WRITE ON!

MEDICAL WRITING NEWSLETTER MONSOON 2012

WORDS FROM THE EDITOR

Hello Readers! WRITE ON
This is the name of our TCS Medical Writing Newsletter. A platform to showcase the writing talent of TCSers and a quarterly publication which is the hub connecting all medical writing services across TCS. The story behind the name The editorial board received about 50 nominations for naming the newsletter. Some close calls for the name were Med Right by Adnan Pathan, Pilcro by Intesar Khatri, and De Medicamentis by Varun Mehta. Finally after a voting round, the editorial board selected WRITE ON as it was simple and encouraged the readers to write on. Some Basics The newsletter is divided into three main sections: Medical Writing Section, which will have topics on medical and scientific writing, skills improvement (communication, interpersonal, and presentation), and also topics on clinical research. Creative section, which will tickle your funny bone and make you smile. This will stimulate your thought process and open a new world for you. Process Highlights, which will provide a summary of the events, happenings, customer appreciations, on-goings, and updates in the TCS medical writing processes. This is the first issue of Write On and as it is being rolled out in the rains, get drenched in the monsoon theme of it. The falling rain reminds me of the famous rain songs that I hum in my mind. So which is your favourite rain song and why do you like it? Write to us and we will publish it in our next issue. We look forward to see what this season has in store for all of us, and also read about the activities of the medical writing teams in the last quarter. Hope you have as much fun reading this, as we had while putting it together for you! So there you go...

Puja Vyas

An Article on Phase 0Microdosing Studies by Varun Mehta

The Creative Corner Tete-a-tete with Mr Deepak Gowda MW Team Highlights Glimpse of the Editorial Team

IN THIS ISSUE

WRITE ON! MONSOON NEWSLETTER

PHASE 0MICRODOSING STUDIES

An article by Varun Mehta
Ever wondered how a drug is developed? What steps are there in the drug development cycle? Typically, before getting approved for marketing and being available to patients, a drug undergoes a long Research & Development process. There are 4 phases in drug development (Phase I to Phase IV) and it takes around 12 to15 years to develop a drug. Phase-I is a trial conducted in small number of healthy volunteers to find safety of a particular drug in humans. During Phase -II, experimental study drug is given to a limited numbers of participants (100-300) to see if it is effective and to further evaluate its safety, while in Phase III, experimental study drug is given to larger groups of participants (1,000 -3,000) to confirm its effectiveness and collect information that will allow the experimental drug to be used safely in patients. Phase-IV is Post marketing surveillance, (after the drug is approved and is being used by the patients). Phase 0 (Human Microdosing Studies) introduced to clinical trial industry in recent years, is not other than a first in human trial conducted in accordance with regulatory guidelines (US FDA, 2006 guidance) for the Investigational New Drug. Distinctive features of this phase include the administration of single dose of the study drug, which is less than the effective dose to a lesser number of participants (10 to 15). These studies are carried out to know the drugs Absorption, Distribution, Metabolism and Elimination (Pharmacokinetics) in human body and take forward them into further development. This enables to take decision based on human models instead of data available from animal studies. [1] A microdosing study does not give any data regarding the safety or efficacy of the molecule, where extremely low, nonpharmacologically active doses of a drugs are used i.e. 'less than 1/100 th of the dose calculated to yield a pharmacological effect of the test substance to a maximum dose of <100 micrograms (European Medicines Agency paper).' For protein products, the US FDA suggests a maximum microdose of less than 30 nanomoles. Thus, Phase 0 trials provide an idea for the selection of the drug candidates and also for the determination of the first dose for Phase I clinical trial.1 The risk of adverse events during Phase 0 trial is less because the drug dose for the administration is in very less quantity which may not produce any pharmacological action. Animal studies are essential before Phase-I clinical trial. But in this case further animal studies for compounds with unsuitable pharmacokinetics profiles may not be essential. The advantages of microdosing are compared below with conventional studies : Features
Time from preclinical to first in man studies Cost Drug required Special requirements Regulatory requirements

Microdosing approach 6-8 months

US$ 0.3-0.5 million < 100 micrograms C14 labelled compound, if using AMS (Accelerator mass spectroscopy) Very few & limited

Conventional approach
12-18 months US$ 1.5-5.0 million About 100 grams None Established firmly

A question arises regarding the accuracy of microdosing: whether the body's reaction to a particular compound is similar when used as microdose and used in its pharmacological dose? If not, it could lead to false negatives (compound being rejected) or false positives (compound acceptable based on microdose data but rejected subsequently when used in pharmacological doses). 3

PHASE 0MICRODOSING STUDIES

An article by Varun Mehta
There may be problems with pharmacokinetic parameters, stability of certain drugs and solubility of drugs at very low dose (microdose).4 Many processes within the body involve the use of specialized transporters, enzymes and binding sites, which could be saturated as the pharmacokinetic profile is very different at the higher therapeutic dose than that observed with the microdose. To sum up, microdosing may help both patients and the pharma industry with earlier availability of new test medication and reduced attrition of compounds at later stages of drug development. Microdosing allows not only selection of drug candidates more likely to be developed successfully, but also helps in determination of the first dose for the subsequent Phase I clinical studies.

References 1. http://onbiostatistics.blogspot.com/2008/03/phase-0-clinical-trial.html 2. Rani PU, Naidu M. Phase 0 - Microdosing strategy in clinical trials. Indian J Pharmacol [serial online] 2008 [cited 2009 May 4];40:240-2. Available from: http://www.ijp-online.com 3. Aboagye EO, Price PM, Jones T. In vivo pharmacokinetics and pharmacodynamics in drug development using positron-emission tomography. Drug Discov Today 2001;6:293-302.[PUBMED] 4. Rowald M. Microdosing and the 3Rs. Publication from National Centre for the Replacement, Refinement and Reduction of animals in research. NC3Rs #5. 2006.p. 1-7. About the Author
Varun Mehta is a medical writer working for the GSK Pharma process in TCS at Nerul, Navi Mumbai

THE CREATIVE CORNER

2012 started with a high level of activity, building on the momentum created by the recent visit of Jackie Brown and Panni Patel from GSK. Also the medical writing engagement with various regulatory document types has added to the zeal. Intesar Khatri received the 2nd prize in the Shutterbug Photography contest conducted by TCS Maitree during Environment Week 4-8th June 2012, hosted across the organization, here is the prize winning photo

Put a stop to the drop. Save Water, Save Life!

Over 70% of the surface of the Earth is covered by water, but only 2.5% is fresh water. If we misuse it, our next generation will lose it. Make every drop count. Save Water, Secure our future generations. Photo and words by Dr. Intesar Khatri Medical Writing, TCS J&J process

The inception of the Medical Writing Newsletter is intended to bring in the discussion forums, regulatory update and related stuff at one platform.
Few words from Sabiha Khan -Document Compilation Specialist from GSK MW team to introduce the Newsletter

THE CREATIVE CORNER

And who got the first prize? Pravin Sail from Financial Disclosure group in GSK Clinical Submission group

If the global warming continues to be as rampant as it is now, we would soon be sailing on sand and not sea leading to a never ending dry" -Pravin Sail

TETE-A-TETE

With Mr Deepak Gowda

Name : Deepak Gowda Nick name : call me Deepu at home only! Your Motto in Life : My motto in life is to develop people. I like to be a coach and mentor professionals so that they will develop and rise high in their future. Which according to you are your best qualities : Adaptive: I am quick and adaptive to changes, and I cherish interacting with different people: or people management is my quality. If not here in this role, then where would you be working and as what? : I would have been a lawyer practicing law! Your favorite dish : Home made Rice & Rasam Your dream holiday :I would love to go on cruise with my wife Your thoughts about Friendship :Friendship is everything to me .. Your thoughts about Marriage: My life turned after marriage, my career, my aspirations changed after my lady luck entered my life. Any challenge faced in your life: I felt helpless when I lost my mother to her health problems. Trying to save my mother was a challenge I faced. The happiest moment in your life: The day my bundle-of-joy :my daughter Anjali was born (I consider her a reflection on my late mother) The best picnic that you had: This one was the best of all- the picnic I attended with about 180 members along with the COO at one of my previous organizations. This 6-day picnic was at Orange County Resort in Kodagu (Karnataka). We had cultural programs, trainings, and trust breakers which increased trust amongst team members and unbelievingly doubled the teams performance after the picnic! Message to Medical Writers: My message to Medical Writers is that they should have the eagle eye to be able to spot the most important result of the trial. My equation of the medical writer is Art of Writing + Passion to Write = Successful Medical Writer It is very important for a medical writer to have the knowledge and skills of writing, but he must also have a passion, which will make him a success!

Mr. Deepak Gowda

Customer Lead TCS GSK

THE MW TEAMS

TCS-J&J AND TCS-GSK HGHLIGHTS

TCS JOHNSON & JOHNSON (JANSSEN)

1. Completed work on >900 deliverables (> 300 narratives) 2. Onsite opportunity for the Medical writers- US (Vaibhav Jain) and Belgium (Abhishek Patil and Naiman Khan) 3. Developed 25% writers as peer reviewers. 4. Increased complexity of the documents (Phase 1 to Phase 3 CSRs, literature summaries, literature reviews, protocols, IB updates, support for critical submissions CSRs, QC Reviews, Clinical Summaries.) 5. The team continues to receive appreciation from the client.

TCS GSK BIO

A small team comprising of 3 medical writers 1. Protocol and CTRS writing was added to the scope of work. Vijay took over as the Team Lead for Sc. Wr. team The team which was involved in preparing report appendices was merged with the scientific writing team, and this team helps the writers devote more time for writing

TCS GLAXO SMITHKLINE

1. TCS GSK Medical writing team successfully completed training for Protocol disclosure. The team started working on live protocol disclosures from June end.
2.

2. 3.

We welcome 3 Medical writers who joined TCS GSK Medical writing team : Kuldeep Zala, Naved Shaikh, and Garvita Arora.

3. GSK leadership team visited TCS Nerul office on 27 Jun2012. We had a townhall dedicated to TCS GSK relationship on this day. The team leads, trainers and some of the associates got an opportunity to have a discussion with the GSK leadership team. It gave them an opportunity to share their experience, concerns and suggestions with each other. 4. Reena Khatri and Puja Vyas from Medical writing team received GSK R and R (rewards and recognition) for their contribution to time critical CSR submission. The team continues to receive appreciation and excellent feedback from the client.

WAY TO GO!!! WRITERS.WRITE ON

EDITORIAL TEAM
EDITOR
TCS GSK Medical Writer

Puja Vyas

CO-EDITORS
TCS GSK Medical Writer TCS GSK Medical Writer

Reena Khatri

Krutika Makhare Dr. Mitali Purohit

Vijayakumar Choodarathnam
TCS GSK Medical Writer TCS GSK Financial Disclosures Process Associate

TCS Janssen Medical Writer

Anupam Mishra

PROOF READING Dr. Nadeem Ansari

TCS Manager SME Medical Writing

TCS Janssen Medical Writer

Harsha Maske

ART DIRECTION, DESIGN AND LAYOUT Abhishek Patil

TCS Janssen Medical Writer

DISCLAIMER Write On! Is a Newsletter with content collaborated by the Medical Writing Teams in TCS with an aim to develop their knowledge and skills. Any of the trademarks, service marks, collective marks, design rights or similar rights that are mentioned, used or cited in the articles of Write On! are the property of their respective owners. Write On is available for private circulation in TCS only."