Medivir delays start of pivotal study of remetinostat in cutaneous

UV light and radiotherapy and topical chemotherapy—all of which have tolerability issues.

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A year ago, Medivir was riding high after reporting midstage data that encouraged it to press ahead with a pivotal trial of its HDAC inhibitor remetinostat in cutaneous T-cell lymphoma (CTCL). It’s hit a snag though—it can’t agree on a design for the study with the FDA.

The Swedish biotech issued a statement this morning saying it had “decided to continue the discussions” with the agency on the design, and that delay means it won’t be ready to start the study this year as planned.

Its shares went on the slide as investors digested the update and tried to work out the implications, with the stock trading down more than 11% at the time of writing. Medivir bought the rights to remetinostat from TetraLogic Pharma for $12 million upfront in November 2016, and the drug is currently its lead pipeline candidate.

Christine Lind, Medivir’s CEO, said “it is of utmost importance that we design a phase 3 study that meets the expectations of the regulatory agencies. Further discussions with the FDA are needed to ensure that we can initiate a pivotal study that will allow us to bring this drug through approval and to patients.”

Medivir is hoping to open up a new CTCL market in the US for the drug worth an estimated $900 million, based on around 15,000 potential patients. It hopes it could provide an active treatment for early-stage CTCL patients who are currently just monitored until their symptoms progress sufficiently to need treatment with topical steroids, UV light and radiotherapy and topical chemotherapy—all of which have tolerability issues.

Last year all seemed to be on track, with Medivir reporting phase 2 data with remetinostat that showed a 40% response rate in 60 patients with a slow-growing form of CTCL called mycosis fungoides (MF), with the highest responses seen in patients treated with a 1% gel formulation of the drug.

The delay is the second pipeline setback for Medivir in recent months, coming after Johnson & Johnson pulled the plug on a hepatitis C virus program partnered with the Swedish biotech after deciding there was little market opportunity. It also lost former chief medical officer John Öhd who departed the company in March who has yet to be replaced. The company’s share price has been cut in half over the last 12 months.

What is GDPR and How to Comply and How to Protect Privacy?

When not implemented properly, can lead to havoc for the company.

A core law concerning the protection of data of all people living in the European Union (EU) is the General Data Protection Regulation (GDPR). The GDPR, which is codified as Regulation (EU) 2016/679, has been formulated to fulfil two important purposes:

  • Placing the control of personal data in the hands of citizens and residents of the EU
  • Easing the regulatory process and environment and standardizing and unifying data protection regulations across the EU with the aim of making global business within the EU easier.

The legislative and secretarial bodies of the EU, i.e., the European Parliament, the Council of the European Union and the European Commission, consolidate and strengthen all aspects relating to data protection for all individuals within the European Union (EU) through the GDPR regulation.  The GDPR also addresses the area of export of personal data to regions outside the EU.

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Gain complete understanding of the GDPR

With the GDPR now being the law that companies that want to do business in the EU have to comply with; it is necessary for them to get proper and thorough understanding of all its elements. This learning is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance. Please visit http://bit.ly/2JurJbE to enroll for this webinar and get a full and proper understanding of the GDPR and how it matters to your business.

Explanation of the advantages and disadvantages of the GDPR

Derk will explain all the aspects of the GDPR, including its benefits and drawbacks. Among the advantages it carries are the greater and clearer insight it offers into Personally Identifiable Information (PII) processing within the company, the boost and synchrony it gives to security controls across the 27 EU members, the increased customer confidence that accrue from stronger safeguards for data protection, and the simplification of the process of doing business in the EU.

However, the GDPR, when not implemented properly, can lead to havoc for the company. It can result in unimaginably high levels of penalties, up to two percent of violating companies’ worldwide revenues, fines of up to € 20 million, complicated lawsuits, loss of reputation, and many liability cases.

The insights that Derk will offer at this webinar will help participants understand how to comply with the regulation in such a manner that their organizations fully derive the benefits of this regulation and neutralize the negative effects of not doing it right.

He will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

This webinar is of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers.

http://data.consilium.europa.eu/doc/document/ST-9565-2015-INIT/en/pdf

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How to Comply with Both in the same Organization

A leading provider of professional trainings in all the areas of regulatory compliance.

Medical devices being a global market; it is not surprising to see many medical device companies marketing their products in both the US and the European Union (EU), two huge markets for these products. Given that these are two different markets; each has its own regulatory requirements. These requirements focus mainly on its Quality Management Systems (QMS). The QMS for the two markets are described in two documents: one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR 820).

On the surface, these two systems appear similar as they have many features in common. But as one delves a little into them, it turns out that they are not identical. A regulatory professional who markets medical devices into these two markets is likely to face crucial questions:

·        Is it possible, and is it permitted to have a QMS on the same site that complies with both requirements?

·        Should one QMS comply with both, and should that be put in place, or is it necessary to have two QMS coexist on the same site?

Thorough learning of the ISO and FDA QMS requirements

Answering questions such as these requires a thorough understanding of the background of both these documents, their legal status, what is expected by the regulatory authorities, and some basic concepts in quality and medical devices quality in specific. This is the learning that a webinar from Compliance4All, a leading provider of professional trainings in all the areas of regulatory compliance, will impart.

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At this webinar, Compliance4All brings the owner of ELC Consulting Services, Eyal Lerner, as expert. Eyal’s organization offers the pharmaceutical and medical devices industries support in all quality related issues, such as Preparation for inspections, CAPA and RCA, quality manual QSM, self-inspection (internal audits), compliance gap analysis, 3rd party audits (FDF and API’s), Management Review, GMP, GLP, MD: ISO 13485:2016 adjustments, DHF, DMR, V&V, 510k submission preparation and ISO 17025 (lab accreditation) and Validation. Eyal has preformed more than 100 audits in various facilities around the world as a lead auditor and auditor.

Please visit http://bit.ly/2JDpIWO to enroll for this webinar and have important doubts about the implementation of the QSRs of the ISO 13485 and 21 CFR 820 regulations clarified.

Offering insights into the two regulations

At this webinar, Eyal will give clarity to participants on how to understand what is required by both. It is necessary for regulatory professionals to understand semantic and substantial differences between the two documents. To give an example, while the ISO requires what it calls a Quality Manual (QM), the FDA QSR does not find mention of such a term. An in-depth look at the policies and Standard Operating Procedures facilitates the ease of handling of such terms. Eyal will focus on other issues that require more attention. He will explain the main features of these areas and describe what should be done from the perspective of a site or a manufacturer which wants to comply with both QMS.

The objective of this learning session is to offer a clear understanding to organizations in the medical devices industry that either develop or plan to market medical devices to USA and Europe of how to plan and implement a QMS that complies with both regulatory authorities. Eyal will help them ask themselves how to get the QMS right and make it work efficiently.

This session is aimed at professionals who are involved in implementing their organizations’ QMS, and includes Medical Devices Quality Personal (QA and QC), Laboratory Managers, R&D Researchers of Medical Devices and Combined Products, Quality Control Staff, and Regulatory Affairs (RA) Staff.

The speaker at this webinar will cover the following areas:

·        Introduction

·        Brief review of regulations and standard: status and history

·        ISO 13485:2016 short review

  • Principals
  • Quality management system
  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

·        FDA QSR (21CFR820) short review

  • Quality System Requirements
  • Design Controls
  • Document Controls
  • Purchasing Controls
  • Identification and Traceability
  • Production and Process Controls
  • Acceptance activities
  • Nonconforming Product
  • Corrective and Preventive Action
  • Labeling and Packaging Control
  • Handling, Storage, Distribution, and Installation
  • Records
  • Servicing
  • Statistical Techniques

·        Comparison between both QMS

  • Common features
  • Variances between both

·        Terms/ vocabulary

  • Comparison between terms

·        Summary.

 

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How to Effectively Manage CROs/Vendors used in the [Pharmaceutical Industry]

It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

Today’s globalized and interconnected world has made outsourcing indispensable. Outsourcing works to the benefit of both parties. Those who outsource can let other, independent companies, usually those that have specialized in this function, to take over several of their secondary processes, so that they can concentrate on the more productive and business-yielding activities. At the other end, the outsourced company earns substantial revenues by carrying out outsourced activities.

In the pharmaceutical industry, it is necessary and important to employ efficient and accurate strategies for this important activity. When projects are outsourced without proper safeguards and monitoring going into them, the outsourcing company has higher chances of inviting FDA actions such as Warning Letters, 483’s, etc.

Putting a selection process in place is very important

Companies should put in place robust structures that help them select vendors successfully and avoid scenarios such as these. These systems should also ensure that other critical aspects of outsourcing activities in GXP areas such as contract design, quality monitoring and risk minimization remain compliant. It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

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Complete learning on how to select CROs/Vendors

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will educate participants on the elements of managing and avoiding common pitfalls with CROs/Vendors.

Laura Brown, an independent Pharmaceutical Project Management and Training Consultant and is Course Director for the M. Sc. in Clinical Research at University of Cardiff’s School of Pharmacy; will be the speaker at this course.

Dr. Brown has over 20 years’ experience of managing clinical research projects in the pharmaceutical industry. She has worked in Project Management for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She is also co-author of two books on Project Management, including Pharmaceutical Project Management, a 2004 publication.

Please enroll for this webinar by visiting http://bit.ly/2JJHZVz

Learning on all elements of CROs/vendor outsourcing

At this webinar, Dr. Brown will combine theory and practical examples to offer a crucial overview of a sponsor’s responsibilities, which will give them the knowledge needed to ensure quality oversight.

In the course of this session, Dr. Brown will cover the following areas:

  • Understand how to Effectively Manage CROs/Vendors used in the Pharmaceutical Industry
  • Build an Understanding of your Responsibilities as the Sponsor or the Vendor: Identifying the Right Level of Management and Oversight
  • Discover Tools and Processes to Manage CROs/other Vendors
  • Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • Measuring CRO Performance including Metrics and Key Performance Indicators
  • Managing and avoiding common pitfalls with CROs/Vendors.

Personnel who work in areas that involve one or more aspects of outsourcing CRO’s/vendors, such as Vendor Management, Global QA/Compliance, Contracts and Outsourcing, VPs, Directors, Outsourcing Department Staff, Purchasing, Finance and Contract, Management Staff, Managers and other personnel involved in selecting and managing cross, will benefit from this course.

Dr. Brown’s webinar is also aimed at helping personnel involved in vendor/CRO/CMO oversight (including those working in Clinical Research, Regulatory Affairs Pharmacovigilance, and Manufacturing) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs/CMO).

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Microorganism levels Necessary to Manufacture Quality Pharmaceutical Product

Understanding of Environmental Control vs. Environmental Monitoring.

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. It is a major determinant in ensuring the quality of a pharma product. Control of the following is crucial to protect the product from contamination:

  • Airborne particulate
  • Microorganisms
  • Temperature
  • Humidity
  • Differential pressure
  • Airflow
  • Air velocity

If these have to be controlled and the quality and safety of the pharmaceutical product are to be assured, it is necessary to design, monitor and validate a clean room HVAC system. It is also necessary to get a proper understanding and testing of the clean room environment according to international regulatory standards from a compliance perspective.

A webinar on giving full understanding of cleanrooms

A complete understanding of all these aspects of a cleanroom will be the content of a highly educative webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this webinar, Roger Cowan, who is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing, will be the speaker.

Roger’s areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.

Please visit http://bit.ly/2xQeo8o to enroll for this webinar.

Cleanroom from all perspectives

It is important that a clean room’s HVAC system is fully understood, properly designed and validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product. At this webinar, Roger will explain the various US and international regulatory requirements for various clean room classifications. He will offer an understanding of Environmental Control vs. Environmental Monitoring.

Roger will then offer a comprehensive overview of the mechanics of cleanroom HVAC, at which elements such as engineering diagrams and schematics, HVAC equipment components, the automated control systems that are available, cleanroom design considerations, the proper building construction and layout necessary for achieving both optimum efficiency of the system and optimum cleaning and sanitization of the clean room, are included.

Principles of HEPA filtration

In addition to the physical aspects of a cleanroom, Roger will also delve into the principles of HEPA filtration. Other issues such as the desired clean room airflow patterns and how to achieve them, proper procedures for HEPA filter leak testing, differential pressure, air velocity, flow rates, air pressure balancing, and temperature and relative humidity controls and specifications are also detailed.

And then, Roger will take up comprehensive procedures for cleaning and sanitization of the clean room environment, where he will review the best disinfectants currently available along with their respective advantages and disadvantages. He will then detail clean room contamination due to personnel, at which both gowning technique and aseptic practices are discussed.

HVAC systems validation and monitoring

Finally, Roger will also detail the full set of requirements for HVAC system validation and ongoing monitoring of the clean room environment with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

This webinar provides high value to personnel in areas such as Quality Assurance, Environmental Monitoring, Microbiology, Manufacturing, Validation, Engineering, and Maintenance.

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How to Effectively Create or Modify Quality Management Systems and Quality-by-Design Practices Documents

A fact that is true almost everywhere in the world is that legal and regulatory requirements and practices have not kept pace with the technological advancements.

Scientific methods for treating diseases and conditions, and the regulatory oversight over them have been growing by leaps and bounds over the past few years. Gene editing via CRISPR and nuclease enzymes such as Cas9, Cpf1 or C2c1, PAM-dependent target recognition, and gene delivery approaches such as adeno associated virus (AAV) and advancements in chimeric antigen receptor (CAR) conjugated T-cell therapies specific to an array of disease-related ligands associated with cancer are some of the hot topics of R and D today.

A fact that is true almost everywhere in the world is that legal and regulatory requirements and practices have not kept pace with the technological advancements. As a result, it is often the regulatory agency, rather than the company manufacturing products in these areas, that is responsible for delaying the release of these high-level products into the market.

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One method by which organizations in these areas can mitigate this situation is to help the regulatory agency understand the submission for approval better by preparing documents that are lucid and easy to understand. This writing skill is a habit that needs to be ingrained in science professionals who make the submissions to the FDA and other regulatory agencies in the world.

Understanding of the ways of preparing well-written documentation

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show the proper and correct method of preparing documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions.

Robert Michalik, a Massachusetts regulatory attorney and founder of RegulatoryPro.com, will be the expert of this very valuable webinar session on Advanced Legal Writing Methodologies for Successful FDA ‘Breakthrough Therapy’ Submissions. Please enroll for this highly valuable webinar by visiting http://bit.ly/2LqRE0A

Adapting new strategies

Proper and well-organized documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions must show how the new product has taken steps for mitigating health risks. The documents submitted for approval should have clarity, and there should be solid quality and quantity of data needed to support investigational and new drug or biologic safety and efficacy claims. When these are lacking, it leads to improper regulatory submissions that lead to project delays, particularly for those in the gene therapy, cell therapy and combination product space.

R&D product manager, quality assurance, regulatory management and clinical professionals who rely on past submission strategies cannot expect to ensure authorization from FDA to proceed. They need to keep updating and sharpening their legal and regulatory writing skills and approaches to meet the challenges.

Most attorneys are taught at law schools to condense complex sets of facts into concise, persuasive arguments that achieve client objectives. The persuasiveness of these presentations goes a long way in determining the regulatory success or failure of many breakthrough therapies.

This webinar will equip professionals involved in preparing documentation for advanced legal writing methodologies for successful FDA ‘Breakthrough Therapy’ Submissions, such as Gene Therapy /Gene Editing R&D Scientists, Regulatory Affairs Professionals, Quality Assurance Professionals, Marketing Professionals, and Scientific and Engineering /Product Development Managers with the legal drafting skills when preparing quality and regulatory documents.

Using writing to enhance chances of regulatory approval

Robert will help them ingrain the legal writing skills and practical techniques that will enhance the chances for success. While good regulatory writing meet FDA branch-level requirements; only the best and most effective submissions can withstand scrutiny at higher levels such as the FDA Division level.

At this webinar, Michalik will cover the following areas:

  • Basic communications skills that all successful attorneys use to win arguments, in legal briefs and oral presentations
  • Step-by-step analysis of how to present both good and poor data in a persuasive manner
  • How to train scientists and engineers to generate “good” data to support legal, regulatory and quality claims?
  • Tips and secrets to framing an argument that makes even poor data look good
  • Examples of good writing that can be useful templates for training and skills development.

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How software requirements are used in validation will be described

Medical devices are used by millions of people around the world, and an error can result in fatal issues.

The current and expected growth of medical devices, the size of the global market for which is put at around $520 billion annually, and expected to reach nearly $700 billion by 2022, is a cause for cheer for those in the industry. It is, however, also a serious reason to call for scrutiny, since medical devices are used by millions of people around the world, and an error can result in fatal issues.

Of high concern is the aspect of software testing for medical devices, because most of these medical devices are powered by software. Further, some software programs are themselves considered medical devices. The basic purpose of testing software for medical devices is to establish and prove that it works as intended and is free of bugs. However, given the complexity of certain devices and the software that go into them; guarantees at this level are not considered sufficient.

The device has to go beyond proving its fitness for use

If a medical device software has to obtain FDA approval; it should be subjected to additional analyses and tests that the FDA feels are necessary to prevent user injuries. The FDA developed these requirements after thoroughly analyzing many medical devices it had recalled.

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This points to the criticality of carrying out software testing for medical devices in a manner that meets the FDA’s requirements. Want to gain this important understanding? A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will put you on the path to understanding what it takes to meet the FDA’s requirements for medical device software.

This webinar is being taught by Edwin Waldbusser, a senior consultant for the medical device industry. Having retired from the industry after over two decades in managing the development of medical devices and having five patents against his name, Edwin has been consulting in the US and internationally in the areas of design control, risk analysis and software validation.

Please register for this webinar by visiting http://bit.ly/2LYkuWY

An understanding of the additional FDA requirements

The requirements of the FDA, that it asks for in addition to the usual testing for software for medical devices, will be explained. This important learning from this webinar will give participants an understanding of the testing that is required in addition to functional tests to produce a validated software product.

The main learning of this course relates to how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. The important learning objective of this course is how to validate medical device software in compliance with FDA objectives. Risk analysis in validation has a key role in this, and Edwin will explain this in detail. He will also describe how software requirements are used in validation.

To reinforce the learning, Edwin will give participants handouts consisting of software traceability matrix form, validation plan template, and validation report form.

Edwin will cover the following areas at this course:

  • Software Validation more than Testing
  • Requirements Traceability
  • Risk Analysis
  • Unit, Integration and System Testing
  • Algorithm Validation
  • Challenges to the Software
  • Configuration Management.

Personnel in charge of medical device software validation, such as Engineering Personnel, Software Developers, QA, and Management will benefit from this course.

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