Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• How To Avoid Last Minute CMC Roadblocks To Approval

  Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. Because of their high-profile importance in development, clinical needs get the emphasis, while the many CMC needs and risks may seem less critical. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

• Breakthrough Therapy Designation And Accelerated Approval With Inadequate CMC Program Development: Hurry Up And Wait

  This article examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s expedited accelerated approval (AA) and breakthrough therapy designation (BTD) programs.

• The Value Of Gene Therapy In Spinal Muscular Atrophy

  A client was developing a potentially curative gene therapy, they needed to translate the clinical benefit into economic terms to engage payers and health technology organizations. By working with the client to develop a cost-effectiveness and budget impact model for a gene therapy in SMA that overcame unique challenges of modeling an early childhood neuromuscular genetic disorder they were able to change the prevailing mindset on how SMA progression is characterized.

• State Of The Channel 2021

  CompTIA’s State of the Channel 2021 provides an in-depth review of the trends shaping the technology ecosystems of US, Canada, UK, Benelux and ANZ.

• Cloning Of Three Cell Types Comparing The Namo™ Single Cell Dispenser To Flow Cytometry And Limited Dilution Cloning

  Limiting dilution cloning (LDC) has been the standard method established for generating clonal cell lines, based on statistical data, but it is time-consuming and can be inefficient. This case study compares methods, using different cell lines, to determine which would deliver the highest number of viable clones.

• Using In-Line Sensors For Real-Time Control

  There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.

• Depositing - The Future Of Hard Candy

  Hard candy depositing is a process that has developed and grown rapidly over the last 20 years. Deposited hard candies and lollipops are now produced in every major confectionery market around the world by manufacturers ranging from regional specialists to major multi-nationals. This paper will review the basic principles of depositing and discuss the fundamental aspects of design that should be considered when engineering a complete depositing solution.

• Spinal Muscular Atrophy Patient Recruitment

  Read about a program which successfully enrolled approximately 300 patients into the global registry within an initial two-year period, which produced robust data used to meet regulatory objectives, inform SMA experts, and support publications.

• Lenovo Generates Significant Net-New Revenue In 6-Week Period With Katapult’s Innovative Financing Options

  Lenovo teamed up with Katapult to provide a lease-to-own financing option for this sub-prime customer segment. In the first six weeks after implementation, Lenovo generated incremental revenue through the new Katapult offering. Over the next few months, as the Katapult and Lenovo teams continued to optimize the new offering, completed originations from pre-approvals increased by 25 percent.

• Three Considerations For Successful Global Sample Processing With A Central Laboratory

  Obtaining timely and high-quality processing services is an industrywide challenge, particularly within the context of global trials. This paper reviews three of the keys to success for global sample processing.

• Unified IRT And Clinical Supply Aligns Processes To Meet Timeline

  Partnering with a single vendor has been proven to significantly reduce errors, demand less time and resource from sponsors, deliver process automation to drive efficiency, and offer a holistic view of data that facilitates smart decision making and continuous improvement. Download Almac’s case study to find out how one sponsor was able to meet ambitious study milestones, thanks to the Almac ONE service.

• Method Development: Managing A Diverse Range Of APIs