Get help from the best in academic writing.

NYU Commercialization Plan to Support Pursuit of A Biopharmaceutical Product Essay

NYU Commercialization Plan to Support Pursuit of A Biopharmaceutical Product Essay.

commercialization of a biomedical product involves consideration of many variables unique to the healthcare sector including financial, technical, legal, regulatory, manufacturing, and marketing concerns. A major objective for the course is to give students an opportunity to translate regulatory requirements for medicinal products into broadly applicable regulatory strategies and submissions. This necessarily involves practicing analytical thinking, and effective communication of scientific and technical information. In completing this Assignment students will have the opportunity to use these skills to demonstrate their understanding of the concepts involved in constructing a lifecycle management strategy for a new class of biopharmaceutical products.InstructionsUtilize the following case study to evaluate and communicate your thinking on developing a compliant life-cycle management strategy: Imagine that
you, as a regulatory science expert, go camping in a remote area of the world, and find an isolated tribe of
people that has not yet communicated with the rest of the world. You discover that this tribe uses several
types of “magic dust” to treat a wide variety of human ailments, each with varying safety
profiles and degrees of efficacy. For example, the tribe uses “magic dust
#1” to treat headaches, nausea, fever and mild systemic pain, “magic
dust #2” to treat cuts and bruises, and “magic dust #3” to treat
insect bites. In fact, you observe
that the tribe has isolated or developed at least 12 different kinds of
“magic dust” and your observations suggest that the “magic
dust” category as a whole seems to have a novel mechanism of action. You
ask the tribe if you can have
samples of each magic dust type to bring back home with you for analysis and
they agree. When you get home, you give these samples to the medical research
community, which discovers that indeed, these “magic dusts” might
possibly be used effectively in the US to treat the conditions for which they
are utilized by the tribe, and that their pharmacodynamic mechanism of action
is, indeed, unique.As a regulatory expert, you
are charged with developing a product development plan to support an NDA submission to the US Food and Drug
Administration (FDA) for each magic dust type. You are also responsible for
developing a post-market approval plan to ensure ongoing maintenance of
regulatory compliance after receipt of an NDA approval. Your plan should
address the following “magic dust” associated questions and/or issues:◦
What
pre-clinical requirements should be summarized in the clinical development plan?◦
How can the
indications for use for each “magic dust” be isolated and refined? Why is it important to do this?◦
How can the
risk vs. benefit profile associated with utilization of the “magic
dust” for clinical purposes be established?◦
Should a randomized
controlled trial design be utilized to conduct clinical research to support an
NDA submission for the “magic dusts” or should an adaptive platform design be utilized instead?◦
Are there intellectual
property issues that should be addressed?◦
How would
you go about addressing pricing and reimbursement
considerations?The commercialization plan should take the form of a 10-12 page written document.
NYU Commercialization Plan to Support Pursuit of A Biopharmaceutical Product Essay

NGR 5209 Florida Agricultural Role of the Social Cognitive Theory Questions.

1. Based on the definitions provided in literature write your own definition of health and state the rationale for the factors you considered in developing the definition. 
2. Interview 3 persons at varying points in the life span (adolescent, young adult, elderly person) to obtain their perspective on health and the health promotion strategies they perform to stay healthy.  Ask them to identify any personal, social, and environmental barriers to pursuing a healthy lifestyle. Suggest health promotion strategies to help them overcome the barriers stated by the interviews. 
Answers to interview:
Young adult- I view health as taking care of my body and mindset. in order to reach my optimal health I write in a daily journal about foods I eat, I drink lots of water, and research healthy diets to meal prep. I also have a goal calendar for my daily workouts, where I workout 5 times a week for 30 minutes to an hour each day. The interviewer reports that being a single mom can be identified as a barrier to pursuing health goals in regards to not having enough time in the day to implement health goals.
STRATEGIES:
Elderly person-  I view health as doing things to keep your blood pressure down, cholesterol down. being in great health includes participating in activities such as exercising, and eating right.  Strategies I perform to stay healthy include eating right by going on a plant based diet to stay moving and healthy. I also garden and drink spring water. Barriers that I have to pursing a healthy lifestyle include having the will power or not being motivated to do the right things to stay on tract.  
STRATEGIES
Adolescent- I view health as living a long healthy life and not being sick. strategies I perform to stay healthy include eating healthy, social distancing, and exercising. Barriers that I have to pursuing a healthy lifestyle include having a sweet tooth.
3. Choose one social cognition theory described in the chapters and use it as a guide to develop an intervention to address a selected behavior change for you.  Identify the stage of change you are in currently as it relates to the selected behavior. 
STRATEGIES
4. Write one long-term goal to obtain the behavior selected and two short-term realistic, measurable implementation strategies to begin to achieve the goal. 

NGR 5209 Florida Agricultural Role of the Social Cognitive Theory Questions

Objectives of Assignment · Using the knowledge gained in class and from readings/evidence based resources watch the youtube video Essay

Objectives of Assignment · Using the knowledge gained in class and from readings/evidence based resources watch the youtube video you have been signed up for. · You are assigned psychosexual (Freud) YouTube Videos Middle Adult https://www.youtube.com/watch?v=UIOCDtM-I28 Guidelines for the Observation: · Prior to watching the video read about growth and development for the age group you will be observing. · Describe what you observe. Be as objective as possible. 1. Compare specific examples of the person’s behavior with the expected “norms” for that age group from the readings (text and/or other references). Include in the Analysis: You should analyze your subjects behaviors according to developmental theorists from the assigned readings in your text, as appropriate for subjects developmental level. You are assigned psychosexual. · Psychosexual (Freud) a. What stage of psychosexual development? b. What aspect of personality is associated with any fixations at any of the stages? Format · Do not use the first person or I. “Refer to yourselves as” the observers.” · Identify the subject by initials only. Do not use the subject’s first name.

Case Study in Correctional Counseling and Formal Referral Process Paper

essay writer free Case Study in Correctional Counseling and Formal Referral Process Paper.

Select one of the following case studies located at the end of each chapter in Correctional Counseling:“The Case of Rick”“The Case of Danny” “The Case of Mary”Write a 700- to 1,050-word paper based on your selected case study.Include the following in your paper:A brief description of the selected caseA description of the concept of helping clients during the case management processThe best intervention practices when working with clients and how this can have a positive effect on a client’s behavioral patternsThe concept of helping and intervention practices that should be used in this caseFormat your paper consistent with APA guidelines.AND……..Write a 1,050- to 1,400-word paper in which you describe the procedure and process a case manager should take when completing formal referrals and linking clients to services within the community.Address the importance of developing an individualized service plan.Format your paper consistent with APA guidelines.
Case Study in Correctional Counseling and Formal Referral Process Paper

Reiss And Ted Baker Are Growing UK Retailers Marketing Essay

Introduction The buying process relies on a wide range of information, which must be researched, analysed and evaluated to achieve a focused merchandise plan. Therefore, the two UK trading retailers that both stock and sell knitwear have been selected. The first one is Reiss fashion brand that has been established in the early 1970s and now Reiss is a multi-national fashion retailer with over 90 stores around the world. The company creates and produces directional and design-led womenswear and menswear and different accessories. The garments can only be purchased through Reiss stores unlike Ted Baker clothing. Thus, Ted Baker is a London-based clothing firm that offers a wide range of collections including menswear, womenswear , accessories, fragrances and eyewear. The company has earned its reputation as ‘No Ordinary Designer Label’ thanks to attention to details and a quirky sense of humour. The brand operates through three main distribution channels which is retail, wholesale and licensing. Consequently, this report will compile a SWOT for the chosen category, draw up a buying cycle and include approximate timings, reference the roles and key responsibilities in the different parts of this buying cycle. Finally, discuss how each retailer presents their range and explain similarities or differences and how these are translated in the store. Company Mission Statement Reiss “Mission is creating and producing directional, design-led menswear, womenswear and accessories by delivering innovative, original products and combining exceptional design, quality and value” (Reiss, 2009). Ted Baker “Mission is to build a thriving company through the creation of a leading designer brand, by conducting ourselves in an efficient and courteous manner and by maintaining Ted’s high standards and integrity” Ted Baker (2009). Knitwear Knitwear as a selected garment category is stocked and sold by Reiss and Ted Baker the two UK trading retailers. What is more, the chosen category has a big enough range represented by each seller. Reiss offers not only women’s jumpers, V-necks, chunky knitwear, dresses but also men’s cashmere jumpers, cardigans and other garments. On the other hand, Ted Baker suggests jersey tops, wraps and many more both for men and women with quirky sense of humour such as looped fringe and popcorn details. SWOT for the Knitwear The aim of any SWOT analysis is to identify the key internal and external factors that are important to achieving the objective (Hamel

The 1960s and Ronald Regan

The 1960s and Ronald Regan.

The prompt will ask you to focus on social, cultural and political developments in the U.S. based on the videos provided Refer to all videos as a main sourceYou cannot use any outside sources1-page essay12 Point/Times New Roman FontDouble-spaced. If submitted single-spaced, it will not be graded. Indent paragraphs.Submit as a PDF or Word Doc only. If submitted in any other format that cannot be opened by me, there will be no extension and a zero score will be recorded. Google docs must be saved as a PDF. Write in complete sentences. Cite the sources – Cite at the end of each sentence when referencing a source or using a quote, (Lecture: Title), (Video: Title), (Reading: Title), etc. Here is your prompt: Use any of the lectures and supplemental sources I have provided to respond to the following prompts using examples and include citation (Cite the sources – Cite at the end of each sentence when referencing a source or using a quote, (Lecture: Title), (Video: Title), (Reading: Title), etc. ****No outside/internet sources that I have not provided can be used, using such sources will result in a failing grade. Prompt: Based on the sources provided, a major social, cultural, and political development, their causes and effects, and their historical significance (this is where your critical thinking comes in, why is this past important?) and analyze the relevancy of history in today’s U.S. society (here is where your analysis comes in, how is it connected to the U.S. today?). Provide 1 example for each element – using 3 different sources (meaning you cannot use the same module source for each element) (Elements in the prompt: social, cultural, and political development/cause and effect). Don’t forget in-text citation!!!!![Please look at attachment Road Map the 1960 before starting] Video 1: https://www.youtube.com/watch?v=QP-v9BTaVW4 Video 2: https://www.youtube.com/watch?v=kyHIwaCVDo4&feature=youtu.be Video 3: https://www.youtube.com/watch?v=9e9GWdT2pEQ&feature=youtu.be Video 4: https://www.youtube.com/watch?v=4QqqMNMZGTA&feature=youtu.be Video 5: https://www.youtube.com/watch?v=VO40SpSBjbc&feature=youtu.be Video 6: https://www.youtube.com/watch?v=dpQ75lOqgtg&feature=youtu.be Video 7: https://www.youtube.com/watch?v=DgKJ6UTRMJ4&feature=youtu.be Video 8: https://www.youtube.com/watch?v=YrEEukxuMxs&feature=youtu.be Video 9: https://www.youtube.com/watch?v=G66myWragTg&feature=youtu.be Video 10: https://www.youtube.com/watch?v=EukElITplo4&feature=youtu.be Video 11: https://www.youtube.com/watch?v=kHWGAEF5GGA&feature=youtu.be Video 12: https://www.youtube.com/watch?v=-HWZw0rzJWM&feature=youtu.be Video 13: https://www.youtube.com/watch?v=4eP_8a7PSik&feature=youtu.be Video 14: https://www.youtube.com/watch?v=WncN6PWEMGo&feature=youtu.be Video 15: https://www.youtube.com/watch?v=wuHE_syTuII&feature=youtu.be Video 16: https://www.youtube.com/watch?v=G-WASW9dRBU&feature=youtu.be Video 17: https://www.youtube.com/watch?v=MIbAVS-cDBs&feature=youtu.be [Please look at attachment Ronald Regan before starting] Video 18 (Ronald Regan): https://www.youtube.com/watch?v=mtBqK9dB-EA&feature=youtu.be https://youtu.be/mtBqK9dB-EA https://youtu.be/kr6zA_78nys https://youtu.be/gTRa6OYhi1g https://youtu.be/pgRknobBvr0 Video 19: https://youtu.be/2h4DkpFP_aw Video 20: https://youtu.be/AYrlDlrLDSQ Video 21: https://youtu.be/_8YxFc_1b_0 Video 22: https://youtu.be/LToM9bAnsyM Video 23: https://youtu.be/5MDFX-dNtsM
The 1960s and Ronald Regan