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06: PreClin Dev-EarlyPhaseCR [clear filter]
Sunday, June 23
 

9:00am

SC43: #43: Back to the Future: Combination Products in the 21st Century
Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-19-520-L04-P; CME 6.50; IACET 6.50; RN 6.50

As innovation abounds in science and medicine, there exist endless new opportunities for combining different technologies to solve some of the world’s most pressing medical issues. The lines between engineering, chemistry, and advanced biologic processes are becoming blurred – the age of combination products is here. There are significant differences between the development processes for drugs, devices, and biologics. Theoretically, if the product complies with the regulations specific for each component of the combination product, then your company should be covered, right? Not quite! The requirements and governing bodies for each part of the product are vastly different making it nearly impossible to reconcile all the rules. Factor in new laws and regulations, such as the 21st Century Cures Act (CCA), and the complexity of compliance increases further. This short course provides an overview and comparison of drug, device, and biologics regulation in the United States, and the complex place where combination products fit within these regulations. It follows the product lifecycle, from development through post-market activities, including classification, pre-clinical and clinical requirements, applicability of Good Manufacturing Practices (GMPs) and quality systems, and labeling requirements. It will also introduce the latest statutes, regulations and guidances that impact combination products and discuss how these changes are affecting the existing market. The short course will be interactive. It has been designed to integrate substantive regulatory knowledge and the real-world problems of combination products. You will dive into case studies of unique combination products and get a sense of the gray areas that make the current regulatory scheme so difficult to navigate. It’s an opportunity to ask questions, share your challenges, gain the insights of your instructors, and learn from the experiences of your colleagues. If you are new to the field of combination products, this course will give you the foundation to move forward in your career. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for regulatory, quality, and clinical professionals and project managers who are new to combination products.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Discuss how combination products fit into the development processes for drugs/biologics and medical devices;
  • Identify the unique challenges of pre-market and post-market requirements for combination products in the US;
  • Discuss how recent regulatory developments, including the 21st Century Cures Act enacted in 2016 and resulting FDA guidances, affect combination products.



Speakers
CB

Caitlin Bancroft

Associate, Regulatory Affairs Consultant, Pharmatech Associates Inc.
avatar for Lynn Hansen

Lynn Hansen

Director, Regulatory Affairs, Pharmatech Associates Inc.


Sunday June 23, 2019 9:00am - 5:00pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Monday, June 24
 

11:00am

#113: Artificial Intelligence in Drug Discovery and Development: Emerging Technologies and Applications
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-527-L04-P; CME 1.00; IACET 1.00; RN 1.00

A discussion of advances in artificial intelligence and related technologies in computer, information and data science, specifically as they apply to challenges and emerging application areas within pre-clinical drug discovery and early drug development.

Learning Objectives

Describe translatable experiences and practices concerning impactful applications of artificial intelligence.

Chair

Scott Spangler, MA

Speaker

Panelist: Activity Metabolomics and ArtificiaI Predictions
Erica Majumder, PhD

Challenges and Opportunities in Near-Term Quantum Computation
Yudong Cao, PhD, MS

Panelist
Craig Lipset, MPH



Speakers
avatar for Craig Lipset

Craig Lipset

Former Head of Clinical Innovation, Pfizer
Craig Lipset has led at the intersection of patient engagement, personal health data, and accelerating clinical research. He created and led Clinical Innovation at Pfizer, developing and scaling “first in industry” approaches to improving patient experience and innovative data... Read More →
avatar for Erica Majumber

Erica Majumber

Associate Director and Senior Safety Science Leader IIDO, Scripps Research
Dr. Majumder is a researcher with Dr. Gary Siuzdak in the Scripps Center for Metabolomics and Mass Spectrometry. Erica specializes in anaerobic metabolism and the activity of sulfur-containing metabolites. Recently, she has been spearheading their lab's new efforts using AI-based... Read More →
YC

Yudong Cao

Co-founder and CTO, Zapata Computing
Yudong Cao is co-founder and CTO of Zapata Computing, a quantum software startup based in Cambridge, MA. His PhD thesis in Computer Science received 2016 Chorafas Award in Computer Science and Informatics. From 2016 to 2018 he worked as a postdoctoral researcher at Harvard University... Read More →
SS

Scott Spangler

Distinguished Engineer, Chief Data Scientist for Life Sciences, IBM Watson
Scott Spangler is Chief Data Scientist, Distinguished Engineer, and Master Inventor in the Watson Health Life Sciences Group at the IBM Almaden Research Center. He has been doing knowledge base and data mining research for the past 25 years. Since coming to IBM in 1996, Scott has... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Featured Topics Artificial Intelligence,Innovative Trial Design,What's Next,Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

1:30pm

#131 SB: On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions
Component Type: Forum
Level: Intermediate
CE: ACPE 0.75 Knowledge UAN: 0286-0000-19-733-L04-P; CME 0.75; IACET 0.75; RN 0.75

New gene editing technology known as “clustered regularly interspaced short palindromic repeats” or CRISPR can alter the genes of cells, including embryos, changing the organism and its descendants, and raising critical ethical, legal, and social concerns. First discovered in 2014, scientists have rapidly used this technology in many species. This technique can also alter genes in microorganisms to create superbugs, and in 2016, the Pentagon listed it as a weapon of mass destruction. In 2018, a Chinese researcher stated that he had edited human embryos and transferred them into a womb, producing twin girls. Yet CRISPR can have ‘off-target’ effects, accidentally eliminating additional DNA, and genes may have multiple, unknown functions. In March 2019, scientists recommended a moratorium on transfer of altered embryos into wombs, and a registry of all CRISPR trials. Questions remain, however of how long such a moratorium should last, when it should end, who should decide, based on what criteria, whether all nations and researchers will agree, and what should be done if non-compliance occurs. Questions emerge of when CRISPR will be “safe enough” for initial research studies, and later for broader clinical use. The first human offspring may need to be followed through adulthood and the birth of their own children. This talk will explore these critical challenges, related to ethical principles of autonomy, risks, benefits and social justice, and how these questions might best be addressed.

Learning Objectives

Discuss the critical challenges related to ethical principles of autonomy, risks, benefits of gene editing technology.

Chair

Robert Klitzman, MD


Speakers
avatar for Robert Klitzman

Robert Klitzman

Professor of Clinical Psychiatry; Director, Masters of Bioethics Program, Columbia University
Robert Klitzman, M.D., is a professor of psychiatry at the College of Physicians & Surgeons, & the Mailman School of Public Health, & the Director of the online and in-person Bioethics Masters & Certificate Programs at Columbia University. He has written over 130 scientific journal... Read More →


Monday June 24, 2019 1:30pm - 2:15pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Featured Topics Precision Medicine
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum

2:15pm

#135: Using Real World Data to Develop a Safety Monitoring Program and Ensure Pre- and Post-Market Continuity
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-538-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss proactively planning and pilot-testing high-quality safety monitoring programs in the pre-marketing phase to ensure timely implementation of monitoring programs and post-marketing safety studies.

Learning Objectives

Describe the role of real world data in active safety monitoring, strengths, and limitations of real world data, and basic pharmacoepidemiological study design considerations; Recognize analytic and logistical considerations in planning and testing a safety monitoring program based on use case examples and translate lessons learned to your own pharmacovigilance team.

Chair

Jeremy Rassen, DrSc, MS

Speaker

Academia Perspective
Noelle Cocoros, DrSc, MPH

Industry Perspective
Kimberly Brodovicz, DrPH



Speakers
KB

Kimberly Brodovicz

Executive Director of Global Epidemiology, Boehringer Ingelheim
Kim Brodovicz is Executive Director, Late Stage Cardiometabolism Team Lead in Global Epidemiology and Real World Evidence at Boehringer Ingelheim. Kim has supported drugs and vaccines from early development to post-approval in a variety of therapeutic areas and has conducted numerous... Read More →
NC

Noelle Cocoros

Research Scientist, Department of Population Medicine, Harvard Medical School
Noelle Cocoros is an epidemiologist with a broad background in public health surveillance, pharmacoepidemiology, and infectious disease epidemiology and has expertise in the use of claims, electronic health records, and registry data for surveillance (FDA's Sentinel System; ESPhealth.org... Read More →
avatar for Jeremy Rassen

Jeremy Rassen

Co-Founder, President and Chief Science Officer, Aetion
Jeremy A. Rassen, MS, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence,Regulator Thinking,Innovative Trial Design,Generics,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:15pm

#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use of the multiple expansion cohort design in oncology trials offers advantages and challenges. This session presents views on the success and hurdles of this design by regulators and industry. Implications for global development are also raised.

Learning Objectives

Discuss the important differences between phase 1 FIH studies and the FIH multiple expansion cohort design; Identify key safety challenges and risk mitigation steps; Discuss ethical consideration with oncology studies involving expansion cohorts; Identify examples of implementation challenges and opportunities of this design; Describe lessons learned from industry and regulators.

Chair

Sherry Leonard, RAC

Speaker

The Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Oncology Drug Development
Pamela Balcazar, MS

Implementation Challenges and Opportunities with FIH Multiple Expansion Cohorts
Sherry Leonard, RAC

Ethical Considerations in Oncology Studies Involving Expansion Cohorts
Lindsay McNair, MD, MPH, MSc



Speakers
PB

Pamela Balcazar

Regulatory Health Project Manager, OHOP, CDER, FDA
Pamela Balcazar is Regulatory Project Manager in the Office of Oncology and Hematology Products (OHOP) at the FDA. In OHOP, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process... Read More →
avatar for Sherry Leonard

Sherry Leonard

Director, Regulatory Affairs, Celgene Corporation
Sherry A. Leonard, RAC, Director, Regulatory Affairs, Celgene Corporation Sherry joined Celgene Corporation in 2014 where she is a Director Regulatory Affairs within the Hematology/Oncology Franchise. She is the global regulatory lead for new chemical entities and biologic products... Read More →
avatar for Lindsay McNair

Lindsay McNair

Chief Medical Officer, WIRB-Copernicus Group (WCG)
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#155: Incorporating Systems-Theory and Human Factors into the Investigations of Serious Harm in Clinical Research
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-570-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how to complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organizational science which addresses human factors and transparency to enhance organizational learning and continuous improvement. This systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future.

Learning Objectives

Identify evidence-based techniques for better defining causal factors in system failure; Recognize that those techniques which can be used now; Appraise how we should best develop these concepts, identify best practice and engage all stakeholders; Discuss how to volunteer to join the team aiming to improve the safety of the system for clinical research.

Chair

Brian Edwards, DrMed

Speaker

Applying CAUSAL Analysis System Theory to the TGN1412 First-In-Human Clinical Trial
Brian Edwards, DrMed

Innovation in First-in-Human Safety
Howard Greenberg, DrMed, MD, MBA, MS

Investigators from the Warfarin-Stimulated Frail Hospitalized Patients Project
Nichola Crust, MSc



Speakers
NC

Nichola Crust

National Investigator, Healthcare Safety Investigation Branch
Nichola has worked at a strategic level in a variety of healthcare settings spanning primary and secondary care. Her roles have included professional nurse leadership and mentoring of nursing teams, mobilisation of new services including service and workforce redesign, and training... Read More →
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

3:30pm

#162: Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-559-L04-P; CME 1.00; IACET 1.00; RN 1.00

Precision Medicines in Clinical Trials (PMCT) are demonstrably impactful in drug development yet are not widely adopted by industry. This forum explores reasons for low adoption from the viewpoints of scientists, drug developers and regulators and explores solutions.

Learning Objectives

Describe the value of precision medicine trials (PMCT) as an innovative approach to drug development; Identify the regulatory, scientific, operational and technical challenges and barriers to the execution of these trials.; Explain key considerations for precision medicine trial design and execution.

Chair

Anita Nelsen

Speaker

Academic Perspective from Korea
Yeul Hong Kim, MD, PhD

Panelist
Edward Abrahams, PhD

Panelist
Rebecca Blanchard, PhD



Speakers
avatar for Edward Abrahams

Edward Abrahams

President, Personalized Medicine Coalition
Edward Abrahams, Ph.D., is the President of the Personalized Medicine Coalition. Representing innovators, scientists, patients, providers and payers, PMC promotes the understanding and adoption of personalized medicine concepts, services and products for the benefit of patients and... Read More →
avatar for Rebecca Blanchard

Rebecca Blanchard

Vice President, Translational Pharmacology, CRISPR Therapeutics
Dr. Blanchard’s career in academia and industry has spanned basic, translational, and clinical research. She is currently responsible for Clinical Biomarkers and Exploratory Research, Assay Development and Pharmacology/Toxicology at CRISPR Therapeutics. After receiving her Ph.D... Read More →
avatar for Yeul Hong Kim

Yeul Hong Kim

Professor, Section of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital
Yeul Hong Kim, MD, PhD, is a Professor in the Department of Internal Medicine at the Korea University College of Medicine in Seoul. He is actively involved in cancer genomic research, using circulating tumor DNA, for lung and gastrointestinal cancers. His primary area of interest... Read More →
avatar for Anita Nelsen

Anita Nelsen

Vice President, Translational Medicine, Parexel
Anita has more than 20 years of experience in the pharmaceutical industry and 29 years of experience in pharmacogenetic, human and molecular genetics research in roles including bench scientist, manager, and business leader. As Head of Translational Medicine Services, Anita leads... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence,Regulator Thinking,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum
 
Tuesday, June 25
 

8:00am

#209: Emerging Issues in CRISPR and Gene Editing Symposium
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-577-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss emerging issues related to gene editing, including standards for off-target effects, immunogenicity issues , and DNA base editors.

Learning Objectives

Describe potential concerns related to immune responses in gene editing; Discuss the concept of on-target and off-target genome editing, and collaborative approaches to address this issue; Identify the difference between gene editing that involves making a double-stranded break in DNA versus DNA base editors that do not.

Chair

Philip (P.J.) Brooks, PhD

Speaker

Immunogenicity Issues Related to Gene Editing
Zuben Erach Sauna, PhD

Update on the Genome Editing Consortium
Samantha Maragh, PhD, MS

Base Editing: Performing Chemsitry on the Genome
Alexis C Komor, PhD



Speakers
avatar for Philip (P.J.) Brooks

Philip (P.J.) Brooks

Program Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences (NCATS), NIH
Philip John (P.J.) Brooks is a Program Director in the NCATS Office of Rare Diseases Research. He is also the Working Group Coordinator for the NIH Common Fund program on Somatic Cell Genome Editing. He earned his Ph.D. in neurobiology from the University of North Carolina at Chapel... Read More →
avatar for Zuben Sauna

Zuben Sauna

Principal Investigator, OTAT, CBER, FDA
Zuben E. Sauna is a Principal Investigator and also a CMC Reviewer at the US Food and Drug Administration. His research interests lie in understanding the pharmacogenetic basis of the immune response to proteins used in therapeutic interventions as these affect efficacy and safety... Read More →
avatar for Alexis Komor

Alexis Komor

Assistant Professor, University of California San Diego
Alexis Komor received her B. S. degree in chemistry from UC Berkeley in December 2008. She then joined the lab of Jacqueline K. Barton at Caltech where she worked on the design, synthesis, and study of DNA mismatch-binding metal complexes and received her Ph.D. in 2014. She pursued... Read More →
avatar for Samantha Maragh

Samantha Maragh

Leader, Genome Editing Program, NIST
Dr. Samantha Maragh Leads the Genome Editing Program at the National Institute of Standards and Technology (NIST). Included in this program is the newly launched NIST Genome Editing Consortium, a public-private partnership to bring together government, industry and academia to address... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#228: Emerging Safety Challenges in New Oncology Treatments
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-591-L04-P; CME 1.00; IACET 1.00; RN 1.00

Immuno-oncology (IO) agents are emerging as essential tools to treat a wide range of solid tumors and their indications for use continue to expand. However, the antitumor immune activity of these agents can also be a threat to healthy tissue, resulting in novel presentations of adverse reactions, sometimes with highly undesirable outcomes. Early recognition and intervention can have a dramatic effect outcomes, particularly for very rare events that are progressive. However, presentation can mimic other less serious conditions that do not require early intervention. Thus, these immune-mediated phenomena have become the focus of intense exploration.

This session will provide a very brief conceptual overview of these agents, followed by two presentations. the first presentation will include methodological considerations for identifying potential predictors, such as transcriptomic biomarkers or specific interleukins, etc., that might aid prevention, facilitate early detection, or predict mortality. The second presentation will provide regulatory considerations in ensuring that benefits of these products outweigh their risks. Both presentations will include examples to illustrate key points. The session will conclude with an opportunity for Q&A.

Learning Objectives

Outline basic mechanistic aspects related to the efficacy and safety of immuno-oncology agents; Describe methodological considerations when identifying utility of markers that can help in the prevention or early diagnosis of IO-associated adverse events; Discuss considerations in benefit-risk assessment and communication for these agents.

Chair

William Gregory, PhD

Speaker

Checkpoint Inhibitor-Associated Myocarditis: Prevention or Early Detection?
Tarek Hammad, MD, PhD, MS, MSc, FISPE

Regulatory Challenges in Benefit/Risk Assessment and Labeling of Immuno-Oncology Agents
Meredith K. Chuk, MD, MHS



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for William Gregory

William Gregory

Worldwide Medical and Safety, Pfizer Inc
He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well... Read More →
avatar for Tarek Hammad

Tarek Hammad

Therapeutic Area Strategy Lead, Global Pharmacovigilance, Sanofi Genzyme
Dr. Hammad joined Sanofi-Genzyme, in 2019, as a Therapeutic Area Strategy Lead in the Global Pharmacovigilance group. Prior to this, he served as the Head of Signal Detection and Benefit-Risk Assessment in Merck KGaA/EMD Serono. Previously, he was an Executive Director of Pharmacoepidemiology... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Tuesday June 25, 2019 10:30am - 11:30am
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#237: The Rare Disease Experience in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-596-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will provide a look at the rare disease patient’s experience, and provide professionals with insight on how to craft accessible trials that meet this patient population’s needs. The session will also focus on the importance of increasing the number of rare disease trials throughout the industry.

Learning Objectives

Discuss how the rare disease patient’s experience differs from those suffering from more common indications, and ways in which it is the same.

Chair

Steven L. Roberds, PhD

Speaker

No Two Patients Are the Same: The Rare Disease Experience in Clinical Trials
Christian Burns

Panelist
Isabelle Lousada, MA



Speakers
avatar for Steven Roberds

Steven Roberds

Chief Scientific Officer, Tuberous Sclerosis Alliance
Steve leads the development and execution of the TS Alliance's scientific strategy through partnerships and conversations with stakeholders including individuals and families affected by TSC, basic and clinical researchers, healthcare providers, government agencies, and other non-profit... Read More →
avatar for Christian Burns

Christian Burns

President, ClinEdge
Christian, an avid entrepreneur and research advocate, is the President & co-founder of ClinEdge & BTC. He is passionate about serving patients and sites by identifying innovative solutions that will transform the traditional clinical trial model. ClinEdge & BTC work directly with... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#264: Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Application UAN: 0286-0000-19-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.

This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.

Learning Objectives

Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.

Chair

Laurie Iciek, PhD

Speaker

New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PhD

Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PhD

Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PhD



Speakers
avatar for Laurie Iciek

Laurie Iciek

Senior Consultant, Nonclinical, Biologics Consulting
Laurie is currently a Sr. Nonclinical Consultant for Biologics Consulting. Previously she spent 17 years in industry as a lead Toxicologist for MedImmune/AstraZeneca, Abbott Laboratories, and Bristol-Myers Squibb. Her academic training is in cellular and molecular immunology and her... Read More →
SN

Simone Nicholson

Toxicologist, AstraZeneca
Simone is a Toxicologist at MedImmune/AstraZeneca, she supports the safety assessment of multiple biologics modalities at all stages of development. Prior to her time at MedImmune, Simone performed in vivo pharmacology and safety studies at Dyax, the antibody library company. She... Read More →
KS

Karin Staflin

Senior Scientist, Genentech, A Member of the Roche Group
Dr. Karin Staflin, PhD., DABT., is a Development Toxicologist within the Safety Assessment Group at Genentech. She is responsible for the safety assessment of early- to late-stage large and small molecule therapeutics, within a range of disease areas. Before joining the Development... Read More →
avatar for Theresa Sweeney

Theresa Sweeney

Vice President, Safety Assessment, Nektar Therapeutics
Dr. Sweeney is currently the Vice President of Safety Assessment at Nektar Therapeutics where she leads a team responsible for evaluating the safety of both large and small molecule drugs. She has more than 25 years of drug development experience at Nektar and Genentech. Her professional... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#263: Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-614-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will highlight recent advances and review challenges and opportunities in rare disease ocular therapies. New therapeutic approaches have emerged including promising gene and cell-based therapies in retinal diseases. Relevant case studies and special considerations will be discussed. We will explore the regulatory and scientific issues with experts to provide insights from the FDA and different sponsors.

Learning Objectives

Identify recent advances in in ocular drug development therapies; Discuss the existing regulatory framework; Describe challenges and opportunities in ocular rare disease drug development highlighting what has been done and what might be done in the future.

Chair

Nita Ichhpurani, PMP

Speaker

Gene Therapy for Inherited Retinal Diseases
Melissa Shiao Hui Liew, MD

FDA/CBER Perspective on the Development of Gene Therapy Products for Retinal Disorders
Wei Liang, PhD

Changing What it Means to be Blind: We're All in This Together
Kristin Smedley



Speakers
avatar for Wei Liang

Wei Liang

Pharmacologist, OTAT, CBER, FDA
Dr. Liang is a Pharmacology/Toxicology Reviewer in the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). She joined OTAT in 2006. Her primary focus is the review of preclinical testing... Read More →
avatar for Nita Ichhpurani

Nita Ichhpurani

Consultant, Phase One Forward
At Pharmacia (now Pfizer), Nita was a discovery Chemist and then PM in Clinical Pharmacology in oncology and CNS research. At MDS PS, she managed Global Central lab teams and later become the Latin American Lab Manager. At MDS PS and Celerion, she managed drug development consulting... Read More →
KS

Kristin Smedley

President, Curing Retinal Blindness Foundation
Kristin Smedley is President and Co-Founder of the Curing Retinal Blindness Foundation, the only patient organization in the world for her two sons’ blindness, CRB1 LCA/RP. Kristin has led the CRBF to raise over $1.3 Million, introduced the first ever legislation in the United States... Read More →
avatar for Melissa Liew

Melissa Liew

Global Head of Translational Medicine-Opthamology, Novartis Institutes of Biomedical Research
Melissa is Vice President and Global Head of Translational Medicine-Ophthalmology, at Novartis Institutes of Biomedical Research, based in Cambridge Massachusetts. In her role, she is working to translate cutting edge basic science discoveries into transformative novel medicines for... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#290: The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-632-L04-P; CME 1.25; IACET 1.25; RN 1.25

In today’s pharmaceutical and biotech industry we are at an inflection point with regard to the future of therapeutic development. In this forum the focus will be to explore how industry, agencies, and academic institutions collaborate to drive innovative technologies to speed therapeutic development. Specifically, the forum will explore how we are leveraging STEM (Science, Technology, Engineering, Mathematics) programs both independently and interactively to enable current and future entrepreneurial opportunities. The goal is to foster an environment where we best take advantage of the opportunities presented by advances in life sciences and technology.

Learning Objectives

Evaluate the quality of interaction among various stakeholders in cure-based drug development; Assess the quality of those interactions in their own environments; Recognize the importance of fostering an environment where creativity and an entrepreneurial spirit is nurtured. Determine how STEM (Science, Technology, Engineering, Mathematics) programs are put to use to address the aforementioned objectives.

Chair

Dan Tierno, MA, MBA

Speaker

Industry Perspective
Yaron Drucker, MBA

Student Perspective
Advaita Chandramohan

Panelist
Melanie Matheu, PhD



Speakers
avatar for Advaita Chandramohan

Advaita Chandramohan

Undergraduate Research Associate, University of Southern California
Advaita Chandramohan is a first year student at the University of Southern California studying Biomedical Engineering with an Electrical emphasis. She is an Undergraduate Research Associate at USC's International Center for Regulatory Science, where she studies the dissemination and... Read More →
avatar for Yaron Drucker

Yaron Drucker

Staffing Lead, Cloud Partners, Google
Yaron has a Bachelor's Degree in Electrical Engineering, and an MBA from Baruch College. In his early career, Yaron worked in aerospace and defense as an EMC/EMI Engineer, and at SAP for a year. He then worked at Microsoft for 7 years in various roles in digital media on the advertising... Read More →
avatar for Dan Tierno

Dan Tierno

Associate Director, Global Clinical Data Sciences and Analytics, Bayer
Mr. Dan Tierno has over 20 years of experience in the pharmaceutical and biotech industry, specializing in drug development, data sciences and analytics for clinical trials, and commercialization of novel small molecule and cell based therapeutics. Mr. Tierno has spoken on training... Read More →
MM

Melanie Matheu

Founder and Chief Executive Officer, Prellis Biologics, Inc.


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#309: Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-650-L04-P; CME 1.25; IACET 1.25; RN 1.25

Neoantigen-based cancer therapy is an approach based on the specific genetic information unique to individual tumor(s) of an individual patient. Such information can be utilized in many ways for cancer treatment, e.g., to generate antigens for vaccination or specific T-cells. Results from earlier clinical trials have shown that this approach is feasible, able to elicit the intended immune response, and in some cases generating anti-tumor activities that may mediate the tumor regression. However, this approach has many scientific and regulatory challenges, for example, optimal ways / algorithms in identifying and selecting neoantigens, and regulatory framework for regulating such products given that drug product and indications are not explicitly defined. This session is intended to address these challenges and discuss the opportunities for the neoantigen-based cancer therapies.

Learning Objectives

Describe the concepts of cancer immunoediting and neoantigen;Discuss the recent advances in neoantigen-based novel cancer therapy, e.g., vaccine and cell-based therapies;Discuss scientific and regulatory challenges, focusing on pre-clinical studies and early clinical trials; Identify opportunities in facilitating and accelerating the development.

Chair

Peter F. Bross, MD

Speaker

CMC Considerations: Regulatory Perspective
Elena Gubina, PhD

CMC Considerations: Industry Perspective
Karin Jooss, DrSc

Clinical Consideration for Early-Phase Trials: Academic Perspective
Aaron M. Miller, MD, PhD

Clinical Consideration for Early-Phase Trials: Regulatory Perspective
Peter F. Bross, MD

Panelist
Alyssa K. Galaro, PhD



Speakers
avatar for Alyssa Galaro

Alyssa Galaro

Biomedical Engineer, DCEPT, OTAT, CBER, FDA
Dr. Galaro joined the Office of Tissues and Advanced Therapies in 2018 as a Pharmacology and Toxicology Reviewer. Prior to joining CBER, she completed her PhD in biomedical engineering at the Johns Hopkins School of Medicine where her research focused on engineering nanoparticle-based... Read More →
PB

Peter Bross

Medical Team Leader, OTAT, CBER, FDA
Peter Bross is a clinical oncology team leader in the FDA Center for Biological Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) and previously worked as a clinical reviewer in the Division of Oncology Drug Products in the Center for Drug Evaluation and... Read More →
avatar for Elena Gubina

Elena Gubina

Expert Biologist, OTAT, CDER, FDA
KJ

Karin Jooss

Executive Vice President of Oncology and Chief Scientific Officer, Gritstone Oncology
Dr. Karin Jooss serves as executive vice president of research, chief scientific officer at Gritstone and interim head of manufacturing. She joined Gritstone from Pfizer, where she was head of cancer immuno-therapeutics, was a member of the vaccine immuno-therapeutics leadership team... Read More →
AM

Aaron Miller

Medical Oncologist, Assistant Professor of Medicine, University of California San Diego
Dr. Miller is a board-certified medical oncologist who specializes in diagnosing and treating gastrointestinal cancers. He is an assistant professor in the Department of Medicine, where he instructs medical students, residents and fellows at UC San Diego School of Medicine. He holds... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking,Advanced Therapies
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

10:30am

#336: Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-678-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug scheduling is implemented by regulatory agencies to mitigate the risk of drug abuse. Learn about the pivotal clinical studies required to evaluate the abuse and dependence potential of CNS-active drugs and the evolving regulatory requirements.

Learning Objectives

Describe the most recent FDA recommendations for the clinical evaluation of abuse and physical dependence of CNS-active drugs; Discuss how this data is used to determine drug scheduling and the implications of controlled substances;Evaluate the best strategies to design robust abuse/dependence potential clinical trials.

Chair

Beatrice Setnik, PhD

Speaker

Panelist
Jack Henningfield, PhD

Panelist
Beatrice Setnik, PhD



Speakers
avatar for Jack Henningfield

Jack Henningfield

Vice President, Research, Health Policy, and Abuse Liabiliy, Pinney Associates
Professor Adjunct, Johns Hopkins School of Medicine, past chief Abuse Potential and Clinical Pharmacology, NIDA. 400+ articles and books related to drug abuse & regulation, public health, and neuropharmacology. My PinneyAssociates focus is on drug development, risk management, and... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →
avatar for Beatrice Setnik

Beatrice Setnik

Dept of University of Toronto; VP, Scientific and Clinical Strategy, Early Phase, Syneos Health
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next,Regulator Thinking,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

2:00pm

#363: Neurodegenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-687-L04-P; CME 1.25; IACET 1.25; RN 1.25

Intense research on the multiple fronts advanced our understanding of neurodegenerative diseases. Many disease-specific animal models have been used to test emergent medicines in neurology. Genetics and mechanism of neuronal pathogenesis contributed greatly and has created a wealth of knowledge and became the bases for novel technologies and multiple therapeutic targets for these neurodegenerative diseases. There is however substantial difficulty in choosing/accessing an optimal model or choosing measurements which would be truly informative of the product’s efficacy in neurodegenerative rare diseases or more prevalent diseases like pediatric neurodegenerative diseases and Alzheimer’s. This session will discuss nonclinical models supporting efficacy in rare neurodegenerative conditions, looking also at the challenges in early development in pediatric neurodegenerative diseases and highlight successes and failures in the development of treatments for dyslipidemia that may be applicable to the treatment of neurodegenerative diseases like Alzheimer’s disease.

Learning Objectives

Describe the importance and value of nonclinical in vivo models in rare neurodegenerative conditions and share highlights on the challenges in early development in pediatric neurodegenerative diseases; Identify optimal strategies for testing putative Alzheimer therapies; Recognize how to select and qualify biomarkers to identify patient and measure relevant drug activity; Define how to apply lessons from development of drugs to prevent Alzheimer Dementia.

Chair

Dinah Duarte, MSc

Speaker

Rare Neurodegenerative Diseases: Early-Stage Challenges and Optimal Animal Models in Orphan Drug Development
Dinah Duarte, MSc

Alzheimers Disease Prophylaxis: Lessons from Lipid Therapeutics
Richard Scheyer, MD

The Challenges in Early Development in pediatric Neurodegenerative Diseases
Scott Demarest, MD



Speakers
SD

Scott Demarest

Assistant Professor, Departments of Pediatrics and Neurology, University of Colorado School of Medicine; Children's Hospital Colorado
Scott Demarest received a Bachelor of Science in biology from the University of Texas at Austin before going on to medical school at the University of Texas Health Science Center in San Antonio. He completed his residency in Pediatrics and child neurology at Children's National Health... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#371: Efficient Pediatric Drug Development: Incorporating Innovative Techniques Using Extrapolation and Historical Information
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-694-L04-P; CME 1.25; IACET 1.25; RN 1.25

Pediatric drug development for adult indications is mandated. Yet children should be protected from unnecessary risks. This session discusses innovative techniques using extrapolation from adult data as an efficient way to study drugs in children.

Learning Objectives

Explain the regulatory and ethical context of pediatric drug development; Discuss the role, assumptions, and data needed for using extrapolation from adult data; Identify innovative approaches using Bayesian methodologies to demonstrate the efficacy of drugs in pediatrics; Discuss ways to integrate pediatric into adult drug development.

Chair

Robert Meland Nelson, MD, PhD

Speaker

The Use of Extrapolation in Pediatric Drug Development
Robert Meland Nelson, MD, PhD

Using Historical Data to Establish More Efficient Clinical Trials
Jeen Liu, PhD

Design and Analytic Strategies for Incorporating External Data in a Global Pediatric Trial
Margaret Gamalo-Stiebers, PhD



Speakers
MG

Margaret Gamalo-Stiebers

Principal Research Scientist, Eli Lilly and Company
JL

Jeen Liu

Associate VP, Biostatistics, Allergan Inc.
I have worked in the Pharma industry for 20+ years as a statistician, currently responsible for biostatistics support of all the ophthalmology products for the company. Prior to joining Allergan, I have worked for Novartis, Astellas and Eisai. My experience in clinical trials covers... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development, Johnson & Johnson
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics, Office of the Commissioner at the U.S. Food and... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Innovative Trial Design
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#385: The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-704-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how human-focused translational technologies help ensure the safety and efficacy of novel therapies, reduce product development costs, shorten time to market and provide an unprecedented opportunity to unlock new possibilities for preclinical drug discovery.

Learning Objectives

Discuss the importance of human cells and/or tissue in early drug discovery for success in clinical trials; Identify strategies for using human cells and/or tissue in every stage of preclinical research (i.e., from target identification to lead optimization and into phase 1; Identify from case studies that describe how data from human cells/tissues can be more predictive than in vivo animal studies.

Chair

Christopher Mathes, PhD, MBA

Speaker

Industry Perspective
Andre Ghetti, PhD

PMDA Update
Satoshi Tsunoda

Translation of Safety Pharmacology Testing to Human Trials: What Do We Know?
Hugo M Vargas, PhD



Speakers
avatar for Andre Ghetti

Andre Ghetti

Chief Executive Officer, AnaBios
Andre Ghetti, PhD, is our Chief Executive Officer. During the last several years, Dr. Ghetti focused on the creation of new tools and strategies to advance biomedical sciences, with special emphasis on enabling the direct study of human biology and pharmacology to accelerate the rate... Read More →
avatar for Christopher Mathes

Christopher Mathes

Chief Commercial Officer, AnaBios
As Chief Commercial Officer (CCO) of AnaBios, Dr. Chris Mathes provides leadership in business development & contributes to strategic direction. Previously, Mathes acted as CCO of Icagen. led the North American business development team for Discovery Services at Charles River & was... Read More →
avatar for Satoshi Tsunoda

Satoshi Tsunoda

Deputy Specialist, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA)
avatar for Hugo Vargas

Hugo Vargas

Executive Director, Amgen Inc.
I am an Executive Director at Amgen, and lead the Safety Pharmacology & Animal Research Center (SPARC) department. My team includes 60+ staff (Thousand Oaks, San Francisco, Burnaby BC) and we contribute actively and extensively to the entire drug discovery and development pipeline... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Thursday, June 27
 

9:00am

#408: FDA Botanicals
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-722-L04-P; CME 1.25; IACET 1.25; RN 1.25

The FDA's relatively new and lesser known classification for Botanical Drug means the US joins many countries that offer practitioners and pateints high quality botanical medicines. Herbal medicines with a history of safety and efficacy, especially those that meet an unmet medical need, now have a track to regulatory approval.

Learning Objectives

Describe the steps to create a scientific and business plan for the US FDA Botanical drug route; Identify the difference between FDA regulations for drugs, botanicals, homeopathic drugs and supplements; Discuss clinical considerations to evaluate the potential of a medicinal herb.

Chair

Douglas S. Kalman, PhD

Speaker

Executing US-FDA Compliant Botanical Drug and Dietary Supplement Studies: Regulatory Made Simple
Douglas S. Kalman, PhD

Panelist
Daniel Fabricant, PhD

Industry Update
Sue McKinney



Speakers
avatar for Douglas Kalman

Douglas Kalman

Vice President, Scientific Affairs, Nutrasource
Douglas S. Kalman PhD, RD, FACN – Dr. Kalman has been involved in over 250 clinical trials and projects within the pharmaceutical, medical and exercise - nutrition related fields. He has published over 75 abstracts and more than 40 peer-reviewed manuscripts. He is a Co-founder of... Read More →
avatar for Sue McKinney

Sue McKinney

Director, Crinum Health Ltd
Sue is a California native, an attorney who has lived in Vietnam 25 years. She’s runs Crinum Health Ltd a biotech affiliated with cGMP facilities and organic plantations producing 100% vertically integrated proprietary botanicals – from farm-to-finished product. Vietnam is a bio... Read More →
DF

Daniel Fabricant

Chief Executive Officer and President, National Products Association
Daniel Fabricant, Ph.D. is CEO and President of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. Most recently, Dr. Fabricant... Read More →


Thursday June 27, 2019 9:00am - 10:15am
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA