GVW Knowledge Digest_Apr'17_v04

GVW KNOWLEDGE DIGEST

April 2017

MAY 17, 2017

GVW TECHNOLOGIES PVT. LTD.
184-187, 1st Floor, Block # 1, Temple Steps, Little Mount, Anna Salai, Chennai–600 015INDIA

1 GVW – Knowledge Digest

Table of Contents

A. JnJ Announcements/Reorganization/People Movements .......................... 3
J&J Financial Standing:................................................................................................................... 3
J&J 2017 1ST Quarter Results ........................................................................................................ 4
J&J Completes Acquisition Of Abbott Medical Optics ................................................................ 5
J&J Reports That Investigational Ebola Vaccine Regimen Induced Durable Immune
Response 1 Year After Vaccination In Phase I Study ................................................................ 5
J&J Publishes Interim Result For Actelion Tender Offer And Declares The Tender Offer
Successful ......................................................................................................................................... 6

J&J Medical Devices Announces Intent To Close Manufacturing Site In Livingston,
Scotland............................................................................................................................................. 6

Johnson & Johnson to pay $148m to woman with ovarian cancer ..................... 6

Johnson & Johnson has been ordered to pay whopping $148m to a Viginia
women, who has claimed that she developed ovarian cancer after the use of
JnJ’s talcum powder for four decades................................................................... 6

Although the scientific agreement behind the lawsuit is still unclear, a Jury of
St.Louis emphatically sided with Ms. Slemp and declared $105m for Punitive
damages.................................................................................................................... 6

"Once again we've shown that these companies ignored the scientific
evidence and continue to deny their responsibilities to the women of America,"
Ted Meadows, a lawyer for the Victim, said in a statement.................................. 6

J&J in a statement said it sympathised with women impacted by ovarian
cancer but planned to appeal. "We are preparing for additional trials this year
and we continue to defend the safety of Johnson's Baby Powder...................... 7

J&J says 10 new drugs could bring in $1B each in sales .................................... 7

B. JnJ Product Competitors and Happenings.................................................. 7
Pfizer 2017 1st Quarter Results ...................................................................................................... 7
Merck 2017 1st Quarter Results ..................................................................................................... 7
Takeda Nix Launch After Gsk Ends Vaxem Hib Production ..................................................... 7
FDA Grants Bavencio® (Avelumab) Approval For A Common Type Of Advance Bladder
Cancer................................................................................................................................................ 9
Pfizer Unveils Atlas®, An Interactive, User-Friendly Website That Provides Global
Antibiotic Resistance Surveillance Data Across 60 Countries .................................................. 9
Pfizer’s Next-Generation Alk/Ros1 Inhibitor, Lorlatinib, Granted Breakthrough Therapy
Designation From Fda For Alk-Positive Metastatic Non-Small Cell Lung Cancer ...............10

Merck receives complete response letter from the u.s. Fda for tecos study with sitagliptin
.......................................................................................................................................................... 10

C. Competitor/Players in our Present & Future Scope-Mapping &
Announcements ..................................................................................................... 11

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2 GVW – Knowledge Digest

Formycon is aiming to bring the first Biosimilar of J&J’s immunology bestseller stelara ....11
Renflexis: 2nd Remicade Biosimilar Gains FDA Approval ......................................................11
Johnson & Johnson's new black-box warning on Invokana could boost its Lilly,
AstraZeneca rivals .........................................................................................................................11
Astrix Technology Group:..................................................................................................................12
D. Systems Players Announcements/ Happenings/ Wins ............................. 13
ACD/Labs Introduces New Product For Managing Impurity Profile Information ..................13
LABVANTAGE Version 8.2 In To The Market!! .........................................................................13
New Field Analytics System For Matrix Gemini LIMS Extends Use To The Field ...............13
STARLIMS Version 11.4 ...............................................................................................................14
Thermo Fisher SCIENTIFIC Acquires Core Informatics ..........................................................14
E. Interesting Case Studies on Their Implementation ................................... 14
1 Victorious Win Out Of 100 LIMS Vendors Assessment – Implementation To Improve Lab
Operations Efficiency.....................................................................................................................14
Significant Efficiencies In Pharma / Biopharma Manufacturing – Chromeleon Cds Software
Implementation ...............................................................................................................................15
F. Coverage of Research reports / Journal articles .......................................... 16
Drug Discovery – Modern Trends................................................................................................16
................................................................................................................................. 16
9 Inventions Of J&J That Changed Life As We Know It!..........................................................16
LIMS Market: Global Industry Analysis And Opportunity Assessment 2016-2026 ..............17
FDA – Up-To-Date News! .............................................................................................................17
The Rise Of Analytics In Pharma Industry .................................................................................18
Year 2017 – An Year To Watch Out For Biosimilars ................................................................18
G. Event Presentations/Key Information......................................................... 19
JNJ Event Participations: ..............................................................................................................19

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A. JnJ Announcements/Reorganization/People Movements

J&J Financial Standing:

Source Credits: Morningstar
More..

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4 GVW – Knowledge Digest

J&J 2017 1ST Quarter Results

2017 First-Quarter Sales of $17.8 Billion Increased 1.6% versus 2016

2017 First-Quarter EPS was $1.61

2017 Adjusted First-Quarter EPS of $1.83 Increased 5.8%*

J&J in April, announced sales of $17.8 billion for the first quarter of 2017, an increase of
1.6% as compared to the first quarter of 2016. Operational sales results increased 2.0% and
the negative impact of currency was 0.4%. Domestic sales increased 0.6%. International
sales increased 2.8%, reflecting operational growth of 3.6% and a negative currency impact
of 0.8%. Excluding the net impact of acquisitions and divestitures, on an operational basis,
worldwide sales increased 1.2%, domestic sales decreased 0.7% and international sales
increased 3.4%.*

The Company is now including the estimated impact of the Actelion transaction in its
financial guidance. As such, the Company increased its sales guidance for the full-year 2017
to $75.4 billion to $76.1 billion. Additionally, the Company increased its adjusted earnings
guidance for full-year 2017 to $7.00 - $7.15 per share.*

Worldwide operational results, excluding the net impact of acquisitions and divestitures,
were negatively impacted by LISTERINE® oral care products, baby care products, and
wound care products, partially offset by growth in over-the-counter products, including
domestic TYLENOL® analgesics.

Strong growth in new products include DARZALEX® (daratumumab), for the treatment of
patients with multiple myeloma and IMBRUVICA® (ibrutinib), an oral, once-daily therapy
approved for use in treating certain B-cell malignancies, a type of blood or lymph node
cancer. Additional contributors to operational sales growth included
STELARA® (ustekinumab), a biologic for the treatment of a number of immune-mediated
inflammatory diseases, and INVEGA® SUSTENNA®/XEPLION®/TRINZA® (paliperidone
palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia
in adults.

During the quarter, the Company announced a definitive agreement to acquire Actelion Ltd.,
a leading biopharmaceutical company, for approximately $30 billion.

Also in the quarter, the Committee for Medicinal Products for Human Use of the European
Medicines Agency issued a positive opinion recommending broadening the existing
marketing authorization for DARZALEX® (daratumumab) for use in combination with
lenalidomide and dexamethasone; or bortezomib and dexamethasone, for the treatment of
multiple myeloma in patients who have received at least one prior therapy. A supplemental
New Drug Application was submitted to the U.S. Food and Drug Administration
for IMBRUVICA® (ibrutinib) for the treatment of chronic Graft-Versus-Host Disease after
failure of one or more lines of systemic therapy.

In April, subsequent to the quarter, a marketing authorization application was submitted to
the European Medicines Agency for ZYTIGA® (abiraterone acetate) to expand the existing
indication to include treatment of men with newly diagnosed high-risk metastatic hormone
sensitive prostate cancer.

Worldwide Medical Devices sales of $6.3 billion for the first quarter 2017 represented an
increase of 3.0% versus the prior year consisting of an operational increase of 3.4%

During the quarter, the company completed the acquisition of Abbott Medical Optics, a
wholly-owned subsidiary of Abbott and global leader in ophthalmic surgery, for
approximately $4.3 billion.

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Additionally, the acquisitions of Megadyne Medical Products, Inc., a privately held medical
device company that develops, manufactures and markets electrosurgical tools, and Torax
Medical Inc., a privately held medical device company that manufactures and markets the
LINX™ Reflux Management System for the surgical treatment of gastroesophageal reflux
disease, were completed.
In April, after the quarter, the acquisition of Neuravi Limited, a privately held medical device
company that develops and markets medical devices for neurointerventional therapy, was
completed. More..

Source Credits: Prnewswire

J&J Completes Acquisition Of Abbott Medical Optics

J&J Vision will reach more patients globally with expansion into cataract surgery. J&J
acquired Abbott Medical Optics (AMO) in Feb 2017, a wholly-owned subsidiary of Abbott.
The all-cash $4.325 billion acquisition was originally announced in Sept. 16, 2016, and
includes ophthalmic products in 3 areas of patient care: cataract surgery, laser refractive
surgery and consumer eye health. These product lines will now join with the world-leading
ACUVUE® Brand Contact Lenses business, and the combined organization will operate
under the brand name Johnson & Johnson Vision (J&J Vision). More..

Source Credits: Prnewswire

J&J Reports That Investigational Ebola Vaccine Regimen Induced Durable Immune
Response 1 Year After Vaccination In Phase I Study

Based on final Phase I data published in JAMA, prime-boost Ebola vaccine regimen induced
antibody response that persisted in 100% of healthy volunteers to at least 1 year following
vaccination

J&J announced that final Phase I clinical trial data published in JAMA: The Journal of the
American Medical Association show that Janssen Pharmaceutical Companies’
investigational “prime-boost” Ebola vaccine regimen induced a durable immune response in
100% of healthy volunteers 1 year following vaccination.

The Phase 1 study was led by the Oxford Vaccine Group at the University of Oxford. It
tested the prime-boost Ebola vaccine regimen being developed by Janssen Vaccines &
Prevention B.V. that is based on Janssen’s AdVac® technology and MVA-BN® technology
from Bavarian Nordic A/S. Healthy volunteers were given 1 vaccine dose to prime their
immune system, and the alternative vaccine to boost their immune response. Additional
Phase I, II and III studies are ongoing to confirm these findings.

Janssen in partnership with Bavarian Nordic rapidly scaled up production of the vaccine
regimen and now has approximately 1,800,000 regimens available, with the capacity to
produce several million regimens if needed. More..

Source Credits: Prnewswire

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J&J Publishes Interim Result For Actelion Tender Offer And Declares The Tender
Offer Successful

JNJ announced in March 2017, that its Swiss subsidiary, Janssen Holding GmbH
("Janssen"), published the provisional notice of the interim result of its all-cash public tender
offer in Switzerland to acquire all publicly held shares of Actelion Ltd (("Actelion") SIX: ATLN)
for $280 per share, payable in U.S. dollars, per the offer prospectus of February 16, 2017.

At the expiration of the main offer period on March 30, 2017, 10:00 a.m. EDT, 4:00
p.m. CEST, a total of 78,629,955 Actelion shares were tendered, corresponding to 73.25%
of the 107,339,642 Actelion shares covered by the tender offer. Including the Actelion shares
tendered, Janssen and Actelion, a person acting in concert with Janssen, held as of the end
of the main offer period 83,195,346 Actelion shares, corresponding to 77.20% of the voting
rights and the share capital of Actelion.

As previously announced, as part of the transaction, Actelion will spin out its drug discovery
operations and early-stage clinical development assets into a newly created Swiss
biopharmaceutical company ("Idorsia Ltd"). The shares of Idorsia Ltd are expected to be
distributed to Actelion's shareholders as a dividend in kind and listed on the SIX Swiss
Exchange on the day of the settlement of the tender offer. Johnson & Johnson will initially
hold 16 percent of the shares of Idorsia Ltd and have rights to potentially increase to 32
percent through a convertible note. More..

Source Credits: Prnewswire

J&J Medical Devices Announces Intent To Close Manufacturing Site In Livingston,
Scotland

J&J Medical Devices announced it has initiated the consultation process with regional and
local works councils to propose its intent to close the Ethicon “Kirkton” manufacturing site in
Livingston, Scotland.

According to a company press release, the closing of the manufacturing site is part of a
global restructuring effort J&J Medical Devices (JJMD) announced in January 2016. This
closing could affect approximately 400 employees. More..

Source Credits: Haelio

Johnson & Johnson to pay $148m to woman with ovarian cancer

Johnson & Johnson has been ordered to pay whopping $148m to a Viginia women, who has
claimed that she developed ovarian cancer after the use of JnJ’s talcum powder for four
decades.
Although the scientific agreement behind the lawsuit is still unclear, a Jury of St.Louis
emphatically sided with Ms. Slemp and declared $105m for Punitive damages.
"Once again we've shown that these companies ignored the scientific evidence and continue
to deny their responsibilities to the women of America," Ted Meadows, a lawyer for the
Victim, said in a statement.

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7 GVW – Knowledge Digest

J&J in a statement said it sympathised with women impacted by ovarian cancer but planned
to appeal. "We are preparing for additional trials this year and we continue to defend the
safety of Johnson's Baby Powder.

Source Credits:
a) https://www.classaction.com/talcum-powder/settlement/
b) https://www.sciencealert.com/record-compensation-payout-by-johnson-johnson-in-a-
case-linking-talc-with-cancer

J&J says 10 new drugs could bring in $1B each in sales

B. JnJ Product Competitors and Happenings

Pfizer 2017 1st Quarter Results
1st-Quarter 2017 Revenues of $12.8 Billion, Reflecting 1% Operational Decline,
Unfavourably Impacted by One Less U.S. Selling Day and Two Fewer International Selling
Days Compared to the Prior-Year Quarter
On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor). On September
28, 2016, Pfizer acquired Medivation, Inc. (Medivation). On February 3, 2017, Pfizer
completed the sale of its global infusion therapy net assets, Hospira Infusion Systems (HIS)
More..
Source Credits: Pfizer

Merck 2017 1st Quarter Results

Worldwide sales were $9.4 billion for the 1st quarter of 2017, an increase of 1 percent
compared with the 1st quarter of 2016, including a 2 percent negative impact from foreign
exchange.

GAAP (generally accepted accounting principles) earnings per share assuming dilution
(EPS) were $0.56 for the 1st quarter of 2017. Non-GAAP EPS of $0.88 for the 1st quarter of
2017 excludes acquisition- and divestiture-related costs, restructuring costs and certain
other items. More..
Source Credits: Merck

Takeda Nix Launch After Gsk Ends Vaxem Hib Production
Takeda has revealed in a release that its plan to launch a Haemophilus influenzae type B
(Hib) vaccine in Japan has been terminated. GlaxoSmithKline, the only manufacturer of the
vaccine, has ended production of Vaxem Hib. Currently only marketed in South Korea,
Vaxem Hib was manufactured at GSK's Rosia, Italy facility.
In early 2016, Takeda won approval for Vaxem Hib in children from 2 months old to under 5
years old in Japan and today was ready to launch until GSK pulled the plug. According
to Takeda, it proposed other solutions that were deemed unfeasible by GSK.

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In 2009, Takeda acquired the rights to Vaxem Hib in Japan from Novartis and in 2015, the
vaccine rights were transferred to GSK.
Source Credits: Takeda

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9 GVW – Knowledge Digest

FDA Grants Bavencio® (Avelumab) Approval For A Common Type Of Advance
Bladder Cancer
2nd Approval for Bavencio® (Avelumab) in less than 2 months , for the treatment of
Urothelial carcinoma, injection for the treatment of patients with locally advanced or
metastatic urothelial carcinoma (UC) which is a disease progression followed by the
platinum containing chemotherapy.
The announcement was made by EMD Serono, the biopharmaceutical business of Merck
KGaA, Darmstadt, Germany, in the US and Canada and Pfizer Inc.
In December 2015, Merck KGaA, Darmstadt, Germany and Pfizer announced the initiation of
a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN
Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as
a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma
whose disease did not progress after completion of 1st-line platinum-containing
chemotherapy. This trial is currently enrolling patients.
According to Merck, the wholesale price for Bavencio based on an average bladder cancer
patient will be about $2,000 a month less than what AstraZeneca will charge for its Imfinzi
treatment. More..
Source Credits: Pfizer, unknown

Pfizer Unveils Atlas®, An Interactive, User-Friendly Website That Provides Global
Antibiotic Resistance Surveillance Data Across 60 Countries
Pfizer Inc. announced the launch of the company’s Antimicrobial Testing Leadership and
Surveillance (ATLAS) website, which is designed to provide physicians and the global health
community with easy access to critical data on the efficacy of various antibiotic treatments
and emerging resistance patterns across more than 60 countries. Understanding evolving
bacterial resistance patterns is a key element in managing the rise of antimicrobial
resistance. To that end, ATLAS can not only help physicians select the most appropriate
treatment choices for their patients, but also enable global health authorities to develop data-
driven antimicrobial resistance mitigation strategies.
ATLAS offers an interactive platform that enables physicians to evaluate data, conduct
analyses, and export tables and figures that include parameters such as pathogen, region,
specimen source and in vitro susceptibility data. The ATLAS database is updated every six
months with new resistance data from healthcare institutions in more than 60 countries as
these become available. More..
Source Credits: Pfizer

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10 GVW – Knowledge Digest

Pfizer’s Next-Generation Alk/Ros1 Inhibitor, Lorlatinib, Granted Breakthrough Therapy
Designation From Fda For Alk-Positive Metastatic Non-Small Cell Lung Cancer
Pfizer Inc. today announced that its investigational next-generation ALK/ROS1 tyrosine
kinase inhibitor, lorlatinib, was granted Breakthrough therapy designation from the U.S. FDA
for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-
small cell lung cancer (NSCLC), previously treated with one or more ALK inhibitors.
Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough
Therapy designation is intended to expedite the development and review of a potential new
medicine if it is intended to treat a serious or life-threatening disease. The Breakthrough
Therapy designation is distinct from the FDA’s other mechanisms to expedite drug
development and review. ALK gene rearrangement is a genetic alteration that drives the
development of lung cancer in some patients. Due to additional mutations that the tumour
may acquire during treatment, disease progression remains a challenge in patients with
ALK-positive metastatic NSCLC.5
The Breakthrough Therapy designation is supported by the efficacy and safety data of an
ongoing Phase 1/2 clinical trial of lorlatinib, which includes patients with ALK-positive
NSCLC who were previously treated with one or more ALK inhibitors. More..
Source Credits: Pfizer

Merck receives complete response letter from the u.s. Fda for tecos study with
sitagliptin
Merck, known as MSD outside the United States and Canada, announced that the U.S.
Food and Drug Administration (FDA) has issued a Complete Response Letter regarding
Merck’s Supplemental New Drug Applications for JANUVIA® (sitagliptin),
JANUMET® (sitagliptin and metformin HCl) and JANUMET XR® (sitagliptin and metformin
HCl extended-release). With these applications, Merck is seeking to include data from
TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing
information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss
next steps with the FDA.
Januvia is available in 3 different formulations, 25 mg, 50 mg and 100 mg tablets. More..
Source Credits: Merck

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C. Competitor/Players in our Present & Future
Scope-Mapping & Announcements

Formycon is aiming to bring the first Biosimilar of J&J’s immunology bestseller
stelara

While there are many companies competing over the JnJ’s hit drug Remicade , Germany’s
Formycon has taken another turn and decided to target a third wave biosimilar (more
complex, and potentially multi-subunit molecules) STELARA.

Stelara is a human monoclonal antibody. Since 2009, the drug has been used to treat
various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its
indications were extended, allowing Stelara to also be used for the treatment of Crohn’s
disease. Formycon has announced FYB202 as the Biosimilar Candidate for Stelara and it is
expected to hit the US market by 2023

Source Credits:

a) http://www.biopharma-reporter.com/Markets-Regulations/Formycon-taking-on-J-J-s-
Stelara-in-third-wave-biosimilar-strategy

b) http://www.formycon.com/en/products/pipeline/

Renflexis: 2nd Remicade Biosimilar Gains FDA Approval

FDA has approved Renflexis (infliximab-abda), a tumor necrosis factor (TNF) blocker from
Samsung Bioepis that is biosimilar to Remicade (Infliximab). Renflexis, given as an
intravenous infusion, is indicated for the treatment of Crohn’s disease, ulcerative colitis,
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The
biosimilar must be shown to have no clinically meaningful differences in terms of safety and
effectiveness from the reference product Remicade. Only minor differences in clinically
inactive components are allowable in biosimilar products. The 1st biosimilar to Remicade,
Pfizer’s Inflectra (infliximab-dyyb) was approved by the FDA in April 2016. More..

Source Credits: Medscape

Johnson & Johnson's new black-box warning on Invokana could boost its Lilly,
AstraZeneca rivals

On May 16, 2017 the FDA has concluded that the SGLT2 drug - Invokana along with related
combos caused increased risk of foot and leg amputation based on the “MedWatch safety
alert”, where it was reported that the patients has suffered amputation twice as the patients

in placebo group during a study.

As a result, the Regulators are requiring JnJ to add a black box to the drug (A black box
warning is the strictest warning put in the labeling of prescription drugs or drug products by
the Food and Drug Administration (FDA) when there is reasonable evidence of an
association of a serious hazard with the drug.)This issue might trigger the physicians to
switch from Invokana to Jardiance or AstraZeneca’s SGLT2 entrant, Farxiga,

Source Credits:

http://www.fiercepharma.com/

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12 GVW – Knowledge Digest

Astrix Technology Group:
Astrix Technology Group is an informatics consulting, professional services and staffing
company servicing the scientific & engineering communities with offices all over US.
Headquarter: New Jersey
Company Size: 500-1000 Employees
Professional Services:

Strategic Planning: Technology selection:

 Business case assessment  Prepare and evaluate “Request for
 Laboratory efficiency assessment proposal (RFP)”
 Systems and technology assessments
 Compliance assessment  “As –Is “ and “To-Be” workflow maps
 Architectural assessment  User requirement specification
 Vendor Evaluation Matrix

LIMS Implementation: Managed Services:

 Business requirement Analysis  Lab Side support
 Project Management  Remote help desk for device and Lab
 Data migration
 User training systems
 Computer system validation  Enterprise Application Lifecycle
 Enterprise Resource Planning
 Customer relationship management Support for Lab Systems
 Quality management systems  Design and implementation
 Document management systems  Organizational Change Management

Scientific Technology management:

 LIMS
 ELN
 LES
 CDS
 SDMS
 Supply Chain & Manufacturing Systems
 Document Management / Knowledge Management
 Database Design, Development, and Optimization

Tools

Major Customers:

AbbVie AstraZeneca Bristol-Myers Squibb

Alcon Genentech Johnson & Johnson

Allergan Merck Novartis

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D.Systems Players Announcements/ Happenings/ Wins

ACD/Labs Introduces New Product For Managing Impurity Profile Information

ACD/Labs, an informatics company that develops and commercializes solutions in support
of chemical and pharmaceutical R&D, announced Luminata™, an informatics system that
enables organizations to establish effective impurity control strategies. This is accomplished
through the assembly analytical, chemical, and process information—all in a single
enterprise informatics environment.

Luminata offers data standardization and visualization for comprehensive substance
impurity characterization as well as the associated formation and fate of impurities, with
chromatographic and spectral data.

Through efficient assembly of data for easy presentation to regulatory bodies, Luminata suits
Quality by Design (QbD) approaches in accordance with various industry practices and
regulatory requirements. More..

Source Credits: ACD/Labs

LABVANTAGE Version 8.2 In To The Market!!

LabVantage Solutions, the leading global laboratory informatics provider, has introduced
LabVantage 8.2, with added features that support electronic laboratory notebooks, method
execution worksheets, biobanking, and environmental monitoring applications to provide
advanced solutions for laboratories.

New Features of LabVantage 8.2 include:

 Plate management improvements

 Storage Explorer on the BioBanking module

 Fully embedded Electronic Lab Notebook

 Lab Method Execution System

 Updated Mobile enhancements

More..

Source Credits: LabVantage

New Field Analytics System For Matrix Gemini LIMS Extends Use To The Field

The new Matrix Gemini Field Analytics System from Autoscribe Informatics extends the
use of the LIMS (Laboratory Information Management System) to the field. Further
enhancing remote access capabilities for Matrix Gemini, the new Field Analytics System
allows test data to be recorded off-line and uploaded to the LIMS when an internet
connection can be re-established.

The Field Analytics System is designed to operate on an Android tablet or mobile device and
sync with the Matrix Gemini LIMS database. It enables users to select and download the
sample information they want from Matrix Gemini. The sample data can be edited and
relevant test results recorded off-line.

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14 GVW – Knowledge Digest

Results are automatically checked as they are entered to ensure they are a valid type
(numeric, test etc.). Updated results are stored until an Internet or mobile data connection
becomes available and it is convenient to upload the data to the Matrix Gemini LIMS
database server.
More..
Source Credits: Autoscribe Informatics

STARLIMS Version 11.4
Abbott Informatics announced the launch of version 11.4 of the world-class STARLIMS
laboratory information management system (LIMS). It includes a completely remodeled
HTML5 subsystem to improve functionality across the board, and support desktop, server
and mobile operating systems and technologies.
Key features include enhanced cyber security and Advanced Analytics (version 10.2), the
latest SDMS (Scientific Data Management System, version 1.8), and faster, more intuitive
performance. More..
Source Credits: Abott Informatics

Thermo Fisher SCIENTIFIC Acquires Core Informatics

Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it
has acquired Core Informatics, which provides a leading cloud-based platform supporting
scientific data management. Core’s offerings will significantly enhance Thermo Fisher’s
existing informatics solutions and complement its cloud platform, which supports the
company’s genetic analysis, qPCR and proteomics systems.
Core’s capabilities include laboratory information management systems (LIMS), electronic
laboratory notebook (ELN) technologies and scientific data management solutions (SDMS).
Core Informatics’ state-of-the-art laboratory data-management solutions are used by leading
biopharma, genomics and other scientific and industrial organizations. More..
Source Credits: Thermo Fisher Scientific

E. Interesting Case Studies on Their Implementation

1 Victorious Win Out Of 100 LIMS Vendors Assessment – Implementation To Improve
Lab Operations Efficiency
Benefited Company Overview:

 ISO/IES 17025:2005 accredited laboratories
 Microbiological testing and analytical services for the Food & Beverage industry
 Uses Validated Methods - AOAC, USDA, AOCS, FDA, ASTA, USP
 Offers range of auditing services for food safety and quality programs
Key Challenges:

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15 GVW – Knowledge Digest

1. Outdated, heavily customized LIMS
2. Expanding need for a robust solution
3. To support frequent customer audits
4. To connect sophisticated lab instruments
Implemented LIMS Features:
 Best Value – Flexibility, Responsiveness, Up-front Price, On-going Maintenance

Costs.
 Ability to handle complex and emerging business needs
 Flexible Sample Types – Reduced Erroneous Test Assignments
 50% Less Time for Page Refresh
 Option to enter multiple data in the same screen
 No Performance compromise with 50+ concurrent usage
 Traceability for Audit purpose
Source Credits: LabVantage

Significant Efficiencies In Pharma / Biopharma Manufacturing – Chromeleon Cds
Software Implementation
Benefited Company Overview:

 Synthesis and separations services to pharmaceutical and biotechnology companies
 14 HPLC and 6 GC systems
 800 test methods and 300 validated methods in use.
 Two-shift operation.
 20 to 30 different projects/ customers in a year
Key Challenges:
1. Large monetary investments for maintaining previous systems
2. Time-invested and Paper based system
3. Runs a two-shift operation, there was always an 8-hour period/day when analyses

would run but could not be monitored.
4. Reporting is cumbersome, different parts come from different sources
Implemented CDS Features:
 Cobra Wizard integration tool – correct setup of peak detection parameters
 System Suitability Testing (SST) piece within Processing Method – Inbuilt 100+ SST

calculations, Automated SST Performance or Abortion if any fails
 Real-time MiniPlot thumbnail images of the chromatography run
Source Credits: ThermoFischer Scientific

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16 GVW – Knowledge Digest

F. Coverage of Research reports / Journal articles

9 Inventions Of J&J That Changed Life As We Drug Discovery – Modern Trends
Know It!
 Development of nanomaterials for
1. When the company started mass-producing bone-targeted drug delivery – Nano
sterile sutures in 1887, it contributed to the advent
of modern antiseptic surgery, which helped reduce delivery systems can target bone cells and
infections and dramatically increased survival rates subcellular organelles. Nanomaterials can target
bone by oral, implant, injectable, and
2. Before J&J introduced new manufacturing transdermal route.
innovations enabling it to produce white absorbent
cotton, surgeons had to use cotton that wasn’t  Structure and dynamics of the
snowy white and sterile insulin receptor: implications for
receptor activation - A new proposed
3. In 1888, the company started making 1st aid kits,
packed with things like bandages and gauze “bow-arrow” model for conformational changes
in insulin receptor. interpretation through docking
4. Dentists everywhere have the company to thank simulations.
for mass-produced dental floss, which J&J 1st
manufactured using leftover suture silk  Animal models of pain and migraine
- Adding 1-to-2 models to discovery platforms
5. J&J began selling disposable sanitary napkins
back in 1896 could enhance drug development in each area

6. A J&J employee came up with the idea for  Minimizing the risk of chemically
BAND-AID® Brand Adhesive Bandages after reactive metabolite formation of new
noticing that his wife needed a way to protect cuts drug candidates - implications for
she got while working in the kitchen
preclinical drug design - Avoidance strategy
7. In 1982, J&J helped make Over-The-Counter widely applied in industry at initial stages of drug
medications safer when it invented safety-sealed, discovery. In vitro assays support rational drug
tamper-resistant packaging design for optimized compounds

 Targeting amino acid metabolism for
cancer therapy - Specific metabolic

pathways can be inhibited for cancer therapy.
Microenvironment and culture conditions
significantly impact metabolic phenotype More..

Source Credits: PubMed

8. During World War II, the company began manufacturing waterproof duct tape, which
soldiers used to repair everything from tents to boots

9. The company revolutionized the vision care industry when it debuted the 1st disposable
contact lenses that could be worn for up to a week. More..

Source Credits: JNJ

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17 GVW – Knowledge Digest

LIMS Market: Global Industry Analysis And Opportunity Assessment 2016-2026
LIMS has become a valuable tool for transferring information, gathering, decision making,
calculation, review. LIMS is a software based Laboratory Information Management System
which enables support modern laboratory operations. LIMS has its broad range of applications
in various fields such as Environmental Sciences, Pharmaceuticals, Petrochemicals. LIMS
provides its applications in Sample Management, Data Mining, Data Analysis and Electronic
Laboratory Network. In Pharmaceutical sector, LIMS provides enormous applications such as
test library included as standard functionality, Dissolution, Disintegration, Dosage Uniformity,
Drug Release, Product Assays and Stability Modules that simplifies Stability Studies. Some of
the key players in LIMS Market are Thermo Fisher Scientific, Inc., Siemens SA, Perkin Elmer
Inc., Labware, Star LIMS (Abbott Laboratories, Abbott Park, U.S.A), Genologics (Illumina,
Inc.), Promium LLc. LabLynx Inc., Autoscribe Informatics, Novatek International, Core
Informatics etc. More..
Source Credits: Future market insights

FDA – Up-To-Date News!
 Approvals:
o New combination treatment for acute myeloid leukemia;
o 1st treatment for a form of Batten disease
o 1st drug to treat tardive dyskinesia
o 2 hepatitis C drugs for paediatric patients
 Expands approved use of Stivarga to treat liver cancer
 Acts against 14 companies for selling illegal cancer treatments
 Statement from Douglas Throckmorton, M.D., Deputy Centre Director for Regulatory
Programs, Centre for Drug Evaluation and Research, on new warnings about the use
of Codeine and Tramadol in children & nursing mothers
 Allows marketing of 1st whole slide imaging system for digital pathology
 Allows marketing of 1st direct-to-consumer tests that provide genetic risk information
for certain conditions
More..

Source Credits: FDA

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18 GVW – Knowledge Digest

The Rise Of Analytics In Pharma Industry

The pharma industry is at the initial stages of a fundamental shift as so-called Enterprise
Analytics and Advanced Data Sciences are embedded across the value chain to influence
business decision making at all levels. This is being done using new methods for rapid
acquisition, curation, analysis, and visualization of large, diverse data sets in cloud-based
storage and distributed computing power platforms.

In one case, a pharma company wanted to better understand the reasons for a promising
cancer drug failure in multiple Phase III trials — that is, late in development — and to
identify patient subpopulations to inform future R&D efforts. Using Advanced Analytics
techniques, the patients were segmented into subpopulations based on Gene Expression
and Mutation Signatures that demonstrated drastically different survival rates (greater than
5 times). Based on this research, the factor that drove the failure of earlier trials was also
effectively identified, also several potentially valuable biomarkers and new targets were
identified. This type of investigation would have been impossible just 10 years ago
because the data and strategies for analysing data with such specificity were at a nascent
stage.

Functions of Enterprise Analytics program in Pharma:

R&D: Optimize design of clinical trials by targeting specific patient subpopulations

Commercial: Inform pricing, market access, contracting strategy, and identification of treatable
patients, all of which are critical to gain “profitable share” in competitive markets

Risk and Compliance: Enable Quality and Compliance functions to monitor risks in real time,
identify outliers, and better allocate resources

Supply Chain: Enhance management of complex, global supply chains by predicting security and
supply risks and quantitatively assessing vendor performance

More..

Source Credits: strategy&

Year 2017 – An Year To Watch Out For Biosimilars

The U.S. pharmaceutical industry entered 2016 with one biosimilar, Sandoz’s Zarxio
(filgrastim). Now, in 2017, the U.S. has seen the arrival of its newest biosimilar on the market,
Pfizer’s Inflectra (infliximab), as well as the approval of its 3rd (Etanercept) and 4th
(Adalimumab) biosimilars. The EU, which currently has 20+ biosimilars approved, continues
to see marketing authorization application submissions and varying levels of biosimilar uptake
among its member countries. According to GPhA CEO Chip Davis, biosimilars have been
deemed the top growth driver for the pharmaceutical industry in 2017. But there’s still a long
way to go before the industry sees widespread uptake of biosimilars. As such, stakeholder
education to build confidence in these treatments remains a primary goal for the industry in
2017. In addition, the complexity of the legal landscape and the payer system, specifically in
the U.S., will be prime challenges facing companies planning to bring a biosimilar to the market
in the year 2017.

More..

Source Credits: Life Science Leader

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19 GVW – Knowledge Digest

G.Event Presentations/Key Information

JNJ Event Participations: Events:

- Participates in UBS Global Healthcare Conference 1: Outsourced Pharma
Conference - Tuesday, May 23, at the Grand
Hyatt New York , will be represented by Dominic The Agenda: An Early Start on Drug
Caruso, Executive VP, CFO, More.. Development and Manufacturing
Outsourcing
- Jefferies 2017 Global Healthcare Conference -
Thursday, June 8, at the Grand Hyatt New York, When? 22 Aug 17
will be represented by Alex Gorsky, Chairman
and CEO, More.. Where? San Diego, CA

- Barclays Global Healthcare Conference - Nature: Learning / Knowledge
Tuesday, Mar. 14, at the Loews Miami Beach enriching
Hotel, Miami, FL. – will be represented by
Jennifer Taubert, Company Group Chairman. Need: Sizable number of GVW
More.. prospects might participate, more
related to Biz opportunities in Drug
Source Credits: Prnewswire development

More..

For further information, please contact Pre-Sales desk
Suggestions and comments are always welcome
Please reach out to us @ [email protected]
Credits:
Content – Minu (A), Sreenidhi (B), LASS(C), Abarna (D,E), Seema (F), Jonisha, Minu (G)
Formatting - Lakshmi

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