cpd white paper april 20, 2016 review hon sum …cpd white paper – april 20, 2016 review – hon...

CPD WHITE PAPER – April 20, 2016 Review – Hon Sum Ko, Leader

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Attendees: Asiyah Yu Lin, Dale Plummer, Kerstin Forsberg, Laszlo Vasko, Maria Benjegard,

Mary Banach, Mitra Rocca, Rashedul Hasan, Steven Hirschfeld, Tarek Elbeik

SLIDE 1

Hon Sum: Not representing any organization


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SLIDE 2

Summary is part of the Introduction. We need to write out a summary and an abstract.

Mitra will give us a Semantic Technology White Paper to see what is included in PhUSE

white papers.

Mary will send out the PhUSE White Paper Template.

Steven said that we must have an Executive Summary. We don’t want people to lose interest.

We want to grab them at the beginning of the read. This Executive Summary will be equivalent

to an abstract. We will write it up when the paper is completely finished.


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SLIDE 3

H: This slide from Tim Williams is saying that Design is just at the beginning of the clinical

development project. Design is not limited to the very beginning

L: This has come up again and again, especially when we began the working group. It is

important to update this slide.

H: We are not only dealing with considerations that are important to the sponsor, but all those

involved in the project. We must think about reporting all the development activities.

L: People think of the process as linear. We are not talking about just one study. Studies are

leading into other studies. Do we want to see subsequent bars on Tim’s slides? It is hard to show

on a linear display.

H: We should write something to address this in the first part of the WP.

Mitra will ask Tim to update this slide for the upcoming webinar

L: Life cycle actually has lots of dotted lines – rather than one single progression.


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SLIDE 4

H: Do we need these questions? There is not much about these subjects right now in the WP.

There were lots of discussions at the CSS in March.

L: We need the institutional memory. This is the key driver.

T: We need other industries and why are they looking at the design process.

Mitra: We do need project memory.

Laszlo will draft a paragraph.

Mary will send out references that Hon Sum found at the Businessweek Design Issue and

references from the building industry in Denmark.


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SLIDE 5

H: What is quality? What do we mean by a quality decision product?

Maria: By a quality product, the focus of our design is not the compound itself, but the output of

the design process.

H: There are two concepts that we are grappling with when we talk about design quality. The

first is the product design and the second is the entire CPD.

S: I think that I could endorse both. The outcome is the claim. The FDA never approves a

product. The product is neutral. The FDA looks at approving a claim. There needs to be

sufficient evidence to support a claim.

H: The label

Mitra: The Office of Pharmaceutical Quality is looking at beyond whether the drug works or not.

There needs to a paragraph on the quality of the developed product. Janet Woodcock was just

giving an example about asthma inhalers for students to bring to school. It is not enough that the

asthma inhaler works, but we need a new design because the students do not want to bring come

the current inhaler to school. The current inhalers do not work for them.


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SLIDE 6

H: Are component and element interchangeable? Usually the elements are final and thought of

differently than components.

T: We are pulling in information from different sources, but mean the same kind of thing.

We will look at how to harmonize these terms.


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SLIDE 7

H: In Figure 1 we have six critical elements and in the text we talk about components

T: We should define our terms

Maria: We will take this discussion offline with Steven, Tarek, and Mary.


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SLIDE 8

H: The framework should apply to all programs, but the variations should not be too much.

T: We need one framework with flexibility.


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SLIDE 9

H: These discussions about clinical trial design are confusing for the reader. The focus of the

paper is on the clinical program design

S: Design for the clinical trial program, but the program needs to fit into the larger business plan

or scientific plan or regulatory plan. All three layers need to be put in the design.

Maria – Steven needs to help us to sort out this confusion.

We will take the discussion offline.


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SLIDE 10

Mary will add references.

Steven will be adding the text to go with the references.


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SLIDE 11

H: Are we discussing population with a condition and incorporating patients in our design

framework?

S: will try to address. We need to identify where and how the patients will be incorporated into

the design.

H: For study outcome we have not mentioned patient population. We need to look at patient

involvement in the design process.

S: need to be specific where we need the patients involved. For feasibility and acceptability the

patients are helpful, for scientific processes the patients would not be helpful.

H: Do you include endpoints in the discussions with the patients?

S: The endpoints do need to be acceptable to a patient.

Mitra: Some sponsors are using social media to determine acceptability of the program,

L: We do need patients earlier in the process. We need earlier input in the decision.

Mary: Where do we put this discussion in the paper?

H: We do not need a whole new section. There is not a lot of information in that section.

S: will add a paragraph discussing patient input into Design.


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SLIDE 12

H: We use the terms CPD, CDP, Design, Development throughout the document.

L: We called it the Clinical Program Development Design .

H: Clinical trial design is a component of a clinical development program.

L: We are always trying sneak the trial word in.

We will SEND out a survey and then change the terms throughout the document.


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SLIDE 13

Figure 4 – additional stage on not – limit to three stage or four

S: four stages – need to have benefit and risk separately – need to fill in larger context

T: is risk/benefit part of the framework

S: it is important decision – favorable risk benefit

Tarek: rather a short paragraph – not too much detail – manuscript later


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SLIDE 14

H: Page 6 needs examples.

T: We used Asiyah’s slides to build on the concept. We can work on an example.


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SLIDE 15

H: We talked about linked WEB data. Need an example.

Mitra: Can use the YOSEMITE Project.


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SLIDE 16

H: Perhaps we can use the ontology from an electric engineer in biomedical research, if the

ontology was built in the medical device industry.

S: We just want to make a point that ontology is different in a different field.

A: The ontology has to agree with whole community, e.g. biomedical researcher, not just one

party.

SLIDES 18 – 36 not discussed on April 20, 2016 – Review and add comments

cpd white paper april 20, 2016 review hon sum …cpd white paper – april 20, 2016 review – hon...

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