Webinar: The Value of Orphan Drug Designation in your Drug Development Program

child-rare-disease-orphan-drugsAs a drug developer you may wonder if you have a portfolio product or development candidate that qualifies as an orphan drug and thus provides options unique to orphan drug development.

There are approximately 7000 known rare diseases and more expected to be identified in the future and your drug may be effective against a rare disease. A number of these orphan diseases are well known, and the epidemiology well characterized, however, there are still numerous rare diseases still in need of an effective treatment.

This webinar will provide an overview of Orphan Drug Designation and the benefits from both a development and commercial viewpoint. It will explore the benefits of early planning and early engagement with the FDA.

A panel of CATO SMS experts will review the key issues encountered during the development of a product receiving Orphan Designation and explore what challenges and options for sponsors may be seen in the coming months.

Webinar Key Learning Objectives:

  • What unique development options does Orphan Drug Designation offer?
  • What are the typical timelines and milestones in an orphan development program?
  • How can FDA’s development designations (Fast Track, Breakthrough, Accelerated Review, Priority Review) be applied in an Orphan program?
  • What are the regulatory nuances of Orphan Drug Designation as it relates to PREA?
  • Case studies on what has and has not been an effective strategy to gain Orphan Drug Designation

Download this Webinar

Original Air Date:  Tuesday, July 28, 2020
Time:  11:00 AM EST/4:00 PM London

Download Now

Featured Speakers

 
greg-hilemanGregory A. Hileman, Ph.D.,
Vice President, Regulatory Affairs

Dr. Hileman more than 35 years’ research and industrial experience, including 25 years in strategic regulatory affairs. He has led drug development meetings with most FDA divisions and contributed to submission of multiple fast track designation requests, breakthrough therapy designation requests, FDA meeting packages, INDs, NDAs, and BLAs. Dr. Hileman currently leads Cato’s regulatory strategy group and serves as primary FDA contact for multiple sponsors. Dr. Hileman has clinical and product development experience in neurology, psychiatry, oncology, gastroenterology, cardiology and women’s health.

 

 
Will-LeeWilliam Lee, Ph.D., R.A.C.,
Vice President, Regulatory Affiars

Dr. Lee has more than 25 years’ research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, including more than 15 years in regulatory affairs. Dr. Lee was involved in the writing of patents and the design and execution of preclinical studies. Dr. Lee has been involved in studies for experimental medications for oncology, peripheral arterial disease, dermatology, and myocardial ischemia. He has also been involved in combination drug/device products. He has been involved in the design of Phase 1 and Phase 2 clinical studies for devices, small-molecule drugs, and biologics. He has also participated in the preparation and submission of various INDs, New Drug Applications, and Food and Drug Administration meeting packages. Dr. Lee has experience in pharmacogenetics and the therapeutic areas of infectious diseases and oncology.

 

Nicholas-Osborne
 
Nicholas Osborne, Ph.D., R.A.C.,
Clinical Writing Scientist, Medical Writing

Dr. Osborne has more than 24 years’ experience in biological and clinical research, with extensive experience in molecular biology, biochemistry, embryology, genetics, epigenetics, and stem cell biology. He has extensive drug and biologic development experience in a variety of therapeutic areas, with particular emphasis on rare diseases.

 
 

Webinar: The Value of Orphan Drug Designation in your Drug Development Program

child-rare-disease-orphan-drugsAs a drug developer you may wonder if you have a portfolio product or development candidate that qualifies as an orphan drug and thus provides options unique to orphan drug development.

There are approximately 7000 known rare diseases and more expected to be identified in the future and your drug may be effective against a rare disease. A number of these orphan diseases are well known, and the epidemiology well characterized, however, there are still numerous rare diseases still in need of an effective treatment.

This webinar will provide an overview of Orphan Drug Designation and the benefits from both a development and commercial viewpoint. It will explore the benefits of early planning and early engagement with the FDA.

A panel of CATO SMS experts will review the key issues encountered during the development of a product receiving Orphan Designation and explore what challenges and options for sponsors may be seen in the coming months.

Webinar Key Learning Objectives:

  • What unique development options does Orphan Drug Designation offer?
  • What are the typical timelines and milestones in an orphan development program?
  • How can FDA’s development designations (Fast Track, Breakthrough, Accelerated Review, Priority Review) be applied in an Orphan program?
  • What are the regulatory nuances of Orphan Drug Designation as it relates to PREA?
  • Case studies on what has and has not been an effective strategy to gain Orphan Drug Designation

Register Now for this Webinar

Date:  Tuesday, July 28, 2020
Time:  11:00 AM EST/4:00 PM London

Register Now

 

Featured Speakers

 
greg-hilemanGregory A. Hileman, Ph.D.,
Vice President, Regulatory Affairs

Dr. Hileman more than 35 years’ research and industrial experience, including 25 years in strategic regulatory affairs. He has led drug development meetings with most FDA divisions and contributed to submission of multiple fast track designation requests, breakthrough therapy designation requests, FDA meeting packages, INDs, NDAs, and BLAs. Dr. Hileman currently leads Cato’s regulatory strategy group and serves as primary FDA contact for multiple sponsors. Dr. Hileman has clinical and product development experience in neurology, psychiatry, oncology, gastroenterology, cardiology and women’s health.

 

 
Will-LeeWilliam Lee, Ph.D., R.A.C.,
Vice President, Regulatory Affiars

Dr. Lee has more than 25 years’ research and industrial experience in gene therapy, cellular immunology, and therapeutic vaccines, including more than 15 years in regulatory affairs. Dr. Lee was involved in the writing of patents and the design and execution of preclinical studies. Dr. Lee has been involved in studies for experimental medications for oncology, peripheral arterial disease, dermatology, and myocardial ischemia. He has also been involved in combination drug/device products. He has been involved in the design of Phase 1 and Phase 2 clinical studies for devices, small-molecule drugs, and biologics. He has also participated in the preparation and submission of various INDs, New Drug Applications, and Food and Drug Administration meeting packages. Dr. Lee has experience in pharmacogenetics and the therapeutic areas of infectious diseases and oncology.

 

Nicholas-Osborne
 
Nicholas Osborne, Ph.D., R.A.C.,
Clinical Writing Scientist, Medical Writing

Dr. Osborne has more than 24 years’ experience in biological and clinical research, with extensive experience in molecular biology, biochemistry, embryology, genetics, epigenetics, and stem cell biology. He has extensive drug and biologic development experience in a variety of therapeutic areas, with particular emphasis on rare diseases.

 
 

On Demand Now – CATO SMS Presentation Participation: PCT Virtual Global Summit Presentation Participation

Featured Speakers/Panelist  – (~ 5 hrs and 49 mins into recording)

 
Jack Snyder, M.D., J.D., Ph.D.
Assistant 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.

Listen to Live Recordinghttps://us02web.zoom.us/rec/share/uvQkAr3srE5LG6Pn9UXfCq0BAYLAT6a81CgZrvBbxRlLUcugdJxUgImKEQ-26vNF

 

PCT Virtual Global Summit was a one day journey into the insightful world of clinical trials. A gathering of experts uncover practical advice from industry-leading researchers, peers, and executives. This virtual event was designed to deliver real value-packed insights, connections with fellow professionals and learn strategies you can put to use the very next day.

PEG is excited to share thier first global virtual Precision in Clinical Trials summit series on June 24th, 2020. The Precision in Clinical Trials virtual global summit was a unique platform for users to network and discuss collaboration in order to achieve their outsourcing and operational strategies.

The virtual summit was tailor-made to address the concerns of trial sponsors who are conducting clinical trials at a local and global level. With an innovation-focused agenda and a host of reliable solution providers, the virtual summit was designed to help the online attendees find solutions to their most pressing clinical trial challenges in 2020 and beyond.

PEG’s motto is “Helping create Precision for Medicine by connecting Companies around the Globe”.

 

On Demand Now – CATO SMS Webinar: Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials

Inflammatory Bowel Disease (IBD) encompasses a cluster of disorders that cause chronic inflammation of the gastrointestinal tract. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are the most common forms of this prototypically complex disorder that presents multiple diagnostic and therapeutic challenges. The advent of machine learning, big data, and artificial intelligence has enabled modeling of huge amounts of clinical trial data to enhance development of novel biomarkers and quantitative histopathologic image processing techniques that may, in turn, improve delivery of targeted treatments, monitoring of disease progression, and detection of meaningful clinical outcomes. Pragmatic trial designs focused on effectiveness, rather than traditional trial designs focused on efficacy, are emerging in the deliberations of regulatory bodies as sponsors push for recognition of the value of new investigative tools and approaches.

In this webinar, experts from Perspectum, CATO SMS, and ProPath will review past and current complexities of IBD clinical trials, and will explore how currently available, cutting edge solutions can change the regulatory landscape and future-proof IBD investigations in the not-too-distant future.

Webinar Key Learning Objectives will focus on improved understanding of:

  • Past and present challenges in IBD clinical trials
  • Present and future aspects of imaging and histopathologic diagnosis in IBD trials
  • Current traditional IBD trial designs and future pragmatic IBD trial designs
  • Evolution of FDA expectations regarding applications of machine learning, big data, and AI in IBD product development

Original Air Date:  Tuesday, June 23, 2020
Time:  12:00 PM EST

Download Now

 

Featured Speakers

 
Jack Snyder, M.D., J.D., Ph.D.
Assistant 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.

 

 
Cory Roberts, MD, MBA
CEO, ProPath

Dr. Roberts has keen knowledge of gastrointestinal and hepatic pathology; a skill honed during his decades of practice in clinical and anatomic pathology. As a well-respected public speaker and author, Dr. Roberts has published numerous books, book chapters and peer-reviewed articles on topics such as celiac disease, metastatic hepatocellular carcinoma, eosinophilic esophagitis, and atrophic gastritis and endocrine cell hyperplasia. Other areas of interest include liver/small bowel transplantation, sessile serrated polyps and molecular diagnostics of colorectal cancer.

 

 
Marc Goldfinger, PhD
Product Specialist, Perspectum

Dr. Goldfinger has worked in the field of diagnostic pathology for over 9 years, in both neuroscience and gastrointestinal disease. Dr. Goldfinger has recently focused on integrating artificial intelligence into MR applications and digitized histopathology to better understand hepatobiliary disease and bowel disease in order to identify novel biomarkers that may better stratify and monitor bowel disorders.

 
 

On Demand Now – CATO SMS Webinar: Pre-Anticipation: Anticipating Obstacles to Approval Before Phase I in Oncology Drug Development

oncology-trialsHow to avoid 11th hour panic when FDA/EMA requires a scientific advisory review

Your chief regulatory officer has just received FDA/EMA notification that an Oncology Drug Advisory Committee (AdCom/SAG-O) has been scheduled to review your recently submitted NDA/BLA/MAA in 90 days. The implications of this review, to a great extent, will determine the ultimate fate of both your product and often your company itself. While your main focus for the next 90 days will be preparation for the AdCom/response to CHMP, experience informs us that many of the crucial issues that require clarification for this response could be addressed earlier in the drug development process.

This unique, inaugural webinar will introduce what CATO SMS calls “Pre-Anticipation,” which will address critical questions that should be (or should have been) raised before your first patient is dosed in Phase 1 studies. Our thorough review of the types of clarifying questions raised by regulatory agencies often leads to “review” issues for companies’ seeking product marketing authorizations.

Our Pre-Anticipation webinar addresses the critical components that should be incorporated into any clinical development plan. These are some of the issues: importance of getting the dose right; understanding the transition of study drug formulation to final commercialization dose forms; do’s and don’ts of appropriate alterations or tweaks to the statistical analysis plan; understanding the pros and cons of early introduction of quality-of-life instruments in clinical development; and considerations of the selection of the study population to reflect the intended real-world population. This webinar is essential for the many disciplines involved in oncology drug development and should enhance regulatory success.

Original Air Date: Monday, May 18 2020
Time:  10am EST / 7am PST
Duration:  1 Hour

Download Now

Featured Speakers

Lynda Sutton
President, Cato Research
Chief Regulatory Officer
Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.

Marc-B-Garnick-MD
Marc B. Garnick, M.D.,
Gorman Brothers Clinical Professor of Medicine Harvard Medical School, Beth Israel Deaconess Medical Center
Dr. Marc B. Garnick is an expert in medical oncology and urologic cancer. He has dedicated his career to the development of new therapeutic programs for the treatment of cancer patients and practices at the Beth Israel Deaconess Medical Center. He is the Gorman Brothers Clinical Professor of Medicine at Harvard Medical School. He is Medical Director for Network Cancer Services at BIDMC.

Dr Garnick has expertise in drug development from three important perspectives: As an academic principal investigator on several drugs that obtained regulatory and marketing approval from FDA; as the Chief Medical Officer and leader of clinical development in several biotechnology companies leading to drug approvals in US and Europe; and as an advisor to several FDA divisions as a Specialized Governmental Employee. He obtained his MD from the Perleman School of Medicine at the University of Pennsylvania, and completed fellowships at the National Institutes of Health and the Dana Farber Cancer Institute.

Inka-Pawlitzky
Inka Pawlitzky, Ph.D.,
Director Oncology Drug Development Affairs
Inka Pawlitzky, PhD, with over 12 years of oncology translational and drug development experience, heads the Oncology Drug Development Affairs team at SMS-oncology. An immunologist by training (PhD Tufts Medical School, Boston), she completed postdoctoral fellowships (Max-Planck Institute for Immunobiology and Epigenetics and Netherlands Cancer Institute) investigating the regulation of DNA rearrangements and pluripotency mechanisms in tumorigenesis. As senior scientist at Leica Biosystems she gained expertise in companion diagnostics. Since 2017, she is responsible for providing expert consultancy services for clinical and regulatory strategies in the areas of oncology drug and diagnostics development at SMS-oncology.

Webinar: Future Proofing Inflammatory Bowel Disease Diagnosis & Clinical Trials

Inflammatory Bowel Disease (IBD) encompasses a cluster of disorders that cause chronic inflammation of the gastrointestinal tract. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are the most common forms of this prototypically complex disorder that presents multiple diagnostic and therapeutic challenges. The advent of machine learning, big data, and artificial intelligence has enabled modeling of huge amounts of clinical trial data to enhance development of novel biomarkers and quantitative histopathologic image processing techniques that may, in turn, improve delivery of targeted treatments, monitoring of disease progression, and detection of meaningful clinical outcomes. Pragmatic trial designs focused on effectiveness, rather than traditional trial designs focused on efficacy, are emerging in the deliberations of regulatory bodies as sponsors push for recognition of the value of new investigative tools and approaches.

In this webinar, experts from Perspectum, CATO SMS, and ProPath will review past and current complexities of IBD clinical trials, and will explore how currently available, cutting edge solutions can change the regulatory landscape and future-proof IBD investigations in the not-too-distant future.

Webinar Key Learning Objectives will focus on improved understanding of:

  • Past and present challenges in IBD clinical trials
  • Present and future aspects of imaging and histopathologic diagnosis in IBD trials
  • Current traditional IBD trial designs and future pragmatic IBD trial designs
  • Evolution of FDA expectations regarding applications of machine learning, big data, and AI in IBD product development

Register Now for this Webinar

Date:  Tuesday, June 23, 2020
Time:  12:00 PM EST

Register Now

 

Featured Speakers

 
Jack Snyder, M.D., J.D., Ph.D.
Assistant 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.

 

 
Cory Roberts, MD, MBA
CEO, ProPath

Dr. Roberts has keen knowledge of gastrointestinal and hepatic pathology; a skill honed during his decades of practice in clinical and anatomic pathology. As a well-respected public speaker and author, Dr. Roberts has published numerous books, book chapters and peer-reviewed articles on topics such as celiac disease, metastatic hepatocellular carcinoma, eosinophilic esophagitis, and atrophic gastritis and endocrine cell hyperplasia. Other areas of interest include liver/small bowel transplantation, sessile serrated polyps and molecular diagnostics of colorectal cancer.

 

 
Marc Goldfinger, PhD
Product Specialist, Perspectum

Dr. Goldfinger has worked in the field of diagnostic pathology for over 9 years, in both neuroscience and gastrointestinal disease. Dr. Goldfinger has recently focused on integrating artificial intelligence into MR applications and digitized histopathology to better understand hepatobiliary disease and bowel disease in order to identify novel biomarkers that may better stratify and monitor bowel disorders.

 
 

On Demand Now – CATO SMS Webinar: Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

COVID-19

The importance of clinical research is in the forefront around the world with COVID-19 as companies race to develop vaccines and antivirals to address the disease. Regulatory agency guidance has presented the industry with a unique opportunity to shift the direction of research to address the myriad of diseases that still need treatments and cures. With protection of health care professionals and clinical trial subjects being paramount, the process and procedures of how we conduct successful clinical trials going forward must be immediately addressed – and for studies currently underway it is even more critical.

The emerging questions are “What is the regulatory guidance regarding how we should proceed with current and proposed clinical studies” and more importantly “Do we have the technology to do so” to keep studies on track and maintain our timelines. We say, ‘yes’!

Regulatory agencies have begun to issue their initial guidance on operational issues regarding clinical trial conduct and how sponsors can maintain the momentum of their ongoing studies.

A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.

Original Air Date:  Thursday, April 30, 2020
Time:  10am EST / 7am PST
Duration:  1 Hour

Download Now

Featured Speakers

Lynda Sutton
President, Cato Research
Chief Regulatory Officer

Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.

 

William T. Lee, Ph.D., R.A.C.
Vice President, Regulatory Affairs

Dr. Lee has more than 20 years’ regulatory experience specializing in gene therapy, cell therapy, and biologics within the rare disease and oncology arenas. He has been involved in the design and execution of preclinical studies, Phase 1, Phase 2, and Phase 3 clinical studies. He has also participated in the preparation and successful submission of various INDs, BLAs and NDAs.

 

Angela Rhodes, B.S.
Associate Director CTO North America

Angela Rhodes has over 12 years’ experience in drug development, 10 years inspecting research sites as a FDA consumer safety officer and 2 years as a clinical research site manager. She has extensive knowledge of FDA regulations, Good Clinical Practice, and Good Manufacturing Practice for drugs, devices, and biologics. She has been responsible for biomedical regulatory actions, preparation Form FDA 483 letters, and seizures throughout FDA-regulated industries. As CRM she is responsible for directing, planning and execution of clinical trials.

 
 

Webinar: Pre-Anticipation: Anticipating Obstacles to Approval Before Phase I in Oncology Drug Development

oncology-trialsHow to avoid 11th hour panic when FDA/EMA requires a scientific advisory review

Your chief regulatory officer has just received FDA/EMA notification that an Oncology Drug Advisory Committee (AdCom/SAG-O) has been scheduled to review your recently submitted NDA/BLA/MAA in 90 days. The implications of this review, to a great extent, will determine the ultimate fate of both your product and often your company itself. While your main focus for the next 90 days will be preparation for the AdCom/response to CHMP, experience informs us that many of the crucial issues that require clarification for this response could be addressed earlier in the drug development process.

This unique, inaugural webinar will introduce what CATO SMS calls “Pre-Anticipation,” which will address critical questions that should be (or should have been) raised before your first patient is dosed in Phase 1 studies. Our thorough review of the types of clarifying questions raised by regulatory agencies often leads to “review” issues for companies’ seeking product marketing authorizations.

Our Pre-Anticipation webinar addresses the critical components that should be incorporated into any clinical development plan. These are some of the issues: importance of getting the dose right; understanding the transition of study drug formulation to final commercialization dose forms; do’s and don’ts of appropriate alterations or tweaks to the statistical analysis plan; understanding the pros and cons of early introduction of quality-of-life instruments in clinical development; and considerations of the selection of the study population to reflect the intended real-world population. This webinar is essential for the many disciplines involved in oncology drug development and should enhance regulatory success.

Register Now for this Webinar

Date:  Monday, May 18, 2020
Time:  3PM London/10AM New York

Register Now

 

Featured Speakers

 
Lynda Sutton
President, CATO SMS
Chief Regulatory Officer

Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.

 

Marc-B-Garnick-MD
 
Marc B. Garnick, M.D.,
Gorman Brothers Clinical Professor of Medicine Harvard Medical School, Beth Israel Deaconess Medical Center

Dr. Marc B. Garnick is an expert in medical oncology and urologic cancer. He has dedicated his career to the development of new therapeutic programs for the treatment of cancer patients and practices at the Beth Israel Deaconess Medical Center. He is the Gorman Brothers Clinical Professor of Medicine at Harvard Medical School. He is Medical Director for Network Cancer Services at BIDMC.

Dr Garnick has expertise in drug development from three important perspectives: As an academic principal investigator on several drugs that obtained regulatory and marketing approval from FDA; as the Chief Medical Officer and leader of clinical development in several biotechnology companies leading to drug approvals in US and Europe; and as an advisor to several FDA divisions as a Specialized Governmental Employee. He obtained his MD from the Perleman School of Medicine at the University of Pennsylvania, and completed fellowships at the National Institutes of Health and the Dana Farber Cancer Institute.

 

Inka-Pawlitzky
 
Inka Pawlitzky, Ph.D.,
Director Oncology Drug Development Affairs

Inka Pawlitzky, PhD, with over 12 years of oncology translational and drug development experience, heads the Oncology Drug Development Affairs team at SMS-oncology. An immunologist by training (PhD Tufts Medical School, Boston), she completed postdoctoral fellowships (Max-Planck Institute for Immunobiology and Epigenetics and Netherlands Cancer Institute) investigating the regulation of DNA rearrangements and pluripotency mechanisms in tumorigenesis. As senior scientist at Leica Biosystems she gained expertise in companion diagnostics. Since 2017, she is responsible for providing expert consultancy services for clinical and regulatory strategies in the areas of oncology drug and diagnostics development at SMS-oncology.

 
 

Webinar: Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

COVID-19

The importance of clinical research is in the forefront around the world with COVID-19 as companies race to develop vaccines and antivirals to address the disease. Regulatory agency guidance has presented the industry with a unique opportunity to shift the direction of research to address the myriad of diseases that still need treatments and cures. With protection of health care professionals and clinical trial subjects being paramount, the process and procedures of how we conduct successful clinical trials going forward must be immediately addressed – and for studies currently underway it is even more critical.

The emerging questions are “What is the regulatory guidance regarding how we should proceed with current and proposed clinical studies” and more importantly “Do we have the technology to do so” to keep studies on track and maintain our timelines. We say, ‘yes’!

Regulatory agencies have begun to issue their initial guidance on operational issues regarding clinical trial conduct and how sponsors can maintain the momentum of their ongoing studies.

A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.

Register Now for this Webinar

Date:  Thursday, April 30, 2020
Time:  10am EST / 7am PST
Duration:  1 Hour

Register Now

 

Featured Speakers

Lynda Sutton
President, Cato Research
Chief Regulatory Officer

Lynda Sutton has over 40 years’ experience in the drug development industry. She has led teams from Pre-IND to Marketing approval for a variety of products including biologics, drugs and drug/device combination products. As Chief Regulatory Officer, she currently serves as the FDA agent for multiple Sponsors for IND and post-marketing products including two with Breakthrough Therapy Designation. She oversees the preparation of regulatory submissions, and ensures that regulatory requirements for the approval and launch of new products are satisfied.

 

William T. Lee, Ph.D., R.A.C.
Vice President, Regulatory Affairs

Dr. Lee has more than 20 years’ regulatory experience specializing in gene therapy, cell therapy, and biologics within the rare disease and oncology arenas. He has been involved in the design and execution of preclinical studies, Phase 1, Phase 2, and Phase 3 clinical studies. He has also participated in the preparation and successful submission of various INDs, BLAs and NDAs.

 

Angela Rhodes, B.S.
Associate Director CTO North America

Angela Rhodes has over 12 years’ experience in drug development, 10 years inspecting research sites as a FDA consumer safety officer and 2 years as a clinical research site manager. She has extensive knowledge of FDA regulations, Good Clinical Practice, and Good Manufacturing Practice for drugs, devices, and biologics. She has been responsible for biomedical regulatory actions, preparation Form FDA 483 letters, and seizures throughout FDA-regulated industries. As CRM she is responsible for directing, planning and execution of clinical trials.