Future Challenges and Opportunities Emerging from the Mapping of The Human Genome

Transcription

1 Ftre Challenges and Opportnities Emerging from the Mapping of The Hman Genome The Second Annal National Congress on the Ftre of the Genome, Biotechnology, and Pharmaceticals in Medical Care November 16, 2000 Clement Bezold, Ph.D. Institte for Alternative Ftres and Alternative Ftres Associates

2 Topics Opportnities and Challenges of Genomics 21st Centry -- Fndamental Change 6 Challenges

3 Opportnities from Genomics and Related Trends Predict disease likelihood Predict therapetic effectiveness & safety Detect disease early Enhance therapetics Improve clinical development and reglation ÒConqering diseasesó Design ot illness, enhance hmans Bring health and health care to all

4 21st CentryÑ Fndamental Change 21st Centry -- The Design Centry Technology and society The environment Health Health care Hmans and hmanity

5 21st Centry -- Fndamental Changes in Health Care Scientific and research advances Genomics enhancing nderstanding and control options Additional Advances of disease and behavior Biomonitoring adding specific detail Shifting paradigms in health care Enhanced, sophisticated self-care Complementary and alternative approaches Wellness and enhancement choices Forecast, prevent and manage paradigm

6 Genomics/ Pharmacogenomics Prediction Targeting and dosing Monitoring Fixing Preventing Redesign, enhancement of hmans

7 Anticipated Benefits of Pharmacogemomics (NIGMS) More powerfl medicines Better and safer drgs the first time More accrate methods of determining appropriate drg dosages Advanced screening for disease Better vaccines Improvements in the drg discovery and approval process Decrease overall cost of health care

8 Challenges from Genomics and Related Trends 1. Pharmacetical economics 2. Smarter markets 3. Drg Reglation 4. Pblic attitdes and policy Privacy, discrimination, intellectal property Eqity 5. Governing evoltion 6. Harnessing Visionary Potential

9 Challenge 1: Pharma Indstry Economics Targeting shrinks many markets Some blockbsters remain Need/demand for lower costs of R&D and FDA approval New pharma players, especially in discovery and development Marketing costs rise and fall

10 Challenge 2: Smarter Markets Markets and marketplaces which give consmers more sophisticated choices and cstomized information for their decisions. By 2010 for most prodcts there will be global awareness of efficacy, cost effectiveness, and price Broader criteria for choice will be inclded

11 Smarter Markets in Health and Pharma Byers, large and small, will have increasing intelligence Otcome measres will be available - systems, individal health care - providers, therapy systems and components Report cards will become biqitos and well sed Consmers will jdge qality, price, and other vales

12 Smarter Markets: Broader Vales Pharma and other genomic companies will be jdged by mltiple bottom lines Broader Qality measres

13 Inherent qality Smarter Markets: Broader Qality Strength, prity; USP standards Fnctional qality Safety, efficacy, cost-effectiveness Contextal qality Crrently: Worker safety = ISO 9000; Environmental protection = ISO Emerging: Sstainability, eqity e.g., Social Accontability (SA) 9000; Natral Step; WHO & Health for All

14 Contextal Qality: ÒHealth For AllÓ Contextal qality: What does ÒgoodnessÓ mean for health Ñ what determines the right things? ÒHealth For All,Ó the WHO/PAHO vision as a Ògold standardó Ñ Health with these vales: Eqity, solidarity, ethics, gender and hman rights US Healthy People 2010 Objectives

15 Challenge 3: Reinventing Drg Reglation Crrent system does not garantee Òsafety and efficacyó in se million hospitalized patients with serios reactions and 106,000 deaths (Lazaro in JAMA 1998) 6.7% of people prescribed drgs have severe adverse reactions Ñ 5th leading Case of death in the US in 1997 (CDC, 2000)

16 Factors Accelerating Reinventing Drg Approval Empowered patients Patient grops and disease volntary organizations Lower clinical trial costs for health providers Information systems, electronic medical records, low cost biomonitoring, Possible changes in intellectal property ÒSmarter MarketsÓ

17 Genomics and Clinical Development Virtal organs, patients and cohorts Genotype and phenotype focsed stdies Inclding phenotypes from Ayrveda, Oriental Medicine Greater access to clinical trials Disease grops play active role in design and recriting

18 Reinventing Drg Reglation Congress will need to rewrite FDAÕs drg process approval process New system will need to be more: Cstomized and predictive Capable of handling mltiple factors, learning from post approval data Flexible and adjstable as options improve Option to lower entry to market threshold, reqiring greater post-market captre of efficacy, side effects; Consmers choose how mch risk they want to take

19 Virtal Organs, Selves and Cohorts Virtal organs will provide Òin silicoó models that embed or nderstanding of hman physiology and that can be sed to test new medicines Many individals will have personalized virtal selves with their organs modeled for continos pdating and testing against new componds Use of virtal cohorts will grow

20 Challenge 4: Pblic Attitdes and Policy Pblic reaction - depends on how well genomics is applied GMOÕs in foods not a good start Policies & protections need to be resolved Privacy Discrimination Intellectal Property Eqity

21 Challenge 5: Giding Hman Evoltion Momentos directions Eliminate disease Enhance hman capacities Olympics Near immortality Designing hmans and hman societies Private and pblic decisions Corporate players are players

22 Challenge 6: Harnessing Visionary Potential Real opportnity for generating significant health gains Opportnity to se these to bring ÒHealth For AllÓ Great threats, risks, in the immediate market Vision needed to ensre companies provide highest vale added and remain competitive.

23 Challenge 6: Harnessing Visionary Potential Genomics forces all players to consider or fndamental contribtion -- what type of healthcare system, health and health gains, and society we are seeking to bild. This discssion contribtes to finding vale added -- this discssion is occrring in several sectors

24 Present Orientation Ftre Vale- Added is defined VISION STRATEGY TACTICS/OPERATIONS Why/What How Percentage of Person/OrganizationÕs Time Reactive Proactive

25 Vision & Vale Added: Trends across sectors Vale- Added Jornalism Corporate Activities Electronic Messaging Qality Health Care Military Medicine Civic Jornalism providing what is significant providing what is news accrate facts Visioning, Co-creation commnity services, collaboration profits efficiency operations Wisdom, Co-creation Vision knowledge information data Vision strategies operations Syndrome Prevention, Commnity Health disease prevention disease treatment Anti-War, Health/ Sstain- ability commnity health personal prevention, fitness disease and combat casalty treatment

26 Challenge 6: Harnessing Visionary Potential Harnessing visionary potential will reqire All players in genomics ensring their own vision is p to the challenges the commnity as a whole (the U.S. and global commnities) have a shared vision and strategies that enable genomics to make its optimal contribtion to ÒHealth For AllÓ and to conscios evoltion

27 Conclsion Genomics gives s great power will make health care and pharma more complex can contribte to significant health gains invites all players to rise to the challenges, especially achieving ÒHealth For AllÓ

28 For More Information Contact: Institte for Alternative Ftres 100 N. Pitt St., Site 235 Alexandria, VA