Tuesday Expo

GRx+Biosims Exposition

An interactive knowledge sharing session that brings together multiple levels of scientific, regulatory and policy disciplines from diverse sectors, industry, academia and health authorities. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding and knowledge sharing. This year’s expo will also feature over 50 project managers from FDA’s OGD and OPQ who will participate in an information exchange opportunity with attendees.

Topics:

Office of Generic Drugs (OGD)

Sunny Pyon, PharmD
Labeling Project Manager, ORO, DLR, OGD, CDER, FDA

Priya Shah, PharmD
Labeling Project Manager, ORO, DLR, OGD, CDER, FDA

Rhonda Rowell, RPh
Filing Project Manager, ORO, DFR, OGD, CDER, FDA

Edward “Ted” Sherwood
Director, ORO, IO, OGD, CDER, FDA

Karen Bengtson
Supervisory Project Manager, ORS, IO, OGD, CDER, FDA

Caliope Sarago, MHSA
Team Lead (Acting) Senior Regulatory Health Project Manager, ORS, IO OGD, CDER, FDA

Shivangi Goel, MS
Project Manager, ORS, IO OGD, CDER, FDA

Maria Monroy-Osorio
Regulatory Health Project Manager, ORS, IO, OGD, CDER, FDA

CAPT Aaron Sigler, PharmD
Deputy Director, ORO, DPM, OGD, CDER, FDA

CAPT Vincent Sansone, PharmD
Supervisory RPM, ORO, DPM, OGD, CDER, FDA

Deborah Adams, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Olga Salis
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Devon Lee, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Catherine Morales, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

CDR Andrew Kim, PharmD
Supervisory Project Manager, ORO, DPM, OGD, CDER, FDA

Megan Tychinski, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

LCDR Sasha Latonis, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Yvonne Le, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

CDR David Eng, PharmD
Supervisory Project Manager, ORO, DPM, OGD, CDER, FDA

Xuan-Mai “Mai” Nguyen, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Sarah Taylor, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Tom Ching, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Meenu Sharma, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

LCDR Warren Simmons
PharmD, Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

CDR Scott Vehovic, RPh, MBA
Supervisory Project Manager, ORO, DPM, OGD, CDER, FDA

CDR Tina Nhu, PharmD, RPM
Team Leader, ORO, DPM, OGD, CDER, FDA

Uzoma Nnebe, PharmD
Regulatory Health Project Manager, ORO, DPM, OGD, CDER, FDA

Christopher Jacobs, RPM
Team Leader, ORO, DPM, OGD, CDER, FDA

CDR Yen Anh Bui, PharmD
Supervisory Project Manager, ORO, DPM, OGD, CDER, FDA

CDR Nicholas Daniel, PharmD, RPM
Team Leader, ORO, DPM, OGD, CDER, FDA

Frank Giannandrea, PharmD, RPM
Team Leader, ORO, DPM, OGD, CDER, FDA

Tram Nguyen, PharmD, RPM
ORO, DPM, OGD, CDER, FDA

LaShaun Washington-Batts, PharmD, RPM,
ORO, DPM, OGD, CDER, FDA

Denise Toyer-Mckan, PharmD
Division Director, ORO, DPM, OGD, CDER, FDA

Allison Schaefer, B.S., M.S., RPM
Regulatory Project Manager, ORO, DPM, OGD, CDER, FDA

Priti Jain, PharmD
Lead Regulatory Health Project Manager, OB, DBPM, OGD, CDER, FDA

Beena Mathew, PharmD, PMP
Senior Regulatory Health Project Manager, OB, DBPM, OGD, CDER, FDA

Theresa Chan, PharmD
Regulatory Health Project Manager, OB, DBPM, OGD, CDER, FDA

James Buening
Regulatory Health Project Manager, OB, DBPM, OGD, CDER, FDA

Chyong-Yi Wu, PhD
Regulatory Health Project Manager, OB, DBPM, OGD, CDER, FDA

Manina Singh, Pharm.D, PMP, RAC
Deputy Division Director, OB, DBPM, OGD, CDER, FDA

Office of Pharmaceutical Quality (OPQ)

Adam Zayed, PharmD
Regulatory Health Project Manager, OPRO, DIII, OPQ, CDER, FDA

Janelle McCutchen, PhD
Branch Chief, OPRO, DIII, OPQ, CDER, FDA

LCDR Adlaide Addo, PharmD
Regulatory Health Project Manager, OPRO, DIII, OPQ, CDER, FDA

Thong Nguyen, PharmD
Regulatory Health Project Manager, OPRO, DIII, OPQ, CDER, FDA

Olugbenga Okubadejo, PharmD
Division Director, OPRO,DIII, OPQ, CDER, FDA

CDR Lana Rossiter, PhD
Branch Chief, OPRO, DIII, OPQ, CDER, FDA

Elisa Nickum, PhD, PMP
Regulatory Health Project Manager, OPRO, IO OPQ, CDER, FDA

Reynolds Cantave, PharmD
Sr. Regulatory Health Project Manager, OPRO, IO, OPQ, CDER, FDA

Salma Srour, PharmD
Regulatory Health Project Manager, OPRO, DII, OPQ, CDER, FDA

Karen Ireland, MS
Sr. Regulatory Health Project Manager, OPRO, DII, OPQ, CDER, FDA

Thuyanh (Ann) Vu, RPh
Regulatory Health Project Manager, OPRO, DII, OPQ, CDER, FDA

Marie Angeline O’Shea, RN, MBA
Associate Director, OPRO, IO, OPQ, CDER, FDA

Maya Johnson-Nimo, MHSA
Lead Regulatory Health Project Manager, OPRO, DII, OPQ, CDER, FDA

CAPT Craig Kiester, RPh, MS
Division Director, OPRO, DII, OPQ, CDER, FDA

LCDR Nuri Tawwab, PharmD
Regulatory Health Project Manager, OPRO, DII, OPQ, CDER, FDA

CAPT Jonee Mearns. MSN, RN
Branch Chief, OPRO, DII , OPQ, CDER, FDA

Office of Compliance – Exports, Imports, and Recalls

Ileana Elder, PhD
Branch Chief, IRSB, OC, CDER, FDA

Andrei Perlloni
Branch Chief, IBC, OC, CDER, FDA

CDR Cristina Dar, M.Eng.
Branch Chief, ECB, OC, CDER, FDA

OM Division of User Fee Management

Gisa Perez, MBA
Generics Branch Chief, GB, DUFM, OM, CDER, FDA

Ali Shariati, MPS
Lead Management and Program Analyst, GB, DUFM, OM, CDER, FDA

Vasilis Anagnostopoulos-King, MS
Management Analyst, GB, DUFM, OM, CDER, FDA

Olivia Souweine, PMP
Management Analyst, GB, DUFM, OM, CDER, FDA

Maria Kim, DPT
Management Analyst, GB, DUFM, OM, CDER, FDA

Benefits of the SD File Format

Post Approval Changes on Complex Generic and Respiratory Products

Darshan Aigal, M.Sc, P.G.D.M
Director, Global complex Generics- Regulatory Affairs Department, Cipla Limited, India

Rashmi Vasant Shetty
Director, North America- Regulatory Affairs Department, Cipla Limited, India

Siva Vaithiyalingam, PhD
VP, Regulatory Affairs, Cipla LTD

Drug Shortage Staff (DSS)

Jeannie David
Senior Program Management Officer, DSS, OCD, CDER, FDA

CAPT Leo Zadecky, RPh, MS
Senior Program Management Officer, DSS, OCD, CDER, FDA

CDR Hyun Son, PharmD, PMP
Senior Program Management Officer, DSS, OCD, CDER, FDA

CAPT Christine Bina, RPh, MPH
Team Leader, Drug Shortage Staff, OCD, CDER, FDA

FDA Electronic Submissions – What’s New?

Heather Crandall
Operations Research Analyst, DDMSS, OBI, OSP, CDER, FDA

Seyoum Senay
Supervisory Operations Research, DDMSS, OBI, OSP, CDER, FDA

Jonathan Resnick, PMP
Project Management Officer, DDMSS, OBI, OSP, CDER, FDA

Injectable Drugs Deficiency Trend Analysis

Cindy Lombardy, MS, MBA, RAC-US
Senior Director, Pharmaceutical Regulatory Affairs, B. Braun Medical Inc.

Kamaal Anas
Corporate Vice President, Regulatory Affairs, B. Braun Medical Inc.

Product Marketing and Supply Notifications

Adam Steinberg, PharmD
Associate Director, Regulatory Affairs, Apotex Corp.

Michael Balon
Global Director, Regulatory Affairs New Product Development, Apotex Inc.

Sandra D’Agostino-Ferlisi
Director, Global Regulatory Intelligence and Policy, Apotex Inc.

Regulatory Requirements and Challenges – High Molecular Weight Species in Peptides: Process Considerations, Characterization and Regulatory Requirements for an ANDA

Nitin Sopanrao Patil, PhD
Head – API R&D, Biocon Limited

Shashi Kant Tiwari
Head of Analytical Research for API & Formulations, Biocon Limited

Anil Sachdeva
Global Vice President, Regulatory Affairs at Biocon Pharma Inc.

The Cumulative Impact of Developments in the Environmental Regulation of PFAS and Pharmaceutical Propellants

Alan Thompson
Director Regulatory Affairs, Teva Pharmaceuticals

Veeranna Lolla, M.Pharm, RAC,
Senior Director Regulatory Affairs, Teva Pharmaceuticals

GDUFA Science and Research Program

Exception Excipients and pH adjusters: Controlled Correspondences

Anand Saxena, M.Sc
Director Regulatory Affairs, Cipla Limited

Kishore Velaga, M.S
Director, Regulatory Affairs, Cipla USA

Michele Crawley, MS, RAC
Director, Regulatory Affairs, Cipla USA

Nitrosamines in Pharmaceuticals – What does the future look like?

Aloka Srinivasan, PhD
Principal and Managing Partner, Raaha LLC

FDA Careers

Elizabeth Okereke, J.D.
Project Specialist, IO, OGD, CDER, FDA

Colleen Lee, J.D.
Acting Deputy Division Director, OGDP, DLRS, OGD, CDER, FDA

Kimberly Witzmann, M.D.
Deputy Director, OSCE, OGD, CDER, FDA

Qing Liu, PhD
Deputy Division Director, OB, DBI, OGD, CDER, FDA

Manina Singh, PharmD
Deputy Division Director, OB, DBPM, OGD, CDER, FDA

Priti Jain, PharmD
Team Leader, OB, DBPM, OGD, CDER, FDA

Carol Holquist, RPh
Associate Director, Regulatory Affairs, OSCE, OGD, CDER, FDA

Christopher Downey, PhD
Division Director, OPMA, DBM, OPQ, CDER, FDA

Derek Smith, PhD
Deputy Office Director, OPMA, OPQ, CDER, FDA

Pallavi Nithyanandan, PhD
Staff Director, OPPQ, OPQ, CDER, FDA

Susan Zuk, PhD
Branch Chief, OPPQ, OPQ, CDER, FDA

Janice Brown, PhD
Branch Chief, OPPQ, OPQ, CDER, FDA

Lillian Zhang, PhD
Branch Chief, OPPQ, OPQ, CDER, FDA

Geoffrey Wu, PhD
Deputy Office Director, OLDP, OPQ, CDER, FDA

Peter Capella, PhD
Division Director, OLDP, OPQ, CDER, FDA

Jeanne Ventura Reyes, J.D.
Regulatory Counsel, OPPQ, OPQ, CDER, FDA

Joel Welch, PhD
Associate Director Regulatory Affairs, OBP, OPQ, CDER, FDA

Dominique Mitchell
Staff Director, OAO, OPQ, CDER, FDA

Angel Jarrett
Management Analyst, OAO, OPQ, CDER, FDA

Alexis Crispin
Management Analyst, OAO, OPQ, CDER, FDA

Annette Edwards
Management Analyst, OAO, OPQ, CDER, FDA

Bibi Jakrali
Management Analyst, OAO, OPQ, CDER, FDA

Jennifer Cristofori
Management Analyst, OAO, OPQ, CDER, FDA

Who should attend:

Possible job titles include:
Regulatory Affairs, Medical Affairs, Business Development, Program Management, Policy, Commercial Development, Scientific Affairs, Research Analyst

About GRx+Biosims 2023

GRx+Biosims 2023 is the premier scientific and regulatory event for the U.S. generics and biosimilars industries, featuring timely programming relevant to technical, regulatory and policy professionals. Top officials and subject-matter experts share their knowledge and best practices to enhance attendees’ understanding of how to succeed in generic and biosimilar development; the regulatory process and approvals; and the evolving policy landscape.