Mentoring and developing next generation of pharma r&d experts
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    Mentoring and developing next generation of pharma r&d experts Mentoring and developing next generation of pharma r&d experts Document Transcript

    • 1Mentoring and Developing Next Generation of Pharma R&D ExpertsDr. Bhaswat S. ChakrabortySr. Vice President, Research & Development,Cadila Pharmaceuticals Ltd., AhmedabadCharacterizing Pharma R&D Scientists: Next GenPharmaceutical scientists come from a vast array of specializations within health sciences, chemistry andbiotechnology majors. Specializations can be very refined and narrowly focused these days, as researchknowledge has exploded since 1980s. A few of the research and development (R&D) functional areas inpharmaceuticals discovery and manufacturing are worth mentioning, e.g., pharmacology, medicine,pharmaceutics, pharmaceutical and medicinal chemistry, immunology, microbiology, biostatistics andepidemiology. In addition, management and resource specializations contribute to these activities forwhich talents come from different but very significant dimensions.Most of the pharmaceutical scientists have had a post graduate training from a recognized academicinstitution in their respective fields. About 10% of these individuals are PhD and MD degree holders.While their academic accomplishments mark their basic qualifications these days, other characteristicsinclude high IQ, goal setting, problem solving and team playing skills. A fraction of these individuals canalso be gifted with a high EQ. Also, an eye for details and writing expressly in technical English or anyother vernacular characterizes a great majority of scientists. Interestingly, many of them are also veryconscious about their intellectual and other gifts.
    • 2Adaptation of a Fresh Graduate in his Functional RolesBy and large, R&D scientists are concentrated in private sector pharma business companies and someacademic institutions. The total number of pharma, biotech and medical devices R&D scientists areestimated to be in excess of 400,000 people globally. Except for a few privileged ones, the vast majorityget a job orientation following their graduation from academia and only after joining their employment.The theoretically oriented scholar can sometimes get surprised as they get a formal training in on-goingprojects and SOPs by the minute stepwise descriptions of processes and rigidity of specifications. Thehierarchy of reporting and the reality of owning the responsibilities are also strikingly novel for most ofthe entry level scientists. A suitable mentor can hold the hands of a fresh graduate during thesebewildering times.While fresh graduates of all disciplines undergo adaptation in this new environment, perhaps one of thesteepest adjustments lies there for a medical graduate entering pharma clinical R&D. She often has towork as a part of large multidisciplinary drug development teams because the clinical R&D departmentof a large company engages in R&D of many therapeutic areas. These physicians have to bring a clinicalperspective to all research and development activities there. Scholarly oriented PhD scientists inpharmacy or other health sciences also face challenges of general co-ordination and focus on eventualcommercial success of their projects.Preclinical drug discovery and development offer numerous opportunities for well trained lifescientists. For any drug it is important to establish that it works, is safe for patients to take, anda working knowledge of how a human body is going to handle it. Broadly these are the areas ofdiscovery biology, drug safety R&D (DSRD) and pharmacokinetics, dynamics and metabolism(PDM). Entry to careers in these departments is possible at a number of levels, from schoolleaver to graduate to PhD, and at more senior levels. Veterinary physicians and pharmacy andtoxicology graduates contribute highly in preclinical drug discovery and development.
    • 3For graduate entry level positions a usual requirement is adequate academic qualifications withsome practical experience. Occasionally vacancies will arise for experienced graduates withtransferable skills and a flexible attitude. Factors affecting availability of these positions will bethe structure of the individual company and where and how it does its research. One can find asuitable job directly or work through an intermediary agency.1Development of Team Playing SkillsAll pharma R&D activities are carried out in “team” set up these days. Teams could be mainly of threetypes: management, operational and expertise. Management teams have the roles of leading and co-ordinating, while operational teams consist of actual delivery of projects and problem solving orientedteam players. Experts give critical input and also provide depth expertise wherever needed. Regardlessof what one’s role is, the mentoring process should establish an equal dignity and importance of all rolessuch that there is no artificial competition and dissatisfaction in one’s mind regarding her role. Ifmentoring (in the sense of preparing the mind of the protégé[e]) is not done properly and adequately,roles remain unclear, domineering and put-down behaviours by certain role players become rampant atthe cost of others.Clear SOPs should be written up for the development of team playing skills. There is a myth in someorganizations that soft skills (mentoring included or implied) cannot be written as procedures. This is nottrue. Mentoring objectives and essentials of the processes must be written down to enhance clarity.Especially SOP for developing team skills warrant written procedures because the roles are diverse andskills required are unique. For example, a leadership role should be encouraged to use his authority in apositive whereas an implementer ought to be mentored for delivering projects on time and buildingquality in those projects. Both of them may be utilizing the skills of a common larger team.Finding a Career MentorMentor in Sanskrit is “Mantradata” or giver of knowledge. The most famous examples of mentor-protégé In India are Krishna-Arjuna (ancient) and Gandhi-Neheru. Mentor in Greek mythology, however,was a friend of Odysseus who placed Mentor and Odysseus foster-brother Eumaeus in charge of his son
    • 4Telemachus, and of Odysseus palace, when Odysseus left for the Trojan War. Since then, the personalname Mentor has been adopted in English as a term meaning someone who imparts wisdom to a lessexperienced colleague.2Sir Humphry Davy was a mentor to Michael Faraday. And we know what a stupendous pupil the latterturned out. While the character mentors impart spiritual and life skills to their younger counterparts, anR&D mentor can inspire and give insight in many career related issues. For example, a mentor canexplain difficult scientific concepts, which can lay foundation of the mentee’s understanding and save agreat deal of time and energy. He can also help the young scientist to design a difficult clinical trial orexperiment and solve problems that the latter is encountering. In addition, the mentor can help theprotégé learn more about the cutting-edge research in the field, i.e. the research that has not yet beenpublished but is still important to know for your own project. Correct interpretation and scope of newFDA guidances is another insight that a mentor can give.Perhaps, one of the most significant contributions of a mentor lies in teaching proper conflict resolutionand pressure diffusing techniques beyond fight and flight. The arts of stress management can be added
    • 5to this category. In fact, a mentor can impart knowledge of many vital life skills to his endearedprotégé(e). The list of probable facilitation and insightfulness of overall mentoring items cannot beexhausted.Talent Grades: Fact or Fiction?Talents are real – there is no doubt about that. In extension, grades of the same talent (sometimessimilar), for example, mastery in research problem solving, are also real, at least pragmatically. Talentsare natural inclinations in many cases. Geniuses are extreme (highest ranked) in this regard. However,even those who are not genius may be highly talented and stably talented. Genuine R&D talents areoften consistent in their performance and productivity and show excellence in their approach to work.However, talents can be developed, improved or both. Continuous development in the area one istrained is not only desirable but is an organizational necessity these days. Cross-disciplinary talents arealso highly sought after since last two decades as majority of R&D projects are cross-disciplinary innature. A young scientist, trained in bioanalytical methods, can be developed to carry out an entirePhase I clinical trial. An organic chemist, trained only in a specialized area of organic chemistry, candevelop his skills to the point that he becomes the master-mind of a very prolific biotech discoveryprogram.Where are We Now in India?Since 1995, relevant industry in India is going through a radical change in its pharmaceutical R&Dprograms. The API and manufacturing aspects of the industry had already caught up with internationalrigors during 80’s and early nineties. Ever since, the pre-clinical and clinical developments are gainingefficiency. For example, in clinical trials, following a steep learning curve in the 1990’s, most of thepharmaceutical giants and CROs now have systems in place to capture the benefits of large,multinational studies while minimizing the problems. These include Hardware and IT infrastructureharmony, support in multiple languages and responding to regulators’ queries from several countries atthe same time. Some aspects of successful management of large, multinational clinical studies havebecome mature through repetition and experience, such as training and support, while others, oftencritical processes, require constant oversight to avoid serious mistakes.3
    • 6This has been largely possible owing to the dedicated contributions from pharma R&D scientists in thiscountry. The young generation of scientists are worthy of repeated mention here.The Glory ForwardThe author is highly optimistic about the current and future glory of Indian pharma R&D scientists. Thereaders should not forget that approximately one out of six pharma scientists in the US is of Indianorigin. Their contributions to global pharma and biotech industries go without saying. A portion ofthese scientists are now transferring their scientific and mentoring knowledge back to India.The combined value of pharma and biotech in India is about US$ 20 billion. If we can sustain the R&Dand other outsourcing activities from overseas and continue to grow, we shall be one of the top 5 globalmarkets in value. The key to this success is also the successful nurturing and mentoring of our scientists.Let the experienced mentors hope that we never falter in this important national goal.References1. Loftus J., Edwards M. (2013). Clinical Discovery.http://www.clinicaldiscovery.com/readArticle.aspx?articleId=462. Wikipedia. http://en.wikipedia.org/wiki/Mentor.3. Chakraborty B. (2012). A Story of Drug Development: from Conception of the Molecule till MarketApproval. Pharma Tech, May-June, 22-26.