Medical Writing Performance Optimization

November 12-13, 2020

Online Livestream

Event Overview

Seasoned professionals will align the most effective medical writing strategies for regulatory submissions, publication planning and research documentation and discuss effective ways to improve the quality of submissions. Learn effective communication strategies to build a successful medical writing team, an essential part of the success of any project. This Medical Writing conference will teach you the skills to create structured content while writing under extreme pressure.

This event will explore regulatory and publications from the top industry experts and discuss digital medical writing tools. Leverage your knowledge of publishing to demonstrate value and build customer loyalty. Take an in-depth look to improve medical writing methods to meet the deadline-driven environment and discover new insight into best practices.

Join the only Medical Writing conference that gives you the most exposure time in front of subject matter experts and top decision-makers who are looking for solutions to improve capabilities that support medical writing!

Hilton East Brunswick


3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

About the Chairperson


Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

Featured Speakers


Craig Lipset

Head of Clinical Innovation


Jeff Kingsley

Chief Executive Officer
IACT Health 


Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice


Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Why Attend?

  1. Meet with subject matter experts and top decision makers who are looking for solutions to improve capabilities that support medical writing
  2. Examine best practices in medical writing
  3. Hear how to build and work effectively with your medical writing team
  4. Learn how to cope with the pressure of medical writing deadlines
  5. Implement mobile learning development and technologies in medical writing

Attendee Profile

You will benefit from attending this event if you are a at a Pharmaceutical, Biotech or Medical Device company, with responsibility in the following areas:

  • Medical Writing
  • Regulatory Writing
  • Regulatory Affairs
  • Publications
  • Regulatory Operations
  • Career Development
  • Freelance
  • Medical Communications
  • Technical Writing
  • Clinical Research
  • Scientific Informations
  • Electronic Submissions
  • Medical Affairs
  • Clinical Communications and Documentation
  • Clinical Publishing
  • Medical Affairs
  • Submissions and Documentation
  • Global Medical Publishing

This conference is also of interest to companies and vendors offering medical writing support from the following areas:

  • Medical Writing Service Providers
  • Regulatory Submissions Providers
  • Clinical Research Organizations
  • Document Application Suppliers
  • Consultants
  • Component Authoring Software Suppliers
  • Publication Service Providers
  • Bibliographic Software Suppliers
  • eCTD Suppliers
  • Structured Content Software Suppliers


November 12th, 2020 | Day 1

8:00 AM - 9:00 AM EST

Registration @ Log-In

9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Best Practices in Medical Writing – Writing and Beyond

  • Establishing a clear line of communication
  • Set manageable expectations with your team

Oanh Stephan - Director of Medical Writing

10:00 AM - 10:45 AM

Build Plain Language Techniques and Skills for Every Medical Writer

  • Emphasize concise writing
  • Effectively cater to your audience
  • Prepare for both simple and detailed documentation

Lisa Brodeur - Technical Writing Team Lead
Baylis Medical Company

Sylvia Baedorf Kassis - Program Manager
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

10:45 AM - 11:00 AM


11:00 AM - 11:45 AM

Clinical Trial Transparency Across the Spectrum of Clinical Development

  • Introduce/refresh attendees on the multiple complex guidances and regulations governing clinical trial transparency
  • Identify key points in the life cycle of a study/clinical program where transparency requirements apply
  • Building capabilities for transparency within your organization

Kelley Hill - Senior Director, Global Medical Writing

11:45 AM - 12:30 PM

Target the Appropriate Audiences in a Patient-Centric Manner

  • Design your research to answer questions that are directed to your audience
  • Clearly articulate your message for patients
  • Implement constant awareness of the reader

Soheil Chavoshi - Executive Director, Scientific Communications & Medical Information
Acadia Pharmaceuticals

Behtash Bahador MS - Associate Director, Relationship Management and Development
Center for Information and Study on Clinical Research Participation (CISCRP)

12:30 PM - 1:00 PM


1:00 PM - 1:45 PM

Discuss Tips, Tricks, and Expectations When Applying for Your Next Position

  • Learn how to stand out amongst every applicant
  • Prioritize the best tools that all medical writers should know when looking for their next job
  • How to let others know your services meet their needs 

Sheetal Patel MD MS - Medical Director, US Medical Affairs
Lundbeck Pharmaceuticals 

Karen Young, PhD, MS - Medical Writer
Lundbeck Pharmaceuticals

1:45 PM - 2:00 PM


2:00 PM - 2:45 PM

“Prove It, Improve It, and Enhance It”: Fair Balance in Medical Communications

  • Appreciate the importance of fair balance, which will identify you as a more ethical researcher and your writing as more acceptable to journals
  • Take a case study approach, understand potential defects in study design and a failure to consider alternative conclusions from reported data
  • Participate in interactive exercises to detect “unfair imbalance” more effectively, including two major sources of error: statistical and human

Stephen Gutkin - Director, Scientific Publication Writing
Ascentage Pharma


November 13th, 2020 | Day 2

8:40 AM - 9:00 AM

Log-In & Networking

9:00 AM - 10:00 AM

Build an Effective Working Culture with your Medical Writing Team

  • Address real challenges while collaborating with your team
  • Rebuild teamwork methodologies around working remotely
  • Instill strategies for updating, marking up and commenting in parallel with your team
  • Receive stakeholders' input and approvals while maintaining the project schedule

Kelley Hill - Senior Director, Global Medical Writing

Oanh Stephan - Director of Medical Writing

Lisa Brodeur - Senior Technical Writer
Baylis Medical Company

Lingjie Guan - Regulatory Documentation Senior Scientist

10:00 AM - 10:45 AM

Unlocking the Key to Internal Alignment between Regulatory Documents and Publications

  • Discuss the gap in the standard practice of aligning the publication plan with regulatory filings
  • Analyze critical precautions to confirm the validity of the presented data
  • New regulations that affect the publications process- EU policy 70, disclosures, lay summaries
  • Find out the key difference in regulatory and publications documents

Sulochana Gawande - Executive Director, Medical Writing
Karyopharm Therapeutics

10:45 AM - 11:00 AM

Morning Break

11:00 AM - 11:45 AM

Ethical Choices in Medical Writing

  • Updates and guidelines COPE, GPP3, ICMJE, and Equator
  • When lines get blurry - how to approach difficult situations with integrity

Tatyana Wanderer - Sr. Director, Medical Writing
Syros Pharmaceuticals

11:45 AM - 12:30 PM

Deploy the Latest Technologies to Improve Efficiency

  • Overcome the skepticism of AI integrations in medical writing
  • Grasp practical applications and look ahead to future development
  • Assess hybrid approaches for structuring documentation

Vishal Soni - Executive, Regulatory and Scientific MW
Virid Biosciences

12:30 PM - 12:45 PM


12:45 PM - 1:30 PM

Impose Ethical Standards on Medical Publications

  • Discuss updates and guidelines COPE, GPP3, ICMJE and Equator
  • Avoid falsification of data, misappropriation of the ideas of others and improper assignment of credit to ensure ethical standards are met
  • Prevent plagiarism and self-plagiarism in your publications

1:30 PM - 2:15 PM

Communicate Clearly and Accurately to Navigate Medical Writing Deadlines

  • Learn how to enhance your content and execute formatting
  • Apply proper systems when handling delayed timelines
  • Internalize communication techniques that will guide you through working remotely

Indira Subramanian - Global Medical Publications

Yue Liu - Associate Director, Oncology Publications, Global Scientific and Medical Publications



Oanh Stephan


Director of Medical Writing


Soheil Chavoshi

Acadia Pharmaceuticals

Executive Director, Scientific Communications & Medical Information


Deepti Sanghavi

Virid Biosciences

Sr Manager, Medical Writing


Kelley Hill


Executive Director, Global Medical Writing, Trial Transparency, and Disclosure


Christopher Michael


GCP Archivist


Vishal Soni

Virid Biosciences

Executive, Regulatory and Scientific MW


Sheetal Patel

Lundbeck Pharmaceuticals

Medical Director, US Medical Affairs


Lisa Brodeur

Baylis Medical Company

Technical Writing Team Lead


Karen Young

Lundbeck Pharmaceuticals

Medical Writer


Yue Liu

Merck & Co., Inc.

Associate Director, Oncology Publications, Global Scientific and Medical Publications


Indira Subramanian

Regeneron Pharmaceuticals

Associate Director, Publications Management, Medical Affairs


Sylvia Baedorf Kassis

Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

Program Manager


Behtash Bahador

Center for Information and Study on Clinical Research Participation (CISCRP)

Associate Director, Relationship Management and Development


Lingjie Guan


Regulatory Documentation Senior Scientist


Sulochana Gawande

Karyopharm Therapeutics

Executive Director, Medical Writing


Stephen W. Gutkin

Ascentage Pharma

Director, Scientific Publication Writing


Tatyana Wanderer


Sr. Director, Medical Writing



Medical Writing Performance Optimization

Single Event


Medical Writing + MedComm 3.0

Both Events


Register 2 Attendees, Get 1 Complimentary Registration*!

Interested in sending groups of 7 or more? Contact us directly for pricing.


Scarritt Group - Official Livestream Partner



Contact Amy Chapman at (561) 571-7687


PM360 - Media Partner