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A Sample Presentation on - Clinical research training program


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A Sample Presentation on - Clinical research training program. This was during my initial venture. A simple plane case study/deck format to give you insight on how to launch a Training program.

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A Sample Presentation on - Clinical research training program

  1. 1. Building Mutually Rewarding Partnership BIOSYSS & Your INSTITUTION
  2. 2. BIOTECH, PHARMA & LIFESCIENCES INDUSTRY IN INDIA A Prospectus “Jobs and Opportunities in Biotech”
  3. 3. • Over one 1.15 lakh students studying in more than 500 institutes • The ratio of Job available : students graduating is lower as compared to IT Let’s acknowledge the truth Opportunities are select and limited
  4. 4. What are we doing? The first question to be asked What is the employability of our students? Which segment of Industry they want to enter? Have they gathered sufficient information about it?
  5. 5. Are my students Employable? Do they have sufficient hands on training? How many project have they done? No of papers published Live Industrial projects?
  6. 6. Ask them: “Which profile of Industry you want to opt for?”
  7. 7. Which profile of Industry they want to opt?  Research & Development (Preclinical): Discovery Research, Bioinformatics and Animal Sciences  Operations: Process/Product Development, Manufacturing and Production and Environmental Health & Safety  Quality: Quality Control, Quality Assurance and Validation  Clinical Research: Clinical Research, Regulatory Affairs and Medical Affairs/ Drug Information  Finance & Administration: Finance, Administration, Information Systems and Legal Counsel  Business Development:  Business Development and Marketing/Sales  Project Management  Science /Technical Writer  Intellectual Property Advisor
  8. 8. Get Updated, Stay Ahead! Track all the scholarships and grants available Subscribe to mailers, magazines and websites Get mentorship
  9. 9. Training  Recruitment  Consulting
  10. 10. We are building India’s largest Bio-Network We are conducting online recruitments as well through our career portal
  11. 11. Career Opportunities in Clinical Research
  12. 12. About The Training Programs
  13. 13. To bring a new drug in market it go through the following processes: 1. Drug Discovery Process : Involves the process of Disease Identification to Generation of Potential Molecule or Lead Candidate 2. Drug Development Process : categorized in of 2 stages - Pre Clinical Development : Involves laboratory testing on Pharmacology, Pharmacokinetics, Toxicology of potential drug molecule on animals - Clinical Development Drug Discovery and Development Process Biosyss Ziven Consulting
  14. 14. Drug Discovery Process Ziven Consulting Identify Disease Identify Drug Target High Throughput Screening Hit Compounds (compounds having ability to interact with target) Lead Candidate (Hit compound with suitable physical, chemical and biological properties) Identify Structure Activity relationship (SAR’s) (How does the activity change as structure is systematically alerted) Identify Pharmacophore (Structural feature directly responsible for activity) Optimization Lead Candidate Biosyss
  15. 15. “Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use” • These may be used for prevention, treatment, diagnosis or for relief of symptoms in a disease. • Clinical trials are conducted by Pharmaceuticals and Biotechnological organization , CRO’s , Research/ Academic Institution and Cooperative groups. Clinical Trials: “An organized research study conducted on human beings for the purpose of investigating new methods of diagnosing, detecting, preventing or treating an illness, disease or disorder” Drug Development Process - Clinical Trials Ziven ConsultingBiosyss
  16. 16. Phases of Clinical Trials Ziven Consulting Phases Goals Subjects Time Phase 0 • Also known as Human Micro-dosing studies • Gather preliminary data on drug pharmacokinetics by single sub-therapeutic dose • To enable go/ no go decision 10- 15 Phase I • Initial Safety and tolerability(pharmacology) • Determine safe Dosage Range (MAD, SAD) • Indentify Side-Effects • Only about 70 % of the experimental drug passes Phase I Trial 20 - 100 Days – Few months Phase II • Effectiveness (therapeutic exploratory) • Dose Response • Further Evaluation on Safety • Only about 35 % of the experimental drug passes Phase I Trial 100 – 300 ~ 1 year Biosyss
  17. 17. Phases of Clinical Trials Ziven Consulting Phases Goals Subjects Time Phase III • Effectiveness ( therapeutic confirmatory) • Monitor Side-effects • Compare to Commonly Used Treatments • Collect information that will allow the drug or treatment to be used safely • Only about 25 % of the experimental drug pass Phase III Trial 1000 – 5000 Several years Phase IV • Post – Marketing (therapeutic use) • Effectiveness in General Population • Optimizing Drug Use Patient population Sample Biosyss
  18. 18. Following types of organizations can conduct clinical trials process: • Pharmaceutical Companies • Biotechnology Companies • Contract Research Organizations (CRO); Site Management Organizations (SMOs) • Research/Academic Institutions Organizations Involved in Clinical Trials Process Ziven ConsultingBiosyss
  19. 19. • Cost – US $ 800 Million approx • Time – 10 – 14 years • Quality (100 % compliance to regulatory guidelines) Factors for Successful Execution of Clinical Trials Ziven ConsultingBiosyss
  20. 20. Conditions that makes India favorable to conduct clinical trails are: • Large number of Hospitals and Doctors • Skilled Manpower • IT- Infrastructure • High Enrollment rate • Wide Spectrum of Diseases • High Patient Population • Economic Environment India : A favorable Destination to Conduct Clinical Trials Ziven ConsultingBiosyss
  21. 21. • Today, global clinical research industry is estimated at 52 billion US$ and Indian CR industry is estimated to be worth US$ 1.8 billion. • An estimated 2,10,000 individuals in US and over 70,000 individuals in UK are employed in CR Industry. • Worth of Pharmacovigilance market worldwide was $1859.9 million in 2008 and is estimated to reach $2252.2 by 2015. • Top companies conducting clinical trials in India include : Pfizer, Glaxo SmithKline, Aventis, Novartis, Novo Nordisk, Astra Zenica etc. • Indian CR Industry is expected to offer 30,000 – 50,000 jobs to healthcare professionals. Market Potential : Clinical Research and Pharmacovigilance Ziven ConsultingBiosyss
  22. 22. • Ziven Consulting is a full service Clinical Research Consultancy having expertise across multiple phases of the clinical development process. • With the team of expertise Ziven offers the consultancy services to the healthcare organizations (Pharmaceuticals, Biotech and CROs etc.). Ziven is primarily involved in providing: 1. Clinical Research Consultancy - Operational Assistance - Functional Office Support - Regulatory Affairs and Pharmacovigilance - Medical Writing 2. Manpower Recruitment 3. Clinical Research Training Introduction : Ziven Consulting Ziven ConsultingBiosyss
  23. 23. With an objective to impart necessary skills in students to enhance their competency level and guiding them to enter in the specialized industry of clinical research , Biosyss (India) and Ziven have joined hands to meet its objective via offering their specialized training programs in clinical research Joining Hands to Nurture Talent Ziven ConsultingBiosyss
  24. 24. BIOSYSS with Ziven is offering the following specialized professional training programs for entry level : • Professional Certificate in GCP and Clinical Research Programs Details: Duration : 6 months (can be completed within 6 months) Modality : Correspondence/ Distance Learning Fee : 12,500 Rs. per program Evaluation : Assignment Based Practical Training Component – Participants will get an opportunity to develop practical orientation through mock Hands-on Training Resource Material. Training Programs in GCP and Clinical Research Ziven ConsultingBiosyss
  25. 25. Clinical Research : Career Growth Ziven Consulting Clinical Research – Job Positions Experience Required Clinical Study Coordinator (CRC), Clinical Trials Assistant (CTA), Trainee Clinical Research Associate (CRA) Fresher Clinical Research Associate (CRA) 1-2 years Project Manager/ Team Leader 3- 5 years Manager-Clinical Research > 5 years Auditors >5 years Director/ VP 8-10 years Job prospects after completing “ Professional Certificate in GCP and Clinical Research” Biosyss
  26. 26. With an objective to provide quality GCP and Clinical Research Training, our industry experts have designed specialized training program to meet the highest expectations: 1. Economical Program Fee: Covers the basic and advance curriculum of clinical research 2. Quality Content: Covers all the content require at the entry and advanced level 3. Placement Assistance: Being a Manpower Consultant in clinical research, we offers an inherent advantage to the participants 4. Experience: With over 12 years and 300 clinical trails of experience our Experts and Consultants have trained large number of working as well as students in clinical research 5. Flexibility: Offer added advantage in terms of completion of training and fee payment options. 6. Ease of study: Being distance learning programs interested candidates can study and complete their training program at their place. Advantage BIOSYSS & Ziven Consulting Ziven Consulting We provide an edge to the training students in terms of Cost, Quality, Duration along-with 100 % placement assistance Biosyss
  27. 27. We intend to provide 100% placement assistance to all successful participants via following channels: • Premium Job Plus package for free (cost around 5k approx) which include:  Resume Development  Interview Preparation  Regular job alerts  Access to the database of relevant Clinical Research Organizations  Access to the database of relevant Clinical Research Consultancies etc. • In-house recruitment placement support and recommendations Placement Assistance Ziven ConsultingBiosyss
  28. 28. Dr. Shriram Inamdar (PGDMLS, PDCR, ACCR and PGD-HA) has over 12 years of extensive experience in clinical research. He has coordinated, managed and supervised more than 250 (Phase I to IV) global clinical trials across a wide range of therapeutic areas with special focus on Oncology and Gastroenterology along with Orthopedics, Cardiology, General Medicine, Psychiatry, Surgery, Dermatology, etc. Many of these being globally highest recruiting site team and awarded & certified for good quality data by CRO/Sponsor/Auditors. Dr. Shriram Inamdar has rich experience in Clinical Operations, Business Development and Coordinating External/Internal Audits. He is instrumental in identifying and developing numerous new investigators sites for quality clinical research and developing innovative strategies for high patient recruitment. Program Director Ziven ConsultingBiosyss
  29. 29. Building Mutually Rewarding Partnership BIOSYSS & Your INSTITUTION