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

11:00am

#111: PhactMI Benchmarking Survey Highlights: How are the Twenty Seven Member Companies Executing on Medical Information Initiatives
Component Type: Forum
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-525-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the phactMI benchmarking survey that was conducted in an effort to assess twenty seven member companies in the US through nine overall topics, such as company background, inquiry management, content development, decision makers, technology and website.

Learning Objectives

Discuss how twenty seven member companies are executing on medical information activities; Identify which technologies are currently being used, how medical content is being created and how inquiries coming from health care providers, patients and caregivers across the nation are being managed; Describe medical information executes on managed care situations and how medical information websites are being created and maintained.

Chair

Rania Gaspo, PhD

Speaker

Structure and Organization of Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information Departments
Kirstie Marasigan, PharmD

How Do Twenty Seven Medical Information Departments Execute on Healthcare Decision Making Materials for Payer Inquiries: A PhactMI(TM) Benchmarking Survey
Andrew Gazo, PharmD, MS

What is Happening Through Product Support, Key Performance Indicators, and Other MI Services: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical MI Departments
Meera Patel, PharmD

How Do We Create Medical Content? Fulfilling Customers’ Medical Information Needs: Insights from a PhactMI(TM) Survey of Twenty Seven US Pharmaceutical Medical Information Departments.
Teresa Flowers, MBA, MS, RPh



Speakers
avatar for Teresa Flowers

Teresa Flowers

Senior Director, Medical Communications, Medical Affairs, Astellas Pharma Inc.
Teresa Flowers is Senior Director, and Global Medical Information Lead at Astellas Pharma Inc. She leads a co-located team of subject matter experts responsible for creating medical Information global core content. She has over 20 years of experience across multiple therapeutic areas... Read More →
avatar for Rania Gaspo

Rania Gaspo

Director, Global Therapy Area Team Lead, External Medical Communications, Pfizer Inc
Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist. Rania joined Pfizer in 2003 where she held positions in medical... Read More →
avatar for Andrew Gazo

Andrew Gazo

Head of CHC Global Content, Medical Information, Sanofi
Andrew Gažo is currently Head of Global Content for Consumer Healthcare in the Sanofi Medical Information Department and is a Board member of phactMI. Andrew has been active in all aspects of Medical Information, including content globalization, compliance monitoring, business development... Read More →
avatar for Kirstie Marasigan

Kirstie Marasigan

Post-Doctoral Fellow, US Medical Affairs and Medical Communications, Genentech, A Member of the Roche Companies
Kirstie Marasigan is a first year US Medical Affairs Post-Doctoral Fellow at Genentech within the Rutgers Pharmaceutical Industry Fellowship Program. In May 2018, she graduated with a PharmD from the University of the Sciences, Philadelphia College of Pharmacy. During her last year... Read More →
avatar for Meera Patel

Meera Patel

Associate Dierctor, Medical Information and Knowledge Integration, Janssen Pharmaceuticals
Meera has 15+ years of experience in Medical Information in the pharmaceutical industry. She is an Associate Director in Medical Information at Janssen Pharmaceuticals where she has oversight of products in infectious diseases. Prior to joining Janssen, she was a Medical Information... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#141: Knowledge Management and Information Sharing to Support Business Continuity
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-541-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will demonstrate how knowledge management is key to support business continuity during times of change. A panel of representatives will present examples of how their companies enable knowledge preservation and information sharing.

Learning Objectives

Discuss different models for knowledge management and information sharing within medical affairs organizations to support continuity and increase organizational efficiency; Identify the key drivers for preserving knowledge and identify ways in which a medical affairs organization can leverage tools and processes to bolster a culture of collaboration.

Chair

Divya Raman, JD, MS

Speaker

Panelist
Anne Arvizu, PharmD

Panelist
Chris Clevenger, PhD



Speakers
avatar for Anne Arvizu

Anne Arvizu

Chief Executive Officer and Medical Affairs Advisor, RxER Communications Corp
Dr. Anne Arvizu is founder and CEO of RxER Communications Corp (www.rxercommunications.com). With 22 years of executive leadership experience in the pharma/biotech industry, she has served in key roles such as Head of Global Med Info, Knowledge Mgmt. and Literature Surveillance for... Read More →
avatar for Chris Clevenger

Chris Clevenger

Managing Director, Rype Health
Chris Clevenger is a Managing Director at Rype Health, a boutique consulting firm focused on helping start-up, small and mid-size biopharmaceutical companies design fit-for-purpose Medical Affairs teams. Prior to joining Rype Health, Chris led Medical Affairs teams at Ultragenyx... Read More →
avatar for Divya Raman

Divya Raman

Program Manager, Medtronic
Divya Raman works at Medtronic, where she is a program manager, leading initiatives related to compliance to the European Union Medical Device Regulation. Divya has been with Medtronic since 2012 in roles within technical communication, regulatory affairs, and medical affairs. Prior... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

8:00am

#201: To Err is Human: Progress and Challenges in the Prevention of Medication Errors
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-572-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will look at progress in the reduction of medication errors due to name confusion. A panel of experts, representing major health authorities and WHO will provide a concise summary of guidelines these bodies have developed to minimize these errors, discuss differences in their approaches and what they see are the challenges that remain.

Learning Objectives

Discuss progress in the reduction of medication errors due to the development of regulations surrounding the development of drug names; Evaluate progress and identify challenges in the development of guidance by FDA, Health Canada, and EMA for proprietary names development and challenges with name confusion in the development of INNs; Describe best practices in the development of acceptable proprietary and non-proprietary names.

Chair

Tony E. Catka, PhD

Speaker

ISMP Perspective
Michael R. Cohen, DrSc, MS, RPh

FDA Perspective
Lubna Merchant, PharmD, MS

WHO Perspective
Raffaella Giovanna Balocco Mattavelli, PharmD, PhD



Speakers
avatar for Tony Catka

Tony Catka

Senior Director, Regulatory Affairs, Addison Whitney, A Syneos Health Company
As the Lead of Addison Whitney's Center for Regulatory Guidance, Tony ensures that Addison Whitney stays abreast of changes that affect drug naming worldwide. He provides analysis of regulatory guidance, precedents, and the emerging environment and collaborates with team members in... Read More →
MC

Michael Cohen

President, Institute for Safe Medication Practices
Michael Cohen, RPh, MS, ScD, is president of The Institute for Safe Medication Practices, a non-profit healthcare organization that specializes in understanding the causes of medication errors and providing error-reduction strategies to the healthcare community, policy makers, and... Read More →
RB

Raffaella Balocco Mattavelli

Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO)
Dr. Raffaella Balocco is a pharmacist Doctor and has a PhD in Pharmacology. She worked at the "Mario Negri Institute for Pharmacological Researches" in Milan before joining the World Health Organization in 1993. From 1993 until 2001 she worked in the regulatory support Unit within... Read More →
avatar for Lubna Merchant

Lubna Merchant

Deputy Office Director, OMEPRM, OSE, CDER, FDA
Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#292: Conversations with the Participant: Layperson Summaries and Return of Results
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-634-L04-P; CME 1.25; IACET 1.25; PDU 1.25 PMI 2166MBS6XA; RN 1.25

In this forum, experts will explore the international patchwork of regulatory requirements and policy recommendations for improving trial participant engagement by publishing layperson summaries and returning research results.

Learning Objectives

Identify best practices in sharing study level trial results; Recognize how to plan for participant dialog in study design.

Chair

James Riddle, MS

Speaker

Panelist
Barbara E Bierer, MD

Panelist
Deborah E. Collyar



Speakers
avatar for Barbara Bierer

Barbara Bierer

Professor, Harvard Medical School
Barbara Bierer, M.D., a hematologist-oncologist, is Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital (BWH). Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center, www.mrctcenter.org), a collaborative... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR)
Deborah Collyar has been a patient engagement leader since her first cancer diagnosis in 1990. She founded the Patient Advocates in Research (PAIR) international network in 1996, "where research meets reality." Deborah infuses hundreds of patient advocates into research programs... Read More →
avatar for James Riddle

James Riddle

Vice President, Strategic Consulting, Advarra
James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular... Read More →
avatar for James Riddle

James Riddle

Vice President, Strategic Consulting, Advarra
James Riddle is the VP of Strategic Consulting for Advarra, where he employs his extensive experience managing large operations and technology teams in the human subject protection field to grow Advarra Consulting worldwide. Mr. Riddle is also a faculty member, mentor, and regular... Read More →


Tuesday June 25, 2019 4:15pm - 5:30pm
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Advanced
  • Featured Topics Patient Focused
  • Credit Type ACPE, CME, IACET, PMI, RN
  • Tags Forum

5:00pm

Community Meet Up: Medical Writing Community Meet and Greet
Component Type: Forum



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 →


Tuesday June 25, 2019 5:00pm - 6:00pm
Community Area 2 Sails San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

8:00am

#319: How to Solve the Problem of Access for Rare Diseases
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-663-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel will share learnings and build on outcomes from the recent Rare Access to Critical Therapies (ACT) Stakeholder Summit convened by Global Genes and the Child Neurology Foundation, two patient advocacy organizations which brought together more than 200 individuals representing key stakeholders in the rare disease drug development space to build awareness and understanding about access to and pricing of rare disease therapies.

Learning Objectives

Discuss critical access issues related to rare disease drug development; Describe lessons learned from recent experiences to improve communication and collaboration among stakeholders and ensure the patient and caregiver needs are truly understood, considered and incorporated into access and pricing decision-making.

Chair

Sissi Pham, PharmD

Speaker

Panelist
Kari Luther Rosbeck

Panelist
Nicole Boice

Panelist
Scott Demarest, MD

Panelist
Sarah Pitluck, MSc

Panelist
Sean Tunis, MD, MSc



Speakers
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 →
avatar for Kari Rosbeck

Kari Rosbeck

President and Chief Executive Officer, Tuberous Sclerosis Alliance
Kari joined the TS Alliance in June 2001 and became President and CEO in November 2007. Kari has been involved in nonprofit fundraising and volunteer management for nearly 30 years. During Kari’s tenure as President and CEO, the TS Alliance established a comprehensive research program... Read More →
avatar for Sarah Pitluck

Sarah Pitluck

Head, Global Pricing and Reimbursement, Spark Therapeutics
Ms. Pitluck is the Head of Global Pricing & Reimbursement (P&R) at Spark Therapeutics. In her current role, Ms. Pitluck priced the first FDA-approved gene therapy for a genetic disease, LUXTURNA®. She is now working to ensure market access for all US patients in need of LUXTURNA... Read More →
NB

Nicole Boice

Founder, Global Genes Project
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 →
ST

Sean Tunis

Senior Strategic Advisor, Center For Medical Technology Policy (CMPT)


Wednesday June 26, 2019 8:00am - 9:15am
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics Patient Focused,Rare Disease
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum