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Mesa Science Associates Inc. - Pharmaceutical Product Development Consultants
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Delivering the expertise you need to bring your idea to market.
Mesa Science Associates Inc.
Lighting the Path Leading the Way
Pharmaceutical Product Development Consultants
Delivering the expertise you need to bring your idea to market.
Mesa Science Associates Inc.4539 Metropolitan Court
Suite 207
Frederick, MD 21704
301-360-3544 301-360-3554 (fax)
FinalPrinterSpreads.indd 1 5/22/14 1:09 PM
Every stage of product development has complex requirements and numerous obstacles to overcome.
Mesa Science Associates can help you reach your goalbecause we provide three powerful ingredients:• An executive team with more than 7 decades of industry
experience in all phases of product development• A partnership of exceptionally skilled research and
research support professionals across the United States• Flexible and scalable services that address your needs at
every stage of product development
MSA’s sole focus is assisting scientists like you through the development process.
MSA’s Core CapabilitiesFormulation ServicesActive pharmaceutical ingredient (API), formulation and assay development
Pre-Clinical ServicesPharmacokinetic, organ safety and toxicity study design, report review and finalization and project management oversight
Non-Human Clinical ServicesDesigning critical efficacy studies report review and finalization and project oversight
Clinical ServicesOperational expertise in study conduct and oversight of Phase I through IV clinical trials, operational support for clinical research facilities, clinical project
management, clinical project financial management, clinical study report review and finalization, clinical trial record management
Regulatory ServicesIND preparation and submission
Manufacturing ServicesDevelopment of CMC sections including drug container closure systems, design of drug stability programs and final drug delivery system configurations
What Sets Us ApartOur experience and our network of top tier experts.• MSA can outsource individuals to provide you with
targeted guidance • MSA can staff a monitoring team to confirm adherence
to protocols, the code of federal regulations and ICH Guidelines
• MSA can manage your entire clinical development program ... and much more.
The professionals ready to serve you fit exacting criteria: • Therapeutic/medical expertise• Clinical development expertise and support• Proximity to study centers and clients• Availability for duration needed• Specialized services
And they provide the full range of solutions:• Data Management• Biostatistics• Laboratory Services• Phase I Clinical Services • Regulatory Services• Physician/Investigator Networks • Medical Monitoring
To get the MSA team working for you, please contact us at 301-360-3544.
The guidance of experts who have traveled the path before.
What’s the secret to turning your inspiration into a success story?
Michael MesaPresident
• Former Director of Applied Product Development: Meridian Medical Technologies / Pfizer
• Highly experienced product development executive and an expert in the injectable drug delivery arena.
• Experience includes leading multi-functional product development teams comprised of design engineers, quality professionals, regulatory experts, pharmaceutical scientists, and manufacturing leaders.
• A named inventor on 14 patents involving drug delivery systems and has incorporated these inventions into a range of approved products that include such items as the EpiPen® and a series of products used for the treatment of organophosporus nerve agent poisoning.
• Managed the development of auto-injectors for the treatment of epileptic seizures including those used in the NIH sponsored RAMPART Study.
Ken Dretchen, PhDVice President and Chief Scientific Officer
• Professor and Chairman of the Department of Pharmacology and Physiology, Georgetown University Medical Center
• Subject matter expert on the toxicity of the major chemical and biological threat agents
• Member of the National Biodefense Science Board (2007-10) reporting to ASPR
• On call advisor to the DHS for biologic and chemical threats agents
• Chair, Data Safety Monitoring Board, Reporting to the Surgeon General of the U.S. Army. “Phase I study on safety, tolerability and pharmacokinetics of MMB4 – a New Oxime.”
• Science Advisor and Pharmacology Consultant for the ATNAA & AAS Human Clinical Studies
Tim Warneke, MSVice President of Operations
• Former Senior Director of Clinical Operations, King Pharmaceuticals / Pfizer
• Expert in Code of Federal Regulations (Title 21), ICH Guidelines, Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• Integrating, leading and managing multi-functional clinical development teams in Phase I -IV
• Multi-center clinical trial conduct in North & South America, Eastern & Western Europe, Asia and Africa
• IND and NDA submissions across multiple therapeutic areas
• Data Safety Monitoring Board, Steering Committee and Endpoint Adjudication Committee management
If you need bio-pharmaceutical services MSA and its partners can take you from laboratory scale to full cGMP manufacturing.
Using traditional as well as new platforms, the MSA team offers an array of bio-pharmaceutical development services. We bring decades of experience and innovation— including GLP and cGMP expertise—to any project.
Early Stage DevelopmentThe MSA team has experience grounded in bioprocess development, scale-up and manufacturing, and includes the following capabilities:
• Therapeutic, vaccine and antibody design, including chimerization and humanization
• Stable mammalian cell line development (NSO, CHO, human)
• Microbial expression systems• Cell culture and fermentation process development
(upstream)• Harvest and purification process development
(downstream)• Assay development• Pre-clinical bio-manufacturing (therapeutics and
vaccines)
Proteomic SolutionsThe MSA team offers cutting edge mass spectometry (MS) based protein identification and quantification services. Capabilities include:• Protein identification and quantification• Post-translational modifications (PTMs) identification• Proteome characterization• Quantitative proteomics (SALIC, iTRAQ, TMT, label-free)
FinalPrinterSpreads.indd 2 5/22/14 1:09 PM
Every stage of product development has complex requirements and numerous obstacles to overcome.
Mesa Science Associates can help you reach your goalbecause we provide three powerful ingredients:• An executive team with more than 7 decades of industry
experience in all phases of product development• A partnership of exceptionally skilled research and
research support professionals across the United States• Flexible and scalable services that address your needs at
every stage of product development
MSA’s sole focus is assisting scientists like you through the development process.
MSA’s Core CapabilitiesFormulation ServicesActive pharmaceutical ingredient (API), formulation and assay development
Pre-Clinical ServicesPharmacokinetic, organ safety and toxicity study design, report review and finalization and project management oversight
Non-Human Clinical ServicesDesigning critical efficacy studies report review and finalization and project oversight
Clinical ServicesOperational expertise in study conduct and oversight of Phase I through IV clinical trials, operational support for clinical research facilities, clinical project
management, clinical project financial management, clinical study report review and finalization, clinical trial record management
Regulatory ServicesIND preparation and submission
Manufacturing ServicesDevelopment of CMC sections including drug container closure systems, design of drug stability programs and final drug delivery system configurations
What Sets Us ApartOur experience and our network of top tier experts.• MSA can outsource individuals to provide you with
targeted guidance • MSA can staff a monitoring team to confirm adherence
to protocols, the code of federal regulations and ICH Guidelines
• MSA can manage your entire clinical development program ... and much more.
The professionals ready to serve you fit exacting criteria: • Therapeutic/medical expertise• Clinical development expertise and support• Proximity to study centers and clients• Availability for duration needed• Specialized services
And they provide the full range of solutions:• Data Management• Biostatistics• Laboratory Services• Phase I Clinical Services • Regulatory Services• Physician/Investigator Networks • Medical Monitoring
To get the MSA team working for you, please contact us at 301-360-3544.
The guidance of experts who have traveled the path before.
What’s the secret to turning your inspiration into a success story?
Michael MesaPresident
• Former Director of Applied Product Development: Meridian Medical Technologies / Pfizer
• Highly experienced product development executive and an expert in the injectable drug delivery arena.
• Experience includes leading multi-functional product development teams comprised of design engineers, quality professionals, regulatory experts, pharmaceutical scientists, and manufacturing leaders.
• A named inventor on 14 patents involving drug delivery systems and has incorporated these inventions into a range of approved products that include such items as the EpiPen® and a series of products used for the treatment of organophosporus nerve agent poisoning.
• Managed the development of auto-injectors for the treatment of epileptic seizures including those used in the NIH sponsored RAMPART Study.
Ken Dretchen, PhDVice President and Chief Scientific Officer
• Professor and Chairman of the Department of Pharmacology and Physiology, Georgetown University Medical Center
• Subject matter expert on the toxicity of the major chemical and biological threat agents
• Member of the National Biodefense Science Board (2007-10) reporting to ASPR
• On call advisor to the DHS for biologic and chemical threats agents
• Chair, Data Safety Monitoring Board, Reporting to the Surgeon General of the U.S. Army. “Phase I study on safety, tolerability and pharmacokinetics of MMB4 – a New Oxime.”
• Science Advisor and Pharmacology Consultant for the ATNAA & AAS Human Clinical Studies
Tim Warneke, MSVice President of Operations
• Former Senior Director of Clinical Operations, King Pharmaceuticals / Pfizer
• Expert in Code of Federal Regulations (Title 21), ICH Guidelines, Good Clinical Practice (GCP) and Good Laboratory Practice (GLP)
• Integrating, leading and managing multi-functional clinical development teams in Phase I -IV
• Multi-center clinical trial conduct in North & South America, Eastern & Western Europe, Asia and Africa
• IND and NDA submissions across multiple therapeutic areas
• Data Safety Monitoring Board, Steering Committee and Endpoint Adjudication Committee management
If you need bio-pharmaceutical services MSA and its partners can take you from laboratory scale to full cGMP manufacturing.
Using traditional as well as new platforms, the MSA team offers an array of bio-pharmaceutical development services. We bring decades of experience and innovation— including GLP and cGMP expertise—to any project.
Early Stage DevelopmentThe MSA team has experience grounded in bioprocess development, scale-up and manufacturing, and includes the following capabilities:
• Therapeutic, vaccine and antibody design, including chimerization and humanization
• Stable mammalian cell line development (NSO, CHO, human)
• Microbial expression systems• Cell culture and fermentation process development
(upstream)• Harvest and purification process development
(downstream)• Assay development• Pre-clinical bio-manufacturing (therapeutics and
vaccines)
Proteomic SolutionsThe MSA team offers cutting edge mass spectometry (MS) based protein identification and quantification services. Capabilities include:• Protein identification and quantification• Post-translational modifications (PTMs) identification• Proteome characterization• Quantitative proteomics (SALIC, iTRAQ, TMT, label-free)
FinalPrinterSpreads.indd 2 5/22/14 1:09 PM
Delivering the expertise you need to bring your idea to market.
Mesa Science Associates Inc.
Lighting the Path Leading the Way
Pharmaceutical Product Development Consultants
Delivering the expertise you need to bring your idea to market.
Mesa Science Associates Inc.4539 Metropolitan Court
Suite 207
Frederick, MD 21704
301-360-3544 301-360-3554 (fax)
FinalPrinterSpreads.indd 1 5/22/14 1:09 PM
