The Associate Reel – 11/17-12/1

Companies with varied self-care industry expertise*

Andrea Leonard-Segal, MD Consulting, LLC - As the former Director of FDA's Division of Nonprescription Clinical Evaluation, Dr. Leonard-Segal can provide unique insights and advice to pharmaceutical companies in the areas of Over-the-Counter (OTC) and prescription drug development. Additionally, she is a rheumatologist with decades of clinical experience.

She assists clients in many ways such as advising on:

• Rx-to-OTC Switch & Direct-to-OTC development programs
• OTC "switch-ability" of prescription drugs
• Regulatory submissions adequacy
• Label comprehension, self-selection, human factor, and actual use studies
• Additional Conditions of Safe Use (ACNUs) and Patient Reported Outcome Instruments
• OTC Monograph issues
• 505(b)(2) applications (including NDA deviations)
• Pediatric Research Equity Act and Pediatric Study Plans
• Dispute Resolution submissions
• Advisory Committee Meetings preparation
• Regulatory requirements, guidance documents, meeting minutes, and advice letters
• Clinical holds and complete responses

Areas of Focus: Consulting - Regulatory & Scientific; Consulting - Rx-to-OTC Switch; Consulting - Strategy; OTC Medical Devices; Over-the-Counter Medications

Connect with: Andrea Leonard-Segal, President & CEO, [email protected]

CG Sawaya Partners, LLC - Sawaya Partners is a dynamic and growing boutique investment bank formed exclusively to serve clients in the consumer industry. The practice is built upon expertise (the experience, talent and insight to deliver results), creativity (the ideas and strategies to find unique and value-added solutions tailored to each client's situation), persistence (the tenacity and drive to pursue excellence in every transaction), integrity (dedication to serving clients' best interests to build lasting trust and respect), network (broad set of relationships with senior management at a wide variety of consumer industry businesses and with the private equity community), and track record (the ability to open doors, close transactions, and exceed client expectations).

Areas of Focus: Financial Services; Investment Banking

Connect with: Fuad Sawaya, Global Group Head Consumer, [email protected]

Cohen Nonprescription Consulting LLC - As a recently retired long-time FDA social science reviewer in the Office of Nonprescription Drugs, I provide strategic consultation on consumer behavior development programs for Rx-to-OTC switches as well as for direct to OTC pathways - including but not limited to ACNU. My relevant experience includes significant involvement in FDA approvals of Opill and Narcan, as well as substantial involvement in numerous ongoing dialogues with a variety of sponsors regarding potential ACNU development programs. I'm a seasoned public presenter (8 Advisory Committee presentations). I also bring an understanding of the business perspective and the consumer research process; earlier in my career, I managed pharma marketing research for a Fortune 500 company.

Areas of Focus: Consulting - Market Data & Consumer Insights; Consulting - Rx-to-OTC Switch

Connect with: Barbara Cohen, President, [email protected]

Knapp Regulatory Services LLC - Knapp Regulatory Services LLC provides clients with over 31 years of experience in the pharmaceutical industry specializing in regulatory support of over-the-counter NDA and monograph products. This experience encompasses a variety of drug therapeutic categories with significant focus on the upper respiratory and pain categories. Expertise includes regulatory strategy, development and implementation, and operational support (ex. advertising review; label preparation and review; regulatory submissions).

Areas of Focus: Consulting - Regulatory & Scientific; Consulting - Strategy; Over-the-Counter Medications

Connect with: Hans Knapp, Director, [email protected]

US Drug & Device Register, Inc. - US Drug and Device Register is a dynamic life sciences market access organization. By keeping time with the ever-changing needs of today's healthcare environment, we assist our clients by developing strategies which yield profitable reimbursement and access to penetrate and thrive in the US markets. For more than two decades we have delivered an unparalleled track record helping clients navigate the US life sciences ecosystem. We offer a 360°approach to facilitating client success in the ever-changing US healthcare environment.

We work with manufacturers locally and globally across Drug, Device, OTC, and Medical-Surgical helping them penetrate the US healthcare system.

Areas of Support:

• Regulatory
• Distribution
• Payer Access
• Institutional Access
• Marketing

Areas of Focus: Consulting - Marketing; Consulting - Regulatory & Scientific; Consulting - Rx-to-OTC Switch; Consulting - Sales; Consulting - Strategy; OTC Medical Devices; Dietary Supplements; Other Products(Beauty, Rx, etc.); Over-the-Counter Medications

Connect with: Mike Kozin, Chief Executive Officer, [email protected]

*Not all companies from any given area of focus may be listed; The Associate Reel will highlight different CHPA Associate Member companies and their area(s) of focus on a random, rotating basis.