I2I – What Makes an Invention Investable?

The Office of Technology Commercialization


Invention to Innovation (I2I)

“What Makes an Invention Investable”

Presented by

Kathleen Clarence-Smith, M.D., Ph.D.
Partner, KM Pharmaceutical Consulting

Date and Time: Thursday, June 4, 2015, 12-1:30pm
Location: Leavey Program Room at the Leavey Center (across from bookstore)

Dr. Clarence-Smith will review the changing investment landscape for the discovery and development of novel pharmaceutical products, and will focus on the challenges associated with obtaining investments in early-stage (IND-stage) projects. She will discuss the barriers to obtaining investments, the strategies to prevail, and future trends.

Lunch will be provided; space is limited.

PLEASE RSVP by June 2, 2015 to Azra Chughtai at acf43 at georgetown dot edu or 202-687-7424

Faculty, entrepreneurs, fellows, students and research administrators should attend.

About Dr. Clarence-Smith:

Kathleen Clarence-Smith, M.D., Ph.D. is a neurologist whose career has been dedicated to developing new pharmaceuticals and shepherding them from early stages onto the market. She has worked in senior positions in large pharmaceutical companies (Sanofi; Roche; Otsuka) and more recently, she has founded, raised money and headed start-up pharmaceutical companies. She is currently a partner at KM Pharmaceutical consulting, and Chief Medical Officer at Chase Pharmaceuticals Board.

At Sanofi (1980-1987), Dr. Clarence-Smith headed the CNS group (preclinical and clinical worldwide). In this position, she continued preexisting programs in depression and Alzheimer’s disease, and launched new programs in bipolar disorder, anxiety, and epilepsy and focused on internationalizing Sanofi’s lead drugs. Under her stewardship, the Sanofi CNS group grew from 20 people to close to 150 people.

At Hoffmann-La Roche (1987-1992), Dr. Clarence-Smith was Head of CNS in charge of neurology and psychiatry drug development worldwide. Two NDAs were successfully and very rapidly approved under her stewardship. She also launched two programs in Parkinson’s disease (both reached NDA), one program in Alzheimer’s disease (also reached NDA), and one program in anxiety (leading to a sNDA).

At Otsuka (1992-1995), while serving as the head of the CNS group, she initiated clinical trials for an antischizophrenia drug, Abilify, and successfully demonstrated that the drug worked in schizophrenia with a unique profile of activity.

In 1996, Dr. Clarence-Smith co-founded Prestwick Chemical, a successful medicinal chemistry company, based in Strasbourg (France) that sells chemical libraries and performs medicinal chemistry on a fee for service basis. Prestwick Chemical clients include major global pharmaceutical companies as well as emerging pharmaceutical companies. In 2014, Prestwick Chemical was acquired by Bionomics.

In 2003, Dr. Clarence-Smith also co-founded Prestwick Pharmaceuticals, a specialty pharmaceutical company that in-licensed and developed drugs for neurological and psychiatric diseases. Dr. Clarence-Smith supervised the development of tetrabenazine from filing to NDA. Tetrabenazine was out-licensed to Ovation and Prestwick Pharmaceuticals was acquired by Biovail.

In 2007, Dr. Clarence-Smith co-founded KM Pharmaceutical Consulting, a pharmaceutical project management firm that manages clinical stage pharmaceutical projects including relationships with Regulatory Authorities. KM clients include ex-US pharmaceutical companies (mainly Japan and the EU), as well as start-up, venture-backed, and mid-size companies in the US.

In 2008, Dr. Clarence-Smith assisted in founding Chase Pharmaceuticals Corporation (CPC), a start-up company focused on the development of a clinical stage Alzheimer drug. Dr. Clarence-Smith is currently the Chief Medical Officer of CPC.

Dr. Clarence-Smith received her M.D. and Ph.D. in Neuroscience at the University of Tours (France) and completed a post-doctoral fellowship at Johns Hopkins University School of Medicine in the Department of Pharmacology and Experimental Therapeutics, headed by Solomon Snyder, M.D. Dr. Clarence-Smith is a board certified neurologist (Salpêtrière). She is one of the founders and a past President of ASENT and is the member of several scientific societies. She is the author of more than 100 peer-reviewed papers and of more than 25 patents. Dr. Clarence-Smith is fluent in three languages: English, French and Italian.