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 (Industry) 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 I (Industry) Level 201: The Intermediate Level continues the patient advocacy conversation through case studies and lectures on current and relevant topics. Available only to individuals who have attended the Introductory Industry track.

Track II (PAO) 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.

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.

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

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.

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.

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

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

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.

Track II Courses:

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

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.

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.

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

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.

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.

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

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

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.

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.
Katie Burns
Vice President
Smithsolve
Jean Campbell
Principal
JF Campbell Consultants
Mary Cobb
President & Founder
PatientVue
Gissoo Decotiis MBF
Head of Global Advocacy Oncology
Daiichi Sankyo
Jill Dolgin, PharmD
Executive Director, Global Head of Patient Advocacy
Applied Genetic Technologies Corp. AGTC
Britta Dornan MPA
Senior Director Public Relations & Patient Engagement
EveryLife Foundation
Patti Engel RN,BSN
President and CEO
Engage Health
Patrik Florencio
Senior Vice President, Global Chief Compliance & Risk Officer
Amicus Therapeutics
Ben Forred, MBA
Project Manager, Translational Research
Sanford Research
Jayne Gershkowitz
Chief Patient Advocate
Amicus Therapeutics
Polly Gill
Clinical Research Specialist CoRDS
Sanford Research
Meredith Grimm R.N.
Clinical Operations and Patient Advocacy Consultant
Stephen Groft PharmaD
Special Volunteer
NIH NCATS
Marlene Haffner MD, MPH
Principal & Founder
Haffner Associates
Barbara Handelin PhD
Founder
NovoKen
Maria Hardin
Senior Advisor
JF Campbell & Consultants
Nancy Harris
Principal
Harris Consulting
Sandra Heibel
Chief Scientific Officer
BioPharma Global, Inc.
Jennifer Helfer, PhD
Senior Director Patient Advocacy & Engagement, Alliance Development
Encoded Therapeutics
Lisa Kearns, MS, MA
Senior Research Associate
NYU School of Medicine, Division of Medical Ethics
Terri Klein
President and CEO
National MPS Society
David LaGreca, MBA
Principal
David LaGreca & Associates
David Lapidus
President
LapidusData
Robert Long
Executive Director
Uplifting Athletes
Alyssa Mendel
Clinical Research Specialist CoRDS
Sanford Research
Nita Patel, R.N.
Senior Director Professional & Patient Advocacy
Amicus Therapeutics
Douglas Paul, PharmaD
Partner & Vice President
Medical Marketing Economics (MME)
Michele Rhee, MPH
Vice President, Patient Affairs & Advocacy
x4 Pharma
Michelle Slattery
Principal
Slattery Health Communications
Chris Smith
President
SmithSolve
Robert Tomaino
Prinicpal
Orphan Communications
Jill Weimer, PhD
Senior Director, Therapeutic Research
Sanford Research
Barbara Wuebbels, R.N.
Board Chair & Co-Founder
Professional Patient Advocates in Life Sciences (PPALS)

Capstone Projects and Reflection Papers:

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  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 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.

It is important to realize that the Sanford/PPALS collaboration is not a traditional conference, but a course of study that ultimately leads to certification of the PPALS curriculum. Based on how PACT is structured and presented, participants should view the Sanford/PPALS PACT as being an ongoing curriculum that continues even after leaving Sioux Falls.

Participants of Track I (Industry), Level 101 (Introductory) will be encouraged to complete a Capstone project while participants of Track II (Patient Advocacy Organization), Level 101 (Introductory) will be encouraged to complete a Reflection Paper.

Participants of Tracks I and II, Level 201 (Intermediate) are encouraged to submit a Case Study for possible use in a future PACT.

While a Capstone project, Reflection Paper, or Case Study are not required for completion of the course, participation in this aspect of the curriculum bestows a certification.

More information on Capstone Projects and Reflection papers

2023 Sanford/PPALS Patient Advocacy Certificate Training (PACT) Information:

The 2023 Sanford/PPALS PACT will be held May 8th to 11th, in Sioux Falls, SD on the Sanford Research Institute’s campus. This is a one-of-a-kind opportunity to learn about the life sciences patient advocacy function which resides within the pharmaceutical and biotech industries as well as within closely affiliated life science entities.  For individuals leading patient advocacy organizations, PACT provides lectures on infrastructure and governance.

PACT is comprised of two Tracks, one for Industry and the other for Patient Advocacy Organizations (PAO) and two levels, Introductory and Intermediate. The Intermediate level for both Tracks is available only to individuals who have already attended the PACT Introductory level course. Seating is limited for each Track and Level to insure an intimate and educational conducive environment.

The May 8, 2023 evening event will be held at the ClubHouse Suites, Sioux Falls, SD.   The full PACT course, May 9 through 11, 2023, will be held on the Sanford Research Institute’s campus, Sioux Falls, SD.

Introductory Level: Available to individuals who are new to the PACT course:

  • Industry Introductory Track I (35 seats) provide individuals who work in a patient advocacy function within a company the opportunity to expand their knowledge on pertinent topics while enhancing their professional development. It also serves as an introduction for individuals who are considering a move into this unique and important career.
  • Patient Advocacy Organization (PAO) Introductory Track II (15 seats) offers senior leadership and board members of PAOs courses that can assist with insights on institutional growth and development.

Intermediate Level: Available only to individuals who have attended the Introductory Industry or PAO tracks (no exceptions):

  • Industry Intermediate Track I (35 seats) The Intermediate Level continues the patient advocacy conversation through case studies and lectures on current and relevant topics.

Basic Schedule:

Monday May 8, 2023                   Welcome reception 6:00 pm (ClubHouse Suites)

Tuesday May 9, 2023                   Day 1 8:00am to 5:00 pm (Sanford campus)

Wednesday May 10, 2023             Day 2 8:00 am to 5:00 pm (Sanford campus)

Thursday May 11, 2023                 Day 3 8:00 am to 3:00 pm (Sanford campus)

The Registration fee includes educational materials, daily shuttle bus from the ClubHouse Suites to the Sanford campus, welcome reception, 1 group dinner, 3 lunches and 6 refreshment breaks

The Sanford/PPALS PACT is supported by registration fees; there are no sponsors or exhibitors in attendance

Date: May 8-11, 2023
Sanford Research Institute, Sioux Falls, SD.

COVID-19 policy:

The 2023 Sanford/PPALS PACT course will primarily take place at the Sanford Research Institute campus. Their COVID-19 policy is as follows:

It is expected that attendees will have received the full course of COVID-19 vaccinations, but will not be required to provide proof in order to be on site. There will be no requirement to prove vaccination status. Individuals who have not been vaccinated will be expected to wear a mask.

There is no mask requirement when people are in non-clinical areas. The PPALS event will take place completely outside of the hospital setting, so attendees will not be required to mask.

Lodging and Travel:
Hotel: We recommend reserving a room 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