preclinical white papers and articles

  1. Once Your Drug Substance Has Been Manufactured, How Do You Successfully Bridge Into Drug Product Development? 6/8/2022

    After your drug substance has been manufactured, the next challenge is formulating your API with other inactive ingredients (excipients) into a finished dosage form (drug product) for clinical trials.

  2. What Do I Do About Incidental Findings In Research? 5/23/2022

    Find out how incidental findings can result from a standard, approved clinical test or intervention and can also be found from a research test or intervention.

  3. The Clinical Development Plan: Ensuring Success 2/17/2022

    For an early-stage pharma/biotech company, the Clinical Development Plan (CDP) can be extremely valuable and a key indicator of potential success of a program. This white paper highlights key components for developing and executing a clinical research strategy once the plan is in place.

  4. How Preclinical And Nonclinical Studies Differ, And Where They Belong 1/11/2022

    Learn when should each term be used, and the appropriate timelines for preclinical and nonclinical studies within a drug development program.

  5. Analysis: Pharma's Path Ahead For COVID-19 R&D 12/17/2021

    Three pressing issues stand out and require the collaborative efforts of the biopharma industry to slow the pandemic, reduce deaths and hospitalizations, and return life to something resembles normality: understanding long COVID, growing the arsenal of anti-infectives and tackling virus variants.

  6. An Evolving Biologics Landscape And Driving Innovation And Opportunity 12/7/2021

    The biologics segment is expanding quickly, with respect to both the level of investment and number of new startups. Explore a more collaborative investment model, the development of novel devices and delivery technologies, and a natural evolution in the CDMO space.

  7. No Shortcuts: Two Pathways To Building A Future For Huntington's Disease Research 11/16/2021

    One of the tenets of clinical research is that findings often result in more questions than answers. For Huntington’s disease, the journey toward understanding and treatment continues to be a methodical one. Dr. Ole Isacson highlights two pathways to ongoing research for this rare disease.

  8. A Changing World In Gene Therapy Research: Exciting Opportunities For Medical Advancement And Biosafety Challenges 10/18/2021

    In this report, key developments are highlighted in the field with a focus on biosafety and provides guidance for performing risk assessments on the currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials.

  9. Supporting Life Sciences From Startups To Commercialization 9/3/2021

    Sikich’s SuiteSuccess for Life Sciences, built on NetSuite, helps companies grow from pre-revenue to commercialization in a fast, painless manner that ensures compliance and allows users to focus on what they do best: developing new medicines for patients who need them.

  10. Physiological Functions Of The Amyloid Precursor Protein: A New Understanding 8/2/2021

    Found in many tissues, the amyloid precursor protein, or APP, is most widely known for its role in Alzheimer’s disease. To find out more about this protein, read the available blog post.