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04: MedAffairs-SciComm [clear filter]
Monday, June 24
 

11:00am

#120: FDA Payer Communication Guidance, Twenty Years in the Making: Now What?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

The FDA Payer Guidance released in 2018 has provided some clarity to industry and payers. The FDA explicitly noted the important difference between information required for medical product approval and what is needed by payers to make decisions about population-based coverage and reimbursement. The FDA Payer Guidance is largely pragmatic regarding HCEI communications and advances industry’s proactive dialogue with payers. However, there remains areas of uncertainty within the guidance. A panel composed of the relevant stakeholders will have an open dialogue on the intention of the guidance, the challenges with developing a guidance for industry and payers, the practical challenges of operationalizing aspects of the guidance, the remaining informational needs of payers from industry to inform access decisions.

Learning Objectives

Discuss how to decrease the anxiety in proactively communicating relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.

Chair

Sissi Pham, PharmD

Speaker

FDA Perspective
Sheila Ryan, MPH, RAC

Panelist
Chris Leo Pashos, PhD

Panelist
Mitchell Higashi, PhD

Panelist
Denise Sanchez, JD, MPH, MS



Speakers
avatar for Mitchell Higashi

Mitchell Higashi

Vice President, Health Economics and Outcomes Research, Bristol-Myers Squibb
Mitch is the Vice President of HEOR at Bristol-Myers Squibb. Prior to joining BMS, he was the Chief Economist for GE Healthcare, where he led global efforts in health economics, pricing, reimbursement, and health policy. Mitch is a published author, including JAMA, and his work in... Read More →
avatar for Chris Pashos

Chris Pashos

Vice President, Global Evidence Strategy, AbbVie Inc.
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He... Read More →
avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →
SR

Sheila Ryan

Acting Director, Division of Supply Chain Integrity, Fda/cder/Office Of Compliance/Office of Drug Security, Integrity and Response
Sheila Ryan, PharmD, MPH, RAC is currently the Acting Director of the Division of Supply Chain Integrity in the Office of Drug Security, Integrity and Response within CDER's Office of Compliance at FDA. She has over 15 years of FDA regulatory experience, including over 10 years in... Read More →
avatar for Denise Sanchez

Denise Sanchez

Executive Director, Regulatory Affairs Advertising and Promotion, Allergan
Denise joined Allergan with 15 years of combined industry, government and law firm experience. Prior industry roles include Regulatory overview of commercial promotion and practices at Ironwood Pharmaceuticals, Celgene Corporation, and Cubist Pharmaceuticals. While at the law firm... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 14B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#160: New Communication Channels for Medical Information
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-557-L04-P; CME 1.00; IACET 1.00; RN 1.00

Technology and social media are redefining the ways that healthcare professionals research, receive, and even share medical information. In this new environment, pharmaceutical companies are evaluating different channels for communicating information to their customers. This session will explore delivery different channels pharmaceutical companies are using and present case studies on new methods that companies are using to share information with healthcare professionals..

Learning Objectives

Identify and evaluate the different channels of medical information delivery currently used in the pharmaceutical industry, including cost effectiveness, usage, healthcare professional preference, and future delivery channels; Discuss specific case studies of pharmaceutical companies successfully implementing new communication channels with healthcare professionals.

Chair

David Bowers, PharmD

Speaker

Evolution of Medical Information Response Delivery Channels in the Pharmaceutical Industry
Walter Frank Eng, PharmD, MBA, RPh

Industry Perspective
Jenny Ko, PharmD



Speakers
avatar for David Bowers

David Bowers

Director, Medical Communications, PPD
David Bowers has 15+ years of experience managing pharmaceutical contact center programs at PPD. As Director of Operations, David supports global medical information for pharmaceutical, biotechnology and medical device clients. He has a background in pharmacy, with a Doctorate of... Read More →
avatar for Walter Frank Eng

Walter Frank Eng

Multidisciplinary Fellow, Novo Nordisk
Walter Frank attended Creighton University where he received his Bachelors of Science in Healthcare Studies, Doctorate of Pharmacy, and Masters of Business Administration. During his studies, Walter Frank worked as a consultant in the specialty pharmacy industry, helped to establish... Read More →
avatar for Jenny Ko

Jenny Ko

Vice President, Specialty and Primary Care Markets, Haymarket Media, Inc.
Jenny is the Vice President, Specialty & Primary Care Markets at Haymarket Media and oversees a growing roster of brands within the Haymarket Medical Network, which serves to provide healthcare professionals with specialty-focused clinical support tools and informational resources... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#207: Leveraging Artificial Intelligence and Natural Language Processing in Medical Writing
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-575-L04-P; CME 1.25; IACET 1.25; RN 1.25

From Watson to self-driving cars to Netflix, the phrase “artificial intelligence” feels like a buzzword. What is reality versus hype and how can this emerging technology impact medical, regulatory, and commercial writing? This session will define the language of artificial intelligence(AI), discuss the potential impact for AI in creation and re-use of medical content, detail the emerging technologies of artificial intelligence in the writing space, and describe the challenges of developing a medical writing tool that uses AI. Participants will leave with an understanding of the practical applications of AI and how those uses could translate into disruption of medical writing, regulatory submissions, and more.

Learning Objectives

Define artificial intelligence (AI) and natural language processing (NLP) in the context of medical writing; Describe the potential for re-use of content across functional areas using AI; Discuss the challenges of developing and socializing an AI tool.

Chair

Robin Whitsell

Speaker

AI in Medical Writing Intelligent Creation and Reuse of Medical Content
Anand Kiran, MBA, MPharm

AI in the Medical Writing Landscape
Julia Forjanic-Klapproth, PhD



Speakers
avatar for Julia Forjanic-Klapproth

Julia Forjanic-Klapproth

President/Senior Partner, Trilogy Writing & Consulting
After receiving her PhD in developmental neurobiology, Julia started her career as a medical writer in the regulatory group at Hoechst Marion Roussel (later Sanofi) in 1997. Since then she has been president of the European Medical Writers Association (EMWA) twice and is an active... Read More →
avatar for Anand Kiran

Anand Kiran

Co-Founder and Executive Vice President, Indegene
Anand Kiran is Executive Vice President of R&D Solutions and Global Delivery, Indegene. He is one of the co-founders of the company. Anand is responsible for business solutions and execution of R&D Solutions (Clinical, Safety, Regulatory and Medical) for Pharmaceuticals/Lifesciences... Read More →
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc.
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, she has 20 years’ experience, specializing in regulatory medical writing and submission strategies. Prior to founding WI, Ms. Whitsell was the assistant director of preclinical... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#234: Quality and Compliance Management in Medical Information/Medical Affairs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-594-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how meeting both quality and compliance high standards can ensure effective success in supporting any pharmaceutical brand which is primarily defined by its image.

Learning Objectives

Discuss the factors that effectively influence and measure quality and compliance; Describe the risk and impact of the performance in quality and compliance; Identify reliable approaches to monitor and measure the performance at local versus global level.

Chair

Philippe Sorel Takam, PharmD, MSc, RPh

Speaker

Industry Perspective
Joseph Mack, JD

Techniques for Successful System Validation
Joseph Pierce



Speakers
avatar for Philippe Sorel Takam

Philippe Sorel Takam

Global Director, Head of Medical Information, PrimeVigilance Ltd
Phil is a time-honoured healthcare professional and holds a Doctorate in Pharmacy (Pharm.D.), a Master Degree in Pharmaceutical Science and three Post-Graduate Diplomas in Medicines Information, Patient’s Clinical Management and Business Administration. Throughout his professional... Read More →
avatar for Joseph Mack

Joseph Mack

Senior Compliance Counsel, US Office of Compliance, Bayer U.S.
At Bayer, Joe Mack is responsible for both advising various businesses on compliance issues and conducting internal investigations. Prior to joining Bayer, Joe served for over nine years as an Assistant U.S. Attorney in the U.S. Attorney's Office for the District of New Jersey. During... Read More →
JP

Joseph Pierce

President, EndPoint Technologies
Joe Pierce has worked with pharmaceutical and biotech companies since 1995, specifically in the area of medical information and medical affairs. He was VP of Sales and Marketing for Online Business Applications, leading that company’s core product IRMS, to become the most widely... Read More →
avatar for Philippe Sorel Takam

Philippe Sorel Takam

Former Global Director, Head of Medical Information and Medical Review, Global CRO
Phil is a time-honoured healthcare professional and holds a Doctorate in Pharmacy (Pharm.D.), a Master Degree in Pharmaceutical Science and three Post-Graduate Diplomas in Medicines Information, Patient’s Clinical Management and Business Administration. Throughout his professional... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-612-L04-P; CME 1.25; IACET 1.25; RN 1.25

Clinical study data is increasingly becoming available in the public domain. This session presents how the data is being utilized by patients and how sponsors are modifying their internal procedures to prepare disclosure-ready documents. Join the Clinical Trial Disclosure Community for a follow up Round Table discussion on Wednesday, June 26, 1:00-2:00PM in the DIA Community Zone 2, Sails Pavilion.

Learning Objectives

Discuss how publicly available clinical data is being utilized by patient organizations; Describe approaches industry is taking to write clinical documents and provide clinical data for disclosure; Discuss Health Canada’s new regulation on publication of clinical trial information.

Chair

Robert Paarlberg, MS

Speaker

Overview of Health Canada’s Public Release of Clinical Information Initiative
Andre Molgat, PhD

Clinical Trial Disclosure and Transparency: An Industry Perspective
Liz Roberts, MSc

How Clinical Data is Being Used by Patients and Patient Organizations
Deborah E. Collyar



Speakers
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has applied a wealth of leadership skills from her successful IT business career to help create patient-centered medical research and healthcare, after her first cancer diagnosis at the age of 32. She founded Patient Advocates In Research (PAIR) in 1996, “where research... Read More →
AM

Andre Molgat

Senior Regulatory Affairs Advisor, Resource Management and Operations Directorat, Health Canada
André Molgat is the Head of Operations for Health Canada's Public Release of Clinical Information initiative. He was previously a core member of the team responsible for the initiative's regulatory and policy development. André has a PhD in biochemistry and post-doctoral training... Read More →
avatar for Robert Paarlberg

Robert Paarlberg

Principal, Paarlberg & Associates LLC
Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob created and directed global regulatory... Read More →
avatar for Liz Roberts

Liz Roberts

Global Public Policy Lead, External Engagement Practice, UCB Inc.
Liz is Senior Director and Global Public Policy Lead at UCB where she is responsible for establishing the strategic framework, guiding principles, and corporate policies that inform clinical trial transparency and responsible data sharing. She also leads other public policy priorities... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#287: A Case Study in Structuring Clinical Content and Structured Content Management (SCM)
Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-630-L04-P; CME 1.25; IACET 1.25; RN 1.25

Join us to hear about our experiences structuring clinical content and conducting a proof-of-concept study with a structured concept management (SCM) solution.

Learning Objectives

Describe what Structured Content Management (SCM) is, and why it should matter to you; Discuss how one company took steps to structure their clinical content and then evaluated SCM in a proof-of-concept study; Identify critical SCM functionalities needed for pharma companies and how they were assessed.

Chair

TK Booker Porter, PhD

Speaker

Structuring Clinical Content and Content Management
Angela M. Horowitz, MPH

Structuring Clinical Content and Content Management
Martha Cruz Naranjo, DVM, PhD



Speakers
avatar for Angela Horowitz

Angela Horowitz

Practice Lead, Structured Content Management, ArborSys Group
Angela Horowitz leads the Structured Content Management (SCM) domain at ArborSys. She has over 15 years of experience in the biotech and pharmaceutical industry, working as a medical writer, business and content analyst, and project manager. Angela has worked with multiple clients... Read More →
avatar for Martha Cruz Naranjo

Martha Cruz Naranjo

Strategic Development Director, Amgen Inc
I am a clinical development professional with over 10 years of experience in the biopharmaceutical industry leading crossfunctional teams in the development of innovative clinical trials across different therapeutic areas. Prior to joining industry I was an academic faculty/researcher... Read More →
avatar for TK Booker Porter

TK Booker Porter

Senior Director, Global Medical Writing, Greenwich Biosciences
T.K. Booker Porter leads global medical writing at Greenwich Biosciences. She is passionate about continuous improvement in an environment that is ever-changing due to shifting global regulatory requirements, trends with patient input, and advances in technology. She has been instrumental... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session

4:15pm

#288: The Changing Landscape of Medical Affairs: Are We Prepared For 2020?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-644-L04-P; CME 1.25; IACET 1.25; RN 1.25

Approximately twelve years ago, pharmaceutical industry leaders convened to create a 10-year future view for medical affairs with the aim of creating a plan for identifying success in the field. In follow-up, a leading consultant company released a white paper five years later reviewing the progress of the plan. This white paper predicted the following areas would be relevant and the primary focus for Medical Affair’s departments in 2020: innovative therapies, patient-centricity, talent acquisition/training, and integrating disparate streams of medical data and knowledge. However, without a crystal ball, future predictions may be unreliable (even from the leading experts) or subject to the changing regulatory and compliance environment for our industry.

With 2020 just one year away, this session will evaluate progress of the industry in establishing success and expertise in these and other areas and and evaluate new and continuing challenges for Medical Affairs professionals as we move into future decades

Learning Objectives

Evaluate the current status of the predictions from the original ‘2020 white paper’ for Medical Affairs departments; Discuss how technology, systems, and organizational models are assisting Medical Affairs departments with their global demands; Evaluate how the evolving regulatory and compliance environment is helping to shape/ morph our Medical Affairs departments and Identify new and emerging areas of focus of the future.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Ann Westra, MD



Speakers
avatar for J. Lynn Bass

J. Lynn Bass

Senior Director, MSLs & Lead, Global Field Medical Affairs, Rakuten Medical
With 20+ years of experience in Medical Science Liaison and Medical Affairs roles across the pharmaceutical industry, Lynn is currently the Sr. Director, MSLs and Field Medical Affairs at Rakuten Medical, Inc. Her industry career has spanned many therapeutic areas and she has authored... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Head, Customer Strategy and Patient Partnership Global Medical Affairs, Hoffmann-La Roche Ltd.
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as Customer Strategy and Patient Partnership for Global Medical Affairs at Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons... Read More →
AW

Ann Westra

Senior Medical Knowledge Expert, McKinsey & Company


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-648-L04-P; CME 1.25; IACET 1.25; RN 1.25

Use of multiple sub-teams, each focused on a topic (eg, safety, efficacy) and responsible for delivering content across multiple documents, can accelerate the delivery of marketing applications. Pros and cons of such approaches will be discussed. Join the Medical Writing Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the basic concepts of a topic-based approach to delivering marketing applications; Identify potential pros and cons of topic-based approaches in order to identify where such approaches may or may not be appropriate to marketing applications in the attendee’s own organization.

Chair

Frank Hubbard, PhD, MS

Speaker

What is Topic-Based Authoring and What is the Problem we are Solving For?
Frank Hubbard, PhD, MS

Accelerated Delivery of Efficacy and Safety CTD Components Using Topic-Based Authoring Strategies
Mary Jean Matus

Topic-Based Authoring: Clinical Pharmacology Components of BLA/NDA Submissions
Lisa Iacono Sheehan, PharmD



Speakers
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my previous... Read More →
MJ

Mary Jean Matus

Consultant, Medical Writer, Audubon PM Associates
Mary Jean Matus is a medical writer with Audubon PM Associates, Inc., a niche CRO specializing in regulatory documents and submissions in markets around the world. Mary Jean has 25 years of quality assurance and medical writing experience across a broad range of therapeutic areas... Read More →
avatar for Lisa Iacono Sheehan

Lisa Iacono Sheehan

Director Global Regulatory Strategy, Bristol-Myers Squibb
Lisa has been at Bristol-Myers Squibb for 15 years. Her first 10 + years was spent in Clinical Pharmacology where she ran clinical pharmacology studies and provided support for oncology and metabolic drug development. For 4 years, Lisa has been a Documentation Lead supporting Clinical... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#333: Pediatric Plans: The Challenges Between Regulations and Reality
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-666-L04-P; CME 1.00; IACET 1.00; RN 1.00

Clinical requirements children are different from adults and the strategy to implement a pediatric study has many challenges, in terms of ethical, operational, and scientific issues. Working with a uniquely vulnerable patient population provides additional complexity, with numerous regulatory requirements. The authoring of key documents to optimize pediatric drug development for regulatory approval is being integrated earlier in the drug development process. This forum features three speakers who will describe the current regulatory framework and changes in drug development in pediatric oncology, the challenges in safety reporting in pediatric clinical trials. and key documents that outline the strategy for developing a drug in pediatric patients.

Learning Objectives

Describe the key regulations governing development of trials in pediatric patients; Describe the structure and required content of a PIP and a PSP; Identify changes in oncology development for pediatric patients and opportunities for scientific collaboration; Identify challenges for accurate safety reporting in pediatric clinical trials.

Chair

Darryl Zachary L'Heureux, PhD, MPharm, MSc

Speaker

Regulatory Changes in Oncology Pediatric Trials
Mark W. Kieran, DrMed, MD, PhD

Solid Planning to Optimize Patient Safety and Clinical Outcomes
Judith A. Blacklidge, BSN, MSN, RN

Key Documents For Pediatric Drug Development
Nancy Katz, PhD



Speakers
JB

Judith Blacklidge

Clinical Quality Management, ExecuPharm, Inc.
Judith Blacklidge has extensive experience in healthcare, pharmaceutical and biotechnology clinical research with roles as diversified as research CRC, CRA, CQA, team leader, program manager, safety scientist, auditor, pharmacovigilance manager, department head and director of research... Read More →
avatar for Nancy Katz

Nancy Katz

President and Principal, Medical Writing Consultant, Illyria Consulting Group, Inc.
Nancy is President of Illyria Consulting Group, Inc., which specializes in the creation of eCTD-compliant documents. As a DIA MW Community member, she chaired the E3 committee, which facilitated a Q & A to ICH E3, and the Education committee. She also serves on its extended core committee... Read More →
avatar for Mark Kieran

Mark Kieran

Clinical Trail Lead, Pediatrics Program Oncology Clinical Development, Bristol-Myers Squibb
Dr. Kieran is currently the Pediatric Clinical Trial Lead in Oncology Clinical Development, Bristol-Myers Squibb. He received his PhD in 1983 from the University of Alberta, Edmonton, Canada, and his MD in 1986 from the University of Calgary. After a post-doctoral fellowship at the... Read More →


Wednesday June 26, 2019 10:30am - 11:30am
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:45pm

#352 RT: Round Table Discussion: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients
Component Type: Session
Level: Basic

Round table discussion tied to session #260: Clinical Trial Disclosure and Transparency: Intersection of Regulators, Industry, and Patients (Tuesday, June 25, 2:00-3:15PM). Seating is limited. To include special guests from the session: Bob Paarlberg, Liz Roberts.

Chair

Nate Root, MSc


Speakers
avatar for Nate Root

Nate Root

Associate Director, Disclosure and Transparency, Ionis Pharmaceuticals
Nate is a disclosure and transparency professional, with over 6 years of experience in the environment, working for and with CROs, Big Pharma, Non-Profit, and Small Biotech. He is a member of the DIA Disclosure Community Core Team, PhUSE CTD initiatives, and creator of the West Coast... Read More →


Wednesday June 26, 2019 12:45pm - 1:45pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#375 RT: Round Table Discussion: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
Component Type: Session
Level: Basic

Join DIA Medical Writing Community for a round table discussion tied to session #307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines? (Wednesday, June 26, 8:00-9:15AM). Seating is limited. To include special guests from the session: Mary Jean Matus, Lisa Iacono

Chair

Frank Hubbard, PhD, MS


Speakers
avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my previous... Read More →


Wednesday June 26, 2019 2:00pm - 3:00pm
Community Zone Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#361: Returning Plain Language Summaries to Research Participants: Best Practices and the Role of the IRB
Component Type: Session
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-685-L04-P; CME 1.25; IACET 1.25; RN 1.25

Many sponsors are developing programs to provide the results of clinical trials to participants as “plain language summaries”. As sponsors develop plain language summary programs, they should consider best practices for the content and preparation

Learning Objectives

Describe current best practices for the content and preparation of plain language summaries; Discuss current guidance for how sponsors should work with Institutional Review Boards (IRBs) having oversight of the clinical trials for which the summaries are provided; Apply learnings from an industry sponsor’s firsthand experience with IRBs during the plain language summary creation/delivery process.

Chair

Kenneth A. Getz, MBA

Speaker

Best Practices for Returning Aggregate and Individual Trial Results to Patients
Jill McNair, MBA

The Role of the IRB in the Review of Lay Language Summaries
Lindsay McNair, MD, MPH, MSc



Speakers
avatar for Kenneth Getz

Kenneth Getz

Deputy Director, Research Professor (PHCM); Founder and Chairmen, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT; CISCRP
Kenneth A. Getz is the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategies and tactics, outsourcing, and global... 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 →
avatar for Jill McNair

Jill McNair

Senior Director, Health Communication Services, CISCRP
Jill has worked in the non-profit sector for over 20 years. She is the Senior Director, Patient Engagement at CISCRP. In this role, she oversees a team dedicated to helping sponsor companies provide trial results summaries in plain language to study volunteers. She is passionate about... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#383: Next-Generation Approaches for Developing Narratives
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-702-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on automated approaches (content and process automation) for generating safety narratives.

Learning Objectives

Discuss automated approaches for generating safety narratives; Describe current challenges and future vision of automated approaches will be discussed in light of current technologies and requirements; Discuss strategies for soliciting feedback from health authorities on automated narratives.

Chair

Ulrike Kochendoerfer, PhD

Speaker

Behavior, Process, and AI Driven Technologies: How They Work Together to Create a Streamlined Narrative Workflow
Justin Savesky

Narrative Writing: Organization and Automation
Mary McKenna, MS, MSc

FDA Perspective
Robert Ball, MD, MPH, MSc



Speakers
avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
avatar for Ulrike Kochendoerfer

Ulrike Kochendoerfer

Director, Medical Writing, Pfizer Inc
Dr. Ulrike Kochendoerfer has over 20 years of experience in pharmaceutical research. She started her career in pre-clinical research in toxicology and biochemistry, before entering the regulatory medical writing field in 2005. Dr. Kochendoerfer holds a PhD from the University of Bonn/Germany... Read More →
MM

Mary McKenna

Head of Medical Writing, Business Ops and Svc, Merck & Co., Inc.
My early career was spent in statistical programming supporting clinical trials. That experience led to building and managing teams of statistical and data management programming groups for global pharmaceutical organizations and CROs. I transferred into Clinical Document Management... Read More →
JS

Justin Savesky

Director, Regulatory Sciences Technology, Synchrogenix, A Certara Company
Justin Savesky, Director, Regulatory Science Technology has been immersed in the technology field for regulatory science for over eight years. As an employee of GlobalSubmit, he focused on the implementation and client management of systems for the Regulatory Operations community... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session