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Re-inventing
Drug Development
Edited by
Jeffrey S. Handen, PhD
Medidata Solutions, Inc.
New York, New York, USA
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Dedicated to my family, Connie, Alex, Max, and Julia Handen
Note
One hundred percent of all authors’ royalties from this book are being
donated to the National Organization for Rare Disorders, https://www.
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Contents
Editor................................................................................................................. vii
Contributors........................................................................................................ix
Index................................................................................................................. 133
v
Editor
Jeffrey S. Handen, PhD, is vice president of professional services with
Medidata Solutions, Inc. Dr. Handen has published in multiple peer-
reviewed and business journals, presented at numerous industry con-
ferences and scientific meetings as an invited speaker, and served as
past editor-in-
chief of the Industrialization of Drug Discovery compen-
dium. Before joining Medidata Solutions he was with Merck Research
Laboratories for 6 years as a director of portfolio and project manage-
ment helping to plan, manage, and execute Merck’s clinical development
portfolio. Prior to Merck, Dr. Handen held management consulting posi-
tions with Computer Science Corporation and IBM Business Consulting
Services (formerly PricewaterhouseCoopers Consulting). With over
20 years’ experience in pharmaceutical and biotechnology research and
development, process reengineering, and systems and process imple-
mentation, Dr. Handen has also held research and management posi-
tions with the University of Pennsylvania and the National Institutes of
Health. As vice president of professional services for Medidata Solutions,
Dr. Handen is responsible for overseeing clinical development business
process integration, solution architecting for optimizing clinical trials
design execution and development, implementation of data-driven met-
rics, and developing and implementing operational metrics to improve
clinical research processes. He holds a PhD in neurosciences from George
Washington University as well as a BS from Duke University.
vii
Contributors
Christopher Bouton, PhD, earned his BA in neuroscience (magna cum
laude) from Amherst College in 1996 and his PhD in molecular neurobi-
ology from Johns Hopkins University in 2001. Between 2001 and 2004
Dr. Bouton worked as a computational biologist at LION Bioscience
Research Inc. and Aveo Pharmaceuticals, leading the microarray data
analysis functions at both companies. In 2004 he accepted the position of
head of integrative data mining for Pfizer and led a group of PhD-level sci-
entists conducting research in the areas of computational biology, systems
biology, knowledge engineering, software development, machine learn-
ing and large-scale omics data analysis. While at Pfizer, Dr. Bouton con-
ceived of and implemented an organization-wide wiki called Pfizerpedia
for which he won the prestigious 2007 William E. Upjohn Award in
Innovation. In 2008 Dr. Bouton assumed the position of CEO at Entagen
(http: //www.entagen.com), a biotechnology company that provides com-
putational research, analysis, and custom software development services
for biomedical organizations. In 2013, Entagen was acquired by Thomson
Reuters and Dr. Bouton became the general manager of Entagen for
Thomson Reuters. Dr. Bouton is an author of more than a dozen scientific
papers and book chapters, and his work has been covered in a number of
industry news articles.
ix
x Contributors
been a part of the Denison organization since 2006 and was the director of
research and development before moving into the president role. She is an
active researcher on the topics of organizational culture, leadership, and
effectiveness with her published research appearing in outlets such as
the Journal of Business and Psychology, Journal of Vocational Behavior, Human
Relations, and Advances in Global Leadership. She is also a regular presenter at
conferences such as the Society for Industrial/Organizational Psychology,
and the Academy of Management. Dr. Kotrba earned her MA and PhD in
industrial/organizational psychology from Wayne State University.
Redefining innovation
Jeffrey S. Handen
Contents
References........................................................................................................... 10
1
2 Jeffrey S. Handen
P.S. Rose says it is n't fair for people to order without knowing the
quality, so we 've done up a little of Mrs. Blossom's in some
Homeepatic (I don't know where that "h" ought to come in) pellet
bottles, and will send you a half-dozen "for samples," March says, to
send to any one to taste you think would like to order. H.C.
Yours devotedly,
HAZEL.
IX
THE PRIZE CHICKEN
The rest joined in the singing with such goodwill that the noise
brought in Chi from the barn. When he was told the reason for the
rejoicing, he looked thoughtful, then sober, then troubled.
"What's the matter, Chi? Cheer up! You have n't got to pick
them," said March.
"'T ain't that; but I hate to throw cold water on any such
countin'-your-chickens-'fore-they 're-hatched business," said Chi.
"'T is n't chickens; it's preserves, Chi," laughed Rose.
"I know that, too," said Chi, gravely. "But suppose you do a little
figuring on the hind-side of the blackboard."
"What do you mean, Chi?" asked Hazel.
"Well, I 'll figure, 'n' see what you think about it. Seventeen
dozen times four, how much, March?"
"Eight hundred and sixteen."
"Hm! eight hundred and sixteen glass jars at twelve and a half
cents apiece--let me see: eight into eight once; eight into one no
times 'n' one over. There now, your jars 'll cost you just one hundred
and two dollars."
There was a universal groan.
"'N' that ain't all. Sugar 's up to six cents a pound, 'n' to keep
preserves as they ought to be kept takes about a pound to a quart.
Hm, eight hundred 'n' sixteen pounds of sugar at six cents a pound--
move up my point 'n' multiply by six--forty-eight dollars 'n' ninety-six
cents; added to the other--"
"Oh, don't, Chi!" groaned one and all.
"It spoils everything," said Rose, actually ready to cry with
disappointment.
"Well, Molly Stark, you 've got to look forwards and backwards
before you promise to do things," said Chi, serenely; and Rose,
hearing the Molly Stark, knew just what Chi meant.
She went straight up to him, and, laying both hands on his
shoulders, looked up smiling into his face. "I 'll be brave, Chi; we 'll
make it work somehow," she said gently; and Chi was not ashamed
to take one of the little hands and rub it softly against his unshaven
cheek.
"That's my Rose-pose," he said. "Now, don't let's cross the
bridges till we get to them; let's wait till we hear from New York."
They had not long to wait. The next day's mail brought three
letters,--from Mrs. Heath, Mr. Clyde, and Jack. Hazel could not read
them fast enough to suit her audience. There was an order from
Mrs. Heath for two dozen of each kind, and the assurance that she
would ask her friends, but she would like her order filled first.
Mr. Clyde wrote that he was coming up very soon and would
advance Hazel's quarterly allowance; at which Hazel cried, "Oh-ee!"
and hugged first herself, then Mrs. Blossom, but said not a word.
She wanted to surprise them with the glass jars and the sugar. Her
father had enclosed five dollars with which to pay Chi, and he and
Hazel were closeted for full a quarter of an hour in the pantry,
discussing ways and means.
Jack wrote enthusiastically of the preserves and chickens, and,
like Hazel, added a postscript as follows:
"Don't forget you said you would write down for me the song
about Love that Miss Blossom sings when she is kneading bread.
Miss Seaton is just now visiting in Boston. I 'm to play in a polo
match out at the Longmeadow grounds next week, and she stays for
that." This, likewise, Hazel kept to herself.
Meanwhile, the strawberry blossoms were starring the pastures,
but only here and there a tiny green button showed itself. It was a
discouraging outlook for the other Blossoms to wait five long weeks
before they could begin to earn money; and the thought of the
chickens, especially the prize chicken, proved a source of comfort as
well as speculation.
As the twenty-first day after setting the hens drew near, the
excitement of the race was felt to be increasing. Hazel had tied a
narrow strip of blue flannel about the right leg of each of her twelve
hens, that there might be no mistake; and the others had followed
her example, March choosing yellow; Cherry, white; Rose, red; and
Budd, green.
The barn was near the house, only a grass-plat with one big elm
in the centre separated it from the end of the woodshed. As Chi
said, the hens were sitting all around everywhere; on the nearly
empty hay-mow there were some twenty-five, and the rest were in
vacant stalls and feed-boxes.
It was a warm night in early June. Hazel was thinking over
many things as she lay wakeful in her wee bedroom. To-morrow was
the day; somebody would get the prize chicken. Hazel hoped she
might be the winner. Then she recalled something Chi had said
about hens being curious creatures, set in their ways, and never
doing anything just as they were expected to do it, and that there
was n't any time-table by which chickens could be hatched to the
minute. What if one were to come out to-night! The more she
thought, the more she longed to assure herself of the condition of
things in the barn. She tossed and turned, but could not settle to
sleep. At last she rose softly; the great clock in the long-room had
just struck eleven. She looked out of her one window and into the
face of a moon that for a moment blinded her.
Then she quietly put on her white bath-robe, and, taking her
shoes in her hand, stepped noiselessly out into the kitchen.
There was not a sound in the house except the ticking of the
clock. Softly she crept to the woodshed door and slipped out.
Chi, who had the ears of an Indian, heard the soft "crush,
crush," of the bark and chips underneath his room. He rose
noiselessly, drew on his trousers, and slipped his suspenders over his
shoulders, took his rifle from the rack, and crept stealthily as an
Apache down the stairs. Chi thought he was on the track of an
enormous woodchuck that had baffled all his efforts to trap, shoot,
and decoy him, as well as his attempts to smoke and drown him out.
But nothing was moving in or about the shed. He stepped outside,
puzzled as to the noise he had heard.
"By George Washin'ton!" he exclaimed under his breath, "what's
up now?" for he had caught sight of a little figure in white fairly
scooting over the grass-plat under the elm towards the barn. In a
moment she disappeared in the opening, for on warm nights the
great doors were not shut.
"Guess I 'd better get out of the way; 't would scare her to
death to see a man 'n' a gun at this time of night. It's that prize
chicken, I 'll bet." And Chi chuckled to himself. Then he tiptoed as
far as the barn door, looked in cautiously, and, seeing no one, but
hearing a creak overhead, he slipped into a stall and crouched
behind a pile of grass he had cut that afternoon for the cattle.
He heard the feet go "pat, pat, pat," overhead. He knew by the
sound that Hazel was examining the nests. Then another noise--
Cherry's familiar giggle--fell upon his ear. He looked out cautiously
from behind the grass. Sure enough; there were the twins, robed in
sheets and barefooted. Snickering and giggling, they made for the
ladder leading to the loft.
"The Old Harry 's to pay to-night," said Chi, grimly, to himself.
"When those two get together on a spree, things generally hum! I 'd
better stay where I 'm needed most."
Hazel, too, had caught the sound of the giggle and snicker, and
recognized it at once.
"Goodness!" she thought, "if they should see me, 't would
frighten Cherry into fits, she 's so nervous. I 'd better hide while they
're here. They 've come to see about that chicken, just as I have!"
Hazel had all she could do to keep from laughing out loud. She lay
down upon a large pile of hay and drew it all over her. "They can't
see me now, and I can watch them," she thought, with a good deal
of satisfaction.
Surely the proceedings were worth watching. The moonlight
flooded the flooring of the loft, and every detail could be plainly
seen.
"Nobody can hear us here if we do talk," said Budd. "You 'll
have to hoist them up first, to see if there are any chickens, and be
sure and look at the rag on the legs; when you come to a green
one, it's mine, you know."
"Oh, Budd! I can't hoist them," said Cherry, in a distressed
voice.
"They do act kinder queer," replied Budd, who was trying to lift
a sleeping hen off her nest, to which she seemed glued. "I 'll tell you
what's better than that; just put your ear down and listen, and if you
hear a 'peep-peep,' it's a chicken."
Cherry, the obedient slave of Budd, crawled about over the
flooring on her hands and knees, listening first at one nest, then at
another, for the expected "peep-peep."
"I don't hear anything," said Cherry, in an aggrieved tone, "but
the old hens guggling when I poke under them. Oh! but here 's a
green rag sticking out, Budd."
"And a speckled hen?" said Budd, eagerly.
"Yes."
"Well, that's the one I 've been looking for; it's dark over here in
this corner. Lemme see."
Budd put both hands under the hen and lifted her gently. "Ak--
ok--ork--ach," gasped the hen, as Budd took her firmly around the
throat; but she was too sleepy to care much what became of her,
and so hung limp and silent.
"I 'll hold the hen, Cherry, and you take up those eggs one at a
time and hold them to my ear."
"What for?" said Cherry.
"Now don't be a loony, but do as I tell you," said Budd,
impatiently. Cherry did as she was bidden; Budd listened intently.
"By cracky! there 's one!" he exclaimed. "Here, help me set this
hen back again, and keep that one out."
"What for?" queried Cherry, forgetting her former lesson.
"Oh, you ninny!--here, listen, will you?" Budd put the egg to her
ear.
"Why, that's a chicken peeping inside. I can hear him," said
Cherry, in an awed voice.
"Yes, and I 'm going to let him out," said Budd, triumphantly.
"But then you'll have the prize chicken, Budd," said Cherry,
rather dubiously, for she had wanted it herself.
"Of course, you goosey, what do you suppose I came out here
for?" demanded Budd.
"But, Budd, will it be fair?" said Cherry, timidly.
"Fair!" muttered Budd; "it's fair enough if it's out first. It's their
own fault if they don't know enough to get ahead of us."
"Did you think it all out yourself, Budd?" queried Cherry,
admiringly, watching Budd's proceeding with wide-open eyes.
"Yup," said Budd, shortly.
They were not far from Hazel's hiding-place, and, by raising her
head a few inches, she could see the whole process.
First Budd listened intently at one end of the egg, then at the
other. He drew out a large pin from his pajamas and began very
carefully to pick the shell.
"Oh, gracious, Budd! what are you doing?" cried Cherry.
"What you see," said Budd, a little crossly, for his conscience
was not wholly at ease.
He picked and picked, and finally made an opening. He
examined it carefully.
"Oh, thunder!" he exclaimed under his breath, "I 've picked the
wrong end."
"What do you mean?" persisted Cherry.
"I wanted to open the 'peep-peep' end first, so he could
breathe," replied Budd, intent upon his work. Cherry watched
breathlessly. At last the other end was opened, and Budd began to
detach the shell from something which might have been a worm, a
fish, a pollywog, or a baby white mouse, for all it looked like a
chicken. It lay in Budd's hand.
"Oh, Budd, you 've killed it!" cried Cherry, beginning to sniff.
"Shut up, Cherry Blossom, or I'll leave you," threatened Budd.
Just then the moon was obscured by a passing cloud, and the loft
became suddenly dark and shadowy. Cherry screamed under her
breath.
"Oh, Budd, don't leave me; I can't see you!"
There was a soft rapid stride over the flooring; and before Budd
well knew what had happened, he was seized by the binding of his
pajamas, lifted, and shaken with such vigor that his teeth struck
together and he felt the jar in the top of his head.
As the form loomed so unexpectedly before her, Cherry
screamed with fright.
"I 'll teach you to play a business trick like this on us, you mean
sneaking little rascal!" roared March. "Do you think I did n't see you
creeping out of the room along the side of my bed on all fours? You
did n't dare to walk out like a man, and I might have known you
were up to no good!" Another shake followed that for a moment
dazed Budd. Then, as he felt the flooring beneath his feet, he turned
in a towering passion of guilt and rage on March.
"You 're a darned sneak yourself," he howled rather than cried.
"Take that for your trouble!" Raising his doubled fist, he aimed a
quick, hard blow at March's stomach. But, somehow, before it
struck, one strong hand--not March's--held his as in a vice, and
another, stronger, hoisted him by the waist-band of his pajamas and
held him, squirming and howling, suspended for a moment; then he
felt himself tossed somewhere. He fell upon the hay under which
Hazel had taken refuge, and landed upon her with almost force
enough to knock the breath from her body. Cherry, meanwhile, had
not ceased screaming under her breath, and, as Budd descended so
unexpectedly upon Hazel, a great groan and a sharp wail came forth
from the hay, to the mortal terror of all but Chi, who grew white at
the thought of what might have happened to his Lady-bird, and,
unintentionally, through him.
That awful groan proved too much for the children. Gathering
themselves together in less time than it takes to tell it, they fled as
well as they could in the dark,--down the ladder, out through the
barn, over the grass-plat, into the house, and dove into bed,
trembling in every limb.
"What on earth is the matter, children?" said Mrs. Blossom,
appearing at the foot of the stairs. "Did one of you fall out of bed?"
Budd's head was under the bedclothes, his teeth chattering
through fear; likewise Cherry. March assumed as firm a tone as he
could.
"Budd had a sort of nightmare, mother, but he 's all right now."
March felt sick at the deception.
"Well, settle down now and go to sleep; it's just twelve." And
Mrs. Blossom went back into the bedroom where Mr. Blossom was
still soundly sleeping.
Meanwhile, Chi was testing Hazel to see that no harm had been
done.
"Oh, I 'm all right," said Hazel, rather breathlessly. "But it really
knocked the breath out of my body." She laughed. "I never thought
of your catching up Budd that way and plumping him down on top
of me!"
"Guess my wits had gone wool-gatherin', when I never thought
of your hidin' there," said Chi, recovering from his fright. "But that
boy made me so pesky mad, tryin' to play such a game on all of us,
that I kind of lost my temper 'n' did n't see straight. Well--" he
heaved a sigh of relief, "he 's got his come-uppance!"
"Where do you suppose that poor little chicken is?"
"We 'll look him up; the moon 's comin' out again."
There, close by the nest, lay the queer something on the floor.
"I 'll tuck it in right under the old hen's breast, 'n' then, if there 's
any life in it, it 'll come to by mornin'." He examined it closely. "I 'll
come out 'n' see. Come, we 'd better be gettin' in 'fore 't is dark
again--"
He put the poor mite of a would-be chicken carefully under the
old hen, where it was warm and downy, and as he did so, he caught
sight of the rag hanging over the edge of the nest. He looked at it
closely; then slapping his thigh, he burst into a roar of laughter.
"What is it, Chi?" said Hazel, laughing, too, at Chi's mirth.
"Look here, Lady-bird! you 've got the Prize Chicken, after all.
That boy could n't tell green from blue in the moonlight, 'n' he 's
hatched out one of yours. By George Washin'ton! that's a good one,-
-serves him right," he said, wiping the tears of mirth from his eyes.
The chicken lived, but never seemed to belong to any one in
particular; and as Chi said solemnly the next morning, "The less said
on this Mountain about prize chickens, the better it 'll be for us all."
X
AN UNEXPECTED MEETING
His friend turned to the others. "That's a go; I 've never seen Sherrill
so hard hit before." Then he fell to discussing the new plan with the
rest.
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