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When should we do the solid state studies and what kind of studies should we undertake? In-sourcing refers to the growing model where companies bring in scientists from an outside organization; they work side-by-side with the company’s internal team to enhance their project resourcing.

We will share our experiences across multiple collaborations and seek open discussion among the participants.

In many instances this forces Phase II to become the defacto Phase III.

This often requires that the process and method employed during Phase II manufacture to be viable for validation or at the least validation readiness within a very short time frame.

Jeffrey Samuel Director, Marketing SK Life Science Roger Hanselmann, Ph. Director of Process Research & Development Akebia Therapeutics Release testing at CMO's vs CRO's for DS and DP... One stop shopping or specialized labs for certain testing? Jennifer Kolucki Scientist, Analytical Development Catabasis Pharmaceuticals, Inc.

What will it take to bring API manufacturing back to the United States?

Why should you contract the services of a second CMO during Clinical Stage Drug Development? President Drug Discovery Alliances & Tricia Scialla Pharmaceutical Outsourcing Professional (Formerly Bristol-Myers Squibb) During early and mid-stage development, a balance must be struck between planning for success and managing attrition of drug candidates, in order to be adequately prepared to move forward (in the event of success) or to cut losses (in the event of attrition). Principal SGL Chemistry Consulting Categorization of HPAPI molecules and how it differs across the industry based on sponsor or CMO and the data available; How to best avoid cross contamination looking at facility design and equipment including considerations for risk assessment when determining where to manufacture.

Celgene Corp Process Development services Abide Therapeutics We are most interested in meeting GMP capable drug substance and drug product manufacturers with a good regulatory history.

An open discussion of experiences would be helpful to many involved in the development process to be aware of what has worked and what has not for those who have experience with expedited development programs.

Dan Torok Director, API Process Development DS In Pharmatics A lot of chemists have moved away from asymmetric hydrogenation and classical resolution to favour enzymes. Davies LLC Let's go with the givens of adding fluorine to and API, i.e. Handling issues to consider with the choice of the timing.

Merck Table #1 Discovery/Medicinal Chemistry Merck Table #2 Process Research & Development Abb Vie, Inc.

Large volume GMP production with Containment Small Volume, Highly Potent GMP production API Solids Processing Regulatory Starting Materials Newron Pharmaceuticals CRO/CMOs for API, Drug Product, Analytical and Clinical Supply Chain Management.

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Continuous processing using small-scale equipment results in improved energy and material use as well as increased capacity. Business Management Director, API Patheon Solid State science is a corner stone of drug development that could significantly impact the vital physical properties such as solubility and dissolution rate as well as API and drug product processability.

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