Webinar: Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH

CATO SMS and Perspectum Diagnostics Presents a Cohosted Webinar:

Non-alcoholic steatohepatitis (NASH) is widely recognized as a challenging disease for drug development. Phase 3 clinical trials require a substantial investment of time and money, and failure can cause costly delays or trial cancellation, wasting resources. Lack of cost-effective patient enrollment methods and the inability to demonstrate efficacy have been cited as the primary obstacles to conducting phase 3 clinical trials. Getting patients enrolled in NASH clinical trials has been challenging as endpoints still require an invasive biopsy and patients are reluctant to have multiple biopsies. As the race to bring the first NASH treatment to market heats up, sponsors will need to rely on cost-effective, non-invasive solutions not just to accelerate patient recruitment, but also to determine their response to treatment.

 Key Topics Covered:

Non-invasive imaging and wet biomarkers​

      • What are the most successful non-invasive biomarkers that are currently available in NASH clinical trials?​
      • Which biomarkers have the most clinical utility to assess metabolic, inflammatory or fibrotic changes as a result of NASH treatment?​

Enrollment and enrichment strategies​

      • How can non-invasive biomarkers be applied to pre-screen patients for enrollment in NASH trials and reduce screen fails?​
      • Differentiate patients with simple fatty liver and those with NASH ​
      • Differentiate low- and high-risk NASH (e.g. NAS>3, F>1) patients ​
      • Differentiate cirrhotic and non-cirrhotic NASH patients​

Monitoring treatment efficacy​

    • How to incorporate non-invasive biomarkers for early efficacy signaling?​
    • How can non-invasive biomarkers be leveraged to monitor trial participants on a long-term basis?

Click button below to register. 
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

Enrollment, Enrichment, and Monitoring Strategies to Accelerate Phase 3 Clinical Trials in NASH
Date: Friday, 28 February  2020
Time: 12 pm (EST) | 9 am (PST) | 6 pm (CET)

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About the Presenters

Jack Snyder, M.D., J.D., Ph.D.
Asst. Managing Director, CATO SMS Washington

Dr. Jack Snyder, BS, MD (Northwestern), JD (Georgetown), PhD (MCV), MFS (GeoWash), MPH-MBA-MSIS (Johns Hopkins) currently directs the Washington office of CATO-SMS Research, serves on the Board of Directors of the American Board of Toxicology, holds a New York Certificate of Qualification to direct clinical laboratories, maintains board-certifications in Addiction Medicine, Medical Toxicology, General Toxicology, Clinical Informatics, Occupational Medicine, General Preventive Medicine, Pathology (Anatomic, Clinical & Chemical), Chemistry (Toxicological & Clinical), Quality Assurance & Utilization Review, Legal Medicine, Public Health, and Regulatory Affairs (US, Europe, Canada, Global), and has been certified as a Project Management Professional, Physician Investigator, Physician Executive, and Medical Review Officer.

 

Carlos Duncker, M.D., Ph.D.
Medical Science Liaison, Perspectum Diagnostics

Carlos started his career as an MD and completed residency programs in Internal Medicine and Nuclear Medicine as well as a PhD in Medicine and Surgery. He was previously the head of the Nuclear Medicine and Molecular Imaging Department at the Children’s Hospital of Mexico, was Medical Advisor to the National Commission of Nuclear Safety and Safeguards and was Professor of Medical Physics at Autonomous National University of Mexico. He has published 176 medical papers and was a Reviewer for the European Journal of Nuclear Medicine and Molecular Imaging for over a decade. He is a Distinguished Fellow of the American College of Nuclear Medicine and a Senior Member of the Mexican Academy of Surgery. Before Perspectum, Carlos managed the hepatology research at the Texas Digestive Disease Consultants. During his time at TDDC, Carlos positioned the hepatology research site as a top enroller for NASH clinical trials with the lowest screen failure rate among all US sites for multiple trials.

On Demand Now – Download Form for CATO Webinar: How Feasible is Feasibility in Clinical Trials?

Confirmation: By checking “Yes”, you agree to us contacting you by email and storing your contact details for future contact. Your contact details will be accessible by employees of CATO but will never be shared with or sold to third parties. Also, you may receive infrequent and relevant marketing communications from CATO, but you can unsubscribe within the emails at any time if these communications are not of interest to you.

On Demand Now – CATO Webinar: How Feasible is Feasibility in Clinical Trials?

How Feasible is Feasibility in Clinical Trials?

Feasibility is often considered the process to determine if a clinical site and investigator are a good fit for a clinical trial when in fact, feasibility assessments begin long before site evaluations. With trials becoming more complex, it is vital for sponsors and CRO’s to collaborate to determine the feasibility of the trial itself. Aggressive timelines and tight budgets make trial feasibility relevant in all components of trial design and clinical strategy. Pre award feasibility assessments consider multiple factors to ensure trial success and operational efficiencies. A panel of CATO SMS experts will discuss the role of pre award feasibility assessments and challenges in order to drive clinical strategies, meet the timelines and trial endpoints in a cost efficient manner.

 Webinar Key benefits for you:

  • Identify key elements in clinical trial feasibility
  • Incorporating feasibility assessments into the big picture
  • Importance of accurate data and relevant resources
  • Discuss the significance of enrollment scenarios
  • Pre award feasibility versus site level feasibility
  • Recognize challenges in study design and how to overcome them
  • What does the future look like in feasibility and clinical strategy

Click button below to register. 
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

How Feasible is Feasibility in Clinical Trials?
Original Air Date: Wednesday, January 29th 2020
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)
Download Now

About the Presenters

Adam Coleman, MSPAS, PAC
Feasibility Manager

Dr. Coleman has more than 15 years of clinical practice as a Physician Assistant with experience in trauma/emergency medicine, internal medicine and sports medicine. He was a faculty member at Duke University school of Medicine where he ran the Emergency Medicine Program for Medical and PA students. He transitioned to clinical research over 5 years ago working on oncology trials in various consulting roles. From there he started a global site identification and site relations department where he and his team utilized their global feasibility capabilities to develop site and network relationships to enhance clinical trial efficiencies with innovative and strategic ideas. At CATO SMS his responsibilities include professionally disrupting the status quo, conducting clinical trial feasibility reviews, clinical strategy development, clinical and medical consulting for projects and bid defense participation while establishing site and investigator relationships.

Laura DiMichelle, Ph.D.
Senior Director, Clinical Strategy

Dr. DiMichele has more than 15 years of clinical and translational research experience. She obtained her Ph.D. in cell and molecular pathology at the University of North Carolina at Chapel Hill School of Medicine, and her work centered on mouse models of cardiac development and disease. Since joining Cato SMS, Dr. DiMichele has served as scientist, clinical study manager, project manager, and program director on numerous projects, and she has authored various types of regulatory, clinical, and scientific documents. At Cato SMS, Dr. DiMichele has many responsibilities, including writing and reviewing regulatory, clinical,and scientific documents; providing clinical trial management, pharmaceutical development, and project management; assisting with Clinical Trial Operations; preparing for and attending Food and Drug Administration meetings; providing scientific consulting; and assisting with the preparation of business development proposals.
 

Ashley Sullivan
Clinical Research Manager

Ms. Sullivan has more than 9 years’ experience in clinical research. As a clinical research manager at Cato SMS, Ms. Sullivan manages the execution of multicenter trials in various phases of development. She serves as the direct contact for the sponsor, sites, clinical research associates, and third-party vendors regarding clinical trial operations activities. Ms. Sullivan also serves as study start-up specialist for assigned trials, responsible for managing expedited study start-up activities. Ms. Sullivan has a sound knowledge of the principles of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) E6 guidelines, and Food and Drug Administration regulations for investigational drugs and devices.

CATO Webinar: How Feasible is Feasibility in Clinical Trials?

How Feasible is Feasibility in Clinical Trials?

Feasibility is often considered the process to determine if a clinical site and investigator are a good fit for a clinical trial when in fact, feasibility assessments begin long before site evaluations. With trials becoming more complex, it is vital for sponsors and CRO’s to collaborate to determine the feasibility of the trial itself. Aggressive timelines and tight budgets make trial feasibility relevant in all components of trial design and clinical strategy. Pre award feasibility assessments consider multiple factors to ensure trial success and operational efficiencies. A panel of CATO SMS experts will discuss the role of pre award feasibility assessments and challenges in order to drive clinical strategies, meet the timelines and trial endpoints in a cost efficient manner.

 Webinar Key benefits for you:

  • Identify key elements in clinical trial feasibility
  • Incorporating feasibility assessments into the big picture
  • Importance of accurate data and relevant resources
  • Discuss the significance of enrollment scenarios
  • Pre award feasibility versus site level feasibility
  • Recognize challenges in study design and how to overcome them
  • What does the future look like in feasibility and clinical strategy

Click button below to register. 
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

How Feasible is Feasibility in Clinical Trials?
Date: Wednesday, January 29th 2020
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)
Register Now

About the Presenters

Adam Coleman, MSPAS, PAC
Feasibility Manager

Dr. Coleman has more than 15 years of clinical practice as a Physician Assistant with experience in trauma/emergency medicine, internal medicine and sports medicine. He was a faculty member at Duke University school of Medicine where he ran the Emergency Medicine Program for Medical and PA students. He transitioned to clinical research over 5 years ago working on oncology trials in various consulting roles. From there he started a global site identification and site relations department where he and his team utilized their global feasibility capabilities to develop site and network relationships to enhance clinical trial efficiencies with innovative and strategic ideas. At CATO SMS his responsibilities include professionally disrupting the status quo, conducting clinical trial feasibility reviews, clinical strategy development, clinical and medical consulting for projects and bid defense participation while establishing site and investigator relationships.

Laura DiMichelle, Ph.D.
Senior Director, Clinical Strategy

Dr. DiMichele has more than 15 years of clinical and translational research experience. She obtained her Ph.D. in cell and molecular pathology at the University of North Carolina at Chapel Hill School of Medicine, and her work centered on mouse models of cardiac development and disease. Since joining Cato SMS, Dr. DiMichele has served as scientist, clinical study manager, project manager, and program director on numerous projects, and she has authored various types of regulatory, clinical, and scientific documents. At Cato SMS, Dr. DiMichele has many responsibilities, including writing and reviewing regulatory, clinical,and scientific documents; providing clinical trial management, pharmaceutical development, and project management; assisting with Clinical Trial Operations; preparing for and attending Food and Drug Administration meetings; providing scientific consulting; and assisting with the preparation of business development proposals.
 

Ashley Sullivan
Clinical Research Manager

Ms. Sullivan has more than 9 years’ experience in clinical research. As a clinical research manager at Cato SMS, Ms. Sullivan manages the execution of multicenter trials in various phases of development. She serves as the direct contact for the sponsor, sites, clinical research associates, and third-party vendors regarding clinical trial operations activities. Ms. Sullivan also serves as study start-up specialist for assigned trials, responsible for managing expedited study start-up activities. Ms. Sullivan has a sound knowledge of the principles of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) E6 guidelines, and Food and Drug Administration regulations for investigational drugs and devices.

On Demand Now – Download Form for CATO Webinar: Regulatory Strategies for Stem Cell–based Therapies

Confirmation: By checking “Yes”, you agree to us contacting you by email and storing your contact details for future contact. Your contact details will be accessible by employees of CATO but will never be shared with or sold to third parties. Also, you may receive infrequent and relevant marketing communications from CATO, but you can unsubscribe within the emails at any time if these communications are not of interest to you.

On Demand Now – Download Form for CATO Webinar: Getting your ducks in a row: Successful Management of Large eCTD Submissions

Confirmation: By checking “Yes”, you agree to us contacting you by email and storing your contact details for future contact. Your contact details will be accessible by employees of CATO but will never be shared with or sold to third parties. Also, you may receive infrequent and relevant marketing communications from CATO, but you can unsubscribe within the emails at any time if these communications are not of interest to you.

On Demand Now – CATO Webinar: Getting your ducks in a row: Successful Management of Large eCTD Submissions

CATO Webinar: Getting your ducks in a row: Successful Management of Large eCTD submissions

Getting Your Ducks in a Row: Successful Management of Large eCTD Submissions

Once gap-analysis of your marketing or investigational new drug application has been completed, Cato Research recommends that planning for the submission of the eCTD application begin. While many companies treat the actual compilation and submission of the application as an afterthought, the activities involved are numerous, complex, and interrelated. The activities must be well orchestrated, as there is no simple button to push.  Cato Research’s experience reveals that detailed planning and management leads to a successful eCTD submission.

A CATO senior regulatory submissions specialist will be joined by a senior regulatory scientist and project manager to discuss the successful planning, organization, and management of marketing applications.  Cato Research’s experience with applications both large and larger will inform the discussion.  Pitfalls, lessons learned, and case studies will be included.

 Webinar Key benefits for you:

  • Understand the range of scope and complexity of large eCTD submissions
  • Identify and prevent common pitfalls
  • Discover planning and organizational tools to avoid delays
  • Learn from successful case studies

Click button below to register. 
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

Getting your ducks in a row: Successful Management of Large eCTD submissions
Original Air Date: Wednesday, November 6, 2019
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)

Download Now

 

About the Presenters

Margaret Schubert, B.A., RAC
Senior Regulatory Submission Specialist

Ms. Schubert has 18 years’ experience in drug development. Before coming to Cato Research she was an assistant clinical trial material project manager for Trimeris, Inc., where she assumed increasing levels of responsibility for the management of clinical trial materials for all clinical trials. For the last 3 years of her tenure at that company, she was solely responsible for these activities. At Cato Research, Ms. Schubert joined the Pharmaceutical Development group and has built upon her previous training and experience and continued to expand her knowledge base of Good Manufacturing Practice (GMP), new regulations for the European Union and Canada, and technical issues. She has been certified as a GMP auditor through the International Society for Pharmaceutical Engineering. Ms. Schubert has assumed primary responsibility for management of clinical trial materials for Pharmaceutical Development activities for a variety of clients. With the Regulatory Operations group at Cato Research, she has attained Regulatory Affairs Certification for the United States (R.A.C. [U.S.]) and, since 2016, has primary responsibility for more than 300 electronic regulatory submissions each year. Ms. Schubert has also assumed increasing responsibilities in the Quality Assurance group over the past 6 years, including document quality control reviews, internal audits, and hosting client audits of Cato Research.

Michelle Villasmil, Ph.D., RAC
Assistant Director, Regulatory Strategy, Pharmaceutics

Dr. Villasmil has more than 16 years’ experience in biological research, with extensive experience in molecular biology, cell biology, and regenerative biology. As a scientist at Cato Research, Dr. Villasmil has many responsibilities, including management of regulatory submissions to the FDA; acting as a regulatory contact for interactions with the FDA; writing and reviewing regulatory, clinical, and scientific documents; assisting with clinical trial management and pharmaceutical development; management of regulatory projects (e.g., INDs, NDAs, BLAs, ANDAs); providing scientific consulting; and assisting with the preparation of strategic development plans. She has gained project experience in therapeutic areas such as infectious diseases, oncology, regenerative medicine, and cardiology. Dr. Villasmil also manages the daily operations of the Cato Research Fellows Department.

CATO Webinar: Getting your ducks in a row: Successful Management of Large eCTD Submissions

CATO Webinar: Getting your ducks in a row: Successful Management of Large eCTD submissions

Getting Your Ducks in a Row: Successful Management of Large eCTD Submissions

Once gap-analysis of your marketing or investigational new drug application has been completed, Cato Research recommends that planning for the submission of the eCTD application begin. While many companies treat the actual compilation and submission of the application as an afterthought, the activities involved are numerous, complex, and interrelated. The activities must be well orchestrated, as there is no simple button to push.  Cato Research’s experience reveals that detailed planning and management leads to a successful eCTD submission.

A CATO senior regulatory submissions specialist will be joined by a senior regulatory scientist and project manager to discuss the successful planning, organization, and management of marketing applications.  Cato Research’s experience with applications both large and larger will inform the discussion.  Pitfalls, lessons learned, and case studies will be included.

 Webinar Key benefits for you:

  • Understand the range of scope and complexity of large eCTD submissions
  • Identify and prevent common pitfalls
  • Discover planning and organizational tools to avoid delays
  • Learn from successful case studies

Click button below to register. 
Even if you will not be able to attend please register and we will send you a recording of the webinar once it’s available.

Getting your ducks in a row: Successful Management of Large eCTD submissions
Date: Wednesday, November 6, 2019
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)
Register Now

About the Presenters

Margaret Schubert, B.A., RAC
Senior Regulatory Submission Specialist

Ms. Schubert has 18 years’ experience in drug development. Before coming to Cato Research she was an assistant clinical trial material project manager for Trimeris, Inc., where she assumed increasing levels of responsibility for the management of clinical trial materials for all clinical trials. For the last 3 years of her tenure at that company, she was solely responsible for these activities. At Cato Research, Ms. Schubert joined the Pharmaceutical Development group and has built upon her previous training and experience and continued to expand her knowledge base of Good Manufacturing Practice (GMP), new regulations for the European Union and Canada, and technical issues. She has been certified as a GMP auditor through the International Society for Pharmaceutical Engineering. Ms. Schubert has assumed primary responsibility for management of clinical trial materials for Pharmaceutical Development activities for a variety of clients. With the Regulatory Operations group at Cato Research, she has attained Regulatory Affairs Certification for the United States (R.A.C. [U.S.]) and, since 2016, has primary responsibility for more than 300 electronic regulatory submissions each year. Ms. Schubert has also assumed increasing responsibilities in the Quality Assurance group over the past 6 years, including document quality control reviews, internal audits, and hosting client audits of Cato Research.

Michelle Villasmil, Ph.D., RAC
Assistant Director, Regulatory Strategy, Pharmaceutics

Dr. Villasmil has more than 16 years’ experience in biological research, with extensive experience in molecular biology, cell biology, and regenerative biology. As a scientist at Cato Research, Dr. Villasmil has many responsibilities, including management of regulatory submissions to the FDA; acting as a regulatory contact for interactions with the FDA; writing and reviewing regulatory, clinical, and scientific documents; assisting with clinical trial management and pharmaceutical development; management of regulatory projects (e.g., INDs, NDAs, BLAs, ANDAs); providing scientific consulting; and assisting with the preparation of strategic development plans. She has gained project experience in therapeutic areas such as infectious diseases, oncology, regenerative medicine, and cardiology. Dr. Villasmil also manages the daily operations of the Cato Research Fellows Department.

On Demand Now – Download Form for CATO Webinar Mind the Gaps

Confirmation: By checking "Yes", you agree to us contacting you by email and storing your contact details for future contact. Your contact details will be accessible by employees of CATO but will never be shared with or sold to third parties. Also, you may receive infrequent and relevant marketing communications from CATO, but you can unsubscribe within the emails at any time if these communications are not of interest to you.