Write on! - Phase 0 "Micro-dosing"

7/29/2019 Write on! - Phase 0 "Micro-dosing"

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WRITE ON!MEDICAL WRITING NEWSLETTERMONSOON2012


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WORDS FROMT H E E D I T O R

Hello Readers! WRITE ON

This is the name of our TCS Medical WringNewsleer. A plaorm to showcase the wring

talent of TCSers and a quarterly publicaon whichis the hub connecng all medical wring servicesacross TCS.

The story behind the name

The editorial board received about 50 nominaons

for naming the newsleer. Some close calls for the

name were Med Right by Adnan Pathan, Pilcro byIntesar Khatri, and De Medicamens byVarun Mehta. Finally aer a vong round, the

editorial board selected WRITE ON as it was simpleand encouraged the readers to write on.

Some Basics

The newsleer is divided into three main secons:

Medical Wring Secon, which will have topics onmedical and scienc wring, skills improvement(communicaon, interpersonal, and presentaon),

and also topics on clinical research.

Creave secon, which will ckle your funny bone

and make you smile. This will smulate yourthought process and open a new world for you.

Process Highlights, which will provide a summaryof the events, happenings, customer appreciaons,

on-goings, and updates in the TCS medical wringprocesses.

This is the rst issue of Write On and as it is beingrolled out in the rains, get drenched in themonsoon theme of it. The falling rain reminds me

of the famous rain songs that I hum in my mind. Sowhich is your favourite rain song and why do you

like it? Write to us and we will publish it in ournext issue. We look forward to see what this

season has in store for all of us, and also read

about the acvies of the medical wring teams inthe last quarter.

Hope you have as much fun reading this, as we had

while pung it together for you! So there you go...

Puja Vyas


3/11

INTHIS

ISSUE

An Arcle on Phase 0Microdosing

Studies by Varun Mehta

The Creave Corner

Tete-a-tete with Mr Deepak Gowda

MW Team Highlights

Glimpse of the Editorial Team


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WRITE ON!

MONSOON NEWSLETTER


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P H A S E 0M I C R O D O S I N G S T U D I E SAn article by Varun Mehta

Ever wondered how a drug is developed? What steps are there in the drug development cycle? Typically,

before geng approved for markeng and being available to paents, 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 nd safety of a parcular drug in humans. During Phase-II, experimental study drug is given

to a limited numbers of parcipants (100-300) to see if it is eecve and to further evaluate its safety,

while in Phase III, experimental study drug is given to larger groups of parcipants (1,000-3,000) to con-

rm its eecveness and collect informaon that will allow the experimental drug to be used safely in

paents. Phase-IV is Post markeng surveillance, (aer the drug is approved and is being used by the pa-

ents).

Phase 0 (Human Microdosing Studies) introduced to clinical trial industry in recent years, is not other

than a rst in human trial conducted in accordance with regulatory guidelines (US FDA, 2006 guidance)

for the Invesgaonal New Drug. Disncve features of this phase include the administraon of single

dose of the study drug, which is less than the eecve dose to a lesser number of parcipants (10 to 15).

These studies are carried out to know the drugs Absorpon, Distribuon, Metabolism and Eliminaon

(Pharmacokinecs) 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 ecacy of the molecule, where extremely low,

nonpharmacologically acve doses of a drugs are used i.e. 'less than 1/100th

of the dose calculated to

yield a pharmacological eect of the test substance to a maximum dose of


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P H A S E 0M I C R O D O S I N G S T U D I E SAn article by Varun Mehta

There may be problems with pharmacokinec 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 pharmacokinec prole is very

dierent at the higher therapeuc dose than that observed with the microdose.

To sum up, microdosing may help both paents and the pharma industry with earlier availability of new

test medicaon and reduced arion of compounds at later stages of drug development. Microdosing

allows not only selecon of drug candidates more likely to be developed successfully, but also helps in

determinaon of the rst dose for the subsequent Phase I clinical studies.

References

1. hp://onbiostascs.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 [cited2009 May 4];40:240-2. Available from:hp://www.ijp-online.com

3. Aboagye EO, Price PM, Jones T. In vivo pharmacokinecs and pharmacodynamics in drug development

using positron-emission tomography. Drug Discov Today 2001;6:293-302.[PUBMED]

4. Rowald M. Microdosing and the 3Rs. Publicaon from Naonal Centre for the Replacement,

Renement and Reducon 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


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T H E C R E A T I V E C O R N E R

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


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T E T E - A - T E T EWith Mr Deepak Gowda

Name : Deepak Gowda

Nick name : call me Deepu at home only!

Your Moo in Life : My moo 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 qualies : Adapve: I am quick

and adapve to changes, and I cherish interacng with dierent

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 praccing 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 aer marriage, my

career, my aspiraons changed aer 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 reecon on my late

mother)

The best picnic that you had: This one was the best of all- the picnic I

aended with about 180 members along with the COO at one of my

previous organizaons. 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 aer 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 mostimportant result of the trial. My equaon of the medical writer is Art of Wring + Passion to Write = Successful Medical WriterIt is very important for a medical writer to have the knowledge and

skills of wring, but he must also have a passion, which will make him

a success!

Mr. Deepak GowdaCustomer LeadTCS GSK


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T H E M W T E A M STCS-J&J AND TCS-GSK HGHLIGHTS

TCS JOHNSON & JOHNSON (JANSSEN)1. Completed work on >900 deliverables (> 300 narraves)

2. Onsite opportunity for the Medical writers- US (Vaibhav Jain) and Belgium (Abhishek Paland 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 cricalsubmissions CSRs, QC Reviews, Clinical Summaries.)

5. The team connues to receive appreciaon from the client.

TCS GLAXO SMITHKLINE1. TCS GSK Medical wring team

successfully completed training for

Protocol disclosure. The team

started working on live protocol

disclosures from June end.

2. We welcome 3 Medical writers who joined TCS

GSK Medical wring team : Kuldeep Zala, Naved

Shaikh, and Garvita Arora.3. GSK leadership team visited TCS Nerul oce on 27

Jun2012. We had a townhall dedicated to TCS GSK

relaonship 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 theman opportunity to share their experience, concerns and

suggesons with each other.

4. Reena Khatri and Puja Vyas from Medical wring team

received GSK R and R (rewards and recognion) for

their contribuon to me crical CSR submission. The

team connues to receive appreciaon and excellent

feedback from the client.

TCS GSK BIO

A small team comprising of 3 medical writers

1. Protocol and CTRS wring was added to

the scope of work.

2. Vijay took over as the Team Lead for Sc.

Wr. team

3. The team which wasinvolved in preparing reportappendices was merged

with the scienc wring

team, and this team helpsthe writers devote more

me for wring

WAY TO GO!!! WRITERS.WRITE ON


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Documents

Write on! - Phase 0 "Micro-dosing"