FAQs
1. Is DavosPharma a manufacturer?
No!
We match each individual project with one of more than
40 GMP development and manufacturing resources globally. All have been
carefully vetted over time by DavosPharma projects, audits by the FDA, Local
Regulatory Authorities, clients and DavosPharma people. The depth of science
practiced collectively by these companies is far more than we could have
put together building our own plants.
DavosPharma represents a number of these manufacturers exclusively;
we work with others on a project-by-project/customer-by-customer basis.
2. How do our clients view DavosPharma?
• Technically competent, with proper references
•
Reputation as a company that does not over promise and under deliver
•
We receive payment upon delivery of product, not best efforts
•
Access to enabling technologies
•
The client’s advocate
•
Consistently
successful performance
3. How do our suppliers view DavosPharma?
• Technically competent, with broad market knowledge
•
Ability to deliver custom development/synthesis projects that fit the
suppliers capabilities
• Successful in building pipelines
for the manufacturer
•
Financially sound partner; accepts credit risks
4. What is a typical project from Emerging Pharma?
A newly formed company, in-licenses an API from NIH/NCI,
Academia or perhaps Big Pharma. They have secured either Angel or Series
A financing. At best, they have a CEO/CFO and a medicinal chemist. In
short, they are virtual. With time lines moving, their drug substance
(API) needs are immediate. Proof-of-concept, and IND submissions are
critical to secure further financing.
DavosPharma has the resources to deliver
API, dosage form and the necessary paperwork to support IND submission,
and has the references to validate.
5. Does DavosPharma act as a consultant or project
manager?
DavosPharma provides project management and consulting
services for most complex
deliverables. When highly qualified consultants are needed, DavosPharma or
the customer hires appropriate assistance.
6. What compounds are in the DavosPharma pipeline?
• Seven launched APIs
• A fungicide
• A
pharmaceutical excipient
• Two NCEs awaiting FDA approval
• More
than 50 NCEs in clinical trials, through Phase III
• A large number
of custom made regulatory intermediates
DavosPharma
has played a vital role in more than
40 of our customers’ NCE
launches over the last 15 years.
7. Who are the DavosPharma clients?
Most large biotechs and innovative pharmaceutical
companies in the USA and the EU, as well as many of the smaller emerging
biotechs in the USA. In 2005, more than 150 companies were invoiced
for custom developed deliverables.
8.How strategic are China and India to DavosPharma
?
China and India are quite important to our future. Together
these countries represent more than 50% of the world’s population
and they are both building GMP chemistry and infrastructure at an increasing
rate. Japan, the US and the EU are no longer investing, just downsizing.
We have been very cautious in selecting and vetting proper
cGMP custom manufacturers in both countries. This process continues.
The groups we have chosen to align with, tend to be medium
in size, with turnover of < $100 million per year. They are best in
class with respect to technology, plant and facilities, health and safety,
and good business practices.
China and India represent about 10% of our turnover.
This % will increase substantially over the next few years.
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