Fidia Pharma USA Inc. Announces Expansion into the Dietary Supplement Market with Launch of CartiJoint.

A world leader in the research, development, and manufacturing of hyaluronic acid (HA)-based products, is introducing CartiJoint™ FORTE, its first product in the dietary supplement category in the USA. CartiJoint™ FORTE is a dietary supplement that supports joint health and mobility with antioxidant activity in a daily dose.*1,2,3 It is uniquely formulated with a bioactive* curcumin extract Bio-Curcumin Curcugreen™ which is 100% natural turmeric along with glucosamine hydrochloride and chondroitin sulfate. Bio-Curcumin Curcugreen™ is from a natural substance with antioxidant activity*. It is a natural extract of Curcuma longa consisting of curcumin, curcuminoids, and oils with high bioavailability compared with standard curcumin and another formula containing curcumin in a pilot study of human volunteers receiving equivalent doses.4 CartiJoint™ FORTE also contains glucosamine hydrochloride and chondroitin sulfate. In the human joint, naturally occurring glucosamine and chondroitin are important structural components that provide support and promote joint mobility and flexibility. 

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Emergence of CRM in Pharmaceutical: Types & Features

Article | July 7, 2023

Introduction In the past, the pharmaceutical industry was solely concerned with the development of new drugs and medical devices, along with improving their clinical efficacy, safety, usability, and superiority over alternatives. However, the rapid transformation of the life science industry from product-based to customer-based has presented pharmaceutical companies with various obstacles, driving them to enhance their customer relationship management (CRM). Due to the proliferation of the medical and life-science industries, customer-focused solutions are becoming increasingly crucial for pharmaceutical enterprises to remain afloat. With the increasing complexity of the industry, the emergence of new business models, and the introduction of cutting-edge technologies, the pharmaceutical industry is under intense pressure to deliver superior products and services to stay on edge. In addition, the Internet has made it possible for new technologies to spread rapidly, giving consumers greater freedom to select products and services that match their individual requirements. Thus, rather than emphasizing product differentiation, drug and medical aid manufacturing companies are focusing on embracing innovative customer-centric solutions, such as pharma CRM software, to assist them in analyzing and prioritizing the wants and needs of consumers. Pharma CRM Solution Types: Roads from Product to Customer Experience As the world turns toward the dictum "the customer is king," superior customer service is no longer a luxury. In addition, as a result of increased digitalization, life science organizations are dealing with vast quantities of data. A study shows that the pharmaceutical industry generates twice as much data every five months. This is because of the increased need to capture and store a plethora of information, such as patient data and insights, HCP interests, prescription writing patterns, sensitive patient program information, and segmentation analysis, among others. CRMs assist pharmaceutical companies in accurately collecting and tracking customer information, decreasing marketing costs, increasing sales, improving customer support, and organizing data collection and storage. With all-time high competitiveness in the pharmaceutical industry, every drug and medical equipment provider is investing huge sums of money to explore new audiences before anyone else in order to get a competitive edge. In response to this, pharma CRM solutions are gaining tremendous traction across the life science industry for building solid relationships with High Lifetime Value (LTV)customers. There are different types of pharma CRM solutions available for pharma organizations to collect, store, and analyze data related to customers. Let’s look at a few: Operational Pharma CRM Operational pharma CRM solutions are ideal for assisting teams in gaining a deeper understanding of customers through the acquisition and management of customer relationships and connections, as well as improving the company's perspective on customers and sales. These systems aid pharmaceutical companies with lead generation and contact conversion. By streamlining numerous business activities such as marketing, sales, customer service, and others, they assist in creating the solid service foundation needed to retain customers and improve customer relationships. Operational pharma CRM solutions capture customer details and use them to automate sales, marketing, and other operations for providing services throughout the customer lifecycle. In addition, the system tracks and stores data related to employees, customers, and leads using a centralized platform to support existing and potential customers in an efficient manner. Analytical Pharma CRM With the increasing significance of understanding the needs of patients and customers, analytical pharma CRM systems are gaining massive popularity among mid-sized and large pharmaceutical enterprises. It is increasingly being used to accumulate and analyze large amounts of data, including sales, marketing, and financial data, and filter this data into trends and insights. Throughout the pharmaceutical industry, analytical pharma CRM solutions are making deeper inroads as they aid in the development of strategies to generate new leads, improve customer satisfaction, boost customer retention, and increase sales and marketing department efficiency. Collaborative Pharma CRM Collaborative pharma CRM enables pharmaceutical organizations to create and improve communication between various company divisions involved in customer service. These departments include marketing, sales, customer service, technical support, external customers, vendors, and distributors. The idea of collaboration in the workforce is not new, but it is one that is constantly being redefined in light of new technological innovations. It assists life-science spaces in automating their back-office operations, customer interactions, and business management, resulting in enhanced transparency among the organization’s teams. As the teams often operate independently, particularly in large pharma enterprises, the adoption of collaborative pharma CRM solutions can aid them in breaking down several communication silos to address fast-changing customer needs and effectively manage customer relationships. Pharmaceutical Customer Relationship Management Solutions: The Features List Constantly rising business expenditures and budgets, along with the emergence of new challenges and issues related to generating revenue, are compelling medical product developers to embrace modern solutions, such as pharma CRM software, for increasing sales and improving customer retention. As complexity in the pharma industry increases and competition in fields such as immunology and oncology continues to intensify, enhancing customer experiences is becoming even more important. With the "one size fits all" approach no longer delivering results, the implementation of robust and resilient tech systems for understanding customer needs and supervising medical operations is becoming necessary for pharmaceutical companies. While extensively focusing on the clinical value of the medication or medical equipment, firms operating in the pharmaceutical sector often overlook a prominent driver for success: the customer experience. By addressing critical pain points across patients’ and prescribers’ journeys, pharma CRM technology assists these companies in increasing customer satisfaction, improving adherence, and boosting revenues. Apart from this, here are some features of pharma CRM that are vital for organizations’ success Provide Integrated Customer Database Workflow Automation Management of Customers’ Accounts Cycle Activity Planning Customization Real-time data and CRM analytics Sales forecasting Why Are Life Science Companies Leveraging Pharma CRM Solutions? Today, the company's success is predominantly determined by its relationship management with customers and potential leads. With the fast-changing life science landscape and increased competitiveness, the need for pharmaceutical firms to manage customer interactions and improve customer engagement is surfacing at a robust pace to build a better brand reputation. It is crucial in the pharmaceutical industry to acquire patients' trust and maintain a stellar reputation for generating revenue and sustaining in a highly regulated environment. Using customer relationship management solutions is an excellent strategy for accomplishing this objective. According to a survey, a CRM system can enhance customer retention rates by 5%. Depending on the industry, this can then result in a profit gain ranging from 25% to 85%. (Source – PharmaVoice) Let’s see some of the reasons why pharma companies are emphasizing embracing customer relationship management solutions: Creates a Strong Connection with Customers Today, it is imperative for pharmaceutical firms to have a better understanding of their customers and their needs. Deploying pharma CRM software assists these companies in accumulating critical data and insights related to customer and patient behavior to comprehend the past, present, and future of their clients’ relationship with the organization. This aids them in creating a stronger connection with their customers. Promotes Efficiency in the Organization Automated procedures are designed to increase efficiency and enhance productivity without compromising operational accuracy. The use of CRM in pharma companies enables the automation of various consumer-facing business operations such as campaign management, marketing, customer service, and sales, among others. This assists medication manufacturers in enhancing the efficiency of their tasks. These solutions also aid in optimizing communication between the different departments, which in turn results in boosting the productivity of the business as a whole. Enhances Business Accessibility from Anywhere Remote access from anywhere is emerging as one of the essential modern needs for businesses today. For example, pharmaceutical CRM executives need to visit hospitals, chemists, warehouse staff, doctors, and stockists for sales meetings and operations. Cloud pharma CRM systems enable these representatives to access clients' and customers' vital information on the go, thus enhancing business accessibility. Improves Customer Service With the rising importance of improving customer service across the life science industry, it is becoming essential for pharma companies to respond to customer queries within the shortest possible time. Deployment of pharma CRM solutions can provide them with easy access to information stored in the database for resolving the query without causing any inconvenience to the customer or client, thereby offering better customer service. From Lead to Customer: Tracks Complete Journey Based on the current industry conditions and purchasing patterns of customers, the need to identify targeted audiences and potential leads is imperative. To get a complete picture of a customer's purchasing behavior, it is crucial for pharmaceutical firms to follow a customer from their initial interest to being a customer. Pharma CRM software enables these companies to track the complete journey of the customer, starting from being a prospective lead to a lifetime paying client. It can also assist in creating new strategies for future objectives. What Says the Future? With the emergence of new regulations, laws, and policies, the procedures and processes widely employed by pharmaceutical organizations have become more rigorous and rigid in the absence of technological assistance. In addition, intense market competition and rising company expenditures are pushing life-science firms to embrace innovative solutions to boost revenue generation, such as pharma CRM software. As the implementation of customer relationship management solutions assists pharmaceutical businesses in countering these obstacles along with optimizing processes, including customer retention, segmentation, behavior analysis, and many others, these solutions are expected to take center stage in the pharma world over the coming years. FAQ What is Pharma Customer Relationship Management Software? Pharma CRM is a tool that enables life science companies to gain sales and marketing efficiency, complete sales campaigns, adhere to compliance requirements, and efficiently monitor customer relationships. How Does CRM work for Pharma Companies? CRM is used to reduce the workload of pharma companies. Here are the steps showcasing how CRM for the pharmaceutical industry works. Capture the leads Optimize lead management Personalize the pitch Generate more customer value Personalize cross-sell and upsell Help customers help themselves What are the 3 main elements of pharma CRM software? These are the three key elements of pharma CRM solutions. Component #1 – Marketing Automation. Component #2 – Sales Force Automation. Component #3 – Customer Service Solutions.

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Pharma Tech

Bridging the Gaps in Complex Patient Journeys by Enriching Data

Article | August 9, 2022

Generating insights about patients on specialty therapies through data aggregation and integration can improve patient outcomes. As the number of specialty drugs expands in complex disease areas, such as autoimmune, multiple sclerosis, oncology, and respiratory illnesses, pharmaceutical companies have shown an increased interest in tracking and understanding real world and clinical data throughout the patient journey to support more targeted decision-making. There are significant challenges in the journeys that patients with complex diseases experience, including gaps, lapses, or delays in therapy. This often includes the initial start of a treatment, as well as when switching to a next-line therapy. These delays or gaps can not only lead to negative impacts for the patients but can affect the manufacturers as well. When specialty product pharmaceutical companies enrich their understanding of the patient journey through aggregated and integrated data, they will be more apt in improving treatment outcomes and making smarter decisions. Complexities with specialty products Over the last several decades, the production and use of specialty drugs has increased as there has been a wider global share of spending in higher-income countries.In the 10 largest developed countries and other high- and upper-middle-income countries,the use of specialty therapies has reached 47% and 37% respectively in 2020, up from 24% and 21% 10 years earlier. Specialty therapies will represent nearly half of global spending in 2025 and almost 60% of total spending in developed markets. The growing number of specialty products in any given market has generated improved patient outcomes, but the stakes are high for manufacturers when it comes to new patient starts and adherence. Specialty products typically demand more complex distribution and more hands-on administration to patients. A wealth of data is available from limited network specialty providers, but to get a broader view of the patients’ entire healthcare experience, integration with third-party claims data is necessary. With access to a greater depth and breadth of data, specialty product manufacturers have opportunities to advance their analytics capabilities and generate greater insights across vital patient touch points. For patients with complex diseases who are being treated with specialty products, there are multiple challenges they may face throughout their journeys: Fragmentation: Patients often need to interact with multiple sites of care, which results in fragmented data. A mix of pharmacy and medical claims can result in an incomplete view of the patient, prescriber, or payer, as well as create distorted views of administrations or doses across treatments which may need to be normalized for analysis. Data gaps: There could also be differences in the various data elements reported by each source, which can vary significantly, whether these are prescription data, laboratory data, claims databases, electronic health records, health registries, or patient reported outcomes data. Furthermore, there can be data lags, varying frequencies across datasets. Finally, multiple pieces of patient data can result in elevated privacy risks. These complexities directly affect manufacturers’ ability to gain insights to support their commercial activities: Finding and understanding potential patients, or tracking patients enrolled on a treatment, but subsequently dropped, can be a challenge as well as understanding comorbidities or concomitant therapies. Targeting HCPs is difficult as prescriber volume across datasets can be unclear and can limit the ability to prioritize healthcare professionals by patient mix, practice, specialty, and treatment dynamics. Aligning pricing, contracting and access, and determining incentives and return on investment (ROI)promotional metrics represent challenges. There is only a partial picture of market access and payer dynamics. Incentive compensation is complex due to duplicate or missing data which causes inequities in geographic or target-based plans. ROI metrics for promotional effectiveness may be over or understated due to inaccuracies in prescriber counts and inability to bridge to associated data. Defining the patient journey Specialty drugs are high-cost, high-touch products with complex manufacturing, dosing, and handling requirements. Often, the patient populations who utilize these drugs are small and dispersed, and may experience late diagnoses, misdiagnoses, lack of treatment options, and limited access to relevant specialists. This makes it difficult to find them and requires more customized market strategies to ensure their physicians have the right data they need at the point of treatment initiation. To generate effective forecasting and commercial strategies, pharmaceutical companies need specialty data tactics which can define every step to help them answer key questions, including: When in the patient journey is treatment prescribed? Who is prescribing it? Which tests, physician appointments, or medical events precede diagnosis? How long are patients typically adherent and what typically complicates adherence or causes a stop? Is the product being used as part of a combination therapy? What triggers the transition to a new line of therapy? What impact do copay assistance, nurse educator services, and other value-added programs have on the patient and physician experience? When pharmaceutical companies can combine the answers to these questions, they gain clarity into the critical milestones that define the patient experience. This enables them to find patients and their physicians more quickly and to be more targeted in their engagement strategies which, ultimately, generates more successful marketing campaigns. Difficulty accessing the data Unfortunately, these datasets can be difficult to access. Many pharmaceutical manufacturers partner with individual specialty pharma service providers to try to meet their data needs. But these resources tend to be limited and often fail to provide the comprehensive view needed to make meaningful decisions. Because most specialty products have such small and dispersed patient populations, patients are rarely served by a single pharmacy, healthcare professional, or healthcare organization. Each time a patient switches a product or line of therapy, it can result in disparate data collected through several channels, including physicians, clinics, hospitals, alternate sites of care, pharmacies, labs, payers, and digital health assets. Additionally, much of the patient journey data never passes through the limited distribution specialty pharmacy network, nor is it collected in a consistent, accessible format, making it difficult to analyze. As more specialty pharmacy service providers launch, it will become more difficult for manufacturers to compile a global view of the product from any single source, or to capture patient data with any degree of granularity. Expanding the view of the patient journey with data aggregation and integration Data aggregation and integration can help specialty pharmaceutical companies obtain an expanded view of the patient journey. The best data aggregation solutions provide pharmaceutical companies with broad sourcesof data as well as integration services that deliver high-level perspectives across patient populations or geographies. The data can be linked back to an individual prescriber, healthcare organization, insurer’s practice, or de-identified patient. By leveraging data from a limited distribution network and integrating with third-party healthcare data assets, including digital patient data, sponsors can identify a greater majority of patients likely to be prescribed or considered for their treatment. Oncology example: One manufacturer might choose three specialty pharmacies for their third-line oral oncology product, but the entire category, which includes first- and second-line therapies, may span well over 10 specialty pharmacies and a multitude of medical claims processors. An experienced data partner will be able to recommend and access data from most of these providers either directly and/or via use of syndicated data assets, to deliver a more complete picture of the patient journey and competitive landscape. The best partners offer more than data aggregation and integration; they provide deep analytics capabilities which empower commercial teams to deliver precise physician, organization, and patient engagements. The best partners will prioritize their efforts based on individual needs. Predictive analytics via artificial intelligence and machine learning capabilities are a must for a patient journey analysis and timely decision-making. Ultimately, good data aggregation and integration will lead to enriched data and insights to generate personalized treatment plans for the right patient at the right time to enhance outcomes. Access to the right data, analytics, and insights drive tangible results for patients and physicians while also ensuring that pharmaceutical companies generate the best ROIs.

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PHARMACY MARKET

Pharma CRM: Fostering Customer Engagement in the Life Science Industry

Article | October 10, 2023

Introduction The pharmaceutical industry is becoming more competitive day-by-day with the proliferation of novel technologies and the increasing introduction of new drug-developing companies. As a result, a significant number of pharmaceutical companies are facing difficulties securing solid financial returns. This has left no other choice for life science organizations than to move to digital-AI-based customer-centric systems to stand out. In addition, unexpected circumstances, such as the lack of in-person interaction with customers, have compelled pharma businesses to invest in cutting-edge, conversion-oriented CRM tools. As CRM in pharma provides a centralized platform for managing all the pharmaceutical data and monitoring relationships with customers, it is increasingly being sought in the industry. This strategy is getting a lot of attention in the pharmaceutical industry as a way to build and keep customer loyalty while moving toward supremacy in its respective segment. How Are CRM Solutions Assisting Pharma Companies to Become Customer-Centric? Several pharmaceutical organizations are looking for new strategies to stay competitive and improve their financial returns. The emergence of the pharma CRM trend has presented pharma businesses with a lucrative opportunity to develop new market approaches by transforming into customer-centric organizations. With real-time reports and analytics, any-time data access, and data availability in one place, novel CRM solutions are assisting pharma businesses in developing solid relationships with pharmacies, health care providers, distributors, suppliers, and even end patients. As the trend of improved customer experience and customer relationships spreads throughout the industry, many companies aiming to stay ahead are leveraging pharma CRM solutions to become more customer-centric and improve their financial returns. What are the key pharma CRM features that assist organizations to become customer centric? Let’s find out. Optimizes Products and Services As more and more businesses enter the pharmaceutical market, existing ones are looking for new ways to cut costs without compromising quality in order to survive and thrive in the respective domain. CRM software assists businesses in optimizing their products and services by creating detailed profiles of patients and potential customers, thereby declining costs and adding customer centricity. This also enables them to provide more tailored drugs, faster treatment delivery, and reduce wastage. Enables Integration with Customer Database It is important for drug manufacturing companies to maintain customer databases as they contain crucial information related to customers, such as customer buying behavior, purchasing patterns, usability, and others. Implementing cloud pharma CRM software enables integration with customer data, providing centralized access to organizations and assisting them to become customer-centric. Redefines the Customer Journey Customers and technologies are constantly evolving, and so are customer expectations. Hence, it is becoming crucial for pharma companies to track customers' journeys and analyze if the customer is in the sales cycle. Pharma CRM software assists these firms in determining whether customers are dissatisfied or are interested in an upsell, thereby making them customer-centric and increasing their revenue. Engages Customers in the Marketing Process Engaging customers within their sales and marketing strategies is of great significance for medical aid-providing enterprises to increase their ROI. As CRM for pharma helps in collecting valuable insights on what works and what does not, it assists these firms in constructing innovative marketing and sales campaigns and strategies as per customers’ interests and needs. This results in engaging customers in the marketing process. The Final Word In an intense competitive environment, it is critical for pharmaceutical organizations to engage the customers and build a better brand reputation to improve sales and ROI. As pharma CRM solutions helps in developing customer-centric services by allowing optimization of processes such as production, marketing, and sales, these solutions are ex

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PHARMACY MARKET

How long will the world wait for the next pandemic of antimicrobial resistance before we act?

Article | October 10, 2023

Antimicrobial resistance (AMR) has become an increasingly serious global health problem in recent years. World Health Organization (WHO) estimates that more than 700,000 people die each year due to drug-resistant infections, and the number is expected to increase in the coming years. How does antimicrobial resistance emerge? Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines. It makes infections harder to treat and increases the risk of disease, severe illness, and death. When we use antibiotics, some bacteria die, but resistant bacteria can survive and even multiply. The overuse of antibiotics and substandard antibiotics make resistant bacteria more common. So, the more we use antibiotics, the more chances bacteria have to become resistant to them. The rise in AMR is caused by multiple factors including the misuse and overuse of antibiotics by humans as well as in livestock and agriculture. Although these are the main drivers in the development of drug-resistant pathogens, the emergence of substandard and falsified antibiotics is another lesser-known, huge contributory factor. Even though AMR is a leading cause of death around the world, it is tracked most closely in clinical high-income settings and developed countries. Unfortunately, this is not the case in low and middle-income countries, where the highest burden is in low-resource settings and low-and middle-income countries (LMICs). These countries are disproportionately affected, in part due to the high burden of communicable diseases. Consequences to human health of AMR AMR poses significant risks to human health, resulting in prolonged and more severe infections, extended hospitalizations, and increased healthcare expenses. It can also lead to an increased risk of death, as an infection may become untreatable. Additionally, it can reduce the effectiveness of medicines and treatments, making it more difficult to manage existing medical conditions. It is even more concerning that it can lead to the emergence of new, more dangerous strains of bacteria, viruses, and other microbes. This would mean medical procedures, such as surgery, including caesarean sections or hip replacements, cancer chemotherapy, and organ transplantation, will become riskier. Counterfeit medicines and antibiotics: Antibiotics are the most counterfeited medicines in the world, as they account for 28% of global counterfeit medicines. Substandard and falsified antibiotics are medicines that do not meet the quality standards set by regulatory authorities. Counterfeit antibiotics are estimated at 5% of the global antibiotic market. These medicines are often of inferior quality or contain incorrect ingredients or incorrect amounts of active ingredients. They may also contain toxic contaminants or be expired, posing serious consequences for patients. Sadly, counterfeit antibiotics are mostly found in LMICs due to a lack of regulation and enforcement, as well as a lack of access to quality healthcare. In many of these countries, the demand for antibiotics is higher than the supply, and counterfeit antibiotics are seen as a cheaper and more accessible alternative. Furthermore, there is a lack of awareness around the dangers of taking counterfeit antibiotics, and there is a lack of resources for health authorities to test for the authenticity of these medicines. Why are antibiotics so rife for counterfeit drugs? Counterfeiters of pharmaceuticals succeed in large part by exploiting weaknesses in supply chains, which are often fragmented with poor regulatory frameworks. Antibiotics are often counterfeited because they are in high demand and can be sold for a large profit. To combat the problem of substandard and falsified antibiotics, governments must take a multi-pronged approach. This should encompass enacting laws and regulations to ensure the quality and safety of medicines, conducting surveillance for detecting and removing substandard and falsified products from the market, as well as providing training and education to healthcare professionals and patients regarding the responsible use of antibiotics. In addition, governments must work to strengthen the pharmaceutical supply chain. This includes increasing the transparency of the supply chain, improving the quality control systems, and introducing traceability systems to track the movement of medicines from the manufacturer to the patient. Medical investment in low and middle-income countries Another neglected aspect by international NGOs and governments is investment in building local laboratory capacity in LMICs to combat antimicrobial resistance. Localized laboratory facilities can help identify, track, and prevent the spread of antimicrobial-resistant infections, as well as provide early warnings of emerging drug-resistant strains. Localized microbiology, surveillance, and quality control laboratories can also play an important role in developing new treatments and interventions for combating antimicrobial resistance. In addition, having localized laboratory capacity can provide more accurate standardized data on the prevalence of drug-resistant infections, which can help inform policy decisions and public health interventions. Affordable medicines Finally, governments must work to increase access to high-quality, affordable medicines. This includes improving the availability of generic medicines, which are typically cheaper alternatives to brand-name drugs. They also need to increase access to newer, more effective antibiotics.

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Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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MHRA gives Bavencio, Inlyta combo Early Access to Medicines status

Pharmatimes | July 22, 2019

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC), and is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility. The combination was approved by the FDA in May this year based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups. There is a significant unmet need for RCC first-line treatments that delay progression and have an acceptable safety profile, as approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

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Is there life beyond Keytruda? Merck makes its case in first investor event in 5 years

fiercepharma | June 20, 2019

Merck CEO Ken Frazier kicked off Thursdays Investor Day presentation by acknowledging that the companys most recently lauded blockbuster, immunooncology drug Keytruda, is also its biggest challenge. “Everywhere I go, the key question I hear from people is ‘What do you have beyond Keytruda?’” Frazier said in his introduction to the investor presentation—the company’s first such event in five years. “But I think what we’re going to be able to show you today is that we do have tremendous growth opportunities beyond Keytruda.” It’s no wonder Frazier finds himself constantly facing the Keytruda question, considering how dominant that one product has been in Merck’s financial reports over the last few years. Even as recently as the first quarter of this year, when Keytruda’s sales leaped 60% to $2.3 billion, the company touted the recent successes that Frazier and his colleagues vowed would drive growth even more, including its new FDA approval for the first-line treatment of non-small cell lung cancer patients who have low levels of the biomarker PD-L1. During Investor Day, Merck’s chief commercial officer, Frank Clyburn, pointed out that Keytruda is just now starting to forge another new market—renal cell carcinoma. He reported that at the recent conference of the American Society of Clinical Oncology (ASCO), clinicians told him the data in kidney cancer would be “practice changing.” Oncologists were also excited about the potential of the drug in adjuvant melanoma, both in the U.S. and overseas, he said. CFO Rob Davis said he is confident that as Merck moves away from selling drugs mostly to a primary-care audience toward more hospital-administered products, the company’s profit margins will expand. Operating expenses will grow at a rate “meaningfully below sales,” he said. And the resulting margin expansion “will translate to accelerated earnings-per-share growth,” he vowed.

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Pharma Tech

Merck Drives New Innovation & Adds Capacity to Advance Next Generation Antibody-drug Conjugate (ADC) Therapies

Merck | October 29, 2021

Merck, a leading science and technology company, today announced that its Life Science business sector has launched new technology and expanded capacity to advance ADC therapies. These initiatives underscore Merck's continued investment in novel modalities and support the company's efforts to double its ADC and high-potent active pharmaceutical ingredient (HPAPI) capacity in the near future. "ADCs have experienced remarkable growth, with commercially approved ADCs tripling in the past three yearsWe are a pioneer in this space, involved in 50 percent of the commercially approved ADCs on the market today. This latest innovation and additional capacity help bring novel treatments to cancer patients around the world and reinforce our commitment to shaping the future of these novel modalities. Andrew Bulpin, head of Process Solutions, Life Science, at Merck With the launch of its ChetoSensar™ technology, Merck is one of the front runners working to address the hydrophobicity of ADCs, in tandem with its CDMO services. Many ADC candidates have poor aqueous solubility and Merck estimates that more than 20 percent of ADC clinical terminations are caused by this issue. The company's new ChetoSensar™ technology improves ADC solubility, therefore giving hope to ADCs that were previously terminated. The payloads commonly used for ADCs are highly-complex molecules that take many steps to synthesize. Based on Merck's calculations, its new DOLCORE™ platform significantly reduces the development and manufacturing time required, increasing speed-to-market for a novel Dolostatin-based ADC payload by up to a year. In addition, the company will enhance the ADC capabilities of its clinical manufacturing facility in St. Louis, Missouri, USA, in December. This facility will provide larger footprint to enable large-scale production including chromatographic purification for early phase clinical supply. This follows last year's announcement of a €59 million expansion of Merck's facility near Madison, Wisconsin, USA, which will double its HPAPI kilo lab capacity and enable the company to expedite the manufacture of HPAPIs, ADC linker/payloads, and complex APIs. This innovation and additional capacity support the company's ambition to accelerate growth through investments in the "Big Three," including the Process Solutions business unit within the Life Science business sector as a key driver. With 15 years of experience developing and manufacturing ADCs, Merck offers unique CDMO services streamlined with a single, highly experienced provider. The company leverages its global network and deep expertise to tailor each molecule's unique journey, while creating the dynamic client partnerships drug manufacturers need to help reach their critical milestones. Merck integrates contract development and manufacturing with the industry's broadest product offering across multiple modalities. Customers can also seamlessly integrate BioReliance® services from the company's leading biosafety testing portfolio. Merck recently announced expansion projects in Darmstadt, Germany; Cork, Ireland; Buchs, Switzerland; Carlsbad, California, USA; Madison, Wisconsin, USA; Jaffrey, New Hampshire, USA; and Danvers, Massachusetts, USA. These expansions are part of an ambitious, multi-year program to increase the industrial capacity and capabilities of the Life Science business sector to support growing global demand for lifesaving medications and to make significant contributions to public health. About Merck Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries. Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

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MHRA gives Bavencio, Inlyta combo Early Access to Medicines status

Pharmatimes | July 22, 2019

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency MHRA has issued an Early Access to Medicines Scheme EAMS positive scientific opinion for Bavencio avelumab used in combination with Inlyta axitinib. The opinion is for the combination as first-line treatment of adult patients with advanced renal cell carcinoma (RCC), and is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility. The combination was approved by the FDA in May this year based on positive results from the Phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival (PFS) compared with sunitinib by more than five months. The study included patients regardless of PD-L1 expression and across IMDC (International Metastatic Renal Cell Carcinoma Database) prognostic risk groups. There is a significant unmet need for RCC first-line treatments that delay progression and have an acceptable safety profile, as approximately 20% to 30% of patients are first diagnosed with RCC at the advanced stage, and 30% of patients treated for an earlier stage go on to develop metastases.

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Is there life beyond Keytruda? Merck makes its case in first investor event in 5 years

fiercepharma | June 20, 2019

Merck CEO Ken Frazier kicked off Thursdays Investor Day presentation by acknowledging that the companys most recently lauded blockbuster, immunooncology drug Keytruda, is also its biggest challenge. “Everywhere I go, the key question I hear from people is ‘What do you have beyond Keytruda?’” Frazier said in his introduction to the investor presentation—the company’s first such event in five years. “But I think what we’re going to be able to show you today is that we do have tremendous growth opportunities beyond Keytruda.” It’s no wonder Frazier finds himself constantly facing the Keytruda question, considering how dominant that one product has been in Merck’s financial reports over the last few years. Even as recently as the first quarter of this year, when Keytruda’s sales leaped 60% to $2.3 billion, the company touted the recent successes that Frazier and his colleagues vowed would drive growth even more, including its new FDA approval for the first-line treatment of non-small cell lung cancer patients who have low levels of the biomarker PD-L1. During Investor Day, Merck’s chief commercial officer, Frank Clyburn, pointed out that Keytruda is just now starting to forge another new market—renal cell carcinoma. He reported that at the recent conference of the American Society of Clinical Oncology (ASCO), clinicians told him the data in kidney cancer would be “practice changing.” Oncologists were also excited about the potential of the drug in adjuvant melanoma, both in the U.S. and overseas, he said. CFO Rob Davis said he is confident that as Merck moves away from selling drugs mostly to a primary-care audience toward more hospital-administered products, the company’s profit margins will expand. Operating expenses will grow at a rate “meaningfully below sales,” he said. And the resulting margin expansion “will translate to accelerated earnings-per-share growth,” he vowed.

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