GUEST COLUMNISTS

  • Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap

    The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

  • New ICH Q14 Guidance Applies QbD To Analytical Procedures

    ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

  • Make This Your New EU IDMP Implementation Strategy

    Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

  • Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting

    The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.

  • How To Evaluate & Manage Safety Risks In Biopharma

    Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

  • Small Molecule Drug Discovery: Can AI Do It All?

    The hope is that AI can solve the single most challenging problem at the heart of modern drug discovery: the reliable prediction of novel small molecule drugs that potently bind to a disease-causing protein and alter its function. This article discusses the challenges and how we can position ourselves to navigate them.

  • FDA Releases Draft Guidance On CMC For Individualized ASO Therapies

    A new FDA guidance released in Dec. 2021 acknowledges the difficulties inherent in manufacturing individualized antisense oligonucleotide (ASO) treatments and offers researchers and manufacturers the opportunity to create policies and procedures that are more likely to be condoned by the FDA in an IND submission.

  • 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma

    Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.

PHARMA ONLINE WHITE PAPERS

  • Single-Use Solutions For Research And Process Development
    4/12/2022

    Can supply chain assurance be maintained while offering an array of possibilities to achieve complex process designs? Learn if your organization could benefit from a modularized and standardized single-use manifold design.

  • Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions
    4/13/2021

    During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.

  • Rational Design & Development Of Long-Acting Injectable Dosage Forms
    1/26/2022

    The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.

  • It Hasn’t Been Easy For Pharma To Be Green
    10/2/2020

    Partnering with a CDMO proficient in green chemistry and manufacturing can help a biotech create the most attractive drug package — one that includes a proven commercialization process minimizing toxic wastes that pose safety concerns or require costly remediation.

  • Navigating Regulatory And Development Milestones
    9/17/2020

    This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

PHARMACEUTICAL ONLINE CONTENT COLLECTIONS

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In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.

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