Big Pharma game heading for console release next month

pharmaphorum | November 19, 2019

First launched as a PC game in 2015, Big Pharma will be available for all three major games consoles – Sony’s PlayStation 4, Nintendo Switch, and Microsoft Xbox One – from next month, according to publisher Klabater. The game – developed by Twice Circled and Positech Games – is described as “part business sim, part logistics puzzle,” and puts players in the hot seat of a biopharma start-up, trying to translate R&D discoveries into blockbuster brands and transform the company into a multinational corporation. Players start with an empty warehouse, and have to buy the equipment and technology to try to turn it into a profitable factory with multiple production lines, whilst also pumping cash into R&D and sending drug-hunting explorers around the world. The game includes a number of challenges and quests to test budding CEOs as they try to build their empire, and discover whether their business approach is closer to disgraced ‘pharma bro’ Martin Shkreli – currently incarcerated – or legendary biotech pioneer Henri Termeer.

Spotlight

Historically, clinical trials have not examined most pediatric medications.This is due to the ethical and practical challenges of conducting pediatric drug trials. Children are 40% of the world’s population. Yet, regulatory agencies have approved only 10% of the drugs on the market for pediatrics.

Spotlight

Historically, clinical trials have not examined most pediatric medications.This is due to the ethical and practical challenges of conducting pediatric drug trials. Children are 40% of the world’s population. Yet, regulatory agencies have approved only 10% of the drugs on the market for pediatrics.

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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.

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PHARMACY MARKET

Inozyme Pharma Announces Partnership with Rady Children’s Institute for Genomic Medicine to Advance Newborn Screening for Genetic Diseases

Inozyme Pharma Inc. | June 17, 2022

Inozyme Pharma, Inc. a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of abnormal mineralization, today announced a partnership with Rady Children’s Institute for Genomic Medicine (RCIGM) to advance and evaluate a novel newborn screening technology to facilitate diagnosis of genetic diseases. The partnership includes several leading genomics, biotechnology companies and patient advocacy groups and focuses specifically on a diagnostic and precision medicine guidance tool called BeginNGS™, which incorporates rapid Whole Genome Sequencing (rWGS®) to currently screen newborns for approximately 400 genetic diseases. “Newborn screening will be essential to identifying and initiating timely intervention in children with rare genetic disorders like GACI (generalized arterial calcification of infancy) as we advance INZ-701 through clinical testing. We look forward to working with Rady Children’s Institute for Genomic Medicine, and with the BeginNGS consortium, to advance the use of this promising screening technology.” Catherine Nester, vice president, physician and patient strategies at Inozyme Pharma RCIGM is in a pilot evaluation that aims to supplement existing newborn screening protocols at birthing hospitals throughout the United States. The pilot program’s goal is for BeginNGS to become the genetic disease screening standard, with testing expanding to approximately 1,000 [disorders] and sequencing of 3.7 million newborns annually. Founding members of the public-private BeginNGS consortium include Inozyme, Alexion, Travere Therapeutics, and several patient advocacy groups that are helping to advance this program. “RCIGM helped pioneer the use of rWGS for diagnosis of genetic disease in intensive care settings,” said Stephen Kingsmore, MD, DSc, president and CEO of RCIGM. “With the proven clinical utility of diagnostic rWGS , we are using that experience to screen, diagnose, and help treat genetic conditions at or before onset of symptoms. Through a public-private consortium of leading organizations such as Inozyme, and advocacy groups in pediatrics, genetics, biopharma, biotech, and information technology, we aim to scale newborn sequencing to every life-threatening childhood genetic disease, RCIGM believes now is the time to end the diagnostic and therapeutic odyssey for all children with treatable genetic diseases.” BeginNGS developed through a research collaboration with Alexion; AstraZeneca’s Rare Disease group; Illumina, Inc.; TileDB; Fabric Genomics; and Genomemon, which uses rWGS to diagnose and identify treatment options for genetic conditions before symptoms begin. This approach represents an advance over current pediatric uses of rWGS that focus mainly on children who are already critically ill. Once a diagnosis is made, BeginNGS uses Genome-to-Treatment (GTRx™), a tool that provides immediate treatment guidelines to help physicians understand genetic conditions and their available treatment options. Addressing the Need for Enhanced Newborn Screening Tools Traditional newborn screening is one of the most successful public health programs in the United States. Of nearly 4 million babies born annually, 98 percent are tested in the first days of life. The BeginNGS test identifies serious childhood diseases that have effective treatments. States currently screen for only 31 to 76 of the hundreds of severe, childhood genetic diseases that have available treatments. Adding a new condition to the screening protocol is slow (5 to 6 years per condition), laborious, and costly. In the last decade, WGS has increased in speed, diagnostic performance, and scalability. BeginNGS will not replace the current biochemical newborn screening paradigm; rather, it is designed to complement the newborn screening processes and infrastructure that are already in place. “We are thrilled at the prospect of newborn screening to assist in early identification of infants affected by ENPP1 Deficiency and ABCC6 Deficiency via Inozyme’s collaboration with Rady Children’s Institute for Genomic Medicine. Early diagnosis is crucial to improving a baby’s chances of survival and long-term health if they have these rare and devastating diseases,” said Christine O’Brien and Liz Molloy, co-presidents of GACI Global. About Rady Children’s Institute for Genomic Medicine Rady Children’s Institute for Genomic Medicine is transforming pediatric critical care by advancing disease-specific healthcare for infants and children with rare disease. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Children’s Hospital-San Diego and a growing network of more than 60 children’s hospitals nationwide. The vision is to expand delivery of this life-changing technology to enable the practice of Rapid Precision Medicine™ at children’s hospitals across the nation and the world. RCIGM is a non-profit, research institute embedded within Rady Children’s Hospital and Health Center. About Inozyme Pharma Inozyme Pharma, Inc. is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton. Through our in-depth understanding of the biological pathways involved in mineralization, we are pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. We are initially focused on developing a novel therapy, INZ-701, to treat the rare genetic diseases of ENPP1 and ABCC6 Deficiencies. INZ-701 is currently in Phase 1/2 clinical trials for the treatment of ENPP1 Deficiency and ABCC6 Deficiency.

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BUSINESS INSIGHTS

EyePoint Pharmaceuticals announced a debt refinancing with Silicon Valley Bank for $45 million in credit facilities

EyePoint Pharmaceuticals, Inc. | March 10, 2022

A pharmaceutical company, EyePoint Pharmaceuticals, Inc.dedicated to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, announced that it has entered into a loan agreement with Silicon Valley Bank to replace its existing credit facility with CRG Servicing LLC for senior secured credit facilities for $45 million (CRG). A $30 million term loan facility and an asset-based revolving credit facility of up to $15 million will be used to replace the existing approximately $40.5 million in liabilities under the previous CRG credit facility, according to the provisions of the new deal. The new facility represents a considerable improvement in economics, lowering the loan interest rate from 12.5 percent to a blended rate of around 5%, saving an estimated $2.8 million in annualized interest. The Silicon Valley Bank agreement stipulates the following: • A $30 million term loan facility with an interest rate equal to the higher of I the Wall Street Journal prime rate plus 2.25 percent or (ii) 5.50 percent. For the first two years of the term loan facility, just interest payments will be required; and • A $15 million asset-based revolving credit facility pays interest at the Wall Street Journal prime rate. The revolving credit facility's availability will be constrained by a borrowing base value of the Company's accounts receivable. “We are very pleased to enter into the new loan agreement with Silicon Valley Bank and replace our existing credit facility with improved economic terms. After strong execution in 2021, we ended the year with over $210 million of cash and investments, positioning EyePoint for these new credit facilities and further improving our balance sheet. We are grateful for the support of our partners at CRG, and we look forward to continued execution of our plan to meet near-term milestones and drive shareholder value.” George O. Elston, Chief Financial Officer of EyePoint Pharmaceuticals "We are delighted to support EyePoint in their pursuit of helping patients with serious eye disorders facing significant unmet need,” said Lauren Cole, Head of East Coast Biotech Credit Solutions at Silicon Valley Bank. “Their pipeline candidate, EYP-1901, a potential six-month intravitreal treatment targeting wet age-related macular degeneration, is a great example of what their proprietary Durasert® technology may accomplish." The terms of the new credit facility with Silicon Valley Bank will be disclosed in the Company's Annual Report on Form 10-K, which is scheduled to be filed with the Securities and Exchange Commission on or before March 11, 2022. The Company has $211.6 million in cash and investments as of December 31, 2021, including over $230 million from two successful follow-on equity offerings in 2021.

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