On 29 July 2021 KIEŁTYKA GŁADKOWSKI KG LEGAL took part in the webinar ‘Cell and gene data innovation and multi-stakeholder data transfer’ (Plan, capture and set the infrastructure for data sharing across the value chain, to optimize commercial strategy), organized by Reuters Events in participation and partnership with Salesforce. The scope of the webinar is within life science and digital health specialization that constitutes one of the core specializations of our law firm.

Some of the panelists included:

Augusto Penjasoff – Business Partner, Global Cell Therapy IT Head in BMS (Bristol Myers Squibb),

Curt Fitzgerald – Director- Service Delivery- C&GT in Novartis,

Gary Gabriel – Global Advisor for Healthcare and Life Sciences in Tableau,

Neary Detrick – Senior Director, Data Management & Analytics in Bluebird Bio,

and Beth Hayes as a moderator- healthcare and lifesciences business consulting – Pharma Lead, Industry Transformation (Salesforce).

The mission of Salesforce company (a partner and a participant of the webinar) is to empower companies to connect with the customers, providers of services and patients in the new and reimagined way. Salesforce serves leading organizations across the industry, including pioneers in CGT (cell and gene therapy).

Important question posed during the webinar concerned personalized medicine.

The response is that the latter is the future of the medicine (so-called a Medicine 2.0). A deliberation about personalized medicine is not a discussion about future in about 10 or 15 years. It drives a magnificent impact across the industry. There was also discussed the question of the difference between the traditional medicine and personalized medicine.

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PLAN, CAPTURE AND SET THE INFRASTRUCTURE FOR DATA SHARING ACROSS THE VALUE CHAIN, TO OPTIMIZE COMMERCIAL STRATEGY.

On July 29, 2021 KG Legal Kiełtyka Gładkowski will take part in webinar ‘Cell and gene data innovation and multi-stakeholder data transfer’ organized by Reuters as part of the activities of Pharma Boardroom (the global platform for C -level healthcare executives) in partnership with Sales force. This online-conference will focus on the life-changing cell and gene therapies and related with it value chains of these therapies and data transfer between the stakeholders.

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A powerful impact of Covid-19 on hospitals and healthcare systems

The coronavirus pandemic and associated restrictions have made it necessary for the healthcare system to adopt telehealth solutions to contact patients remotely and ensure adequate safety for patients whose health conditions require a face-to-face and physical visit to a specialist. It can be said that Covid-19 somehow motivated healthcare institutions to adopt hybrid models of care, the introduction of which had been considered for a long time.

According to the Accenture 2021 Digital Health Tech Vision report, the majority (86%) of 399 healthcare managers from six countries believe that their healthcare organization’s business and technology strategies are becoming inseparable. Underscoring this point is a new survey from FoxitSoftware examining the shift to paperless medical documents and processes, including which departments continue to use paper and why. It turns out that the Covid-19 pandemic situation made healthcare organizations want to make most paper records into digital records as quickly as possible. According to Deboshree Sarkar, Product Marketing Manager and Healthcare Marketing Vertical Leader with Foxit, “collecting, managing, and sharing the data from healthcare documents securely has become the top priority for every healthcare organization we have worked with”.

“Urgent” adoption of electronic document formats by health care organizations

“Since the start of the Covid-19 public health crisis, how big of a priority has it been to adopt an electronic document format for patient-facing healthcare forms and documents?” – a whopping 46% of respondents replied “significant” or “urgent”. Many of the hospitals forced to rapidly expand the virtual care services now are faced with the need to digitize those paper-based documents that they continue to use for tasks such as patient feedback. The fundamental problem is therefore how to reduce paper dependence as much as possible and digitize these documents. Of the respondents who completed the survey, 41% are from the C-Suite, 9.4% are health practitioners, 9.4% are in quality, compliance or operations, and 7.8 percent are in IT.

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The Annual General Meeting will be held online, during which decisions will be made, among others, on the expanding cross-border cooperation and new opportunities to increase law firm legal services as part of participation in life science organizations of the association.

BioLawEurope F.m.b.A comprises a network of independent law firms, i.e. a collective number of licensed attorneys operating nationally under a common trademark or name, but not necessarily in the form of a corporation, and individual attorneys registered and licensed in one or more European jurisdictions and specialized in the rendering of legal services to commercial as well as non-profit based natural and legal persons, including universities and organizations operating, investing in and/or servicing biotech, pharma, food supplement, medical device and/or dentistry industry related.

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INTRODUCTION TO THE MARKET OF BIOCIDAL PRODUCTS IN POLAND IN THE LIGHT OF EUROPEAN UNION REGULATIONS IN THE ASPECT OF GENETICALLY MODIFIED ORGANISMS

DEFINITION OF BIOCIDES

Legal definition of the term “biocidal product” placed on the market is obvious. This definition is provided in Article 3.1 of the Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012. Under EU law, a biocidal product is, in principle, “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action (…)”.

Thus, in relation to the basic core of the legal definition, a biocidal product is therefore understood as a product with a basic biocidal function.

This issue is also addressed by the Polish Act of 9 October 2015 on biocidal products. It mainly stipulates the conditions for using and making biocidal products available on the Polish market and the authority responsible for the application of Regulation 528/2012, i.e. the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

FIRST GENETICALLY MODIFIED MOSQUITOES IN THE USA

A very interesting example of the introduction of genetically modified organisms is the mosquito released in the United States, on which the biotechnology company Oxitec conducted research. It was about a ten-year battle for permission to carry out the experiment. The main reason for such a long process were the protests of Florida residents who feared the bites of the new insects and the disruption of the ecosystem. The whole experiment involves releasing a bioengineered male mosquito to copulate with wild females, which transmit many diseases through their bites, including yellow fever, dengue and the Zika virus.

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