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12th Portfolio Management & Pipeline Optimization for Generics

Building a Pipeline Strategy to Achieve the Highest Portfolio Value in a Competitive Environment

September 11-12, 2019
The Study at University City | Philadelphia, PA

marcus evans Noth America

What our delegates think of us:

An interview with Robert Shapiro, Global Director, Portfolio Management at Apotex Inc.

Ahead of the 12th Portfolio Management & Pipeline Optimization for Generics, we spoke with Robert Shapiro, Global Director, Portfolio Management at Apotex Inc. on how to revolutionize product selection to drive a competitive edge in the market.

Robert, you will be giving a solo presentation on the topic, “Revolutionize Product Selection to Drive a Competitive Edge in the Market” What are some of the key takeaways the attendees can expect from your session?   

The US generic pharmaceutical industry is in the midst of a major change. Generic companies with large portfolios of “easy-to-make” oral solid dosage forms have seen their stock prices drop substantially over the past 5 years. This has led to several companies optimizing their portfolios by divesting low performing products. In other words, we are seeing a shift in portfolio strategy from a breadth portfolio to a more-limited portfolio with a majority of highly profitable products. This is not a surprise. The number of new Branded opportunities (leading to PIV opportunities) is shrinking and the opportunities that do exist see heavy competition. It is common to see 30+ generic companies filing ANDAs on a New Chemical Entity molecule. It is harder to remain profitable in the “easy-to-make” dosage forms. To succeed, generic companies need to sell differentiated products, such as complex dosage forms. These types of products have less competition and are more insulated from pricing pressures (but come with greater development and regulatory risk).

What are some of the trends emerging in the generics industry that you will look forward to discussing at this event?   

Over the past few years, analysts pointed to biosimilars as the next big thing for generic pharmaceuticals. Biosimilars cost between $100 M and $250 M to develop and take 7 to 8 years. However, only ~10 biosimilars have launched to date and most of those launches are from Branded companies or biopharmaceutical specialty companies. The jury is still out whether the biosimilars strategy has been successful for generic companies and I look forward to some discussion on this topic.

There has also been discussion on whether price erosion of generic molecules has “bottomed out” or whether further price erosion should be expected. This will tell us whether the generic companies have weathered the storm or if they should expect more headwinds to come. It seems that customer consolidation and the increase in number of foreign and virtual generic companies will continue to have an impact on the price.

The FDA continues to scrutinize the quality systems of many foreign manufactures with several generic companies and API suppliers receiving 483s, warning letters or even import alerts. This creates a lot of risk for those companies that face the regulator’s wrath but also creates opportunities for those that have successful inspections. I am looking forward to discussing how companies can capitalize on these opportunities as part of their portfolio strategies.

In your opinion, what do you think some of the top struggles generic companies are currently facing when it comes to portfolio management and pipeline optimization strategies? What quick advice would you have to offer?  

It is never easy to say goodbye – especially to products where employees spent their blood, sweat and tears to develop and commercialize. However, to succeed in the changing environment, generic companies must cancel low-value products and redeploy resources to higher profitable ones. True, there may be a one-time hit on the balance sheet but to succeed, a company cannot be everything to everyone.

Generic companies also struggle with identifying ways to outmaneuver other generic companies for earlier entry opportunities. My advice is for generic companies to identify how they can be differentiators and exploit those, such as building a portfolio with a specific hard-to-make technology.

Finally, companies will need to shift from a focus on internal development to external development as it is most likely that third parties who have expertise in different technologies to develop and manufacture the complex products will be required. My advice is to incentivize the Business Development team to find the right partner and invest in building trust in the relationship.

You have spoken at Marcus Evans events in the past. What are some of the main factors that influenced your decision to participate again?   

The Marcus Evans conference provides an excellent opportunity to share ideas and network on portfolio strategies. I personally love self-reflecting on what other speakers are talking about, how they are tackling their own problems, and brainstorming how I can apply their general feedback to my company’s issues.  I often return to the office after the conference full of novel and creative ideas.

Robert Shapiro is one of our keynote speakers

Why you should attend this marcus evans conference?

Practical insights from active practitioners in your sector

• Shoufeng Li PhD
  Founder & CEO
  Aucta Pharmaceuticals
  
  Sami Yusuf, PHARM. D., MS., MBA
  Vice President, Corporate Development
  Upsher-Smith Laboratories
  
  George Cokenakes
  Associate Director
  Sigmapharm Laboratories LLC
  
  Erika Geimonen, Ph.D.
  Vice President, Business Development
  Amring Pharmaceuticals
  
  Dahai Guo
  Chairman & CEO
  Zennova Pharmaceutical
  

Case study: 
Revolutionize Product Selection to Drive a Competitive Edge in the Market (12th September at 11:15 am)

• Identifying future areas of product development to beat competitors
• Developing niche products to diversify the portfolio and reduce the impact of market change
• Ensuring optimal resource allocation by adhering to company overall strategy
• Evaluating potential commercial strategies to optimize market access

For registration pricing and multiple attendee discounts, please contact:

Melini Hadjitheori 
melinih@marcusevanscy.com