Lone Mountain Biotechnology -Latest News and Updates
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Following an extremely successful year in the Professional Consulting Business, which has included experience
with over 15 different clients ranging from Large Pharmaceutical companies to small start-ups, we have learned that
we can provide unique capabilities to the pharmaceutical industry.
During this last year, Lone Mountain has
developed close relationships with a number of highly experienced professionals who have agreed to sub-contract through Lone
Mountain in the following areas: Clinical Trial Design and Implementation, Pre-Clinical Studies, Process Sciences, Analytical
Methods Development, GXP Compliance, Comparability Studies, Stability Studies, Virology, Microbiology, Marketing, and
Regulatory Affairs. Each of these Consultants has personally worked with me during my 25 years of successfully
leading Genentech's Regulatory and Quality Organizations, and has a proven track record!
Working with a number
of clients this group including myself has very effectively assisted clients in rapidly resolving highly complex issues involving
Drug Development. We work to gether efficiently and collaboratively focusing our attention on your specific goals. The
experience of working once again with this group of consultants has proven to be both enjoyable and incredibly
effective. The client effectively gets access to a "Dream Team" of professionals who have previously brought over
17 drugs to the market over 25 years. Please go to the "ABOUT US" page of this website to see the list of Lone Mountain Consultants.
Over the last year we have facilitated
numerous "type C" meetings between our clients and the FDA. These meetings have proven to be incredibly valuable.
In these meetings clients in various early stages of drug development are able to provide key information to the Agency and based
on this information package, ask FDA critical questions about their drug development programs. FDA has been both gracious
and timely, giving the clients invaluable insights, and guidance into how best to configure their programs and their resolve
issues. Written responses to the clients' questions are provided by the agency in a timely manner, and often serves as a valuable
first introduction for the client into the Regulatory Drug Development process. The clients who have availed themselves of
these meeting have come away with invaluable information, and a good sense of how the agency thinks and operates.
We have also been highly involved in the development of various Biosimilars over the past year with three different
clients. We have learned that molecular differences do occur when cell lines and processes are changed, but that these differences
can be readily adjudicated. We have been successfully involved in cell line development as well as process development for
a number of Biosimilar candidates, and have made presentations, which are available on request.
the new health care legislation includes a pathway for Biosimilars in the US we will be representing clients to the FDA with
respect to how to best develop a Biosimilar Development Pathway including Clinical and CMC requirements.