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WITH PRESCRIPTION PRICES ON THE RISE, THIS STARTUP IS SHAKING UP PHARMA FROM THE INSIDE OUT

MURIEL VEGA | July 10, 2019 | 219 views

In 2017, U.S. healthcare spending grew 3.9 percent, reaching $3.5 trillion. On average, that’s more than $10,000 per person. Smaller employers are having a hard time keeping up with rising costs, causing many to move to high-deductible plans that shift the cost burden onto the employee, says Reuben Buckareff. “Everybody wants to retain good employees. We’ve got a really tight labor market. Employers are stuck between a rock and a hard place because their insurance keeps going up every year. Benefits are the second largest line item after payroll,” Buckareff tells Hypepotamus. “With high-deductible policies, people are having to deal with more and more of their own decision-making as employers shift since they can’t afford insurance.” With high deductible plans comes higher-cost prescriptions, as well. This can be mitigated by searching for a better deal at a specific pharmacy or provider, but how do you know where you can find those deals in real-time? Clutch Health wants to help you do just that. The app captures electronic prescriptions that come in from a doctor. The patient can pick the most affordable price from pharmacies in the area right on the app. It then quickly forwards the prescription to the chosen pharmacy.

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Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 20, 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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PHARMA TECH

What are the advantages of PCD Pharma Company?

Article | August 9, 2022

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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PHARMA TECH

WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | July 13, 2022

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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PHARMA TECH

Precision Medicine: New Horizons in Pharmaceuticals

Article | July 20, 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.

Read More
PHARMA TECH

Quality Management Solutions: Meeting Complex Needs Across Pharma

Article | August 9, 2022

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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PHARMA TECH

Biomaterials Emerging as a Blessing in the Pharmaceutical Industry

Article | July 13, 2022

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

Read More

How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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Pharmsource, LLC

Pharmsource, LLC is one of the most trusted and fastest growing Rx wholesalers in the country. We take responsibility to ensure the strength of the pharmaceutical supply chain. We are focused on serving the interests of our customers through service, integrity and value.

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Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

Globenewswire | June 01, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma. “The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.” The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST. “This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.” About Ciltacabtagene Autoleucel (cilta-cel) Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5 Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9 In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10 About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13 About the Janssen Pharmaceutical At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

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PHARMA TECH

XtalPi Announces Collaboration with Lilly, Using AI + Robotics to Uncover First-in-class Therapeutics

PRNewswire | May 31, 2023

Today, XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, announced an AI drug discovery collaboration of up to $250 million in upfront and milestone payments with Eli Lilly and Company. The collaboration will leverage XtalPi's integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target. XtalPi has established itself as an industry leader in combining mutually informative AI "dry lab" algorithms with large-scale "wet lab" robotics to empower pharmaceutical innovation. Building upon existing success, XtalPi will work closely with the Lilly team to harness the power of its proven one-stop AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development. XtalPi's ID4Inno™ small-molecule drug discovery platform touts a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge that can generate and investigate a target-specific mega chemical space and quickly zero in on the most promising lead series. Each group of synthesized molecules is tested using XtalPi's internal biochemical, cellular, pharmacodynamic, and pharmacokinetic assay capabilities, feeding project-specific R&D data into generative AI models in iterative design-make-test-analyze cycles until a candidate with optimal drug properties emerges. XtalPi's fleet of hundreds of autonomous robotic workstations can carry out precise and energy-efficient parallel chemical synthesis and assays 24/7. This high-quality real-world data generated with speed and at scale, combined with over 500 AI models and quantum physics algorithms, continuously enhance XtalPi's capability to predict and authenticate novel drug candidates with greatly accelerated timeframes and reduced experimental costs. XtalPi's AI + robotics platform is supercharging the shift of pharmaceutical R&D from labor-intensive trial-and-error research to a computation and automation-intensive model, empowering scientists to achieve more with less. Serving over 200 pharmaceutical clients and research institutions from around the world, XtalPi is now bringing its proprietary autonomous lab to Cambridge, MA as its drug discovery business continues to grow. Dr. Jian Ma, CEO of XtalPi, says, "With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets. We are honored that Lilly has chosen XtalPi's AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide." About XtalPi XtalPi is a pharmaceutical technology company powered by AI and robotics to improve the speed, scale, novelty, and success rate of drug discovery and development. With operations in both China and the U.S., XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. Its integrated AI "dry lab" and large-scale robotics "wet lab" capabilities form an iterative feedback loop that empowers continuous innovation to address the unmet needs of patients worldwide.

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PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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PHARMA TECH

Janssen Seeks European Commission Approval of a New Indication for CARVYKTI® for the Earlier Treatment of Patients with Relapsed and Refractory

Globenewswire | June 01, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma. “The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.” The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1 The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST. “This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.” About Ciltacabtagene Autoleucel (cilta-cel) Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5 Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9 In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10 About Multiple Myeloma Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13 About the Janssen Pharmaceutical At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.

Read More

PHARMA TECH

XtalPi Announces Collaboration with Lilly, Using AI + Robotics to Uncover First-in-class Therapeutics

PRNewswire | May 31, 2023

Today, XtalPi Inc., a pioneering pharmaceutical technology company powered by artificial intelligence (AI) and automation, announced an AI drug discovery collaboration of up to $250 million in upfront and milestone payments with Eli Lilly and Company. The collaboration will leverage XtalPi's integrated AI capabilities and robotics platform to de novo design and deliver drug candidates for an undisclosed target. XtalPi has established itself as an industry leader in combining mutually informative AI "dry lab" algorithms with large-scale "wet lab" robotics to empower pharmaceutical innovation. Building upon existing success, XtalPi will work closely with the Lilly team to harness the power of its proven one-stop AI drug discovery solution to deliver a novel compound, which Lilly will pursue in clinical and commercial development. XtalPi's ID4Inno™ small-molecule drug discovery platform touts a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge that can generate and investigate a target-specific mega chemical space and quickly zero in on the most promising lead series. Each group of synthesized molecules is tested using XtalPi's internal biochemical, cellular, pharmacodynamic, and pharmacokinetic assay capabilities, feeding project-specific R&D data into generative AI models in iterative design-make-test-analyze cycles until a candidate with optimal drug properties emerges. XtalPi's fleet of hundreds of autonomous robotic workstations can carry out precise and energy-efficient parallel chemical synthesis and assays 24/7. This high-quality real-world data generated with speed and at scale, combined with over 500 AI models and quantum physics algorithms, continuously enhance XtalPi's capability to predict and authenticate novel drug candidates with greatly accelerated timeframes and reduced experimental costs. XtalPi's AI + robotics platform is supercharging the shift of pharmaceutical R&D from labor-intensive trial-and-error research to a computation and automation-intensive model, empowering scientists to achieve more with less. Serving over 200 pharmaceutical clients and research institutions from around the world, XtalPi is now bringing its proprietary autonomous lab to Cambridge, MA as its drug discovery business continues to grow. Dr. Jian Ma, CEO of XtalPi, says, "With a closed loop of AI and quantum physics algorithms working in sync with the data factory of large-scale robotics experiments, XtalPi is uniquely equipped to tackle challenging novel targets. We are honored that Lilly has chosen XtalPi's AI + robotics drug R&D platform as a partner in achieving more fruitful pharmaceutical innovation and bringing much-needed treatments to patients worldwide." About XtalPi XtalPi is a pharmaceutical technology company powered by AI and robotics to improve the speed, scale, novelty, and success rate of drug discovery and development. With operations in both China and the U.S., XtalPi has pioneered a new model for drug R&D that leverages a tightly interwoven trifecta of AI, autonomous labs, and expert domain knowledge. Its integrated AI "dry lab" and large-scale robotics "wet lab" capabilities form an iterative feedback loop that empowers continuous innovation to address the unmet needs of patients worldwide.

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PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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