The Test of Changing Exploratory Development into Business Achievement.

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Biotechnology Industry Organization (BIO) considered applicable to the area. ... The biotech business is still exceptionally divided, and more solidification is unavoidable ...
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The Challenge of Transforming Scientific Innovation into Commercial Success Dr. Norbert Riedel Kellogg Biotech Symposium April 16, 2004

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Healthcare is Changing Rapidly Increasing time of total populace Increased commonness of life-undermining conditions Cost-regulation weight from governments and different payors Expanding tolerant learning and strengthening More various wellsprings of advancement Personalized Medicine Rapid mechanical change

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Predicted 2003 and 2007 deals in the main nine markets in Europe and the main five in chose different locales at ex-producers\' costs utilizing conjecture trade rates. Source: IMS Market Prognosis Global

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Top Ten Companies Worldwide in Prescription Sales for the First Six Months of 2003

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Leading Major Companies by Profitability (benefit as % of offers) in 2002

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Leading Companies Ranked by Pharma R&D Spending in 2002

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Major New US Product Approvals

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BIO\'s Biotech Drug Approval List Also endorsed in 2003 were 13 extra recombinant proteins, monoclonal antibodies, little particle items and chose tissue-built items. Biotechnology Industry Organization (BIO) considered important to the part. Except for FluMist and Advate, every one of these items were exchanged from the Center for Biologics Evaluation and Research (CBER) to CDER, however were excluded on CDER\'s rundown of NME endorsements for 2003.

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Major new EU item endorsements

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With just 31 new dynamic substances a year ago, the highly vaunted upheaval in medication improvement still appears far off.

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Blood, insusceptible and immune system issue Cancer CNS Disorders Infectious ailments, including biodefense Tissue building Surgical circumstances Trauma Increase in Life-Threatening Conditions Presents Major Growth Opportunities Small atoms, biopharmaceuticals and immunizations for:

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Bioinformatics Blood wellbeing (prions) Drug conveyance Homecare Medication mistake counteractive action Personalized Medicine Internet-based clinical trials Minimally obtrusive surgery Nanotechnology Proteomics Stem cells Cell treatment Tissue designing Organ substitution Telemedicine/remote patient checking What\'s Next in Technology?

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Technological Changes are Creating New Possibilities Contemporary 1920s 1950s 1980s Major New Drug Classes Combinatorial little atoms, creator peptides Recombinant human proteins, monoclonal antibodies, nucleic acids Antibiotics Cardiovascular medications, antihypertensives psychotropics Combinatorial science, combinatorial peptides Genetic building, tissue culture New Drug Sources Proteins Genomics, proteomics, utilitarian genomics, high-throughput screening, transgenic/knockout model frameworks, transcript profiling New Target Identifaction Tools Molecular science, sub-atomic hereditary qualities, PCR, rDNA Biotechnology, cell science Targets Genes, hereditary administrative components, signal transduction pathways, protein-protein and protein-macromolecular communications Human subjects Microorganisms, creature models Enzymes, receptors Sources: Pharmaceutical Research and Manufacturers of America, ING Baring Furman Setz

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Future Mandate for R&D Shorten disclosure courses of events Strengthen advancement endeavors Increase research profitability

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Timelines in medication improvement Targets chose Lead arrangement chose Candidate leads chose IND endorsement NDA endorsement Lead determination Lead streamlining ( in vitro ADMET) Target recognizable proof Target choice Preclinical assessment ( in vivo ADMET) Clinical assessment Safety/Efficacy Marketing & deals Monitoring-ADR OLD PARADIGM Lead ID 1.5-4 yr 1.5-1 yr 1-2 yr 1-2 yr 8-10 yr 0.5 yr 0.5 yr 1-1.5 yr 1-1.5 yr 7-9 yr Increased proficiency in medication advancement Technological drivers: Genomics, proteomics, metabonomics, illness models, combinatorial science, HTS, bioinformatics… Increased lifecycle of new medications NEW PARADIGM 2-6 yr

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35% 30% 35% Even little upgrades in compound choice will effectsly affect benefits With up to 70% of clinical trial spending squandered on trials of fizzled mixes… Annual spending in clinical trials … a 1 percent change in choice can spare $7 million from each $1 billion of a yearly improvement spending plan. Absolute: $20 billion $700 million potential change opportunity by enhancing determination process Drugs that fall because of choice of wrong focuses For each $1 billion of a yearly advancement spending plan… Successful medications … 70% is spent on fizzled drugs $70 million for a 10 percent change Drugs that fall because of poor science

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Drug Discovery in the 21st Century High Throughput Screening Genomics/Proteomics Novel Targets Informatics Therapeutic Areas Informatics Combinatorial Chemistry

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Medicinal physicist Pharmacologist/toxicologist Clinical analyst Molecular researcher/bioinformatician Characterize system of activity Prioritize lead mixes Characterize \'off target\' impacts Develop surrogate markers Understand clinical reactions Discovery Preclinical Clinical Target choice Lead streamlining IND NDA

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HIGH-EFFICIENCY PROTEOMICS (connected to little atom drug disclosure) Informatics Proteomics Sorting of cells from tissue, in vitro cell society Affinity chromatography (MDLC) Quantitation & Identification (LC-MS, MS/MS) Genome arrangement ( recognizable proof & in silico triage) INPUT: Normal & Disease Samples (+ in vitro ) Affinity catch of protein class ( in vitro/invivo ) Proteomic profiling of contrasts Validate with class-particular inhibitors ( in vitro/in vivo ) Structure-based medication outline OUTPUT: Optimized lead X-beam crystallography Focused library (+ science) Class-particular agonists/rivals Activity-based proclivity reagents Chemistry

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QUANTITY Library Generation Medicinal Chemistry QUALITY TARGET VALIDATION cell-based SAR Functional Genomics Proteomics LEAD PROFILING ASSAY DEVELOPMENT MET/TOX Primary Screening HIT VALIDATION cell-based

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Key Srategies for Success Industrialization of lead distinguishing proof Data warehousing and entryways for learning access Customer bunches Innovation Commercialization Internet-based clinical trials Computer-helped trial configuration and recreation

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IBM\'s New Business Model for Pharma Accurate Assessment of the Threshold of Innovation Investment New Products Discovery Marketing Development Manufacturing Sales Traditional Products High Density Products Targeted Treatment Solutions New improvement approach Adaptive trials and in-life testing Rolling dossier Outcomes – situated showcasing EMRs Smaller and more intelligent deals power Integrated media New ailment drove approach Multiple store network models

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Integrating Into Networks of Innovation is a Key Growth Strategy Areas of Strength Areas of Weakness Academia Preferred Flows Biotech Start-up Companies Large Healthcare Companies Regulatory Marketing & Sales Exploratory Research Development Manufacturing

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Key Business Challenges for Biotech Create a vital vision for "adult" organizations Deliver income to bolster valuations Structure esteem expanding unions with customary pharmaceutical organizations Evaluate mergers and acquisitions Build creation limit

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Challenge: Define Strategic Vision What is the proper vision? Completely coordinated pharmaceutical organization or unadulterated revelation motor? What restorative/innovation center ought to an organization have? Diagnostics, conveyance or medications? Innovation Play? What supporting capacities, procedures are required? Revelation to improvement to portfolio administration to showcasing

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Challenge: Translate Innovation Into Earnings How do organizations amplify the estimation of their: Technology stages Identify the suitable targets and instruments Development applicants Balance specialized and business hazard Marketed items Expand limit and create line expansion techniques

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Challenge: Structure Value-Maximizing Alliances amongst biotechs and pharma firms will turn out to be considerably more critical How do biotechs adjust transient financing needs with long haul esteem amplification? What are the components of win-win cooperations? What key structures and procedures can shape future unions?

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Some of the more noteworthy arrangements marked amongst pharma and biotech organizations a year ago. Valuations can\'t be specifically thought about in light of the fact that they have not been consistently figured.

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Biotech Disappointments Merck & Co drops Celltech compound Novo Nordisk tries to stop Pfizer finishing its hormone substitution treatment bargain Lilly drops Ono\'s sivelestat Lilly closes an arrangement to create oral insulin with Generex Biogen closes Icos bargain Bayer racks key PPL venture Pfizer closes manage Phytopharm\'s P57 stoutness venture AstraZeneca hauls out of an arrangement with NicOx Cambridge Antibody Technology/Abbott bargain turns sour GlaxoSmithKline scraps its oral insulin manage Nobex Abbott scraps its diabetes manage Karo Bio Pfizer hands back Celltech\'s antiheumatic Pfizer returns item rights to Debiopharm

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Challenge: Evaluate M&A The biotech business is still exceedingly divided, and more combination is inescapable Successful organizations will proactively assess: When is the correct time for M&A? What properties make an applicant alluring? What collaborations exist, and how rapidly would they be able to be figured it out?

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Biotech organizations are solidifying among themselves or being purchased up by pharma

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