Download Pharma/biotech companies do better job than most providing career

July 29, 2013
Breaking News and
Market Intelligence for
the Clinical Trials Industry
CRA acquires Comprehensive division…2
A CenterWatch Publication
PhRMA and EFPIA endorse trial data
sharing principles…3
Survey: Pharma/biotech companies do better job
than most providing career development, flexibility
P
harmaceutical and biotechnology companies, increasingly concerned about
the high cost and challenge of replacing skilled employees, have done a better job
than companies from other industries investing
in their workers’ careers and adopting policies
to keep them engaged, according to a new
survey released by Randstad Pharma, a global
staffing and HR services firm.
Pharma/biotech companies received
a higher rating from employees (52%)
compared to companies in other industries
(35%) for creating career development and
training programs for their workers. And
60% of pharma/biotech workers reported
their employers provide regular performance reviews, compared with only 44%
of employees polled across all industries.
The Pulse on Study Conduct…6
The survey identified career advancement
programs as one of the most important
issues for employees: 29% of workers in the
pharma/biotech sector rated training and
professional development as one of top
three areas they value in their workplace.
In addition, a higher percentage of
pharma/biotech employees (48%) said their
companies offered flexible hours or working
arrangements, compared to 41% across all
industries. One-third of pharma/biotech
employees want this type of flexibility in the
workplace, making it the top-ranked benefit
among pharma/biotech respondents.
“Clients in this space are investing more
in these areas that are important to employees,” said Greg Coir, president of Randstad
page 4
»
WCG Academy to offer protocol-specific training
T
he WIRB-Copernicus Group (WCG)
has launched a new partnership to
provide state-of-the-art, customized
online training for clinical research professionals that includes competency exams to
measure site staff understanding of specific
study protocols.
WCG has partnered with UL Quality,
Compliance and Learning (formerly
EduNeering)—which has built a cloudbased platform used by the FDA to train and
certify its inspectors in quality and compliance—to form the WCG Academy. The academy gives sponsors and CROs online tools to
train investigative site staff and ensure their
understanding of the protocol throughout a
clinical study. Courses, however, are not lim-
ited to site personnel and can be used across
the clinical research enterprise.
The Academy’s protocol training offers
both generalized and customized, studyspecific training on protocols for site personnel. Study-specific protocol training includes
optional competency tests and measures of
understanding. Additionally, study-specific
protocol training includes FAQs and checklists site personnel can consult to follow
protocol requirements.
“This is especially important, since site
personnel may have a high turnover rate
during the course of a multi-year trial,” said
Donald Deieso, Ph.D., executive chairman
of the WCG. “Having online courses and
Volume 17, Issue 30. © 2013 CenterWatch. All rights reserved.
page 5
»
Drug & Device Pipeline News…7
CenterWatch has identified 22 drugs
and devices that have entered a new
trial phase this week.
Trial Results…8
CenterWatch reports on results for
four drugs.
Biotech Review…9
Biotech briefs from BioWorld Today.
CWMarketplace…10
Industry service provider profiles.
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2 of 10
Industry Briefs
Study Conduct
■■
Tempe, Ariz.-based Clinical Research
Advantage (CRA), a wholly owned network
of clinical trial sites, has expanded both
its geographic and therapeutic reach by
acquiring the late phase division of Comprehensive Clinical Development (CCD).
CRA said the acquisition will allow it to
offer pharmaceutical sponsors and CROs an
across-the-board solution for their diverse
clinical research needs. Founded in 1992,
CRA includes 63 sites operating under CRA
and Radiant Research. Both brands conduct stage II-IV clinical trials. CRA focuses
on family practice and general medicine,
while Radiant conducts multi-specialty
and consumer trials. CRA acquired Radiant
Research in 2012. CCD conducts psychiatric
clinical trials, specifically in schizophrenia,
bipolar disorder, depression and Alzheimer’s
disease. CCD has participated in the development of every major psychiatric drug
that has been developed over the past 10
years. “By adding Comprehensive Clinical
Development to the CRA family of trial sites
we are able to increase our capabilities to
meet the needs of the growing pharmaceutical marketplace,” said Mark S. Hanley, chief
executive officer of CRA. Based in Miramar,
Fla., CCD was founded in 1998 and operates
four independent sites in Atlanta, Ga., Cerritos, Calif., Holliswood, N.Y., and Washington,
D.C. The combined companies will continue
to function under the names CRA and CCD,
but will be looking to integrate and streamline their operations where appropriate.
well as technical support, for the development and production of pharmaceuticals,
diagnostics, and drug/device combination
products from discovery through Phase IIb.
The majority of VxP Pharma’s labs are in the
U.S., plus facilities in Europe and Asia. All
VxP sites have been fully audited by CRO
Solutions/VxP Pharma, as well as by global
pharmaceutical and biotechnology clients.
Most sites have also been audited by the
FDA and other regulatory agencies.
■■
ResearchDx, a contract diagnostics
organization (CDO), has purchased and will
relocate to a 30,000-square-foot facility in
Irvine, Calif. The facility will support continued expansion of in vitro diagnostic (IVD)
development services to the pharmaceutical, biotechnology, diagnostic development
and clinical laboratory industries. According
to ResearchDx, new healthcare initiatives
toward personalized medicine and the
corresponding need for IVD tests to come
to market alongside pharmaceuticals as
companion diagnostics (CDx) is changing
the way drug companies target diseases
and treatments for patients.
R&D Trends
■■
Venture capitalists invested $6.7 billion in
913 deals in the second quarter of 2013,
according to the MoneyTree Report from
PricewaterhouseCoopers (PwC) and
the National Venture Capital Association (NVCA), based on data provided by
Thomson Reuters. Quarterly VC investment activity rose 12% in terms of dollars
and 2% in the number of deals compared
to the first quarter of 2013 when $6 billion
was invested in 896 deals. The biotechnology sector saw increases in both dollars and
number of deals. Companies receiving VC
funding for the first time, as well as those
companies in the early stage of development, experienced jumps in dollars invested.
“As the exit window continues to open,
we’ll continue to see VCs shifting their focus
back to companies in the earlier stages of
development,” said Mark McCaffrey, global
technology partner and software leader at
PwC U.S. “In particular, startups that are able
to drive innovation by developing disruptive technologies that are easy to deploy
and deliver ongoing value to the user will
be of great interest to venture capitalists.”
Biotechnology was the second largest
sector for dollars invested with $1.3 billion
going into 103 deals, up 41% in dollars and
4% in deals from the prior quarter. Medical
device investing of $543 million into 71 deals
represented a 1% decline in both dollars and
deals. Investments in the life sciences sector
overall (biotechnology and medical devices)
rose 25% in dollars and 2% in deals, purely on
the strength of biotech investing. Early stage
dollar investments rose to their highest level
in six quarters, rising 63% in dollars and 18%
in deals, to $2.5 billion going into 480 deals.
The average early stage deal was $5.2 million,
up significantly from $3.7 million in the prior
quarter. Seed/early stage deals accounted for
57% of total deal volume in Q2, compared to
51% in the first quarter. First-time financing
(companies receiving venture capital for the
page 3
CROs/Service Providers
■■
CRO Solutions has launched VxP Pharma,
a wholly owned subsidiary headquartered
in Indianapolis. VxP Pharma is comprised
of the combined services of the independently owned and operated “niche” CROs
of CRO Solutions. VxP Pharma will offer
pharmaceutical development services, as
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3 of 10
Industry Briefs (continued from page 2)
first time) dollars increased 24% to $1.1 billion going into 302 companies in Q2, a 10%
increase in the number of deals from Q1. The
life sciences sector experienced a dramatic
increase in first-time financing, more than
doubling in dollars from Q1 to $328 million,
with 33 life sciences companies receiving VC
funding for the first time in Q2, up from only
22 companies in Q1.
■■
Wisconsin-based nonprofit Aurora Health
Care’s Research Institute will launch a
quarterly peer-reviewed research journal
The Journal of Patient-Centered Research
and Reviews, with the first edition expected
in early 2014. The journal will be available
online with limited print copies. It will
serve as a resource for Aurora researchers
to publish original research and reviews for
the medical community, and will be geared
to a multi-specialty audience in medicine,
healthcare and basic science. It will be
indexed to major databases, including
Medline, and searchable in archives such
as PubMed, hosted by the U.S. National
Library of Medicine. Dennis Baumgardner, M.D., was named editor and will lead a
scientific editorial board. The journal will be
accessible to academic medical centers, universities, medical institutions and the public.
Ethics/Regulatory
■■
The European Federation of Pharmaceutical Industries and Associations (EFPIA)
and the Pharmaceutical Research and
Manufacturers of America (PhRMA) have
endorsed joint Principles for Responsible Clinical Trial Data Sharing: Our Commitment to
Patients and Researchers. “Biopharmaceutical
companies commit to enhance these efforts
by making additional information available
to the public, patients who participate in
clinical trials and to qualified researchers,”
said Christopher Viehbacher, president of
EFPIA and CEO of sanofi. “The data-sharing
commitments reflect EFPIA member companies’ strong support for sharing clinical trial
data to benefit patients and foster scientific
discovery in a way that maintains patient privacy, the integrity of regulatory systems and
incentives to invest in biomedical research,”
said Richard Bergström, director general of
EFPIA. Companies will dramatically increase
the amount of information available to
researchers, patients and the public: Patientlevel trial data, study-level trial data, full clinical study reports and protocols for medicines
approved in the U.S. and E.U. will be shared
with scientific and medical researchers upon
request and subject to terms necessary to
protect patient privacy and confidential
commercial information; researchers will
be encouraged to publish their findings;
companies will work with regulators to
provide a factual summary of trial results to
participating patients; and the synopses of
clinical study reports submitted to the FDA,
EMA or national authorities of E.U. member
states will be made available after approval.
At a minimum, results from all phase III trials
and results of significant medical importance should be submitted for publication.
Implementation begins January 2014.
Sponsors
■■
■■
Vivus and New York-based First Manhattan
(FMC), an investment advisory firm and the
owner of 9.9% of Vivus’ outstanding shares,
entered a settlement agreement in their
proxy contest. Five members of the Vivus
board resigned, and six FMC nominees were
appointed. The board was expanded from
nine to 11 members. Anthony P. Zook was
named Vivus’ new CEO and was appointed
to the board. Zook previously was executive
vice president, global commercial operations
for AstraZeneca, and president of Medimmune. He succeeds Leland Wilson, who will
depart as CEO but has agreed to serve in an
advisory role to ensure a seamless leadership transition. Vivus’ board also appointed
Michael Astrue chairman. He previously was
CEO of Transkaryotic Therapies and chairman of the Massachusetts Biotechnology
Council. Vivus sells obesity drug Qsymia
in the U.S. “We intend to move quickly on
our four main goals: expand use of Qsymia
through targeted patient and physician
education, find the right partner for Qsymia,
quickly create a pathway for approval in
Europe and eliminate expenses not essential
to expanding use of Qsymia,” said Astrue.
Bristol-Myers Squibb will open a North
America capability center in January 2014 and
create 579 life sciences jobs by 2017 in Tampa,
Fla. The Tampa Bay region is gaining reputation as a hub for R&D in life sciences; over 600
life sciences companies employing more than
13,200 operate in Tampa. The world’s local central lab. Global reach. Local expertise.
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CWWeekly July 29, 2013
4 of 10
Features (continued from page 1)
Survey
Pharma, a division of Randstad Holdings
that focuses on the clinical side of the
pharma/biotech industry. “They are listening.
They are allowing for more flexibility.”
The Randstad Pharma survey was designed to measure employee attitudes and
perceptions about their companies along
with factors driving employee engagement
and retention. The survey, conducted online
in March and April, surveyed 3,282 adults
currently employed full time in a range of
industries; the survey included 161 respondents from the pharma/biotech sector.
While the survey found pharma/biotech
companies have done a better job than
companies in other industries in addressing
employee concerns about the workplace environment, it also showed companies in this
sector need to provide more opportunities
for career advancement to keep their skilled
employees from moving to other organizations. Half of respondents (49%) said they
feel they must change jobs in order to advance their careers, and 37% indicated they
will seek a job in a different company within
the next six months. Another 43% said they
would be likely to accept an enticing offer
from another company.
“For the most part, these are highly motivated people who are looking for career pro-
“For the most part, these are
highly motivated people who are
looking for career progression.
If their current employer is
not offering professional
development and career path, we
see that as a motivating factor for
people wanting to make a change
more so than compensation.”
—Greg Coir, president, Randstad Pharma
gression,” said Coir. “If their current employer
is not offering professional development
and career path, we see that as a motivating
factor for people wanting to make a change
more so than compensation.”
Coir said pharma/biotech companies
have made greater investments, compared
to companies in other industries, in training
programs and professional development,
and have allowed more flexible working
arrangements, as they have recognized
the significant cost and detriment of losing
good talent. The independent Center for
American Progress estimates replacing an
employee costs approximately one-fifth of
that worker’s annual salary. In addition, Coir
said other costs of losing an employee in
the pharma/biotech sector are difficult to
quantify. For example, when an experienced
study manager in a highly specialized clinical trial leaves, the study might stop until a
replacement can be found. There is a high
demand for talent in this space, said Coir,
particularly in clinical operations, biometrics, safety and medical writing. “If you lose
an employee, it’s really challenging to find
someone with the right skill set.”
The survey results suggested the need for
more targeted retention strategies and investments to keep employees engaged in their
jobs. In addition to flexible work arrangements
and professional development programs,
respondents said they want high-performing
workers to receive bonuses and promotions
(30%). And while 47% of employees in this sector said their companies have formal systems
in place to recognize or reward top employees,
compared to 25% in all industries, only 39%
said their companies offered promotions or
bonuses to high-performing employees.
“While we see positive momentum within
the industry,” Coir said, “companies must
continue to put an emphasis on engagement strategies.”
—Karyn Korieth
eCOA FORUM
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CWWeekly July 29, 2013
5 of 10
Features (continued from page 1)
WCG Academy
briefing materials available 24/7 will assure
greater continuity of critical knowledge.”
Deieso said ensuring the competency
of those who design, manage and conduct
clinical trials is critical to protecting human
subjects and meeting the scientific objectives of clinical research. “Unfortunately,
there are too many incidents in which a
trial fails because site personnel didn’t
understand the protocol,” he said. “Trials are
conducted by human beings. Human beings
need to have the requisite knowledge to do
well. If they don’t have the knowledge, then
the trial is jeopardized.”
As drug sponsors and CROs adopt online
site training programs to reduce costs and
increase compliance, other vendors also
have integrated protocol-specific training
into their offerings. Firecrest Clinical, for
example, which was acquired by global CRO
Icon, offers customized training modules
that allow users to learn study-specific information needed for the day-to-day conduct
of a clinical trial. HealthCarePoint, which
recently launched online education courses
in partnership with CDISC, offers tools for
CROs and sponsors to develop their own
protocol-specific training. Other CROs and
vendors offer similar training modules.
The WCG Academy provides global site
staff access to more than 100 online courses;
those offered as part of the Good Clinical
Practice (GCP) curriculum are authored or
reviewed by the FDA through a partnership
between the agency and UL. Courses, which
are offered in 17 languages, provide train-
“We feel this partnership will
foster transformation in clinical
research by improving the quality
of clinical trial conduct and
ensuring human safety.”
—Lynne Budnovitch, general manager,
UL Quality, Compliance and Learning
ing on FDA ethics and safety requirements,
research updates and best clinical practices.
The system also can distribute study protocols directly to sites. Once the study begins,
the WCG Academy provides site staff with a
simple checklist of critical protocol elements
they can reference at any time with questions; for example, if a patient is a few days
late for a visit, staff can refer to an online FAQ
to determine the proper course of action.
The online resource also allows training
for site personnel hired after the clinical
study has begun, keeps track of when site
staff need to renew training and provides
refresher courses to avoid any regulatory
exposure, study delays or operational inefficiencies. “We can also tell if someone hasn’t
done well and has to repeat it,” said Deieso.
“The important thing is not that they had
to repeat it, but that they have the requisite
knowledge.”
The creation of the WCG Academy, which
was announced last month, is part of a plan to
bring together disparate parts of the ethical
review process to create greater efficiency
in clinical research. WCG companies include
Western Institutional Review Board (WIRB),
Copernicus Group Institutional Review
Board (CGIRB) and IRBNet, a research compliance software application supporting IRBs in
the U.S. Earlier this year, the WCG formed an
exclusive partnership with Mytrus, a clinical
technology and services company, to offer
an internet-based application that replaces
paper-based processes for obtaining patient
consent for clinical trial participation.
“We feel this partnership will foster transformation in clinical research by improving
the quality of clinical trial conduct and ensuring human safety,” said Lynne Budnovitch,
general manager of UL.
Deieso said the WCG Academy is an important part of his company’s plan to build a
“one-stop” integrated solution for the ethical
oversight process. Sponsors and CROs that
use WIRB-Copernicus ethical review boards
can negotiate a contract that also includes
Mytrus’ electronic informed consent process
and training through the WCG Academy.
“This would be instead of having several
contracts. For example, if you were going
to train on a protocol, it would be good to
have the IRB who approved the protocol
to author and check the course to be sure
that it’s consistent precisely with what was
approved,” Deieso said. “We want our group
of companies to make one circle of all the
knowledge-related services in a clinical trial.
We hope to make an impact.”
—Karyn Korieth
Are
your
monitors
running
out
of
yellow
s1ckies?
> Get
unstuck.
Use
coordinators.
Trained.
Experienced.
Dedicated.
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CWWeekly July 29, 2013
The Pulse on Study Conduct
M
6 of 10
By Elizabeth Weeks-Rowe
y position in study start-up requires
I evaluate a diverse group of investigative sites for study consideration,
from large academic institutions that cover
several city blocks and dedicated research sites
with the latest in high-tech diagnostic equipment to the small, yet effective, single investigator private practice. This process affords the
opportunity to engage with investigators and
site staff and discover the reasons they succeed,
or struggle, with the trials they conduct.
The unanimous goal of site staff during
the selection process is to positively represent
their site and capabilities to sponsor representatives. Sometimes sponsors presume
larger, dedicated research organizations with
the staff and expertise to rapidly expedite
contract and essential documents—and the
budget to employ dedicated recruitment staff
for rapid patient recruitment—are the logical
first choice. Alternatively, renowned academic
institutions often are headed by Key Opinion
Leaders who helped develop protocol content,
so these site selection visits sometimes are
mere formalities and their participation is
nearly guaranteed. This leaves the smaller site
hybrid of private practice/investigative site as
a secondary, or even tertiary, choice, which
can leave it feeling overlooked and less important compared to its larger counterparts.
Recently, I conducted a site selection teleconference with an investigator being considered for participation in a respiratory study.
After the protocol discussion with the investigator and his staff, I began the most crucial part of
the meeting, the one-on-one discussion with
the lead study coordinator. The majority of site
logistical and clinical information is obtained
here, and so it can have a great impact on the
site selection decision, depending on the quality of data obtained. This particular investigator
was in private practice in a small town in the
Northwest, and his staff consisted of his medical
assistant, study coordinator and receptionist.
I have learned over the years that establishing an easy dialogue with the study coordinator
offers far more insight into the inner workings
Key questions to ask sites at
study start-up
1. Has the site had any prior FDA
audits/483 letters?
2. How long does it take for a contract
and budget to be executed?
3. How long does it take for IRB approval
of a study?
4. Does the investigator have experience as
a PrincipaI Investigator and experience
in the indication under study?
5. Does the investigator have a backup?
6. Does the site have any competing studies and how will it manage them all?
7. Does the site have an experienced
study coordinator as well as backup?
of a site than an impersonal “follow your checklist” exchange in which facts, not foundation,
are gathered. I make it a point to identify a commonality, which will serve as the impetus for
the dialogue I require to discover the facts. This
particular study coordinator was not participating in the banter. She was extremely businesslike and a bit defensive, which led me to forego
friendly exchange for the checklist procedure.
I was curious about her atypical behavior, but I
had a job to do and proceeded accordingly.
Our exchange went something like this:
Me: “Please could you give me the name
and contact information for those individuals
responsible for contracts and budgets.”
Study coordinator: “That would be me.”
Me: “OK. Then may I have the name and
contact information for the individual responsible for regulatory documents?”
Study coordinator: “Also me.”
Me: “Then may I have the name and contact information for the data manager?”
Study coordinator: “Again, that would be me.”
After a pause, she volunteered insight into
her initial attitude:
Study coordinator: “Look, I will save you a
lot of question time. I do everything: contracts,
regulatory, data entry, phlebotomy, patient care,
specimen processing, spirometry. My backup is
the medical assistant. We don’t have a recruiter
© 2013 CenterWatch. Duplication or sharing of this publication is strictly prohibited. or extra staff. We aren’t a big site like the others
you visit. It is just us, and we do the best we can.”
I began to see a picture of a small investigative site that conducted only several studies a
year, competing and sometimes failing against
bigger institutions. I could see an experienced
and proficient study coordinator who was a
little defensive explaining the site’s small structure, perhaps as a result of past experiences
with individuals whose idea of the ideal site
was quite narrow and who did not understand
that the quality of investigators and data produced has nothing to do with how large the
institution, how shiny the equipment or how
lauded the investigator.
I told the study coordinator my experience
with smaller sites, for the most part, had been
extremely positive. Using discretion in the manner and number of studies they conducted often
led to steady enrollment and quality data. I also
explained that, in my experience, having one or
two individuals responsible for everything often
was more consistent and efficient than sites
with an army of individuals responsible for key
activities, which required more correspondence,
more follow-up and, sometimes, less efficiency.
Her response made me smile: “Oh” was all
she said. And then I could see her mood brighten, and the resulting conversation led to an
informative exchange during which I gleaned
an accurate picture of the site’s experience and
process. This ultimately led to site selection.
In research, as in life, it is best not to judge
a book by its cover—or by its size, equipment
or reputation. Elizabeth Blair Weeks-Rowe, LVN, CCRA, has
spent more than a dozen years in a variety of
clinical research roles including CRA, CRA trainer,
CRA manager and business development director. She has written and edited newsletters for
several CROs, created training curriculum for
CRA/clinical research educational and training
programs, and is a contributing writer to several
research publications. She currently works in
relationship development/study start-up in the
CRO industry. Email [email protected].
CWW1730
CWWeekly July 29, 2013
7 of 10
Drug & Device Pipeline News
Company
Drug/Device Medical Condition
Status
Sponsor Info
Genmab
HuMax-TFADC
multiple solid tumors
IND filed with the FDA
(609) 430-2481
www.genmab.com
Ablynx
ALX-0171
pediatric respiratory syncytial virus
Phase I trials initiated
+32 (0)9 262 00 00
[email protected]
Arrowhead
Research
ARC-520
chronic hepatitis B
Phase I trials initiated
(626) 304-3400
[email protected]
Pulmatrix
PUR0200
chronic obstructive pulmonary disease Phase Ib trials initiated
(781) 357-2333
[email protected]
Invion
INV102
(nadolol)
chronic bronchitis
Phase II trials initiated
enrolling 136 subjects in the U.S.
+61 7 3295 0500
http://invion.com.au/
Invion
INV103
mild systemic lupus erythematosus
Phase II trials initiated
enrolling 32 subjects in the U.S.
+61 7 3295 0500
http://invion.com.au/
Merrimack
MM-111
Pharmaceuticals
advanced gastric, esophageal and
gastroesophageal junction cancers
Phase II trials initiated
(617) 441-1000
http://merrimackpharma.com/
OncoGenex
OGX-427
Pharmaceuticals
metastatic bladder cancer
Phase II trials initiated enrolling
(425) 686-1500
180 subjects in the U.S. and Europe www.oncogenex.com
Akebia
Therapeutics
AKB-6548
anemia
Phase IIb trials initiated
(513) 985-1920
www.akebia.com
MediciNova
MN-166
progressive multiple sclerosis
Phase IIb trials initiated
(858) 373-1500
[email protected]
Cubist
bevenopran
Pharmaceuticals
chronic pain, opioid-induced
constipation
Phase III trials initiated
enrolling 1,800 subjects
(781) 860-8660
www.cubist.com
Imprimis
Impracor
Pharmaceuticals
acute osteoarthritis knee pain
Phase III trials planned
in the U.S.
Josh Berg, (858) 704-4041
http://imprimispharma.com
Tesaro
niraparib
ovarian cancer
Phase III trials initiated
enrolling 360 subjects
www.tesarobio.com
University of
Louisville
adult stem
cells
severe refractory angina
Phase III trials initiated
in the U.S.
http://louisville.edu/research/
Astellas
Astagraf XL
immunosuppressant
Approved by the FDA
(800) 888-7704
www.us.astellas.com
Janssen Biotech
Simponi Aria
rheumatoid arthritis
Approved by the FDA
(800) 526-7736
www.janssenbiotech.com
GlaxoSmithKline Mekinist
unresectable or metastatic melanoma
Approved by Health Canada
http://us.gsk.com/
GlaxoSmithKline Tafinlar
unresectable or metastatic melanoma
Approved by Health Canada
http://us.gsk.com/
ArmaGen
Technologies
AGT-182
mucopolysaccharidosis type II
Orphan Drug designation
granted by the FDA
(310) 917-1275
[email protected]
OXiGENE
ZYBRESTAT
ovarian cancer
Orphan Drug designation
granted by the EMA
www.oxigene.com
Topo Target
Belinostat
malignant thymomas
Orphan Drug designation
granted by the EMA
+45 39 17 83 92
[email protected]
Verastem
VS-6063
(defactinib)
mesothelioma
Orphan Drug designation
granted by the FDA
(617) 252-9300
www.verastem.com
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CWWeekly July 29, 2013
8 of 10
Trial Results
Oncology
■■
■■
Amgen released results from a phase II
study of XGEVA (denosumab) in adults and
skeletally mature adolescents diagnosed
with giant cell tumor of bone (GCTB). In the
international, open-label, phase II study
enrolling 282 patients, there were three cohorts: patients with surgically unsalvageable
GCTB (Cohort 1), patients with salvageable
GCTB whose surgery was associated with severe morbidity (Cohort 2) and patients who
transferred from a previous XGEVA GCTB
study (Cohort 3). All three cohorts received
subcutaneous XGEVA 120mg every four
weeks with loading doses on days eight and
15. In Cohort 1, 96% (163/169) of patients
had no disease progression after a median
follow-up of 13 months. In Cohort 2, 74%
(74/100) of patients required no surgery and
62% (16/26) of patients who had surgery
underwent a less morbid procedure than
planned. XGEVA was approved June 13 by
the FDA for the treatment of adults and skeletally mature adolescents with GCTB that is
unresectable or where surgical resection is
likely to result in severe morbidity.
Bayer HealthCare issued results from a
phase III study of Xofigo in castration-resistant prostate cancer (CRPC) patients with
symptomatic bone metastases. The randomized, double-blind, placebo-controlled,
international study enrolled 921 patients in
100 centers in 19 countries. Patients were
stratified based on their baseline alkaline
phosphatase (ALP) level, current bisphos-
phonate use and whether or not they had
received docetaxel prior to enrollment.
Treatment consisted of up to six intravenous
injections separated by four weeks. Xofigo
improved overall survival (OS) at the prespecified interim analysis (HR=0.695, [95%
CI: 0.552-0.875], p=0.00185); median OS
was 14.0 months with Xofigo (95%
CI: 12.1-15.8) vs. 11.2 months with placebo
(95% CI: 9.0-13.2). These findings were
supported by an exploratory analysis performed before patient crossover with an
additional 214 events in which Xofigo
showed improvement in OS (HR=0.695,
[95% CI: 0.581-0.832]); median OS was
14.9 months in the Xofigo arm (95%
CI: 13.9-16.1) v. 11.3 months in the placebo
arm (95% CI: 10.4-12.8). These data supported
the FDA approval of Xofigo injection in May.
Hematology
■■
Isis Pharmaceuticals reported results
from a phase II trial of ISIS-APOCIII for the
treatment of patients with high to severely
high triglycerides on stable doses of fibrates.
The double-blind, randomized, placebo-controlled, 13-week study enrolled 26 patients
who received either a 200mg or 300mg dose
of ISIS-APOCIII, or placebo, via weekly subcutaneous injections. All patients were on stable
doses of fibrates with average baseline levels
of fasting triglycerides between 282mg/dL
and 457mg/dL. Patients treated with ISISAPOCIII experienced reductions of up to
70% in apolipoprotein C-III (apoC-III) and up
to 64% in triglycerides. In addition, patients
treated with ISIS-APOCIII experienced an up
to 52% increase in high-density lipoprotein
cholesterol (HDL-C), the ‘good’ cholesterol,
and an up to 77% reduction in apoC-III-associated very low-density lipoprotein (VLDL)
particles. Isis also is evaluating ISIS-APOCIII
in this phase II study as a monotherapy in
patients with severely high triglycerides.
Immunology
■■
Inovio Pharmaceuticals has released results
from two phase I trials (HVTN 070 and HVTN
080) of Pennvax-B preventative HIV DNA
vaccine, HVTN 070 without electroporation
and HVTN 080 with electroporation. Both
trials were multicenter, randomized clinical
trials, with 070 enrolling 120 patients and 080
enrolling 48 patients. Robust T-cell responses
were generated in 89% of subjects who
received three vaccinations of Pennvax-B,
which consists of 1mg of each of three DNA
plasmids (encoding for HIV gag, pol and env
proteins) along with 1mg of IL-12 DNA plasmid, followed by intramuscular electroporation with Inovio’s CELLECTRA device. Three
or four vaccinations with a 2mg dose of each
Pennvax-B plasmid plus 1.5mg of IL-12 DNA
generated fewer responses when delivered
without electroporation. Six months after
vaccination, T-cell response rates remained
strong and persistent in the subjects who
received only three doses delivered by
CELLECTRA EP. Of 24 positive CD4 or CD8 Tcell responders following the third in month
three, 79% (19/24) showed persistent CD4 or
CD8 T-cell responses at month nine. Clinical Research Conference - 2013 West
OCTOBER 27-30, 2013 • THE VENETIAN/Palazzo • LAS VEGAS
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CWW1730
CWWeekly July 29, 2013
9 of 10
Biotech Review
■■
GlaxoSmithKline sent three top global
executives to China to deal with an expanding scandal that has seen four executives
detained and one confess on national TV.
Abbas Hussein, president of global business outside of the U.S., has been tasked
with managing the unfolding scandal
in China. Hussein said GSK China executives “appear to have acted outside of our
processes and controls, which breaches
Chinese law. We have zero tolerance for any
behavior of this nature.” GSK committed to
fully support Chinese authorities’ efforts to
reform the medical sector, and it intends
to look at its business model in China and
proposes lowering drug costs to be more
affordable. GSK’s China operations have not
had a general manager since Mark Reilly
left for the U.K. July 5 for what were supposed to be routine meetings. He has not
yet returned. The company’s vice president
of finance for China, Steve Nechelput, has
been barred from international travel by
national authorities. GSK said Nechelput
is not under investigation. Authorities are
investigating transactions worth $488 billion involving 700 travel agencies. GSK was
first notified of the investigation June 27,
but it had been underway for six months.
The four GSK executives detained by police
are all Chinese nationals. A GSK spokesperson would not comment on the status
of individuals involved in the investigation. One of the four, VP and operations
manager Liang Hong, admitted on national
TV to using travel agencies to fake business
expenses, pay bribes and increase drug
sales. “It means he is hoping for leniency
in his own case, perhaps a lighter prison
sentence or a suspended sentence,” said
Richard Cassin, a lawyer and corruption
expert who also publishes the FCPA Blog.
“The drug company allegedly arranged for
payments to doctors and medical officials
in exchange for them buying or recommending the drug company’s products.”
In January, China’s top judicial authorities
issued an updated interpretation on the
enforcement of bribery laws and set out
specific punishments for certain industries
and provided reduced sentences for suspects who confess. The life sciences industry was singled out. A number of systemic
factors make corruption more widespread
in China’s healthcare industry, including a
fragmented distribution system that leads
to large unwieldy sales forces and the low
pay of doctors and health officials who
supplement their income with benefits
from drug makers. Corporate travel agency
abuse also is common; many provide legitimate services, but using travel agencies is a
way for employees to circumvent company
procedures.
■■
■■
Stockholders in Novadel Pharma of
Bridgewater, N.J., approved the sale of
substantially all of the company’s assets to
Suda of Australia. However, not enough
stockholders gave approval for liquidation
and dissolution of the company and the
proposal did not pass. Novadel will therefore pursue other options.
London-based Redx Pharma is moving toward the launch of a third research
division, securing a conditional offer from
the U.K.’s Regional Growth Fund (RGF) for
a unit specializing in metabolic disease.
That will complement centers specializing
in oncology and anti-infectives, formed
with the company in late 2010 around
a drug modification and repurposing
platform spun out of AstraZeneca. Those
two centers employ about 100 staff each,
and Neil Murray, CEO of Redx Pharma,
said the metabolic unit is expected to be a
similar size. Murray said no private money
is required because the company is close to
signing its first out-licensing deal and has
others in negotiation. The new division will
be called Redx Metabolic, but Murray said
its scope will be wider, covering cardiovascular and inflammatory diseases. If the RGF
© 2013 CenterWatch. Duplication or sharing of this publication is strictly prohibited. grant is confirmed, Redx Metabolic will be
up and running by March 2014, with about
300 employees. If that rate of growth is
unusual for a biotech startup yet to land
its first deal, Murray said Redx is positioning itself in the space left vacant by recent
pharma restructurings.
■■
■■
Biogen Idec of Weston, Mass., said in a
report by Reuters News the death of a patient
who had taken its multiple sclerosis drug,
Tecfidera, was unlikely to be linked to the
compound. Biogen said it was made aware
of the death of a 59-year-old woman who
had been treated with Tecfidera, approved
by the FDA in March, and that it was actively
gathering facts about the case. In May,
Biogen delayed the European launch of
Tecfidera until the second half of this year to
clarify the drug’s regulatory data protection.
Analysts seemed generally unconcerned,
with Credit Suisse analyst Ravi Mehrotra calling news stories “a storm in a tea cup.”
Quest PharmaTech of Edmonton, Alberta,
entered a long-term strategic relationship
with AD Biotech of Chuncheon, South
Korea. AD Biotech has provided $2 million
in clinical development funding to Quest
and will provide up to $10 million more in
return for Quest common shares and future
revenue-sharing. The deal enables Quest
to fund its clinical development programs
and gives it access to AD Biotech’s antibody,
protein transduction domain and manufacturing technologies. The stories included in Biotech Review
have been provided to CenterWatch with
full permission of BioWorld Today and its
publisher, AHC Media LLC, 3525
Piedmont Road, Building 6, Suite 400,
Atlanta, GA 30305. Call (800) 688-2421
or (404) 262-5476 for more information,
www.bioworld.com.
©2013 AHC Media LLC
CWW1730
CWWeekly July 29, 2013
10 of 10
CWMarketPlace
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(617) 948-5100 or [email protected].
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COMMUNICATIONS
CONTRACT RESEARCH ORGANIZATIONS
Academic Network, a Stericycle Company
Westat
(503) 228-3217
[email protected]
www.academicnetwork.com
[ V I E W P R O FI LE ]
CONTRACT RESEARCH ORGANIZATIONS
Ancilla, LLC
[ V I E W P R O FI LE ]
Medpace Clinical Pharmacology
(513) 366-3220
[email protected]
www.medpacecpu.com
[ VI E W P R OFI L E ]
INVESTIGATIVE SITE NET WORK (NON SMO)
Criterium
(310) 377-7517
[email protected]
www.criteriuminc.com
(301) 294-4402
[email protected]
www.westat.com/clinical_trials
(404) 661-0657
[email protected]
[email protected]
[email protected]
[ VI E W P R OFI LE ]
Summit Research Network Management, Inc
[ V I E W P R O FI LE ]
(503) 972-9818
[email protected]
www.summitresearchnetwork.com
[ VI E W P R OFI LE ]
SITE MANAGEMENT ORGANIZATION (SMO)
REGISTRAT-MAPI
(859) 223-4334
[email protected]
www.registratmapi.com
Remington-Davis Clinical Research
[ V I E W P R O FI LE ]
(614) 487-2560
[email protected]
www.remdavis.com
[ VI E W P R OFI LE ]
TECHNOLOGY SOLUTIONS
Richmond Pharmacology Ltd
+44 (0) 20 8664 5200
[email protected]
www.richmondpharmacology.com
Patient Profiles
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