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“Regulatory, Quality & Clinical Due Diligence: The Oft-Overlooked Keys to Successful Transactions."
A Webinar Presented by The Weinberg Group
Wednesday, June 23, 2010
As development costs rise and pipelines shrink, it is increasingly important to identify new products and technologies that may have better odds of success than the uncertainties associated with truly novel products. Large and small companies alike are buying and selling ideas, technologies, and products and it is imperative for companies to understand what they are
buying - good and bad. The forgotten keys to success in life sciences transaction often are the regulatory, clinical and quality aspects of due diligence.
Joel Falk, Executive Vice President, and Michael Swit, Vice President, discussed how drug, device and biologic firms can best implement due diligence that exposes the risks lurking in a product or company's regulatory, clinical or quality history and learn key tips on what to look for and how.
This webinar was designed to help companies understand the importance of due diligence, and how it can best be utilized.
To learn more, please contact Tim Mullane.
“Science in the Courtroom.”
A Webinar Presented by The Weinberg Group
Thursday, May 6, 2010
Toxic tort and product liability cases typically have important scientific issues central to the litigation. While it’s generally recognized that all aspects of the science must be understood when building a defense, many attorneys are unsure how to effectively communicate scientific issues in the courtroom. But in today's CSI world, explaining the science is vital to winning litigation when human health and/or environmental issues are debated. This webinar talked about using the science to develop the right story, and discuss ideas for challenging the scientific arguments of the plaintiff.
Ted Dunkelberger, Senior Director, and Daniel Cooper, Esq., discussed how scientific use has evolved over time and how sound scientific evidence affects:
n Daubert hearings
n Expert development
n Demonstrative evidence
n Jury trials
This webinar was designed to help litigators and all attorneys better understand how science is part of the winning argument when presented well.
To learn more, please contact Tim Mullane.
“Claims-based Marketing and the Importance of Good Science."
A Webinar Presented by The Weinberg Group
Thursday, April 29, 2010
Whether you’re a pharmaceutical company, a food manufacturer, a cosmetic company or any other consumer goods company – making substantive, scientific claims in today’s world is becoming more complex and more difficult. In an unprecedented move, FDA warned 16 food and beverage makers against making product claims that don't strictly adhere to federal labeling rules, and recent fines for DDMAC violations are in the multi-billions. Companies must answer to FDA, FTC, NGOs, and, ultimately, consumers. With the complexity of these claims increasing, getting it right is all the more important. Those that do this properly are given huge advantages - in both market appeal and product differentiation.
Matthew Weinberg,,Chief Executive Officer, and Marla Scarola, Consultant, discussed how you can differentiate your product by making scientific claims that will work in today’s market, are based in fact, and will pass regulatory muster. They answered questions such as:
n What are the most common mistakes companies make with claims?
n Why do some health claims work and others don’t?
n How can structure/function claims be used?
n What place, if any, is there for puffery?
n Who reports the majority of violations to FDA and FTC?
This webinar was designed to help companies understand how to make scientific claims work for them in today’s complex market.
To learn more, please contact Tim Mullane.
“A Look at European Pharmaceutical Regulatory Bodies and Their Interplay with EMEA."
A Webinar Presented by The Weinberg Group
Wednesday, April 14, 2010
Last year the FDA announced that it intended to build closer ties and coordinate its efforts with European regulatory counterparts, such as the European Medicines Agency (the EMEA). U.S. drug and biologic manufacturers, in efforts to extend product life and gain critical market share, are conducting more and more product launches on a global scale as they seek to bring their products to markets beyond the U.S. It is therefore becoming more and more important for healthcare manufacturers to understand the similarities and differences between the U.S. and European regulation of pharmaceutical and biological products.
Presenter: Joel Falk, Executive Vice President, discussed an overview of Competent Authorities in the European Economic Area (EEA) and their responsibilities, the different routes to approval (centralized vs. decentralized), the Coordination Group for Mutual Recognition and Decentralized Procedures-Human (CMD(h)), the use of European experts and the European Directorate for Quality of Medicines.
This complimentary, one-hour, invitation-only webinar was designed to help guide clinical, quality and regulatory professionals through the complex intricacies of the EMEA and other European regulatory agencies.
To learn more, please contact Tim Mullane.
“Recent Sponsor and CRO Warning Letters: What Happened and What We Can Learn.“
A Webinar Presented by The Weinberg Group
Wednesday, March 10, 2010
Presenter: Carol Bognar, Senior Director, discussed what can be learned from the recent warning letters regarding clinical practices that have invalidated major trials over the last year. Carol is an experienced regulatory professional with a broad range of Quality Assurance experience, including over 15 years in Clinical Auditing. She answered the following questions:
- Why did one of the largest pharmaceutical companies receive a scathing Warning Letter
from the FDA?
- Was there fraud and/or misconduct activity detected by the FDA at one of the
clinical sites?
- What should you be doing now to safeguard the integrity of your clinical trials and data?
- What lessons can be learned from recent FDA actions?
This complimentary, one-hour, invitation-only webinar was designed for clinical, quality and regulatory professionals to help them understand what actions they should be taking to protect the investments they are making in their clinical trials.
To learn more, please contact Tim Mullane.
“Understanding CDRH’s Utilization of New Science in Regulatory Decision-Making.“
A Webinar Presented by The Weinberg Group
Wednesday, February 24, 2010
On February 18th the FDA hosted a meeting regarding key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the U.S. In addition, on February 9th, the FDA held a meeting to identify strategies and means for incorporating new science into the regulatory decision making process within the agency's Center for Devices and Radiological Health (CDRH). Understanding FDA's new goals and the outcomes from this meeting will be an important key to success for future 510(k) and PMA submissions.
Presenters: Joel Falk, Executive Vice President, and Diane Minear, Vice President, discussed highlights from the meeting, including:
- What will the criteria be for changing CDRH’s expectations of the evidence necessary for pre- or
post-market regulatory decisions? What are potential ‘‘triggers’’ for making such changes?
- How will CDRH handle communicating changes to outside parties?
- When such changes are warranted, how will CDRH apply them to devices currently under review,
or products currently on the market?
This complimentary, one-hour webinar was designed to help decision makers and regulatory staff at medical device companies to understand the changes occurring at CDRH.
To learn more, please contact Tim Mullane.
“Best Practices in Finding and Qualifying Expert Witnesses“
A Webinar Presented by The Weinberg Group
Wednesday, February 17, 2010
In the high cost world of litigation, choosing the right-minded expert witnesses is critical; even more so when it comes to litigation involving technical and scientific information. In these cases it’s crucial to identify and develop testifying experts who can effectively convey information to both judges and juries, who can understand and invalidate plaintiff’s experts’ claims, and who have the credibility to effectively illustrate all sides of the argument.
Presenter:
Ted Dunkelberger, Senior Director, and Chris Arthur, Researcher, discussed:
- Proven methods for finding the right expert witnesses for your case, with an eye toward their
direct examination
- How to qualify experts and their reports, including verification of experts' methodologies
and theories
- How to prepare experts to introduce complex scientific and technical information in a succinct
and comprehensible manner
- Strategies for preparing for your opponent's experts, including invalidating opposing experts,
their methodology and testimony
- The importance of using experts to understand plaintiff's best case arguments
This webinar was designed to help attorneys better understand how to find, and use, expert witnesses.
To learn more, please contact Tim Mullane.
“Understanding What FDA is Looking for in Post Market Safety Assessments: Going Beyond AERS.“
A Webinar Presented by The Weinberg Group
Wednesday, December 16, 2009
As we all know, getting a drug approved by FDA is hardly the last step. FDA’s oversight continues well past approvals and it has become even more vigilant about safety and efficacy. This greater focus means postmarket safety assessments are playing a growing, and increasingly critical, role within your regulatory group. This webinar covered how to get the information FDA is looking for and how to communicate this information, both good and bad, to FDA.
Presenter:
Bob Roth, Ph.D., Medical Director, discussed:
- VigiBase, the international equivalent of AERS
- Drug Abuse Warning Network (DAWN)
- National Poison Data System (NPDS)
- Useful analyses and data presentations
- Application to special risk settings
This webinar was designed to help decision makers and regulatory affairs professionals understand what FDA is looking for in post market safety assessments.
To learn more, please contact Tim Mullane.
“A Stricter FDA: How Will it Impact the 510(k) Process?“
A Webinar Co-Presented by The Medical Device Manufacturers Association and The Weinberg Group
Wednesday, December 2, 2009
The FDA is currently undergoing a significant shift in leadership, policies and practices. One place where this is highly apparent is in the approval of medical devices, and specifically the 510(k) process. Threats to the integrity of its approvals, as seen in a knee device cleared in 2008, led the FDA to announce on September 23rd that a review of the 510(k) process will be conducted by the Institute of Medicine. Obviously, medical device companies are very concerned. The findings of the report, due out in 2011, may result in fundamental changes to the process that could slow the pace of innovation, increase costs, and raise the regulatory burden on medical device companies.
Presenters:
Diane Minear, Vice President, The Weinberg Group
Jeffrey Cossman, M.D., Chief Scientific Officer, The Cossman Group
They discussed potential ramifications of the review of the 510k process, the impact on medical device development, and what companies should be doing now to prepare.
To learn more, please contact Tim Mullane.
“European Regulation on Advanced Therapies“
October 21, 2009
Rapid advances in molecular and cell biology have led to the development of novel treatments such as the administration of whole cells, DNA (gene therapy) and tissue engineered materials. These products present unique challenges and specific legislation to control these has been introduced in the European Union in the form of the Regulation on Advanced Therapy Medicinal Products (ATMPR).
Presenters:
Dr. Michael Leek, Vice President, and Angus Cameron, Senior Director, discussed:
- The Advanced Therapy legislation and guidelines and benefits available to companies
- Common regulatory issues faced by cell therapy companies
- Different approaches to cell therapies, including stem cells
- The effect of the ATMPR on cell therapy companies and available exemptions
- Current activities in the cell therapy area and future prospects
This webinar was designed to help regulatory executives understand the Advanced Therapy Medicinal Products Regulation.
To learn more, please contact Tim Mullane.
“ANDA vs. 505(b)(2) - When and Why”
September 30, 2009
The cost of development and the uncertainty of regulatory review make the development of new drugs and even new forms of older drugs a risky proposition. Generic drugs can utilize the ANDA pathway or, with some allowed changes, the 505(j)(C) regulatory route. This simplifies the development process and greatly shortens the time to market for products that fit the definition. But, what if your product cannot fit the generic definition for approval through an abbreviated pathway? Many companies have employed a 505(b)(2) strategy.
Presenters:
Joel Falk, Executive Vice President
Nick Fleischer, R.Ph., Ph.D, Vice President, Clinical Pharmacology & Biopharmaceutics, discussed:
- The definitions that delineate when you can use either the 505(j) or 505(b)(2) strategy
- A clear understanding of FDA expectations for each type of submission
- Background knowledge to effectively gather required information and plan for each strategy
- An understanding of the benefits of the different submissions (e.g., time, cost, exclusivity)
This webinar was designed to help regulatory executives understand some of the nuances of these two regulatory pathways, as well as the advantages and disadvantages of the ANDA and the 505(b)(2).
To learn more, please contact Tim Mullane.
“The Politics of Science - What Corporations Can Learn from NGOs”
September 16, 2009
NGOs and other organizations have mastered the art of attacking products by focusing on the alleged environmental or human health effects of both products and their ingredients. At times, they have resorted to using pseudo science or incomplete data sets to exploit ambiguities and create potentially bad press. Most products in today’s day and age have some risks, but the product’s utility may balance these out. When focusing only on risk, companies play into NGOs and other’s hands. Best-in-class companies clearly and thoroughly communicate both risk and benefit in a way that provides a comprehensive picture to consumers and regulators.
Presenters:
Joe Huggard, General Manager, International Operations
Matthew Weinberg, CEO, discussed:
- Understanding the consequences of inaction or inadequate action
- Why NGOs and others focus solely on the risks of products and ingredients, despite their obvious societal benefits
- The real need for corporations to build a more comprehensive risk/benefit product profile based on sound science and research
- The importance of distinguishing between hypothesis-generating research and long-standing, extensively peer-reviewed research when communicating the value of your products
- The practical scientific and socio-economic steps corporations should take when building a product profile
- A case study of an association that highlighted a product’s benefit to defend against an extensive assault
This webinar was designed to help senior executives both understand the politicization of the process, and that product strategy must go beyond the pure strength of the scientific case and create a narrative around the benefits of the product.
To learn more, please contact Tim Mullane.
“FDA’s New Strategy on Enforcement – the Growing Perils of Inadequate Compliance"
September 9, 2009
On August 6th, FDA Commissioner Margaret Hamburg outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.” With greater scrutiny and a more streamlined enforcement process, it is critical that firms be prepared to respond and take corrective action quickly upon receiving a warning letter.
Presenters:
Michael Swit, Esq., Vice President,
Matthew Weinberg, CEO, discussed:
- The post-inspection response deadline: effective September 15th, replies to FDA 483 inspectional findings must be received within 15 business days or the replies will not be considered by FDA in deciding whether to issue a warning letter
- The new accelerated and streamlined warning letter process
- Systematic follow-up after enforcement actions: the end of prolonged negotiations between companies and FDA and repeated warning letters
- The new formal “close out” process in which FDA recognizes that a firm, when applicable, has resolved the issues from an inspection
- What you can do to prepare for and properly reply to FDA inspections and warning letters
- Understanding the consequences of inaction or inadequate action
- How aggressive FDA will be under its new leadership
This webinar was designed to help senior life science executives understand what the new strategy means to them, how to maximize the chances that an FDA inspection will not trigger additional agency enforcement action and, if it does, how to respond.
To learn more, please contact Tim Mullane.
“Evaluating Product Risk in a Rapidly Changing Environment”
June 3, 2009
With the dramatic increase in legislative and regulatory focus on the environment, consumer health and safety, and employee health and safety, companies' products are more vulnerable to attack than ever. These attacks can be based on pseudo-science with regards to the ingredients, the manufacturing, the use and/or the disposal of products or byproducts.
Tom Golojuch, Senior Director, and Matthew Weinberg, CEO, discussed how to learn how leading-edge companies are conducting scientific risk benefit analyses to make decisions and develop strategies to protect their products. They shared a methodology for conducting these types of assessments, in addition to case studies of how companies can use these assessments to strategically protect and/or reposition their products.
This webinar was designed to help corporate leadership better understand how to weigh risks and benefits in a changing environment.
To learn more, please contact Tim Mullane.
“Global Lessons in Developing Biosimilars”
May 27, 2009
The path to lowering the cost of health care requires innovative thinking throughout the drug development process. Important biologic medicines are soon coming to the end of their exclusive marketing periods and follow-on biologics - also called biosimilars - are poised to be introduced in greater numbers in the US once Congress, as expected this year, enacts a formal abbreviated pathway. This webinar will provide insights from biologic development in Europe and the US, and lessons learned from the process that has unfolded to date.
Presenters:
Bob Roth, M.D., Ph.D., Medical Director,
Nick Fleischer, Ph.D., Vice President,
Peter Cooper, Ph.D., Vice President, discussed:
- The challenges associated with launching biosimilars
- The state of regulatory pathways to approval based on case experience
- Best practices and lessons learned in developing biosimiliars
- A view of the future US abbreviated pathway for biosimiliars
This webinar was designed to help senior life science executives understand the market opportunity in pursuing biosimilars.
To learn more, please contact Tim Mullane.
“FDA Call for Data on non-PMA Class III Devices - Key Points To Consider”
April 20, 2009
On April 9, FDA ordered manufacturers of 25 types of pre-1976 Class III devices to submit detailed data on those devices by August 7, 2009.
Presenters:
Diane Minear, Vice President and
Michael Swit, Vice President, discussed key issues on FDA's initiative, including:
- Understanding the significance of FDA's call for data
- Whether to keep your device in Class III or seek to reclassify into Classes II or I
- Strategic approaches to a successful submission
- How to obtain scientific data to support your data filing
- Consequences of failing to comply with FDA's requirements
This webinar was designed to help decision makers and regulatory affairs staff at affected medical device companies understand and respond to FDA's call for data on non-PMA Class III devices.
To learn more, please contact Tim Mullane.
“Pharmaceutical Development in Europe – Key Points to Consider"
April 15, 2009
The European drug development pathway and marketing authorisation processes present some key differences to those in the US. Within Europe, there are means by which costs can be reduced, and chances of approval increased, through an understanding of the guidelines and regulatory processes.
Presenters:
Angus Cameron, Senior Director
Dr. Peter Cooper, Vice President, discussed:
- Understanding the European clinical trial process
- How to obtain scientific advice from European agencies
- Appreciating the advantages of orphan medicine and SME designations
- Learning about the different review processes available to applicants within the EU
This webinar was designed to help regulatory affairs and pharmaceutical development staff understand key aspects of European product development programmes and how they differ from those in the US.
To learn more, please contact Tim Mullane.
“The Top Ten Ways to Ensure Successful FDA Meetings"
March 2, 2009
FDA Meetings, regardless of when they occur -- from the pre-IND/IDE, to End-of-Phase 2, to pre-submission filing stages -- can make or break your chances of bringing your product to final approval. Ensuring successful meetings is, thus, a key part of your overall product development plan. Discussed:
Presenters:
Joel Falk, EVP of Product Regulation & Compliance
Michael A. Swit, VP of Product Regulation & Compliance, discussed:
- Guaranteeing your submissions provide compelling support to your goals for the meeting
- Considering requesting a meeting at a time outside of the traditional stages
- Structuring your questions to maximize favorable replies
- Preparing for the actual meeting -- the "Tiger Team"
- Deciding whether to commit or not to commit
- Determining whether to bring your CEO and, if so, how best to leverage them
As well as other methods to increase success with the FDA.
This webinar was designed to help senior life science executives understand how to maximize success when meeting with the FDA regulators that control your product's destiny.
To learn more, please contact Tim Mullane.
“Medical Monitoring: Igniting Future Litigation and Strategies for Defense”
February 19, 2009
Current and future technological advances in medical monitoring and diagnostic equipment will provide plaintiffs’ counsel yet another tool for their arsenal. These rapidly-evolving technologies can detect increasingly early warning signs of illness. Thus, they will be used in an attempt to substantiate toxic claims, potentially allowing plaintiffs to expand a class or demonstrate the defendant's liability. Understanding the use and limitations of this technology requires deep scientific expertise and will be essential for successful litigation.
This webinar was designed to help in-house litigation departments and legal leadership better understand the intricacies of the science surrounding medical monitoring technology and the promise and threats that these technologies pose. Ted Dunkelberger, Senior Director, and Dr. Robert Roth, Medical Director reviewed and discussed the technology, including its current and planned usages, and shared strategies and techniques for combating medical monitoring claims in litigation.
To learn more, please contact Tim Mullane.
“The Ten Most Common Obstacles to Meeting Your Development Milestones”
January 29, 2009
It has never been more important to meet your development milestones than it is in today's climate. Everyone, from major players to smaller start-ups, is feeling the pressure to meet milestones because cash is becoming tighter, innovation is slowing and regulators are becoming more rigorous.
Presenters:
Joel Falk, EVP of Product Regulation & Compliance, and
Jeff Antos, VP of Product Regulation & Compliance, discussed:
- Deciding whether to commit or not to commit
- The disconnect between product development plans and regulatory submissions
- When preclinical and biocapability studies really matter
- Common errors in clinical-sponsored research
- Oversights in preclinical and clinical data analysis
- Integrating milestones and timelines
This webinar was designed to help senior life science executives understand why companies fail to meet their milestones.
To learn more, please contact Tim Mullane.
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