Incentives for InnovationPartnerships for Drug Development

Incentives for Innovation Partnerships for Drug Development

Dr. Swati Bal-Tembe May 12 Ma 12, 2011

International C f I t ti l Conference on Equity and Access to Medicine E it dA t M di i Role of Innovation and Institutions

Drug discovery and development g y p

• New drug in the market > $1 billion • Patents to protect market exclusivity • Leverage for obtaining funds, technologies; or for licensing/cross-licensing • Att Attractive assets to potential investors, collaborators and ti t t t ti l i t ll b t d acquiring companies Company’s • Strategy based on Company s business model and business environment

© 2011

Dr. Swati Bal-Tembe

May 12, 2011

Drug Discovery and Development

• HTS / Virtual Screening • NP / Focused Library / Combichem/ Fast Follow-on Follow on • Rational Drug design

Target Identification & Validation

Lead p Development

Preclinical Studies

Clinical Trials

Market

IND

NDA

• • • •

NCE Me-Too Lifecycle Extensions NDDS

© 2011

Dr. Swati Bal-Tembe

May 12, 2011

“Me-Too Drugs”

S O N N O O N H

S O N O

Pioglitazone US 4,687,777 687,

O

N H

Rosiglitazone US 5,002,953 002,

O N

N S O N H

O

F F

F O N N S O N H

O

O N S N O N H

O F

F

Omeprazole US 4,255,431 255,

Lansoprazole US 4,628,098 628,

Pantoprazole US 4,758,579 758,

© 2011

Dr. Swati Bal-Tembe

May 12, 2011

Markush Structure

We claim: A compound of Formula 1

(RX)0-4 RA L1 X

(RY)0-4 Y L2 L3 RB

Formula 1

Wherein rings X and Y independently represent 5 to 7 membered heterocycle, aryl or heteroaryl ring that may be substituted with 0-4 y , y y g y substituents described by RX and RY respectively Wherein L1 is O, NH, CH2 or a bond L2, L3 RA, RB, RX, RY

© 2011 Dr. Swati Bal-Tembe May 12, 2011

CHALLENGES

© 2011

Dr. Swati Bal-Tembe

May 12, 2011

Challenges

• Crisis in the Pharmaceutical industry • Patent cliff • Expiration of blockbuster patents • Fewer regulatory...