Nice find.
However since follica doesn't release results or anything i don't think many people care here : ( . I do care about every treatment though.
Everybody is holding their breath for replicel right now we only have 2 months left and we will see if we will baldies for the rest of our lives or not.
Thanks for that mate, will investigate further : ) . Always feel better when progress is seen ; - 0 .
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Follica Phase 3?
See below in red, looks like follica may be on it's way to Phase 3.
Definitions:
Impd: Investigational Medicinal Product Dossier
IND: Investigational New Drug Application
(CTM): Clinical Trial Materials Manufacturing
Shikha Barman's Experience
Vice President and Head, Pharmaceutical Development
Follica, Inc.
Privately Held; 1-10 employees; Biotechnology industry
January 2010 – Present (2 years 1 month)
RESPONSIBILITIES
1. Providing guidance in targeted Drug Delivery/Pharmaceutical Sciences for development of core IP; co-inventor in company IP; spearheading new targets; assisting in the selection of druggable compounds.
2. Responsible for the following departments: Preclinical and Clinical Pharmaceutical Sciences (CMC/Analytical/Formulations), Pharmacokinetics and Toxicology. Task allocation, task implementation and budget setting/management.
3. Cross-functional interface with Preclinical Biology and Clinical Development for company’s development program strategies in regenerative medicine, hair follicle neogenesis and new targets. Interfacing with CROs to implement various aspects of each program. Interfacing with experts/consultants to define regulatory/toxicology strategy; Interface with IP/BD for strategic development of company programs.
4. Responsible for CTM manufacturing/release for IND/IMPD submissions for Phase I/II/III programs; responsible for PK, Toxicology and CMC sections for IND submissions.
Senior Executive Director, Drug Development
Follica, Inc.
Privately Held; 1-10 employees; Biotechnology industry
February 2009 – March 2010 (1 year 2 months)
ACCOMPLISHMENTS
1. IMPD submission to German regulatory authority for initiation of a Phase II clinical trial in Androgenetic Alopecia (AGA) using company’s novel IP; co-drafted sections of CMC, toxicology and preclinical studies. Successfully co-ordinated clinical supplies/pharmacy operations in EU trial.
2. Co-inventor in multiple patent applications in hair growth, wound healing, scar reduction and cosmetics. Co-author in company publications in progress.
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