March 28, 2019
Three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.
April 10, 2019
DSI, the leading Chemistry, Manufacturing and Controls consulting firm, today announced its participation in CPhI North America, the only Pharmaceutical Industry Event for the North American Supply Chain. This three-day event will be held on April 30-May 2, at the Lakeside Center at McCormick Place, Chicago, Illinois.
April 16, 2019
The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.
May 10, 2019
I have never been so simultaneously energized and exhausted than during BIO Week. From the moment you arrive in the city, you’ll experience morning to evening activity. From keynote speeches with luminaries, to panels and partnering meetings with pharma CEOs, to a number of parties ranging from circus performers to whiskey tastings, to yes… Cheesesteak options!
May 22, 2019
Some individuals have an off-kilter sense of risk. They may play it overly safe and refuse to make even the most prudent bets on their development program. Or they may gamble willy-nilly, putting all their chips on wildly unpredictable long shot CMC strategies and preceding advice.
May 30, 2019
what makes a drug development program? Much like a Philly cheesesteak, the pursuit of greatness is the assurance that any given compound meets requisite technical and quality elements in each stage of development to allow for the ultimate successful commercialization of the drug.