Articles

11. Brochure: Biologics Contract Manufacturing & Technology Solutions 1/30/2012

    DSM provides turn-key biologic manufacturing solutions, contract manufacturing for preclinical development, clinical trials or commercial supply and reduced cost, risk, and time to market.

12. Brochure: Pharma Sterile Dosage Forms 1/30/2012

    DSM offers pharmaceutical and biopharmaceutical customers a lyophilization system with unique benefits. It has the precision to serve increasingly demanding lyophilization cycles, a critical requirement for successful product launches and high commercial yields. 

13. Combination Products 2.0: Applying The New FDA Regulations 1/20/2012
    Combination products, those that contain medical devices embedded with pharmaceutical or biologic components, have become a large and growing segment of the medical device market. Some analysts estimate they represent over 30% of all new product submissions to the FDA. By Steven Richter, Ph.D
14. Executive Insights Into CMO Selection: Greg Troiano, BIND Biosciences 11/11/2011

    Life Science Leader magazine put together an executive roundtable article on the CMO selection process for a 2011 special supplement. The intent — to gain a better understanding of the some of the challenges faced during the partnering and provide insights on how to overcome. By Rob Wright

15. Alkermes Contract Pharma Services 9/28/2011

    With Alkermes Contract Pharma Services, you have the opportunity to outsource your development, scale-up and manufacturing requirements to a trusted, experienced and dedicated expert in outsourcing services.

16. Late Phase Research 5/11/2011
    The post-marketing environment is evolving rapidly — and without the right strategy, new challenges can squeeze precious value out of your investment.
17. Data Driven Market Success 5/11/2011
    A Quintiles customer needed an experienced post-marketing ally who could plan for the unknown and design an observational study to eventually include several affiliates, thousands of sites, and more than 55,000 patients, with start-ups staggered over time.
18. Q&A: Understanding The 505(b)(2) Approval Pathway 5/28/2009

    By the time he founded Camargo Pharmaceutical Services in 2003, Ken Phelps had already amassed more than 30 years of experience in the health science and services industry. With a broad background in drug development, specifically the 505(b)(2) regulatory approval pathway, Phelps has aided in the successful FDA approval of numerous compounds. Today, his company provides a full spectrum of drug development capabilities, from pre-clinical feasibility assessments to clinical program development to regulatory review and submission.

    In this Q&A, Phelps discusses 505(b)(2) — how it differs from 505(b)(1), its myriad of benefits, its continuing evolution, and its current and future impact on drug development.