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Drug Discovery, Delivery and Development at the University of Kansas Bringing Pharmaceutical Industry Best Practices to an Academic Setting. Scott Weir, PharmD, PhD Office of Therapeutics, Discovery and Development University of Kansas Cancer Center. Our Work Is Imperative.

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Drug Discovery, Delivery and Development at the University of Kansas Bringing Pharmaceutical Industry Best Practices to an Academic Setting

Scott Weir, PharmD, PhD

Office of Therapeutics, Discovery and Development

University of Kansas Cancer Center


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Our Work Is Imperative

Cancer is the #1 killer under the age of 85

12,760 will be diagnosed with cancer in 2007

5,290 will die from cancer in 2007

Kansas’ cancer rates are falling at less than 1/3 of the national average

In 2007, cancer rate in Kansas (-0.6) was half national average (-2.1)

American Cancer Society. Statistics for 2007.


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Our Work Is Imperative

Underserved Region

National Cancer Program

Closest NCI Comprehensive Cancer Center is at least 250 miles away

Statewide Access Problem

Limited access to cutting-edge clinical trials in rural populations

Cancer Center (24)

Comprehensive Cancer Center (39)

Planning Grant (6)

NCI Designated Centers


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NCI Progress

NCI Designation Differentiators

Drug Discovery & Development

Community-based Approach

Office of Therapeutics Discovery & Development

Clinical

Trials

Office

Results

More advanced cancer prevention, early detection, treatment, and survivorship


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Drug Discovery, Delivery & Development

Why are we in this risky business?

  • Patients

    • Conduct research which leads to improved disease treatment, prevention and control therapies

    • Support efforts to establish an NCI designated Comprehensive Cancer Center

    • Support regional clinical and translational research efforts, i.e., Heartland Institute for Clinical and Translational Research

  • University

    • Increase overall research funding

    • Trains the next generation of drug discovery and development scientists

    • Create commercial opportunities for the University

  • Region

    • Contributes to life sciences and economic growth


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The Vision

Drug Discovery, Delivery and Development

  • Establish KU as the number one academic institution in advancing anti-cancer agents from discovery to patients

  • Establish a University-wide, fully integrated organization

  • Be recognized as a top academic institution in the commercialization of pharmaceutical intellectual property


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KUCC Model

Discover

Develop

Basic, Drug Discovery & Translational Research

Drug Development & Clinical Research

2016Vision

NCI Designation Pathway

World-classCancer Care

Education & Outreach

Deliver


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The Strategy

Drug Discovery, Delivery and Development

  • Balanced drug pipeline

    • Focus on novel therapies and targets

    • Improved delivery of marketed drugs

  • Alignment with KU Translational Research priorities

    • NCI designation of University of Kansas Cancer Center

    • Heartland Institute for Clinical and Translational Research

  • Leverage internal and external (outsourcing) expertise

  • Bring pharmaceutical industry best practices to KU

    • High performance project teams

    • “Pharma” drug profiling

  • Partnering with industry and other academic institutions


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Drug Discovery, Delivery & Development

KU Strengths

  • #4 School of Pharmacy (based on total NIH funding, #1 based on NIH funding per faculty FTE)

  • Established KU cores and centers

  • University priority and commitment

  • Stowers Institute for Medical Research

  • Ewing Kauffman Foundation

  • Wealth of drug development resources in the region

  • Life sciences growth in the region

  • Focus on collaboration with academic, non-profit and industry partners


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Management Oversight of the Program

Scott J. Weir, PharmD, PhD

Director, Office of Therapeutics Discovery & Development

20 years at Marion Laboratories, MMD, HMR, Aventis, Quintiles and Aptuit

Expertise in advancing compounds from discovery to clinical proof of concept

Management of drug discovery, delivery and development

Drug Discovery, Delivery & Development

G. Sitta Sittampalam, PhD

  • Deputy Director, Office of Therapeutics, Discovery and Development

  • 23 years at Eli Lilly & Company

  • High throughput screening and lead optimization expertise

  • Oversight of biology and chemistry interface



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Drug Discovery, Delivery & Development

Reengineered Drug Discovery Process

DevelopmentCandidate

Target -> Chemical Hit

Chemical Hit -> Lead

Lead ->

1

Target

Selection

&

Validation

2

Target

Production

3

High

Throughput

Screening

4

Chemical

Hit

Identification

5

Define Lead

Selection

Criteria

6

Prediction of

Physio-

Chemical

Properties

7

In vitro

Potency &

Selectivity

In vivo

Proof

of Concept

8

Early

ADMET

9

Pre –

Formulation

Screening

10

In vivo and

In vitro

ADMET

Profiling

11

Prepare for

IND

Enabling

Activities

  • Information technology

  • Chemoinformatics

  • Bioinformatics

  • Regulatory strategy

  • IP management

Enabling Processes

  • Project prioritization

  • Project management

  • Compound management

  • Process chemistry

  • Communications


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Drug Discovery Leadership

Barbara N. Timmermann, PhD

Chair, Department of Medicinal Chemistry and University Distinguished Professor

27 years experience in natural products chemistry

Principal Investigator, Center for Cancer Experimental Therapeutics

Leadership role in reengineering KU Drug Discovery

Drug Discovery, Delivery & Development

Jeffrey Aube', PhD

  • Professor of Medicinal Chemistry

  • Director, Chemical Methodology and Library Design Center of Excellence

  • 24 years experience in medicinal chemistry

  • Directing chemistry support laboratory for KU Drug Discovery program


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Drug Discovery Leadership

G. Sitta Sittampalam, PhD

Deputy Director, Office of Therapeutics, Discovery and Development

23 years at Eli Lilly & Company

High throughput screening and lead optimization expertise

Oversight of biology and chemistry interface

Drug Discovery, Delivery & Development

Rathnam Chaguturu, PhD

  • Director, High Throughput Screening Lab

  • 24 years industry experience in drug discovery at FMC Corporation and Sierra Biosciences

  • Pioneer of high throughput screening technology


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Drug Delivery Center

Planning grant from Kansas Bioscience Authority to establish world-class innovation center

Builds on KU’s strong history in drug delivery

Managed as an industry unit by pharma experts

Collaborations with

Universities

Industry

Venture Capital

Federal Funding Sources

State Economic Development Organizations

Foundations and Societies

Current plan to grow drug delivery research and service work from currently ~$4.5M to ~$15M annually

Drug Discovery, Delivery & Development


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DDC Large Molecule Core Competencies

Drug Discovery, Delivery & Development

A) Biophysical characterization, pre-formulation, and formulation of macromolecules (Process steps 1 & 3)

B) Stabilization of macromolecules and their complexes

C) Solid formulations of biopharmaceuticals using lyophilization/freeze drying

D) Adjuvant API formulations for vaccine delivery

Core Competencies

E) Problem solving - Formulation, delivery and process development

F) Novel methodologies for macromolecule characterization


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Drug Discovery, Delivery & Development

DDC Small Molecule Core Competencies

A) Formulation of small molecule drugs for preclinical and clinical studies including solid and liquid dosage forms

B) Development of novel drug delivery technologies.

C) Problem solving in preclinical drug development.

D) Physical and chemical characterization of drug molecules.

Core Competencies

E) Design and synthesis of prodrugs.

F) Development of bioanalytical methods.

G) Rodent and non-rodent pharmacokinetic and pharmacodynamic studies.


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Drug Delivery Leadership

Valentino Stella, PhD

Distinguished Professor, Pharmaceutical Chemistry

Principle Investigator, NCI Contract, Development of Dosage Forms and Delivery Systems for Antitumor Agents

Formulated Taxol®, Velcade®, pentostatin

Pro-drugs

Development of Captisol®

DDET

Roger A. Rajewski, PhD

  • Director, Biotechnology Innovation and Optimization Center

  • 18 years industrial and academic experience

  • Pro-drugs

  • Development of Captisol®

  • Leadership role in reengineering KU Drug Discovery


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Drug Delivery Leadership

Charles (Russ) Middaugh, PhD

Higuchi Distinguished Professor, Pharmaceutical Chemistry

Laboratory for Macromolecular and Vaccine Stabilization

Protein folding and stabilization

Formulation and delivery of peptides, proteins, nucleic acids, viruses and bacteria as pharmaceutical agents

Pharmaceutical industry experience

DDET


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High performance project teams

Led by project managers with pharma and CRO experience

Project planning

Objectives

Go/no go decision points

Decision criteria

Completely integrated with IP management activities

Integrated plans including studies conducted with industry partners

Pharma “profiling” aids to best position IP for licensing

Drug Discovery, Delivery & Development

Project Management


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Project Management

Melinda Broward, BSc, MSc

Project Director, Office of Therapeutics, Discovery and Development

19 years pharmaceutical industry experience

Expertise in preclinical drug safety (toxicology and safety pharmacology), early ADME and high throughput screening

Drug Discovery, Delivery & Development

Michael B. Hughes, BSc, MBA

  • Project Director, Office of Therapeutics, Discovery and Development

  • 14 years pharmaceutical industry experience

  • Expertise in analytical chemistry, pharmaceutics and project management


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Drug Discovery, Delivery & Development

Collaboration

  • Stowers Institute for Medical Research

  • Kansas Bioscience Authority

  • Kansas Technology Enterprise Corporation

  • Children’s Mercy Hospital

  • OncImmune Inc.

  • Mayo Clinic Comprehensive Cancer Center

  • Scripps Research Institute

  • Beckloff Associates

  • Cerner Corporation

  • Universities

  • Local Start-Up Companies

  • Contract Drug Development Organizations

  • Non-profit foundations and societies



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Funding Sources

R&D Infrastructure

NIH and NCI funded centers and cores

KTEC Biotechnology Innovation and Optimization Center

Kansas Bioscience Authority

KU Endowment

Federally funded projects

Reproductive Biology Center of Excellence

Alzheimer’s Disease

Partnering

Supporting existing local companies and future start-ups

Licensing technology to pharma

Translational research focused foundations and societies

Drug Discovery, Delivery & Development


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Drug Discovery, Delivery & Development

Final Messages

  • KU Drug Discovery and Development is a cross-campus, multi-institutional program

  • Success is being driven by

    • Applying industry best practices to university

    • Creating an integrated, efficient drug discovery and development organization

    • Establishing high performance, highly collaborative project teams through effective planning and management

    • Leveraging relationships with other institutions and industry partners to advance projects and strengthen our program

  • KU Drug Discovery and Development plays a key role in establishing an NCI designated comprehensive cancer center at the University of Kansas


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