Thursday, May 3, 2018

FDA 21 CFR Part 11 Compliance – Validation Seminar 2018 (Washington DC, United States, June 28-29, 2018) – ResearchAndMarkets.com | Business

DUBLIN–(BUSINESS WIRE)–May 2, 2018–The “FDA 21 CFR Part 11 Compliance – Validation Seminar 2018” training has been added to ResearchAndMarkets.com’s offering.

Part 11 / Annex 11 Computer Systems Validation (CSV) is implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

Spreadsheets are a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this results in spreadsheets being among the most under-documented systems used in GxP environments because:

Users regard them as part of the desktopThe ease with which applications can be built without much trainingThe data processing power that they can haveLack of knowledge that spreadsheets need to be validatedLack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become low hanging fruit during FDA or other regulatory inspections and many warning letters have been issued.

Agenda

Day 1 Schedule

Lecture 1: Types of SpreadsheetsLecture 2: Excel Validation at a High LevelLecture 3: FDA Use of Excel SpreadsheetsLecture 4: Excel Validation Master Plan (VaMP)

Day 2 Schedule

Lecture 5: Excel Risk Assessment & RequirementsLecture 6: Excel Functional & Design SpecificationLecture 7: Verification & Testing for Excel CSVLecture 8: Quality Assurance for Excel CSV

For more information about this training visit https://www.researchandmarkets.com/research/wnfbcg/fda—21—cfr—part?w=4

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CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

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For GMT Office Hours Call +353-1-416-8900

Related Topics:Pharmaceuticals,Drug Discovery,Pharmaceutical Manufacturing

KEYWORD:

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 05/02/2018 03:31 PM/DISC: 05/02/2018 03:31 PM

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Wednesday, May 2, 2018

Seasoned Scientific Experts and Strategic Pharmaceutical Industry Veterans Join Cerenis’ Scientific Advisory Board in Oncology

TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:

CERENIS Therapeutics (Paris:CEREN) (FR0012616852 – CEREN – PEA-PME
eligible)
, an international biopharmaceutical company dedicated to
the discovery and development of HDL-based innovative therapies for
treating cardiovascular and metabolic diseases, as well as new HDL-based
vectors for targeted drug delivery in the field of oncology, announces
the creation of its Scientific Advisory Board in Oncology (SAB-Oncology)
with five key appointments: Briggs Morrison, MD, who will
serve as the Chairman of the SAB, Mark Frohlich, MD, Aurélien
Marabelle
MD, PhD, Robert Schneider, PhD and Robert J.
Spiegel
, MD, FACP.

Jean-Louis Dasseux, founder and CEO of Cerenis, commented: “Cerenis
is fully committed to implement its strategy in targeted HDL drug
delivery. Creating this SAB in Oncology represents another important
step forward for the company following the asset acquisition of Lypro
Biosciences. More steps will follow as the company is leveraging its
leading expertise in HDL, its intellectual property, its unique
large-scale recombinant human apoA-I and HDL manufacturing and its
clinical experience in HDL development to create a unique HDL drug
delivery platform. Cerenis intends to develop products based on HDL drug
delivery to allow for selective targeting to effectively kill cancer
cells while protecting normal tissues. We are very happy to have such
prestigious leading experts bringing not only a wealth of experience
across research and clinical development, but also a hands-on experience
in pharmaceutical and drug development strategies. This is essential to
guide us in prioritizing and driving forward our drug delivery platform
and clinical programs in Immuno-oncology and Chemotherapy.”

Briggs Morrison, MD, SAB Chairman, commented: “I
am very enthusiastic about joining Cerenis’ Oncology Scientific Advisory
Board to help the company develop promising new products for
Immuno-oncology and Chemotherapy, and to help the Cerenis management
understand this exciting but complex field. Targeted drug delivery has
always been a ‘holy grail’ in Oncology and Cerenis may be at the point
where such a challenge can be overcome with novel HDL technology
developed by the company. For the first time we have pharmaceutical
grade HDL, that may act as a universal carrier for diverse payloads
including antigens, nucleic acids, and chemotherapeutic agents with a
high specificity toward the targeted cells.”

Mark Frohlich, MD, SAB member, commented: “The concept of
targeted delivery to cancer using nanoparticles is highly attractive.
However, historical nanoparticle platforms, such as liposomal
formulations, have failed to deliver on their promise. Challenges have
included difficulties in manufacturing a consistent product, poor in
vivo stability, and highly inefficient tumor targeting. The Cerenis HDL
platform holds great potential to overcome these challenges and deliver
on the promise of targeted nanoparticle delivery.”

The SAB-Oncology will work closely with Cerenis’ management team as it
develops its targeted HDL drug delivery platform in immuno-oncology and
chemotherapy and it is actively preparing to bring a lead product
candidate into clinical studies. The Company believes its targeted HDL
drug delivery platform has the potential to transform the treatment
paradigm in immuno-oncology and chemotherapy, a market representing more
than $30 billion. Cerenis is positioned to leverage its considerable IP
positions and manufacturing expertise to make unique contributions in
this important therapeutic space.

Briggs Morrison, MD: Chairman of Cerenis’ SAB Oncology – Former
Head of Global Medicines Development and Chief Medical Officer at
AstraZeneca

Briggs W. Morrison received his B.S. in biology from Georgetown
University, his M.D. from the University of Connecticut Medical School,
completed residency training in Internal Medicine at the Massachusetts
General Hospital, and completed a fellowship in Medical Oncology at the
Dana-Farber Cancer Institute. He did post-docs with Dr. Philip Leder at
Harvard Medical School, and Dr. Lee Nadler at the Dana-Farber Cancer
Institute. He joined Merck & Co., Inc. in 1995, where he held various
R+D positions including leading the Clinical Oncology Department.
Subsequently he was appointed Head of Clinical Development at Pfizer in
2007, and became the Head of Global Medicines Development and Chief
Medical Officer at AstraZeneca in 2012. He is currently the CEO of
Syndax Pharmaceuticals.

Dr. Morrison has overseen the development of numerous biopharmaceutical
products in multiple therapeutic areas, from First-In-Human trials
through to global regulatory approvals. He is currently a Board member
of private companies Oncorus and Repare Therapeutics, and is an advisor
to a number of other private biotechnology companies. In addition, Dr.
Morrison is a Board member of the Alliance for Clinical Research
Excellence and Safety (ACRES), a non-profit organization dedicated to
optimizing the global clinical research system.

Mark Frohlich, MD – Former Executive V.P. of Portfolio Strategy at
Juno Therapeutics

Dr. Mark Frohlich has been involved in the development of cellular
immunotherapies for cancer for more than 15 years. He was recently EVP
of Portfolio Strategy at Juno Therapeutics, prior to its $9 billion
acquisition by Celgene. He previously served as EVP of R&D and Chief
Medical Officer of Dendreon Corporation, where he led the clinical team
responsible for the approval of the first cellular immunotherapy in the
US and Europe (Provenge®). Prior to that he led the clinical team at
Xcyte Therapies, developing autologous activated T cells for cancer. Dr.
Frohlich is a medical oncologist. He is a graduate of Harvard Medical
School and Yale College.

Aurélien Marabelle, MD, PhD – Clinical Director of the Cancer
Immunotherapy Program at Gustave Roussy Cancer Center

Dr. Aurélien Marabelle’s clinical practice is dedicated to early phase
clinical trials in Cancer Immunotherapy. His translational research is
focused on mechanisms of action of immune checkpoint monoclonal
antibodies. He works as a senior medical oncologist and an investigator
in the Drug Development Department (DITEP) directed by Dr. Christophe
Massard. He is coordinating a team focusing on cancer immunotherapy
translational research projects in the INSERM U1015 lab directed by Prof
Laurence Zitvogel. Dr. Marabelle is a member of ESMO, ASCO, EATI and
AACR.

Robert Schneider, PhD – Albert Sabin Professor of Molecular
Pathogenesis, Professor of Radiation Oncology

Dr. Robert Schneider is associate Director of the NYU Cancer Institute,
Director of Translational Cancer Research, and Co-director of the Breast
Cancer Research Program at NYU School of Medicine.

He is also the Associate Dean for NYU Technology Ventures and
Partnerships, which has transformed NYU’s technology transfer and
commercialization into a leading therapeutics development and new
company academic enterprise. Dr. Schneider is also an active researcher,
and performs basic, translational, and clinical research on the
molecular basis of metastatic breast and ovarian cancers,
interconnections with the inflammatory response, and the development of
new therapeutics. He is the author of more than 160 peer-reviewed
publications. He has received a number of awards in recognition for his
achievements, including the 2012 Susan E. Donelan Hope for the Future
Award for breast cancer research from the Dana Farber Cancer Institute;
the 2011 Distinguished Alumnus Award & Commencement address from the
University of Delaware; the 2010 Judah Folkman Memorial lecture from the
Chemotherapy Society, among others. Dr. Schneider is a co-founding
scientist of six biotechnology/small pharmaceutical companies including
ImClone Systems (New York), PTC Therapeutics (New Jersey), Canji (San
Diego), Gencell (Paris) and ENB Therapeutics (New York). Dr. Schneider
received his Ph.D. in biomedical sciences from the Mount Sinai School of
Medicine and was a postdoctoral research fellow in the Department of
Molecular Biology at Princeton University.

Robert Spiegel, MD – Former Sr. V.P. for worldwide Clinical
Research and Chief Medical Officer at Schering-Plough

Dr. Spiegel has over 30 years of extensive R&D and operational
experience in biopharmaceuticals including Big Pharma, biotech, and
academic startups as well as interactions advising venture capital and
private equity.

Dr. Spiegel spent over 25 years at Schering-Plough where he joined as
the first Director for Oncology Clinical Research, and subsequently held
a series of senior executive positions, including Senior Vice President
for worldwide Clinical Research and Chief Medical Officer. During his
time at Schering-Plough he took numerous drug candidates through
clinical development and was involved with over 30 NDA approvals at the
FDA. For the last five years Dr. Spiegel has been a consultant to the
biotech industry and has served on the Boards of multiple biotech
companies He currently serves on the Boards of Directors of Geron Corp,
Edge Therapeutics, and Neximmune Inc. and is Chairman of Vidac
Therapeutics. He is currently the principal of Spiegel Consulting LLC
and an Assistant Professor of Medicine at Weill Cornell Medical College.
He is also a Senior Advisor to private equity firm Warburg Pincus and an
Advisor to the Israel Biotech Fund.

Dr. Spiegel received his B.A. from Yale University and his M.D. from the
University of Pennsylvania. He completed his specialty training at the
National Cancer Institute, National Institutes of Health (NIH).

About CERENIS: www.cerenis.com

CERENIS Therapeutics is an international biopharmaceutical company
dedicated to the discovery and development of innovative therapies for
the treatment of cardiovascular and metabolic diseases. HDL is the
primary mediator of the reverse lipid transport, or RLT, the only
natural pathway by which excess lipids is removed from arteries and is
transported to the liver for elimination from the body.

CERENIS is developing a portfolio of lipid metabolism therapies,
including HDL mimetics for patients with genetic HDL deficiency, as well
as drugs which increase HDL for patients with a low number of HDL
particles to treat atherosclerosis and associated metabolic diseases
including Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic
Steato-Hepatitis (NASH). Capitalizing on its expertise, Cerenis is
developing the first HDL-based targeting drug delivery platform
dedicated to the oncology field (immuno-oncology and chemotherapy).

CERENIS is well positioned to become one of the leaders in the HDL
therapeutic market, with a broad portfolio of programs in development.

About Targeted HDL Drug Delivery

HDL particles, loaded with an active agent, hold the promise to target
and selectively kill malignant cells while sparing healthy ones. A wide
variety of drugs can be embedded in these particles targeting markers
specific to cancer cells and bring these potent drugs to their intended
site of action, with lowered systemic toxicity. Cerenis intends to
develop the first HDL-based targeting drug delivery platform dedicated
to the oncology market, including immuno-oncology and chemotherapy.

Financial Agenda:
Annual Shareholder Meeting: June 25th,
2018

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ValGenesis and PharmOut Announce a Partnership Founded on a Paperless Validation Initiative.

New partnership offers cost-effective paperless validation to GMP-governed organisations in Australia

ValGenesis and PharmOut
Announce a Partnership Founded on a Paperless Validation Initiative.

New partnership offers cost-effective
paperless validation to GMP-governed organisations in Australia

Cost-effective
paperless validation now available to Australian GMP-governed organisations
with announcement of new partnership

Melbourne,
Australia, April 27 2018.

 

PharmOut, the Asia
Pacific’s leading Pharmaceutical consulting organization, has announced a strategic
partnership with ValGenesis Inc, a pioneer in paperless validation software
systems.

Pharmaceutical,
medical device and other industries that must be compliant with Good
Manufacturing Practice (GMP) incur considerable costs in creating, maintaining
and storing the mountain of paper documents required for the routine operation
of their manufacturing facilities. Australian companies have also long
struggled with a shortage of experienced validation professionals, further
adding to their costs.
 

This new
partnership offers a cost-effective and innovative validation solution to
Australian companies. Combining the expertise of PharmOut’s large team of
validation consultants with the ValGenesis Validation Lifecycle Management
System will deliver faster, cheaper validation services in Australia. It will
also deliver all the advantages a paperless system offers, making Australian
manufacturers more competitive in global markets.

PharmOut’s
founder, Trevor Schoerie said: “As the largest provider of outsourced
validation services in the Asia Pacific region, our customers were asking us
for ways they could slash both the cost and time required to meet their
validation obligations. We evaluated the available software solutions and found
that ValGenesis was the stand-out product. We realised that we could train our
consultants to become experts in the ValGenesis software, allowing us to fast
track the delivery of validation services, whilst also providing all the
benefits of a paperless solution to our customers.”

“By allowing
life science companies to manage their validation processes electronically, the
ValGenesis Validation Lifecycle Management System (VLMS) significantly reduces
the validation cycle time and cost, eliminates potential data integrity issues
in the validation process, enables standardization and enforces consistency and
compliance in the corporate validation process.” said Robert van der Laan, Vice
President of Professional Services at ValGenesis” “ValGenesis VLMS has been
implemented by 10 out of the top 20 global life science companies. We seek to
align our product roadmap with the evolving regulatory landscape to help our
clients to enable and enforce regulatory compliance. We are confident our
partnership with PharmOut will help the ValGenesis VLMS system become the
de-facto standard for paperless validation across the life science companies
based in Australia and New Zealand” he said.

PharmOut looks
forward to working with ValGenesis into the future and supporting their
expansion into Australia.

You can find
out more about each company and the solutions they provide on the
ValGenesis and PharmOut websites.

About PharmOut

PharmOut is an international consultancy
founded in 2006 which has grown a strong reputation in offering leading GMP
compliance, validation, regulatory, engineering and architectural consulting
services solutions to the 
pharmaceutical and life science industries.

PharmOut holds ISO 9001:2015 certification
from 
LQRA and our Quality Management System is certified to the ISO
9001:2015 standard for the provision of 
engineering, architectural design and consultancy services.

 

About
ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform
serving as the foundation for managing compliance-based validation activities
in Life Sciences companies. ValGenesis, Inc. provides the first enterprise
application to manage the corporate validation lifecycle process. As the only
system for managing validation execution and approval 100% electronically,
ValGenesis was selected by an industry peer review committee to receive the
Parenteral Drug Association (PDA) New Innovative Technology Award. The solution
is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. For
more information, visit ValGenesis’website at 
https://ift.tt/KIvRBS

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Tuesday, May 1, 2018

New partnership supports customers in implementation of serialisation solutions

A new partnership has been formed between Mettler Toledo PCE (product inspection specialists) and R-Pharm Germany (contract manufacturer) to support pharma customers in the implementation of serialisation and aggregation solutions.

Through this collaboration, customers will be able to experience Track & Trace systems first hand in a live production facility, enabling them to understand the available options and develop solutions to meet their specific requirements more effectively.

The implementation, or upgrading, of serialisation systems is becoming more pressing as compliance with the Falsified Medicines Directive (FMD) bears down — coming into effect in February 2019.

In addition to helping customers develop their own Track & Trace solutions, the R-Pharm facility — equipped with Mettler Toledo PCE technology — can also provide a bridging service for pharmaceutical customers until their own plant is upgraded.

“Our clients expect from us a direct connection to their own ERP or MES systems, or would like to use serial numbers of cloud systems such as Tracelink,” said Michael Unbehaun, engineering manager at R-Pharm. “Therefore, we make sure that our software systems are always state of the art and successively expand the interface palette. In this way, we can ensure efficient and rapid on-boarding of new clients and enable them to exploit the potential of our lines.”

The companies have also started to offer combined workshops to provide a more intensive discussion of selected topics, from line integration and its process organisation to data exchange with cloud providers. For those looking to delve deeper, subject-specific training will be offered via a new T&T User Academy, including sessions on topics ranging from the development of so-called SOPs (Standard Operating Procedures) to pharmaceutical validation of machines or OEE management tactics.



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Monday, April 30, 2018

Leistritz to Host Pharmaceutical-Nutraceutical Extrusion Seminar

Leistritz announced its Pharmaceutical-Nutraceutical Extrusion Seminar will take place on June 6–7, 2018. The two-day event will focus on the latest melt extrusion and granulation technologies for pharmaceutical and nutraceutical products and will include classroom sessions at the Holiday Inn in Clinton, NJ, and extrusion demonstrations at the nearby Leistritz Process Laboratory in Somerville, NJ.

Day-one seminar topics include:

  • “Twin Screw Extrusion Theory, Tips and Test Results” with Charlie Martin, Leistritz
  • “Twin Screw Design, Processing Guidelines, and Scale-Up” with Bill Thiele, Leistritz
  • “Developments in Twin Screw Granulation” with Mike Thompson, McMaster University
  • “Hot-Melt Extrusion Viewed as a Special Polymer Compounding” with Costas Gogos, Polymer Processing Institute
  • “Downstream Extrusion Equipment for Processing Shape Extrusions in Pharmaceutical Applications” with Bob Bessemer, Conair Group
  • “Continuous Twin-Screw Melt Granulation of Thermally Labile Drug/Case Study” with Tony Listro, Foster Delivery Science.

Live demonstrations at the Leistritz laboratory will showcase:

  • Nano-16 twin screw extrusion system processing 50-gram batch samples
  • Film/lamination extrusion system as used for transdermal or dissolvable film applications
  • Melt extrusion of poorly soluble active ingredients
  • Foaming of an extrudate via sCO2 injection
  • Wet and melt granulation.

Day-two seminar topics include: 

  • “Design and Application of Twin Screw Extruder Elements” with Brian Haight, Leistritz
  • “Understanding the Extrusion Design Space of HPMCAS” with Kevin O’Donnell, Dow Food, Pharma & Medical
  • “Industrial Pharmaceutical Application Converting a Fluid Bed Granulation Process to Twin Screw Wet Granulation” with Crystal Miranda, Merck
  • “Polymers Meeting the Challenges with Poorly Soluble APIs by HME” with Shaukat Ali, BASF
  • “Solubility Enhancement and Targeted Delivery Using Eudragit and Eudraguard for Active Pharmaceutical Ingredients and Dietary Supplements” with Firouz Asgarzadeh, Evonik
  • “Twin Screw Granulation: A Case Study for Enabling an Adaptive Study Plan” with Steve Pafiakis, Bristol-Myers Squibb
  • “Stabilizing Meloxicam During Twin Screw Extrusion” with Abbe Hasar, Merck
  • “Granulation Technologies, Developments and Applications” with Tom Durig, Ashland Specialty Ingredients
  • “Die and Downstream Extrusion Techniques” with Augie Machado, Leistritz
  • “Cleaning and Validation of Extrusion Equipment” with Bert Elliott, Leistritz
  • “Control Systems for Pharma Extrusion” with Pete Palmer, Wolock & Lott
  • Interactive screw assembly/design demonstration.

In addition to the presentation materials, attendees will receive a copy of the recently published second edition of the Pharmaceutical Extrusion Technology textbook.

For more information, contact Sarah Scovens, e-mail [email protected], 908.685.2333, x614.

Source: Leistritz

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