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February 19, 2014

Leerink's Global Healthcare Conference 2014 Focuses on a Variety of Emerging Health Products

leerink.pngOn February 12 and 13, 2014, Leerink Partners LLC ("Leerink") held its annual Global Healthcare Conference at the Waldorf-Astoria Hotel in New York, New York. Each year the Conference includes emerging themes in healthcare, where Leerink's equity analysts moderate discussions with MEDACorp specialists to provide unique and timely insights.

In addition to the company presentations, this year's line up featured the following panels or keynote speakers with some observed comments or trends:

• Panel: The Future of Medical Devices in an Evolving Landscape: A Shifting Emphasis to Patient Monitoring and Customizable Solutions

  • Patients view surgeons that incorporate robotics in their practice as the better doctors, driving more surgeons to utilize them in their practice. As surgeons become more familiar with these devices, patients may have more options for surgical procedures and implants.

  • Larger companies are looking at controlling infections caused by implanted medical devices with special coatings--either anti-infectives or antibiotics, particularly for use in higher-risk patients. There is an increasing need, however, for implants to have built-in tools for monitoring the devices. But as medical devices become more complex, such as hip, knee, or total joint replacements, these devices will require preapproval marketing applications ("PMAs") with clinical data rather than less costly and time-consuming 510(k)-type premarket clearance applications. Since PMAs cost companies more than 510(k) applications, these newer devices will cost third party payors and patients more.

  • Hospitals continue to be under a lot of pressure not to lose patients, so they may seek lower margins by having surgeons add anti-infective coatings or antibiotics rather than purchasing more costly versions with the coatings or by importing "generic" implants from other countries that may not be as rugged as the versions cleared for use in the U.S. FDA's new unique device identifiers and improved monitoring, however, may reduce use of such imported devices with unclear pedigrees.

Continue reading "Leerink's Global Healthcare Conference 2014 Focuses on a Variety of Emerging Health Products" »

February 7, 2014

FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition

DNApurple.jpgOn February 4, 2014, the U.S. Federal Trade Commission ("FTC") held a Workshop entitled: "Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition". The Workshop was well attended and sought to solicit a variety of views on the marketing of follow-on biologics, currently referred to as "biosimilars" under the Biologics Price Competition and Innovation Act ("BPCIA").

Briefly, the BPCIA defines "biosimilarity" as "[T]he biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." A biosimilar is submitted as a 351(k) application, which must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and a clinical study or studies, unless FDA determines, in its discretion, that certain studies are unnecessary. To meet a higher standard of "interchangeability," an applicant must provide sufficient information to demonstrate biosimilarity, and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. According to the BPCIA, interchangeable biosimilar products may be substituted for the reference product without the intervention of the prescribing healthcare provider.

As explained by Edith Ramirez, FTC Commissioner, many state legislatures have either passed or are considering legislation to explain how to handle biosimilars that are not interchangeable (and sometimes including interchangeable biosimilars), which may affect competition for the market at this juncture before even one biosimilar has been approved. In particular, many of the state laws or bills include provisions for prescriber notification of possible biosimilar substitution for the referenced innovator biologic product. FDA and other regulatory bodies are still considering universal nomenclature for biosimilars, which may either create the same or similar names for biosimilars and their referenced innovator biologic products. The FTC sees similarities between biosimilars and how generics were first perceived and opportunities to either facilitate or hinder acceptance of biosimilars in the market that they wanted to explore in this Workshop.

Continue reading "FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition" »

February 3, 2014

REMS Summit Hosted by ExL Pharma Delivers Thought-Provoking Stakeholder Discussion

Banner REMS.pngOn January 28-29, 2014, ExL Pharma hosted its 6th Annual Risk Evaluation and Mitigation Strategies ("REMS") Summit in Alexandria, Virginia. For the first time since the Summit has been held, key members from the FDA's Division of Risk Management attended. In particular, Claudia Manzo, Director, FDA Division of Risk Management, spoke in the main opening panel along with FLH Partner Brian J. Malkin and Yola Moride, Ph.D., FISP, Professor, Université de Montréal. The opening panel featured a discussion of some key take aways from FDA's Public Meeting on Standardizing and Evaluating REMS in July 2013 and follow-up meeting in December 2013 to identify and discuss new methods for communicating risk information as part of REMS to health care providers and its target populations. The Summit also featured a pre-conference workshop on regulatory negotiation and internal and external audits for REMS, as well as a concluding roundtable session, which focused on some of the key topics raised. The Summit was closed to the media to help encourage a free exchange of ideas.

As promised, the Summit built upon recent REMS events and discussions featuring the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies to share their perspectives, experiences, and leverage the discussions in a well-rounded and interactive platform to take a proactive approach covering:

  • 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.

Tempered by thoughtful observational comments provided by the Summit's Chairperson, Mibhor D'Silva, Vice President Safety and Pharmacovigilance, Astellas, and insight from the various keyholders, Summit participants were not only challenged to provide their opinions but also their insight for improving REMS going forward. While many of the discussions focused on the impact of REMS on healthcare settings or health care providers, the goal of REMS to provide better patient risk information and treatment outcomes was also emphasized. Many of the participants commented that they learned much from each other, in particular the logistics of REMS implementation in health care settings, where updates are a constant challenge.

If you have any comments or ideas to share or are interested in speaking at the 7th REMS Summit in 2015 please contact Kai Hahn, Senior Conference Director, khahn@exlpharma.com.

January 15, 2014

The FDA Is Speaking at the 6th REMS Summit

Banner REMS.pngDon't miss your chance to learn and network with REMS experts from organizations such as the FDA, Pfizer, Novartis, the University of Michigan, Vivus, Purdue Pharma, Biogen, New Haven Hospital, Lehigh University, Sanofi and many more at the 6th REMS Summit. Join our outstanding speaker faculty and reserve your seat now - RESERVE YOUR SEAT TODAY

The OIG report in 2013 stated a lack of comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety. In response to that the FDA held a public meeting in July and December to discuss how REMS programs can be improved, standardized and evaluated. To foster the exchange between the different stakeholders further, EXL Pharma has put together an event that features a cross section of small to large pharmaceutical companies, pharmacy organizations, hospitals, academia and solution providers, who will leverage key ideas presented at those meetings.

DOWNLOAD THE COMPLETE BROCHURE HERE

Hot topics include:

  • Get an update on the FDA's report and an outlook on what to expect in 2014

  • Highlight Antitrust issues raised by REMS programs

  • Address challenges and opportunities in a single shared REMS and REMS that involve CME

  • Discuss standardization approaches and initatives

  • Leverage risk mitigation tools and strategies from other industries for Life Sciences

  • Evaluate differences and similarities of RMP vs REMS

  • Outline recent studies on the impact of eHealth

  • Discuss meaningful metrics to measure the burden

  • Hear case studies on REMS modification

  • Engage in Roundtables to discuss REMS challenges with peers
Check out the Agenda

For information on exhibiting & sponsorship opportunities, please contact Eric Morrin at 212-400-6228 or emorrin@exlpharma.com


Press Contact: Shari Gelfand, 917-258-5145 or sgelfan@exlpharma.com

January 9, 2014

FLH's Brian Malkin Speaks at Montgomery County Department of Economic Development Program: Innovative Strategies for New Product Development

MontgomeryCountyEconomicDevelopment.jpgOn February 5, 2014, FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: "Innovative Strategies for New Product Development". The event will be held at the Montgomery County Department of Economic Development offices in the Shady Grove Innovation Center, 9700 Great Seneca Highway, Rockville, Maryland 20850 from 8-10 am.

The program will begin with networking and then launch into Mr. Malkin's presentation designed to help you take your innovative biomedical research to the commercial product stage. Mr. Malkin will share his insight from working with biotechnology companies and working as a Regulatory Counsel at FDA for over 9 years at FDA in the Office of the Commissioner and the Center for Drug Evaluation and Research, where he was worked on all types of FDA-regulated products.

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
Janis.Pitts@MontgomeryCountymd.gov.

January 2, 2014

Cellular and Gene Therapy Advisory Committee Meeting Rescheduled for February 2014

genetherapy.jpgOn February 25-26, 2014, FDA will hold a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. A majority of the meeting will concern oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. While FDA will post meeting materials at least two business days before the meeting, one item that will likely be discussed is a workshop held in September 2002 on Evidence Based Assisted Reproductive Technologies (ART) that concerned oocyte modification. Approximately half of the second day will focus on considerations for the design of early-phase clinical trials of cellular and gene therapy products, which was the topic of a revised guidance published on July 2, 2013. This meeting was originally scheduled for October 22-23, 2013 but was postponed "due to resource constraints arising from the government shutdown."

The July Draft Guidance provided recommendations to assist in designing early-phase clinical trials of cellular therapy ("CT") and gene therapy ("GT") products, collectively referred to as "CGT products", which covers most Phase 1 trials and some Phase 2 trials. FDA considers clinical study designs for CGT products to be different because of the way the products work and the potential for substantial risk. In the past, FDA halted CGT therapies due to experiences that included: (1) multiple-organ failure and death of a subject receiving a GT product for ornithine transcarbamylase deficiency, (2) late-onset T-cell leukemia in subjects who received a GT product for X-linked severe combined immunodeficiency, and (3) the development of tumors in the brain and spinal cord of a patient who received intrathecal allogenic stem cells for ataxia telangiectasia.

FDA's Guidance on early-phase clinical trials explained that unlike many small molecule drugs, there is much less experience across a broad population with CGT products, leading to more uncertainty with clinical study design and controls. Some CGT products persists in humans for an extended time period and the administration may involve surgery or other invasive procedures that may require use of an investigational medical device. Allogenic CT products, GT vectors, and proteins that may be produced by CGT products have the potential to produce an immune response that may produce an unintended adverse reaction or sensitivity to a CGT product in the future. CGT products are cellular products and so mimic the complex, dynamic nature of living cells, which can migrate within the recipient's body.

Continue reading "Cellular and Gene Therapy Advisory Committee Meeting Rescheduled for February 2014" »

December 18, 2013

IBC Patent Litigation Conference Features Issues Confronting the Creation of a Unified Patent Court, Pay-for-Delay, and More

unifedpatentcourtmap.jpgOn December 11-12, 2013, IBC Legal Conferences held its annual International Patent Litigation Conference. This Conference has historically brought together an impressive cast of speakers, and the 2013 Conference was no exception.

Opened by the Rt. Hon. Sir Robin Jacob, Hugh Laddie Professor of Intellectual Property Law, UCL and former Lord Justice of Appeal Court of Appeal of England and Wales, the audience was regularly treated throughout to his strong views on the burning issues. Kevin Mooney, Partner, Simmons & Simmons, chaired the Conference, which began with an update on the Unified Patent Court ("UPC") and a panel commentating on the multitude of possible scenarios and outcomes. Neil Feinson, International Policy Director of the United Kingdom's ("UK's") Intellectual Property Office ("IPO"), also provided a number of updates. He expects that the UK will ratify the Unified Patent Court Agreement by March 2015, and he reiterated that the whole project was expected to be self funding in the long run, cost effective, and competitive. But there are still a lot of unknowns, Feinson explained, such as the likely number of cases and court running costs, making calculations of costs and therefore fees to be charged difficult to estimate. The UK is working on addressing the unknowns, he said, and it is expected that as the Court gets underway, there likely will be fee reviews on a regular basis. The UK IPO is ultimately responsible for the information technology system, and Feinson expects that an "off the shelf" solution will be purchased rather than a new design.

A free 361-page book covering the 15th Draft on Rules of Procedure in three languages was made available to participants, but the book is likely to be out of date fairly soon, as Mooney and his team of rules drafters are well on the way to coming out with clarifications and updates. The final version of the Rules could be out as early as June 2014.

Continue reading "IBC Patent Litigation Conference Features Issues Confronting the Creation of a Unified Patent Court, Pay-for-Delay, and More" »

December 12, 2013

China IP Conference at George Washington Law School Suggests Reforms Making Progress

GW Law China IP Conference 2013

Yesterday, The George Washington University Law School hosted its third annual China Intellectual Property ("IP") Conference: Patent and Trade Secrets: A Public Discussion on How to Protect Technologies in China. The Conference focused on the impact of the resolution and spirit of the recent Third Plenum of the 18th Communist Party on the commercial rule of law and IP. Moderated by Mark Cohen, Senior Counsel, China, United States Patent and Trademark Office ("USPTO") and John Whealan, Intellectual Property Advisory Board Associate Dean for Intellectual Property Law Studies, George Washington Law School, the Conference featured a deep bench of legal experts from academia, government, corporations, trade associations, and domestic and international law firms. Keynote speakers included Randall R. Rader, Chief Judge, U.S. Court of Appeals for the Federal Circuit, David J. Kappos, Former Director, USPTO, and Teresa Stanek Rea, Former Deputy Director, USPTO. Rather than a typical PowerPoint-type presentation format, the Conference featured roundtable discussions with input from the audience, who included seasoned IP prosecutors and litigators with experience in China.

The first panel discussed overall fiscal and other developments in China and how they related to IP changes. Whealan noted that it has been difficult to develop an Chinese economy that depends on IP when the corporate managers are government employees (i.e., no "real" managerial class) and the judicial system is semi-legislative (e.g., it added copyright law before there was a formal copyright law). Rader said that the Chinese use IP as an "area of experimentation" beyond the usual, where he saw some positive movement in the judicial system. For example, Rader explained that he used to say that companies should use something other than the courts to enforce their patent rights; now, he thinks if you do "everything right," you can win. Rader has also been involved in IP information/education exchanges with the Chinese judicial system, which has helped to lead to thoughts about developing a specialized IP court in China. He was also encouraged by the selection of a lawyer for the Supreme People's Court. Further, over time he has witnessed a transformation from China's manufacturing economy that undervalued IP to an economy more dependent on innovation, where there has been a need for greater IP protections.

Cohen observed that while China has been developing its IP program, there has been less emphasis to protect pharmaceutical patents and no national trade secret protection. In some sense, China approached IP protections backward: first there was IP (1983) then there was property law (2007), which never allowed IP law to develop properly. Cohen believed that the Chinese judicial system needs more transparency--important or "embarrassing" cases often are deliberately not published, leading to disclosure of "model decisions" that do not mirror what happens, and no "real Markman [claim interpretation] cases." Added to that are provincial government control differences, Conrad Wong, Attorney-Advisor, Enforcement Unit, Office of Policy and External Affairs, USPTO, described, and differences of opinion regarding nondisclosure agreements (e.g., employees believe they are not bound by IP rights to their previous employer).

Continue reading "China IP Conference at George Washington Law School Suggests Reforms Making Progress" »

December 6, 2013

Working Together in a Single Shared REMS System ...

is a beneficial yet challenging task. In May 2013 Prometheus Laboratories submitted a Citizen Petition to the FDA, requesting more guidance on rulemaking on the standards and processes for establishing a single, shared Risk Evaluation and Mitigation Strategies ("REMS") System. One of the stated reasons why Prometheus asked for greater clarification of the single, shared REMS process is the concern over antitrust risk. Antitrust issues associated with REMS and the benefits and challenges of a collaboration in a single shared REMS are two hot topics on the agenda of the

6th Risk Evaluation and Mitigation Strategies Summit
at the Westin Alexandria, January 28-29th 2014 in Alexandria, VA

RESERVE YOUR SEAT TODAY and save up to $300
EARLYBIRD EXPIRES DECEMBER 13th 2013
Please Use Priority Code: C453MP1

This event features a cross section of small to large pharmaceutical companies, pharmacy organizations, hospitals, academia and solution providers and provides a platform to share best practices and leverage fruitful discussion with regards to:

C453-photostrip.jpg
DOWNLOAD THE COMPLETE BROCHURE HERE

Hot topics include:

  • Get an update on the FDA's report
  • Highlight Antitrust issues raised by REMS programs
  • Address challenges and opportunities in a single shared REMS and REMS that involve CME
  • Leverage risk mitigation tools and strategies from other industries for Life Sciences
  • Evaluate differences and similarities of RMP vs REMS
  • Outline recent studies on the impact of eHealth
  • Discuss meaningful metrics to measure the burden
  • Hear case studies on REMS modification
  • Engage in Roundtables to discuss REMS challenges with peers

logo.png

December 3, 2013

FTC Biosimilar (Follow-On Biologics) Workshop Next Week on Naming Proposals and Competition

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for dna.jpg[Update: The Workshop was cancelled on December 10, 2013, due to weather-related closure of the federal government. On December 30, 2013, FTC announced the Workshop would be held on February 4, 2014, at the FTC Conference Center at 601 New Jersey Avenue, NW, Washington, D.C. and will be webcast. FTC will publish an updated agenda and list of speakers. The comment period is unaffected by the rescheduling of the event, i.e., due by March 1, 2014.]

On December 10, 2013, the Federal Trade Commission ("FTC") will host a Workshop on the Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics. FDA has yet to receive its first biosimilar application filed under the Biologics Price Competition and Innovation Act of 2010 ("BPCIA"). Despite this, the FTC believes that some state legislatures have already passed laws that may affect substitution of biosimilars for their referenced innovator biologic products. As a result, the FTC is concerned that these laws may deter the development of biosimilars and raise the costs for consumers without biosimilar options.

FTC's Workshop plans to cover some of the following questions:

  • How would the new state follow-on biologic substitution laws passed this year, or similar proposals pending in other states, affect the competition expected between or among biosimilar, interchangeable and reference biologic medicines?
  • What are the rationales behind new state proposals and laws for regulating follow-on biologic substitution?

Continue reading "FTC Biosimilar (Follow-On Biologics) Workshop Next Week on Naming Proposals and Competition" »

December 2, 2013

Q1 Productions Maximizing Patient, Observer & Clinical Reported Outcomes Conference

Thumbnail image for Thumbnail image for Q1 ProductionisAddressing Industry Concerns Regarding FDA Regulation and Compliance While Improving Utilization of Clinical Outcome Assessments via Increased Instrument Efficiency and Use of Innovative Technologies to Ensure FDA Label Inclusion

Clinical outcome assessments within the pharmaceutical industry provide critical data to researchers to support a variety of claims, from safety to cost effectiveness, to regulatory bodies as well as healthcare providers and third-party payers. Pharmaceutical executives are eager to maximize the use of outcome assessments, but must understand the optimal tools that will enable them to effectively collect, validate, and analyze the information gathered from patients, clinicians and proxy caregivers.

The Maximizing Patient, Observer & Clinical Reported Outcomes Conference will provide an opportunity for executives throughout the industry for high-level education and networking, blending perspectives from academia, industry-veterans, and regulatory authorities. This event will take place in Alexandria, VA on January 13-14, 2014. Sessions will cover a range of topics, including presentations highlighting various instruments that can be utilized to collect reported outcomes, as well as new applications and mobile technologies, modernizing the methods through which this information is gathered. Insightful commentary will also provide detail on validation methods, as well as techniques for working with the range of observers and with the most appropriate tools for those populations.

Continue reading "Q1 Productions Maximizing Patient, Observer & Clinical Reported Outcomes Conference" »

November 8, 2013

Korea-Maryland USA Bio Expo Held in Rockville, Maryland Last Week

Korea-MD, USA Bio Expo Opening Ceremonies.JPGOn November 7 and 8, 2013, FLH attorneys Brian J. Malkin, Charlie J. Raubicheck, and Scot B. Pittman attended and participated as sponsors of the 3rd Annual Korea-Maryland, USA Bio Expo. The Expo hosted leading Korean pharmaceutical, biotechnology, and medical device companies at the Universities at Shady Grove Conference Center in Rockville, Maryland. The event provided networking opportunities and seminars from industry professionals with the goal to encourage collaboration of Korean biotechnology businesses utilizing the resources in the Washington, D.C. area.

The opening ceremonies featured presentations by a variety of local and Korean representatives committed to helping Korean business set up operations in the United States, particularly Maryland, and specifically Montgomery County. The speakers included:


  1. Ambassador for Green Growth & Environment, Kyungryul An

  2. Embassy of the Republic of Korea, Consul-General Do-ho Kang

  3. Maryland Secretary of State, John P. McDonough

  4. BioMaryland Center Executive, Director Judy Britz

  5. Montgomery County Executive, Isiah Leggett

  6. Montgomery County Department of Economic Development Director, Steve Silverman

  7. Hanbat National University Graduate School, Dean Byung Wook Ahn

  8. George Washington University, Department Chair of East Asian Languages and Literatures Young-Key Kim-Renaud.

The Maryland representatives highlighted some of the advantages for doing business in Maryland. For example, Maryland offers income tax credits equal to 50% of an eligible investment for investors in Qualified Maryland Biotechnology Companies ("QMBCs"). This tax credit program offers incentives for investment in seed and early stage, biotech companies, up to $250,000. To qualify, companies are required to: be less than 15 years old; have their headquarters and base of operations in Maryland; employ fewer than 50 people, and have a valid certification from the Department of Business and Economic Development ("DBED"). Investors are required to submit applications prior to making an investment. DBED reviews the applications and issues initial credit certifications within 30 calendar days.(http://www.choosemaryland.org/businessresources/pages/biotechnologyinvestmenttaxcredit.aspx ). Chevy Chase, Maryland also is home to a branch of NEA, one of the country's largest venture capital funds, with the potential to help support Maryland businesses such as those in the biotechnology field.

Continue reading "Korea-Maryland USA Bio Expo Held in Rockville, Maryland Last Week" »

November 7, 2013

GPhA's Fall Technical Conference Delivers Messages of GDUFA, Quality, and More - Day 2

gpha-headerLogo.gifDay 2 of the Generic Pharmaceutical Association ("GPhA's") annual Fall Technical Conference focused on RTR issues, FDA's efforts to update the inactive ingredient database, stability, Uhl's OGD update, and closing remarks.Some of the key take aways for RTRs is that once year three of GDUFA kicks in, FDA will take a closer look at RTR issues such as DMFs, which need to be accepted for referencing rather than just filed prior to the ANDA. In the past, many sponsors had filed their ANDAs close in time--and sometime simultaneously--with the ANDA to prevent competitors and referenced drug holders alike from suspecting their ANDA filing in advance of a patent challenge notice. Now FDA is recommending that DMFs be filed at least six months in advance to permit a completeness assessment for filing. FDA's recommendation is based on an observation that it typically takes between two to five months for DMF holders to address submission deficiencies.

Johnny Young, M.A.L.A., Regulatory Health Project Manager, OGD, explained that OGD has been viewing excipients more critically than before, e.g., ophthalmic drugs need to be Q/Q even though the current regulations provide certain exceptions, based on what has been learned. Young also noted that there are new microbiology and stability requirements for ANDA that may also lead to RTRs, and he recommended that industry take a careful look at the new RTR guidance as well as ANDA checklist, which is regularly updated. Representing industry's viewpoint, Robert Pollock, M.S., R.Ph., Senior Advisor and Member of the Board, Lachman Consultant Services, Inc. said that the proposed five-day turn around to remedy a RTR prior to its issuance (from the current 10-day scheme) may prove to be difficult for industry to meet. Pollock also thought that it would be important for ANDA applicants to submit higher-quality ANDAs at the onset rather than hoping to fix them later, even when there is a rush to be the first patent challenger for 180-day exclusivity, because a RTR could remove that incentive.

During a question-and-answer period, FDA explained that its new RTR guidance put into writing many of the policies it had been following, so not that much in it was particularly new. Ian Margand, R.Ph., Regulatory Support Management, OGD, explained that for GDUFA to work, ANDA applicants have to take a greater responsibility for their DMF holders. In particular, ANDA applicants need to provide time for their DMF holders to provide an adequate DMF for their ANDA to be filed. Regarding labeling carve-outs to attempt to avoid certain Orange Book-listed patents with method-of-use claims or unexpired exclusivity, Young said that like other RTR issues, FDA will provide ANDA applicants with five days to fix prior to receiving an RTR, if the carve out is not in line with the Agency's expectations of appropriate carve outs.

Continue reading "GPhA's Fall Technical Conference Delivers Messages of GDUFA, Quality, and More - Day 2" »

November 6, 2013

GPhA's Fall Technical Conference Delivers Messages of GDUFA, Quality, and More - Day 1

gpha-headerLogo.gifOn October 29-30, 2013, the Generic Pharmaceutical Association ("GPhA") held its annual Fall Technical Conference that featured a Keynote by Director, Center for Drug Evaluation and Research ("CDER"), Janet Woodcock, M.D., the Acting Office of Generic Drugs ("OGD") Kathleen "Cook" Uhl, M.D., and a variety of other FDA and industry speakers. While the Conference included typical fare such as bioequivalence issues, a predominant topic was FDA's implementation of the Generic Drug User Fee Act ("GDUFA").

Starting with Woodock's Keynote, her message was OGD's reorganization, including the development of the Office of Product Quality ("OPQ") to help drive home the message that abbreviated new drug applications ("ANDAs") need to be high quality for OGD to meet its GDUFA goals. Some of the changes Woodcock spoke about included reviewing generics by dosage form by specialized groups and centralizing elements of the generics program in 2015: microbiology, project management, and a policy office with policy functions for chemistry, manufacturing, and controls, quality issues, and inspections. Woodcock described OGD as having assembled "SWAT teams" to handle specific types of ANDA applications in the backlog, noting that next year will be critical to control the backlog before GDUFA measures kick in 2015.

Next a barrage of quality presentations from FDA and industry followed, emphasizing the need to develop quality metrics, methods to develop internal audit programs to continuously monitor identified quality issues, and FDA's expectations for quality going forward. FDA said that Quality by Design ("QbD") needs to be second nature, focusing on metrics that are clinically relevant to patient safety and health. Some metrics suggested included: batch/lot failure rates (rejected, reworked), right the first time, demonstration of active pharmaceutical ingredient/excipient compatibility and stability, and standards for sampling/acceptance plans. Rather than just include passing bioequivalence studies, FDA explained that sponsors need to explain how they arrived at a bioequivalent drug product and their scale-up plans.

Continue reading "GPhA's Fall Technical Conference Delivers Messages of GDUFA, Quality, and More - Day 1" »

November 5, 2013

Korea-Maryland, USA Bio Expo 2013 in Rockville, Maryland Later this Week

korea-MD Bio Expo.jpgOn November 6-9, 2013, the 3rd Annual Korea-Maryland, USA Bio Expo will showcase the best opportunity meet with Korea's leading pharmaceutical, biotechnology, and medical device companies. The main show dates are November 7th and 8th at the Universities at Shady Grove Conference Center in Rockville, Maryland. Some of the major events associated with this Expo include:

  • 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 including FLH's key FDA/Regulatory Partners Charles J. Raubicheck and Brian J. Malkin. Topics that will be covered on the main show dates include: (1) Investigational New Drug (IND) Process - Nonclinical, (2) Chemistry Manufacturing and Controls (CMC) Process, (3) Clinical Study Design Phase I, Phase II, Phase IIA, Phase III - Drugs, (4) Pharmacometrics and Clinical Study Design, (5) Current Good Manufacturing Practice (cGMP) and its Role in Regulatory Drug Quality, (6) Current Drug Shortages and Orphan Drug Disease Pharmaceutical Development, (7) Innovative Strategies for New Drug Development, and (8) the Patent Process for Drug Repurposing Development.
  • 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.