Biopharmaceutical Regulatory Filing
I am writing on behalf of a consulting firm that conducts expert interviews in support of industry-wide studies for many of the world's fortune 1000 companies. We help businesses answer questions by engaging with the world’s most relevant experts. So far we have delivered over 750 studies with input from over 15,000 individuals. We are an authorized zintro partner.
For a current study, we would like to speak with someone who has extensive biopharmaceutical regulatory filing experience and can provide insight into qms, equipment, consumables, protocols/procedures, incoming/outgoing specifications, environmental conditions, etc.
Please see below for some sample questions and topics that we are interested in discussing:
- if multiple, identical sites were deployed into key geographies, could they be interchangeably used to supply an approved biologic into markets where regulatory approval had been achieved?
- what degree of freedom to move site of manufacturing exists during the clinical trial process?
- if possible, what would be required to enable this degree of operational flexibility (i.E., allowing the biomanufacturer to push production to any of the identical sites based upon a variety of factors)?
- which regulatory agencies would enable this approach? Which would not?
Specific to the biopark:
- who owns the qms for a drug made in biopark?
- how is it to be managed in respect of shared components (e.G., wfi)?
- how would required changes or audit concerns on one company affect other companies on site?
Please note that we are only interested in your personal point of view and expert insight and are not seeking any confidential information.
We are scheduling 45-60 minute discussions with experts this and next week and are happy to offer a negotiable usd 250 compensation for each interview. Please note that we are handling the standard zintro fee separately, hence the expert is not involved in paying this.
We would welcome any referrals to other relevant experts as well.
elianny+7 Other Responses
I am looking to speak with 4 individuals for a 45-60 minute phone interview. We are interested in speaking to individuals within the biopharmaceutical industry whose work responsibilities entail working with cmo/cros on a supplier and buyer side specifically for the lyophilization service. They must be able to discuss lyophilization pricing and have an extensive knowledge of how the cmo industry operates, specifically in aseptic fill-finish.
Here is a respondent breakdown:
**lyophilization supplier specialist (2)**
- works for a company like baxter, vetter, emergent biosolutions, wockhardt
- maybe helps set the price for lyophilized products
- has access to accounting personnel, has a good idea of why the sample costs what it does as well as the profit margin and bottom line
- can provide insight into the market and trends—including technology and equipment
- can speak about business and sales, as well as how to retain business
- understands what the customer is looking for
**lyophilization buyer specialist (2)**
- works for a company such as pfizer, novartis (a pharma company that uses cmo for lyo services)
- knows cost of lyophilized samples as he purchases on a regular basis
- has opinions about the cost of lyophilization and can easily discuss the industry in general, as well as lyophilization specifically
- has specific needs/demands for lyo and can speak about what he/she finds appealing
- knows about lyo brands and competitors and can distinguish between the companies
**lyophilization expert (2)**
- has an expert amount of knowledge regarding lyo and lyo trends
- can be someone from academia
- plus if they can speak about cost/price
must have worked in lyophilization for over 3 years. Must demonstrate an ability to speak about lyophilization and cmo/cro agencies. We would like to be presented with a bio of the respondent (name, position, company) and perhaps a linkedin account. Kindly share these details via zintro.
Thank you.+14 Other Responses