August 24, 2023
Host: Oliver Ball, Business Development Team, Dark Horse
Presenter: Uzma Shoukat-Mumtaz - Senior Consultant, Dark Horse (4+ years with company)
Opening Remarks
Oliver Ball: Okay, welcome, everybody. We're just waiting a few minutes for people to filter in. We'll be starting just in a moment.
Okay, we're a couple minutes past, so I think we can begin. Thank you, everybody for joining the first of the unbridled Excellence Webinar series by Dark Horse consulting.
My name's Oliver Ball. I'm part of the business development team here at Dark Horse.
This is the first of a series of webinars that we're going to deliver which are really designed to leverage some of the experience that our course has gathered over the projects that it has performed over the last 9 years.
So try and give you a bit of insight and experience into the lessons that we learnt across our core competencies and the projects that we've performed.
As you know, we're totally specialized in the cell and gene therapy space with Dark Horse having had now more than 300 clients in this space, representing about 650 projects.
So you know, across that side of the experience, there's some really deep knowledge of the space which we're hoping to share some of our thoughts from with you in this webinar series.
We actually have 2 further webinars already on the calendar. The next is on the twenty-sixth of September at the same time, which will be on the topic of preparing facilities for inspection by competent authorities. It'll be led by David Jassek, senior consultants.
And we also have a third webinar on the 25th of October, again at 9 AM Pacific, hosted by Alicia Fedorovich and Josh Beckett. They will be covering the topic of phase appropriate analytical methods developments for cell and gene therapies.
The details of those webinars are on our website and do keep your eye out for other announcements coming up later in the year, and also through until early next year, where we will be announcing additional webinars on a variety of our topics.
If you have any ideas or suggestions or questions for other topics that you would be interested in us covering, then please do submit those suggestions when you register for future content for future webinars, or you can email them to us contact us at Dark Horse consulting group.com.
We will have a QA session at the end of the webinar today. So if there are any comments or questions that come up throughout the course of the webinar today, please do submit them in the QA chat function in the Zoom Platform and Uzma will get to those at the end of the presentation.
There will also be on demand viewing available for those who have to drop off early, or you want to share the webinar content with your colleagues. We'll circulate information about how to access that following the webinar today.
So without any further ado, I would like to introduce Uzma Shoukat-Mumtaz, our senior consultant at Dark Horse, who will be leading the webinar. Uzma's been with us for more than 4 years now, having worked at Geron and a number of other cell therapy companies where she's got a huge amount of experience, not only in working with CDMOs, but in a much broader range of activities as well.
And she's also the keeper of keys on our internal CDMO database. So she's very well positioned to speak on this topic, and I'm very glad to hand over the reins. If you'll excuse the continued horse related puns to Uzma, who will start the content presentation.
So it's over to you.
Presenter Introduction
Uzma Shoukat-Mumtaz: Yeah, thank you, Oli, and thank you everyone for joining me. Today I'm really excited to be talking about one of my favorite projects to work on at Dark Horse, which is helping my clients with their CDMO selection, or identifying a suitable manufacturing partner for their program.
Oli gave you know, a nice introduction, but I wanted to just add a little bit more information on my background. So, as Oli said, you know I am a senior consultant at DHC. I've been with the practice now for a little over 4 and a half years.
I have a bachelor's of Science degree from San Jose State University. I am a San Francisco Bay area native, just recently moved out to Dallas, Texas, about a couple of years ago. I have over 12 years of industry experience in the cell therapy space where I've worked in manufacturing process development, product development and tech transfer.
At Dark Horse I've had the opportunity to work with many different clients on many different projects all the way from, you know, starting from regulatory writing all the way to performing voice of customer surveys. And so really, really looking forward to giving you guys more information on one of my favorite topics which is our CDMO selection process.
Presentation Overview
Uzma Shoukat-Mumtaz: So today's presentation will cover an introduction into the CDMO selection process, also giving a little bit information on the purpose and scope of this presentation. Then I'll be going into the main content of the presentation, which is the actual CDMO selection process going through all the different steps of the process. And then also discussing, you know, the types of methodologies that we use to evaluate the CDMO proposals, and then walking through the criteria that we use as our guide, for when we are selecting or providing our recommendations to our clients in regards to a suitable CDMO for their program.
So if you haven't already, I encourage you to go over to DHC's website to check out all the different types of consulting services that we provide to cell and gene therapy companies, and you'll see as one of them is again, you know, assisting clients in selecting their suitable contract development and manufacturing organization or CDMO.
And this is a process where we will prepare a request for proposal or RFP that is tailored to the client's program. We will submit that proposal to the CDMOs, receive the proposals from them, collect the data, evaluate and determine, you know which CDMO is best suited for our client's program.
And so I'll go through in detail the steps in the CDMO selection process and provide more general information about it as well.
CDMO Selection Process - 7 Steps
Uzma Shoukat-Mumtaz: So you know, for our process, you know, we've been able to break it down into 7 steps, as you can see here on the screen.
One thing to note is that yes, it seems like, oh, that 7 steps seems like a lot. But you know one thing that we do keep in mind as we do perform these tasks in parallel or staggered because we do want to be mindful of our time, our client's timeline and goals, and so we try our best to work as efficiently as possible. So, you know, we were not necessarily performing these steps sequentially, but we are doing that concurrently or staggered.
Step 1: Reviewing Program Information and Drafting Process Flow Diagrams
Uzma Shoukat-Mumtaz: So first up, I'm going to talk about reviewing program information and drafting the process flow diagrams. So when a client comes to us wanting to help them identify their suitable manufacturing partner, we'll start off with a kick off meeting, and in this kick off meeting, we'll introduce ourselves, provide our background, and we'll also give an overview of the CDMO selection process.
In that meeting as well, we will also ask the client to provide an overview of their program, and what attributes they are looking for in their CDMO. And this will be important later on when I discuss talking about how we generate the CDMO shortlist in the next few slides.
Then we'll also ask the client to provide a list of relevant documents for us to review. So the client will populate a secure data room with the documents and materials for us to review. And so this can be like batch records, protocols, technical reports, presentations, and any information on the planned clinical trials as well.
And so we use that information, we review it, we'll look through it. If there's any questions we have, we'll go back to the client to follow up on any gaps or address any questions that we have and so gather all the information, organize it in order just for us to start drafting the RFP as well as the process flow diagram.
So the RFP is a document that basically will describe in detail all the client's program requirements. And it's also kind of like an official invitation inviting the CDMOs to submit a proposal for the client's program.
One thing that we like to include, which is really important is a process flow diagram. So the process flow diagram, as you can see as an example here on the screen helps us to codify the process, and also gives a one page visual of what the manufacturing process looks like. So here is an example of a 5 swim lane process flow diagram which is capturing, you know, the key materials, what are the unit operations, what are the testing requirements, methods as well as any key equipment and comments that need to be noted about the process.
And so, you know, one thing to note is that we have presented this process flow diagram in front of health authorities. So you know, not only have we used it in our RFPs, we've also used it in other documents as well.
Step 2: Preparing User Requirements and Specifications
Uzma Shoukat-Mumtaz: Alright. So next thing that we want to draft is preparing the user requirements and specifications. So this is a really big and important section in the RFP. And this really lists all the requirements in detail for the client's program. And so the types of requirements that will be included, will be like regulatory requirements, business considerations, process equipment requirements, any facility operation requirements as well any personnel and quality requirements as well. So as you can see here on the screen, here are just some examples of what those URS items will look like, so they'll be divided up in sections.
And they'll have, you know, a row with CDMO requirement and another row with the specification for that requirement. We'd like to use these URS to assess on you know how this CDMO will comply to meet the client's requirements, and it also provides the CDMO as a guide on how they can narrate their strategy and the proposal, and complying to those requirements.
The types of requirements can vary, you know, between the client and how many requirements there are can also vary between the client. So, for example, a client that is in a late stage clinical development, will have more URS items versus maybe a client that may be earlier in their clinical development. Some clients also have requirements for development, so that section may be heavy on those requirements as well.
You know, and sometimes clients will come to us, and they may not really know what it is that they're looking for, what their program requirements are. So we do have templates that we work from and then we build it up from there and tailor as we learn more and more about the client's program.
Step 3: Drafting Other RFP Components
Uzma Shoukat-Mumtaz: Alright. So I mentioned about the process flow diagram and the URS. There are also other components to the RFP that will also be drafted.
So as the URS and the process flow diagram are being prepared, we'll also start preparing the other sections. And so there are many sections included in the RFP. So first up, you know, we'll have, of course, the purpose which is stating the purpose of the RFP. Then we'll have a background section which includes information on the client, their company, their program, and just kind of high level information on their manufacturing process and drug product as well.
We'll have a section on general instructions on how the process is, you know our RFP process and how the proposal should be submitted. So, for example, there'll be a statement saying that you know the proposal should be submitted in an electronic format.
Then we'll have a section on critical consideration, which is basically a list of major factors that may influence the selection of the preferred manufacturing partners, such as you know, a client's timeline. So we'll have a note, and they're saying that okay, client is looking into tech transfer as early as January 2024, and looking to start clinical manufacturing in the third quarter of, let's say, the next the following year, 2025.
So we'll have important major factors like that in there.
Then we'll have contact information. So this is contact information regarding like who will be receiving the proposal both on the client side and on Dark Horse side, and also that you know that is just clear, and who will be the point people for this RFP process.
Then we'll have the content of the proposal. So this is giving guidance to the CDMOs, you know what types of information we are expecting to be included into the proposal. So, for example, not only describing the strategy, but you know, including, like a timeline a proposed timeline, and as well as a proposed budget for the proposal.
Then we'll have a section on a proposal review. And this basically is giving insight to the CDMO so that they understand how we will be reviewing the proposals.
Then we'll have a scope of work section. And so this is also another pretty heavy section which will have more detailed information on the manufacturing process, more detailed information on the shipping requirements, drug product release testing specification. If there's also in process testing that'll be described there and any other important requirements or scope of work that need to be detailed that will be included and also be a reference to where the process flow diagram will be located.
Next we'll have the URS. As I mentioned, this is a very large section, so we'll take up most of the document. It can be somewhere between like 5 pages to like 10 pages, or even 15 pages, depending again on the requirements for a client's program.
Then we have a section on listing out the deliverables. And so this is basically setting up the expectation that if a client is partnering with the CDMO, what are the expectation in terms of deliverables? So this can be such as executed batch records, completed technical reports that have also been reviewed. This could be certificate of analysis of the release drug product, any analytical reports, as well as deliverables in terms of expectations of attendance through project update status updates, meetings as well.
Then we'll have a schedule which lists out all the events in the CDMO selection process all the way starting from when the RFP is submitted, when the proposals are expected to be returned, or, you know, turned around and submitted to us, and then the timing of the review process. And then finally, you know, when the selection will be made. So all of those important events will be listed along with important dates, and as well as who will be responsible for those events to occur, and ensuring that they happen on time as well.
And then we'll have a terms and conditions section which basically just outlines, you know, all the contractual obligations and rights, and just making sure all of that is clear. And then, lastly, we have appendices. In the appendices, we'll have the process flow diagram, a list of equipment and any other documents related to the RFP in the program requirements. So sometimes, we may include the release requirements or specifications in that section as well.
Step 4: Generating the CDMO Shortlist
Uzma Shoukat-Mumtaz: Alright. So next up is generating the CDMO shortlist.
So, as I mentioned, when we do the kickoff meeting, we do ask the client, you know, what are your CDMO attributes? What are you looking for in that ideal manufacturing partner? And so, you know, there are a variety of attributes that a client could be looking for. So, for example, regulatory requirement, you know, they may be looking for a CDMO that can support, you know, regulatory filings in various jurisdictions, having clean rooms that are compliant to different regulations.
Being able to support, procuring, you know, qualifying, releasing material to be used in the manufacturing process. For clients that are looking for development support, there may be strong emphasis there in that attribute, and then, of course, drug product release is always critical for almost every client that I've worked with, you know, because there's always you know, we're thinking about here, you know, being able to get the drug product as quickly as possible to, you know, to the patient. And so being able to release a drug product within the designated timeframe will be an important attribute.
Another attribute that we sometimes do get asked to include is location. Sometimes clients will like a CDMO that is close to them distance wise where it's just like a quick flight over nothing too long, so that you know, if they want to be on site they can easily do that as well.
So once we have, you know, collected that information from the client on what attributes they're looking for in a CDMO, we will take that list and use it to filter and create a you know, high level initial list of potential CDMOs. So we have an internal CDMO database that lists over 150 CDMOs globally. And that list is going. I think we're getting close to like 200 now, and so we'll take that list, you know, filter it out to get our, you know, like maybe it will end up being like 20 or 30 CDMOs, and then we'll pair it down even more based on, you know, the client's budget, their scope of work, and then also our own internal experience and knowledge of the CDMO as well.
Once we get our short list put together, we'll present it to the client in a memo format or an email describing our reasons for why the client should consider submitting the RFP to the selected CDMOs.
Step 5: CDMO Outreach and NDA Process
Uzma Shoukat-Mumtaz: So once the CDMO shortlist has been agreed upon, the client gives a green light that we can move forward and outreach to the CDMOs, we will immediately start the NDA/CDA process. So which is basically sending out all the contracts to the CDMOs for review and signatures. We like to get this started as soon as possible, because it does take time, you know, can take somewhere between a few weeks, or even few days. So we understand that, you know each CDMO has their own process on how the review cycle is, and so we want to be fair and make sure that there's plenty of time to get those CDAs reviewed and executed.
While that is going in the background, we will set up introductory calls, and this is kind of like a virtual handshake, you know, between the client and CDMO for them to, you know, get familiarized with each other. So this is an opportunity for the client to present at a high level of their program and then for the CDMO to also present their capabilities at a high level. So this is kind of like, you know, a little bit of a teaser of what's coming up in the RFP.
Once the CDAs have been fully executed, then we can share the RFP and have more detailed discussions about the client program and requirements and being sure to emphasize the schedule because it's really important. We try our best to adhere to that schedule because we want to make sure again that we are mindful of the client's timeline and goals, and stay close to that as much as possible.
And you know, DHC will take care of pretty much majority of all the client and CDMO interactions, and really what it is, you know, we're trying to take away all the hassle and headache from the client, so they don't have to worry about it. So we will make sure, you know that the process and everyone is following the schedule.
Step 6: Proposal Analysis
Uzma Shoukat-Mumtaz: Alright. So now the real fun starts. This is my absolute favorite part, which is doing the analysis. And so once we receive the proposal we will right away start analysis of the CDMO proposals, and we'll look at, you know, all the parts. We'll really, you know, read each line in detail, and really looking at, you know, did the CDMO pay attention to what was in the RFP, and did they provide the narrative and the strategy and the responses that we were looking for.
Now, one way we like to do the analysis is a quantitative analysis using a decision matrix. And this allows us to kind of give us a fair analysis of each CDMO. So, as I mentioned, I talked about the URS items. So for each URS item, we do give it an importance rating. So some URS items will be more important than others. So, for example, something that may be critical to a client, is maybe a specific equipment needs to be used in their process, such as like an automated cell counter. There's a specific one that needs to be used for their testing. Something that may be a nice to have, which may get a lower rating in terms of importance is maybe it would be nice to have to have like some type of a camera in the manufacturing suite for the client to be able to view remotely their manufacturing process being carried out in real time.
So we'll rate each URS item, give them an importance rating, and the next step, what we'll do is we'll look at the responses and strategy that the CDMO has provided in the proposal and give those a rating. So a high rating will be, for example, that the CDMO says, okay, yes, we comply. We have this requirement in place so we're good to go. Something in the middle would be like, oh, we're kind of working on it. But we will work with the client to get this requirement in place, and a low rating will be nope, we don't have this requirement. We have no intention of getting this working on a strategy to put this requirement in place. So you know, that will give them either a low rating, or it may be considered as a deal breaker.
And so once we have those ratings in place, we'll multiply across the board to give the overall rating for each CDMO. And also this kind of allows us to see, you know where each CDMO stands in comparison to each other, based on their responses.
Budgetary Analysis
Uzma Shoukat-Mumtaz: Next up is, we'll do a budgetary analysis. Now, each CDMO will present their budget in different ways. And so we try to normalize it. So we're not comparing apples to oranges to bananas because it becomes very hard and confusing for the client to understand. So we try to normalize it so that you know we're, it's easy to understand, and how the CDMOs compared to each other. So what I like to do is I like to break down the work packages presented by the CDMOs into different buckets, so, as you can see, like to, you know, bucket into like roughly 4 categories. And then I will compare the overall cost between each CDMO also. Here are as an example of pie charts of 6 different CDMOs, and the size of the pie is representative and relative to the overall cost. So for example, CDMO one has a larger pie. So they budgeted the program to be at a higher cost versus CDMO 6. Now you see CDMOs 5 and 6 have a similar size, but the breakdown of their costs are a little bit different. So it's really great visual to kind of see overall like the breakdown of the costs between all the CDMOs.
And then the other thing I do want to mention that we do have to include some assumptions in there. So, for example, to help us normalize the cost analysis, you know, we will add some assumptions in there, such as you know, the total duration the client may need to be in a clean room suite, how many production batches there will be per month, and if there are development activities or extra engineering months that need to be considered, we'll add that there also as an assumption.
Step 7: Final Report and Recommendations
Uzma Shoukat-Mumtaz: Alright. So once we have compiled all the information, and we have done all the analysis, we'll put it all together in a final report for the client. So in that report will include all the client's program information, what the requirements are, what was the methodology that we use for evaluating the proposals, what were the results of that proposal, and then, lastly, of course, our recommendation on the lead candidates, as well as what the next step should be.
So usually we like to recommend the top 2 candidates to our client, maybe 3 if it seems like it's really close, then submit quality and operational questionnaires to do a further analysis, to really kind of inch out who would be more on top compared to the other.
So the quality questionnaires give us a deeper understanding of the CDMO's quality system and the operational questionnaires can address any questions that we may have regarding, let's say, their training program background of their SMEs, you know, how are they segregating client materials? How are they maintaining client confidentiality and things like that, that we may want a deeper understanding about of that particular CDMO.
And usually at that point, once we receive the responses to the questionnaire, you know, one candidate will be above the others. Sometimes, still, you know, it could be still a toss up between one or 2, but regardless you know what happens at this point, we always recommend to the client before you make your final decision, we do say, you know, do an on-site audit, and that's something that Dark Horse has supported many clients on, on doing on-site audits, not just from a quality perspective, but looking at the facility as well as a technical and operational side as well.
プロセスの概要と次のステップ
ウズマ・シュウカット＝ムムタズ： CDMO選定プロセスの要点をまとめます。CDMOは、多くのクライアントにとって開発および製造の両面で新規プログラムや拡大プログラムを支える重要なリソースです。効率的かつ徹底した選定プロセスを実現するためには、詳細でカスタマイズされたRFP（提案依頼書）から始めることが不可欠です。
評価を行う際は、提案内容が整合しているか、またその戦略がクライアントのプログラムURS（ユーザー要求仕様書）、スケジュール、予算に適合しているかを確認します。
公平な評価を担保するため、定量的な分析も取り入れています。また、最終決定を下す前には、必ず現地監査を実施し、質問票を提出してさらなる評価を行うようクライアントに推奨しています。これにより、確信を持って決定を下すことができます。
選定後のサポート
ウズマ・シュウカット＝ムムタズ： 選定がゴールではありません。私たちは選定後もクライアントを継続的にサポートします。CDMOが決定した後の次のステップは技術移転です。まずは意向表明書（LOI）の送付から始まり、発注書（PO）の発行、そしてサービス契約および品質契約の締結に向けた調整を行います。また、RFPで提示された情報を補完し、より詳細な内容を盛り込んだ技術移転パッケージの作成も支援します。
技術移転において私たちが提供するその他の支援として、担当者の派遣や現地でのトレーニングがあります。昨年、私は2社のクライアントに対して実際に現地へ赴き、トレーニングの支援や技術移転活動の監督を行いました。直接クライアントと顔を合わせ、現場で協力しながら技術移転の成功をサポートできたことは、非常に有意義な経験でした。
ウズマ・シュウカット＝ムムタズ： 本日はご参加いただき、誠にありがとうございました。Dark Horseで私が最もやりがいを感じているプロジェクトの一つを共有できたことを嬉しく思います。これは私たちが日常的に取り組んでいる業務です。皆様に聞いていただけたことを光栄に思います。この内容が皆様の参考になれば幸いです。
お時間をいただきありがとうございました。それでは、質疑応答に移ります。
画面共有を停止しますので、ライブで質問が来ているか確認します。
質疑応答
ウズマ・シュウカット＝ムムタズ： では、最初の質問です。「CDMO選定において企業が犯す最大のミスは何だと思いますか？」というご質問ですが、私がこれまで見てきた中でクライアントにとってマイナスになり得るのは、焦って判断を下してしまうケースです。
とにかくコストが安く、プロセスを最速で完了してくれるCDMOを選ぼうとする傾向があります。もちろんそれらも重要な要素ですが、私はCDMOのこれまでの実績、経験、そして成功率をしっかりと見極めることが非常に重要だと強調しています。
次の質問です。「スライド15を見ると、プロセスフロー図をCDMOに送った後にNDA（秘密保持契約）を締結しているようですが、これについてコメントはありますか？」ご説明しますと、NDAの締結はRFPの作成と並行して進めています。プロセスフロー図はNDAが完了した後にRFPと共に送付するものであり、それ以前に共有することはありません。
「意思決定マトリックスにおいて、クライアントごとに異なる重み付けをしていますか？また、スコアを掛け合わせる以外の手法は検討していますか？」というご質問ですが、はい、クライアントごとに重み付けは変えています。URSの各項目に対する優先順位はクライアントによって異なるからです。
例えば、クライアントAにとって重要なことがクライアントBにとってはそうではない場合があるため、確実に差別化を図っています。分析手法については、スコアの掛け合わせだけが唯一のアプローチというわけではありません。
他にも考慮すべき点はあります。例えばコミュニケーションです。CDMOは私たちの質問に回答してくれたか、タイムリーに対応してくれたか、一緒に仕事がしやすかったか、といった点を確認します。また、戦略についても見ています。URS（ユーザー要求仕様書）に準拠した明確な戦略が提示されているかを確認します。
次はこれですね。RFP（提案依頼書）の一般的な回答期限はどのくらいか、またCDMO側でプロセスを迅速化するために役立つことは何か、という質問です。通常、CDMOには3〜4週間の提案期間をお願いしています。私たちが迅速化を図っているのは、評価プロセスの方です。
すべてのCDMOから提案が出揃うのを待ってから評価を始めるのではなく、時間を節約するようにしています。CDMOには、疑問点を早期に解消できるよう、できるだけ早い段階で電話会議や技術的な打ち合わせを設定するよう依頼しています。これにより、提案書のレビュー期限ギリギリまで待つことなく、時間を有効に活用できます。
次は「過大な約束をするものの、品質やスケジュールの面で期待外れなベンダーをどのように見分けるか」という質問です。これについては、品質および運用に関するアンケートが役立ちます。また、現地監査を行うことで、提案書に記載された情報が事実と一致しているかを確認できます。
サラさん、一つ良い質問があります。これについて答えていただけますか？ポイント・オブ・ケア（POC）製造の今後の進展をどう予測しますか？また、クライアントのためにその評価も行っていますか？
サラ・ミルズ： はい、ウズマさん！ビデオの操作権限は私にありますね。私の顔を映す必要はないかもしれませんが、ビデオを追加します。皆さん、こんにちは。ご一緒できて光栄です。私はダークホースでセルセラピーCMCグループのシニアプリンシパル兼ヘッドを務めているサラ・ミルズです。
ポイント・オブ・ケア製造は成長分野であり、業界内でさまざまな形で評価が進んでいると認識しています。現時点での私たちのスタンスとしては、クライアントから要望があれば、まず適切なサービスプロバイダーの評価プロセスに組み込み、次にRFPのユーザー要求仕様書（URS）の項目として適切に盛り込むようにしています。
URSの素晴らしい点は、それが「生きた文書」であるということです。QMS（品質マネジメントシステム）内でRFPとは独立して管理・運用できます。開発が進み、プロセスが変更・修正されるたびに、URSを更新し、バージョン管理を行うことが可能です。RFPの作成やプロセス進行と並行して、他の用途にも活用できる文書が手に入るというメリットもあります。ウズマさんが言及したプロセスフロー図（PFD）も同様で、これらは重要な文書として、開発のあらゆる段階でクライアントやスポンサーをサポートします。URSも同じように活用できます。
もしポイント・オブ・ケアに関心がある、あるいは特定のグループで評価したいという場合は、ユーザー要求仕様書に含めることをお勧めします。さらに、社内のCDMOデータベースやサービスプロバイダーのデータベースを活用して、そのニーズに最適なベンダーを特定することも可能です。
ウズマ・シュカット＝ムムタズ： ありがとうございます。
次に進みます。非常に良い質問が来ています。「開発の初期段階と後期段階で、CDMOを切り替えることはよくありますか？」という質問ですが、答えは「はい、間違いなくあります」。初期開発向けに特化したCDMOもあれば、後期開発向け、あるいはその両方をカバーできると謳うCDMOもあります。
クライアントが何を求めているかによります。将来を見据えたCDMOを求めているのか、あるいは初期段階から後期段階への移行をサポートしてくれるCDMOを求めているのか。私たちは、クライアントが求めるフェーズに最適なCDMOを探すお手伝いもしています。ですから、切り替えは決して珍しいことではありません。
「なぜこのようなプロセスを経てCDMOを選定する必要があるのか。友人から勧められたベンダーや、評判の良いベンダーではいけないのか」という良い質問です。
ダークホースのプロセスが優れている理由は、非常に詳細かつ徹底している点にあります。先ほども言いましたが、クライアントの要件はそれぞれ異なり、万人に合う「ワンサイズ・フィッツ・オール」な解決策はありません。同僚からの推薦や、ニュースで有名な企業と提携しているといった情報があっても、そのCDMOが自社や自社のプログラムにとって本当に適しているかを確認するために、評価プロセスを経ることが非常に重要です。
「最近設立された新しいCDMOを特定するにはどうすればよいか」という質問ですが、これはまさにダークホースが現在取り組んでいることです。先ほど述べたように、私たちは社内データベースを構築しており、日々成長しています。新しいCDMOとも常に連絡を取り合うよう努めています。RFPに向けて他にどのような選択肢があるかを知りたい場合は、ぜひ私たちにご相談ください。現在、私たちのリストには200社近いCDMOが登録されており、その数は増え続けています。
さて、次の質問です。「CDMOとの契約は通常長期にわたりますが、長期的な財務の持続可能性についてはどう考えますか？クライアントのためにその健全性を評価したり考慮したりしますか？」という点ですが、これは私たちの要件の一つです。URSには、クライアントのプログラムに応じて、通常5〜6年といった指定期間中、クライアントをサポートできる財務能力があることをCDMOに求めています。ですから、これは私たちが必ず確認し、CDMOにも詳細な情報提供を求める項目です。
追加の質問です。「自社の製品プロセスがまだ開発段階で、プロセスフロー図を作成できるか不安です。初期の非臨床開発グループでこの戦略を使用した経験はありますか？」という質問ですが、もちろんあります。私たちはあらゆる臨床開発フェーズのクライアントを支援しています。プロセスフロー図のテンプレートを用意しており、そこからクライアントのPFDに必要な詳細情報を肉付けしていきます。開発段階であれば、まずはテンプレートに基づいたハイレベルなPFDを作成し、クライアントのプロセスが確立されるにつれて情報を追加していくという進め方をしています。
以上で、いただいた質問はすべてカバーできたと思います。貴重なお時間をいただきありがとうございました。さらに質問がある場合は、ぜひご連絡ください。ウェブサイトやLinkedInからいつでもお問い合わせいただけます。どんな質問でも歓迎します。
閉会の挨拶
サラ・ミルズ： ありがとうございました。
ウズマ・シャウカット＝ムムタズ： ええ、皆さんありがとうございました。