Patient Advocacy Certificate Training (PACT)

Overview:

Professional Patient Advocates in Life Sciences (PPALS), in conjunction with Sanford Research Institute, created the Patient Advocacy Certificate Training (PACT) course of study for health and life science professionals and leaders of patient advocacy organizations to enhance their professional development. This specially designed curriculum focuses on increasing the competencies and expertise of patient advocates in the life sciences and assisting PAO senior leadership and board members to work on their governance and infrastructure skills.

This two-track program has been created to provide valuable training from a faculty who are recognized as experts in their respective fields of patient advocacy, drug development, scientific and medical research, communications, regulatory/compliance topics, non-profit governance and public policy.

Track I (Level 101): For individuals who work in the patient advocacy and life sciences area in the biotech/pharma or related industries. Individuals who wish to learn more about the patient advocacy function are encouraged to attend as well. Track I participants are encouraged to research, design, and implement a Capstone Project based on their professional development.

Track II (Level 101): For individuals in a senior management capacity or a member of the Board of Directors for a non-profit health patient advocacy organization. Track II participants may complete a Reflection paper based on their PACT experience.

Curriculum Content

General Session Courses: for Tracks I & II

General Session lectures may vary slightly depending on faculty’s availability.

CoRDS Registry: Everything You Wanted (and Should) Know: An important lecture that provides a better understanding of how the CoRDs Registry operates and benefits the rare disease community.

Drug Development: An Overview: Discussion surrounding what is involved with and who are the stakeholders throughout the drug development process. Topics included in this lecture are the challenges of developing a drug, helpful resources, regulatory requirements, development strategies, the Orphan Drug Act (ODA), 21st Century Cures, and the differences between the FDA and the EMA.

Drug Development and Patient Advocacy Groups: A current topic of conversation, this lecture reiterates the importance of including the patient voice in the Clinical Trial Process. Topics covered may include Patient Reported Outcomes, natural history studies, focus groups, registries, biobanks, and protocol review.

History of Patient Advocacy and Rare Disease Community: Discussion on the evolving role of patient advocacy in the pharmaceutical industry company which includes the identification of major societal, policy and legislative influences that have contributed to its changing role.

Sanford: Who We Are; What We Do: This lecture is an introduction to Sanford Research Institute’s research programs, resources and services provided to the rare disease community.

Track I Courses:

Building Your Patient Advocacy Function (Lectures 1 & 2): This 2 part lecture identifies the steps needed to build a viable patient advocacy function by discussing these important topics company goals, roles and responsibilities, overall plan, garnering internal support and more. Faculty: Jill Dolgin

Understanding the Best Practices and Challenges of Interacting with the Non-Profit Sector: Lecture reviews the important aspects of how to interact ethically and responsibly with non-profit organizations. Faculty: Jean Campbell

Telling Your Patient Advocacy Story: This lecture discusses the best practices involved with how to develop a responsible and effective patient advocacy communication plan. Faculty: Chris Smith

The Four-Legged Table Relationship between Industry, Academia, Patient Groups & Regulatory Agencies: This course explains the relationship needed between patients, industry, academia and regulatory agencies to move drug development programs forward as well as how to identify key goals each group must achieve to be successful in getting a seat at the table. Faculty: Jayne Gershkowitz, Barbara Wedehase, Barbara Wuebbels and TBD

Public Policy: What is the Role of Industry in Public Policy? Lecture addresses how the Patient Advocacy function can interact with and engage with their public policy colleagues. Faculty: Diane Dorman

Patient Advisory Boards: Guidance provided on what they are, what is their function and best practices on establishing them. Faculty: Jayne Gershkowitz and Barbara Wuebbels

The ROI of Patient Advocacy: An important discussion regarding the ever present topic of Patient Advocacy’s Return on Investment for a company. Faculty: Nita Patel

How to Best Approach Vendor Selection: Best practices on how to evaluate, hire and manage third party vendors to assist with various internal and external patient advocacy projects and programs. Faculty: Patti Engel

Track II Courses:

Communication for Patient Advocacy Organizations: Common sense approaches to developing a solid plan for communicating with the patient community. Faculty: Frieda Hernandez

Maintaining a Patient Advocacy Organization: An Annual Check-up: Discussion of governance and board best practices needed to manage a responsible and effective patient advocacy organization. Faculty: David LaGreca

Introduction to Rare Disease Public Policy: Providing an understanding of how a Patient Advocacy Organization can participate in legislative matters and encourage its community to do so. Offers an explanation of the alphabet soup of government acronyms and important health legislation. Faculty: Diane Dorman

Working with Industry: Discover the best practices of how to engage in an appropriate and transparent relationship with companies. Faculty: Barbara Wedehase

Reimbursement and Access to Drugs: Receive a better understanding of how individuals can utilize Patient Assistance Programs, Medicare and Medicaid programs to improve their ability to get and afford medications. Faculty: Maria Hardin

Understanding the Clinical Trial Process: Provide PAOs the tools to share with their respective communities what is involved with a clinical trial and the importance of considering to be a participant. Faculty: Barbara Handelin

Public Policy on State and Local Levels: Gain the understanding of the importance of building state and local legislative relationships. Faculty: Meg Leal

CoRDS Registry for PAOs: Discover the nuts and bolts along with the value of bringing a CoRDs registry to your patient community. Faculty: Austin Letcher

Building and Sustaining Non-Profit Relationships: Understanding the need to foster and keep ties with individuals, community, healthcare professionals and other entities that can enhance the mission and vision of a non-profit. Faculty: David LaGreca and Nancy Harris

PACT’s Distinguished Faculty:
Our faculty is comprised of well-respected and recognized individuals who are considered experts in their respective fields. They bring a wealth of knowledge to each of their lectures based on their experiences and fortes. Our faculty may vary from year to year depending on their availability however the content of these lectures remains constant.
Max Bronstein
Senior Director
Health Policy & Corporate Affairs at Audentes Therapeutics
(2016)
Jean Campbell
Principal
JF Campbell Consultants
(2016, 2017, 2018)
Archane Chatterjee, MD
Head of Pediatrics
University of South Dakota Sanford School of Medicine
(2016)
Gissoo Decotiis
Deputy Director
Oncology Advocacy Relations, Bayer Healthcare
(2016)
Jill Dolgin, PharmD
Head of Patient Advocacy
AGTC
(2016, 2018)
Diane Dorman
Principal
DD Consulting
(2016, 2017, 2018)
Patti Engel
President
Engage Health
(2016, 2017, 2018)
Margie Frazier
Executive Director
Batten Disease Support and Research Association
(2016)
Jayne Gershkowitz
Senior Vice President & Chief Patient Advocate
Amicus Therapeutics
(2016, 2017, 2018)
Stephen Groft, PharmD
Senior Advisor to the Director
NCATS, NIH
(2016)
Marlene Haffner, MD
Principal & Founder
Orphan Solutions & Haffner Associates, LLC
(2016)
Barbara Handelin, PhD
Founder & CEO
NovoKen
(2016, 2018)
Maria Hardin
Senior Advisor
JF Campbell Consultants
(2016, 2017, 2018)
Sandi Heibel, PhD
Chief Science Officer
BioPharma Global & Senior Consultant, Haffner Associates, LLC
(2017)
Frieda Hernandez
Vice President Business Development
Continuum Clinical
(2016, 2017, 2018)
David LaGreca
Principal
David LaGreca & Associates
(2016, 2017, 2018)
Austin Letcher
Senior Research Associate
Coordination of Rare Diseases, Sanford Research
(2017, 2018)
Meg Leal, Esq.
President
MWL Consulting
(2016, 2017, 2018)
Nita Patel, RN
Director, Professional & Patient Advocacy
Amicus Therapeutics
(2016, 2017, 2018)
David Pearce, PhD
Executive Vice President
Innovation & Research, Sanford Health
(2016, 2017, 2018)
Chris Smith
President
SmithSolve LLC
(2016, 2017, 2018)
Robert Tomaino
Medical Editor
Orphan Communications
(2016, 2017, 2018)
Barbara Wedehase, MSW
Principal
BAW Consulting
(2016, 2017, 2018)
Barbara Wuebbels, RN
Board Chair & Co-Founder
Professional Patient Advocates in Life Sciences (PPALS)
(2016, 2017, 2018)

Capstone Projects and Reflection Papers:

Capstone Project: During the PACT course, participants in Track I will be paired with a mentor, to be selected from the faculty who are teaching the workshops. Participants and mentors will determine a topic and a time frame for completion of the project. After the conference, the mentor will guide, support and assist the participant in researching, implementing and writing about his/her Capstone Project. The Capstone Project should be completed within a year and will undergo a review of relevancy and value to the Patient Advocacy function.

The Capstone Project is based on a real-life problem or issue related to the participant’s professional work in Patient Advocacy and should provide application of skills and knowledge learned in the PPALS Professional Patient Advocacy Program as a foundation.

2018 Sanford/PPALS Patient Advocacy Certificate Training (PACT) Information:

Date: May 9-11, 2018
Sanford Research Institute, Sioux Falls, SD.
Deadline for course registration is Friday, May 4, 2018.

  • May 9, 2018: 6:00 pm: Evening Reception and Opening Session for Tracks I & II at Club House Hotel & Suites (2320 S. Louise Avenue, Sioux Falls, SD 57106)
  • May 10, 2018: 8:30 am to 5:30 pm: General sessions; Track I & II workshops at Sanford Research Institute (2301 E 60th Street North, Sioux Falls, SD)
  • May 11, 2018: 8:30 am to 4:30 pm: General sessions; Track I & II workshops at Sanford Research Institute (2301 E 60th Street North, Sioux Falls, SD)

*New for 2018! A pre-PACT Journalism Workshop will be offered on May 9, 2018 from 1 pm to 5 pm by CheckOrphan for Track II attendees only. Registrants for Track II course will be automatically enrolled in this course at no extra cost. The journalism workshop will be held at the ClubHouse Hotel & Suites. Please contact Rob Derham at robert.derham@checkorphan.org for additional information.

Lodging and Travel:
Hotel: We recommend reserving a room as soon as possible as currently we do not have a room block at the Club House Hotel and Suites, 2323 S Louise Avenue, Sioux Falls, SD 57106. Please call 1-800-CLUBINN; or 1-605-361-8700 to make your room reservations. Please inform hotel that you are reserving a room to attend the Sanford/PPALS PACT course.

Travel: Sioux Falls is serviced by Sioux Falls Regional Airport, Joe Foss Field