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Agenda

A Forum for Emerging and Innovative Pharma, Biotech, Device and Diagnostic Companies

October 17-18, 2018
  • San Francisco, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, OCTOBER 17, 2018

7:30

Pre-Conference Summit Registration and Continental Breakfast

8:30

PRE-CONFERENCE SUMMIT

Compliant Patient Support Summit — How Does Your Program Stack Up to Effectiveness Benchmarks

Summit Objective:

As scrutiny continues to increase surrounding patient support programs, it is critical that compliance functions are taking action to mitigate risk associated with Patient Assistance Programs (PAPs), reimbursement hub services, nurse educator programs, coupon and copay programs and foundation support. This summit explores patient services compliance challenges to equip attendees with practical solutions to move toward a compliant framework in light of evolving regulations.

8:30

Summit Chair’s Welcome and Opening Remarks

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

8:45

Ensure Compliant Reimbursement Hub Services to Enhance Patient Access

Amy Greenstein
Manager
Polaris Management Partners

9:30

Update on PAPs, Foundation Support, Coupons and Copay Programs

Nicole Serena
Director, PSP Consulting Services, Matrix Healthcare Strategists;
Ex Director, Patient Access, Bayer Inc, Canada

10:15

Networking and Refreshment Break

10:45

Compliant Oversight and Management of Nurse Educator Programs

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

11:45

Summit Chair’s Closing Remarks

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

12:00

Close of Summit

12:00

Main Conference Registration and Lunch for Pre-Summit Workshop Attendees

1:00

Chairman’s Welcome and Opening Remarks

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

1:15

CCO KEYNOTE PANEL Collaborate with Critical Stakeholders to Navigate the Evolving Healthcare Landscape

MODERATOR:

John Kelly
Member and Managing Partner, Bass Berry & Sims;
Former Assistant Chief, Health Care Fraud, U.S. Department of Justice

PANELISTS:

Averi Price
Vice President, Chief Compliance Officer
Radius Health

M. Fabiana Lacerca-Allen
President, Ethiprax;
Former SVP & Chief Compliance Officer, Elan Pharmaceuticals

2:15

ENFORCEMENT PANEL Fraud and Enforcement Trends — Current and Former Prosecutor Perspectives

MODERATOR:

Ernie Hernandez
Senior Director, Healthcare Compliance Officer
Adamas Pharmaceuticals

PANELISTS:

Chinhayi Coleman Cadet
Assistant U.S. Attorney, Northern District of California
U.S. Attorney’s Office

Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office for the District of New Jersey

John Kelly
Member and Managing Partner, Bass Berry & Sims;
Former Assistant Chief, Health Care Fraud, U.S. Department of Justice

Robert Marasco
Partner, Dinsmore & Shohl LLP;
Former Assistant U.S. Attorney, District of NJ and Southern District of CA

3:30

Networking and Refreshment Break

4:00

Calibrate Your Compliance Training: A Practical Framework

Daniel O’Connor
Senior Vice President
PharmaCertify™

Jeremy Lutsky
Senior Legal & Compliance Counsel
Theravance Biopharma US

4:45

ROUNDTABLE DISCUSSION Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)

Chrissy Bradshaw
Principal
Porzio, Bromberg & Newman, P.C.

James Schneider
Associate Director, Legal Healthcare Compliance
Seattle Genetics

Brian Segobiano, CIPP/E
Associate Director, Governance, Risk & Compliance
Navigant

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO THURSDAY, OCTOBER 18, 2018

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

8:45

Build a Strategic Approach to Risk Identification, Monitoring and Auditing

MODERATOR:

Chrissy Bradshaw
Principal
Porzio, Bromberg & Newman, P.C.

PANELISTS:

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

Jeremy Lutsky
Senior Legal & Compliance Counsel
Theravance Biopharma US

Ernie Hernandez
Senior Director, Healthcare Compliance Officer
Adamas Pharmaceuticals

9:30

Monitoring and Auditing Spotlight —
Ride-Alongs, Speaker Programs, Donations and Grants

Graham Rich
Manager
Potomac River Partners

Jonathan Wilkenfeld
President
Potomac River Partners

10:15

INTERACTIVE EXCHANGE Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned

MODERATOR:

Gary C. Messplay
Partner, FDA and Life Sciences
King & Spalding

CONVERSATION CONTRIBUTORS:

Ishita Arora
Compliance Manager
Horizon Pharmaceuticals

Danielle Davis
Director, Compliance
Insys Therapeutics, Inc.

Eric Jen
Associate Director, Compliance
Heron Therapeutics, Inc.

Jenny Shire
Associate Director, Travel and Professional Programs
Daiichi Sankyo, Inc

11:00

Networking and Refreshment Break

11:30

CHOOSE BETWEEN TWO MASTER CLASSES (A-B)

A. Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication

Sharon Delshad
Director, Compliance and Legal Affairs
Nalpropion Pharmaceuticals, Inc.

Gary C. Messplay
Partner, FDA and Life Sciences
King & Spalding

 
B. Navigate Third-Party Relationships and Outsourcing Arrangements

Richard J. Ciamacca
Vice President, Secretary and General Counsel
Amring Pharmaceuticals

12:15

Networking Luncheon

CALIBRATE TO YOUR ORGANIZATION’S SIZE — COMPLIANCE PROGRAM BENCHMARKING BASED ON COMPANY RESOURCES

1:15

How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy

Sharon Delshad
Director, Compliance and Legal Affairs
Nalpropion Pharmaceuticals, Inc.

1:45

Managed Markets Compliance — Mitigate Risks in Relationships with Payers

Becky Hsiao
Senior Legal Manager, Americas Region, Diabetes Group
Medtronic

2:15

Collaborate with Medical Affairs and Elevate MSL Oversight

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

3:00

Close of Conference and Chairman’s Closing Remarks

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, OCTOBER 17, 2018

7:30

Pre-Conference Summit Registration and Continental Breakfast

8:30

PRE-CONFERENCE SUMMIT

Compliant Patient Support Summit — How Does Your Program Stack Up to Effectiveness Benchmarks

Summit Objective:

As scrutiny continues to increase surrounding patient support programs, it is critical that compliance functions are taking action to mitigate risk associated with Patient Assistance Programs (PAPs), reimbursement hub services, nurse educator programs, coupon and copay programs and foundation support. This summit explores patient services compliance challenges to equip attendees with practical solutions to move toward a compliant framework in light of evolving regulations.

8:30

Summit Chair’s Welcome and Opening Remarks

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

8:45

Ensure Compliant Reimbursement Hub Services to Enhance Patient Access

Amy Greenstein
Manager
Polaris Management Partners

9:30

Update on PAPs, Foundation Support, Coupons and Copay Programs

Nicole Serena
Director, PSP Consulting Services, Matrix Healthcare Strategists;
Ex Director, Patient Access, Bayer Inc, Canada

10:15

Networking and Refreshment Break

10:45

Compliant Oversight and Management of Nurse Educator Programs

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

11:45

Summit Chair’s Closing Remarks

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

12:00

Close of Summit

12:00

Main Conference Registration and Lunch for Pre-Summit Workshop Attendees

1:00

Chairman’s Welcome and Opening Remarks

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

1:15

CCO KEYNOTE PANEL Collaborate with Critical Stakeholders to Navigate the Evolving Healthcare Landscape

MODERATOR:

John Kelly
Member and Managing Partner, Bass Berry & Sims;
Former Assistant Chief, Health Care Fraud, U.S. Department of Justice

PANELISTS:

Averi Price
Vice President, Chief Compliance Officer
Radius Health

M. Fabiana Lacerca-Allen
President, Ethiprax;
Former SVP & Chief Compliance Officer, Elan Pharmaceuticals

2:15

ENFORCEMENT PANEL Fraud and Enforcement Trends — Current and Former Prosecutor Perspectives

MODERATOR:

Ernie Hernandez
Senior Director, Healthcare Compliance Officer
Adamas Pharmaceuticals

PANELISTS:

Chinhayi Coleman Cadet
Assistant U.S. Attorney, Northern District of California
U.S. Attorney’s Office

Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office for the District of New Jersey

John Kelly
Member and Managing Partner, Bass Berry & Sims;
Former Assistant Chief, Health Care Fraud, U.S. Department of Justice

Robert Marasco
Partner, Dinsmore & Shohl LLP;
Former Assistant U.S. Attorney, District of NJ and Southern District of CA

3:30

Networking and Refreshment Break

4:00

Calibrate Your Compliance Training: A Practical Framework

Daniel O’Connor
Senior Vice President
PharmaCertify™

Jeremy Lutsky
Senior Legal & Compliance Counsel
Theravance Biopharma US

4:45

ROUNDTABLE DISCUSSION Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)

Chrissy Bradshaw
Principal
Porzio, Bromberg & Newman, P.C.

James Schneider
Associate Director, Legal Healthcare Compliance
Seattle Genetics

Brian Segobiano, CIPP/E
Associate Director, Governance, Risk & Compliance
Navigant

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO THURSDAY, OCTOBER 18, 2018

8:00

Continental Breakfast

8:30

Chairman’s Review of Day One

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

8:45

Build a Strategic Approach to Risk Identification, Monitoring and Auditing

MODERATOR:

Chrissy Bradshaw
Principal
Porzio, Bromberg & Newman, P.C.

PANELISTS:

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

Jeremy Lutsky
Senior Legal & Compliance Counsel
Theravance Biopharma US

Ernie Hernandez
Senior Director, Healthcare Compliance Officer
Adamas Pharmaceuticals

9:30

Monitoring and Auditing Spotlight —
Ride-Alongs, Speaker Programs, Donations and Grants

Graham Rich
Manager
Potomac River Partners

Jonathan Wilkenfeld
President
Potomac River Partners

10:15

INTERACTIVE EXCHANGE Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned

MODERATOR:

Gary C. Messplay
Partner, FDA and Life Sciences
King & Spalding

CONVERSATION CONTRIBUTORS:

Ishita Arora
Compliance Manager
Horizon Pharmaceuticals

Danielle Davis
Director, Compliance
Insys Therapeutics, Inc.

Eric Jen
Associate Director, Compliance
Heron Therapeutics, Inc.

Jenny Shire
Associate Director, Travel and Professional Programs
Daiichi Sankyo, Inc

11:00

Networking and Refreshment Break

11:30

CHOOSE BETWEEN TWO MASTER CLASSES (A-B)

A. Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication

Sharon Delshad
Director, Compliance and Legal Affairs
Nalpropion Pharmaceuticals, Inc.

Gary C. Messplay
Partner, FDA and Life Sciences
King & Spalding

 
B. Navigate Third-Party Relationships and Outsourcing Arrangements

Richard J. Ciamacca
Vice President, Secretary and General Counsel
Amring Pharmaceuticals

12:15

Networking Luncheon

CALIBRATE TO YOUR ORGANIZATION’S SIZE — COMPLIANCE PROGRAM BENCHMARKING BASED ON COMPANY RESOURCES

1:15

How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy

Sharon Delshad
Director, Compliance and Legal Affairs
Nalpropion Pharmaceuticals, Inc.

1:45

Managed Markets Compliance — Mitigate Risks in Relationships with Payers

Becky Hsiao
Senior Legal Manager, Americas Region, Diabetes Group
Medtronic

2:15

Collaborate with Medical Affairs and Elevate MSL Oversight

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

3:00

Close of Conference and Chairman’s Closing Remarks

Gregory S. Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.