieving alignment with strategy across functions and geographies: Today, businesses are moving faster than ever and organisations are seeing possible competitors in areas they never knew existed before. With so much choice about where to focus, you really want your workforce to align around one strategy. Underperformance is inevitable if everybody is off working in ten different directions. Improving the customer experience: Creating an effective customer experience is about more than just ensuring your customers receive the products and services they desire in a timely and efficient manner. It’s also about creating touchpoints with real people who can organically evangelise and grow your brand through their social media and offline interactions with friends and family. Your customers are engaging with multiple communication channels– official websites, social platforms, virtual platforms, medical science liaisons, sales reps, and more. Everyone needs to be aware of, and understand, the moments that matter to your customer and the business along that customer journey and how they contribute to delivering that positive experience. This is more likely to be achieved with a cross-functional approach to strategy development. Business Agility: Cross-functional teams are typically small, adaptable, and flexible. Such teams can move faster as they don’t have to wait and rely on other departments or external sources. They can help in tackling any silo mentality and bridge gaps between team members. They can come together to consider new information and/or changes to adapt the strategy if necessary and/or react to any setbacks immediately. They are better placed to make decisions when problem-solving amidst uncertainty. In summary, the rapidly changing environment and new information requires medical affairs, along with access and reimbursement and commercial, to work together, to ensure that patient’s benefit from the value of new innovative therapies. Companies stand a better chance of creating a winning strategy if it is created by a cross-functional and geographically diverse team. With every team member bringing their abilities and knowledge to the table, the strategy over time can only move from strength to strength. However, if not supported correctly, a cross-functional team working on strategy can be dysfunctional and chaotic, and result in a laborious and time-consuming approach to strategy development. Digital strategy platforms such as Nmblr offer an inclusive and structured process to facilitate a strategy discussion and allow people to bring forward ideas. They do this by: working against silos – the structure provided, levels the playing field. The guidance provided equips people from different disciplines to contribute to the conversation.

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Modern Phenotypic Drug Discovery

Article | April 17, 2020

Nature Reviews Drug Discovery makes these points well. It goes over historical and recent successes of the phenotypic approach, and discusses some areas that it's opening up for discussion and research. One of these is the long-vexed question of polypharmacology: what do you do when your active compound doesn't seem to have a single target, but rather hits a whole list of stuff at varying degrees of potency? Seen from a pure target-based viewpoint, this is a failure, and you'd better start working on something else. But to be honest, there are a lot of drugs out there (and not all of them ancient legacy compounds by any means) that work this way, even if their developers didn't think so at the time. So it's not to be disparaged on principle, but that said, it's still a difficult area to make progress in because of all the variables. A good enough phenotypic hit, though, makes its own case that it's worthy of further investigation and development, even if it's not "clean" by rigorous target-based standards. But as always, your phenotypic screen had better be a good one. That is, it had really better model the human disease in a useful way, and have a good signal/noise. The authors note that you're much better off with assays that involve a gain-of-function/gain-of-signal readout, as opposed to ones that could read out just through cellular stress or cytotoxicity, which is an invitation to chase your tail. Another area the paper brings up is searching lower-molecular-weight compounds than are usually screened, down to fragment-sized. There are quite a few useful drugs out there with really low molecular weights - ibuprofen, aspirin, metformin, dimethyl fumarate, lacosamide and more - and any screening program would be happy to have discovered something as useful as those. As the authors note, hits like these in phenotypic screens might be another case of polypharmacology, or they might be hitting pathways whose "tone" we have not understood well (and for which micromolar inhibitors might work out just fine). At any rate, there might be an opportunity for fragment phenotypic screening, and even of covalent fragments (which will call for even more attention to the validity of the underlying screening model, I'd say). The paper discusses the question of target ID, which for most phenotypic programs feels like a natural progression. Most of us are innately biased towards thinking in terms of drug targets, so when a phenotypic compound emerges we want to know what it's "really" doing. And most of the time, there is such a target in there somewhere, although finding it can be quite a haul. I know of several compounds that have been kicking around for years that are obviously doing something in the assays, but no one has ever been able to pin down quite what that is! This paper makes the case for getting out of a binary mindset for target identification. They point out, correctly, that target ID is a means to an end, and that you do not actually need to identify your target to go on to clinical trials and go to the FDA for approval. I always find it surprising to find how many people are surprised by that, but it's true. You also need to realize that knowing a target may not tell you nearly as much as you would want about a compound's mechanism of action, if your new target lands in the middle of a bunch of not-well-worked-out biology. There's a good case to be made that modern chemical biology and imaging techniques have made it easier to progress things, even if you're not quite sure how they're working. We can extract huge amounts of information about the cellular effects of a given compound, and if you do a good job of matching this against a closely related structure that's phenotypically inactive, you can make a lot of headway. This doesn't mean that you shouldn't bother trying to find the target - as mentioned, this is a great way to expand the knowledge of the underlying disease, and can lead to other new programs spinning off of the phenotypic effort. But it does mean that you shouldn't freeze in fear if you don't have a target to point to. The FDA wants to see safety and efficacy, and that's what we should want to see, too, for starters. But as the paper notes at the end, phenotypic screening is going to advance at the pace of good model development. Many of these same chem-bio tools can be brought to bear on this question as well, along with advances in cell culture, organoids, and other new assay technologies. You're not going to be able (realistically) to recapitulate all the features of a human disease, so you will probably find yourself concentrating on certain features that you can make the case for driving a project on. I was very happy to see this paper reference Jack Scannell's paper on translatability (blogged about here), because its point is crucial to the whole phenotypic screening endeavour. If your underlying assay is flawed, there is nothing you can do in any other part of the project to make up for it. A poorly translatable assay is a sign that you should spend your time trying to fix it, or to go do something entirely different instead. It is not a sign that you should just keep on going, because "it's the best thing we've got". If it isn't good enough, it isn't good enough. I don't get to quote A. E. Houseman much around here, but he's right: "The toil of all that be. Helps not the primal fault; It rains into the sea. And still the sea is salt." If you don't fix your assay up front, you are raining into the sea.

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PHARMA TECH

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | June 2, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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What are the advantages of PCD Pharma Company?

Article | February 17, 2020

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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Spotlight

Intercept Pharmaceuticals

We are a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, including primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. We are committed to improving patients’ lives as we partner with leaders in the liver community to provide support and educational resources that help address unmet needs.

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BUSINESS INSIGHTS

COEUS Holdings Announces Partnership With Insight Consulting Group (ICG) to Address the Healthcare Industry’s Changing Research and Insight Landscape

COEUS Holdings | September 18, 2021

COEUS Holdings, LLC, and its subsidiaries, together a leading boutique life sciences technology and consulting firm, today announced that it has entered a partnership with Insight Consulting Group (ICG). The partnership seeks to bridge the gaps between payers, healthcare providers, and consumers by developing insights and strategies that are reflective of today’s integrated needs. The partnership will produce and apply comprehensive insights to inform strategy that could advance access to more medications and help to address the unmet needs of Physicians and Patients. While ICG’s expertise, proprietary processes, and deliverables will be leveraged by various organizations that are part of COEUS Holdings’ group of subsidiaries, Mirador Global, led Chuck Peipher, Managing Partner, will be most regularly engaged. Mirador delivers consulting expertise in early commercial development for global and domestic drug commercialization and market access efforts. This partnership takes direct aim at the delivery of game-changing insights and market research that will take shape in a variety of touchpoints through the commercial development process. Together, we’ll be able to work more quickly and effectively through this partnership given the common knowledge of the social sciences, brand development processes, and a commitment to our clients who are focused on serving the needs of Physicians and Patients. - Chris Schnaars, Principal at Insight Consulting Group. Ultimately, all stakeholders in the healthcare ecosystem (patients, caregivers, HCPs, influencers, extenders, payers, and provider organizations) must work together to create an optimal care environment. Through shared resources that deliver deeper research and insights, the ICG and COEUS partnership will facilitate a more comprehensive and robust understanding of how healthcare clients can meet the needs and achieve ideal outcomes for all stakeholders. The ICG and COEUS partnership will enable clients to realize the benefits of working with one team, with end-to-end research and payer capabilities. It’s the combination of insights being leveraged simultaneously during the design and development of marketing and payer strategies that will deliver incremental value to the industry. About ICG ICG inspires deeper healthcare understanding by bringing its clients’ most important interactions into research. Understanding human needs and translating them into behavioral insights is at the forefront of the design of our deliverables. ICG brings high proficiency and experience to analysis of insights, raising the bar of confident decision making and commercial impact. ICG is focused on meeting people where they are (not where we want them to be) and understanding what true core human and emotional needs can be addressed to influence behavior and impact outcomes. About Mirador Global LP Founded in 2016, Mirador Global LP is an international consulting practice that specializes in strategic global commercial development for specialty diseases, including rare diseases, oncology/​immuno-oncology, immunology, and CNS disorders. Mirador Global client engagements are developed bringing together Global Marketing, Analytics, Market Access, HEOR, Medical Affairs, R&D, and other functions delivered by a team of pharmaceutical industry experts. The company provides its clients with a bio-pharma line of sight unlike any other unique to Mirador Global. About COEUS Holdings The COEUS Holdings teams are singularly driven to optimize market access and commercialization infrastructure for pharmaceutical products. COEUS is a multi-specialty, commercially aligned consultancy, offering a comprehensive suite of informed solutions for successful engagement with organized customers, providers, and patients. Leveraging years of collective real-world market expertise, we offer unique perspectives into clinical and business opportunities to support your brands’ position in the marketplace. COEUS mission is to ensure patient access beyond the prescription. We focus on becoming your ally in navigating the healthcare universe. COEUS teams advance thought leadership, technology solutions, and communication initiatives to ensure your brands’ lifelong success. Together, we strive to redefine access solutions in the evolving domestic and global managed care markets.

Read More

Pharma companies are 'kidnapping' patients with free drugs

Pharmaceutical | December 18, 2016

Health Minister Simon Harris has accused international pharmaceutical companies of "kidnapping" Irish patients with samples of life-saving drugs before demanding a ransom from the Government once the free trial is over…

Read More

BUSINESS INSIGHTS

COEUS Holdings Announces Partnership With Insight Consulting Group (ICG) to Address the Healthcare Industry’s Changing Research and Insight Landscape

COEUS Holdings | September 18, 2021

COEUS Holdings, LLC, and its subsidiaries, together a leading boutique life sciences technology and consulting firm, today announced that it has entered a partnership with Insight Consulting Group (ICG). The partnership seeks to bridge the gaps between payers, healthcare providers, and consumers by developing insights and strategies that are reflective of today’s integrated needs. The partnership will produce and apply comprehensive insights to inform strategy that could advance access to more medications and help to address the unmet needs of Physicians and Patients. While ICG’s expertise, proprietary processes, and deliverables will be leveraged by various organizations that are part of COEUS Holdings’ group of subsidiaries, Mirador Global, led Chuck Peipher, Managing Partner, will be most regularly engaged. Mirador delivers consulting expertise in early commercial development for global and domestic drug commercialization and market access efforts. This partnership takes direct aim at the delivery of game-changing insights and market research that will take shape in a variety of touchpoints through the commercial development process. Together, we’ll be able to work more quickly and effectively through this partnership given the common knowledge of the social sciences, brand development processes, and a commitment to our clients who are focused on serving the needs of Physicians and Patients. - Chris Schnaars, Principal at Insight Consulting Group. Ultimately, all stakeholders in the healthcare ecosystem (patients, caregivers, HCPs, influencers, extenders, payers, and provider organizations) must work together to create an optimal care environment. Through shared resources that deliver deeper research and insights, the ICG and COEUS partnership will facilitate a more comprehensive and robust understanding of how healthcare clients can meet the needs and achieve ideal outcomes for all stakeholders. The ICG and COEUS partnership will enable clients to realize the benefits of working with one team, with end-to-end research and payer capabilities. It’s the combination of insights being leveraged simultaneously during the design and development of marketing and payer strategies that will deliver incremental value to the industry. About ICG ICG inspires deeper healthcare understanding by bringing its clients’ most important interactions into research. Understanding human needs and translating them into behavioral insights is at the forefront of the design of our deliverables. ICG brings high proficiency and experience to analysis of insights, raising the bar of confident decision making and commercial impact. ICG is focused on meeting people where they are (not where we want them to be) and understanding what true core human and emotional needs can be addressed to influence behavior and impact outcomes. About Mirador Global LP Founded in 2016, Mirador Global LP is an international consulting practice that specializes in strategic global commercial development for specialty diseases, including rare diseases, oncology/​immuno-oncology, immunology, and CNS disorders. Mirador Global client engagements are developed bringing together Global Marketing, Analytics, Market Access, HEOR, Medical Affairs, R&D, and other functions delivered by a team of pharmaceutical industry experts. The company provides its clients with a bio-pharma line of sight unlike any other unique to Mirador Global. About COEUS Holdings The COEUS Holdings teams are singularly driven to optimize market access and commercialization infrastructure for pharmaceutical products. COEUS is a multi-specialty, commercially aligned consultancy, offering a comprehensive suite of informed solutions for successful engagement with organized customers, providers, and patients. Leveraging years of collective real-world market expertise, we offer unique perspectives into clinical and business opportunities to support your brands’ position in the marketplace. COEUS mission is to ensure patient access beyond the prescription. We focus on becoming your ally in navigating the healthcare universe. COEUS teams advance thought leadership, technology solutions, and communication initiatives to ensure your brands’ lifelong success. Together, we strive to redefine access solutions in the evolving domestic and global managed care markets.

Read More

Pharma companies are 'kidnapping' patients with free drugs

Pharmaceutical | December 18, 2016

Health Minister Simon Harris has accused international pharmaceutical companies of "kidnapping" Irish patients with samples of life-saving drugs before demanding a ransom from the Government once the free trial is over…

Read More

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