Archive for February, 2012
« Older EntriesRx Drug Pricing Boot Camp – West Coast Edition
February 29th, 2012
in Healthcare |
The ninth iteration of ACI’s National Rx Drug Pricing Boot Camp promises to supply crucial information on effective and efficient management of government pricing programs to drug manufacturers, PBMs, plans, and pharmacies. Marrying a primer on the basics of pricing for government payor programs and a comprehensive, in-depth, training program, this conference ensures that pricing groups and other related departments are well-versed in critical concepts and methodologies. Further, you will be apprised of trends, best practices, and imminent changes in government payor programs and pricing areas. This course will enhance your understanding of complicated pricing calculations and will bring you up to speed on the latest in government pharmaceutical pricing.
Gain best practices to comply with new regulations
At press time, CMS has yet to issue its new regulations governing the calculation AMP. It is anticipated that at the time of this event the CMS rule will be finalized and the industry will be facing the challenge of complying with and responding to these new rules. This conference will bring you up-to-the-minute information on recently enacted rules, regulations, and CMS guidance, detailing how your company can incorporate changes resulting from the implementation of health care reform into your pricing and compliance practices. Our faculty of pricing experts will help maximize your company’s participation in government payor programs by eliminating the confusion and uncertainty created by health care reform.
Network with and learn from your fellow pricing and reimbursement professionals
In addition to intensive training in core pricing concepts, the 9th National Rx Drug Pricing Boot Camp is also an excellent forum for drug pricing professionals to network with their peers. This event typically has about 80% of its attendees come from drug manufacturers, PBMs, plans and pharmacies, making it an excellent place to hear experts from other companies on how they overcome pricing challenges.
Maximize the value of attendance with pre- and post-conference workshops featuring background information and in-depth analysis of pricing issues
- The Pre-Conference Workshop A: Government Payor Pricing 101: Primer for Professionals New to Pharmaceutical Pricing has been designed specifically for those attendees who need a basic introduction to the complex subject of government drug pricing. This workshop will set the stage for the main conference and help attendees fl ow seamlessly into the conversations over the following days.
- The Post-Conference Workshop B: The Master Class on Federal Government Contracts and Pricing: FSS, VA, DoD, and More will build on the pricing fundamentals covered during the main conference and delve into the core pricing competencies for the “Big Four” government agencies.
Global Encryption Controls
February 28th, 2012
in Intellectual Property |
How this conference differs from other events: American Conference Institute’s 3rd Advanced Summit on Global Encryption Controls is an industry-led program that will provide an optimal benchmarking opportunity for companies on how to reduce new, complex and emerging compliance risks worldwide. Don’t miss this opportunity to obtain critical information that is not available in print or on the web. Network and learn from export counsel and compliance officers experienced in navigating foreign encryption control regulations, in key jurisdictions, including China, Asia and Europe.
Countries such as China, Russia, India, France, Ireland, the UK andCanada are all developing comprehensive laws on the import and export of encryption items – requiring specific licenses or authorizations to import, use and export items with encryption technology.
The Wassenaar Arrangement and other international agreements such as the Trans Pacific Partnership, are becoming more influential as countries seek to work together on developing a comprehensive set of encryption regulations. Knowing each country’s specific laws is essential for companies that do business on a global scale.
As the global landscape is changing dramatically each year, export compliance professionals must understand both foreign and U.S. encryption regulations. More and more, companies are using encryption items to protect the integrity of their information. In addition, more employees are traveling internationally, bringing up the challenge of remaining compliant with import laws as they enter each country.
The need for a comprehensive compliance program that incorporates all regulations and policy developments is necessary to prevent severe monetary fines, loss of import/export privileges and criminal penalties.
Key topics will include:
- How international agreements affect the import and export of cryptography
- Obtaining export permits from the SEMB in China
- Preventing steep fines for export violations in Malaysia and Hong Kong
- How to handle technology transfers through cloud computingwithout violating encryption regulations around the globe
- Russia’s recent joining of the WTO, the U.S.-Russia 2006 Bilateral Agreement and what this means for your export compliance program
- How to use Ireland and the Netherlands as key software and hardware EU distribution centers
- Complying with Israeli encryption registration and distribution requirements to prevent strict penalties and license revocation
- Complying with Canadian and Mexican export controls to prevent business losses and delays
Also, benefit from interactive pre-summit working groups:
April 17, 2012
Group A: When and How to Obtain an ERN, Apply License Exception ENC, and Self-Classify: A Practical Guide to What Every Export Controls Professional Needs to Know
Group B: Employee Travel with Encryption Controlled-Items: Preventing Unauthorized Access and Setting up Internal Compliance Procedures for International Travel
ITC Litigation & Enforcement
February 27th, 2012
in Litigation |
As the ITC braces for what is expected to be another year of record filings, one fact is clear – the ITC has quickly become the new “rocket docket.” Despite talk of the continued strain on resources at the ITC, companies across industries continue to view the International Trade Commission as the most valuable forum for quickly resolving high-stakes IP infringement disputes. Offering great benefits for patent holders while creating tremendous challenges for those who sit on the opposing side, one must come to the ITC well-equipped to litigate under the highest pressure in order to achieve success.
The 4th annual installment of American Conference Institute’s Expert Forumon ITC Litigation & Enforcement will provide attendees with a combination of insider insights and in-depth practical guidance from an industry-leading faculty of judges, senior ITC officials and expert litigators in the field.
New for this year:
• A special two-session Focus on Customs Enforcement that will addressProposed Initiatives Relevant to the Enforcement of ITC Exclusion Ordersas well as insights into How to Successfully Seek Enforcement of ITC Exclusion Orders and Address Re-Designs and Work Arounds
The one and only forum for practitioners in the industry to get updated on current issues impacting practice before the ITC, learn how to master the unique procedures and nuances of ITC practice while getting updated on the evolution of key legal issues impacting Section 337 investigations.
Medical Device Patents
February 26th, 2012
in Pharmaceuticals / Biotech / Life Sciences |
Amidst pivotal case law changes affecting the patentability of devices and landmark patent reform legislation, it is more crucial than ever for medical device companies to diligently protect intellectual property and maximize device patent life through a cohesive prosecution and litigation strategy. In response to the challenges facing the device industry in this daunting economic climate including the looming medical device tax, ACI’s Advanced Summit on Medical Device Patents provides a forum for the key players- preeminent in-house IP counsel, patent prosecutors and litigators, the PTO, and judges – to unite and share their collective knowledge to provide you with the most up to date strategies you can immediately incorporate into your practice. Featuring first-hand insight from the USPTO and retired judges in medical device litigation hotbeds including the Eastern District of Texas, this event is the premiere conference for medical device companies to devise strategies to strengthen patent rights and seize market share.
Remain competitive in this constantly burgeoning market and strengthen your device patent portfolio
Learn how to use the major developments in prosecution and litigation from leading members of the patent bar who are setting the standards in the device industry, including representatives from Boston Scientific, C.R. Bard & Medtronic. Complete your training by attending the pre-conference session designed to prepare both prosecutors and litigators for the entire process of getting a device to the market, The 510(k) Process and Patentability: Reformulating Patent Strategies in Light of Changes in the Regulatory Approval Process.
Capitalize on an epic and international opportunity for global growth.
While this is a time of great challenges for device companies, there is also a sky-high potential for growth in both domestic and previously untapped global markets. Indeed, a leading industry report estimated that the device industry was worth more than $300 billion in 2011 with the U.S. representing the largest market with sales in excess of $95 billion. At this conference, expert international and domestic practitioners will arm you with the tools to heighten patent protection in both established and emerging markets.
Do not miss your chance to be part of the most in-depth and comprehensive conference analyzing and strategizing techniques to protect your medical device patent portfolio amidst rapidly-evolving industry standards.
Life Sciences Collaborative Agreements & Acquisitions
February 24th, 2012
in Healthcare |
With future success dependent on building successful partnerships, attendACI’s 16th Advanced Forum on Structuring, Negotiating and Managing Life Sciences Collaborative Agreements and Acquisitions to learn how to be able to secure the best terms available for meeting your company’s critical needs. A front line faculty of leading deal-makers will help you to develop a dynamic alliance strategy and negotiate successful and lucrative deals.
You will learn best practices that will enable your company to advance its key business development strategies, including putting more products in the pipeline and providing for jumpstarts in revenues. Specific guidance will be provided on how to structure transactions to allow for entry into important emerging markets, and on building flexible provisions for potential future M&A into your agreements. You will learn how to structure options and payments in alternative ways to meet specific financial needs, and to provide for the sharing of costs and risks relating to clinical trial results and securing regulatory approvals. In addition, special insights will be provided for overcoming the unique challenges raised by negotiating with different types of research institutions.
While collaborations can be used to replenish pipelines and open up emerging areas, potential partners are increasingly seeking to retain valuable product rights, and power dynamics make it difficult to secure licenses or market access without granting potentially lucrative co-development options. In addition, international competition is increasing, markets are changing, and M&A activity is heating up again and must be factored into any negotiation going forward.
Add significant value to your experience by attending our Post-ConferenceMaster Class: Life Sciences M&A/Strategic Alliances Due Diligence Boot Camp
This in-depth session will help ensure that you make informed decisions regarding how the IP at issue will increase the company’s overall value, either by expanding product lines or entering new markets. Special attention will also be paid to antitrust and other legal risks that may occur when the diligence process fails to sufficiently identify areas of current government concern and inquiries.
PTO Procedures Under The America Invents Act
February 23rd, 2012
in Hatch-Waxman |
We Have Entered the Era of Patent Reform and the Evolution of PTO Procedures.
Master the Intricacies of PTO Practice in the Wake of
the America Invents Act.
Learn the “Ins and Outs” of New PTO Procedures and
When They Are Best Utilized.
In response to the many questions surrounding these procedures and their mode of utilization, ACI has designed this conference on PTO Procedures under the America Invents Act to serve as your practical and tactical guide for PTO practice post- Patent Reform. An all star faculty comprised of top PTO practitioners, in-house patent counsel, and high ranking PTO officials will walk you through the challenges associated with anticipated regulations; the new priority landscape; supplemental proceedings; post-issuance procedures, including post grant review and inter partes review; and estoppel. They will help you develop the strategies that you need to assess your options within the scope of patent reform and when the utilization of these new procedures makes the most sense.
To enhance and complete your conference experience, we are pleased to offer the following training and strategy sessions:
• Patent Reform Boot Camp for PTO Practice: Laying the Foundation for New and Amended PTO Procedures under the America Invents Act will provide you with the legal and regulatory backdrop for the new and amended procedures discussed in the main conference; and
• The Master Class on Parallel Proceedings: Strategies for Preserving Causes of Action and Your Case in Chief in Multiple and Simultaneous Forums will provide pointers and tactics for simultaneous patent challenges before the PTO, Federal Courts and even the ITC.
Reserve Your Place Now At This Critical and Essential Cross- Industry Patent Reform Event
Residential Mortgage Litigation and Regulatory Enforcement
February 22nd, 2012
in Financial Services |
With a renewed regulatory focus stemming from the implementation of the CFPB, residential mortgage litigation is more prominent than ever. The authority of the state Attorneys General continues to expand to enforce the new regulations, and it is critical that both in-house and outside counsel remain up-to-date on emerging borrower and investor claims as well as ongoing state and federal investigations. Defending against fair lending claims under TILA and SCRA, mitigating loss in loan servicing and responding to allegations of HAMP and MERS violations, and attacking the latest bankruptcy claims are all key.
In response, American Conference Institute is pleased to announce its 8th National Forum on Residential Mortgage Litigation & Regulatory Enforcement. Our unparalleled faculty of regulatory and enforcement officials, renowned jurists, expert in-house counsel, and leading outside counsel will provide you insights and strategies tailored to defend against new claims and adapt to the evolving regulatory landscape. Topics will include:
- Adapting to evolving state and federal regulatory initiatives in light of new regulations under the CFPB
- A look at the latest investor claims and regulatory initiatives in capital markets litigation
- Legal and compliance strategies for preventing and defending against TILA and SCRA claims
- Responding to allegations of HAMP and MERS violations and minimizing risk through proper procedures and loss mitigation strategies
- Navigating the foreclosure litigation process and foreclosure mediation programs, including standing and compliance issues, proof of MERS assignments, and refuting claims of loan documentation error
- Combating the use of bankruptcy as a borrower tool
- Prevailing against the latest bankruptcy litigation claims
- Managing and defending against residential mortgage class actions
Plus, register for the Pre-Conference In-Depth Focus Sessions
A | Residential Mortgage Litigation Focus on the Hotbed of California
B | Defending and Managing Claims/Class Actions in an Unrivaled Litigious Environment
Learn about complying with the Sunshine Act at ACI’s Fraud and Abuse in the Sale and Marketing of Drugs:
February 21st, 2012
in Advertising & Marketing, Pharmaceuticals / Biotech / Life Sciences |
The deadline for commenting on the “Sunshine” provisions of the Affordable Healthcare Act close Friday, and industry groups say more time is needed if payment disclosures are going to clarify the payment system instead of muddying it.
At issue is concern that a list of payments will read like a list of payoffs. Industry groups say what’s missing is the requirement that companies and doctors say why payments were remitted or received.
“We believe the work physicians do with pharmaceutical companies is of real value, but it takes good context, such as descriptions of research of educational outreach, for patients to understand that value,” said PhRMA spokesperson Kate Connors in an e-mail. Connors could not elaborate on the organization’s comments which were still in draft phase at the time of publication.
The catch is that the current reporting requirements don’t demand that the payments be explained, and the industry says it is vital to include this in the reporting standards. The Centers for Medicare and Medicaid Services is charged with interpreting the law and setting up the reporting requirements.
Coalition for Healthcare Communication’s executive director John Kamp agrees with PhRMA and told MM&M in a phone interview that the current reporting rules will make every payment a questionable one. “These aren’t bribes. These are fees for services provided,” he said. Kamp said the industry already has registries CMS could look to as templates, and cited drug maker Pfizer and medical equipment maker Stryker as examples.
Kamp’s Coalition for Healthcare Communication and the CME Coalition are also bothered by the proposal to include continuing medical education courses in the registries. Kamp said CMS is skewing the legislation, which clearly exempts these courses from the reporting registries. “They don’t have that right. It was wrong as a matter of law, it was wrong as a matter of policy,” he said.
Continuing medical education comes under the umbrella of indirect payments, which the Sunshine law excludes from reporting.
The CME Coalition said in its comments that rolling these courses into the non-exempt category will “create the erroneous impression that CME instructors have an inappropriate relationship with the organizations that support the programs.” The Coalition’s comments, which it published on its website, noted that there is a built-in firewall in the med-ed category between the industry and healthcare practitioners. The Coalition said grantors cannot dictate curriculums, make their grants conditional, or advertise in educational materials, and that these safeguards maintain the integrity of the education effort and the participants.
Kamp said CMS should hold the comment period open longer and suggested it would take six months to hammer everything out — for more comments to be fielded, the proposed rules modified, and a new comment period established. “Go forward with all the rest” he said, but added “there’s plenty of time for them to get it right, before the registry goes public.”
Tags: ACI, Biotech, Legal conferences, Marketing, Pharma
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Reinsurance Disputes in Litigation & Arbitration
February 21st, 2012
in Ethics Credits |
With the growing contentiousness of reinsurance disputes and the constantly increasing time, expense and uncertainty of arbitration proceedings, it is critical that insurers, reinsurers and the outside counsel who represent them are able to devise and pursue effective strategies for success in disputes. Dodd-Frank, recent NAIC revisions and new priorities and trends in state regulation are already having a huge effect on the reinsurance industry, and with continuing fallout from catastrophic events, asbestos and other long tail claims it is important for companies and their counsel to get ahead of these potential disputes while ensuring the best strategies to resolve them in arbitration.
ACI’s Advanced Forum on Reinsurance Disputes in Arbitration and Litigation is designed to offer cedents, reinsurers, brokers, attorneys and other reinsurance professionals valuable insight into the dispute and arbitration process. Our faculty of regulatory and enforcement officials, renowned jurists, experienced arbitrators and leading outside counsel will provide insights and strategies for managing disputes and winning arbitration awards. Hear directly from insurance commissioners on NAIC action and the latest trends in state enforcement, as well as from leaders in the reinsurance industry, including in-house counsel from: Willis Re, SCOR, Aon Benfield, Chartis, Aspen U.S. Holding, The Hartford, RGA Reinsurance Group, Partner Re, Allstate, Liberty Mutual Group, Trans Re and RiverStone-US.
Topics will include:
- An in-house think tank with insight from major corporations on the latest risks, claims and trends and how outside counsel can adapt as a result
- A panel of 5 state insurance commissioners moderated by the Chief State Liaison at the NAIC, with a discussion of recent NAIC action and revisions, new priorities and emerging trends in state regulation, and the impact of it all for reinsurance litigators and arbitrators
- View from the Bench led by Federal Magistrate judges who will provide their expert views on overturning arbitration decisions, umpire and arbitrator disqualification, loss allocation and consolidation, and agreements to maintain confidentiality
- A panel of experienced arbitrators will show you how to resolve the thorniest issues of discovery, claim consolidation and acting outside the scope of the contract
Plus, complete your conference experience with two in-depth focus sessions:
A- Reinsurance Case Law Update: Recent Notable Decisions and Their Impact on Reinsurance Disputes
B - On the Horizon: Longstanding and Emerging Reinsurance Disputes Regarding WTC, Asbestos, Mortgage Backed Securities, Hydro-Fracking and Natural Disaster Claims
Brain Injury Litigation Summit
February 20th, 2012
in Employment & Benefits |
Jury verdicts for brain injury litigation claims are on the rise and can range in the $10-$16 million. With so much at stake, it is essential for both plaintiff and defense attorneys and in-house insurance and hospital professionals to remain abreast of all that is happening in the brain injury litigation landscape.
Attend ACI’s Premier Summit on Brain Injury Litigation and hear from an unparalleled medical and legal faculty that will provide new tips and strategies for establishing causation/alternative causation theories and developing a solid case from the very beginning stages of litigation. Learn how to craft courtroom strategies for effective jury communication, use cutting edge technology for demonstrative evidence, interview engaging and knowledgeable medical expert witnesses, and assess the monetary value of your case.
Recently, there has been a surge in mild to moderate traumatic brain injury litigation. Because of this shift in focus, it is essential for outside counsel to learn how to detect mild to moderate traumatic brain injury, understand subtle nuances and wade through sophisticated medical terminology. Our panel of leading medical and legal experts will guide you through the complex medical terms associated with mild to moderate traumatic brain injury. No longer is the MRI/CAT scan the only game in town in detecting and imaging a brain injury. Experts in the field will explain the science behind the current and emerging neuroimaging tests to detect mild to moderate TBI that are shaking the industry and creating controversy. Outside counsel will benefit from a thorough review of these neuroimaging tests and determine which are worth spending the cost up front and which are “junk science.”
Furthermore, pre-trial costs can reach in the six figures making it vital for outside counsel to have the necessary tools to assess the monetary value of the case before hand in order to maximize the strength of the case. Telling the jury the extent of the brain injury through use of demonstrative evidence such as 3D animation and brain slicing video has become the norm. This costly method can be effective and useful if the right medical expert witness can testify, deconstruct complex medical terms and engage with the jury. Learn how to wade through the myriad of choices out there in terms of demonstrative evidence and which will add value to your case.
PLUS, add value to your attendance by also registering for the Post-Conference Strategy Sessions on the Intersection of Law & Science:
- Successfully Litigating a Brain Injury Case from Start to Finish
- Sound Discovery Practices Related to Depositions, Social Media, Expert Witnesses and Lay Witnesses
This event is a premier, must-attend event for outside counsel, medical professionals, and insurance professionals involved with brain injury litigation cases. You will not want to miss this unparalleled opportunity to obtain up-to-the-minute information and critical advice from the nation’s leading medical and legal experts.
