50th Annual International Industrial Pharmaceutical Research & Development Conference
“Designing Drug Delivery Systems: Past, Present and Future Opportunities for Treating Our Patients”

Monday, June 2

Check-in throughout the day

6:15pm

Evening reception/dinner

Evening (after dinner)

Special Event: Historical Perspective Celebrating 50 Years of the June LOL Conference

• What the June LOL Conference has meant to attendees, the UW-Madison and the scientific community
• What will the future bring?

Speaker: George Zografi (University of Wisconsin)

Tuesday, June 3

Morning Session
8:30am

Introduction/Welcome

8:45am

Keynote: The Science and Business of Drug Delivery: Past, Present and Future

a. Why is drug delivery important and why was it first introduced?
b. Conventional drug delivery versus controlled drug delivery
c. Overview of past, present, future trends in drug delivery

1. targeted delivery
2. prodrugs
3. modified oral release
4. gene delivery
5. temporal delivery
6. transdermal, pulmonary, etc.

d. Has the benefit/risk balance for controlled drug delivery versus conventional drug delivery changed since the inception of drug delivery?
e. Characteristics of a successful drug delivery product

Speaker: Felix Theeuwes (Durect Corp.)

10:00am

Break

10:30am

Keynote: Drug Delivery and the Patient – Bridging the Patient and Societal Needs for Drug Delivery

a. Discussion of patients’ needs, medical needs; past versus present versus the future
b. What is the future of reimbursement – from both the payer and the marketing and scientific perspectives?
c. What are the characteristics of a successful drug delivery product?
d. Has the balance between benefit and risk for controlled drug delivery versus conventional drug delivery changed since the inception of drug delivery?
e. Discussion of LCM and drug delivery – are they one in the same?
f. What is the future of LCM?
g. Discussion of how drug delivery can provide the patient with reduction of side effects, convenience and compliance versus the risks and benefits that the patient may be exposed to
h. Discussion of disease states that require non-conventional drug delivery approaches

1. Oncology
2. Diabetes
3. CVD

Speaker: John Patton (Nektar)

12:00pm

Lunch

Afternoon unscheduled; open for recreation and/or one-on-one discussions

Evening Session

7:15pm

Physiology Lesson: The Current Understanding Regarding Routes of Administration
(Focus on the properties of drugs that are important to physiology, transit and the disease state)

a. Oral and oral mucosal delivery
b. Topical and transdermal delivery
c. Ocular delivery
d. Parenteral delivery
e. Rectal delivery
f. Colonic delivery
g. Intranasal delivery
h. Pulmonary delivery

Speaker: Ron Burnette (University of Wisconsin)

8:15pm

Pharmaceutics Lesson: Modified and Controlled Drug Release and Delivery

a. Designing drug delivery platforms – general principles of past, present and future trends

1. Overview of functionality/release mechanisms and practices for various routes of delivery

• Primary focus on: injectable, oral, transdermal, pulmonary

2. Methods/models for measuring and understanding drug release and delivery

• Diffusion mechanisms/theory
• Dissolution testing
• Erosion versus diffusion-based release

3. Introduction of PK, PD and physiology as needed to increase understanding of delivery application

Speaker: Jim Wright (BIND Bioscience)

Wednesday, June 4

8:30am

Ensuring Success of Controlled Release Candidates: Proof of Principle Studies
(emphasis on methods for predicting absorption, emphasis on IV, oral, transdermal and pulmonary routes)

a. Basic pharmacokinetics linked to physicochemical properties of the drug
b. Addressing the medical need – understanding and treating specific disease states
c. Animal models and their applicability
d. Methods used

1. e.g, remote controlled capsules and gamma scintigraphy

e. In vitro and in vivo assessment

Speaker: Alan Parr (GSK)

9:30am

Matching Up Drug and Delivery Needs: Delivering Small Molecules

a. Impact of BCS designation on choice of delivery platform
b.Choosing drug delivery platforms:

1. therapeutic area example
2. LCM example
3. safety example
4. modification of BA example (solubility or targeted delivery)

Speaker: Ray Skwierczynski (Millennium Pharmaceuticals)

10:30am

Break

11:00am

Matching Up Drug and Delivery Needs: Delivering Large Molecules

a. Challenges in delivering large molecules

1. proteins, monoclonal antibodies, genes, nucleosides

b. The evolution of insulin delivery

1. oral, pulmonary, subcutaneous routes
2. finding the appropriate delivery platform

Speaker: Gene McNally (Pharma Development Concepts)

12:00pm

Lunch

Needs Sharing Discussions – topics to be announced

Evening Session

Applied Drug Delivery Approaches: Current Platforms
(Case studies with focus on use of excipients/new materials and manufacturing approach for each platform discussed along with examples of commercialized products)

7:15pm

Novel Oral Transmucosal Technologies

Speaker: Derek Moe (Cima Labs)

7:55pm

Commercial Product Case Study: PEGylation
(via injectible route of delivery)

Speaker: David Filpula (Enzon Pharmaceuticals)

8:35pm

Commercial Product Case Study: Nanoparticles

Speaker: Ed Elder (School of Pharmacy, University of Wisconsin-Madison)

9:15pm

Adjourn

Thursday, June 5

Morning Session

8:30am

Case Study: Pulmonary

Speaker: Jeff Weers (Nektar)

9:10am

Case Study: Convergence technologies
(drug eluting stents, prosthesis, ITRANS – ocular delivery)

Speaker: Yen Lane Chen (Boston Scientific)

9:50am

Break

10:20am

Case Study: Blood-Brain Delivery

Speaker: Beth Hill (Centocor)

11:00am

Case Study: Oral and Injectible Nanoparticles
(solid/lipid nanoparticles (SNL), carrier systems, magnetic nano and microparticles targeted delivery)

Speaker: Panos Constantinides (Biopharmaceutical & Drug Delivery Consulting)

12:00pm

Lunch

Needs Sharing Discussions – topics to be announced

Evening Session

7:15pm

Case Study: Transdermal
(passive and active delivery platforms)

Speaker: Brad Phipps (Alza)

7:55pm

Panel Debate: Innovative Drug Delivery Approaches to Life Cycle Management (LCM)

Questions to the panel:

1. Have the tools and skills used for the development of a drug delivery platform/product become part of the standard development process? Where do these tools and skills reside? In big Pharma or at specialty pharma companies? Where should they be in the future?
2. When does taking the risk to develop a product for a pipeline molecule (NCE/NME) in a new delivery platform become acceptable, if ever?
3. How should we balance the economics and technology of drug delivery product development and commercialization in a global economy (benefit/risk and benefit/value)? How does one demonstrate that a medical need can be addressed through the use of drug delivery systems?
4. Where will innovation in the area of drug delivery come from? How will we continue to ensure that our patients are being provided with not only the best medicines, but also the best delivery for the product and the patient population? Who are we marketing our products for?

9:00pm

Adjourn

Friday, June 6

Morning Session

8:30am

CMC Challenges in Drug Delivery – an Industry Perspective

a. Challenges with use and approval of new devices and excipients
b. Suggestions for enabling use of new excipients and devices
c. Risk/Benefit assessment
d. QbD

Speaker: Jeff Blumenstein (J & J)

9:30am

Regulatory Considerations in LCM

a. Risk analysis and management – Q9
b. QbD impact – Q8
c. What are the regulatory challenges for new devices, excipients, biosimilars and drug delivery platforms?

Speaker: Speaker to be announced

10:30am

Closing Remarks/Adjourn

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