SlideShare ist ein Scribd-Unternehmen logo
1 von 35
TAILOR MADE MEDICINE




 BY,
 DR. SHREERAJ SHAH
 ASSOCIATE PROFESSOR,
 DEPT.       OF      PHARMACEUTICAL
 TECHNOLOGY,
 L.J. INSTITUTE OF PHARMACY,
 AHMEDABAD.
CONTENTS
   Introduction
   Definition
   Brief History
   Difference between common drug and personalize medicine
   Driving the Movement to Personalized Medicine
   Goals for personalized medicine
   Benefits of Personalized Medicine
   Limitation of personalized medicine
   Potential applications
   Selected Personalized Medicine Drugs, Treatments, and Diagnostics
   Biomarker and theranostics with reference to medicine of 2050
   Future of “Theranostics”
   “Medicine 2050”- with respect to Personalized medicines
   Societal Benefits and Costs
   Conclusion
   References
                                                                        2
INTRODUCTION
   Scientific achievements have had an immeasurable influence on
    the uses of innovative biopharmaceuticals and methods in
    medicine. These breakthrough discoveries have contributed to an
    irreversible change in the perception and use of diagnostics in
    contemporary treatment of many illnesses.
   Today, in addition to the well-established types of physical and
    chemical examination and our growing understanding of
    biochemical processes occurring in the body, we now have at our
    fingertips state-of-the-art diagnostics and therapies based on the
    molecular pathomechanisms of illnesses.
   Although the discovery of specific pathogens revolutionized
    medicine in the 19th and 20th centuries, making it possible to
    create pharmaceuticals essential to treat certain illnesses,
    generally improve health, or extend patients’ lives.
   So this will require the implementation of a fully innovative,
    individualized approach to illness and its treatment in patients. 3
TAILOR MADE MEDICINE OR PERSONALIZED
MEDICINE

    Personalized medicine refers to the tailoring of medical
     treatments to the individual characteristics of each
     patient.

    It does not literally mean the creation of drugs or
     medical devices that are unique to a patient but rather the
     ability to classify individuals into subpopulations that
     differ in their susceptibility to a particular disease or
     their response to a specific treatment.

    Preventive or therapeutic interventions can then be
     concentrated on those who will benefit, sparing expense
                                                                   4
     and side effects for those who will not.
“It’s far more important to know what person the
 disease has than what disease the person has.”

 Hippocrates (ca. 400 BCE)




                                                   5
BRIEF HISTORY
   1898:- Sir Archibald Garrod coins the term “chemical individuality” to describe inherited
    predispositions to metabolizing sulphonal drugs.
   1900:- Gregor Mendel’s work, conducted in 1865 and largely ignored, is rediscovered,
    launching the genetic era.
   1902:- Lucien Cuenot advances the hypothesis that genetically determined differences in
    biochemical processes could be the cause of adverse reactions after the ingestion of drugs.
   1941:- The relationship between genes and the production of proteins is discovered.
   1956:- The “chemical individuality” hypothesis is proven when a genetic deficiency of
    glucose-6-phosphate dehydrogenase is found to be linked to antimalarial primaquine
    toxicity.
   1959:- The term “pharmacogenetics” is coined by the German geneticist Friedrich Vogel.
   1967:- The genetic code is cracked, revealing how DNA sequences code for protein.
   1975:- Gene sequencing techniques are invented.
   1977:- Metabolism of drugs by enzymes of the CYP450 system is identified as a key
    genetically determined cause for variation in drug response.
   1983:- A polymerase chain reaction technique is invented for in vitro amplification of
    DNA sequences.
                                                                                             6
   1990:- The Human Genome Project is launched.
   April 2003:- The sequencing of the human genome is declared complete
    after 13 years and a $3 billion investment.
    May 2004:-The Office of the National Coordinator for Health Information
    Technology is established.
   November 2004:- The Personalized Medicine Coalition (PMC) is launched
    with 18 members from industry, government, and academia.
   December 2004:- The Oncotype DX® gene profile for optimizing breast
    cancer therapy is introduced.
   March 2005:- The FDA issues a Guidance for Industry on
    Pharmacogenomic Data Submissions.
   April 2005:- The FDA issues a white paper on co-developed diagnostic
    therapeutic products.
   October 2005:- A haplotype map of the human genome is published,
    providing a powerful tool for linking genetic variation to disease
    susceptibility and response to treatment.
   February 2006:- The National Institutes of Health (NIH) launches the
    Genes, Environment and Health Initiative.                              7
   August 2006:- Senator Barack Obama introduces the “Genomics and
    Personalized Medicine Act.”
   February 2007:- MammaPrint® becomes first predictive genetic test for breast cancer to
    receive formal approval by the FDA. A major genome-wide association study identifies
    gene variants linked to type 2 diabetes.
   March 2007:- The Department of Health and Human Services (HHS) announces the
    Personalized Health Care Initiative.
   June 2007:- The Wellcome Trust Case Control Consortium analyzes 17,000 Britons to
    find genetic variants linked to bipolar disorder, high blood pressure, coronary artery
    disease, Crohn’s disease, type 1 and type 2 diabetes, and rheumatoid arthritis.
   August 2007:- The FDA re-labels the blood thinning drug warfarin to recommend
    adjusting the dose based on genetic variation.
   April 2008:- James Watson’s genome is sequenced in two months for $1,000,000.
   May 2008:- The Genetic Information Non-Discrimination Act (GINA) is signed into law.
    The first high-resolution sequence map of human genetic variation is produced.
   July 2008:- The FDA recommends genetic testing before taking the HIV drug abacavir
    to reduce allergic reactions.
   August 2008:- Pharmacy benefits manager Medco collaborates with FDA to study the
    impact of genetic testing on the prescription of drugs and their effectiveness.
   September 2008:- The President’s Council of Advisors on Science and Technology
    (PCAST) issues the report, Priorities for Personalized Medicine.
   October 2008:- Ten prominent individuals release their genomic data as part of the
    Personal Genome Project.
   March 2009:- Massachusetts General Hospital announces plans to genotype every cancer
                                                                                       8
    patient to implement personalized medical care.
   April 2009:- Senate brings personalized medicine into national budget discussions.
Difference between common drug and personalized
medicine
     Current Practice       Personalized Medicine




      One size fits all




                           The right treatment
       Trial and error     for the right person
                           at the right time        9
Personalized medicine recognizes that individual patients may react in very 10
different ways to the same treatment given for the same problem. The goal
           is to tailor therapies based on a patient's DNA profile.
WHAT IS DRIVING THE MOVEMENT TO
PERSONALIZED MEDICINE?


          Consumer Demand for:-
          Safer and More Effective Drugs



           Faster Time to a Cure




           Cost-Effective Healthcare
                                           11
GOALS FOR PERSONALIZED
    MEDICINE
   Identify genetic differences between people that affect drug
     response

   Develop genetic tests that predict an individual’s response to
     a drug

   Tailor medical treatment to the individual
              # Increase effectiveness
              # Minimize adverse side effects




                                                                     12
BENEFITS OF PERSONALIZED MEDICINE


  Shiftemphasis in medicine from reaction to
   prevention

  Select   optimal therapies

  Increase   safety, reduce adverse drug reactions

  Increase   patient compliance

  Reduce    the time, cost, and failure rate of clinical trials
                                                                   13
  Reduce    the overall cost of healthcare
LIMITATION OF PERSONALIZED
    MEDICINE
   Healthcare workforce      (incl. physicians): currently no
    adequate training to make use of Personalized Medicine, not
    implemented in medical school curricula

    Public may be inhibited by full participation in personalized
    medicine research or clinical care, unless full genetic privacy
    is put in place

   Healthcare IT needed for linking patient information to
    genomic research (Electronic Medical Records)
                                                                      14
POTENTIAL APPLICATIONS
   Fields of Translational Research termed "-omics"
    (genomics, proteomics, and metabolomics) study the
     contribution of genes,        proteins, and   to human
      physiology and variations of these pathways that can
    lead
      to disease susceptibility. It is hoped that these fields
    will
     enable new approaches to diagnosis, drug development,
     and individualized therapy.

     I. Pharmacogenetics

     II. Pharmacometabonomics
                                                            15

    III. Cancer management
I. PHARMACOGENETICS:-
   Pharmacogenetics (also termed pharmacogenomics) is the
    field of study that examines the impact of genetic variation on
    the response to medications.

   This approach is aimed at tailoring drug therapy at a dosage
    that is most appropriate for an individual patient, with the
    potential benefits of increasing the efficacy and safety of
    medications.

.
                                                                 16
EXAMPLES OF PHARMACOGENETICS:-

   Genotyping variants in genes encoding Cytochrome
    P450 enzymes (CYP2D6, CYP2C19, and CYP2C9),
    which metabolize neuroleptic medications, to improve
    drug response and reduce side-effects.




                                                           17
II. PHARMACOMETABONOMICS:-
   Researchers at Imperial College London have demonstrated that
    pre-dose metabolic profiles from urine of rats and humans can be
    used to predict how they will metabolize drugs such
    acetaminophen (paracetamol).

   The authors observed that individuals having high pre-dose
    urinary levels of p-cresol sulfate, a gut bacteria co metabolite,
    had low post-dose urinary ratios of acetaminophen sulfate to
    acetaminophen glucuronide.



                                                                  18
III. CANCER MANAGEMENT:-
 Oncology is a field of medicine with a long history of
  classifying tumor stages based on anatomic and pathologic
  findings. This approach includes histological examination of
  tumor specimens from individual patients (such as HER2
  (Human Epidermal Growth Factor Receptor 2 /Neu in breast
  cancer). Thus, "personalized medicine" was in practice long
  before the term was coined.
 New molecular testing methods have enabled an extension of
  this approach to include testing for global gene, protein, and
  protein pathway and/or somatic mutations in cancer
  cells from patients in order to better define the prognosis in
  these patients and to suggest treatment options that are most
  likely to succeed.                                            19
EXAMPLES OF PERSONALIZED CANCER
 MANAGEMENT:-
(A) Testing for disease-causing mutations in the BRCA1
   (human caretaker gene that produces a protein called breast
   cancer type 1 susceptibility protein, responsible for repairing
   DNA) and BRCA2 genes, which are implicated in familial
   breast and ovarian cancer syndromes.
     Discovery of a disease-causing mutation in a family can
    inform "at-risk" individuals as to whether they are at higher
    risk for cancer and may prompt individualized prophylactic
    therapy including mastectomy and removal of the ovaries.
     This testing involves complicated personal decisions and
   is
                                                                20
    undertaken in the context of detailed genetic counseling.
(B) Minimal residual disease (MRD) tests are used to quantify
    residual cancer, enabling detection of tumor markers before
    physical signs and symptoms return. This assists physicians
    in making clinical decisions sooner than previously possible.

(C) Herceptin (Trastuzumab; trade name Herceptin), a
  monoclonal          antibody that       interferes       with
  the HER2/neu receptor ) is used in the treatment of women
  with breast cancer in which HER2 protein is overexpressed.




                                                                21
INEFFECTIVE THERAPIES CAN CAUSE HARM

   Estimated 100,000 deaths per year

   6th leading cause of death in the US

    Medication-related health problems account for an
    estimated
    3% to 7% of hospital admissions

   During their hospital stay, 15% of patients experienced
    adverse drug reactions
                                                              22
   Increased patient non-compliance
ONE SIZE DOES NOT FIT ALL

   ANTI-DEPRESSANTS        38%

   ASTHMA DRUGS           40%

 DIABETES   DRUGS          43%

   ARTHRITIS DRUGS        50%

   ALZHEIMER’S DRUGS      70%

   CANCER DRUGS           75%
                                                                  23
                       Here, study was carried out on 100 patient for
                       each disease condition.
 A report from the Personalized Medicine
  Coalition: The Case for Personalized Medicine puts
  the advent of personalized medicine in context:
  "Since the mapping of the human genome in 2003,
  the pace of discovery, product development, and
  clinical adoption of what we know as personalized
  medicine has accelerated."
 For the pharmaceutical industry the advances in
  personalized medicines are something of a
  revolution. With arguably the most significant
  investment in bringing products to market than any
  other industry – it’s estimated that it takes 15 years
  and $1 billion in development, testing and licensing
  to bring a drug to market – personalized medicine
  brings with it significant opportunities to bring
  much greater efficiencies to the highly costly area of   24

  clinical trials.
SELECTED PERSONALIZED MEDICINE DRUGS,
TREATMENTS, AND DIAGNOSTICS
    THERAPY           BIOMARKER/TEST                              INDICATION

                                                Breast cancer: “…for the treatment of patients with
    Herceptin®                                 metastatic breast cancer whose tumors over express the
  (trastuzumab)       HER-2/neu receptor         HER2 protein and who have received one or more
Tykerb® (lapatinib)                                        chemotherapy regimens for their
                                                                 metastatic disease.”

                      Aviara Breast Cancer     Breast cancer: Calculates a combined risk analysis for
    Tamoxifen         IndexSM (HOXB13,       recurrence after tamoxifen treatment for ER-positive, node-
                            IL17BR)                             negative breast cancer.

                                             Breastcancer: Prognosticimmunohistochemistry (IHC) test
                                                           used for postmenopausal, node
  Chemotherapy           Mammostrat®            negative, estrogen receptor expressing breast cancer
                                                patients who will receive hormonal therapy and are
                                                        considering adjuvant chemotherapy.

                                             Breast cancer: Assesses risk of distant metastasis in a 70
  Chemotherapy           MammaPrint®
                                                            gene expression profile.

                                              Cardiovascular disease: “an increased bleeding risk for
                                                                                                    25
   Coumadin®
                           CYP2C9              patients carrying either the CYP2C9*2 or CYP2C9*3
    (warfarin)
                                                                      alleles.”
Cardiovascular disease: Predicts risk of statin-induced neuro-myopathy, based on a
        Statins              PhyzioType SINM
                                                                    patient’s combinatorial genotype for 50 genes.

                                                       Cardiovascular disease: “Doses should be individualized according to the
      Atorvastatin                LDLR                recommended goal of therapy. Homozygous Familial Hypercholestremia (10-
                                                                   80mg/day)and heterozygous (10-20mg/ day).”

                                                    Colon cancer: “Variations in the UGT1A1 gene can influence a patient’s ability to
Camptosar® (irinotecan)          UGTIA1             break down irinotecan, which can lead to increased blood levels of the drug and a
                                                                              higher risk of side effects.”

  Erbitux® (cetuximab)
                                  KRAS                 Colon cancer: Certain KRAS mutations lead to unresponsiveness to the drug.
        Gefitinib

                                                      Colon cancer: “Patients enrolled in the clinical studies were required to have…
  Erbitux® (cetuximab)
                                                   evidence of positive EGFR expression using the DakoCytomation EGFR pharmDx™
        Gefitinib            EGFR expression
                                                   test kit.” EGFR positive individuals are more likely to respond to the drug than those
        Vectibix®
                                                                              with reduced EGFR expression.


Erbitux® (cetuximab) and
 Vectibix® (panitumab)                              Colon cancer: Provides information of the expression of key molecular targets—
                                Target GI™
      Fluorouracil                                                   KRAS, TS, and TOPO1—to guide therapy.
 Camptosar®(irinotecan)



                                                   Epilepsy and bipolar disorder: Serious dermatologic reactions are associated with
                                                    the HLAB*1502 allele in patients treated with carbamazepine. “Prior to initiating
Tagretol (carbamazepine)       HLA-B*1502
                                                     Tegretol therapy, testing for HLA-B*1502 should be performed in patients with
                                                             ancestry in populations in which HLAB*1502 may be present.”


                                                    Heart transplantation: Monitors patient’s immune response to heart transplant to
Immunosuppressive drugs    AlloMap® gene profile
                                                                          guide immunosuppressive therapy.
                                                                                                                                   26
                                                   HIV: “Patients who carry the HLA-B*5701 allele are at high risk for experiencing a
   Ziagen® (abacavir)          HLA-B*5701            hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir,
                                                                screening for the HLA-B*5701 allele is recommended.”
Multiple diseases: FDA classification 21 CFR 862.3360: “This device
                                          is used as an aid in determining treatment choice and individualizing
Drugs metabolized by      Amplichip®
                                                   treatment dose for therapeutics that are metabolized
     CYP P450           CYP2D6/CYP2C19
                                            primarily by the specific enzyme about which the system provides
                                                                  genotypic information.”


      Rifampin                             Multiple diseases: N-acetyltransferase slow and fast acetylators and
      Isoniazid              NAT          toxicity- “slow acetylation may lead to higher blood levels of the drug,
    Pyrazinamide                                         and thus, an increase in toxic reactions.”


                                          Non-Hodgkin’s lymphoma: Detects CD-20 variant (polymorphism in
                         PGx PredictTM:
     Rituximab                            the IgG Fc receptor gene FcgRIIIa) to predict response to cancer drug
                           Rituximab
                                                                      rituximab.

                                            Pain: “Patients who are known or suspected to be P450 2C9 poor
                                                            metabolizers based on a previous
Celebrex® (celecoxib)       CYP2C9          history should be administered celecoxib with caution as they may
                                              have abnormally high plasma levels due to reduced metabolic
                                                                       clearance.”

     Risperdal®                              Psychiatric disorders: Predicts risk of psychotropic-induced
    (resperidone)       PhyzioType PIMS   metabolic syndrome, based on a patient’s combinatorial genotype for
Zyprexa® (olanzapine)                                                 50 genes.


                                            Stomach cancer: “Gleevec® is also indicated for the treatment of
 Gleevec® (imatinib
                             c-KIT                                                                         27
                                            patients with Kit (CD117) positive unresectable and/or metastatic
     mesylate)
                                                   malignant gastrointestinal stromal tumors (GIST).”
BIOMARKER AND THERANOSTICS WITH
       REFERENCE TO MEDICINE OF 2050
   In medicine, a biomarker is a term often used to refer to a protein measured
    in blood whose concentration reflects the severity or presence of some
    disease state.
   More generally a biomarker is anything that can be used as an indicator of a
    particular disease state or some other physiological state of an organism.
   A biomarker can be a substance that is introduced into an organism as a
    means to examine organ function or other aspects of health. For
    example, rubidium chloride is used as a radioactive isotope to evaluate
    perfusion of heart muscle. It can also be a substance whose detection
    indicates a particular disease state, for example, the presence of
    an antibody may indicate an infection.
   More specifically, a biomarker indicates a change in expression or state of
    a protein that correlates with the risk or progression of a disease, or with the
    susceptibility of the disease to a given treatment.
   Biomarkers are characteristic biological properties that can be detected and
    measured in parts of the body like the blood or tissue                         28
   In oncology the most commonly used biomarkers are enzymes and hormones linked with
    tumors. They can be detected using biochemical tests, although their presence is not always
    indicative of the presence of a specific tumor. For example, an increase in the levels of the
    prostate-specific antigen (PSA) indicates a high likelihood of a prostate tumor being
    present, but it can also be a result of a mild hyperplasia. Similarly, raised levels of the
    carcino embryonic antigen (CEA) are characteristic in between 60–90% of colon cancer
    cases and 50–80% of pancreatic cancers.
   Now it is possible to monitor the course of many illnesses by studying differences in the
    structures of nucleic acids.
   DNA biomarkers include chromosome abnormality, single nucleotide polymorphisms
    (SNPs), a change in the number of copied DNA fragments, or differences in the degree
    of methylation of promoter regions. Research shows that using a biomarker that defines
    the degree of DNA methylation may be a factor in differentiating between prostate cancer
    from mild hyperplasia.
   RNA biomarkers include differences in the transcription levels, or RNA molecules that
                                                                                              29
    take part in regulation.
BRINGING BIOMARKERS TO MARKET
 Bringing biomarkers into general use must be preceded by
  thorough analyses of their safety in patients, reliability, efficacy,
  and the financial implications of their use in diagnostics
 In the US, the steps involved in introducing a new biomarker
  include:
     identification of relevant information in the patient’s biological material (using
      DNA microarrays, gene chips, restriction fragment length polymorphisms (RFLP)
      and others, depending on type),
     establishing possible applications, and final step
     clinical and analytical validation

       The final stage must be carried out, if the biomarker is to be
        approved by the FDA for clinical use, although it can be
        bypassed if it is to be used purely for research. The final
        decision regarding bringing a biomarker to market lies with
        the Center for Medicaid & Medicare Services (CMS),
        responsible for carrying out an analysis of costs versus     30
        benefits including social aspects.
FUTURE OF “THERANOSTICS”
   Researchers have even suggested introducing a new term “Theranostics,”
    (a portmanteau of therapeutics and diagnostics) which is a proposed process
    of diagnostic therapy for individual patients - to test them for possible
    reaction to taking a new medication and to tailor a treatment for them based
    on the test results.
   Effort to promote this new coin-age show how far advanced the introduction
    of personalized medicine is in various branches of medicine. Some scientists
    are no longer debating whether such medicines are will be used at all, but
    when its use will become widespread in clinical practice.
   Personalized medicine (with Theranostics) is closely linked with several
    clinical applications, and is most advanced in oncology and infectious
    diseases. In the latter case, defining the genotype of the virus (HIV, hepatitis
    B and C) and establishing the viremic concentration play a crucial role in
    selecting an appropriate therapy, predicting its efficacy, discovering any
    drug resistance and any necessary modifications of the treatment.
                                                                                  31
“MEDICINE 2050”- WITH RESPECT TO
PERSONALIZED MEDICINES
   The personalization of medicine is an irreversible process whose
    benefits can already be observed, and whose potential benefits cannot
    be overstated. This is excellently illustrated by a communication from
    the European Commission on 10 December 2008, which includes a
    declaration of support for scientific research in pharmaceutical
    development
   “With the emergence of new technologies like pharmacogenomics
    and patient-specific modelling and disease simulators, personalised
    medicine is now on the horizon. In the long term, doctors may be able
    to use genetic information to determine the right medicines, at the
    right dose and time. This field is already affecting companies’ business
    strategies, the design of clinical trials and the way medicines are
    prescribed. Although it is too early to say whether ‘omics’
    technologies will indeed revolutionize the sector, the Commission
                                                                          32
    closely monitors the area and will reflect on how it can support its
    development.”
SOCIETAL BENEFITS AND COSTS
   Alongside the high hopes and optimism brought by the prospect of “made to
    measure” medicine, there are also some ethical concerns. The most frequently cited
    examples revolve around personal data protection, potential discrimination by
    insurance firms or employers against people who have a tendency towards certain
    illnesses, or personal stigma. These may become deciding factors in whether this
    novel treatment strategy ultimately gains societal acceptance, therefore they should be
    put forward for thorough discussion, eventually leading to concrete legislative
    measures
   Doubts may also arise because of the potential costs of introducing personalized
    medicine. In this instance it is essential to take a close look at the problems of
    efficacy and safety of current therapies, and the intentions and options in investing in
    innovative technologies
   In this specific instance it is very important to stress that a significant part of the
    diagnostic costs should be recompensed through targeted and effective therapeutics.
    Contemporary biopharmaceuticals (hormones, interferons and interleukins) are
    very expensive, and yet ineffective, and therefore unnecessary (or badly dosed) use of
    expensive drugs is wasteful
   The application of proteomics and transcriptomics to personalized medicine will     33
    make it possible to optimize the possibilities of medicine in both economic and social
    aspects.
CONCLUSION
   We cannot predict what medicine will be like in 2020 or
    2050, although we can be certain that it will be quite
    different from what it is today. The scientific, economic,
    and social circumstances all indicate that “tailor-made”
    medicine is likely the way of the future.




                                                                 34
REFERENCES
(1) President’s Council of Advisors on Science and Technology (PCAST) “Priorities for
     Personalized Medicine” September 2008

(2) Brian B. Spear, Margo Heath-Chiozzi, Jeffrey Huff, “Clinical Trends in Molecular
     Medicine, Volume 7, Issue 5, 1 May 2001, Pages 201-204.

(3) National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology


    for Colon and Rectal Cancer. Volume-2, 2009

(4) Abrahams A, Ginsburg GS, Silver M. The Personalized Medicine Coalition: Goals
     and

    strategies. Am J Pharmacogenomics , 2005;5(6): 345-355.

(5) Personalized Medicine Coalition May 2009
                                                                                   35
(6) The future of red biotechnology, Tailor made medicine, by Aleksandra Małyska

    and Tomasz Twardowski page no:-12-15

Weitere ähnliche Inhalte

Was ist angesagt?

Polymers of Controlled Drug Delivery System
Polymers of Controlled Drug Delivery SystemPolymers of Controlled Drug Delivery System
Polymers of Controlled Drug Delivery SystemNabeela Moosakutty
 
Personalized medicines
Personalized medicines Personalized medicines
Personalized medicines Sachin G
 
DRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITRODRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITROAnkit Malik
 
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...Naveen Reddy
 
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...RUSHIKESHSHINDE80
 
Microencapsulation methods
Microencapsulation methodsMicroencapsulation methods
Microencapsulation methodsJehan Essam
 
Post marketing servillence
Post marketing servillencePost marketing servillence
Post marketing servillencebdvfgbdhg
 
Personalised medicines 1 (1)
Personalised medicines 1 (1)Personalised medicines 1 (1)
Personalised medicines 1 (1)JyotiMhoprekar
 
Regulatory terminologies used in PV (Pharmacovigilance)
Regulatory terminologies used in PV (Pharmacovigilance)Regulatory terminologies used in PV (Pharmacovigilance)
Regulatory terminologies used in PV (Pharmacovigilance)MubasheeraMg
 
Penetration enhancer with their examples
Penetration enhancer with their examplesPenetration enhancer with their examples
Penetration enhancer with their examplesAnkita Rai
 
Osmotic drug delivery system
Osmotic drug delivery systemOsmotic drug delivery system
Osmotic drug delivery systemDr. Shreeraj Shah
 
NEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptxNEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptxAmitSahu546305
 
Drug safety evaluation in clinical trial
Drug safety evaluation in clinical trialDrug safety evaluation in clinical trial
Drug safety evaluation in clinical trialVikas Sharma
 

Was ist angesagt? (20)

Polymers of Controlled Drug Delivery System
Polymers of Controlled Drug Delivery SystemPolymers of Controlled Drug Delivery System
Polymers of Controlled Drug Delivery System
 
Pharmaogenomics
PharmaogenomicsPharmaogenomics
Pharmaogenomics
 
Personalized medicines
Personalized medicines Personalized medicines
Personalized medicines
 
DRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITRODRUG PRODUCT PERFORMANCE, IN VITRO
DRUG PRODUCT PERFORMANCE, IN VITRO
 
INDA/NDA/ANDA
INDA/NDA/ANDAINDA/NDA/ANDA
INDA/NDA/ANDA
 
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...
Personalized medicine, Pharmacogenomics, customized drug delivery systems,3d ...
 
Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicine
 
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...
Documentation In Pharmaceutical Industry(Master Formula Record,DMF,Distributi...
 
Pharmacogenetics
PharmacogeneticsPharmacogenetics
Pharmacogenetics
 
Microencapsulation methods
Microencapsulation methodsMicroencapsulation methods
Microencapsulation methods
 
Post marketing servillence
Post marketing servillencePost marketing servillence
Post marketing servillence
 
Personalised medicines 1 (1)
Personalised medicines 1 (1)Personalised medicines 1 (1)
Personalised medicines 1 (1)
 
Regulatory terminologies used in PV (Pharmacovigilance)
Regulatory terminologies used in PV (Pharmacovigilance)Regulatory terminologies used in PV (Pharmacovigilance)
Regulatory terminologies used in PV (Pharmacovigilance)
 
Penetration enhancer with their examples
Penetration enhancer with their examplesPenetration enhancer with their examples
Penetration enhancer with their examples
 
Telepharmacy
TelepharmacyTelepharmacy
Telepharmacy
 
Osmotic drug delivery system
Osmotic drug delivery systemOsmotic drug delivery system
Osmotic drug delivery system
 
NEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptxNEW DRUG APPLICATION (NDA).pptx
NEW DRUG APPLICATION (NDA).pptx
 
Drug safety evaluation in clinical trial
Drug safety evaluation in clinical trialDrug safety evaluation in clinical trial
Drug safety evaluation in clinical trial
 
Nda
NdaNda
Nda
 
Personalized medicines
Personalized medicinesPersonalized medicines
Personalized medicines
 

Andere mochten auch

Personalized Medicine: Current and Future Perspectives Personalized Medicin...
Personalized Medicine: Current and Future Perspectives 	 Personalized Medicin...Personalized Medicine: Current and Future Perspectives 	 Personalized Medicin...
Personalized Medicine: Current and Future Perspectives Personalized Medicin...MedicineAndHealth
 
Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicinePeter Egorov
 
Precision medicine the future of_healthcare
Precision medicine  the future of_healthcarePrecision medicine  the future of_healthcare
Precision medicine the future of_healthcareThomas Wilckens
 
Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicineMadiheh
 
Towards Personalized Medicine
Towards Personalized MedicineTowards Personalized Medicine
Towards Personalized MedicineMichel Dumontier
 
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...Health IT Conference – iHT2
 
Gene Express Jaima Presentation September 04, 2008 Chiba
Gene Express Jaima Presentation September 04, 2008 ChibaGene Express Jaima Presentation September 04, 2008 Chiba
Gene Express Jaima Presentation September 04, 2008 ChibaDavid Lester
 
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...neuropeptide
 
Personalized Medicine in Diagnosis and Treatment of Cancer
Personalized Medicine in Diagnosis and Treatment of Cancer Personalized Medicine in Diagnosis and Treatment of Cancer
Personalized Medicine in Diagnosis and Treatment of Cancer Maryam Rafati
 
Personalized medicine optum labs
Personalized medicine   optum labsPersonalized medicine   optum labs
Personalized medicine optum labsMassTLC
 
Diagnostics and personalized medicine
Diagnostics and personalized medicineDiagnostics and personalized medicine
Diagnostics and personalized medicineWinton Gibbons
 
Forum on Personalized Medicine: Challenges for the next decade
Forum on Personalized Medicine: Challenges for the next decadeForum on Personalized Medicine: Challenges for the next decade
Forum on Personalized Medicine: Challenges for the next decadeJoaquin Dopazo
 
Precision Medicine: Opportunities and Challenges for Clinical Trials
Precision Medicine: Opportunities and Challenges for Clinical TrialsPrecision Medicine: Opportunities and Challenges for Clinical Trials
Precision Medicine: Opportunities and Challenges for Clinical TrialsMedpace
 
Personalized Medicine Overview
Personalized Medicine OverviewPersonalized Medicine Overview
Personalized Medicine Overviewahelicher
 

Andere mochten auch (18)

Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicine
 
Personalized Medicine: Current and Future Perspectives Personalized Medicin...
Personalized Medicine: Current and Future Perspectives 	 Personalized Medicin...Personalized Medicine: Current and Future Perspectives 	 Personalized Medicin...
Personalized Medicine: Current and Future Perspectives Personalized Medicin...
 
Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicine
 
Theranostics
TheranosticsTheranostics
Theranostics
 
Precision medicine the future of_healthcare
Precision medicine  the future of_healthcarePrecision medicine  the future of_healthcare
Precision medicine the future of_healthcare
 
Personalized medicine
Personalized medicinePersonalized medicine
Personalized medicine
 
Towards Personalized Medicine
Towards Personalized MedicineTowards Personalized Medicine
Towards Personalized Medicine
 
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...
Health IT Summit Atlanta 2014 - Keynote Presentation "Big Data, Value Analysi...
 
Gene Express Jaima Presentation September 04, 2008 Chiba
Gene Express Jaima Presentation September 04, 2008 ChibaGene Express Jaima Presentation September 04, 2008 Chiba
Gene Express Jaima Presentation September 04, 2008 Chiba
 
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...
Personalized Medicine Opportunity Analysis - Team Neuropeptide - Stanford Ven...
 
Personalized Medicine in Diagnosis and Treatment of Cancer
Personalized Medicine in Diagnosis and Treatment of Cancer Personalized Medicine in Diagnosis and Treatment of Cancer
Personalized Medicine in Diagnosis and Treatment of Cancer
 
Personalized medicine optum labs
Personalized medicine   optum labsPersonalized medicine   optum labs
Personalized medicine optum labs
 
Diagnostics and personalized medicine
Diagnostics and personalized medicineDiagnostics and personalized medicine
Diagnostics and personalized medicine
 
Genetics of Scleroderma: Towards Personalized Medicine in the Genomic Age
Genetics of Scleroderma: Towards Personalized Medicine in the Genomic AgeGenetics of Scleroderma: Towards Personalized Medicine in the Genomic Age
Genetics of Scleroderma: Towards Personalized Medicine in the Genomic Age
 
Personalized Medicine
Personalized MedicinePersonalized Medicine
Personalized Medicine
 
Forum on Personalized Medicine: Challenges for the next decade
Forum on Personalized Medicine: Challenges for the next decadeForum on Personalized Medicine: Challenges for the next decade
Forum on Personalized Medicine: Challenges for the next decade
 
Precision Medicine: Opportunities and Challenges for Clinical Trials
Precision Medicine: Opportunities and Challenges for Clinical TrialsPrecision Medicine: Opportunities and Challenges for Clinical Trials
Precision Medicine: Opportunities and Challenges for Clinical Trials
 
Personalized Medicine Overview
Personalized Medicine OverviewPersonalized Medicine Overview
Personalized Medicine Overview
 

Ähnlich wie Tailor made medicine

Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review)
Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review) Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review)
Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review) Makrani Shaharukh
 
Personalized Medicine & Pharmacogenomics
Personalized Medicine & PharmacogenomicsPersonalized Medicine & Pharmacogenomics
Personalized Medicine & Pharmacogenomicsfooziatabassum
 
Personalized Medicine: A New Normal for Therapeutic Success
Personalized Medicine: A New Normal for Therapeutic SuccessPersonalized Medicine: A New Normal for Therapeutic Success
Personalized Medicine: A New Normal for Therapeutic SuccessSarvan Mani
 
BIOSIMILARS AND ITS FUTUE
BIOSIMILARS AND ITS FUTUEBIOSIMILARS AND ITS FUTUE
BIOSIMILARS AND ITS FUTUEAsmitaGpt
 
Medicine in the future by mahmoud ihab
Medicine in the future by mahmoud ihabMedicine in the future by mahmoud ihab
Medicine in the future by mahmoud ihabmihabm
 
Clinical pharmacology history roles & research
Clinical pharmacology history roles & researchClinical pharmacology history roles & research
Clinical pharmacology history roles & researchBhaswat Chakraborty
 
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013) Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013) Global Medical Cures™
 
Handout-Session-1-Genomics.pptx
Handout-Session-1-Genomics.pptxHandout-Session-1-Genomics.pptx
Handout-Session-1-Genomics.pptxAnandKumar279666
 
Dr Dev Kambhampati | FDA- Paving the Way for Personalized Medicine
Dr Dev Kambhampati | FDA- Paving the Way for Personalized MedicineDr Dev Kambhampati | FDA- Paving the Way for Personalized Medicine
Dr Dev Kambhampati | FDA- Paving the Way for Personalized MedicineDr Dev Kambhampati
 
personalized medicine
personalized medicinepersonalized medicine
personalized medicineManoj Bajait
 
Personalized Medicines - Enhancers of Life's Quality and Their Future
 Personalized Medicines - Enhancers of Life's Quality and Their Future  Personalized Medicines - Enhancers of Life's Quality and Their Future
Personalized Medicines - Enhancers of Life's Quality and Their Future SindhBiotech
 
Rare Diseases: A Report on Orphan Drugs in the Pipeline
Rare Diseases: A Report on Orphan Drugs in the PipelineRare Diseases: A Report on Orphan Drugs in the Pipeline
Rare Diseases: A Report on Orphan Drugs in the PipelinePhRMA
 
Personalised medicine
Personalised medicinePersonalised medicine
Personalised medicineKushal Saha
 
Personalized medicine ppt
Personalized medicine pptPersonalized medicine ppt
Personalized medicine pptIrene Daniel
 
Emerging Technologies and Tools in Precision Medicine Research
Emerging Technologies and Tools in Precision Medicine ResearchEmerging Technologies and Tools in Precision Medicine Research
Emerging Technologies and Tools in Precision Medicine ResearchClinosolIndia
 
Personalized medicine in the US
Personalized medicine in the USPersonalized medicine in the US
Personalized medicine in the USPRIME
 
PatientBillofRights
PatientBillofRightsPatientBillofRights
PatientBillofRightsBarry Duncan
 

Ähnlich wie Tailor made medicine (20)

Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review)
Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review) Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review)
Personalized Medicine: A Utilization In Pharmaceutical Field.(A Review)
 
Personalized Medicine & Pharmacogenomics
Personalized Medicine & PharmacogenomicsPersonalized Medicine & Pharmacogenomics
Personalized Medicine & Pharmacogenomics
 
Personalized Medicine: A New Normal for Therapeutic Success
Personalized Medicine: A New Normal for Therapeutic SuccessPersonalized Medicine: A New Normal for Therapeutic Success
Personalized Medicine: A New Normal for Therapeutic Success
 
BIOSIMILARS AND ITS FUTUE
BIOSIMILARS AND ITS FUTUEBIOSIMILARS AND ITS FUTUE
BIOSIMILARS AND ITS FUTUE
 
Medicine in the future by mahmoud ihab
Medicine in the future by mahmoud ihabMedicine in the future by mahmoud ihab
Medicine in the future by mahmoud ihab
 
Clinical pharmacology history roles & research
Clinical pharmacology history roles & researchClinical pharmacology history roles & research
Clinical pharmacology history roles & research
 
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013) Global Medical Cures™ | Paving way for Personalized Medicine (2013)
Global Medical Cures™ | Paving way for Personalized Medicine (2013)
 
Handout-Session-1-Genomics.pptx
Handout-Session-1-Genomics.pptxHandout-Session-1-Genomics.pptx
Handout-Session-1-Genomics.pptx
 
Dr Dev Kambhampati | FDA- Paving the Way for Personalized Medicine
Dr Dev Kambhampati | FDA- Paving the Way for Personalized MedicineDr Dev Kambhampati | FDA- Paving the Way for Personalized Medicine
Dr Dev Kambhampati | FDA- Paving the Way for Personalized Medicine
 
med genetics
med geneticsmed genetics
med genetics
 
personalized medicine
personalized medicinepersonalized medicine
personalized medicine
 
Personalized Medicines - Enhancers of Life's Quality and Their Future
 Personalized Medicines - Enhancers of Life's Quality and Their Future  Personalized Medicines - Enhancers of Life's Quality and Their Future
Personalized Medicines - Enhancers of Life's Quality and Their Future
 
Ispectrum magazine #13
Ispectrum magazine #13Ispectrum magazine #13
Ispectrum magazine #13
 
Rare Diseases: A Report on Orphan Drugs in the Pipeline
Rare Diseases: A Report on Orphan Drugs in the PipelineRare Diseases: A Report on Orphan Drugs in the Pipeline
Rare Diseases: A Report on Orphan Drugs in the Pipeline
 
Personalised medicine
Personalised medicinePersonalised medicine
Personalised medicine
 
Personalized medicine ppt
Personalized medicine pptPersonalized medicine ppt
Personalized medicine ppt
 
Emerging Technologies and Tools in Precision Medicine Research
Emerging Technologies and Tools in Precision Medicine ResearchEmerging Technologies and Tools in Precision Medicine Research
Emerging Technologies and Tools in Precision Medicine Research
 
Personalized medicine in the US
Personalized medicine in the USPersonalized medicine in the US
Personalized medicine in the US
 
PatientBillofRights
PatientBillofRightsPatientBillofRights
PatientBillofRights
 
Marsh pers strat-mednov2014
Marsh pers strat-mednov2014Marsh pers strat-mednov2014
Marsh pers strat-mednov2014
 

Mehr von Dr. Shreeraj Shah

Mehr von Dr. Shreeraj Shah (8)

Recent advances in GRDDS
Recent advances in GRDDSRecent advances in GRDDS
Recent advances in GRDDS
 
Niosome
Niosome Niosome
Niosome
 
Detailed study of the equipments as per sch m
Detailed study of the equipments as per sch mDetailed study of the equipments as per sch m
Detailed study of the equipments as per sch m
 
Bioadhesive drug delivery system
Bioadhesive drug delivery systemBioadhesive drug delivery system
Bioadhesive drug delivery system
 
Intelligent drug delivery system
Intelligent drug delivery systemIntelligent drug delivery system
Intelligent drug delivery system
 
Sonophoresis
Sonophoresis Sonophoresis
Sonophoresis
 
Iontophoresis
Iontophoresis Iontophoresis
Iontophoresis
 
Insitu gel drug delivery system
Insitu gel drug delivery systemInsitu gel drug delivery system
Insitu gel drug delivery system
 

Kürzlich hochgeladen

2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx
2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx
2024.03.23 What do successful readers do - Sandy Millin for PARK.pptxSandy Millin
 
How to Solve Singleton Error in the Odoo 17
How to Solve Singleton Error in the  Odoo 17How to Solve Singleton Error in the  Odoo 17
How to Solve Singleton Error in the Odoo 17Celine George
 
What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?TechSoup
 
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRA
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRADUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRA
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRATanmoy Mishra
 
EBUS5423 Data Analytics and Reporting Bl
EBUS5423 Data Analytics and Reporting BlEBUS5423 Data Analytics and Reporting Bl
EBUS5423 Data Analytics and Reporting BlDr. Bruce A. Johnson
 
How to Make a Field read-only in Odoo 17
How to Make a Field read-only in Odoo 17How to Make a Field read-only in Odoo 17
How to Make a Field read-only in Odoo 17Celine George
 
Optical Fibre and It's Applications.pptx
Optical Fibre and It's Applications.pptxOptical Fibre and It's Applications.pptx
Optical Fibre and It's Applications.pptxPurva Nikam
 
The Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsThe Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsEugene Lysak
 
How to Send Emails From Odoo 17 Using Code
How to Send Emails From Odoo 17 Using CodeHow to Send Emails From Odoo 17 Using Code
How to Send Emails From Odoo 17 Using CodeCeline George
 
Riddhi Kevadiya. WILLIAM SHAKESPEARE....
Riddhi Kevadiya. WILLIAM SHAKESPEARE....Riddhi Kevadiya. WILLIAM SHAKESPEARE....
Riddhi Kevadiya. WILLIAM SHAKESPEARE....Riddhi Kevadiya
 
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINT
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINTARTICULAR DISC OF TEMPOROMANDIBULAR JOINT
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINTDR. SNEHA NAIR
 
Diploma in Nursing Admission Test Question Solution 2023.pdf
Diploma in Nursing Admission Test Question Solution 2023.pdfDiploma in Nursing Admission Test Question Solution 2023.pdf
Diploma in Nursing Admission Test Question Solution 2023.pdfMohonDas
 
3.21.24 The Origins of Black Power.pptx
3.21.24  The Origins of Black Power.pptx3.21.24  The Origins of Black Power.pptx
3.21.24 The Origins of Black Power.pptxmary850239
 
Drug Information Services- DIC and Sources.
Drug Information Services- DIC and Sources.Drug Information Services- DIC and Sources.
Drug Information Services- DIC and Sources.raviapr7
 
10 Topics For MBA Project Report [HR].pdf
10 Topics For MBA Project Report [HR].pdf10 Topics For MBA Project Report [HR].pdf
10 Topics For MBA Project Report [HR].pdfJayanti Pande
 
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...Dr. Asif Anas
 
Protein Structure - threading Protein modelling pptx
Protein Structure - threading Protein modelling pptxProtein Structure - threading Protein modelling pptx
Protein Structure - threading Protein modelling pptxvidhisharma994099
 
Quality Assurance_GOOD LABORATORY PRACTICE
Quality Assurance_GOOD LABORATORY PRACTICEQuality Assurance_GOOD LABORATORY PRACTICE
Quality Assurance_GOOD LABORATORY PRACTICESayali Powar
 

Kürzlich hochgeladen (20)

2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx
2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx
2024.03.23 What do successful readers do - Sandy Millin for PARK.pptx
 
How to Solve Singleton Error in the Odoo 17
How to Solve Singleton Error in the  Odoo 17How to Solve Singleton Error in the  Odoo 17
How to Solve Singleton Error in the Odoo 17
 
Prelims of Kant get Marx 2.0: a general politics quiz
Prelims of Kant get Marx 2.0: a general politics quizPrelims of Kant get Marx 2.0: a general politics quiz
Prelims of Kant get Marx 2.0: a general politics quiz
 
What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?What is the Future of QuickBooks DeskTop?
What is the Future of QuickBooks DeskTop?
 
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRA
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRADUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRA
DUST OF SNOW_BY ROBERT FROST_EDITED BY_ TANMOY MISHRA
 
EBUS5423 Data Analytics and Reporting Bl
EBUS5423 Data Analytics and Reporting BlEBUS5423 Data Analytics and Reporting Bl
EBUS5423 Data Analytics and Reporting Bl
 
How to Make a Field read-only in Odoo 17
How to Make a Field read-only in Odoo 17How to Make a Field read-only in Odoo 17
How to Make a Field read-only in Odoo 17
 
Optical Fibre and It's Applications.pptx
Optical Fibre and It's Applications.pptxOptical Fibre and It's Applications.pptx
Optical Fibre and It's Applications.pptx
 
The Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George WellsThe Stolen Bacillus by Herbert George Wells
The Stolen Bacillus by Herbert George Wells
 
How to Send Emails From Odoo 17 Using Code
How to Send Emails From Odoo 17 Using CodeHow to Send Emails From Odoo 17 Using Code
How to Send Emails From Odoo 17 Using Code
 
Riddhi Kevadiya. WILLIAM SHAKESPEARE....
Riddhi Kevadiya. WILLIAM SHAKESPEARE....Riddhi Kevadiya. WILLIAM SHAKESPEARE....
Riddhi Kevadiya. WILLIAM SHAKESPEARE....
 
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINT
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINTARTICULAR DISC OF TEMPOROMANDIBULAR JOINT
ARTICULAR DISC OF TEMPOROMANDIBULAR JOINT
 
March 2024 Directors Meeting, Division of Student Affairs and Academic Support
March 2024 Directors Meeting, Division of Student Affairs and Academic SupportMarch 2024 Directors Meeting, Division of Student Affairs and Academic Support
March 2024 Directors Meeting, Division of Student Affairs and Academic Support
 
Diploma in Nursing Admission Test Question Solution 2023.pdf
Diploma in Nursing Admission Test Question Solution 2023.pdfDiploma in Nursing Admission Test Question Solution 2023.pdf
Diploma in Nursing Admission Test Question Solution 2023.pdf
 
3.21.24 The Origins of Black Power.pptx
3.21.24  The Origins of Black Power.pptx3.21.24  The Origins of Black Power.pptx
3.21.24 The Origins of Black Power.pptx
 
Drug Information Services- DIC and Sources.
Drug Information Services- DIC and Sources.Drug Information Services- DIC and Sources.
Drug Information Services- DIC and Sources.
 
10 Topics For MBA Project Report [HR].pdf
10 Topics For MBA Project Report [HR].pdf10 Topics For MBA Project Report [HR].pdf
10 Topics For MBA Project Report [HR].pdf
 
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...
Unveiling the Intricacies of Leishmania donovani: Structure, Life Cycle, Path...
 
Protein Structure - threading Protein modelling pptx
Protein Structure - threading Protein modelling pptxProtein Structure - threading Protein modelling pptx
Protein Structure - threading Protein modelling pptx
 
Quality Assurance_GOOD LABORATORY PRACTICE
Quality Assurance_GOOD LABORATORY PRACTICEQuality Assurance_GOOD LABORATORY PRACTICE
Quality Assurance_GOOD LABORATORY PRACTICE
 

Tailor made medicine

  • 1. TAILOR MADE MEDICINE BY, DR. SHREERAJ SHAH ASSOCIATE PROFESSOR, DEPT. OF PHARMACEUTICAL TECHNOLOGY, L.J. INSTITUTE OF PHARMACY, AHMEDABAD.
  • 2. CONTENTS  Introduction  Definition  Brief History  Difference between common drug and personalize medicine  Driving the Movement to Personalized Medicine  Goals for personalized medicine  Benefits of Personalized Medicine  Limitation of personalized medicine  Potential applications  Selected Personalized Medicine Drugs, Treatments, and Diagnostics  Biomarker and theranostics with reference to medicine of 2050  Future of “Theranostics”  “Medicine 2050”- with respect to Personalized medicines  Societal Benefits and Costs  Conclusion  References 2
  • 3. INTRODUCTION  Scientific achievements have had an immeasurable influence on the uses of innovative biopharmaceuticals and methods in medicine. These breakthrough discoveries have contributed to an irreversible change in the perception and use of diagnostics in contemporary treatment of many illnesses.  Today, in addition to the well-established types of physical and chemical examination and our growing understanding of biochemical processes occurring in the body, we now have at our fingertips state-of-the-art diagnostics and therapies based on the molecular pathomechanisms of illnesses.  Although the discovery of specific pathogens revolutionized medicine in the 19th and 20th centuries, making it possible to create pharmaceuticals essential to treat certain illnesses, generally improve health, or extend patients’ lives.  So this will require the implementation of a fully innovative, individualized approach to illness and its treatment in patients. 3
  • 4. TAILOR MADE MEDICINE OR PERSONALIZED MEDICINE  Personalized medicine refers to the tailoring of medical treatments to the individual characteristics of each patient.  It does not literally mean the creation of drugs or medical devices that are unique to a patient but rather the ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment.  Preventive or therapeutic interventions can then be concentrated on those who will benefit, sparing expense 4 and side effects for those who will not.
  • 5. “It’s far more important to know what person the disease has than what disease the person has.” Hippocrates (ca. 400 BCE) 5
  • 6. BRIEF HISTORY  1898:- Sir Archibald Garrod coins the term “chemical individuality” to describe inherited predispositions to metabolizing sulphonal drugs.  1900:- Gregor Mendel’s work, conducted in 1865 and largely ignored, is rediscovered, launching the genetic era.  1902:- Lucien Cuenot advances the hypothesis that genetically determined differences in biochemical processes could be the cause of adverse reactions after the ingestion of drugs.  1941:- The relationship between genes and the production of proteins is discovered.  1956:- The “chemical individuality” hypothesis is proven when a genetic deficiency of glucose-6-phosphate dehydrogenase is found to be linked to antimalarial primaquine toxicity.  1959:- The term “pharmacogenetics” is coined by the German geneticist Friedrich Vogel.  1967:- The genetic code is cracked, revealing how DNA sequences code for protein.  1975:- Gene sequencing techniques are invented.  1977:- Metabolism of drugs by enzymes of the CYP450 system is identified as a key genetically determined cause for variation in drug response.  1983:- A polymerase chain reaction technique is invented for in vitro amplification of DNA sequences. 6  1990:- The Human Genome Project is launched.
  • 7. April 2003:- The sequencing of the human genome is declared complete after 13 years and a $3 billion investment.  May 2004:-The Office of the National Coordinator for Health Information Technology is established.  November 2004:- The Personalized Medicine Coalition (PMC) is launched with 18 members from industry, government, and academia.  December 2004:- The Oncotype DX® gene profile for optimizing breast cancer therapy is introduced.  March 2005:- The FDA issues a Guidance for Industry on Pharmacogenomic Data Submissions.  April 2005:- The FDA issues a white paper on co-developed diagnostic therapeutic products.  October 2005:- A haplotype map of the human genome is published, providing a powerful tool for linking genetic variation to disease susceptibility and response to treatment.  February 2006:- The National Institutes of Health (NIH) launches the Genes, Environment and Health Initiative. 7  August 2006:- Senator Barack Obama introduces the “Genomics and Personalized Medicine Act.”
  • 8. February 2007:- MammaPrint® becomes first predictive genetic test for breast cancer to receive formal approval by the FDA. A major genome-wide association study identifies gene variants linked to type 2 diabetes.  March 2007:- The Department of Health and Human Services (HHS) announces the Personalized Health Care Initiative.  June 2007:- The Wellcome Trust Case Control Consortium analyzes 17,000 Britons to find genetic variants linked to bipolar disorder, high blood pressure, coronary artery disease, Crohn’s disease, type 1 and type 2 diabetes, and rheumatoid arthritis.  August 2007:- The FDA re-labels the blood thinning drug warfarin to recommend adjusting the dose based on genetic variation.  April 2008:- James Watson’s genome is sequenced in two months for $1,000,000.  May 2008:- The Genetic Information Non-Discrimination Act (GINA) is signed into law. The first high-resolution sequence map of human genetic variation is produced.  July 2008:- The FDA recommends genetic testing before taking the HIV drug abacavir to reduce allergic reactions.  August 2008:- Pharmacy benefits manager Medco collaborates with FDA to study the impact of genetic testing on the prescription of drugs and their effectiveness.  September 2008:- The President’s Council of Advisors on Science and Technology (PCAST) issues the report, Priorities for Personalized Medicine.  October 2008:- Ten prominent individuals release their genomic data as part of the Personal Genome Project.  March 2009:- Massachusetts General Hospital announces plans to genotype every cancer 8 patient to implement personalized medical care.  April 2009:- Senate brings personalized medicine into national budget discussions.
  • 9. Difference between common drug and personalized medicine Current Practice Personalized Medicine One size fits all The right treatment Trial and error for the right person at the right time 9
  • 10. Personalized medicine recognizes that individual patients may react in very 10 different ways to the same treatment given for the same problem. The goal is to tailor therapies based on a patient's DNA profile.
  • 11. WHAT IS DRIVING THE MOVEMENT TO PERSONALIZED MEDICINE? Consumer Demand for:- Safer and More Effective Drugs Faster Time to a Cure Cost-Effective Healthcare 11
  • 12. GOALS FOR PERSONALIZED MEDICINE  Identify genetic differences between people that affect drug response  Develop genetic tests that predict an individual’s response to a drug  Tailor medical treatment to the individual # Increase effectiveness # Minimize adverse side effects 12
  • 13. BENEFITS OF PERSONALIZED MEDICINE  Shiftemphasis in medicine from reaction to prevention  Select optimal therapies  Increase safety, reduce adverse drug reactions  Increase patient compliance  Reduce the time, cost, and failure rate of clinical trials 13  Reduce the overall cost of healthcare
  • 14. LIMITATION OF PERSONALIZED MEDICINE  Healthcare workforce (incl. physicians): currently no adequate training to make use of Personalized Medicine, not implemented in medical school curricula  Public may be inhibited by full participation in personalized medicine research or clinical care, unless full genetic privacy is put in place  Healthcare IT needed for linking patient information to genomic research (Electronic Medical Records) 14
  • 15. POTENTIAL APPLICATIONS  Fields of Translational Research termed "-omics" (genomics, proteomics, and metabolomics) study the contribution of genes, proteins, and to human physiology and variations of these pathways that can lead to disease susceptibility. It is hoped that these fields will enable new approaches to diagnosis, drug development, and individualized therapy. I. Pharmacogenetics II. Pharmacometabonomics 15 III. Cancer management
  • 16. I. PHARMACOGENETICS:-  Pharmacogenetics (also termed pharmacogenomics) is the field of study that examines the impact of genetic variation on the response to medications.  This approach is aimed at tailoring drug therapy at a dosage that is most appropriate for an individual patient, with the potential benefits of increasing the efficacy and safety of medications. . 16
  • 17. EXAMPLES OF PHARMACOGENETICS:-  Genotyping variants in genes encoding Cytochrome P450 enzymes (CYP2D6, CYP2C19, and CYP2C9), which metabolize neuroleptic medications, to improve drug response and reduce side-effects. 17
  • 18. II. PHARMACOMETABONOMICS:-  Researchers at Imperial College London have demonstrated that pre-dose metabolic profiles from urine of rats and humans can be used to predict how they will metabolize drugs such acetaminophen (paracetamol).  The authors observed that individuals having high pre-dose urinary levels of p-cresol sulfate, a gut bacteria co metabolite, had low post-dose urinary ratios of acetaminophen sulfate to acetaminophen glucuronide. 18
  • 19. III. CANCER MANAGEMENT:-  Oncology is a field of medicine with a long history of classifying tumor stages based on anatomic and pathologic findings. This approach includes histological examination of tumor specimens from individual patients (such as HER2 (Human Epidermal Growth Factor Receptor 2 /Neu in breast cancer). Thus, "personalized medicine" was in practice long before the term was coined.  New molecular testing methods have enabled an extension of this approach to include testing for global gene, protein, and protein pathway and/or somatic mutations in cancer cells from patients in order to better define the prognosis in these patients and to suggest treatment options that are most likely to succeed. 19
  • 20. EXAMPLES OF PERSONALIZED CANCER MANAGEMENT:- (A) Testing for disease-causing mutations in the BRCA1 (human caretaker gene that produces a protein called breast cancer type 1 susceptibility protein, responsible for repairing DNA) and BRCA2 genes, which are implicated in familial breast and ovarian cancer syndromes.  Discovery of a disease-causing mutation in a family can inform "at-risk" individuals as to whether they are at higher risk for cancer and may prompt individualized prophylactic therapy including mastectomy and removal of the ovaries.  This testing involves complicated personal decisions and is 20 undertaken in the context of detailed genetic counseling.
  • 21. (B) Minimal residual disease (MRD) tests are used to quantify residual cancer, enabling detection of tumor markers before physical signs and symptoms return. This assists physicians in making clinical decisions sooner than previously possible. (C) Herceptin (Trastuzumab; trade name Herceptin), a monoclonal antibody that interferes with the HER2/neu receptor ) is used in the treatment of women with breast cancer in which HER2 protein is overexpressed. 21
  • 22. INEFFECTIVE THERAPIES CAN CAUSE HARM  Estimated 100,000 deaths per year  6th leading cause of death in the US  Medication-related health problems account for an estimated 3% to 7% of hospital admissions  During their hospital stay, 15% of patients experienced adverse drug reactions 22  Increased patient non-compliance
  • 23. ONE SIZE DOES NOT FIT ALL  ANTI-DEPRESSANTS 38%  ASTHMA DRUGS 40%  DIABETES DRUGS 43%  ARTHRITIS DRUGS 50%  ALZHEIMER’S DRUGS 70%  CANCER DRUGS 75% 23 Here, study was carried out on 100 patient for each disease condition.
  • 24.  A report from the Personalized Medicine Coalition: The Case for Personalized Medicine puts the advent of personalized medicine in context: "Since the mapping of the human genome in 2003, the pace of discovery, product development, and clinical adoption of what we know as personalized medicine has accelerated."  For the pharmaceutical industry the advances in personalized medicines are something of a revolution. With arguably the most significant investment in bringing products to market than any other industry – it’s estimated that it takes 15 years and $1 billion in development, testing and licensing to bring a drug to market – personalized medicine brings with it significant opportunities to bring much greater efficiencies to the highly costly area of 24 clinical trials.
  • 25. SELECTED PERSONALIZED MEDICINE DRUGS, TREATMENTS, AND DIAGNOSTICS THERAPY BIOMARKER/TEST INDICATION Breast cancer: “…for the treatment of patients with Herceptin® metastatic breast cancer whose tumors over express the (trastuzumab) HER-2/neu receptor HER2 protein and who have received one or more Tykerb® (lapatinib) chemotherapy regimens for their metastatic disease.” Aviara Breast Cancer Breast cancer: Calculates a combined risk analysis for Tamoxifen IndexSM (HOXB13, recurrence after tamoxifen treatment for ER-positive, node- IL17BR) negative breast cancer. Breastcancer: Prognosticimmunohistochemistry (IHC) test used for postmenopausal, node Chemotherapy Mammostrat® negative, estrogen receptor expressing breast cancer patients who will receive hormonal therapy and are considering adjuvant chemotherapy. Breast cancer: Assesses risk of distant metastasis in a 70 Chemotherapy MammaPrint® gene expression profile. Cardiovascular disease: “an increased bleeding risk for 25 Coumadin® CYP2C9 patients carrying either the CYP2C9*2 or CYP2C9*3 (warfarin) alleles.”
  • 26. Cardiovascular disease: Predicts risk of statin-induced neuro-myopathy, based on a Statins PhyzioType SINM patient’s combinatorial genotype for 50 genes. Cardiovascular disease: “Doses should be individualized according to the Atorvastatin LDLR recommended goal of therapy. Homozygous Familial Hypercholestremia (10- 80mg/day)and heterozygous (10-20mg/ day).” Colon cancer: “Variations in the UGT1A1 gene can influence a patient’s ability to Camptosar® (irinotecan) UGTIA1 break down irinotecan, which can lead to increased blood levels of the drug and a higher risk of side effects.” Erbitux® (cetuximab) KRAS Colon cancer: Certain KRAS mutations lead to unresponsiveness to the drug. Gefitinib Colon cancer: “Patients enrolled in the clinical studies were required to have… Erbitux® (cetuximab) evidence of positive EGFR expression using the DakoCytomation EGFR pharmDx™ Gefitinib EGFR expression test kit.” EGFR positive individuals are more likely to respond to the drug than those Vectibix® with reduced EGFR expression. Erbitux® (cetuximab) and Vectibix® (panitumab) Colon cancer: Provides information of the expression of key molecular targets— Target GI™ Fluorouracil KRAS, TS, and TOPO1—to guide therapy. Camptosar®(irinotecan) Epilepsy and bipolar disorder: Serious dermatologic reactions are associated with the HLAB*1502 allele in patients treated with carbamazepine. “Prior to initiating Tagretol (carbamazepine) HLA-B*1502 Tegretol therapy, testing for HLA-B*1502 should be performed in patients with ancestry in populations in which HLAB*1502 may be present.” Heart transplantation: Monitors patient’s immune response to heart transplant to Immunosuppressive drugs AlloMap® gene profile guide immunosuppressive therapy. 26 HIV: “Patients who carry the HLA-B*5701 allele are at high risk for experiencing a Ziagen® (abacavir) HLA-B*5701 hypersensitivity reaction to abacavir. Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended.”
  • 27. Multiple diseases: FDA classification 21 CFR 862.3360: “This device is used as an aid in determining treatment choice and individualizing Drugs metabolized by Amplichip® treatment dose for therapeutics that are metabolized CYP P450 CYP2D6/CYP2C19 primarily by the specific enzyme about which the system provides genotypic information.” Rifampin Multiple diseases: N-acetyltransferase slow and fast acetylators and Isoniazid NAT toxicity- “slow acetylation may lead to higher blood levels of the drug, Pyrazinamide and thus, an increase in toxic reactions.” Non-Hodgkin’s lymphoma: Detects CD-20 variant (polymorphism in PGx PredictTM: Rituximab the IgG Fc receptor gene FcgRIIIa) to predict response to cancer drug Rituximab rituximab. Pain: “Patients who are known or suspected to be P450 2C9 poor metabolizers based on a previous Celebrex® (celecoxib) CYP2C9 history should be administered celecoxib with caution as they may have abnormally high plasma levels due to reduced metabolic clearance.” Risperdal® Psychiatric disorders: Predicts risk of psychotropic-induced (resperidone) PhyzioType PIMS metabolic syndrome, based on a patient’s combinatorial genotype for Zyprexa® (olanzapine) 50 genes. Stomach cancer: “Gleevec® is also indicated for the treatment of Gleevec® (imatinib c-KIT 27 patients with Kit (CD117) positive unresectable and/or metastatic mesylate) malignant gastrointestinal stromal tumors (GIST).”
  • 28. BIOMARKER AND THERANOSTICS WITH REFERENCE TO MEDICINE OF 2050  In medicine, a biomarker is a term often used to refer to a protein measured in blood whose concentration reflects the severity or presence of some disease state.  More generally a biomarker is anything that can be used as an indicator of a particular disease state or some other physiological state of an organism.  A biomarker can be a substance that is introduced into an organism as a means to examine organ function or other aspects of health. For example, rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle. It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection.  More specifically, a biomarker indicates a change in expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of the disease to a given treatment.  Biomarkers are characteristic biological properties that can be detected and measured in parts of the body like the blood or tissue 28
  • 29. In oncology the most commonly used biomarkers are enzymes and hormones linked with tumors. They can be detected using biochemical tests, although their presence is not always indicative of the presence of a specific tumor. For example, an increase in the levels of the prostate-specific antigen (PSA) indicates a high likelihood of a prostate tumor being present, but it can also be a result of a mild hyperplasia. Similarly, raised levels of the carcino embryonic antigen (CEA) are characteristic in between 60–90% of colon cancer cases and 50–80% of pancreatic cancers.  Now it is possible to monitor the course of many illnesses by studying differences in the structures of nucleic acids.  DNA biomarkers include chromosome abnormality, single nucleotide polymorphisms (SNPs), a change in the number of copied DNA fragments, or differences in the degree of methylation of promoter regions. Research shows that using a biomarker that defines the degree of DNA methylation may be a factor in differentiating between prostate cancer from mild hyperplasia.  RNA biomarkers include differences in the transcription levels, or RNA molecules that 29 take part in regulation.
  • 30. BRINGING BIOMARKERS TO MARKET  Bringing biomarkers into general use must be preceded by thorough analyses of their safety in patients, reliability, efficacy, and the financial implications of their use in diagnostics  In the US, the steps involved in introducing a new biomarker include:  identification of relevant information in the patient’s biological material (using DNA microarrays, gene chips, restriction fragment length polymorphisms (RFLP) and others, depending on type),  establishing possible applications, and final step  clinical and analytical validation  The final stage must be carried out, if the biomarker is to be approved by the FDA for clinical use, although it can be bypassed if it is to be used purely for research. The final decision regarding bringing a biomarker to market lies with the Center for Medicaid & Medicare Services (CMS), responsible for carrying out an analysis of costs versus 30 benefits including social aspects.
  • 31. FUTURE OF “THERANOSTICS”  Researchers have even suggested introducing a new term “Theranostics,” (a portmanteau of therapeutics and diagnostics) which is a proposed process of diagnostic therapy for individual patients - to test them for possible reaction to taking a new medication and to tailor a treatment for them based on the test results.  Effort to promote this new coin-age show how far advanced the introduction of personalized medicine is in various branches of medicine. Some scientists are no longer debating whether such medicines are will be used at all, but when its use will become widespread in clinical practice.  Personalized medicine (with Theranostics) is closely linked with several clinical applications, and is most advanced in oncology and infectious diseases. In the latter case, defining the genotype of the virus (HIV, hepatitis B and C) and establishing the viremic concentration play a crucial role in selecting an appropriate therapy, predicting its efficacy, discovering any drug resistance and any necessary modifications of the treatment. 31
  • 32. “MEDICINE 2050”- WITH RESPECT TO PERSONALIZED MEDICINES  The personalization of medicine is an irreversible process whose benefits can already be observed, and whose potential benefits cannot be overstated. This is excellently illustrated by a communication from the European Commission on 10 December 2008, which includes a declaration of support for scientific research in pharmaceutical development  “With the emergence of new technologies like pharmacogenomics and patient-specific modelling and disease simulators, personalised medicine is now on the horizon. In the long term, doctors may be able to use genetic information to determine the right medicines, at the right dose and time. This field is already affecting companies’ business strategies, the design of clinical trials and the way medicines are prescribed. Although it is too early to say whether ‘omics’ technologies will indeed revolutionize the sector, the Commission 32 closely monitors the area and will reflect on how it can support its development.”
  • 33. SOCIETAL BENEFITS AND COSTS  Alongside the high hopes and optimism brought by the prospect of “made to measure” medicine, there are also some ethical concerns. The most frequently cited examples revolve around personal data protection, potential discrimination by insurance firms or employers against people who have a tendency towards certain illnesses, or personal stigma. These may become deciding factors in whether this novel treatment strategy ultimately gains societal acceptance, therefore they should be put forward for thorough discussion, eventually leading to concrete legislative measures  Doubts may also arise because of the potential costs of introducing personalized medicine. In this instance it is essential to take a close look at the problems of efficacy and safety of current therapies, and the intentions and options in investing in innovative technologies  In this specific instance it is very important to stress that a significant part of the diagnostic costs should be recompensed through targeted and effective therapeutics. Contemporary biopharmaceuticals (hormones, interferons and interleukins) are very expensive, and yet ineffective, and therefore unnecessary (or badly dosed) use of expensive drugs is wasteful  The application of proteomics and transcriptomics to personalized medicine will 33 make it possible to optimize the possibilities of medicine in both economic and social aspects.
  • 34. CONCLUSION  We cannot predict what medicine will be like in 2020 or 2050, although we can be certain that it will be quite different from what it is today. The scientific, economic, and social circumstances all indicate that “tailor-made” medicine is likely the way of the future. 34
  • 35. REFERENCES (1) President’s Council of Advisors on Science and Technology (PCAST) “Priorities for Personalized Medicine” September 2008 (2) Brian B. Spear, Margo Heath-Chiozzi, Jeffrey Huff, “Clinical Trends in Molecular Medicine, Volume 7, Issue 5, 1 May 2001, Pages 201-204. (3) National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology for Colon and Rectal Cancer. Volume-2, 2009 (4) Abrahams A, Ginsburg GS, Silver M. The Personalized Medicine Coalition: Goals and strategies. Am J Pharmacogenomics , 2005;5(6): 345-355. (5) Personalized Medicine Coalition May 2009 35 (6) The future of red biotechnology, Tailor made medicine, by Aleksandra Małyska and Tomasz Twardowski page no:-12-15

Hinweis der Redaktion

  1. Minimal residual disease  (MRD) is the name given to small numbers of leukaemic cells that remain in the patient during treatment, or after treatment when the patient is in remission (no symptoms or signs of disease). It is the major cause of relapse in cancer and  leukaemia . Up until a decade ago, [ when? ]  none of the tests used to assess or detect cancer were sensitive enough to detect MRD. Now, however, very sensitive molecular biology tests are available – based on  DNA ,  RNA  or  proteins  – and these can measure minute levels of cancer cells in tissue samples, sometimes as low as one cancer cell in a million normal cells. In cancer treatment, particularly leukaemia, MRD testing has several important roles: determining whether treatment has eradicated the cancer or whether traces remain, comparing the efficacy of different treatments, monitoring patient remission status and recurrence of the leukaemia or cancer and choosing the treatment that will best meet those needs (personalization of treatment). The tests are not simple, are often part of research or trials, and some have been accepted for routine clinical use.