Close
Worksheet 1: User Input & Project Specifications
By zceie01, on 1 June 2014
User input provided in worksheet 1 is used to produce a project risk profile and estimates for the duration of subsequent development stages. In addition, user input provided in worksheet 1 forms the basis for the cash flow statement, and NPV calculations produced in worksheet 2, as well as the scenario analyses produced in worksheet 3.
After the user presses the “start” button, users are asked to provide basic specifications of the product in box 1:
Box 1: Product specification and pricing
Box 1 prompts the user to provide a number of product specifications and information about the product’s pricing at launch.
1. Origin material and most recently completed development stage
The user specifies whether the cell therapy is an allogeneic or autologous cell therapy product. In addition, the user should specify the latest stage of the development process the product is (about to) complete. These specifications will be used to assess the development times and risks associated with the cell therapy product and will for example inform the duration of the different development stages and the discount rates that are applied to cash flows in the cash flow statement.
The earliest development stage that users can indicate for their product is the pre-clinical stage. Thus, the tool is especially useful for business planning and valuation exercises for products that are entering one of the formal clinical trials stages. We suggest that users who are conducting business planning and valuation exercises for projects that are not yet ready for clinical trials use the tool to illustrate the valuation and development path for projects once these enter clinical trials.
2. Therapeutic focus
The user should select the primary application area of the product. This information will be used to assess the development times and risks associated with the cell therapy product. If the user does not specify a specific therapeutic focus, the tool will use industry-level averages to assess the project’s risks and expected development times. Also, if the user specifies a specific therapeutic focus but the tool does not contain data on more than one project with a similar therapeutic focus (for example because the user is among the first to develop a cell therapy project in that area), cell therapy industry averages are used to calculate expected risk rates and development times associated with the project.
3. # dosage(s) per treatment
The user should select the average number of dosages that patients will be prescribed as part of their treatment. This information will be used as a part of revenue calculations.
4. Price($) per dosage
The user should specify the price the user will charge payers per dosage. This information will be used in the calculation of revenue streams associated with the project.
5. Manufacturing
The user is asked whether the manufacturing strategy entails in-house or outsourced manufacturing. If a user selects “outsourcing” as a manufacturing strategy, the total manufacturing costs will be 30% times higher than if the user selects “in-house manufacturing”. However, the user will not incur separate manufacturing set-up costs if the “outsourcing” option is selected.
Once the user presses ‘next’, figures 1 and 2 are updated based on the project’s characteristics. The line in Figure 1 presents a customised risk profile for the user’s cell therapy project, that highlights expected chances the project will fail at subsequent development stages based on data the BRITS team collected on similar projects (i.e. projects that use the same origin material and have a similar therapeutic focus). The bars in figure 1 present a customised overview of the expected development times for the project during subsequent stages based on data, the BRITS team collected on similar projects. No bars are shown if we have fewer than 2 observations for projects that are similar in terms of the used origin material and the therapeutic focus. Figure 2 displays average durations of the clinical trials stage the project will progress to next. The figure displays historical averages for projects using the same origin material and breaks these down by therapeutic application.
Failure rates displayed in figure 2 will be used to discount cash flows in worksheets 2 and 3; Development times displayed in figure 2 will be used to determine the duration of the various stages of development in the cash flow statements of worksheets 2 and 3.
By clicking ‘next’, at the bottom of box 1, the user also prompts box 2 to appear.
Box 2: Post-approval manufacturing costs
In order to provide users with an estimate of manufacturing costs of the product once it is approved, the user is asked to provide the following information:
- The number of cells in a single dosage.
- The estimated number of dosages that users expect to manufacture per year after the product is approved.
- The estimated lot sizes used in the manufacturing process.
Based on the information provided by users, the tool calculates the expected manufacturing costs per dosage based on optimal manufacturing specifications. These expected manufacturing costs will be used to calculate post-launch manufacturing costs in the tool’s cash flow projections. If the user wishes to change the expected post-launch manufacturing costs, the user can override the manufacturing cost estimate and provide an alternative estimate at the bottom of box 2.
Box 3: Development costs
In order to calculate product development costs incurred for running clinical trials and for manufacturing the product used during trials, users are prompted to provide specifications for the clinical trials protocol, and manufacturing processes they plan to use. Estimates will be more precise if the user is able to provide more project-specific values in box 3. However, the BRITS team has collected data on ‘typical’ values for running clinical trails and manufacturing processes for allogeneic cell therapy projects. These values will be used as default values unless the user inserts project-specific ones.
Users are asked to provide information on the number of patients that will be enrolled during each of the subsequent clinical trials, per patient costs of running these trials, manufacturing costs for a single treatment used in clinical trials, and the manufacturing process being used (Planar, MC-SUB, or other).
The BRITS tool estimates the duration of the different clinical trials stages based on information about the origin material and therapeutic focus of the project, which the user provides in Box 1: Product specification and pricing. However, the user may override the durations for the different clinical trials stages that are based on average development times for similar projects that are provided by the tool by inserting alternative values here.
The user may click the box ‘Consider time delay costs if technology changes (mo)’, to account for time delays that are a result of changes to the manufacturing process.
Box 3.1: Manufacturing set-up costs
Manufacturing process costs constitute a substantial cost component of early-stage cell therapy projects. Box 3.1 helps users incorporate these costs in business planning and project valuation exercises. Estimates will be more precise if the user is able to provide more project-specific values. However, the BRITS team has collected data on ‘typical’ values for costs associated with (changes in) manufacturing processes for allogeneic cell therapy projects. These values can be found in Case Study 2, the Process Change Case. This case study provides ‘typical’ values for a range of manufacturing strategies that can be employed in the development of cell therapy projects.
Users can enter expected costs associated with the different clinical trial stages as well as the pre-market stage when firms set up manufacturing processes for the marketed product. Manufacturing process costs are divided up across the following categories:
- Process development costs
- Technology transfer & process characterisation costs
- PPQ batches costs
- Product stability costs
- Comparability & bioequivalence costs
- Clinical trial bridging study costs
Users are recommended to include clinical trial bridging study costs if they decide to change manufacturing technology from one clinical trials stage to the next. These costs are often estimated by multiplying the clinical costs for one patient enrolled in clinical trials during the preceding stage by fifteen.
Finally, by checking the box ‘time delay associated with technology change (years)’, the tool will incorporate this delay and add the time required to change the manufacturing technology. Delays will be reflected in longer development times in the cash flow statements of worksheets 2 and 3.
Once the user presses ‘next’, the tool consolidates the information provided into two categories, namely Part I. Post-Launch Product Contribution Margin , and Part II. Development Costs.
- Part I provides an overview of the components that make up the contribution margin associated with the cell therapy product once the product is marketed.
- Part II provides an overview of the components of the project’s development costs.
Box 4: Market penetration, staff costs, and other, fixed costs
Box 4 prompts the user to provide information about the expected market penetration at launch, the annual growth rate of the product’s market, staff costs, and other fixed costs associated with the project.
Market penetration
The user should provide estimates of the potential market size for various applications of the product (i.e. as a frontline treatment, as a second line treatment, or other). In addition, by clicking on the drop-down box the user can provide an estimate of the market penetration, measured as a proportion of the target market that is reached during the first year the cell therapy is on the market. The tool assumes that during each of the subsequent year this level of market penetration doubles until, 100% of the target market has been reached. Information on market penetration and growth is used to calculate the revenues generated by the commercialisation of the cell therapy that are displayed in worksheets 2 and 3.
Staff costs
The user should provide estimates of numbers of employees that will be employed across different staff roles along the project’s development trajectory. Default values for salary levels associated with these roles have been obtained from a recent study on staff compensation levels at biotechnology firms published in Nature Biotechnology. The user can change these salary levels according to the specific circumstances of the project. Information on staffing will be used to calculate staff costs in worksheets 2 and 3.
Other, fixed costs – A third part of box 4 allows the user to insert information on other, fixed costs that are expected to be incurred along the various commercialisation stages of the cell therapy project. These costs will be incorporated into the project costs displayed in worksheets 2 and 3.
Once the user clicks on the ‘next’ button, the information provided in box 4 is automatically consolidated in a number of figures that break down various cost items.
Once the user clicks on ‘Go to NPV analysis’, the user is ushered to Worksheet 2 where a cash flow statement for the user’s cell therapy project and NPV value will be produced.
66 Responses to “Worksheet 1: User Input & Project Specifications”
- 1
- 2
-
3
Mannat Clothing wrote on 12 May 2023:
Are you looking for best ready to wear sale in Pakistan? Look no further than Mannat Clothing! They are currently having a sale on many of their top brands, including Chaap, Sunehri Rutt, and Morbagh. This sale is an excellent opportunity to save on some of your favorite clothing brands.
-
4
Panache Apparel wrote on 12 May 2023:
Panache Apparel is a popular online clothing brand in Pakistan specializing in luxury lawn collection. Every one of their exquisitely designed embroidered lawn suits is a must-have for any fashion-conscious person looking to stand out. With a keen eye for detail and quality, Panache Apparel has gained a loyal following in the country’s fashion industry, offering a unique and elegant take on traditional lawn suits.
-
5
Qhaaf Bedding wrote on 13 May 2023:
Qhaaf Bedding is an esteemed brand of bed sheets in Pakistan that provides a diverse range of premium bedding items. The waterproof mattress protector, which guards your mattress against liquid spills and stains, is one of their popular products. Their waterproof mattress covers give your mattress an additional layer of defense, enhancing hygiene and extending its life. Qhaaf Bedding’s waterproof bedding solutions help create a cozy and salubrious sleep setting.
-
6
Subhash Shastri wrote on 3 July 2023:
A must read post! Good way of describing and pleasure piece of writing. Thanks!
Best Astrologer in India -
7
companysuggestion wrote on 3 July 2023:
Good web site you have got here.. It’s hard to find quality writing like yours these days.
One Person Company Registration -
8
companysuggestion wrote on 3 July 2023:
This is an impressive post. Keep on blogging. This is an excellent post, thanks.
Partnership Firm Registration -
9
Dainik Astrology wrote on 3 July 2023:
Simply unadulterated brilliance from you here. I have never expected something not as much as this from you.
husband wife dispute problem solution -
10
Novel Web Solution wrote on 3 July 2023:
Thanks for the nice blog. It was very useful for me. I’m happy I found this blog.
Flipkart Account Management Services -
11
Maharana Cab wrote on 3 July 2023:
Thank you very much for sharing good content. Useful blog information, wanted to thank you for this excellent read!! Keep it up!
Bus Rental in Jaipur -
12
Maharana Cab wrote on 3 July 2023:
Thank you for the information that you provide, it helped me a lot
Bus Rental in Jaipur -
13
Harivansh Tours wrote on 3 July 2023:
Thank you so much for sharing your thoughts. This is exactly what I needs.
Car Rental in Jaipur -
14
Emma Harriet wrote on 6 July 2023:
Gracias por compartir buen contenido. Información útil sobre el blog, quería agradecerles por esta Puerto Madryn escorts excelente lectura. avanza.
-
15
williamsteve wrote on 23 August 2023:
Thanks for sharing some nice information. I appreciate your effort in publishing a remarkable post. Traffic Lawyer Shenandoah VA
-
16
David wrote on 5 October 2023:
If you’re feeling anxious about your upcoming examinations, we’d like to introduce you to our esteemed take my exam online service. Our experienced team is dedicated to helping you excel in your online exams. Entrust us with your exam preparations to ensure you’re well-rested. We are committed to delivering exceptional results; now is your opportunity to shine.
-
17
emilysmith wrote on 17 October 2023:
This process clearly highlights the significance of user input. Just as in an academic journey, guidance like online dissertation help is crucial for the best outcomes.
-
18
Confidus Solutions wrote on 20 October 2023:
A personal banker is a bank employee, usually working in retail banking, who helps customers manage their funds and offers different solutions for their financial needs, such as opening savings or other accounts, investing in money markets, procuring certificates of deposits or other commercial banking products and planning for retirement or children’s university costs. Personal bankers usually work with private customers to help them with their banking-related questions or issues.
https://www.confiduss.com/en/banks/account-management/personal/ -
19
SemUps wrote on 1 November 2023:
I just discovered your blog, and I’m already hooked! Your content is so informative and engaging. The way you break down complex topics into easy-to-understand articles is truly commendable. best Social Media Marketing panel
-
20
yati singhal wrote on 7 November 2023:
seems like a fantastic starting point for any project. It’s essential to clearly define user inputs and project specifications to ensure a successful outcome. This resource makes it easier to get things on the right track. Thanks for sharing!
-
21
yati singhal wrote on 8 November 2023:
User input and clear project specifications are the keys to success in any project. It’s awesome to see the importance of collaboration and communication in action! ✨ #ProjectSuccess
- 22
- 23
-
24
harbii wrote on 6 December 2023:
بناء المساجد في إفريقيا هو جزء مهم من التراث الثقافي والديني في القارة. يُعَدُّ بناء المساجد في إفريقيا أحد أبرز العناصر التي تعكس التنوع الثقافي والإسلامي في المنطقة. تتميز معظم هذه المساجد بالهندسة المعمارية الفريدة واستخدام المواد المحلية في بنائها، ما يمنحها طابعاً خاصاً وجمالية فريدة.تُعتبر المساجد مركزًا للعبادة والتجمع الاجتماعي في المجتمعات الإفريقية، حيث تستخدم لأغراض دينية وتعليمية واجتماعية. بالإضافة إلى ذلك، يسهم بناء المساجد في تعزيز التواصل الثقافي والروحاني بين مختلف الطوائف والثقافات الموجودة في القارة الإفريقية. إن بناء المساجد يعكس أيضاً الازدهار الديني والنمو المستدام للإسلام في القارة والتزام الناس بممارسة دينهم بشكل فعال ومستدام.
-
25
Bolamd Thomas wrote on 8 December 2023:
Realmente buena información, es muy útil, gracias por compartir post tan informativo. Saludos por tu desempeño, espero que sigas publicando artículos tan buenos.
Rosario Escorts -
26
Lucas Henry wrote on 13 December 2023:
I read this post your post so nice and very informative post thanks for sharing this post, I think You should write On “powder coating alloys
-
27
Media Readings wrote on 13 December 2023:
Unleash your creativity, boost your income, and own your schedule with a digital marketing side hustle! Dive into the dynamic world of online opportunities, where every click could be your next success story. Ready to turn your passion into profit? Let the digital journey begin!
-
28
Robert wrote on 21 December 2023:
Absolutely fantastic! Your insight on this topic is truly enlightening. It’s evident that you’ve put a lot of thought into your perspective, and your positive approach is both refreshing and inspiring. Keep sharing your valuable thoughts – they make a meaningful contribution to the conversation. blue prism course
- 29
- 30
-
31
Write My Dissertation Services wrote on 3 January 2024:
Our Write My Dissertation Services are here to help you in the best possible way if you only want the best experts in town to take on your challenging projects and dissertations.
-
32
Write My Dissertation Services wrote on 3 January 2024:
Our Write My Dissertation Services are here to help you in the best possible way if you only want the best experts in town to take on your challenging projects and dissertations.
-
33
kainat azam wrote on 11 January 2024:
A fine piece of information, however, ranking among the topmost searches in Pakistan is not very much easy as it seems. There are SEO experts in every marketing firm who pave there way to aloft websites on the popular search engines.
dddgcc -
34
Steave Brain wrote on 20 January 2024:
I really enjoyed reading this article, thanks for sharing this user input and project specifications. You can try this real estate photo editing.
-
35
james1165 wrote on 23 January 2024:
Cheap assignment help services offer affordable solutions for students struggling with academic workload. These services provide assistance across various subjects, ensuring quality and timely completion. Tailored to fit tight budgets, they are accessible for all students, aiming to enhance understanding and improve grades without breaking the bank. Their cost-effectiveness is especially beneficial for students juggling part-time work and studies.
-
36
nursing dissertation help wrote on 25 January 2024:
I want to always read your blogs. I love them Are you also searching for Nursing writing Help? we are the best solution for you.
-
37
Nursing Writing Help wrote on 25 January 2024:
I want to always read your blogs. I love them Are you also searching for Nursing Writing Services ? we are the best solution for you.
-
38
Just boxit wrote on 29 January 2024:
Navigating user input and project specifications is crucial, especially in a field as intricate as local moving. It’s fascinating to see how technology and user insights are transforming the moving experience. With local moving being a personalized endeavor, understanding user input helps tailor services to unique project specifications. The intersection of user needs and project intricacies in the local moving landscape showcases the industry’s commitment to efficiency and customer satisfaction. It’s exciting to witness this synergy unfold.
-
39
Marina wrote on 31 January 2024:
The “User Input & Project Specifications” represent the fundamental basis for achieving smooth project development, where accuracy aligns with user expectations. Successfully managing this critical stage is comparable to conducting a symphony of necessary elements. If you are looking for direction in this complex procedure, I recommend getting aid from “Help with My Dissertation,” a resource that guarantees clarity and quality in transforming specifications into powerful solutions.
-
40
Watermelon game wrote on 5 February 2024:
This article is very nice and helpful, I like it very much, thanks for sharing this. You can also play new games in Watermelon Game
-
41
abogado criminal firma dc wrote on 8 February 2024:
Thanks for sharing this informative blog! I appreciate the effort you put into providing such detailed information. abogado criminal firma dc
-
42
nursing research paper help wrote on 13 February 2024:
. Good blog. Keep sharing. I love them Are you also searching for nursing research paper help? we are the beExcellentst solution for you. We are best known for delivering nursing research paper writing services to students without having to break the bank
-
43
nursing help wrote on 13 February 2024:
. Good blog. Keep sharing. I love them Are you also searching for nursing research paper help? we are the beExcellentst solution for you. We are best known for delivering nursing research paper writing services to students without having to break the bank
-
44
Nursing assignment writers wrote on 13 February 2024:
Your blogs are great.Are you also searching for Nursing assignment writers ? we are the best solution for you. We are best known for delivering great nursing assignments.
-
45
keven john wrote on 15 February 2024:
Defining clear project specifications is essential for successful project completion. If you’re struggling with this aspect of your project, consider seeking assistance from london assignment help for guidance tailored to your project needs.
-
46
BSNS Consulting wrote on 7 March 2024:
At BSNS Consulting, we offer you unparalleled Business Advisory Services near me. Our team of expert consultants is dedicated to providing personalised solutions that drive growth and success for your business. Whether you’re a startup or an established company, our strategic insights and industry knowledge will empower you to make informed decisions and achieve your goals.
-
47
We Buy Dead Stocks wrote on 11 March 2024:
Inventory liquidation Buyers are companies that purchase overstocked, discontinued, or unwanted products from businesses. We Buy Dead Stocks specialises in buying liquidation stock, providing an efficient solution for businesses looking to offload surplus inventory quickly.
-
48
Tuskr App wrote on 11 March 2024:
Tuskr, a cutting-edge cloud-based test management software, revolutionizes testing processes with advanced features. Craft detailed test cases with ease, integrate seamlessly with chat and issue tracking systems, and enjoy robust security measures. Tuskr simplifies test runs and effortlessly generates comprehensive reports. Explore our free plan and flexible pricing options tailored for all team sizes. With Tuskr, experience streamlined test management. Enroll in your free trial today and witness the transformation of your testing processes with test management tools.
-
49
Project Management Software wrote on 12 March 2024:
Celoxis is a project portfolio management software that allows project leads and organizations to easily strategize, balance priorities, and optimize resources across projects and portfolios. With features promoting effective communication & collaboration, Celoxis enables accurate tracking, evaluation, and progress visibility of your project portfolio, ensuring it’s in sync with organizational goals. Benefit from strategic decision-making, risk management, and scenario analysis for more successful projects.
-
50
TipTop Enrichtung wrote on 13 March 2024:
A friseurstuhl is a specially designed chair that offers comfort and support to clients during a hair salon visit. These chairs are often adjustable in height and have a recline feature for ease of operation.. Explore our collection of stylish and comfortable barber chairs to provide the best experience for your customers.
-
51
angela wrote on 14 March 2024:
You made some very good points here. Wonderful… I think you’ve brought up some really good points. Keep doing what you’re doing.
Esenyurt Konut Projeleri -
52
Kenichigenes wrote on 21 March 2024:
I simply could not leave your web site prior to suggesting that I actually loved the standard info an individual provide on your guests?
Is gonna be again ceaselessly in order to check out new posts -
53
Ethanfadi wrote on 23 March 2024:
This design is incredible! You most certainly know how to keep a reader amused. Between your wit and your videos, I was almost moved to start my own blog (well,almost…HaHa!) Excellent job. I really loved what you had to say, and more than that, how you presented it. Too cool!
-
54
Ludlowjustin wrote on 25 March 2024:
Heya i’m for the primary time here. I came across this board and I in finding It truly useful & it helped me out much. I’m hoping to provide something again and help others such as you aided me.
-
55
harmeen kaur wrote on 31 March 2024:
Very nice post. I just stumbled upon your weblog and wanted to say that I have really hamilton seo company enjoyed surfing around your blog posts. After all I will be subscribing to your feed and I hope you write again very soon
-
56
jazz wrote on 31 March 2024:
This is a very good tips especially to those new to blogosphere, brief and accurate information…dental in calgary Thanks for sharing this one. A must read article
-
57
Canon Casper wrote on 1 April 2024:
Excellent post. I was checking continuously this blog and I’m impressed! Very useful information particularly the last part I care for such info a lot. I was seeking this certain info for a very long time. Thank you and good luck.
-
58
Frenchie Maclean wrote on 1 April 2024:
Have you ever thought about including a little bit more than just your articles?
I mean, what you say is valuable and all. However think about if you added some great visuals or videos to give your posts more!
Your content is excellent but with images and clips, this blog could undeniably be one of the greatest in its niche. Wonderful blog! -
59
Imtiyaz Kasim wrote on 1 April 2024:
I’m not sure the place you are getting your information, however great topic. I needs to spend some time finding out more or understanding more. Thank you for excellent information I used to be on the lookout for this info for my mission.
-
60
Digital Brains Tech wrote on 1 April 2024:
Thanks for share Your information,
We are a Professional Link Building Services provider in USA. Our expert link builder can help you to generate high-quality backlinks through various SEO activities.
-
61
Russell wrote on 2 April 2024:
Jaoyeh Trading Ltd is a reputable trading company specializing in the export of high-quality products from China. With a focus on customer satisfaction, they offer a wide range of products including electronics, home appliances, and textiles.
-
62
We Sell Dead Lots wrote on 4 April 2024:
Electrical items suppliers in UAE – We Sell Dead Lots is your trusted partner for sourcing premium electrical items in the UAE. Our network of reputable suppliers ensures a wide range of high-quality products, from essential components to advanced machinery. With competitive pricing and a commitment to customer satisfaction, we provide reliable solutions to meet your specific needs. Trust We Sell Dead Lots as your go-to supplier for all your electrical item needs in the UAE.
-
63
دار الصيانة wrote on 7 April 2024:
العزل هو عملية تهدف إلى منع انتقال الحرارة أو الصوت أو الرطوبة أو الروائح بين البيئات المختلفة. يلعب العزل دورًا حاسمًا في تحسين كفاءة استخدام الطاقة وتوفير الراحة والحفاظ على جودة الهواء الداخلي في المباني والمساكن.
بالنسبة للعزل الحراري، فإن العزل المناسب يقلل من انتقال الحرارة بين الداخل والخارج، مما يعزز الكفاءة الحرارية للمبنى. يمكن تحقيق العزل الحراري من خلال استخدام مواد عازلة مثل العزل الحراري بالألياف الزجاجية أو العزل الحراري بالبوليستيرين الموسع (EPS) أو العزل الحراري بالألياف الصخرية. يتم تطبيق هذه المواد على الجدران والسقوف والأرضيات لمنع انتقال الحرارة من الخارج أو الداخل.
أما بالنسبة للعزل الصوتي، فإنه يهدف إلى تقليل انتقال الصوت بين الغرف والمساحات المختلفة. يمكن استخدام مواد عازلة صوتية مثل العزل الصوفي أو العزل الصوتي بالألياف الزجاجية لتقليل الضوضاء المزعجة وتحسين الخصوصية داخل المبنى.
. -
64
Terron India wrote on 8 April 2024:
Best filling machines offer numerous advantages to manufacturers. They improve efficiency by automating repetitive tasks, reduce labor costs, minimize product wastage, and ensure consistent filling accuracy.
-
65
Gayle Harris wrote on 10 April 2024:
Check out this awesome web development agency in canada that can help you elevate your online presence.
-
66
Netsol Water wrote on 19 April 2024:
Thanks for the sharing such kind of inforvative content . We are the leading sewage treatment plant manufacturer Working towards water and wastewater treatment.
Hey, thanks for sharing a very helpful and informative blog.
Platinum