# Presentation: 145442

## Increasing Financial Incentives for R&D

**Industry Perspective**
**Andrew MacKnight**
**GlaxoSmithKline**

## The Value of Vaccines 

**6 million deaths are prevented.****2**** **
**400 million life years are saved.****2**
**750,000 children are saved from****disability.****3**** **

*2. Ehreth J. The Global Value of Vaccination. Vaccine (2003); 21(7-8): 596-600.*
*3. Ehreth J. The Global Value of Vaccination. Vaccine (2003); 21(7-8): 4105-4117.*

**Every year....**

**...****due to vaccines.**

## Vaccines – A Growing Market

**From $8 billion in 2000 - > $18 billion by 2010**
**Technological innovation**
**Demographics**
**Value of Prevention**
**But High Risk**
**Cost of R&D**
**Variable demand**
**Infrastructure focused on pediatric immunization**
**Litigation**

##     The Emerging Role of the Consumer 

**    ****The Emerging Role of the Consumer**

**Treatment **
**of existing **
**diseases**
*   *
*   ****No-one really wants to become a customer***

_**HEALTH**_
**Soundness of body & mind**
**Absence of disease**

_**WELLBEING**_
**Healthy, Happy**
**Equilibrium**
**Body & Mind**
**Psychological contentment**
**Peace of mind**

_**SICKNESS INDUSTRY**_
**(Reactive)**

_**WELLNESS INDUSTRY**_
**(Proactive)**

**FUNCTIONAL**

**EMOTIONAL**

_**WELLNESS**_
**Enhanced physical ****& mental health**
**Feeling of Vitality**
**Commitment to keep              in this state**

**+**

**ILLNESS**

**WELLBEING**

** ****Decreasing costs to individual and community**

**        ****Increasing productivity / self-sufficiency**

***GREATEST***
***VALUE POINT***

***GREATEST***
***COST POINT***

**+**

## Industry Pipeline

**Pediatric**
_**Phase II/III**_
**Rotavirus**
**MMRV**
**N. Meningitides**
_**Early Phase**_
**Men B**
**SARS**

**Adolescent/Adult**
**Human Papillomavirus**
**Tdap **
**Herpes Simplex**
**N. Meningitides**
**Chlamydia**
**Cytomegalovirus**
**Epstein Barr Virus**
**Dengue**
**HIV**

**Adult/Elderly**
**S.Pneumo ****(conjugate)**
**Zoster**
**RSV**
**Flu ****(adjuvanted)**

**Notes:**
More adolescent, adult vaccines
Innovation = complexity e.g. conjugation in meningitis, new adjuvant systems, pneumococcal vaccines 7v-11 (incr coverage)

## Adolescent/Adult Immunization

**Pipeline rich in adolescent and adult vaccines**
**Multiple challenges – **
**financial, social, psychological, political **
**Well established infrastructure needed**
**VFC and 317 programs emphasize childhood immunizations**
**State and local infrastructures encourage childhood immunizations**

**Notes:**
Adolescents hard to convince that not invincible.....

## Vaccines R&D

**Notes:**
Look for unmet medical need ..... 

## R&D Complexity

- Identify Antigens

- Produce Antigens

- Test in Animals

- Proof of Concept

- Phase I

- III

- File

- x

- Registration

- x

- up to $10m

- up to $54m

-   $500m

- x

- x

-                                   3-5 yrs 	              2-3yrs 	        2-4 yrs 	         1 yr

- x

- Transfer Process to Manufacturing

- Build Facility

- II

- Research (Inc. Immunology)

- Preclinical Development (Inc. Formulation Science)

- Clinical Development (Inc Post Marketing Surveillance

**R&D Complexity**

## Distribution Complexity

**facilities**

**Packing**
**materials**

**Transportation**

**Monitoring**
**devices**

**Customers’**
**education**

**+**

**+**

**+**

**+**

- Links

- Cold Chain management

**Distribution Complexity**

**Notes:**
Not just about R&D, distribution and logistics also important --- product integrity...

## Clinical Complexity

_**Rotavirus**_
**  ****Infection - disease rate**
**- days**
** ****>63,000 infants**
**  ****6 month follow-up**

_**Human Papilloma Virus**_
** ****Infection - disease rate**
** ****- decades**
**>28,000 women**
**  ****intensive 4 year follow-up**

**Scale**

**Endpoint/Duration**

**Notes:**
Rotavirus – one of the largest pre-licensure trials in vaccine history
HV – full pelvic exams every 6 mos

## Fostering Innovation – Improving Public Health

**R&D**
**Review of GMP processes for vaccines**
**Dialogue on foreign data in BLAs**
**Tax credits for R&D investments**
**Market **
**Support for adolescent/adult vaccines**
**Distinct public/private markets**
**Legal**
**Strengthen VICP**

**Notes:**
Use private market to set the value of the product.....benchmark for public, not vice versa
Tax credits for capital investments
Consistent framework for acceptance of foreign data