Two Day Course: Signal Detection and Regulatory Expectations (London, United Kingdom – November 25-26, 2018) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Signal
Detection and Regulatory Expectations”
conference has been
added to ResearchAndMarkets.com’s offering.

Featuring signal evaluation for both innovator and generic products
under the newly revised Module IX Signal Management and quantitative
assessments.

Increasingly the most common critical findings in Regulatory Inspections
are being given for signal detection and management – so the need to
identify potential signals and risks in patients has never been greater.
The protection of patients through robust and clear methodologies for
signal detection amidst the ever increasing regulations requires that
Companies need to have trained and competent staff to perform such
activities. This course will provide a detailed overview of all aspects
of safety reviews and signal detection within a Company and will cover
signal evaluation for both innovator and generic products under the
newly revised Module IX Signal Management and quantitative assessments.

Benefits in attending:

  • Clarify the EU regulatory requirements for signal detection
  • Understanding the new frequency requirements for safety review
  • How to use the Eudravigilance quantitative signal tool
  • Understand the safety review cycle and the safety review meeting and
    process
  • Discuss safety communication – the CCSI/SCSI and labelling
  • Gain a better understanding of risk benefit analysis – benefit-risk
    assessments and benefit-risk outcomes

Who Should Attend:

This course will be of interest to those working in drug
safety/pharmacovigilance as well as Regulatory personnel responsible for
amending the labelling for products and for the production of the
CCSI/DCSI.

Agenda:

Day One

An introduction to safety signals

  • History of safety signals
  • The nature of safety signals
  • The definition of safety signals
  • Safety sources for signal detection

Causality and signal detection

  • Causality assessments for signal review
  • Data quality in safety assessments
  • Causality versus incidence (DMEs and IMEs)

Generic and innovator products

The safety review meeting and process

  • Setting up a safety review
  • Risk determinations for a safety review signal trackers
  • Information and templates for safety review
  • Logistical safety and product safety
  • Information from safety reviews

Safety assessments life cycle

  • Pre-clinical safety
  • Clinical safety
  • Class related safety issues
  • Post-marketing safety
  • Product suspensions and withdrawals

Safety assessments life cycle continued

The regulatory requirements for signal detection – Module IX

  • The frequency of safety reviews (risk assessment)
  • The EU and signal detection requirements
  • The USA requirements for signal detection
  • Signal detection and benefit-risk assessments
  • The regulators and signals

The signal review cycle

  • Safety profiling
  • Signal detection, validation, confirmation
  • Analysis and prioritisation, assessment
  • Recommendation for action

Day Two

Quantitative and qualitative signal detection

  • Standard MedDRA queries (SMQs) and signal detection
  • ICSRs and case quality
  • Follow up methodology and regulatory requirements
  • Events of special interest

Signals and their discussion

  • Signals and DSURs
  • Signals and PSURs / PBRERs
  • Signals and risk management plans / REMs and minimisation
  • Signals and labelling

Safety communication

  • The CCSI / DCSI and labelling
  • Triaging for safety amendments
  • Emerging safety issues
  • Urgent safety restrictions
  • Product suspension and withdrawal

Quantitative signal analysis

  • Signal detection methodologies
  • Background – why quantitative signal detection?
  • Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
  • Regulatory and industry activity (including Eudravigilance)

EVDAS and the EU

  • The PRAC and signals
  • The EVDAS system
  • Signals arising from EVDAS

Risk benefit analysis

  • Calculating the extent of benefit by indication
  • Identifying significant product risks
  • Benefit-risk assessments
  • Benefit-risk outcomes
For more information about this conference visit https://www.researchandmarkets.com/research/gnxxs4/two_day_course?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceuticals

Global Cognition Supplements Market 2018-2022 to Post a CAGR of 14% CAGR Over the Next Four Years | Technavio

LONDON–(BUSINESS WIRE)–#Food–The global cognition supplements market is expected to post a CAGR of
close to 14% during the period 2018-2022, according to the latest market
research report by Technavio.


A key factor driving the growth of the market is the increasing
preference towards maintaining a healthy lifestyle. Increasing health
consciousness among people has led to a higher consumption of foods that
provide greater health benefits. With an aim to lead a disease-free
life, people are increasingly engaging in physical activities, and
choosing organic and homemade food. This has also increased the
consumption of dietary supplements that help maintain the daily dose of
vital nutrients required by the body and are, therefore, associated with
good health. Therefore, with changes such as these, the market is
expected to show a positive outlook over the next few years.

This market research report on the global
cognition supplements market 2018-2022
also provides an analysis
of the most important trends expected to impact the market outlook
during the forecast period. Technavio classifies an emerging trend as a
major factor that has the potential to significantly impact the market
and contribute to its growth or decline.

This report is available at a USD 1,000 discount for a limited time
only:
View
market snapshot before purchasing

In this report, Technavio highlights the increasing growth and
acceptance of e-commerce as one of the key emerging trends in the global
cognition supplements market:

Global cognition supplements market: increasing
growth and acceptance of e-commerce

The proliferation of e-commerce platforms and the increasing number of
consumers shopping on these platforms have simplified the diffusion
process of adoption. Consumers can easily navigate through these
platforms and access a wide range of products. Growing e-commerce
provides an opportunity for vendors to open their own online portals to
ease the customers’ shopping experience showcase their product line and
improve their visibility by representing multiple products on a single
page. Online retailing helps vendors cater to their customers directly
rather than through a distributor. Many vendors are adopting online
retailing and internet marketing as a strategy to diversify their
geographic focus. Therefore, online retailing will emerge as the fastest
channel of distribution during the forecast period.

“Apart from growth and acceptance of e-commerce, the rise in aging
population and use of social media to market products are two major
factors that are expected to boost the growth of the overall market,”
says
a senior market research analyst at Technavio.

Global cognition supplements market:
Segmentation analysis

This market research report segments the global cognition supplements
market by application (memory enhancement, mood and depression
alleviation, attention and focus improvement, and others) and
geographical regions (APAC, EMEA, and the Americas).

The memory enhancement segment led the market in 2017 with a market
share of over 36%, followed by the mood and depression alleviation and
attention and focus improvement segments respectively. However, during
the forecast period, the mood and depression alleviation segment is
expected to show the highest incremental growth.

Looking for more information on this market? Request
a free sample report

Technavio’s sample reports are free of charge and contain multiple
sections of the report such as the market size and forecast, drivers,
challenges, trends, and more.

Some of the key topics covered in the report include:

Market Landscape

  • Market ecosystem
  • Market characteristics
  • Market segmentation analysis

Market Sizing

  • Market definition
  • Market size and forecast

Five Forces Analysis

Market Segmentation

Geographical Segmentation

  • Regional comparison
  • Key leading countries

Market Drivers

Market Challenges

Market Trends

Vendor Landscape

  • Vendors covered
  • Vendor classification
  • Market positioning of vendors
  • Competitive scenario

About Technavio

Technavio
is a leading global technology research and advisory company. Their
research and analysis focuses on emerging market trends and provides
actionable insights to help businesses identify market opportunities and
develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavio’s report library consists
of more than 10,000 reports and counting, covering 800 technologies,
spanning across 50 countries. Their client base consists of enterprises
of all sizes, including more than 100 Fortune 500 companies. This
growing client base relies on Technavio’s comprehensive coverage,
extensive research, and actionable market insights to identify
opportunities in existing and potential markets and assess their
competitive positions within changing market scenarios.

If you are interested in more information, please contact our media team
at media@technavio.com.

Contacts

Technavio Research
Jesse Maida
Media & Marketing Executive
US:
+1 844 364 1100
UK: +44 203 893 3200
www.technavio.com

Introduction to the In-Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 Course: London, UK – November 26-27, 2018 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Introduction
to the In-Vitro Diagnostic Regulation (IVDR)”
conference has
been added to ResearchAndMarkets.com’s offering.

The new In-Vitro Diagnostic Device Regulation (EU) 2017/746 came into
force in May 2017 with a transition period of 5 years. The IVD
Regulation is significantly different from the IVD Directive, including
changed classification rules and requirements for conformity assessment.
It is intended to strengthen the current approval system for in-vitro
diagnostics, making substantial changes to the existing IVD Directive
(98/79/EC) legislation.

The IVD Regulation introduces a new risk-rule classification system
based on the Global Harmonization Task Force (GHTF) rules for
classification which, for the first time, takes patient impact into
consideration. This change to the classification system will have an
impact on all manufacturers of IVDs. The majority of IVDs are currently
self-declare devices but under the new regulation about 80% of IVDs
require some form of conformity assessment by a Notified Body.

By attending this course, you will:

  • Gain a comprehensive overview of the new IVD regulation
  • Be aware of how the role of the Notified Body will change under the
    IVD regulation
  • Understand the requirements of the Technical Documentation for an IVD
  • Plan your labelling requirements and strategies
  • Know the key changes to ISO13485
  • Learn how IVDs are classified
  • Understand the requirements for clinical evidence
  • Know the vigilance and Post Market Surveillance (PMS) requirements for
    IVDS

Who should attend:

  • Regulatory affairs personnel
  • Persons responsible for regulatory compliance
  • Quality assurance professionals
  • Those responsible for OEM/Subcontractor control of IVDs
  • Economic operators, importers, distributors

Agenda:

Day One

  • Introduction to IVDs
  • Historical overview of the current IVD Directive (98/79/EC)
  • Introduction to IVD regulation (EU) 2017/746
  • Notified Bodies (NB)
  • Key changes to IVD Regulation
  • Compiling the technical documentation for an IVD
  • Labelling requirements and strategies
  • Day one wrap up and introduction to day two
  • Close of day one

Day Two

  • Welcome and recap on day one
  • ISO13485:2016
  • Risk-Based classification
  • Workshop – Product classification
  • Risk management
  • Workshop – Risk management
  • Clinical evidence and common specifications
  • Vigilance and Post Market Surveillance (PMS)
  • Case studies: Reporting/recalls
  • Key timelines and practical considerations
  • Discussion: Preparing a roadmap for transition
  • Wrap and close of forum

For more information about this conference visit https://www.researchandmarkets.com/research/z4nmjw/introduction_to?w=4

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: In
Vitro Diagnostics

Global Lysosomal Disease Treatments: Technologies and Markets, 2023 with Profiles of Major Players – Astellas Pharma, Astrazeneca, Eli Lilly and Co., Merck & Co. and Novo Nordisk A/S – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Lysosomal
Disease Treatments: Technologies and Global Markets”
report has
been added to ResearchAndMarkets.com’s offering.

The lysosomal storage disease treatment market has been divided by type
of indication into: Gaucher’s Diseases, Fabry Diseases, Pompe’s
Syndrome, Mucopolysaccharidosis and more. Mucopolysaccharidosis is
further segmented into Hunter syndrome, Hurlers Syndrome and Moriquo
syndrome. The market is also segmented by routing of administration into
IV and oral. The market has been divided into hospitals, clinics and
other facilities into end users by type of treatment into enzyme
replacement therapy and substrate reduction therapy. The market has been
segmented into North America, Europe, Asia-Pacific and RoW.

The major drivers influencing the market are orphan drug status; this is
a major driver of the market. Increasing awareness, rising focus by
pharmaceutical companies and early diagnosis as well as newborn
screening are the other drivers. The market also faces a few restraints
that include expensive drugs, change in payer policies, lack of proper
training and knowledge, nature of disease and concerns in diagnosis.
Restraints are overcome by the drugs that aid in improving the lifespan
and quality of life for the patients.

The U.S. is the major market for lysosomal storage disease treatment. It
was the first country to implement orphan drug status and to provide
many incentives for orphan drugs for treating rare diseases. Europe is
the second-largest market; it also stands by the Orphan Drug Act.
Asia-Pacific is showing the highest growth rate during the forecasted
period. In China and India, the market is limited due to the high prices
of the drugs.

The lysosomal storage diseases market is a subset of the larger orphan
drugs market and is impacted by any change in regulation and policy on
orphan drugs. There is an increasing focus on LSD as there are effective
diagnostic systems to detect greater numbers of patients.

The market for Lysosomal storage diseases is a concentrated market with
many large players present in the market. Major players in the market
are Sanofi, Pfizer, Shire, and others.

The Report Includes:

  • Analyses of global market trends, with data from 2017, estimates for
    2018 and projections of compound annual growth rates (CAGRs) through
    2023
  • Segmentation of the global market by cancer therapy indication,
    treatment type, route of administration, end-use, application, and
    geographical region
  • Information on the current regulatory environment, and a trend
    analysis of recent government policies and regulations for lysosomal
    disease treatments
  • Assessment of lysosomal storage diseases by the accumulated substrate
    and the profitability of focusing on ultra-orphan diseases
  • Profiles of major players in the industry, including Astellas Pharma,
    Astrazeneca, Eli Lilly and Co., Merck & Co., Inc., and Novo Nordisk A/S

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market Overview and Background

  • History
  • Definition
  • Lysosomes
  • Lysosomal Storage Diseases
  • Most common LSDs
  • Symptoms of Lysosomal Storage Diseases
  • Diagnosis of Lysosomal Storage Diseases
  • Treatments for Lysosomal Storage Diseases
  • Market Dynamics
  • Drivers
  • Restraint
  • Importance of Patient Support Groups
  • Regulatory Options for Faster Drug Approval
  • Epidemiology Lysosomal Storage Disorders

Chapter 4 Treatment Options for Lysosomal Storage Diseases

  • Enzyme Replacement Therapy (ERT)
  • Oral Substrate Reduction Therapy (SRT)
  • Pharmacological Chaperone Therapy (PCT)
  • Gene Therapy

Chapter 5 Market Breakdown by Disease Type

  • Gauchers
  • Diagnosis
  • Treatment
  • Oral Substrate Reduction Therapy (SRT)
  • Fabry Disease
  • Type 1 Classic Phenotype
  • Pompe Disease
  • Causes
  • Treatment
  • Mucopolysaccharidosis (MPS)
  • Hurlers (MPS I)
  • Hunter Syndrome (MPS II)
  • Morquio Syndrome (MPS IV)
  • Others

Chapter 6 Market Breakdown by Route of Administration

  • Oral Route of Administration
  • Intravenous Route of Administration

Chapter 7 Market Breakdown by End Use

  • Hospitals
  • Clinics
  • Others

Chapter 8 Market Breakdown by Treatment Type

  • Enzyme Replacement Therapy Market
  • Substrate Reduction Therapy

Chapter 9 Market Breakdown by Region

Chapter 10 Company Profiles

  • Actelion Pharmaceuticals Ltd.
  • Amicus Therapeutics
  • Arena Pharmaceuticals Inc.
  • Astellas Pharma
  • Astrazeneca
  • Biomarin Pharmaceutical Inc.
  • Eli Lilly And Company
  • Lexicon Pharmaceuticals, Inc.
  • Merck & Co., Inc.
  • Novo Nordisk A/S
  • Sangamo Therapeutics, Inc.
  • Sanofi Genzyme
  • Shire

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Endocrine
and Metabolic Disorders Drugs

Immune-Onc Therapeutics Announces Key Executive Appointments and Series B Funding

PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a privately
held cancer immunotherapy company dedicated to the discovery and
development of novel biologic treatments for cancer patients, today
announced the appointments of Dr. Adrian Jubb as Chief Medical Officer
and of Dr. An Song as Senior Vice President of Development Sciences. Dr.
Jubb joins Immune-Onc from Achaogen where he served as Vice President
and Head of Early Development. Dr. Song joins Immune-Onc from Genentech
where she held positions of increasing responsibility over her 16-year
tenure at the company and most recently served as a Senior Director
within Genentech’s Research and Early Development (gRED) organization.

In addition, Immune-Onc announced it received Series B funding of more
than $33 million from leading investors, including Northern Light
Venture Capital, Vivo Capital, and the Stanford-StartX Fund, to advance
its pipeline programs.

“As we prepare to move from translational research into the clinic,
Adrian and An’s decades of industry expertise in drug development will
be critical in advancing our mission to develop novel biotherapeutics
for hard-to-treat cancers,” said Charlene Liao, Ph.D., co-founder,
president and chief executive officer of Immune-Onc Therapeutics.
“Adrian and An embody many of the core values of Immune-Onc: dedication
to patients, passion for science, and excellence in execution. I am
delighted to have them join Immune-Onc’s leadership team.”

As Chief Medical Officer, Dr. Jubb is accountable for the clinical and
regulatory strategy and execution of Immune-Onc’s portfolio. As Senior
Vice President of Development Sciences, Dr. Song has overall
accountability for translational development of Immune-Onc’s portfolio,
including preclinical PKPD and toxicology evaluation, clinical
pharmacology, bioanalytical and biomarker/diagnostic development and
certain analytical aspects of technical development. Both Dr. Jubb and
Dr. Song are based at Immune-Onc’s headquarters in Palo Alto and will
join the company’s Executive Committee.

About Dr. Adrian Jubb

Adrian Jubb, M.B. Ch.B., Ph.D., F.R.C.Path., is a physician-scientist
with 17 years of experience across research and clinical development in
oncology, infectious disease and neuroscience. Most recently, Dr. Jubb
served as Vice President and Head of Early Development at Achaogen,
where he played a leading role in the development and FDA approval of
ZEMDRITM for the treatment of serious multi-drug resistant
infections. Prior to Achaogen, Dr. Jubb was a Medical Director in
Oncology at Genentech and supported numerous oncology clinical
development programs over the course of his tenure, including AVASTIN®,
MetMAb, COTELLIC® and Apo2L.

Dr. Jubb holds an M.B. Ch.B. (Bachelor of Medicine and Surgery) degree,
with honors, from the Faculty of Medicine and Health at the University
of Leeds, United Kingdom. His scientific training was conducted in the
research laboratories of Genentech, leading to the award of a Ph.D.
through the University of Leeds. Dr. Jubb is also a Fellow of the Royal
College of Pathologists (F.R.C.Path.), having completed joint clinical
and academic postgraduate training at the Oxford Deanery and the
University of Oxford, United Kingdom. Following his training, Dr. Jubb
was appointed to a faculty position in the Nuffield Department of
Clinical Laboratory Sciences, University of Oxford, where he led several
projects in the fields of angiogenesis and oncology as a principal
investigator. Dr. Jubb has authored over 55 scientific publications,
including numerous first and senior author papers in top-tier journals
(e.g., Journal of Clinical Oncology, Lancet Oncology, Nature Reviews
Cancer), and is a named inventor on 4 issued patents.

About Dr. An Song

An Song, Ph.D., is a translational scientist with 22 years of experience
across basic research and drug development in oncology, autoimmunity,
metabolic, infectious, and neurodegenerative diseases. Dr. Song joins
Immune-Onc from Genentech where, as a Senior Director in BioAnalytical
Sciences, she led the Assay Development and Technology group for the
company’s large molecule portfolio globally and was a member of numerous
scientific review bodies within the Genentech Research and Early
Development (gRED) organization. During her 16-year tenure at Genentech,
Dr. Song contributed to, and oversaw 40+ IND/CTA and BLA/MAA regulatory
filings for products including Rituxan@, Avastin®,
Herceptin®, Lucentis®, Kadcyla® and
Tecentriq®. In addition, Dr. Song played a significant role
in the development and approval of Ocrevus®.

Dr. Song holds a B.S. in Biochemistry from Nanjing University in China.
She received her Ph.D. in Biochemistry & Molecular Biology from Indiana
University and completed a postdoctoral fellowship in immunology at
Stanford University. Upon completion of postdoctoral work in T-cell
activation she joined Stanford as a Research Assistant Professor and as
faculty of the Immunology Program. Dr. Song has published a number of
original manuscripts, review articles and book chapters, as well as
contributed to several industry white papers on immunogenicity and
antibody Fc effector function evaluation. She is an active member of
American Association of Pharmaceutical Scientist (AAPS), having served
as an executive member of the Biotech Section and the chair of
Therapeutic Product Immunogenicity (TPI) Focus Group/Community.

About Immune-Onc Therapeutics, Inc.

Immune-Onc Therapeutics, Inc. (“Immune-Onc”) is a privately held cancer
immunotherapy company dedicated to the discovery and development of
novel biologic treatments for cancer patients. The company aims to
translate unique scientific insights in the tumor microenvironment and
immune suppressive pathways to develop first-in-class biotherapeutics.
Immune-Onc has a promising pipeline built upon strategic collaborations
and cutting-edge research from The University of Texas, Albert Einstein
College of Medicine, and Memorial Sloan Kettering Cancer Center.
Headquartered in Palo Alto, California, Immune-Onc has assembled a
diverse team with deep expertise in drug development and proven track
records of success at leading biotechnology companies. For more
information, please visit www.immune-onc.com.

Contacts

Cooper Communication Group
Tara Cooper, 650-303-7306
media@immuneonc.com

#jobs #lifescience Manufacturing Technicians (GMP)

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Manufacturing Technicians (GMP) .MA-Norwood, Job Title: Manufacturing Technician I Job Summary •We are seeking a Manufacturing Associate position based at to our new GMP Manufacturing site in Norwood, MA. •The individual in this role will be part of a cohesive team responsible for enabling production of high quality mRNA-based medicines for evaluation in human clinical trials. The candidate will apply existing and new knowledge of laboratory

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#jobs #lifescience Hyper Recruitment Solutions (HRS): Bid Proposal Development Manager

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Hyper Recruitment Solutions (HRS): Bid Proposal Development Manager .
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