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Research careers in drug discovery & development

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Research careers for science graduates in drug discovery & development

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Research careers in drug discovery & development

  1. 1. RESEARCH CAREERS IN DRUG DISCOVERY & DEVELOPMENT Dr. Bhaswat S. Chakraborty Sr. VP & Chair, R&D Core Committee Cadila Pharmaceuticals Ltd. 1
  2. 2. CONTENTS  Discovering & Developing New Drugs: Overview  Discovery  Development  Lead Compound to Regulatory Approval  Regulatory Approval to Marketing  Drug DD Multi-Disciplines  Drug DD & Other R&D Scientists  Adaptation of a Fresh Graduate in his/her R&D Roles  Team playing  Finding a Mentor  Notes on working in Big Pharma  Demystifying Myths  Concluding Remarks 2
  3. 3. DISCOVERING & DEVELOPING NEW DRUGS: OVERVIEW  Highly time and cost intensive  Three stages:  Discovery: Identifying new compounds that help treat disease  Development: Administering the new drug to animals and humans to make sure it is safe and effective  Manufacturing: Producing the new drug in large quantities for distribution 3
  4. 4. IMPACT OF NEW MEDICINES IN LAST 100 YRS  Human life expectancy has doubled both developed and developing economies  One of the main reasons: better medicines than before  In some cases a better QoL  Backbone of effective and safe medicines  Research in the areas drug discovery, preclinical, formulation development and clinical studies  However, last two decades have seen very high cost of drug R&D  ~couple of billion US dollars  Despite this intimidating expense and the patents-warfare, R&D for good medicines are on  Good medicines are still being discovered and developed 4 Chakraborty B.S. (2012) PharmaTech, 3: 22-26
  5. 5. 5 New Medicine Marvels
  6. 6. DRUG DISCOVERY  Selection and characterization of the target disease  Disease must be well understood and characterized  Protein (usually) associated with the disease can be targeted by a lead compound with desirable properties  Which may cure the disease or control it  With HTS robotics, data processing and control softwares, liquid handling devices, and sensitive detectors, a researcher can now conduct millions of chemical, genetic or pharmacological tests in few days  Such in silico molecular modeling is actually a tremendous acceleration of the drug discovery process  40 years to understand the cholesterol biosynthesis pathway to develop the statin drugs – those that inhibit the enzyme HMG-CoA reductase, the rate limiting step in cholesterol biosynthesis  But 3 yrs for a molecular-level understanding of the role of the HER-2 receptor in breast cancer to develop Herceptin® 6 Chakraborty B.S. (2012) PharmaTech, 3: 22-26
  7. 7. DRUG DISCOVERY 7 Chakraborty B.S. (2012) PharmaTech, 3: 22-26
  8. 8. 8
  9. 9. DEVELOPMENT OF THE LEAD COMPOUNDS    Only 3-4 lead compounds emerge per 2000 structures examined  Subjected to preclinical efficacy and safety and toxicity testing  The first in humans, viz. Phase I studies  Human toxicity, maximum tolerated dose and pharmacokinetics (ADME – absorption, distribution, metabolism and elimination) of the administered drug  Also be a slight hint of human efficacy of the lead drug in some cases  If the toxicity profile and tolerability of the drug are acceptable  Tested in limited number of patients first (a Phase II study)  finally in a substantial number of patients in epidemiologic setup (Phase III study)  Results from clinical trials are fed back to enhance the next round of target selection and lead identification and optimization  Highest goal of drug DD is that the drug is safe & effective in its proposed use(s) & benefits outweigh the risks 9
  10. 10. DEVELOPMENT OF THE LEAD COMPOUNDS 10 Figure 2: The lead compounds are screened in animals and then select lead compounds, only a few, are taken to the subsequent clinical studies. Chakraborty B.S. (2012) PharmaTech, 3: 22-26
  11. 11. LEAD COMPOUND TO REGULATORY APPROVAL 11 Chakraborty B.S. (2012) PharmaTech, 3: 22-26
  12. 12. 12
  13. 13. REGULATORY APPROVAL TO MARKETING  At the end of Phase II, the FDA and sponsors try to come to an agreement on Phase 3 conduct  How often the FDA meets with a sponsor varies, but this is one of two most common meeting points prior to NDA  The other most common time is pre-NDA, right before an NDA is submitted  Phase III studies begin if evidence of effectiveness is shown in Phase II  Ph III: more information about safety & effectiveness,  Studying different populations and different dosage  Using the drug in combination with other drugs  N=Hundreds to about 3,000  Results of Phase III studies provide the main evidence of efficacy and safety in a Regulatory application  Following the Regulatory approval the drug can be marketed in that country  Post-marketing study commitments (Phase IV) are conducted after the FDA has approved a drug for marketing 13
  14. 14. Biology Chemistry Assay development Analytical Chemistry Cellular Biology Medicinal and Synthetic chemistry Electrophysiology Rational Design Genomics and molecular biology Computational chemistry Medicine In silico and de novo design (Behavioral) pharmacology High-throughput screening Physiology Related Sciences Protein biochemistry, expression, and synthesis Engineering Protein engineering and biopharmaceuticals Mathematics Proteomics Statistics Structural biology and crystallography Bio and chemi-informatics Veterinarian siences IT, hardware and software design Bell M, Science Careers, March 19, 2004 COMMON DRUG DISCOVERY DISCIPLINES
  15. 15. DRUG DD & OTHER R&D SCIENTISTS  Most of the pharmaceutical R&D scientists have a post graduate training from a recognized academic institution in their respective fields  About 10% of these individuals are PhD, MD & MVSc degree holders  Other requirements include high IQ, goal setting, problem solving and team playing skills  Can also be gifted with a high EQ or MBA degree (necessary for management positions)  An eye for details and writing expressly in technical English  Inclination for experiments, hypothesis generation  Training in research methologies  …. 15 Chakraborty B.S. (2013) PharmaTech, 4: 18-20
  16. 16. ADAPTATION OF A FRESH GRADUATE IN HIS/HER R&D ROLES  R&D scientists are mostly concentrated in private sector pharma business companies and some academic institutions  400,000 people globally in pharma, biotech and medical devices R&D  Majority get a job orientation following their graduation from academia and only after joining their employment  Formal training in on-going projects and SOPs by the minute stepwise descriptions of processes and rigidity of specifications  The hierarchy of reporting and the reality of owning the responsibilities are also strikingly novel for most of the entry level scientists  Challenge is to be a part of large multidisciplinary drug discovery & development teams  A suitable mentor can hold the hands of a fresh graduate during these bewildering times 16 Chakraborty B.S. (2013) PharmaTech, 4: 18-20
  17. 17. DEVELOPMENT OF TEAM PLAYING SKILLS   All pharma R&D activities are carried out in “team” set up these days  Teams could be mainly of three types:  Management, operational and expertise  Management teams have the roles of leading and co-ordinating  Operational teams consist of actual delivery of projects and problem solving oriented team players  Experts give critical input and also provide depth expertise wherever needed  Desirable that there is no artificial competition and dissatisfaction in one’s mind regarding her role  If roles remain unclear, domineering and put-down behaviours by certain role players become rampant at the cost of others. 17 Chakraborty B.S. (2013) PharmaTech, 4: 18-20
  18. 18. FINDING A CAREER MENTOR  Mentor in Sanskrit is “Mantradata” or giver of knowledge  E.g, Krishna-Arjuna (ancient), Gandhi- Neheru, Sir Humphry Davy- Michael Faraday  R&D mentor can inspire and give insight in many career related issues  Can explain difficult scientific concepts, which can lay foundation of the mentee’s understanding and save a great deal of time and energy  Help the young scientist to design a difficult clinical trial or experiment and solve problems  Correct interpretation and scope of new FDA & other Science guidances is another insight that a mentor can give 18 Chakraborty B.S. (2013) PharmaTech, 4: 18-20
  19. 19. 1. You don’t get to publish Not true. Most pharmaceutical companies strongly encourage publication of scientific work and often link bonus payments to high publication levels. 2. You don’t get to go to conferences Not true. Pharmaceutical companies generally encourage scientists from all levels to attend key conferences as both delegates and presenters. 3. You just screen or make compounds all day   Not true. A drug discovery operation is made of many different disciplines and involves many activities including a lot of basic research. 4. You are not free to follow your own interests or to be innovative Not true on both counts. Innovation and creativity is strongly encouraged and scientists spend significant time exploring new hypotheses and approaches   5. The science is not as good as in academia Not true. Pharmaceutical companies claim many high-profile publications, patents and groundbreaking concepts every year. Bell M, Science Careers, March 19, 2004 THE FIVE MYTHS OF WORKING FOR INDUSTRY
  20. 20. WHERE TO FIND AN EMPLOYMENT?  Large drug manufacturing and biotech companies in PBE  Contract research organizations (CROs)  Academic institutions  Governmental agencies  Regulatory  Research  Policy  Laboratories developing new drug therapies  Universities or hospitals  Supervising clinical drug trials  Manufacturing centers for large-scale production of medications  Pre-Clinical CROs 20
  21. 21. BIG PHARMA & THE PHARMACEUTICAL-BIOTECH ECOSYSTEM (PBE)  Big pharma is atop the ecosystem with capital and resources needed to commercialize new drugs  Their goal is to enrich their drug development pipeline, leveraging their expertise in regulatory submission, reimbursement, and commercialization of product  They are the integrators, orchestrating the drug development process with members of the ecosystem  The ecosystem concept offers a richer context than established supply chain models because the PBE is a dynamic, growing environment  Members can use funding from big pharma to build business that potentially can compete against established companies 21 McCarthy R, Science Careers, March 19, 2004
  22. 22. TIER 1 AND 2 SUPPLIERS IN THE PBE 22
  23. 23. PREPARING FOR A CAREER IN THE PBE  First, increase the value of your skills so it can benefit yourself and your employer  Going to graduate school and training in laboratories with intellectually stimulating environments  Sometimes working as a technician in a university research laboratory can be helpful  Second, understand the dynamics of value shifts in the PBE.  Develop an interest in technology management  New concepts such as disruptive technology and open innovation are changing the way established companies are developing new products  Third, engage in dialogue with others who are more experienced than you in this field  And lastly, remain a lifelong student  Genomics/proteomics revolution are just beginning  Opportunities for technology-astute scientists are abound in future 23 McCarthy R, Science Careers, March 19, 2004
  24. 24. YOU MAY SPECIALIZE IN:  Designing new drug therapies using natural or synthetic (man-made) ingredients  Discovering new ways to use existing drugs to treat different types of disease  Studying how disease affects the body and what causes some people to develop certain types of disease  Studying how the human body responds to medications, so scientists can develop better, safer drugs Test drugs on animals and humans to ensure safety and efficacy  Determining the most effective formulation and dosage for a specific drug  Working on improving the drug manufacturing process  Ensuring the consistent quality of prescription medications  Advising corporations or government agencies, including the Food and Drug Administration, on issues related to pharmaceutical development  Monitoring drug adverse reactions  And many more areas.... 24
  25. 25. CONCLUDING REMARKS  The discovery or isolation of the drug, whether it is a small or large molecule is an exciting but a complex process of studying its structure (along with thousand of related structures), mechanism of action, and physicochemical properties  Safety and Efficacy are main concerns in Preclinical & Clinical phases; CMC is the subject of API & formulations  Pharmaceutical R&D scientists come from a vast array of specializations within health sciences, chemistry and biotechnology majors  Specializations can be very refined and narrowly focused these days  Industry, Government and Academia are main employers  Adaptation and continued education are key factors of success  Big Pharma & the Pharmaceutical-Biotech Ecosystem (PBE) are the career builders & sustainers in general 25
  26. 26. THANK YOU VERY MUCH 26

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