Company-Sponsored Research Agreements:What Academic Laboratories Should Know Before                 Accepting        Prese...
Live Webinar on Thursday, August 16, 2012 at 2:00 PM EST.Social Media Exclusive PromotionFirst 5 registrants receive FREE ...
Company-Sponsored Research Agreements:What Academic Laboratories Should Know Before Accepting  •   Biotech companies conti...
Presentation Goals1. Provide insight into the   regulated environment under   which biotech companies are   required to op...
Presentation Outline1. Introduction        • Defining TE/RM products        • Product evaluation2. Requirements for study ...
Defining TE/RM productsWhy use TE/RM products as the example?•   Tissue Engineered/Regenerative Medicine (TE/RM)    produc...
Defining TE/RM•products   Tissue Engineering/Regenerative Medicine    (TE/RM) refers to a broad range of emerging    techn...
Defining TE/RM products - Cells1.   Cell populations with application in TE/RM may be     broadly divided into two categor...
Defining TE/RM products - Biomaterials•   The most straightforward classification of    biomaterials is based on source, w...
Defining TE/RM products - Construct1.   Any TE/RM product or product candidate     incorporating a cellular ABI may be def...
Product Evaluation1.   There is an established pathway for pharmaceutical compound development and     review by the FDA. ...
Product Evaluation1.   TE/RM product parameters to be tested in vitro often include cell viability,     morphology, phenot...
Protocol Development•   Preclinical studies, sometimes referred to as preclinical development or    nonclinical studies, f...
Protocol Development  • Title - name of what is being tested  • Testing Facility and Sponsor Facility information - contac...
Good Laboratory Practices (GLP)•   Good Laboratory Practice (GLP) ensures consistency and reliability of    non-clinical l...
Good Laboratory Practices (GLP) A GLP study requires: • Staff documentation, including responsibilities for all personnel ...
Good Laboratory Practices (GLP)• The purpose of quality  management is to make sure that  mistakes are not made during the...
Good Laboratory Practices (GLP) •The effectiveness of GLP •Personnel training:        • Controls        • Record Keeping  ...
Good Laboratory Practices (GLP) 1.   A Standard Operating Procedure (SOP)      is an approved, written procedure      desc...
Good Laboratory Practices (GLP) •   Information headings for the     remainder of the document •   The procedure itself sh...
Project Control  • The project, which is a set of interrelated tasks, should be  ‘under control’ (maintaining the output w...
Intellectual Property (IP)•   Intellectual property is defined as creations of    the mind for which property rights are  ...
Intellectual Property (IP)•   Continuing to secure additional IP,    as well as leverage existing IP, are    critical to a...
Publication Rights •   A clear description of     publication policy (i.e.: who     owns the data, who needs to     be con...
Assets appealing to commercial sponsors•   Cell-based assays, culturing    techniques•   Unique in vitro and in vivo model...
Suggested Resources• GLP Guidelines   CFR Code of Federal regulations Title 21   http://www.accessdata.fda.gov/scripts/cdr...
Summary and Closing Remarks •   Company-sponsored research agreements     can serve academic researchers well •   Follow G...
Live Webinar on Thursday, August 16, 2012 at 2:00 PM EST.Social Media Exclusive PromotionFirst 5 registrants receive FREE ...
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Company-Sponsored Research Agreements: What Academic Laboratories Should Know Before Accepting

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During this interactive Webinar your expert presenter, Dr. John Ludlow, PhD, will cover the general requirements for manufacturing and testing cell-based products in a regulatory compliant manner, sponsor expectations, awardee responsibilities, project control, and publications rights.

Key Take-Aways:

Understand the general requirements for manufacturing and testing cell-based products in a regulatory compliant manner
Learn how cell-based products are evaluated
Study protocol development
How to develop “Good Laboratory Practices” that meet the needs of the academic researcher and the biotechnology company researcher
Acquire tissue engineered and regenerative medicine product definitions
Why discussions regarding ownership of IP need to take place well in advance

Published in: Education, Technology, Business
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Company-Sponsored Research Agreements: What Academic Laboratories Should Know Before Accepting

  1. 1. Company-Sponsored Research Agreements:What Academic Laboratories Should Know Before Accepting Presented by John W. Ludlow, Ph.D. For more information visit http://bit.ly/816webinar www.principalinvestigators.org
  2. 2. Live Webinar on Thursday, August 16, 2012 at 2:00 PM EST.Social Media Exclusive PromotionFirst 5 registrants receive FREE Live Webinar Attendanceby entering coupon code Free0816 at check-out.Five seats already taken? Receive 50% off by entering code50%0816 at check-out. Offer valid until 08/16/2012. Free webinar valid only for Live format.To Register click the Order Now button or Visit http://bit.ly/816webinar Registration Includes: •Access for one phone line (unlimited listeners) •Expert answers to your tough questions •Complimentary attendee package with presentation handouts •Live Q&A session (you may also e-mail your questions in advance) •No Risk! 100% satisfaction guarantee
  3. 3. Company-Sponsored Research Agreements:What Academic Laboratories Should Know Before Accepting • Biotech companies continue to look for cost-effective ways to conduct studies in support of product development • Academic laboratories are a practical solution due to their lower cost of services compared to commercial Contract Research Organizations (CRO) • This is especially true for studies supporting development of tissue engineered and regenerative medicine products, as they often require unique services which are typically outside the usual CRO catalogue • Company-sponsored research agreements can serve academic researchers well, given the downward trend of the funding rate at NIH, NSF, and private foundations, due to increasing applications coupled with stagnant budgets
  4. 4. Presentation Goals1. Provide insight into the regulated environment under which biotech companies are required to operate2. Better position the academic laboratory so that the needs of the company sponsor can be metAreas of emphasis for academic laboratory positioning arehighlighted in yellow
  5. 5. Presentation Outline1. Introduction • Defining TE/RM products • Product evaluation2. Requirements for study conduct • Protocol development • Good Laboratory Practices (GLP)3. Sponsor expectations and awardee responsibilities • Project control • Intellectual property and publication rights4. Assets appealing to commercial sponsors5. Suggested resources6. Summary and closing remarks
  6. 6. Defining TE/RM productsWhy use TE/RM products as the example?• Tissue Engineered/Regenerative Medicine (TE/RM) products are relatively new with respect to commercial development of treatment strategies• Regulatory agencies (ie: FDA) are still developing guidelines• CROs may be at a disadvantage with respect to the services they can provide for TE/RM products• These factors help to position academic laboratories as the “go-to” place to have critical work performed for biotech companies developing TE/RM products, provided certain expectations are met by the academic laboratory
  7. 7. Defining TE/RM•products Tissue Engineering/Regenerative Medicine (TE/RM) refers to a broad range of emerging technologies that employ cells, biomaterials or cell/biomaterial combinations (referred to as “constructs”) to reconstitute functional tissue or organ-like structures ex vivo (neo-organs) and/or to catalyze organogenesis de novo by leveraging the body’s innate ability to regenerate itself• Tissue engineering and regenerative medicine are two terms often used synonymously• A subtle difference between these terms may be that tissue engineering emphasizes the biomaterials and engineering components, while regenerative medicine accentuates the cellular contribution
  8. 8. Defining TE/RM products - Cells1. Cell populations with application in TE/RM may be broadly divided into two categories: • Stem and progenitor cells • Committed cell types2. The cell is the primary Active Biological Ingredient (ABI)3. Mechanisms of action include • Leverage the “classical” properties of stem cells (self-renewal, multi-lineage differentiation potential) • Action-at-a-distance paracrine signaling pathways, whereby native stem and progenitor cell populations are recruited • Release cytokines and growth factors that promote angiogenesis and neo-vascularization, modulate inflammatory, fibrotic and apoptotic cascades and interfere with the onset of pathology while promoting repair and regeneration • Niche-specific directed differentiation towards defined developmental lineages as regulated by contextual signaling cues derived from the surrounding tissue or organ parenchyma
  9. 9. Defining TE/RM products - Biomaterials• The most straightforward classification of biomaterials is based on source, which may be of natural or synthetic origin• Examples of naturally occurring biomaterials include gelatin, fibrin, hyaluronic acid (HA), chitosan, silk, collagen and alginate• Such naturally derived biomaterials are typically well tolerated upon introduction within the body and tend to reflect properties of native extracellular matrix (ECM) well• Naturally sourced biomaterials are potentially problematic, presenting difficulties in sourcing, quality control, reliability and reproducibility across lot to lot• Synthetic biomaterials such as poly-co-glycolic acid (PGA), poly-lactic-co-glycolic acid (PLGA) and poly-L-lactic acid (PLLA), offer better reliability and reproducibility
  10. 10. Defining TE/RM products - Construct1. Any TE/RM product or product candidate incorporating a cellular ABI may be defined as a bi- component “construct” or combination product composed of: • Cellular ABI • Biomaterial or scaffold2. As currently understood, the role of biomaterials within today’s TE/RM products may include: • Providing space for tissue repair and regeneration • Providing a foundation for the expansion and delivery of therapeutic exogenous cell populations • Serving as a framework for the deposition of extracellular matrix and paracrine signaling factors • Providing a foundation for the regeneration of neo-tissue and neo-organs in a manner appropriate to the local micro-environment
  11. 11. Product Evaluation1. There is an established pathway for pharmaceutical compound development and review by the FDA. Developers of TE/RM products have to improvise certain parts of this established pathway, especially when it comes to ADME Tox testing •Adsorption •Distribution •Metabolism •Excretion •Toxicity2. Both in vitro and in vivo animal testing is required before the FDA will allow any medicinal product to be tested in humans. These studies need to be well defined, controlled, and monitored3. TE/RM products rarely, if ever, lend themselves to such pharmacologic and toxicologic studies as the ‘small molecule’ drug compound development programs have
  12. 12. Product Evaluation1. TE/RM product parameters to be tested in vitro often include cell viability, morphology, phenotype, function, cryopreservation, biocompatability2. Biomarker analysis of TE/RM products is the best correlation to the established regulatory path of ADMET testing which pharmaceutical compounds go through, and may include: • Multiplex cytokine array and secretome analysis to address function, potency, and fitness of use • Flow cytometry and immuno-histochemical staining to assess protein expression and phenotype • Automated biochemical analyzers for metabolite analysis • Real-time polymerase chain reaction to quantitate gene expression
  13. 13. Protocol Development• Preclinical studies, sometimes referred to as preclinical development or nonclinical studies, focus on obtaining safety data prior to testing in humans during a clinical trial• Data from iterative and feasibility testing is also collected and analyzed during the pre-clinical studies• The protocol contains the study plan• This document allows for investigators at multiple sites to conduct the study in an identical manner, which is critical for the data to be combined and analyzed together• The protocol serves as a reference tool for study managers and administrators, in addition to providing the investigator with a description of their duties and responsibilities• In general the protocol explains the objective of the study, its design and methodology• The academic investigator should work with the sponsor on protocol development
  14. 14. Protocol Development • Title - name of what is being tested • Testing Facility and Sponsor Facility information - contact info • Study objectives – what is to be accomplished • Regulatory compliance – following of SOP, GLP • Animal welfare compliance • Study personnel – names, titles, training • Study schedule – when start, timelines, when completed • Test system information – animals used • Study design – a description of sequence and duration • Test device information – what is being tested (test article) • Technical and analytical procedures - include chain of custody • Data analysis – usually statistical • Reporting – a final report that has been audited for accuracy • Biosafety precautions • Collection and retention of source data - electronic, notebook • Protocol amendments/deviations – changes made during progression of the study
  15. 15. Good Laboratory Practices (GLP)• Good Laboratory Practice (GLP) ensures consistency and reliability of non-clinical laboratory and research organization results by instituting a quality system of controls• GLP guidelines focus on the processes undertaken for non-clinical safety study planning, performance, monitoring, recording, achievement, and reporting• GLP certification was established by regulatory agencies to garner a degree of confidence that the work submitted to them is properly conducted and adequately documented to allow for anyone skilled in the art to replicate the results• GLP study costs are approximately 10-times the cost of conducting a non-GLP study, and are not necessary until an organization needs to obtain regulatory approval for further product development• Since many academic laboratories do not have the infrastructure to rigorously comply with these guidelines, having an outside auditor come in and assess the level of compliance, and provide a detailed report, may be advised
  16. 16. Good Laboratory Practices (GLP) A GLP study requires: • Staff documentation, including responsibilities for all personnel involved • An approved and valid study design • A quality management program • Personnel training documents • Standard Operating Procedures (SOP) • Study performance (including study plan and how the study will be conducted) • Statistical analysis of study data (where applicable) • Results reporting • Records and reports storage
  17. 17. Good Laboratory Practices (GLP)• The purpose of quality management is to make sure that mistakes are not made during the study which can negatively impact the outcome• Quality management will focus on: • Controls • Record keeping • Personnel competence for the assigned tasks
  18. 18. Good Laboratory Practices (GLP) •The effectiveness of GLP •Personnel training: • Controls • Record Keeping • Personnel competence for the assigned tasks
  19. 19. Good Laboratory Practices (GLP) 1. A Standard Operating Procedure (SOP) is an approved, written procedure describing how a task or operation is to be performed 2. It ensures that operations are performed over time in as close to an identical manner as possible, and that this performance is in compliance with applicable regulations 3. The following is a list of information essential to all SOP: • Heading • Approval or Effective Date • Version Control • Introduction • Scope • Purpose • Approval Signature • Document History
  20. 20. Good Laboratory Practices (GLP) • Information headings for the remainder of the document • The procedure itself should be described in short steps
  21. 21. Project Control • The project, which is a set of interrelated tasks, should be ‘under control’ (maintaining the output within a desired range) by strictly adhering to the protocol • Careful attention to detail during protocol development should alleviate the need for amendments/deviations • The sponsor has project control regarding protocol amendments/deviations • The academic investigator has project control regarding execution of the protocol
  22. 22. Intellectual Property (IP)• Intellectual property is defined as creations of the mind for which property rights are recognized under intellectual property law• Owners of IP are granted certain exclusive rights, thereby denying others the right to perform the same action or produce the same product in the same manner• These exclusive rights permit the owners to benefit from the property they have created, thereby producing a financial incentive for creating and investing in IP• A patent by itself does not grant the inventor the right to commercialize the protected technology; a patent grants the right to exclude others from commercializing it
  23. 23. Intellectual Property (IP)• Continuing to secure additional IP, as well as leverage existing IP, are critical to a company’s success• Ultimately, IP needs to be translated into a revenue-generating product for a company to enjoy some degree of financial stability• A discussion regarding ownership of IP needs to take place well in advance of any work performed
  24. 24. Publication Rights • A clear description of publication policy (i.e.: who owns the data, who needs to be consulted as to if or when the data can be published, who is responsible for publications) should be included in the Protocol • This description is often provided by the sponsor • Work with the sponsor to ensure that this policy is compatible with the academic laboratory/institution policy
  25. 25. Assets appealing to commercial sponsors• Cell-based assays, culturing techniques• Unique in vitro and in vivo models• Biomaterials synthesis, characterization• Specialized equipment• A reasonably regulatory compliant operation• Commercial-friendly technology transfer office
  26. 26. Suggested Resources• GLP Guidelines CFR Code of Federal regulations Title 21 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58• SOPs http://www.biopharminternational.com/biopharm/Article/Assuring-the-Effective-Use-of-Standard-Operating-P/Arti• Personnel training and documentation http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySy stemsRegulations/MedicalDeviceQualitySystemsManual/ucm122447.htm• Biotechnology Centers http://www.biotech.sunysb.edu/ http://www.ncbiotech.org/ http://www.pabiotechbc.org/biotech/directory.htm• University Technology Transfer Office http://www.techtransfer.umich.edu/
  27. 27. Summary and Closing Remarks • Company-sponsored research agreements can serve academic researchers well • Follow GLP guidelines as close as possible • Adherence to the study protocol, timetable, and final reporting are crucial
  28. 28. Live Webinar on Thursday, August 16, 2012 at 2:00 PM EST.Social Media Exclusive PromotionFirst 5 registrants receive FREE Live Webinar Attendanceby entering coupon code Free0816 at check-out.Five seats already taken? Receive 50% off by entering code50%0816 at check-out. Offer valid until 08/16/2012. Free webinar valid only for Live format.To Register click the Order Now button, Visit http://bit.ly/816webinar orCall 800-303-0129 ext 506. Registration Includes: •Access for one phone line (unlimited listeners) •Expert answers to your tough questions •Complimentary attendee package with presentation handouts •Live Q&A session (you may also e-mail your questions in advance) •No Risk! 100% satisfaction guarantee

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