4th Annual Ultra Orphan Conference

Addressing the Needs of Ultra Orphan Patient Populations by Creating and Measuring Value

Strategies for Delivering Outcomes and Value for Patients, Physicians, Payers, and Manufacturers

September 19 – 21, 2011

St. Louis, MO

 

The international orphan drug marketplace is expected to grow some 30 percent by 2014, fueled by the entrance of big pharmaceutical companies and U.S. legislation favoring development and coverage. This growth promises to improve the health of patients with debilitating and life-threatening disorders. Since there is a tremendous cost to develop therapies for smaller populations, how does the manufacturer increase the likelihood of a positive return on investment?

 

The primary key to a successful drug launch is creating value. The world needs therapies that create value through lower costs and higher quality. Orphan drugs can be very effective, but are almost always so expensive that overlooking their intrinsic value is easy to do. Therefore, defining, delivering, and measuring value post-launch becomes a critical component to any orphan drug strategy. How value is defined depends on who is asked.

 

What is the value of therapy and support programs to patients, payers, physicians, to manufacturers, to the healthcare system, and to society — and why should anyone care?

 

Centric asks the question: What is the value you are delivering to healthcare?

 

Register at the Ultra Orphan Conference Website or use the contact information below to register and attend this unique conference dedicated to the orphan and ultra-orphan marketplace. You are invited to know more about this vital marketplace and gain new insight into delivering these high-cost, low-volume drugs to patients who desperately need them.

 

For information about speakers and talks please visit the 4th Annual Ultra Orphan Conference Website

 

We look forward to seeing you in St. Louis!

 

 

FEATURED TOPICS | SPEAKERS

 

The Politics of Drug Pricing

Featured Speaker: Michael McCaughan, Editor in Chief, Prevision Policy, LLC

• Key themes in recent pricing controversies in the U.S.: What drives the policy and the politics?

• What makes orphan drugs special—and what doesn’t

• Potential policy solutions and implications for the “ultra orphan” sector

 

Economic and Clinical Value: Table Stakes for Future Success

Featured Speaker: Rita Numerof, PhD., President, Numerof & Associates, Inc. (NAI)

• How is value defined by patients, physicians, and payers?

• The manufacturer’s opportunity

• Making the case for lifetime value

 

Payer, Patient, Physician, Manufacturer (Panel)

Moderator: Jill Sackmann, PhD., TNumerof & Associates, Inc. (NAI)

Invited: Dr. Chris Forrest, Children’s Hospital of Philadelphia

Invited: Dennis Matheis, President, Blue Cross Blue Shield of Missouri

• Provide perspectives on variation in value definition

• How the value definition may change over time

• What should companies be doing to demonstrate value to each constituent

Hear panel members comment on economic and clinical value from their perspective.

 

Reducing the development burden for ultra orphan therapies -The challenges of personalized medicine

Featured Speaker: Ed Kaye, M.D., Chief Medical Officer, AVI BioPharma

• Personalized genetic medicine – unique regulatory, reimbursement, and development challenges

• Opportunities – approval for a class of therapy, reducing development costs up front

• Individualized outcomes and quality of life tools designed to measure the impact of therapies on specific diseases

 

Global Rare Disease Registry Project

Featured Speaker: Kyle Brown, Chief Executive Officer, PatientCrossroads

The Global Rare Disease Registry Project’s goal is to establish a replicable online registry template that will in turn be used to start a registry for all rare diseases. The project will start by working with 12 patient organizations to establish a replicable registry model. The partners involved in the project are: The Children’s Hospital of Philadelphia, CheckOrphan, Medscape, and PatientCrossroads. The end goal is to increase patient participation and provide more reliable data at a fraction of the current cost to ensure an increased number of orphan disease products move more efficiently to the marketplace.

 

Setting up and Supporting Your Value

Featured Speaker: Douglas Paul, PharmD, MS, Vice President & Partner, MME, LLC

• Experience in ultra orphan ex-US that may be coming

• Take the good, avoid the bad from that experience

• Start measuring in U.S., need to start measuring from day one

• What is coming in U.S. from ex-US experience

 

How to Generate and Measure Value through Primary Market Research

Featured Speaker: Kenneth Tomaszewski, PhD, MS, President, KJT Group Course Director, Health Economics, University of Rochester

• Which outcomes can be influenced

– How this is unique for orphan drugs

• Constituent model

– Which outcomes are most important to each group

– Research to tailor messaging and marketing

•Research case studies

– Orphan disease patients

– Research to tailor messaging and marketing

 

Changes in Distribution Approaches and Impact on Value – how to get value out of your channel service relationships

Featured Speaker: Dan Desmarais, Partner, BioSolutia, Inc.

• What it was: a product sale; What it is: a service sale

• Stop talking to distribution vendors, start talking to partners

• Start with your goals and objectives (which should be patient-centered), then create

your value equation

• Get actionable, timely data to

– support value proposition to each constituent

– allow Continuous Quality Improvement (CQI) process

– measure over time the continued success of the program

 

Outcomes Approach at Pfizer

Featured Speaker: Greg Simon, Senior Vice President, Patient Engagement, Pfizer, Inc.

• The value of satisfying the unmet need

• Approaching personalized medicine

• Comparative effectiveness and orphan drugs

 

Translating Value Propositions into the Language and Currency of Payers

Featured Speaker: Adina Safer, Partner, AccelusPartners, LLC

• How does an orphan drug company best approach managed care

• What a manufacturer needs to do and show to demonstrate value to managed care

• How to position your product /What kind of economic models are key to proving

value

 

Value Defined at sanofi-aventis

Featured Speaker: Dr. William L. Daley, M.D., M.P.H., Vice President Medical Affairs, Aging, Business Development & Licensing, SANOFI US

• Sanofi’s experience in discovering, developing, and commercializing therapies for

rare diseases

• Shift focus from cost to value

• Communicating and achieving value

 

Building Partner Relationships to Deliver and Measure Outcomes

Featured Speaker: Craig Kephart, President, Centric Health Resources, Inc.

• Start with the end in mind

• Value, outcomes, experience, tools

• Direct model positioning for today’s and future SP market

 

State of the Industry Address – Pharma/BIO 3.0

Featured Speaker: James C. Greenwood, President & Chief Executive Officer, Biotechnology Industry Organization (BIO)

• Biotechnology innovation is the best hope of finding treatments and cures for

rare diseases

• We need the right policy environments to unleash the promise of biotech

innovation

• We need an FDA that turns hope into cures