Articles Posted in Events

FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: “Innovative Strategies for New Product Development” on February 5, 2014. The program will be held at the Montgomery County Department of Economic Development offices at 111 Rockville Pike, 8th Floor, Rockville, Maryland 20850 from 8-10 am.

Planned topics include:

  • Drug Development Trends
  • Special Regulatory Approval Strategies
  • Opportunities for Extending the Market
  • Protecting Your Investment
  • Raising Capital to Finance Research and Commercial Products
  • Other Regulatory Considerations.

Specific topics include special FDA regulatory approval strategies (e.g., priority review, fast track, breakthrough therapy, accelerated approvals, orphan drugs, and 505(b)(2) NDAs), drug repurposing, patent protection and exclusivities, labeling, and manufacturing considerations.

A light breakfast will be served along with refreshments. Following an initial networking session, Mr. Malkin will cover the above topics in an intimate setting where the audience can participate and ask questions and offer additional insight to one another in a dynamic and informal environment.

If you would like to attend, please RSVP by January 29, 2014 to:

Janis Pitts Director, Life Sciences Strategy Montgomery County Department of Economic Development 111 Rockville Pike, Suite 800 Rockville, Maryland 20850 240-777-2016

On January 30, 2014, FLH Partner Brian J. Malkin will speak at the New York State Bar Association’s (“NYSBA’s”) Annual Meeting of the Food, Drug and Cosmetic Law Section. Mr. Malkin will introduce and speak with Molly Muldoon, FDA’s former Chief of Staff, on “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation–Perspectives from Two Former FDA Officials”. Ms. Muldoon was formerly an FDA Chief of Staff, overseeing operations and liaising with senior FDA leadership on key issues including the Affordable Care Act, Deepwater Horizon, food safety regulations and food borne outbreaks. Mr. Malkin is a former regulatory counsel at the FDA, who specializes in the strategic analysis of how policy affects FDA and IP innovation. Ms. Muldoon will discuss how effective communication, cooperation and collaboration remain critical to implement policy within FDA. She will also discuss the role of patient groups and other valuable stakeholders to work with FDA in shaping the development of FDA policies and how to achieve all of this in an increasingly political environment. In addition, the Meeting will feature the following presentations: Les Weinstein, Esq. former Ombudsman for the Center for Tobacco Products and for the Center for Devices and Radiological Health speaking on “The Role of the FDA Ombudsman–Who They Are, What They Do and How They May Assist You”; Frederick H. Fern, Harris Beach PLLC; John A. Murphy III, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America; and Irving L. Wiesen, Law Offices of Irving L. Wiesen, P.C. speaking on “Compounding Pharmacies: Regulatory Solutions to a National Health Crisis”; George J. Annas, William Fairfield Warren Distinguished Professor and Chair Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health, School of Medicine and School of Law and David S. Weinstock, LifeCell Corporation, speaking on “Ethical Conflicts in Clinical Medicine and Research: Consent to DNA Screening, Research on Extremely Premature Infants and International Drug Trials”. The Section’s meeting will conclude with its Annual Business Meeting.

On January 28, 2014, FLH Partner Brian J. Malkin will speak on a panel “Understand the FDA Report [Risk Evaluation and Mitigation Strategies (“REMS”) Standardization] and the Impact on the Industry” at ExL Pharma’s 6th Risk Evaluation and Mitigation Strategies Summit held on January 28-29, 2014 in Alexandria, Virginia. Joining Mr. Malkin in the panel will be Yola Moride, Ph.D., FISP, Professor, Université de Montréal to help provide an international perspective of this Report with planned topics to include:

  • Outlining of the FDA’s findings since the public meeting in July 2013
  • Explore the implications and impact on the industry
  • Outlook on developments in 2014
  • Assess changes to the existing regulations
  • Understand the real lifecycle of a REMS and the different decision points for modification
  • Trends in the conversation of the different regulatory bodies.

The Summit will build upon recent REMS events including the recent Health and Human Services Office of Inspector General Evaluation Report (“OIG”), coupled with the OIG Semi-annual Report to Congress (March 2013), FDA’s recent Public Meeting on REMS Standardization and the public docket for FDA’s eagerly-anticipated REMS Standardization Initiative Report. While the OIG reports appear to indicate that FDA lacks comprehensive data to determine whether REMS improve drug safety, FDA continues to require REMS in some instances following a drastic reduction in the number of drug products with a REMS. Together, this provides an opportunity and a choice for industry officials to either: more proactively engage and partner with FDA in designing and evaluating such programs or accept the status quo.

Part of the key goals of the 6th Risk Evaluation and Mitigation Strategies Summit is to collect the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies share their perspectives, experiences, and leverage the discussions from the FDA public meeting in July 2013. The Summit then provides a well-rounded platform to take a proactive approach and discuss:

  • Recent developments and initiatives
  • Possible frameworks for standardization
  • Tools for evaluation
  • Best practices for modification
  • Methods to measure the burden
  • Lessons learned from various REMS programs
  • Innovative approaches to improve REMS effectiveness
  • What can be learned from other industries
  • Challenges working in single shared REMS.

On December 11, 2013, FLH Scientific Advisor Howard E. Rosenberg, Ph.D. will speak on: “Patent Settlements/Pay-for-Delay – are they so incompatible?” as part of the International Broadcasting Convention (“IBC”) International Patent Litigation Conference held in London, England, at The Bloomsbury Hotel, 16-22 Great Russell Street, London WC1B 3NN.

Dr. Rosenberg’s presentation is a “Case Study” with the following description:

Both in Europe and USA there is pressure for curbing aspects of patent settlements, consequently it has resulted in hotly debated missives from both sides of the divide. Can a patent dispute be resolved in which a settlement can occur where a commercial advantage is obtained by both litigants or is it solely the public purse that has to be of concern?

The IBC website includes a comment from The Right Hon. Professor Sir Robin Jacob explaining the focus of the Conference:

These are interesting times for patent law and procedure. This makes for uncertainty in many directions. Patentees, potential defendants and advisors to both sides are increasingly having to base their actions and predictions on less and less firm material. They need all the help they can get.

This conference is aimed at exploring some of the major questions of the day. IBC Legal have brought together many of the key players in this complex and fast changing world to debate and discuss where things are and may be going. It will be an exciting event – one not to be missed if you really want to know what’s going on.

Dr. Rosenberg looks forward to seeing you there at the IBC International Patent Litigation Conference.

On November 8, 2013, FLH’s key FDA/Regulatory Partners Charles J. Raubicheck and Brian J. Malkin will present on a variety of FDA/Regulatory topics at the 3rd Annual Korea-Maryland, USA Bio Expo. The Expo will showcase the best opportunity meet with Korea’s leading pharmaceutical, biotechnology, and medical device companies. The main show dates including these and other presentations are November 7th and 8th at the Universities at Shady Grove Conference Center in Rockville, Maryland. Specifically, Mr. Raubicheck and Mr. Malkin will present on: Guidelines for Current Good Manufacturing and Quality Control, Generic Pharmaceutical Development Manufacturing, Discussion of Current Drug Shortages Affecting the U.S. Market, Current Initiatives for Underserved Diseases, Current Initiatives for Repurposing Pharmaceuticals and New Development, Biosimilar Strategies and Current Guideline Discussion, and Biosimilars/Follow-on Biologics, Pertinent FDA Guidance.

The Expo features:

  • Korea’s regional officials from the Gangwondo, Jellonamdo, Kyeongsangnamdo, and Chungcheonbukdo Provinces will be in attendance.
  • Evening Reception with presentations from Korean companies and their technology development on November 7th from 6:00pm-8:30pm.
  • Seminars from industry professionals on business development and regulatory affairs.
  • Exhibitors from U.S. and Korea presenting opportunities from both countries to build collaborations.
  • General admission to the exhibition hall is free to the general public.

Frommer Lawrence & Haug LLP is proud to be a sponsor of Korea-Maryland, USA Bio Expo 2013 and looks forward to participating in this event to help make it be one of the greatest international fairs between Korea and the United States to foster mutual cooperation for the development of new pharmaceuticals, medical robotics technology, stem-cell research, medical devices, environmentally-friendly energy research, and additional innovations.

On October 29, 2013 FLH’s Brian J. Malkin and Julie E. Kurzrok will present an “Update on FDA’s Draft Guidance for Electronic Source Data in Clinical Investigations” at Q1 Productions Conference Clinical Data Management Innovation held in Alexandria, Virginia. The two-day Clinical Data Management Innovation Conference (October 28-29) will take a look at innovative strategies and technologies affecting forward-thinking companies involved in clinical studies and clinical data management. Executives in clinical data management for the life sciences industry face increasing challenges managing the level of data increasingly demanded by regulatory authorities and third-party payors. In addition, many later-phase studies are now multi-center studies being conducted simultaneously, where clinicians want immediate access to cross-center data.

The Conference will focus on topics of interest to clinical data managers (“CDMs”) as well as individuals who supervise or support CDMs to better understand the evaluation and selection of new technologies to meet FDA’s and other regulatory requirements for collecting and managing clinical data. In addition to presentations on FDA’s requirements, such as the one FLH is providing, the focus will be on industry executives rather than consultant or vendor corporations providing real-world insights into the pros and cons of a wide variety of technologies, as well has how they have been implanted on site. As with other Q1 conferences, there will be ample opportunities for education and knowledge sharing, as well as interaction and peer-to-peer networking throughout the program.

Key Conference Takeaways include:

  • Ratify Current Regulatory Concerns with FDA and CDISC Notified Bodies.
  • Developing Strategies on Managing Limited Resources
  • Implementing Innovative EDC Systems
  • Preserving the Integrity of Captured Data
  • Addressing the Ever-Evolving Clinical Data Management Landscape
  • Engaging In Educational Small Group Discussions and Panel Sessions with Senior CDM Executives.

FLH Partner Brian J. Malkin will join more than 700 generic industry professionals and FDA staff who attend the Generic Pharmaceutical Association’s (“GPhA’s”) Fall Technical Conference in Bethesda, Maryland from October 28-30, 2013. This unique educational conference has become the vehicle for key FDA officials to disclose and discuss the key regulatory and technical issues affecting pending or yet-to-be-filed generic products. Here, more than a dozen top FDA officials, including a keynote from the Director of the Center for Drug Evaluation and Research (“CDER”), Janet Woodcock, M.D., and panel discussions will discuss the issues affecting the generic drug industry and ultimately innovators and all of us in FDA regulatory affairs in a meaningful way.

Topics to be discussed include:

• The impact of the Generic Drug User Fee Act (“GDUFA”)
• Quality metrics and how they are effectively used and reviewed • FDA compliance, including inspections and enforcement • FDA’s thoughts on generic versions of complex drug products • Clinical endpoint studies • Microbiology and sterility • The Office of Generic Drug’s filing review • Stability issues and testing • How to handle different inactive ingredients • Office of Generic Drug Director’s Update
Mr. Malkin plans to attend the main conference from October 29-30, 2013, and looks forward to meeting you at GPhA’s Fall Technical Conference and sharing with you his thoughts about the information shared and discussed. THe full agenda for the Conference may be found here.

On September 11-12, FLH’s Partner Brian J. Malkin will attend GPhA[Generic Pharmaceutical Association]/FDA’s ANDA [Abbreviated New Drug Application] Labeling Workshop / USP [United Pharmacopeial Convention] User Forum. The Conference provides a unique opportunity for attendees to hear straight from FDA’s Office of Generic Drugs (“OGD”) Labeling Review Staff, who are responsible for reviewing and approving ANDAs. The Workshop will provide industry with current information on the ANDA labeling review process as well as the many issues facing the generic industry when submitting ANDA labels. Some key topics to cover include:

  • Recommendations for industry on handling last-minute labeling “carve-outs”
  • The impact of REMS on the ANDA labeling review process
  • MedGuide Requirements>
  • Risk management plan challenges
  • Pediatric exclusivity considerations
  • Best practices for ANDA labeling

In addition, the Conference features presentations from USP staff about recent trends in USP’s monograph process and how changes in monographs can affect ANDA labeling and approvability. USP is a scientific, nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines. Some of the topics USP staff will cover include pharmaceutical quality standards and the USP-NF standards- setting process, in addition to the following topics:

  • Pending Monograph process
  • Flexible Monographs
  • General Chapters Updates
  • Navigating the USP-NF
  • General Notices
  • USP Dictionary of USAN

In addition, USP will explain how members of the pharmaceutical community may get involved with the USP monograph process and more.

On September 10, 2013, FLH’s Partner Brian J. Malkin will be attending the Food and Drug Law Institute’s (“FDLI”) Conference, “Safeguarding the Functional Food and Dietary Ingredient Supply Chain“. The Conference will address a variety of compliance issues and the emerging requirements for functional foods and dietary supplement manufacturers and distributors in view of the FDA Food Safety Modernization Act (“FSMA”). FSMA has been called “the most sweeping reform of our food safety laws in more than 70 years” and was signed into law by President Obama on January 4, 2011. FSMA shifts the focus from responding to contamination to preventing it to ensure the U.S. food supply is safe.

Conference attendees will hear from top FDA officials. For example, the Conference features a Keynote Address from the Director of FDA’s Division of Dietary Supplement Programs, Daniel Fabricant, Ph.D. In addition, industry experts will provide insight on how FDA may implement FSMA’s supplier verification requirements of the Food Safety Modernization Act (FSMA). In particular manufactures will gain a greater understanding of what regulatory requirements can be expected in the coming months by discussing the key regulatory provisions of supply chain safety, the differing definitions for ingredients used in functional foods versus ingredients used in dietary supplements, and by analyzing trends in supply chain quality testing.

On July 25 and 26 FDA will hold a Public Meeting at its White Oak campus on risk evaluation and mitigation strategies (“REMS”). FLH Partner Brian J. Malkin plans to attend to take advantage of many of the lessons learned at a recent Q1 Productions Global Risk Management Conference blogged on here. Mr. Malkin is schedules to speak on a panel on Thursday, July 25, on shared REMS. According to FDA’s website for the Public Meeting topics to cover include:

[I]nput on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.

To obtain input from stakeholders about REMS standardization and evaluation, FDA will hold a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS.

The docket for written comments will remain open indefinitely. However, submit comments no later than September 16th to be considered for FDA’s report of its findings on standardization and identification of priority projects.


Background materials are now available on FDA’s website here.