SuperlativeBio       "We Provide Superlative Biosciences Services." Superlative BioSciences Corporation 4734 Sabre Lane Manlius, New York 13104 Please call us at (315) 383-3496 or email tarsioj@superlativebio.com View Joseph F. Tarsio's profile Services Provided by Superlative BioSciences Corporation ♦ Superlative BioSciences Corporation Conducts Research & Development in the Following Area of Mammalian Cell Biology: Biologics & Biosimilars Development, Cell & Tissue Therapy, Stem Cells, and Combination Products Development ♦ Superlative BioSciences Corporation Provides Consultation On: Biologics, Biosimilars, Pharmaceuticals, Medical Devices, In Vitro Diagnostics or Personalized Medicine Products & Services, Cell & Tissue Therapy, Stem Cells, and Combination Devices Regulatory Guidance The Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, CAPA, FMEA, Trending, and Complaint Handling FDA/GLP, FDA/GTP, FDA/QSR, FDA/GMP, ICH, EMA, CE Marking & ISO Documents Management Preparation of SOPS, Master Batch Records (MBRs), CMC and Validation FDA Filings (CBER or CDER) & Inspections ♦ Other Business Services Provided Are: Technology Evaluation Market Reports Preparation of Business Plans Preparation of Marketing Plans Preparation of Biotechnology & Biomedical Articles and Online Study Guides ♦ We Also Help Companies Prepare Small Business Grant Applications and Handle Their Submissions: SBIR and STTR Awards to the United States NIH, NSF, FDA, CDC, EPA, DOD, DOT and DHS Renewable Energy Grants Preparation and Writing Preparation of Supplies or Services Contract Proposals to All Agencies Grant Writing to US and International Private Foundations   Example Quality Presentation by Superlative BioSciences Corporation Corrective and Preventive Action (CAPA) Presentation Created by Superlative BioSciences Corporation Example Scientific Questions Answered by Staff Members of Superlative BioSciences Corporation Biotechnology Questions & Answers on LinkedIn: Show:   Questions (0) | Answers (7) ·         Are serum biomarkers currently being used for cancer diagnosis/treatment? Asked by Kinneri Shah| 1 day ago in Biotech | Open Joseph F.’s answer: Kinneri: Please find below some useful information that I would like to share in response to your question: Are serum biomarkers currently being used... see more ·        What are the greatest challenges for the pharmaceutical industry with the move towards personalised medicine? Asked by Luke Connoley | 9 days ago in Biotech | Closed Joseph F.’s answer: In terms of drug development strategy and personalized medicine, I do believe that a recent valid approach and challenge would be in applying... see more ·         What is the current status of using biomarkers and genomics a routine diagnostic tool to individualize cancer treatment? Asked by Rahul Sanap | 1 month ago in Biotech | ClosedThis answer was selected as a Good Answer Joseph F.’s answer: Rahul, I would like to offer, if I may, the following three items to the discussion of cancer biomarkers: 1) A general approach to cancer biomarkers... see more ·         Is quantitative measurement of cell signaling state useful as a PAT for bioprocess? Asked by Jeffrey Radding  | 3 months ago in Biotech | Closed Joseph F.’s answer: In the cell culture/fermentation area, one approach to PAT would be to blend statistical process control with on-line physical and molecular sensors... see more ·         Can our preclinical/drug discovery labs be GLP and would it be effective? Asked by Erin (Loutzenhiser) Kriebel | 3 months ago in Biotech | Closed Joseph F.’s answer: You want to be a GLP-certified laboratory if the data that you are producing for a client will be used by the FDA in judging the acceptability of... see more ·         What do you think will be the future of bioequivalence industry ,especially CROs which are involved in bioequivalence (BA/BE) study after 2011 as most of the drugs will lose the patent protection. Asked by Jayeeta Bhattacharya (Sen) | January 29, 2009 in Biotech | Closed Joseph F.’s answer: Jayeeta: In regards to the future of bioequivalence studies that would be needed for the establishment of biosimilar (biogenerics) in the United... see more ·         Difference in recombinant protein source Asked by Rahul Sanap | February 1, 2009 in Biotech | Closed Joseph F.’s answer: Another aspect to consider is GlycoFi’s humanized Pichia pastoris platform that was recently acquired by Merck's recent acquisition of GlycoFi.... see more   FDA Links: 2012 Tentative FDA Advisory Committee Calendar - All FDA Centers Clinical Trials Information Drug Approvals at FDA Medical Device Approvals and Clearances at FDA FDA Press Releases and Announcements FDA Warning Letters Guidance Documents for FDA-Regulated Products Index to Drug Specific Information Medwatch Safety Alerts Information About SBIR and STTR Grants SBIR (Small Business Innovation Research) is a federal government program administered by 12 federal agencies for the purpose of helping to provide early-stage Research and Development funding to small technology companies. Solicitations are released periodically from each of the agencies and present technical topics of R&D which the agency is interested in funding. Companies are invited to compete for funding by submitting proposals that address the technical topic needs of the agency's solicitation. Each of these 12 agencies have various needs and flavors. To learn more about the needs of a particular agency, click on the links in the table below. STTR (Small Business Technology Transfer) is a smaller scale federal government program similar to SBIR. This program is administered by only 6 federal agencies. The major difference between the SBIR and STTR is that for the STTR the small business is required to work with a not-for-profit research institution or national laboratory on the proposed project. Superlative Biosciences Corporation can assist companies in applying for the SBIR & STTR programs. We can help you identify which agency or agencies will be interested in your technology, assist with writing and reviewing the proposal. If you need additional information or have any questions or comments, please use the contact form below.     Recommended eBooks Biotechnology and Biopharmaceuticals Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs defines biotechnology from the perspective of pharmaceuticals. The first section focuses on the process of transforming a biologic macromolecule into a therapeutic agent, while the second section provides a brief overview of each class of macromolecule with respect to physiological role and clinical application. Additional detail is also provided in the second section for each FDA approved, recombinantly derived biopharmaceutical for each category of macromolecule. The final section looks to the future and the new advances that will enhance our ability to develop new macromolecules into effective biopharmaceuticals. This last section discusses various drug delivery strategies while also describing gene and cell therapy strategies. The Regulatory Challenge of Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book’s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. Recommended Printed Books Sponsoring Products and Services Click on AlwaysOnConnect.com to compare features and save money on purchasing the latest smartphones, laptops, netbooks, tablet computers, HDTVs, and other communication and electronics products and services. Do You Need More Computing Capacity, Click Here to Find Out About Amazon's Cloud Computing Services. Build a Web site yourself! It's a Snap, with easy to use instructions and templates provided by Network Solutions that you can customize to meet your needs. Please contact us at (315)-383-3496 or tarsioj@superlativebio.com Thank you for visiting Superlative BioSciences Corporation   © Copyright 2008-2012 Superlative BioSciences Corporation. All Rights Reserved.