Study Group: Biopharmaceuticals Manufacturers (US)
Council Members in this Study Group: 37
This study group may include physicians, care providers, and researchers specializing in internal medicine, cardiology, oncology, dermatology, emergency medicine, family medicine, neurology, obstetrics-gynecology, psychiatry, radiology, nursing, optometry, genetics, and mental health. It may also include experts knowledgeable on diagnostic labs, disease management, medical devices, long term care, surgery centers, health management, pharma, and biotechnology, among others.
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Leading Experts in this Study Group
Hany SalamaVice President, Commercial Operations
NEOSTRATA COMPANY, INC.
Hany Salama, ME, MBA, CPM, is the Vice President, Commercial Operations at The NeoStrata Company. He has global responsibilities for commercial planning, supply chain, and manufacturing operations for all clinical and marketed products. Mr. Salama is...
Frank MalinoskiPresident
TD Consultancy, LLCFrank Malinoski, MD, PhD, is President of TD Consultancy, LLC, which he has run since 2004. Until April 2009 Dr. Malinoski was Senior Vice President of Medical and Scientific Affairs at MedImmune, in Gaithersburg, Maryland. Dr. Malinoski has over 20...
- Leo Pavliv
VP Operations
CUMBERLAND PHARMACEUTICALS, INC.Leo Pavliv, RPh, MBA, is Vice President Operations at Cumberland Pharmaceuticals in Tennessee. His job responsibilities include directing overall drug development activities for numerous products, regulatory affairs, product development, clinical and...
Peter CulpepperChief Financial Officer
Provectus Pharmaceuticals, Inc.Peter Culpepper is the Chief Financial Officer at Provectus Pharmaceuticals. Mr. Culpepper has experience in prescription (therapeutic), biotech, healthcare OTC, specialty pharma, and medical device products. Previous to that, Mr. Culpepper served as...
GLG NewsSM Analyses by this Study Group's Leading Experts(?)
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
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September 25, 2009
Analysis by: Frank Malinoski, President,Sanofi Pasteur Commends Results of First HIV Vaccine Study to Show Some Effectiveness in Preventing HIV | www.pipelinereview.com
This is the first proof of concept that some protection can be achieved with a complex vaccine schedule using two products in prime-boost (sanofi-pasteur (EURONEXT: SAN and NYSE: SNY)and Global Solutions for Infectious Diseases with ties to VaxGen (OTCBB VXGN)).This will not be a product &Need to use these data to build next generation vaccine.Need to share these data broadly to engage those who have left the field.
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Four of Five H1N1 Vaccines Approved
September 16, 2009
Analysis by: Frank Malinoski, President,FDA Approves Vaccines for 2009 H1N1 Influenza Virus Approval Provides Important Tool to Fight Pandemic | www.fda.gov
Four manufacturers have received approval for their H1N1 vaccines: CSL, MedImmune, Novartis, and sanofi-pasteur.FDA confirms single dose at 15 ug for injectable vaccine and standard dose for LAIV is adequate with robust immune responses.Testing in pediatrics not yet complete.GSK was not among those approved even though they are part of the government contract.
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A September to Watch-- and Remember: H1N1 Vaccine 1st Tipping Point Positive
September 11, 2009
Analysis by: Frank Malinoski, President,Response After One Dose of Monovalent Influenza A (H1N1) Vaccine-- Preliminary Report | content.nejm.org
The Southern Hemisphere influenza season showing H1N1 declining to "normal" levels (WHO release 11 Sep 09 CSL published data on their egg based subunit vaccine with over 90% response rate to the 15 ug (standard) dose. Accompanying article with similar positive results with adjuvant by Novartis. If other inactivated vaccines behave the same, there's likely no need for adjuvant or second dose. Still no firm word on vaccine supply timing.
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FDA Regulatory Tiger Gets Teeth
August 20, 2009
Analysis by: Frank Malinoski, President,FDA Commissioner Outlines Six-Step Plan for Improved Enforcement | pharmtech.findpharma.com
FDA announced 6 steps to improve enforcement with implementation to begin in September 2009 The downside for the pharmaceutical industry is the need to ensure that deadlines for responding to regulatory issues are met within established guidance. The upside likely resides in outside contract firms (problem solving consultants, CROs and the like) who will be hired to ensure timelines are met. Not yet specified, but a likely target for action will be post-marketing commitments.
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GSK Boost an indication of Merck's Deeper Problem?
August 20, 2009
Analysis by: Frank Malinoski, President,Accelerated Approval of Hiberix to Help Sustain Adequate Vaccine Supply Vaccine Approved as a Hib Booster Dose | www.fda.gov
The Hib vaccine shortage that began in 2007 when Merck voluntarily recalled PedVAXHib and COMVAX Hib products, has resulted in inadequate immunization of children (recommendation to stop 4th dose) Clusters of disease have been reported since the shortage began The accelerated approval of GSK's Hib vaccine for booster will help prevent the return of this deadly disease
Members in this Study Group include these company types:
- Pharmaceuticals Manufacturer
- Biotechnology Manufacturer
- Pharmaceuticals/Biotechnology Research Services
- Consultancy, Pharma-Focused
- Individual/Small Consultancy
Members in this Study Group often have these job titles:
- Director
- Manufacturing Director
- Consultant
- President
- Chief Financial Officer
- Quality Control Supervisor
- Research & Development Manager
- Research Scientist
- Operations Executive
- Owner
- Chief Medical Officer