Articles by Conrad J. Heilman, Jr., PhD - BioPharm International



Articles by Conrad J. Heilman, Jr., PhD

Conrad J. Heilman, Jr., PhD

Senior Vice President at Tunnell Consulting

The Company at the Crossroads. Part 2: Build or Buy?
November 1, 2008

When making critical decisions such as whether to build or buy critical capabilities, companies need a decision-making approach that weighs risks and rewards as a science with adequate inputs, repeatable processes, and measurable results. The method must also accommodate the human factor by encouraging wide participation and providing the kind of neutral decision criteria that satisfies participants about the objectivity of the process.

The Company at the Crossroads. Part 1: To Commercialize or Not?
September 1, 2008

Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.

Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and Manufacturing
July 1, 2008

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals
May 1, 2008

The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification.

Preparing for Your First IND Submission: The Devil is in the Details
January 1, 2008

In the process of developing breakthrough biopharmaceuticals with profound therapeutic promise, the many detailed requirements for a successful investigational new drug (IND) submission may seem petty, but they are not. With an IND, you are essentially moving from the cloistered world of the laboratory into a highly regulated industry where details not only matter, but are also greatly magnified by the overriding requirements of safety and efficacy. Treat those details with forethought and you will eventually succeed. Treat them as an afterthought and all of your pioneering science, state-of-the-art technology, and therapeutic ambition could come to nothing. At the very least, your progress to market could be delayed significantly. And if, like most young biopharmaceutical companies, you are on a short financial leash, such delays can be fatal for securing additional funding.



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