1. The Lawyer | 11 May 20156 7The Lawyer | 11 May 2015
The in-house interview
Health in February 2013 as a legal
consultant, charged with setting up
Genomics England.
It was he who registered the ven-
ture as a company at Companies
House and he who is now guiding
the company through the minefield
of sequencing 100,000 peoples’ en-
tire genomes by the end of 2017.
Project mission
The project celebrated a landmark
last month when it diagnosed its
first patients. The two received a di-
agnosis for the symptoms that had
plagued their families for genera-
tions, and will now receive person-
alised treatments and be able to in-
form future generations about their
condition.
The project aims to transform the
way we approach health and drugs.
“A huge number of cancer drugs
are sledgehammers to crack a nut,”
Maltby says. “Genome sequencing
will change that and will let us see
what drugs are more likely to work
for patients.”
The criteria for patient recruit-
Gene
believerFor pioneer Genomics England to sequence 100,000 genomes and revolutionise
patient care, it leans heavily on its GC to build the necessary support systems,
protect its knowledge and forge commercial relationships
Nick Maltby
Genomics England
Title: General counsel and
company secretary
Industry: Health and life
sciences
Reports to: Executive chairman
Sir John Chisholm
Number of employees: Around
70
Size of legal team: Two
Main external firms: Bristows,
Fieldfisher
Annual legal spend: £350,000
patients so far. It is a huge challenge.
“This has never been done on this
scale and at this speed,” says Malt-
by. “From a scientific perspective
there are issues that no one else has
ever had to solve.”
Commercial offering
Aside from scientific study, Genom-
ics England has a commercial agen-
da. The Government-established
project has been championed as a
stimulator of growth.
“We need to work out our offer,”
reveals Maltby. “We need to know
what is attractive, what we should
focus on and not focus on and what
sort of things researchers want.”
The data currently being collect-
ed will be housed in a data centre,
which will act as a reading library
for around 5,000 interested parties.
Genomics England will be in charge
of authorising and monitoring any
access to the database and approv-
ing or denying studies.
“We’re looking to derive value
from our database,” Maltby ac-
knowledges. “We won’t charge the
NHS and academia but we will
charge others for access to the data.
“One of the things we’re wrestling
with is how much of a tech transfer
capability we need. We could get
somebody else to do file patent
claims and protect IP for the whole
system, or we could do it ourselves.”
The 5,000 interested parties will
include pharmaceutical compa-
nies, which Maltby envisions
Genomics England working closely
with on projects such as speeding
up approval periods for new drugs.
At the moment the current time
from developing a drug to it being ap-
proved for use is 17 years. Maltby esti-
mates this could be greatly reduced,
perhaps to around three years, with
the help of Genomics England.
“Big pharma could come to us
and ask for 100 people with a cer-
tain condition in order to test
drugs,” he suggests. “Accelerating
the process for new drugs is a huge
issue for that market.”
Further along, Maltby believes
that genomics treatment could be-
come standard across the NHS, with
the database growing all the time.
“The rest of the world wants to
copy this,” he says. “It is pushing
the boundaries of science.”
and see how they match certain
symptoms. Once you know what is
wrong you can treat it better.”
Capability building
In order to deliver better treatment,
Maltby first has to build the systems
that can execute it. This is where his
background in hospital private fi-
nance initiative projects comes into
its own.
“There are significant IP and data
protection aspects to the project but
first we have to build capability,” he
says. “We have to do a lot of pro-
curement: we have to put in place a
genome sequencing body; put in
place a centre where the data will
go; find someone to store samples;
find someone to transport samples;
find someone to make sense of sam-
ples once they are sequenced.”
The project has procured centres
around the country to recruit pa-
tients, take samples, collect data and
send it to the project’s main team for
sequencing and interpretation.
Over the next two and a half years
that team will sequence 96,500
genomes, having sequenced 3,500
“There are
significant IP and
data protection
aspects to the
project, but first
we have to build
capability”
Inside line
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Nick Maltby CV
2013-present: General counsel and company secretary, Genomics
England
2013: Legal consultant, Department of Health
2009-12: Partner, Bircham Dyson Bell
2002-09: Partner, DLA Piper
1997-02: Partner, Pinsent Curtis
1993-97: Solicitor, Pinsent Curtis
1988-93: Solicitor, Allen & Overy
1986-88: Trainee solicitor, Allen & Overy
ment vary by disease, ensuring that
only patients who further scientific
enterprise are selected.
Currently, the project focuses on
understanding rare diseases and
studying how cancer mutates.
However, the almost boundless
scale on which genomics work
takes place is made all the more dif-
ficult by the project’s innovative na-
ture. To be able to draw any conclu-
sion from a sequenced genome a
comparison is needed. That com-
parison needs to be as close to the
average genome as possible, strip-
ping out unusual aspects and build-
ing the prototype for the average
human.
It’s what Genomics England re-
fers to as a ‘reference’: a standard
genetic profile.
“We refine and reference,” Maltby
says. “We are now up to version 38.
The first one we did was a specific
person, so we could not see what
was exceptional about him.
“But add more and more and you
eventually create a reference. We
then work out patients’ variants
“A huge number
of cancer drugs are
sledgehammers
to crack a nut.
Genome
sequencing will
change that”
Becky Waller-Davies
The 100,000 Genomes Project is
halfway through a four-year mis-
sion to sequence 100,000 genomes
and discover more about cancer
and rare diseases. At its helm is gen-
eral counsel Nick Maltby.
The project is being delivered by
Genomics England, which was set
up and owned by NHS England, and
is based in the Queen Mary Univer-
sity’s Charterhouse campus. Until
September 2013, Maltby and six
others were based in the Depart-
ment of Health. One and a half years
later, he and 70 staff occupy a series
of rooms at the university, having
graduated from a science lab.
Formerly a commercial and pro-
jects partner at Bircham Dyson Bell,
Maltby arrived at the Department of