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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

8:30

Chairperson’s Opening Remarks

Joseph Fuhr
Professor
Widener University

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

Mark Walsh, PhamD, BCPS
Director, Clinical Pharmacy Strategy
HealthTrust

10:45

Networking and Refreshment Break

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

11:15

Demonstrating the “Sameness” of Complex APIs in Generics — Challenges Under Current Regulatory Framework

Aloka Srinivasan
Vice President, Regulatory Practice
Lachman Consultant Services

12:15

Networking Luncheon

1:30

Leading Frameworks for In Vitro and Human Studies for Evaluation of Heat Effect on Transdermal and Dermal Products

Sherin Thomas, PhD Candidate
Stinchcomb Lab
University of Maryland, Baltimore

2:30

Networking and Refreshment Break

3:00

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

4:00

Closing Roundtable Discussion

Armed with cutting-edge content and critical insights, take advantage of this open audience exchange to ask tailored questions for your most pressing issues. The content for this session is driven by participants and can cover key areas from development to commercialization.

4:30

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

Joseph Fuhr
Professor
Widener University

Strategies for Operationalizing Your
CGDP Development Plan

8:45

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

Joseph Fuhr
Professor
Widener University

Bringing Your CGDP from
Laboratory to Market

9:45

Commercial Considerations for Drug Pricing in the Biosimilars Market

Edric Engert
Managing Director, Abraxeolus Consulting;
former Senior Vice President, Teva Pharmaceuticals

10:45

Networking and Refreshment Break

11:00

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

Lakshmi Raghavan
Founder and President
Solaris Pharma Corporation

12:00

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

8:30

Chairperson’s Opening Remarks

Joseph Fuhr
Professor
Widener University

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

Mark Walsh, PhamD, BCPS
Director, Clinical Pharmacy Strategy
HealthTrust

10:45

Networking and Refreshment Break

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

11:15

Demonstrating the “Sameness” of Complex APIs in Generics — Challenges Under Current Regulatory Framework

Aloka Srinivasan
Vice President, Regulatory Practice
Lachman Consultant Services

12:15

Networking Luncheon

1:30

Leading Frameworks for In Vitro and Human Studies for Evaluation of Heat Effect on Transdermal and Dermal Products

Sherin Thomas, PhD Candidate
Stinchcomb Lab
University of Maryland, Baltimore

2:30

Networking and Refreshment Break

3:00

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

4:00

Closing Roundtable Discussion

Armed with cutting-edge content and critical insights, take advantage of this open audience exchange to ask tailored questions for your most pressing issues. The content for this session is driven by participants and can cover key areas from development to commercialization.

4:30

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

Joseph Fuhr
Professor
Widener University

Strategies for Operationalizing Your
CGDP Development Plan

8:45

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

Joseph Fuhr
Professor
Widener University

Bringing Your CGDP from
Laboratory to Market

9:45

Commercial Considerations for Drug Pricing in the Biosimilars Market

Edric Engert
Managing Director, Abraxeolus Consulting;
former Senior Vice President, Teva Pharmaceuticals

10:45

Networking and Refreshment Break

11:00

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

Lakshmi Raghavan
Founder and President
Solaris Pharma Corporation

12:00

Close of Conference