Marrying Medical Affairs with Marketing

MEDICINMANField Force Excellence
TM
April 2014 | www.medicinman.net
Marrying
Medicalaffairs
andMarketing
In an era of increas-
ing regulatory pres-
sure and social activ-
ism, medical advisers
who can provide
better insights about
patient care will en-
able pharma compa-
nies to deliver true
value and differen-
tiate themselves in
the crowded market-
place.
A
t the INMAS 2014, (see here) it was
enlightening to hear Sharad Tyagi, MD of
Boehringer Ingelheim say,“Medical Affairs is at
the core of pharma business and is the only function
in a pharma company which can truly bridge the gaps
between science and business.”According to him,
people in this function are probably the only ones who
understand the“Why”,“What”and“How”of pharma
business. That is certainly true as pharma is about
patient care and not just sales targets.
The faculty at INMAS 2014 was a display of the
abundant talent of medical advisers in Indian Pharma.
Companies like Pfizer are pioneering roles like regional
medical advisers, that are field-based and available to
the field force on demand.
It has been my experience while conducting
workshops on KOL Management (see here), that very
few Indian companies use medical affairs as a strategic
partner. Instead, KOL Management becomes one more
business development initiative that caters to the ego
and other needs of doctors with a large prescription
potential.
In an era of increasing regulatory pressure and social
activism, medical advisers who can provide better
insights about patient care will enable pharma
companies to deliver true value and differentiate
themselves in the crowded marketplace. Considering
the fact that most doctors find it difficult to manage
time between patient care and knowledge updation,
medical advisers embedded into the field force can
bridge the gap – both in the knowledge of doctors
and the field force.
With the roll out of the Sunshine Act in the US, pharma
will need better umbrellas and sun screens to do
business without getting burnt with heavy fines. GSK
has taken the lead by ending the practice of giving
sales targets to its field force and has announced that
it will be employing doctors to cater to the clinical
information needs of doctors. Under the proposed
changes, GSK aims to have the new compensation
plan for sales staff rolled out globally by early 2015.
It expects the changes in doctors’payments to be in
effect around the world by 2016.
Editorial
Since 2011
“
”

“
Anup Soans | Editorial: Marrying Medical Affairs and Marketing
It is clear that doctors do not see much value in product
centered promotions by sales force. Dr. Adam Urato, who
gives lectures to doctors about conflicts of interest in
medicine, says -“I’m interested in practicing evidence-
based medicine. If there is a product that is out there and
it works and it is good for the patient, I will use it. If not, I
won’t use it.”1
GSK Chief Executive Andrew Witty says:“We recognize
that we have an important role to play in providing
doctors with information about our medicines, but this
must be done clearly, transparently and without any
perception of conflict of interest.”1
Doctors are also business savvy. Richard Vautrey, a
GP in the U.K., said pharma companies have sharply
reduced their spending on doctor payments and medical
education in the U.K. in recent years. Glaxo’s move“may
be a sign that companies recognize that the investment
now made in that direction doesn’t influence doctors
in terms of their prescribing,”he said.“It’s probably a
business decision rather than for any other reasons.”1
These trends have important pointers for Indian Pharma.
While India is unlikely to adopt these changes anytime
soon, it can certainly innovate its current model of
influencing doctors. Field sales people will remain at
the forefront of pharma sales in India, but their thrust
can shift from sales to science that benefits patients.
Medical advisers embedded in the field force can take
up the challenge of enhancing the knowledge of field
force through digital and social media. One-to-one
communication is the most effective way of increasing
learning effectiveness and by understanding the unique
clinical scenario of each territory, medical advisers are
in a unique position to leverage the digital revolution to
empower their field force with much needed knowledge
and confidence needed to move corridor calls to
meaningful interactions.
Despite being one of the world’s largest producers of anti-
TB drugs, India is plagued with extreme forms of TB that is
resistant to standard treatment protocols. This is primarily
due to improper treatment regimens and non compliance
and non availability of drugs. Surely, Indian Pharma can
provide the right scientific insights to manage these and
many other disease burdens peculiar to India through a
new business approach that recognizes its responsibilities
to patients and partners with doctors through its medical
advisers and field force. -AS
2 | MedicinMan April 2014
References:
1.“Drug Firms CurbTies to Doctors. Glaxo to End
Payments for Drug Promotion.”TheWallStreetJournal.
http://on.wsj.com/1dkMtru
Connect with Anup Soans on LinkedIn | Facebook | Twitter
Meet the Editor
Anup Soans is an Author, Facilitator and the
Editor of MedicinMan.
Write in to him: anupsoans@medicinman.net
With the roll out of the
Sunshine Act in the US,
pharma will need better
umbrellas and sun screens
to do business without
getting burnt with heavy
fines. GSK has taken the
lead by ending the practice
of giving sales targets to
its field force and has now
announced that it will be
employing doctors to cater
to the clinical information
needs of doctors. ”

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1. Listening to the Patient.......................................5
The answer to the simple question - “Dear patient,
to which degree has your health problem been
solved or alleviated?” - might be your company’s
most important metric.
Hanno Wolfram
2. Getting the Bang for Your Buck from
Training....................................................................6
What you do post-training is crucial to the long-
term effectiveness of your training programs.
K. Hariram
3. 3 Principles of Steve Jobs .............................12
Using Empathy, Focus and Imputation to deliver
value and to delight your customers.
Prof. Vivek Hattangadi
4. Is Indian Pharma Future-Ready ..................14
The nature of healthcare delivery is changing
rapidly. Can Indian pharma keep pace?
Salil Kallianpur
5. Trial by Fire ......................................................17
Much rhetoric has muddied the water of what
exactly is at stake for clinical trials in India.
Dr. Viraj Suvarna
6. 42 Years at Pfizer.............................................21
Sudhir Ganguly recently retired after a 42 year stint
at Pfizer.
MedicinMan Volume 4 Issue 4 | April 2014
Editor and Publisher
Anup Soans
CEO
Chhaya Sankath
COO
Arvind Nair
Chief Mentor
K. Hariram
Advisory Board
Prof. Vivek Hattangadi; Jolly Mathews
Editorial Board
Salil Kallianpur; Dr. Shalini Ratan; Shashin
Bodawala; Prabhakar Shetty; Vardarajan S;
Dr. Mandar Kubal; Dr. Surinder Kumar
International Editorial Board
Hanno Wolfram; Renie McClay
Executive Editor
Joshua Soans
MedicinMan Academy:
Prof. Vivek Hattangadi, Dean, Professional Skills
Development
Letters to the Editor: anupsoans@medicinman.net
CONTENTS (Click to navigate)

P
harmaceutical companies rightfully want to know if their
marketing, promotional, educational and other efforts deliver
value. The question is, who decides whether health-care or
drug producers delivered value?
Hypothesis 1:
The decision if any value has been added is made by the patient.
Hypothesis 2:
Any person becomes a patient because he or she has a problem
which makes the person to approach the healthcare system. The
then patient’s only objective is that the problem be solved or allevi-
ated – full stop.
Consequence:
There is nothing easier than asking the patient if the value has been
delivered. There is one question only:
“Dear patient, to which degree has your health problem been solved or
alleviated?”
(Please, let no one hide behind the sentence:“We are not allowed
to…”!
Every patient, educated, informed or not, will know perfectly well his
or her individual answer.
Collect this answer from as many patients as possible, declare these
numbers as your“Key KPI”and declare the improvement of this one
and only value as your company goal!
A lot of praise, improved public opinion, new trust and better repu-
tation will follow. Revenue will be a result. -HW
E
ListeningtothePatient
The answer to the simple question - “Dear patient, to which degree has your health problem
beensolvedoralleviated?”-mightbeyourcompany’smostimportantmetric.
Hanno Wolfram is Managing Director at
Innov8 GmbH, Germany.
Write to Hanno: hanno@innov8.de
Hanno Wolfram

E
K. Hariram
I
happened to be a part of this conversation recently.
The CEO was asking his Sales Manager & HR head,
“What is the point in spending money on sales
training? Every year I find that we spend money on
training programs. The reason cited is that the Sales Reps’
skills have to be improved. I do not find any perceptible
change in their selling behaviors and the same is not
reflected in their productivity. So are you going to spend
the time and resources again this year on training them?
Who is responsible once the training is done?”
The CEO is not wrong in questioning the spending
on training or his doubts about its impact on Reps’
productivity. Quite often, for the sales head and the HR,
training tends to become a periodic ritual and helps them
to achieve their KPI objectives. Training is also looked at as
a panacea for solving sales problems.
How is it possible to directly correlate ROI and training?
Is it appropriate to look for improved returns or outcome
because REPS are put through the training grind every
year?
Generally I have observed that during or after the
training sessions, feedback from the participants is very
What you do post-training is crucial to the
long-term effectiveness of your training
K. Hariram is the former MD (retd.) at
Galderma India.
He is Chief Mentor at MedicinMan and a
regular contributor. khariram25@yahoo.com
GETTINGTHE
‘BANGFORYOUR
BUCK’FROM
TRAINING

K. Hariram | Getting the Bang for Your Buck from Training
encouraging. No doubt, there are fresh perspectives and
newer skills are picked up. Also, the trainees feel more
confident as they feel that they have more clarity in
tackling some of their problems.
To some extent this is true, but what is often overlooked
is,‘how long the new learning lasts?’
It has been statistically proven that around 80% of the
learning’s’are lost by the end of 30 days, unless there is
an EXPERIENTIAL learning through periodic and proper
reinforcement.
Why is this not included into the TRAINING process?
Who is responsible for this proper and periodic
reinforcement? Often, in the busyness of chasing
business this is ignored or overlooked.
Training involves direct cost and indirect cost including
selling time. Hence when there is no impact on selling
behaviors and increased productivity, doubts are bound
to arise.
So the solution lies in looking at the problem from a
different angle. They are:
1. Incorporate timely and periodic reinforcement post
training – to be through Front/Second line managers.
2. Front/second line managers to be trained on
COACHING skills and better understanding of their role,
particularly ON THE JOB COACHING.
3. Bring clarity in the field visit objectives of LINE
managers.
4. Follow up on the outcome of the field visit.
The fundamentals are very clear. If you want the‘BANG
FOR THE BUCK’spent on training Reps’, then include
training front/second line managers as effective coaches.
If you expect the reinforcement to automatically happen,
then you will continue to question the effectiveness of
training cost. -KH
The familiar proverb of“Give a man a fish, you feed him
a day and teach man to fish and you help him to feed
himself longer”is very apt when it comes to ON THE JOB
COACHING to reinforce what is learnt in training sessions.
-KH
“
”
It has been statistically
proven that around
80% of classroom
learning is lost by
the end of 30 days,
unless there is an
EXPERIENTIAL
learning through
periodic and proper
reinforcement.

EMPOWER YOUR FIELD FORCE
KA$H=CASH
REPEAT Rx
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KNOWLEDGE  ATTITUDES  SKILLS  HABITS
MEDICINMAN

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WHY SHOULD ANY-
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THE HALF-TIME COACH
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Signature Programs for Second-line and Senior Managers
Based on the best-selling book by Anup Soans, this program
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Methodology
Webinars and E-Learning
All programs are fully customizable. A pre-program questionnaire is used to capture the
needs and expectations of the participants. Company’s may request a demonstration of a
particular module at no expense (except conveyance to venue).
Programs incorporate the principles of adult learning and are highly participative, audio-vi-
sual and activity-based. Important truths are conveyed through games, stories and videos.
Companies are advised to give participants the books on which the programs are based
for continued learning and development. The same may be procured from the author at a
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Company’s may choose to deliver a program as a webi-
nar - giving the advantage of scale and lowering costs.
Audiences are kept engaged using visually stimulating
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Most recently 1,000 reps of a leading MNC were
trained over four webinars with excellent feedback.
Customized issues of
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from the company can be
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their continuous learning
and development.
MedicinMan currently
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professionals.
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Case Studies
iSharpenMMy Success is My Responsibiliti

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A
few days back I finished reading‘Steve Jobs’, the
authentic biography of Steve Jobs by Walter Isaacson.
The three principles of Steve Jobs as told to his biog-
rapher Walter Isaacson has created a great impact in my mind.
I would like to share this:
1. Empathy
2. Focus
3. Impute
The first was empathy, an intimate connection with the feel-
ings of the customer:“We will truly understand their needs
better than any other company.”
The second was focus:“In order to do a good job of those
things that we decide to do, we must eliminate all of the unim-
portant opportunities.”
The third and equally important principle, awkwardly named,
was impute. It emphasized that people form an opinion about
a company or product based on the signals that it conveys.
“People DO judge a book by its cover,”he wrote.“We may have
the best product, the highest quality, the most useful software
etc.; if we present them in a slipshod manner, they will be per-
ceived as slipshod; if we present them in a creative, profession-
al manner, we will impute the desired qualities.”
Let us dwell a little more on these principles.
1. Empathy
Empathy is about understanding people. Empathy and sympa-
thy are not synonyms, they have different connotations. In
sympathy, we feel sorry for a person. For example, when a
friend of yours loses his job, we have‘sympathy’for the friend
because we perceive the distress of the friend. When we have
‘empathy’for the friend we go into a similar emotional state
of the friend if we accurately perceive the friend’s situation
or predicament. Empathy is identifying ourselves with and
Prof. Vivek Hattangadi
Using Empathy, Focus and Imputation to deliver value and to delight your customers.
E
3PRINCIPLESTHAT
DROVESTEVEJOBS
Prof. Vivek Hattangadi is a Consultant
in Pharma Brand Management and Sales
Training at The Enablers. He is also visiting
faculty at CIPM Calcutta (Vidyasagar
University) for their MBA course in
Pharmaceutical Management.
vivekhattangadi@theenablers.org

understanding the situation, feelings and motives of
the other person. It is our ability to not only know or
detect what others are feeling, but to also experience
that emotion ourselves. It is about empathy with the
customer – both internal i.e. our medical representa-
tives and the external customers – the doctors and
the retailers. In all our interactions, we need to have
empathy with our medical representatives if we have
to establish our leadership. Emotional Intelligence is a
prerequisite for effective leadership.
2. Focus
Focus means to eliminate the many unimportant
things, so as to do a good job of the important things.
It means we need to understand our priorities and
focus on important issues rather than end up doing a
‘fire-fighting’job when the important tasks become
urgent. Learning to prioritize and then focusing on
the most important issues is a skill which we must all
develop. The most important skill is avoid the migra-
tion of‘important but not urgent work to important
and urgent’(fire-fighting). In the Mahabharata, when
Dronacharya was testing the shooting skills of his
pupils, all could see the beautiful leaves and flowers on
the trees, the blue sky and so on. On the other hand,
Arjuna could see only the eye of the bird – he was fo-
cused! That is the kind of focus we all need to develop
in our activities. Focus on important tasks!
3. Impute
Impute literally means to relate to a particular cause or
source; attribute the fault or responsibility to the actual
cause (for e.g. imputed the rocket failure to a faulty
gasket). Our doctors and retailers form an opinion
about a company or product based on the signals that
they receive from us during our interaction. “People
do judge a book by its cover”. We may have the best of
the products and of the highest quality. However, if we
present our products to the doctors in a slipshod man-
ner, our products may be perceived by the doctors as
slipshod. If we present them in a creative, professional
manner, we will impute the desired qualities.
Therefore, the first-line managers need to empathize
with the medical representatives, and focus on their
development so that we impute their growth to our
leadership skills. -VH
Vivek Hattangadi | 3 Principles that Drove Steve Jobs
“
”
Empathy is identifying
ourselves with and
understanding the
situation, feelings and
motives of the other
person. It is our ability
to not only know or
detect what others
are feeling, but to
also experience that
emotion ourselves.
It is about empathy
with the customer
– both internal
i.e. our medical
representatives and
the external customers
– the doctors and the
retailers.

R
apid change across the pharmaceutical industry in
India is causing many companies to re-evaluate their
sales and marketing strategies. The rampant generic
nature of the market leaves it commoditized with little to no
leg-room for branding and differentiation. The threat of price
control and loose IP laws discourage the launch of innovative
products leaving little hope of adding freshness to the port-
folio. In such a scenario companies must focus on maximizing
returns on revenues that accrue from existing products. Doing
more with less, in an increasingly competitive market, inevita-
bly puts pressure on the sales force.
Today, sales forces have to prepare themselves to deal with
two significant shifts in disease and healthcare management
that can change the way they work in the future.
As a response to disease patterns moving from acute to chron-
ic, the first is a fundamental and significant shift in healthcare
philosophy and medical research – from a world in which we
“react”to disease and illness after it has happened, to one in
which we will be doing far more in advance to“prevent”spe-
cific health care problems. The driver for this massive change
is the emergence of extremely specialized and highly person-
alized medical treatments based upon one’s own particular
DNA.
The second shift (which is because of the first) is that health-
care is now becoming:
1. Predictive – forewarn people of susceptibility to diseases.
2. Preventative – empower them with information and re-
sources to take preventive measures and to keep themselves
healthy.
Salil Kallianpur
The nature of healthcare delivery is changing rapidly. Can Indian pharma keep pace?
“
”
Pharmaceutical
companies have
managed their
business in much
the same way
for decades. But
significant changes
in government
regulations, market
conditions, and
technology will
force the industry
to look for new
business models
and practices.
E
ISINDIANPHARMAFUTURE-READY?
“

3. Personalized – provide information that is most
relevant to them and what they want to know instead
of generic and unimaginative information (n=1, R=G).
4. Participative – make people a part of decisions
made about their health. After all, it’s their lives.
Enable them and trust them to hold themselves
accountable.
The common underlying cause for these two shifts is
the advent of technology.
Are the industry’s sales forces, with their current struc-
ture and training, capable of leveraging to their ad-
vantage the impact that the advent of technology has
on the way patients seek treatment and on the way
doctors treat them? The recipe for success is probably
a pinch of creativity and a fist full of effectiveness.
Pharmaceutical companies have managed their
business in much the same way for decades. But sig-
nificant changes in government regulations, market
conditions, and technology will force the industry to
look for new business models and practices. With a lit-
tle bit of creativity, companies can achieve a lot more
and adapt quicker to the changes. Sales teams must
evolve to adapt to the impact that technology will
have on the pharma business model. Consider a few
changes in the buyer-seller dynamic that is expected
to emerge in the pharmaceutical industry causing a
deep seated transformation in its fundamentals.
1. In 1–2 years we will see a hybrid salesperson
emerge, and they will be technically, culturally, social-
ly, and skillfully diverse and astute.
2. In the Western world today about 85% of buy-
er-seller interactions happen online through social
media and video. Customers will not need a field
salesperson to come on-site as regularly as they do
today.
3. With the amount of information available through
technology, the Internet, social media, smart phones,
tablets etc, the customer won’t need to engage early
in the sales cycle. A total of 60% of the buying process
will already be completed before connecting with a
salesperson.
4. Virtual interactions will replace face-to-face field
visits. Right now, Skype, web conferencing, and video
are quickly catching on over face-to-face visits and
traditional meetings in other industries. Tele-consult-
ing or tele-medicine is common. If doctors prefer to
see patients online, what are the chances he / she will
Salil Kallianpur | Is Indian Pharma Future-Ready?
“
”
In the West today
about 85% of buyer-
seller interactions
happen online
through social media
and video. Customers
will not need a field
salesperson to come
on-site as regularly as
they do today.

want to see a sales rep in person?
5. With India moving towards Universal Health Cov-
erage, doctors will no longer be the decision-makers.
We will be up against non-medical decision-makers
who may be tele-commuters or technologically savvy
people.
6. It is only a matter of time before healthcare provid-
ers would start prescribing mHealth apps as soon as
they prove to be as or more effective than prescrip-
tion drugs.
So if your most important customers today (doctors)
are not going to be the most important customers
tomorrow, how well are we prepared to deal with
non-medical people who are more clued on to
technology and seek information from the internet,
intranets, online groups, social media, patient activist
groups etc? If doctors choose to decrease person-
al interaction and seek information, diagnosis and
treatment remotely, what impact will that have on the
current model?
Maintaining ongoing commercial operations, as it has
been managed over the last decades, is economically
unsustainable. Pharmaceutical companies must adapt
to a new environment, which is more demanding
than ever before. They must adopt lower cost models
across the whole value chain and improve productivi-
ty and efficiency in their commercial approaches. Dis-
passionately analyzed, almost every“innovation”that
we hear about in the industry is merely a tweak of the
existing business and / or model. For an industry that
has made colossal investment into research, pharma
is uncharacteristically risk-averse when it comes to the
changes coming in health technology.
None of the changes mentioned above essentially
threaten the fundamentals of the current model. The
pharmaceutical business, in India, will continue to be
a B-2-B model for the foreseeable future. However,
customer needs and wants will evolve as technology
adoption spreads. Patients who have more access
to trustworthy information will seek to participate
in decisions pertaining to their health while health
providers will work to predict and prevent illness to
contain costs. These developments create exciting
opportunities for pharma marketers to differentiate
and deliver value. The more creatively and effectively
they do it, the better. -SK
Salil Kallianpur is
Commercial Head - Classic Brands
Center of Excellence, GSK. He is a
well-known pharma blogger and
social media enthusiast.
salilkallianpur.wordpress.com
Salil Kallianpur | Is Indian Pharma Future-Ready?
“
”
If your most
important customers
today (doctors) are
not going to be the
most important
customers tomorrow,
how well are we
prepared to deal with
non-medical people
who are more clued
on to technology and
seek information
from the internet,
intranets, online
groups, social media,
patient activist
groups etc?

I
n Munnabhai MBBS, Boman Irani, as Dean of a Medical
College, tells medical students on their first day, that
doctors need to be clinical. He meant that as a doctor
one cannot be too close to a patient as this can reduce
objectivity and come in the way of sound clinical deci-
sion-making. So what does clinical mean? The concise
Oxford dictionary puts it as being coldly detached, dispas-
sionate, and objective. Etymologically, it is derived from
the Greek word,‘klinikos’, meaning bed or the bedside of
the patient.
Against this backdrop, one can’t help but reflect on the
current media rhetoric surrounding the way clinical trials
are being conducted in the country. I am not for a mo-
ment discounting all that is being showcased but I would
like to see this balanced with data. In any field, there will
always be good and bad apples. One swallow does not a
summer make. Similarly, a few bad apples should not spoil
the entire basket. Before tainting and distorting reality
let’s put the facts on the table and then decide.
The word,‘trial’itself means an experiment. A participant
(not a subject as no one is being subjected to the experi-
ment) is one who is informed of everything that participa-
tion in the clinical trial entails, and only after s/he has fully
comprehended, and checked with his/her family doctor
and relatives, is s/he expected to consent. Of his/her own
volition, understanding that participation involves pos-
sible risk and possible benefit, so as long as one believes
that the benefit is worth the risk, one willingly partici-
pates. It is this altruistic motive which makes a participant
a hero. Not a guinea pig.
A“guinea pig”is a misnomer as the animal is neither a pig
(it is a rodent), nor from Guinea (from the Andes moun-
tains). Even if one wishes to do a trial on animals, one
needs to have permission from an ethics committee which
Dr. Viraj Suvarna
E
TRIALBYFIREClinical trials in India have come under a
lot of fire recently from civil society and the
media. While there is no doubt an element of
risk involved, much rhetoric has muddied the
water of what exactly is at stake.
Dr. Viraj Suvarna is
Medical Director, Boehringer Ingelheim
India Private Limited.

Dr. Viraj Suvarna | Trial by Fire
oversees research on animals. Those who feel that clinical
trial participants are simply made to sign an informed
consent document need to witness the process. A patient
or participant information leaflet, written in a language
that the participant can understand, is first explained to
the participant in his/her own language. All queries that
the participant may have are addressed by the principal
and principled investigator/delegate. The informed con-
sent form is also explained similarly. Innovative methods
could include use of a speaking book which talks to the
participant, the way books for children are designed, of
what s/he is getting into when being part of a clinical trial.
One could also think of using an iPad and make the partic-
ipant see for himself/herself exactly what the participant
will need to go through from beginning to end of the
clinical trial. This way the participant sees himself/herself
going through all steps of the trial, and only after the
process has been explained does the participant make
his/her decision. No force, no incentive. Vulnerable pop-
ulations are not selected. Those who cannot make their
own decisions are provided with assistance. Functionally
literate participants may also be recruited with due legal
precautions (impartial witness) being adhered to. Ethics
committee members can and do oversee the process, and
can do random spot checks. Video-recording of the pro-
cess, with protection of the participant’s confidentiality, is
another suggestion.
As a sponsor of the trial, investigator selection is para-
mount. Training is meticulously done. Regular oversight
by a clinical research associate, quality standards person,
and auditor follows. Inspection by a regulatory authority
is also done, even by the US FDA and/or the EMEA as data
from global trials, involving patients in India, is a part of
global regulatory dossiers.
The Drugs Controller General of India (DCGI)’s office now
refers global clinical trial applications to the New Drugs
Approval Committee (NDAC), comprising academic
experts from the respective therapeutic area and pharma-
cology. Going forward, the DCGI will ensure that contract
research organizations, ethics committees, and sites are
accredited. The serious players in clinical research will sur-
vive while the fly by night operators will be weeded out.
In short, there are enough checks and balances from
all“participants”in clinical trials, each of whom has an
equal responsibility towards the ultimate participant, the
patient.
Since 1994-95, global clinical trials have been placed in
India by multinational ethical research-based corporations
and the quality and ethical standard, viz.,‘Good Clinical
“
”
There are enough
checks and balances
from all “participants”
in clinical trials, each
of whom has an
equal responsibility
towards the ultimate
participant, the
patient.

Research Practice’, is rigorously followed across the globe.
Even if locally applicable regulatory requirements are
relatively lax in some countries, the MNC’s Standard Op-
erating Procedures, which are stricter than any regulatory
standard, are adhered to.
It is a myth to think that trials in India are cheaper. In fact
because this is an out of pocket market where most have
to pay for their healthcare related expenses, and very few
are reimbursed, sponsors have to spend much more per
patient, having to pay for all laboratory tests and diagnos-
tic procedures.
It is incorrect that India is being used as the destination
for global clinical trials. The number of trials being placed
in India and the number of participants from India in glob-
al trials is decreasing, and more trials are being placed in
China, Korea, other Asian countries, Central and Eastern
Europe, and Latin America among the merging markets.
At any point in time, the participant can withdraw from
the trial without any problem or reason given. If an
adverse event is experienced, the care of the participant
is borne by the sponsor at no cost to the participant or
institute. If the event is serious or results in death as an
outcome, and is judged, to be related to the trial or drug
tested in the trial, by the investigator and confirmed by
the ethics committee, the same is compensable, though
ideally the relatedness should be in agreement with the
sponsor. This does not happen in many developed mar-
kets where one has to claim for compensation. In India,
the clause for compensation is included in the informed
consent document. A formula for the same has also been
proposed recently. It is only to be fervently hoped that
this process is not misused.
In what are called,“outcome trials”, death or a serious
adverse event is an endpoint, i.e., a point at which the trial
for that patient has ended. Naturally in such trials many
such events are anticipated. However, such trials are also
important as approving a new drug, only based on softer
endpoints, e.g., blood pressure or HbA1c reductions, are
not enough in the long run, as has been repeatedly seen
with some drugs, which had to be withdrawn from the
market later.
Rarely is a new drug compared to a placebo. The placebo
is almost always used as an add on to standard therapy in
both arms, which makes it that much more difficult for a
new drug to demonstrate efficacy, but in the interest of
patient safety this is the preferred way of evaluating a new
drug, even if this means many promising molecules may
fall by the way side.
When so much is happening in the right direction, why
“
”
It is incorrect to
say that India is
being used as the
destination for global
clinical trials. The
number of trials
being placed in India
and the number of
participants from
India in global trials
is decreasing, and
more trials are being
placed in China,
Korea, other Asian
countries, Central
and Eastern Europe,
and Latin America
among the merging
markets.

are we not looking at the full picture before passing judg-
ment on the way clinical trials are being conducted in In-
dia? Why are we not considering the tremendous benefits
that accrue to clinical trial participants, doctors, institutes
and society at large, besides of course the foreign direct
investment inflow into the country? In many oncology
trials the participants avail of the drug even after the trial
is over, for the life of the participant, till disease progress-
es or the participant cannot tolerate the drug. Why are
we not thinking of the development of clinical research
(CR) in the country that this will stimulate? When doctors
are investigators in good clinical research practice it also
helps them be better doctors in clinical practice.
Sponsors may draft protocols but it is doctors who
ultimately review, make changes, and finally approve the
document after the protocol development meeting. It is
the doctor’s patients whose data enters case report forms
from source documents. It is this data that gets into the
database, gets analyzed, and then included in the final
study report. Only when all investigators are in agreement
with the statistical analysis plan, analysis and report, does
the report get signed after the end of study meeting.
From the report is written the manuscript and again only
after all the doctors, who participated in the trial, review
and approve the content, does it get submitted to a
peer-reviewed journal and finally published.
Even negative trial results are published. Data Safety Mon-
itoring Boards and Data Steering Committees, indepen-
dent of the sponsor, can do interim analyses and decide
on premature stopping of a trial based on futility, over-
whelming efficacy or unacceptable safety in one arm.
It begs the question,“whose trial is it anyway?”It is
really a sponsor’s trial? Or is it an experiment in which all
stakeholders own and share equal responsibility? Let us
all exhort ourselves to remember this and do our duty
diligently. We owe it to all our participants whose altruistic
motive has helped advance medical science and enabled
many more patients and their loved ones benefit from
their participation.
Credibility begins with CR (Clinical Research). -VS
Disclaimer: These are thoughts of the writer, in his
personal capacity, and not as an employee of Boehringer
Ingelheim India Private Limited.
“
”
When so much is
happening in the
right direction, why
are we not looking at
the full picture before
passing judgment on
the way clinical trials
are being conducted
in India? Why are we
not considering the
tremendous benefits
that accrue to clinical
trial participants,
doctors, institutes
and society at large,
besides of course
the foreign direct
investment inflow
into the country?

Special Feature
Abdul Basit Khan
Ajay Kumar Dua
Amlesh Ranjan
Amrutha Bhavthankar
Andris A. Zoltners
Anthony Lobo
Aparna Sharma
Arvind Nair
Atish Mukherjee
B. Ramanathan
Chayya Sankath
Craig Dixon
Devanand Chenuri
Venkat
Dinesh Chindarkar
Dr. Amit Dang
Dr. Aniruddha
Malpani
Dr. Hemant Mittal
Dr. Neelesh Bhandari
Dr. S. Srinivasan
Dr. Shalini Ratan
Dr. Surinder Kumar
Sharma
Dr. Ulhas Ganu
Geetha G H
H. J. Badrinarayana
Hakeem Adebiyi
Hanno Wolfram
Hitendra Kansal
Iyer Gopalkrishna
Jasvinder Singh
Banga
Javed Shaikh
Jitendra Singh
John Gwillim
Jolly Mathews
Joshua Mensch
K Hariram
K. Satya Mahesh
Ken Boyce
Mahendra Rai
Mala Raj
Manoj Kumar
Mayank Saigal
Milan Sinha
Mohan Lal Gupta
Neelesh Bhandari
Neha Ansa
Nishkarsh Likhar
Noumaan Qureshi
Parveen Gandhi
Pinaki Ghosh
PK Sinha
Prabhakar Shetty
Vivek Hattangadi
Rachana Narayan
Rajesh Rangarajan
Ralph Boyce
Renie McClay
Richa Goyel
Richard Ilsley
RM Saravanan
Sagar S. Pawar
Salil Kallianpur
Salil Kallianpur
Sally E. Lorimer
Sandhya Pramanik
Sanjay Munshi
Shafaq Shaikh
Shalini Ratan
Sharad Virmani
Shiv Bhasin
Spring Sudhakar
Subba Rao Chaganti
Sudhakar Madhavan
Tony O’Connor
V. Srinivasan
Varadharajan K.
Vijaya Shetty
Vishal V. Bhaiyya
Vishal Verma
Vivek Hattangadi
William Fernandez
Our Authors
MEDICINMAN invites contributions from Pharma professionals on topics related to Field Force
Excellence. See: www.medicinman.net/author-guidelines for more information.
Sudhirda, as Sudhir Ganguly is
fondly called, bids adieu to Pfizer.
Working for one company for 42
years must be something of a record in Pfizer worldwide and
perhaps in the industry too. As Partha Ghosh put it, in 60
years of his life, Sudhirda spent only 18 years outside Pfizer!
He was a boyish 18-year-old graduate when he joined Pfizer
in October 1971 as a sales representative.
His first posting was in Kakinada on the Andhra coast where
he found himself to be the only Bengali in town. It was the
first among many challenges that saw floods, wars, boy-
cotts…and, on the personal front, cancer at the fag end of a
rewarding career.
He faced each challenge with poise. In Kakinada, he learned
Telugu to converse with his customers in their language.
You could never find him complaining, colleagues aver. He
never thought of leaving Pfizer as the company offered him a
learning experience he thought no one else could give.
He picked on new colleagues' positive attributes, showing
how they could use their strengths to achieve things they did
not think possible.
As the head of field force training he groomed several hun-
dreds of sales colleagues who are grateful to him not only
for teaching them how to sell, but how to be exemplars of
integrity, professionalism and – something that he finds erod-
ing today – connecting with fellow colleagues at a personal
– familial, social, human -- level. Many of the photos in the
audio visual screened at the farewell showed him with sales
colleagues and their family members who all belonged to a
larger, extended Pfizer family.
His colleagues have a wealth of anecdotes that reveal the
person and also take you to the times and towns of yester
-years. Colleagues gave him an emotional farewell at the HO
cafeteria on October 23.
42YEARSATPFIZER!
E

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