FDA Lawyers Blog

On July 11, FLH Partner Brian J. Malkin will speak at Q1 Productions' Global Clinical Risk Management & Regulatory Policy Conference in Alexandria, VA on the topic "Developing a Single, Shared REMS in a Collaborative Setting". Joining Mr. Malkin will be Mark A. Collings, Ph.D., M.B.A., Director, REMS Programs, Pharmacovigilance and Risk Management, Endo Pharmaceuticals, Inc. The session description reads:

The FDA approves single, shared REMS for product categories with similar risk management programs to help relieve some of the burden on healthcare providers and pharmacies. The development of shared REMS requires that multiple companies and the FDA work in tandem to unify data and risk minimization systems, a model which some companies have also used to help organize risk management plans internationally. By ensuring a strong cross-corporate collaboration, internal regulatory policies, data analysis and communication systems can be synchronized internationally for advanced risk management programs.

• Structuring lines of communication within shared REMS network

• Establishing similar regulatory policies

• Utilizing data from all companies for international RMP development.

The Conference will be held on July 11-12, 2013. Throughout this two-day program, executive from industry will have an opportunity to discuss and debate the many challenges associated with profiling the risk of products as well as minimizing these risks and meeting regulatory expectations. As with all Q1 programs, the focus of the event will not only lie upon the educational content, but also providing attendees with an opportunity to network and build relationships across this highly dynamic and evolving market.

On April 23, FLH Partner Brian J. Malkin will speak at FDLI's Annual Meeting in Washington, D.C. in the Concurrent Breakout Session for the Center for Biologics Evaluation and Research ("CBER"). During the Concurrent Breakout Session, representatives from each FDA center will discuss the three most important developments from last year and their three most important goals in 2013. Following the FDA center representative presentations, food and drug law stakeholders responding to their presentations. This year Diane Maloney, Esq., Associate Director for Policy, CBER, will be presenting for CBER, and Mr. Malkin will be responding as a food and drug law stakeholder. Scott Cunningham, Partner, Covington and Burling, will moderate the session. The Concurrent Breakout Sessions are always a big draw for attendees at FDLI's Annual Conference, and Mr. Malkin hopes to see you there and at the CBER Breakout Session.

FLH Partner Brian J. Malkin will attend the Massachusett's Biotechnology Council's ("MassBio's") Annual Meeting in Cambridge, Massachusetts on March 14-15, 2013. FLH is a member of MassBio, reflecting FLH's commitment to the development and promotion of new biological and related products. Each year, the MassBio Annual Meeting focuses on the most timely and critical challenges facing the Massachusetts biotechnology industry. The meeting program is pulled together by a Steering Committee of leaders in the industry and the agenda encompasses keynote presentations, panel discussions, interactive working sessions, and extensive networking opportunities for all MassBio members. This year, keynote presentations feature John Crowley, Chairman & CEO of Amicus Therapeutics, Inc. and FDA Commissioner Margaret A. Hamburg, M.D. Key topics of interest include personalized medicine and companion diagnostics, biosimilars, RNA therapeutics, healthcare reimbursement strategies, research resource sharing opportunities and a variety of orphan drug candidate topics. Mr. Malkin looks forward to seeing you and catching up on the latest biotechnology developments with some of the best biotechnology leaders in the Massachusetts area and beyond.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on two topics at the 2013 Annual Meeting of the New York State Bar Association, Food, Drug, and Cosmetic Law Section in New York City on January 24, 2013 : 1) Pivotal Cases for FDA Practitioners: 2012-2013 Updates and 2) In-House/Outside Counsel Panel: Effective Communication Regarding FDA/Regulatory Advice. For the Pivotal Cases, Mr. Malkin will be joined by Janet Linn from Eckert Seamans Cherin & Mellott, LLC, and Mr. Malkin's In-House/Outside Counsel Panel includes Geoffrey Levitt, Senior Vice President and Associate General Counsel, Worldwide Regulatory and Policy Law, Pfizer, Inc.; Michael DiBello, Vice President and Associate General Counsel - Regulatory, Aceto Corp.; and Afia Konadu Asamoah, Associate, Covington & Burling LLP. Mr. Malkin hopes the In-House / Outside Counsel panel will be of interest for advancing effective interactions between FDA regulatory affairs professionals.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will present on "Mastering the Intricacies of the Orphan Drug Designation Process: A Step-by-Step Guide to Navigating the Pathway" on November 29, 2012. Mr. Malkin's presentation is part of ACI's inaugural conference, "Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process" in Boston, Massachusetts from November 28-29, 2012. Mr. Malkin's presentation will include how to assess whether a compound/indication qualifies for orphan drug designation, what benefits may be achieved by obtaining an orphan drug designation prior to product/indication approval, and how to respond to a rejection for an orphan drug designation request, including demonstrating clinical superiority. For more information, see here.

Charles Raubicheck, head of our firm's FDA practice, will chair a panel and deliver an address at the "U.S. & Brazil Conference: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law and Regulation," to be held on September 10-11, 2012 in Sao Paolo, Brazil.

The conference, sponsored by The Food and Drug Law Institute ("FDLI"), will bring together representatives of companies, venture capital firms, government agencies, law firms and other groups involved in the drug, device and food industries. They will engage in high-level discussions about respective commercial, trade, legal and other aspects of doing business in this country and Brazil, the world's 6th largest economy.

Mr. Raubicheck's panel will focus on the interplay between regulatory and intellectual property issues pertinent to pharmaceuticals. His presentation is entitled "NDAs, ANDAs, FDA's Orange Book, and Patent Term Extensions."

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will present a controversial topic concerning the type of clinical trials that FDA will require for biosimilar product applications entitled: "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials". Mr. Malkin will address what FDA has said about its "selective and targeted approach" for biosimilar clinical trials and how biosimilar applicants may be able to rely on certain clinical trial data from the innovator's product, as well as assessing the risks and benefits for conducting such clinical trials. Mr. Malkin's presentation is part of the American Conference Institute's 14th Advanced Summit on Clinical Trials: Ensuring Safe and Compliant Domestic and International Clinical Trials on July 17-18, 2012 in Boston.

On July 12, 2012, FLH Partner Brian Malkin will present on a number of key issues affecting generic drugs, biosimilars, and biobetters in the evolving landscape at the Q1 Productions Conference, Regulatory Clearance and Commercialization of Generic Drugs & Biosimilars in Alexandria, Virginia. Mr. Malkin will kick off the Conference in a panel discussion: "Preparing for the Evolution of the Generic Drug and Biosimilar Industry," which will focus on the entry of biosimilars in the coming years amidst a changing landscape of reduced small molecule generic opportunities. At the end of the day, Mr. Malkin will conclude the biosimilars track with a presentation, "Biobetters and Extending into the Marketplace Beyond Patent Expiration," which will consider how companies can identify biobetter opportunities and assess the risks and benefits from developing a biobetter rather than a biosimilar product. For more information, please see Q1 Productions.

FLH Partners Sandra Kuzmich, Ph.D., Brian J. Malkin, David Herman, Of Counsel Deena Levy Weinhouse, Associates Kathleen N. Ehrhard, Ph.D., Ami E. Simunovich, Pharm.D., R.Ph., and Scientific Advisors Ali Berkin, Ph.D. and Russell A. Garman, Ph.D. will join the world's leading biotechnology companies at the Annual BIO International Convention this year, to be held in Boston, Massachusetts from June 18-21. The FLH team will be located at Booth # 2705, where they will feature information about Life Sciences at FLH, including a number of articles and presentations on biotechnology authored by FLH, and will answer questions about FLH's Life Science practice and how it helps to maximize the value of our clients' assets.

FLH Partner Brian Malkin will attend the Food and Drug Law Institute's ("FDLI's") Annual Conference in Washington, D.C. on April 24-25. For 55 years, FDLI's Annual Conference has been considered the venue for food and drug law lawyers and professionals to hear from FDA and industry about new and emerging topics covering all the products FDA regulates. FDLI has reported that this year's event is expected to draw more than 600 attendees, who will hear directly from FDA's key leaders including Commissioner Margaret Hamburg; Deputy Commissioners Deborah Autor, Stephen Spielberg, and Michael Taylor, various representatives from FDA's six product Centers; newly-appointed Chief Counsel Eliabeth Dickinson, as well as a number of former Chief Counsels. An updated agenda is available here.

FDA Lawyers Blog is a Media Partner of FDLI's 55th Annual Conference. Prior to FDLI's Annual Meeting, Mr. Malkin will participate in a FDLI Monograph Committee Meeting on April 23 and will be working out of Frommer Lawrence & Haug LLP's Washington, D.C. office next week. Mr. Malkin looks forward to seeking you and catching up at FDLI's Annual Conference this year.

FLH Partner Brian J. Malkin will attend the Generic Pharmaceutical Association's ("GPhA")'s Annual Conference in Orlando, Florida, from February 22-24. More than 500 attendees will join Mr. Malkin to hear from industry experts and other opinion leaders regarding insight into critical economic, regulatory, and legislative issues, particularly FDA's new proposed generic user fees, impacting the health care and generic pharmaceutical sector. Each year, GPhA's Annual Conference features presentations by leading industry CEOs, economists and financial analysts, FDA regulators, and state and federal officials. This year's conference features a keynote address by Margaret A. Hamburg, M.D., FDA Commissioner. More information about the conference may be found here.

On February 15-16, FLH Partner Brian J. Malkin will attend Leerink Swann's 2012 Global Healthcare Conference in New York City. This year's Conference features a Keynote Address by FDA's Director of the Center for Drug Evaluation and Research ("CDER") Janet Woodcock, M.D., entitled "New Trends in Drug Regulations and Innovation" as well as a panel presentation on biosimilars entitled "Biosimilars Take the Stage" featuring Dr. Woodcock as well as Steven Kozlowski, M.D., CDER's Director of Office of Biotechnology Products, and Keith Own Webber, Ph.D., CDER's Deputy Director, Office of Pharmaceutical Science, Acting Director, Office of Generic Drugs. Each year, Leerink Swann's Conference brings together nearly two hundred company presentations as well as specialty panels to provide a unique and productive forum to navigate the investing landscape.

Founded in 1995, Leerink Swann is recognized as a leading healthcare investment bank to a broad range of institutional, life sciences, corporate, and high-net-worth clients that are positioned to shape the future of healthcare. All of its services are enhanced by the expertise of its proprietary MEDACorp network of 35,000+ physicians, researchers, and healthcare professionals providing insights into cutting edge advances in healthcare.

American Conference Institute presents: The Comprehensive Guide to PATENT REFORM For Life Sciences Companies: The critical industry forum on the Leahy-Smith America Invents Act
*Jan. 31-Feb. 1, 2012* Flatotel * New York, NY

Attend and hear USPTO Insights and Guidance on the AIA:

Teresa Stanek Rea
Deputy Under Secretary of Commerce for Intellectual Property and Deputy
Director, USPTO

Janet Gongola
Patent Reform Coordinator, USPTO

Keynote Address:
Robert L. Stoll
Former Commissioner for Patents, USPTO

With the historic passing of The America Invents Act, H.R. 1249, the United States is now facing the most significant patent reform in more than 60 years. Patent reform is now a reality. With countless complicated nuances throughout the statute and the unknown implications of these provisions looming, patent practitioners have been left with a multitude of questions regarding the overwhelming potential ramifications of the AIA on their patent practices. One thing is clear - with so much at stake for life sciences companies, you must plan now for the changes both in effect already and on the horizon in order to protect and defend invaluable intellectual property.

The expert faculty will discuss answers to the most pressing questions facing patent practitioners resulting from the AIA including:

• What does "first to file" actually mean under the AIA requirements? Which system can you or should file under - the current first to invent or the new first to file (or both)? And how do you avoid first-to-file bubble filings before 3/15/2013?
• When can on-sale and public use activity be considered prior art? Has secret §102(f) prior art been eliminated?
• Do you need to include best mode in the application or not and what happens if you don't? Is best mode completely toothless now? How will examiners be able to address the best mode issue?
• What will be required in the PGR process? What type of discovery? Expert witnesses? How do the estoppel provisions alter your analysis of whether to engage in the PGR system?
• What estoppel provisions are associated with IPRs and how are these different from the inter partes reexamination provisions? When do you file a 3rd party parallel IPR?
• What does the prohibition to patenting human organisms actually mean for the life sciences industry?
• What qualifies as a micro-entity and how do micro entities take advantage of the new fee reduction provisions available to them? Do you need to file an IDS with prioritized examination applications?

For more Information, please visit our website: http://www.americanconference.com/patentreform

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on a hot issue concerning 180-day exclusivity for first Paragraph IV applicant generics, "Exclusivities and Forfeitures: New Developments, Controversies and Concerns" at the American Conference Institute's 12th Annual Maximizing Pharmaceutical Patent Life Cycles Conference New York City, held from October 4-5, 2011. Now that FDA has issued a number of forfeiture rulings, some of which have been successfully challenged in court, FDA has started issuing decisions without offering an opportunity for public comments. Come and find out the latest developments in this area and how it may affect your pharmaceutical product development.

FDA Lawyers Blog readers may obtain a $200 discount by mentioning FDA Lawyers Blog and using the code "FDA 200". You may register for the conference here.

Frommer Lawrence & Haug LLP ("FLH") will attend the Biotechnology Industry Organization's ("BIO's") International Convention this year, to be held in Washington, D.C on June 27-30. Come visit FLH at Booth 2857, where FLH will feature information about Life Sciences at FLH, including a number of articles and presentations on biotechnology authored or presented by FLH and will answer questions of fellow participants and exhibitors about FLH, its Life Sciences practices, and its thoughts about biotechnology.

FLH's team at BIO 2011 includes FLH Partners Sandra Kuzmich, Charles Raubicheck, Brian J. Malkin, Elizabeth Leff, Associates Kathleen Ehrhard, Shelly Fujikawa, Brian McGuire, Ami Simunovich, and Scientific Advisors Ali Berkin, Russell Garman, and Blaine Hackman.