Biosimilars: Past, Present and Future

The first webinar of the year is on Biosimilars.
With the regulatory pathway for creating biosimilars getting close to legislative approval in the US, there has been increasing excitement in the biotech industry. Biosimilars are projected to be multi-billion dollar industry which unlike the generic drugs will cost a lot more to develop and make considerably higher revenues. What will the new pathway look like, what are the fine prints of the process, is it really going to be as profitable as projected, how does it protect the biotech and the generic industry, who finally wins in the process – patients or industry? Our first webinar this year will discuss these burning questions and more. There are several diverse opinions, some realities and many still to-be-determined factors that everyone thinking about biosimilars should know about. FDA’s perspective on biosimilars, the basics of the process, the potential issues and possible resolutions will be discussed.

Webinar Series: Drug Development in the First Decade of the 21st Century

The last 10 years have seen the medicinal product industry go through some remarkable changes in practically every aspect of the business. The decade saw emergence of state-of-the-art technology for discovery of new products, development of lesser known regulatory processes, global expansion of markets, increased regulatory oversight, and new financial models for funding development and increasing profitability. The next decade is expected to be the decade for emergence of personalized medicine, shifting of focus of healthcare from treatment to prevention, biotech products overtaking chemical drugs in number of products, new business models. This year in our seminar series we will discuss the various developments of the past decade and how they could yield more productivity, higher quality of life, better products, and sustained profitability of the medicinal product development business.

The list of topics and tentative dates are:

January 26th
Biosimilars: Past, Present and Future
February 23rd
Statistical Issues with Developing Diagnostic Kits
March 30th
Healthcare Reforms and the Drug and Device Industry
April 27th
Patient Reported Outcomes in Clinical Trials: Better Endpoints,Bigger Issues
May 25th
Medical Device Regulation in India: What, When, Where and How of Getting Medical Devices to the Indian Marketplace
June 29th
India and China: Protecting Your Intellectual Property in Emerging Markets
July27th
Role of Strategic Planning in Drug Development: Increasing Success by Reducing Risk
August 31st
Botanical Drug Products: Addressing CMC Issues for Complex Products
September 28th
Government Grants: Money with Responsibility
October 26th
Doing Pharmaceutical Business in India
November 23rd
Therapies Based on Stem Cell: Hope and Hype
December 21st
Computational Modeling: In Silico Development of Drugs

Introduction...

Regulatory landscape is full of opportunities and land-mines. Like a moving target regulatory processes rapidly change all the time. New processes are introduced and old one revised or eliminated constantly. This blog will help the readers to keep abreast with the latest developments in the regulatory scene all over the World with special emphasis to US, EU and Indian processes. We will bring you information from all over the World along with investigative analysis of what it means in plain language. Of course, our opinion about the same will be spattered all over. You could be a decision-maker, a researcher, student or a patient; this blog will have information for all of you packaged in small, sweet packets for easy digestion along with suggested ways for benefiting from the same or avoiding the mine-field.

This blog will work in conjunction with my webinar series “Drug Development in the First Decade of the 21st Century”. We will be blogging throughout the month about the most important events in the pharmaceutical industry, in particular those related to the topic of that month’s webinar. Fresh blogs will be posted every Tuesday and Friday. The Friday posting is in our series called “Regulatory Updates” where we will bring you the hottest news releases from regulators all over the World.