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Agenda

Best Practices and Breakthrough Strategies for High-Value Opportunity

March 26-27, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Tuesday, March 26, 2019

7:30

Registration and Continental Breakfast

8:00

Chairperson’s Opening Remarks

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

Advancements and Regulations Expanding the Complex Generics Marketplace

8:45

REGULATORY SPOTLIGHT FDA Guidance and Policy Development Aimed at Increasing Patient Access to High-Quality Generics

Brian McCormick
Vice President, Chief Regulatory Counsel
Teva Pharmaceuticals

9:45

Navigate the Market Dynamics and Clinical Considerations of the Complex Generics Landscape

Jason J. Braithwaite, PharmD, MS, BCPS
Senior Director, Clinical Pharmacy Services, HealthTrust;
Director, PGY-2 Residency Program, University of Tennessee College of Pharmacy

10:30

Networking and Refreshment Break

11:00

Health Economics of Complex Generics —
A Look at Efficiency, Value and Outcomes

Joseph Fuhr
Professor
Widener University

12:00

Networking Luncheon

The Complex Generic Drug Product (CGDP) Regulatory and Development Toolkit

1:15

Examine the Considerations in Demonstrating Complex API Sameness

Aloka Srinivasan
Vice President, Regulatory Practice
Lachman Consultant Services

2:15

Best Practices for CGDPs with a Locally-Acting Route of Delivery

Lakshmi Raghavan
Founder and President
Solaris Pharma Corporation

3:00

Networking and Refreshment Break

3:30

Leading Frameworks for In Vitro and Human Studies for
Transdermal and Dermal Semisolids

Audra Stinchcomb
Professor, University of Maryland, Baltimore (UMB);
Chief Scientific Officer and Founder, F6 Pharma

4:15

Key Concepts for CGDPs with Drug and Device Constituents —
Orally Inhaled and Nasal Drug Products (OINDPs

Guenther Hochhaus
Professor, College of Pharmacy
University of Florida

5:00

Close of Day One

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

DAY TWO Wednesday, March 27, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

Strategies for Operationalizing Your
CGDP Development Plan

8:45

An Inside Look at the Pre-ANDA Program for CGDPs

Janis Picurro
Principal Consultant
Lachman Consultant Services

9:30

Best Practices for Transitioning from Small Molecule Simple Generics to Complex Generics

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

10:15

Networking and Refreshment Break

Bringing Your CGDP from
Laboratory to Market

10:45

Commercial Considerations and Portfolio Strategy for Complex Generics

Speaker TBA

11:30

The Future of Complex Generics — Possibilities, Realities and Outcomes

Speaker TBA

12:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE Tuesday, March 26, 2019

7:30

Registration and Continental Breakfast

8:00

Chairperson’s Opening Remarks

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

Advancements and Regulations Expanding the Complex Generics Marketplace

8:45

REGULATORY SPOTLIGHT FDA Guidance and Policy Development Aimed at Increasing Patient Access to High-Quality Generics

Brian McCormick
Vice President, Chief Regulatory Counsel
Teva Pharmaceuticals

9:45

Navigate the Market Dynamics and Clinical Considerations of the Complex Generics Landscape

Jason J. Braithwaite, PharmD, MS, BCPS
Senior Director, Clinical Pharmacy Services, HealthTrust;
Director, PGY-2 Residency Program, University of Tennessee College of Pharmacy

10:30

Networking and Refreshment Break

11:00

Health Economics of Complex Generics —
A Look at Efficiency, Value and Outcomes

Joseph Fuhr
Professor
Widener University

12:00

Networking Luncheon

The Complex Generic Drug Product (CGDP) Regulatory and Development Toolkit

1:15

Examine the Considerations in Demonstrating Complex API Sameness

Aloka Srinivasan
Vice President, Regulatory Practice
Lachman Consultant Services

2:15

Best Practices for CGDPs with a Locally-Acting Route of Delivery

Lakshmi Raghavan
Founder and President
Solaris Pharma Corporation

3:00

Networking and Refreshment Break

3:30

Leading Frameworks for In Vitro and Human Studies for
Transdermal and Dermal Semisolids

Audra Stinchcomb
Professor, University of Maryland, Baltimore (UMB);
Chief Scientific Officer and Founder, F6 Pharma

4:15

Key Concepts for CGDPs with Drug and Device Constituents —
Orally Inhaled and Nasal Drug Products (OINDPs

Guenther Hochhaus
Professor, College of Pharmacy
University of Florida

5:00

Close of Day One

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

DAY TWO Wednesday, March 27, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

Strategies for Operationalizing Your
CGDP Development Plan

8:45

An Inside Look at the Pre-ANDA Program for CGDPs

Janis Picurro
Principal Consultant
Lachman Consultant Services

9:30

Best Practices for Transitioning from Small Molecule Simple Generics to Complex Generics

Berangere Tissot
General Manager – West Chester
SGS Life Sciences

10:15

Networking and Refreshment Break

Bringing Your CGDP from
Laboratory to Market

10:45

Commercial Considerations and Portfolio Strategy for Complex Generics

Speaker TBA

11:30

The Future of Complex Generics — Possibilities, Realities and Outcomes

Speaker TBA

12:15

Close of Conference