Drug Discovery Featured Articles & Applications

  1. Pharmaceutical Lifecycle Management Strategies – Maximize Returns And Minimize Risk

    The patent cliff and a reducing drug pipeline are the two biggest challenges faced by innovator companies today. With the expiry of blockbuster drugs and early entry of generics, the pharmaceutical industry has lost about $157 billion in sales between 2010 and 2015. This is hampering the industry’s ability to fund drug development programs. Until about two decades ago, most drugs had an effective patent life of about 17 years, but changes to regulatory requirements and challenges by generic companies has resulted in only about 7 to 11 years of market exclusivity for innovators’ drugs.

  2. Route Scouting In API Development: A Luxury Or Necessity?

    In pharmaceutical domain, until about 30 years ago the term “process R&D” meant just making a chemical process scalable. Most of the brighter chemists chose to spend their time in “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to the critical aspects of scale up like safety, waste management or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines), far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst performing sectors when measured in terms of waste produced per unit of product made. Over the years, the pharma industry have recognized the need to change and develop more efficient processes. Thus was born a new field of chemistry called process research.

  3. End-to-end Technology Transfer Services In Oral Solids And Sterile

    In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.

  4. Ozonolysis Development Solutions For Safety Studies And Scale Up

    Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.

  5. Our Approach On Tech Transfer For Early Phase GMP Manufacturing

    Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.

  6. The Upswing Of Sterile Injectables

    The $330 bn global sterile market is expected to reach $525 bn by 2020, growing at a CAGR of 11% -with North America contributing 48% while APAC is expected to record highest CAGR of 13%.

  7. Cross-Lab Data Collaborations – The Future Of Immunotherapy?

    In January, UC San Francisco announced a research alliance with AbbVie, Amgen, and BMS supporting the collection and analysis of at least 500 tumor samples from more than 10 different forms of cancer to ultimately improve patients’ responses to cancer immunotherapy.

  8. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  9. What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  10. Critical Opportunity For Pharmaceutical And Process Understanding

    Industry-wide initiatives, such as Continued Process Verification (CPV), Process Analytical Technology (PAT) and Quality by Design (QbD), are driving today’s pharmaceutical manufacturers to improve product and process quality and efficiency. From a high level, product and process understanding in manufacturing includes identifying and monitoring Critical Process Parameters (CPPs) and Key Performance Indicators (KPIs) for one site or across the extended manufacturing network comprised of geographically dispersed sites and contract manufacturing organizations. Analysis of process data helps improve understanding for better decision-making.