Upcoming Xtalks Webinar Will Discuss Pharmaceutical Commercial Launch Readiness With Secrets to De-Risk and Accelerate Success

XTALKS | July 18, 2020

Commercial launch readiness is a critical stage in a product life cycle. While the world hangs on pharma’s ability to discover a COVID cure or vaccine, the global economic downturn will only increase price pressures overall for the industry. The era of increasing competitive and price pressure is not going away and capturing full value from every product launch is critical. However, history shows that only a third of product launches meet analyst expectations. Teams with the ability to optimize commercial launch readiness through insight, differentiation, efficiency and risk mitigation will lead the pack.

Often teams, whether in a start-up, mid, or large pharma, lack extensive experience in commercial launch readiness. This influences the brand’s ability to meet forecast and achieve market access targets.

Leveraging the breadth and depth of launch experience from scores of launches across primary care, rare disease, oncology and specialty, this webinar will discuss typical commercial launch readiness risk areas, best practices approaches for commercial readiness and securing market access and measurement.

Spotlight

The FTC's recent $1.2 billion settlement over the drug Provigil has brought so-called "pay for delay" deals for generic drugs back into the spotlight. Opponents say these deals delay generic medications to market, costing consumers billions. But drug companies say that the deals help get generics to market by avoiding lengthy patent litigation. NewsHour's Megan Thompson reports.

Spotlight

The FTC's recent $1.2 billion settlement over the drug Provigil has brought so-called "pay for delay" deals for generic drugs back into the spotlight. Opponents say these deals delay generic medications to market, costing consumers billions. But drug companies say that the deals help get generics to market by avoiding lengthy patent litigation. NewsHour's Megan Thompson reports.

Related News

BUSINESS INSIGHTS

Ginkgo Bioworks and Novo Nordisk to Collaborate on Expression Systems for Pharmaceutical Products

Ginkgo Bioworks and Novo Nordisk, | June 08, 2022

Ginkgo Bioworks the leading horizontal platform for cell programming, announced a collaboration with Novo Nordisk, a leading global healthcare company, to create novel expression hosts for pharmaceutical products. hundreds of millions of people are living with diabetes, obesity, and other serious chronic diseases, putting a strain on individuals, families, and healthcare systems. More effective medicines could improve treatment options for these people. Using synthetic biology, Ginkgo and Novo Nordisk will collaborate to unlock the potential of expression systems, which may accelerate and enhance the discovery and development of Novo Nordisk's biological medicines. "Novo Nordisk is constantly pushing the boundaries for innovative tools to bring new treatments to people living with diabetes and other serious chronic diseases. Using synthetic biology and the reprogramming of expression system genomes, we have the potential to engineer biological systems that will expand the chemical space of biological medicines." Brian Vandahl, Senior Vice President, Global Research Technologies, Novo Nordisk "It's an honor to work with partners like Novo Nordisk that not only have an incredible range of critically important products, but that also provide us with the opportunity to do meaningful work that could help so many patients," said Jason Kelly, CEO and cofounder of Ginkgo Bioworks. "At Ginkgo, we are always on the lookout for projects that will have an outsized impact on people's lives and well-being. We're excited to be working with Novo Nordisk in our efforts to use biology to create better medicines for patients with chronic diseases." Under the terms of the partnership, Ginkgo and Novo Nordisk will launch a multi-year collaboration. Ginkgo will receive an upfront R&D fee and is eligible to receive milestone payments as the parties advance in the collaboration. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.

Read More

BUSINESS INSIGHTS

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

Sutro Biopharma, Inc.; Astellas Pharma Inc. | June 28, 2022

Astellas Pharma Inc. and Sutro Biopharma, Inc. announced a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates. The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise. “We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality. iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies.” William J. Newell, Sutro’s Chief Executive Officer Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies.” A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely*1. This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action. This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available. Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States. Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercises this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

Read More

PHARMA TECH

Cadence Expands into Molecular Simulation with Acquisition of OpenEye Scientific, a Pioneering Leader in Computational Molecular Design

Cadence | July 26, 2022

Cadence Design Systems, Inc. announced that it has entered into a definitive agreement to acquire privately held OpenEye Scientific Software, Inc., a leading provider of computational molecular modeling and simulation software being widely and increasingly used by pharmaceutical and biotechnology companies for drug discovery. The addition of OpenEye’s technologies and experienced team with its deep scientific expertise accelerates Cadence’s Intelligent System Design™ strategy and expands its total addressable market bringing Cadence’s computational software expertise to apply proven algorithmic, simulation and solver advances to life sciences. Technological advancements, coupled with the rising demand for new drugs across a range of diseases, are driving increased demand for computational drug design. The growing utilization of computational techniques in drug discovery for pharmacology, chemical synthesis and drug screening to study the 3D structure of molecules is a major factor fostering the growth of the global biosimulation market, which has an estimated TAM of $2B and predicted to have a compound annual growth rate (CAGR) of approximately 15% over the next five years. Biosimulations are a critical tool for pharmaceutical research as they provide atomic-level insight into molecular interactions, and there’s a growing demand for high-performance simulation of larger biological systems over longer time scales. Cadence continues executing its Intelligent System Design strategy and has successfully leveraged its computational software expertise to expand into the system analysis space to address the electromagnetics, thermal and computational fluid dynamics (CFD) challenges in the high-tech electronics, aerospace and defense, and automotive sectors. Cadence is now extending that computational software core competency to molecular modeling and simulation that is targeted to life sciences. OpenEye, an industry leader in computational molecular design, has pioneered physics-based approaches and the cloud-native Orion® software platform to accelerate advances in human health. The acquisition allows pharmaceutical and biotechnology companies to benefit from more robust drug discovery solutions that combine OpenEye’s innovative molecular modeling and simulation software solutions for drug discovery with Cadence’s algorithmic and solver expertise, efficient large data management infrastructure, and leading AI/ML and cloud solutions. OpenEye’s products are used by 19 of the top 20 pharmaceutical companies globally—including Pfizer and AstraZeneca—as well as numerous biotechnology companies and academic institutions. Orion, OpenEye’s market-leading cloud-native software-as-a service (SaaS) platform, is growing rapidly as pharmaceutical and biotechnology users embrace its flexibility and scalability to perform complex molecular calculations on a large scale. “Drug discovery is an increasingly complex process that requires significant investment in research and development. The pending acquisition of OpenEye, with its scientifically tested methodologies and expertise, accelerates Cadence’s Intelligent System Design strategy with our entry into a new system domain of life sciences. Cadence’s deep computational software expertise drives further innovation in algorithms that enhance the reliability, efficiency and speed of molecular simulations. We look forward to welcoming such an accomplished team and are delighted to accelerate innovation and improve research and development productivity in the pharmaceutical and biotechnology industry.” Dr. Anirudh Devgan, president and CEO of Cadence “We founded OpenEye to stretch the boundaries of what’s possible in computational drug discovery,” said Dr. Anthony Nicholls, CEO of OpenEye Scientific. “Our 3D search technology, programming toolkits, and more recently, our cloud platform, Orion, have led the industry for more than 25 years, and this opportunity to join with Cadence to pursue even greater scale and accuracy is simply amazing. We foresee a time when pharmaceutical design, no matter the modality, is predominantly computational. The realization of that goal with our skills and Cadence’s resources and expertise is going to have a profound impact on human health.” Under the terms of the definitive agreement, Cadence will pay approximately $500 million in cash. The acquisition is expected to contribute immaterial revenue this year and about $40 million in fiscal 2023. It is expected to close in the third quarter of 2022, subject to completion of Hart-Scott-Rodino regulatory review and customary closing conditions. About Cadence Cadence is a pivotal leader in electronic systems design, building upon more than 30 years of computational software expertise. The company applies its underlying Intelligent System Design strategy to deliver software, hardware and IP that turn design concepts into reality. Cadence customers are the world’s most innovative companies, delivering extraordinary products from chips to boards to complete systems for the most dynamic market applications, including hyperscale computing, 5G communications, automotive, mobile, aerospace, consumer, industrial and healthcare. For eight years in a row, Fortune magazine has named Cadence one of the 100 Best Companies to Work For. About OpenEye Scientific OpenEye Scientific is an industry leader in computational molecular design through rapid, robust and scalable software, toolkits, technology and design services, and Orion®, the only cloud-native fully integrated software-as-a-service molecular modeling platform that runs on Amazon Web Services. Combining unlimited computation and storage with powerful tools for data sharing, visualization and analysis in an open development platform, Orion offers unprecedented capabilities for the advancement of pharmaceuticals, biologics, agrochemicals, and flavors and fragrances. Founded in 1997, OpenEye Scientific is a privately held company headquartered in Santa Fe, N.M., with offices in Boston, Mass.; Cologne, Germany; and Tokyo, Japan.

Read More