Tuesday, November 17, 2015

Exclusive Interview with DDP Speaker Bob Nissen, President, Nissen Consulting Group, LLC

As a member of the expert speaking faculty at the upcoming Drug Delivery Partnerships event taking place January 20-22, 2016 in Palm Beach Gardens, FL, Bob Nissen, President, Nissen Consulting Group, LLC sat down with the DDP team for this exclusive Q&A style interview.

At the event, Bob Nissen will be leading a roundtable discussion. The OTC pharmaceutical market on a global basis has been estimated by industry sources to be nearly $100 billion, and continues to grow. Projecting out over the next several years, OTC business will be strengthened by Rx-OTC switches, new categories (especially nutritionals), and emerging markets. This roundtable discussion will focus on:

  • Review the business by category and geographical segment, providing insight on what opportunities exist for branded and private label businesses
  • Examine the integration of novel and differentiating drug delivery for better products

Want to learn more? Download the complete agenda now.


1. Has the Drug Delivery Ecosystem evolved? What does it look like today?

I can only comment relative to the Over the Counter (OTC) pharma business- which represents $119 billion in worldwide annual sales, and $29.5 billion in U. S. annual sales according to the Nicholas Hall 2014 DB6 database. Oral drug delivery is the vast majority of the business in the U. S., with more than 80%; topical products (dermatology) and nasal delivery represent the most of the remainder of the business. Medical devices are a very small portion of the OTC business. Injectables are not relevant among OTC's- they are utilized for pharma products and animal health. Although there is a shift toward new forms among oral OTC's- long acting medicines, better tasting forms (gummies, drinks, chewables- especially among vitamins and supplements), and traditional tablets are still a large part of the OTC business.

2. What is the next big thing in Drug Delivery as we move into 2016?

In the OTC space, we see a continued development of better tasting forms, although this will be regulated as it relates to certain OTC categories where overuse can be harmful to consumers. Intellectual Property (IP) will be crucial to new brand introductions and brand extensions, as novel items will be promoted more aggressively. Medical devices may continue to be more of a part of the OTC landscape (e. g. Icy Hot, primarily a topical pain reliever, introduced a tems device for pain relief in late 2014).

3. What are some of the newest and most evolving technologies you have your eyes on? And what’s next in connectivity?

It's all about technologies which will appeal to consumers to provide a better solution to their healthcare needs, and increase compliance

Over time, OTC's usage, especially in important maintenance areas (e. g. low dose aspirin and its daily use for heart healthy benefits) will be tracked on smart phones and other devices frequently followed by consumers. Apps and reminder messages will also likely evolve more and more as it relates to OTC usage of maintenance items (vitamins, fiber supplements, probiotics, etc.), as well as items crucial to their well being.

4. When do you start to look at utilizing drug delivery systems?

DD systems are evaluated for OTC's in advance of a new product launch, when considering brand extensions, as lifecycle management additions for Rx to OTC switches, and as a way to appeal to new users or improve compliance for existing OTC products. The incorporation of new forms within OTC's can sometimes be done quickly (1-2 years prior to launch), especially in light of the monograph and DSHEA regulatory approval routes. However, in the case of NDA's,( e. g. sustained release orals, dermatology products with enhanced penetration capabilities, etc.), the planning in advance of launch can sometimes be five years or more.

5. What are your thoughts on how innovation is going to be pressured as a result of changes in the site of care?

OTC's will continue to benefit from increased self selection and more products switching from prescription to OTC. Innovation needs to focus on changing trends in the home and workplace, the aging and more active population, and greater use of self care, especially maintenance self care to insure a more healthy and improved lifestyle.

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