Event: Formulation Development and Excipient Selection

October 10, 2018
4:30 pm to 7:00 pm
6828 Nancy Ridge Drive, Suite 100, San Diego, CA 92121

So you have finally selected a drug candidate, how to turn it into a finished product? The journey from lab to shelf can be long and expensive. This educational session will provide a glimpse into some of the factors at the formulation development stage that may lead to successful first-in-human studies. Come to hear from the experts on considerations on dosage form development and excipient selection for different drug substances including small molecules with poor bioavailability and low solubility and innovative biologics. Case studies will be showcased to demonstrate how to overcome some of the challenges encountered during early phase development and why experience matters.

Click here to register early to reserve a seat and to mingle with like-minded drug discovery and development gurus. Registration will be open starting at 4:30PM. Presentations will start at 5:00PM. Appetizers and non-alcoholic drinks will be served.

The event will wrap-up with a tour of our cGMP manufacturing facility for clinical supply and commercial drug products for those who are interested.

Agenda:

4:30PM               Registration

5:00PM               Formulation of Liquid Filled Capsules for Bioavailabilty Enhancement in preclinical and clinical studies – Robert Giannini, Ph.D., VP, CSO and CTO, IRISYS

5:30PM               Excipients: not so inert substances – A journey through one category of excipients often underestimated – Marie-Eve Koziol, Adjuvants Research & Clinical Program Manager Parenteral, Biologics and Topical DDS Business Development Manager SEPPIC Inc. / Air Liquide Healthcare North America

6:00PM               Q&A and Open Discussions

6:30PM               IRISYS cGMP Facility Tour

Speaker Bios:

Robert Giannini, Ph.D., VP, Chief Scientific & Technology Officer, IRISYS

Dr. Giannini has more than 30 years of pharmaceutical industry experience. His breadth of knowledge includes development of a wide range of dosage forms such as controlled/extended release solids, oral liquids, and injectables. He has been responsible for all aspects of dosage form development and manufacture: pre-formulation, formulation development, analytical methodology, stability, process validation, regulatory compliance/submissions, and day- to-day production for currently marketed products. Dr. Giannini joined IRISYS in 2004 and has been the primary author and principal investigator on most of the Company’s proposals that resulted in the awarding of numerous NIH development and manufacturing contracts.

From 1981 to 1985 Dr. Giannini served as a Senior Scientist – Solid Dosage Forms, and then as Unit Supervisor – Novel Drug Delivery Systems at Wyeth Laboratories. In 1985 he joined Key/Schering Plough as Section Head – Solid Dosage Form Development. This was followed by a position as Vice President – Pharmaceutical Research and Development at a small venture capital funded firm called Himedics. In 1991, he joined Watson Laboratories as Director of Product Development where he was responsible for the development of generic products from formulation to ANDA submission.

Dr. Giannini was awarded a Ph.D. in Industrial Pharmacy from the University of Maryland at Baltimore for research in the area of solid dosage form design.

Marie-Eve Koziol, Adjuvants Research & Clinical Program Manager

Parenteral, Biologics and Topical DDS Business Development Manager

SEPPIC Inc. / Air Liquide Healthcare North America

Mrs Koziol has more than 20 years of formulating experience with a broad knowledge in topical drug delivery systems, solid dosages development and more recently, injectable forms with expertise in therapeutic and prophylactic vaccines.

With most of her career spent working for specialty excipient manufacturers, Mrs. Koziol brings a different perspective on the importance of excipients from quality, functionality and regulatory stand points. In her current position, Mrs Koziol has the opportunity to work in the clinical environment, directly with principal investigators to assist clinical teams in the formulation therapeutic vaccines mostly working with complex biologic drug substances in exploratory oncologic treatments.