Drug Discovery Featured Articles & Applications

  1. Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies 9/27/2017

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.

  2. Why Pharma Needs A New Approach To Patient Engagement In Drug Development 9/21/2017

    Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients.  As a result, the patient is becoming more of a “consumer” in the traditional sense.

  3. Integrated Delivery Networks & The Future Of Drug Development 9/20/2017

    IDN characteristics can include shared clinical guidelines, a common technology platform, and the ability to jointly negotiate with payers on contracts that may involve financial risk for quality and patient outcomes. Simply put, IDNs are healthcare ecosystems unto themselves. 

  4. Genome Editing & The Future Of Drug Discovery 8/10/2017

    The genome editing market is estimated to reach $3.5 billion in 2019 — an increase from $2 billion in 2014 — with a CAGR of 13 to 14 percent.1,2 The factors driving this market include increased R&D funding for genomic research, a growing demand for synthetic genes, new technologies in genome editing, and high utilization in plant breeding. However, high regulatory stringencies, lengthy approval processes, and ethical issues associated with the fear of genetic research hamper market growth. This article examines the utilization of genome editing tools and technology and their impact across the drug discovery industry.

  5. Integrating The Payer Perspective Into Drug Development 7/11/2017

    This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.

  6. Building A Productive Relationship With The FDA: Beyond The Science 5/17/2017

    At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.

  7. What To Know About Thailand’s Life Sciences Industry 5/12/2017

    About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.

  8. Interacting With The FDA — Best Practices For Drug Development Success 4/6/2017

    When it comes to dealing with and interacting with the FDA, attitude plays an important part in ensuring the agency is on your side. How do you do this?

  9. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t) 3/20/2017

    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. 

  10. What Outcomes-Based Contracts Mean For Drug Development And Drug Pricing 3/17/2017

    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 prices.