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Embrace, Engage and Inspire

Embrace, Engage and Inspire

Microarray Platform For The Analysis of miRNA Gene Expression:

Objectives: Micro RNA arrays are powerful tools for studying the role of small non-coding RNA in complex disea

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Objectives: Micro RNA arrays are powerful tools for studying the role of small non-coding RNA in complex diseases. Microarray technology enables comprehensive investigation of microRNA expression, and furthers our understanding of recently discovered noncoding RNAs. Our client wanted to establish that data produced from microarrays techniques can be an integral part of drug discovery. The ultimate goal was to use and analyze the genetic information to develop new ways to treat, cure and even to prevent thousands of diseases that afflict humankind.

The Isotopian Knack: Highly scattered data was provided by the client as excel sheets and micro-array reports from the laboratory. Our scientific team analyzed the changes in the miRNA expression profile which is extremely important for deciphering the biological context of differentially expressed genes for various diseases. We also evaluated the regulation pathways which are related to the diseases in a certain way. We used text, tables and graphics to make this highly complex data understandable.

Upshot: Number of original articles, clinical documents, case reports and review articles have been published by us on miRNA microarray analysis for the treatment range of diseases such as diabetes, chronic kidney diseases, stroke, muscular dystrophy, spinal cord injury and stroke etc.

The Client Says: Client appreciated Knowledge Isotopes for in-depth understanding of the data and llucid presentation in the manuscripts. The client retuned to us with more projects.

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Regulatory Writing- Dossier For Submission In US Based Regulatory Body:

Need: A US consulting company with no internal regulatory medical writing resources had identified the need fo

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Need: A US consulting company with no internal regulatory medical writing resources had identified the need for regulatory writing and support to write a dossier to be submitted to US regulatory body. The timelines to submit the document were short. Client spotted us in acknowledgement section appearing in one of the research article published in one of the International Journal.

The Isotopian Knack: In the first telecom, our senior writer grabbed an idea of content of document and instructions for updating it. The PDF document (reference document) containing 500 pages was divided in different sections. Of 6 Sections, we were assigned 4 lengthy sections for editing, formatting and updating as per the latest sources shared. Every page had minimum 4-5 comments to be addressed. We had to work with the global team across different time zones.

We adopted one of the best strategies to deliver the project by considering the timelines, therapy area, and all above the best resources. We followed the step by step process to accomplish the job. We delegated the project to our 3 subject matter expertise, including one team lead and two assistants. We prepared separate working draft in word for updation and side by side addressed comments in PDF document. Every section was thoroughly reviewed and updated as per the instructions given. At the end of every step, we connected with client to resolve our queries and to seek their feedback.

With two internal revisions and simultaneous QC at client’s end, we succeeded not only to deliver the project before timelines but also we submitted a complementary worksheet of missing data and few flaws to be fulfilled at their end.

Upshot: We received appreciation from the client for our efforts and later signed another contract for more regulatory assignments.

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Developing a Review Article For Pipeline Molecule:

Objectives:One of the top global pharmaceutical company approached us to write a review article which will gen

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Objectives:One of the top global pharmaceutical company approached us to write a review article which will generate a need for a new antibiotic for the treatment of an acute infection. The ultimate goal was to collect information from literature about the condition, available treatment modalities, unmet needs, steps to develop new ways to treat, cure and even to prevent thousands of diseases that afflict humankind. However, the client was not clear on how he wants to present this information.

The Isotopian Knack:After an initial call with the client, the writer prepared a table of content and a brief outline. The client shared his feedback on the outline and gave a go ahead for developing the draft. Information and data was collected from literature. Previously available treatments options and challenges were analyzed. An effective data was produced with the use of text, tables and graphics to maximize its strength in conveying important information and results.

Upshot:After carefully vetting the client’s needs, a review article containing all the necessary information was produced. This review article is also a scientific approach for the marketing of a new drug molecule.

The Client Says:Manuscript was approved by the client. However, few modifications were recommended by the client in writing. Knowledge isotopes team assists the client with editing the document, adjudicating comments, incorporating needed revisions, and preparing it for review. Client appreciated knowledge isotopes for standardized work process and was happy that the review could be communicated to the journal in time.

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Strategy To Frame Persuasive Power Point Presentation: Advisory Board

Name of Program:Indian KOLAdvisory Board MeetingProgram

The Client:A Global biopharmaceutical compa

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Name of Program:Indian KOLAdvisory Board MeetingProgram

The Client:A Global biopharmaceutical company

The Challenge:The client approached us with a challenging project that required the generation of consensus opinion on the treatment algorithm in Indian pediatric population for respiratory diseases. Knowledge Isotope (KI) team had to create a worthwhile slide deck to be presented in an advisory capacity.

Objectives:Our motive of slide deck preparation was to deliver all the aspects of Advisory Board Meeting (ABM) on the day of meet. We tried to summarize critical elements entailed for a prestigious slide deck. Our majorfocus was to replicate the actual delivery as closely as possible in the allocated time. The challenge was to deliver the presentations for 10 ABM members in 10 calendar days.

The Isotopian Knack:The agenda for the preparation of slide deck was procured from our client which included distinct topics to make slide deck. Keeping to time limit, we outlined the main points structured in a logical order mentioned in agenda andprioritized slide set as per need at an early stage in the planning process. Our two resources worked on this project to prepare a comprehensive slide deck within timelines. These two resources were provided an open resource for literature search and data QC. Initially, our resources thoroughly focused on relevant literature search. Subsequently, ten slide sets were made on the basis of literature by dividing in such a way, each medical writer took five slide deck. This partition reduced burden of time limits on our resources.

Upshot:A unique slide template was prepared and approved by the client. The slides included minimal text and more data driven figures, tables and creative visual animations. Eventually, we sent every slide after completion to our client for pre-reads.

The Client Says :Because of our stellar performance on this initiative as well as several other projects with this pharmaceutical client, KI was appreciated by the client as well as the investigators. KI was able to provide KOLs with quick, efficient solutions and address their needs without delay, providing the highest quality experience.

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Attending Advisory Board Meetings and Developing Expert Opinion Report For Publication:

Need: Advisory board meetings (ABMs) have been used since long by the pharmaceutical companies to gain medical

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Need: Advisory board meetings (ABMs) have been used since long by the pharmaceutical companies to gain medical and commercial insights about a specific drug/product. A group of experienced professionals or key opinion leaders (KOLs) from a specific therapy area are invited to share their experiences and needs on a specific/pre-decided agenda. These are long duration projects; require technical expertise to provide writing support at every phase from pre-meet till publication. Knowledge Isotopes is experienced and has subject matter expertise for covering such meetings and provide end to end support to the pharma clients.

Isotopian Knack: A multi-national pharmaceutical company required to cover ABM for a specific therapy area. One of our expertise medical writer (EMW) took a telecom with the client and after understanding the objective of meet, other client requirements and considering the timelines of the project prepared a strategy for project execution. The questionnaire and agenda to be discussed in the meet were shared with us.

For pre-meet preparation, literature search was done on relevant topics. A creative, useful and comprehensive slide deck was prepared on the basis of questionnaire and literature search. Excel sheet and word document including literature search was shared with client ten days prior to the meet. The presentations on specific topics were prepared for the presenters as per outline provided by them.

Our EMW collated the expert opinions in the form of minutes of meeting (MOM). Three days post meet, we shared the detailed MOM with our clients. On the basis of suggestions received from all KOLs, a final draft was prepared. The manuscript published online within 3 months of post meet.

What Client Says: Client appreciated our work for the gold standard quality and commitments to execute the project within timelines. We are acknowledged in every published document delivered by us.

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