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The recent Pharmaceutical Pricing and Reimbursement Conference was held November 16-17th, in Washington D.C. was Q1 Productions’ first program to concentrate on the challenges the pharmaceutical industry is facing in relation to payment structures and reimbursement of new and existing therapies. This conference brought together several different perspectives and topics from leaders in regulatory, public policy, business development, health outcomes and commercial development. Through out the conference discussions focused on what tools pharmaceutical companies will need as the promise of new policies will change the way companies will define success in the pricing and reimbursement of new and existing products. The role comparative effectiveness will play in the development of new products, how the healthcare reform could bring more government involvement into pricing, as well as understanding how pharmcoeconomics will change entire business models, were a few of the main themes that were discussed over the two day meeting.

Dr. Larry Atkins, Schering Plough (now Merck) started the conference off by taking an in depth look at some of the issues pharmaceutical companies will face surrounding the new reform such as, comparative effectiveness research, 340B, follow-on biologics as well as the notion of a public insurance plan. Michael Ruggiero, Astellas concentrated on another hot topic; Medicare and Medicaid. He focused on how legislation will accelerate changes in the market landscape for new products, how manufactures will have a less prominent role as source of product information as well as policy initiatives that will further empower payers, especially government agencies. Other interesting topics of the day came from Barbara Edelman Lewis, Eisai Pharmaceuticals and her views on global trends in pricing & reimbursement, Tom Mullin and Dr. Gene Reeder, Xcenda discussing how to increase coverage by understanding how to communicate better with payers, and Josephine Sollano, Pfizer using real life experiences to demonstrate how working with R&D earlier in product development can enhance reimbursement outcomes. A dynamic panel discussion on the effect of the aging population on new therapies concluded the first day of the meeting.

Day two began with a very engaging presentation from David Parker, Boston Healthcare, He used several positive case studies that showed; by establishing value for your product you can drive market access. Margaret Pasquale, Warner Chilcott spoke on in house case studies involving using pharmacoeconomics and outcomes research can bring value based agreements a competitive edge for pharmaceutical companies. Other highlights of the day were Mick Kolassa, Medical Marketing Economics; he demonstrated how by using market research and understanding customers, pharmaceutical companies can begin to improve their pricing methods. Nancy Davidson, The Aequitas Group drew from her past experience working for CMS to show how implementing reform initiatives such as, pricing, contracting and utilization will have a profound effect on pharmaceutical and biotech products. Other unique perspectives came from Brian Seiz, Express Scripts describing the role of pharmacy benefit managers, and Nikhil Gadre, Spectrum Pharmaceuticals focused on how understanding and utilizing forecasting can add value to your products. The day ended with a successful presentation from Elise Berliner, AHRQ describing how use of clinical data can improve success in gaining reimbursement.

Overall the conference provided attendees with a chance to engage in thought-provoking conversations and networking amongst peers in the industry.  We very much look forward to hosting this event again in 2010! I would like to thank all of our wonderful speakers and sponsors in making our 1st Pharmaceutical Pricing and Reimbursement conference a great success.

Comments on our presenters

• Great use of real life experiences!
• Spot on performance, wonderful presentation on pricing methods!
• Nice explanation of trends in pricing for other countries
• Very good discussion on pharmacoeconomics
• Strong presentation, well engaged
• The use of real life data was very informative

Q1 Productions recently interviewed Roshawn Blunt, the Managing Director at The Aequitas Group, on the many challenges US pharmaceutical companies are facing in obtaining pricing & reimbursement for their therapies. The interview focused on the impact of new health policies on the pharmaceutical industry as well as the impact of the continued growth in the generics market.

The Aequitas Group will be sponsoring the upcoming Pharmaceutical Coverage and Reimbursement Conference, to be held this November 16-17th in Washington DC.

About the Aequitas Group
The Aequitas Group brands themselves as a boutique healthcare advisory firm that specializes in developing clinical and economic solutions that define product value to third-party payors, hospital administrators, investors, providers, and patients. Using their extensive technical expertise across the payor and purchaser landscape, their consultants identify market trends to position products for maximum patient access.

Q1 Productions recently interviewed Efraim Roe, The Executive Director of Medical Devices at Premier Research, on current challenges for device companies conducting clinical trials in Europe. The interview focused on the impact of new medical device directives as well as developments in the Eastern European Market.

Premier Research will be sponsoring the upcoming Medical Device Clinical Trials Conference, to be held November 2-3rd in London.

About Premier Research

Premier Research is a leading global solutions-driven CRO committed to therapeutic focus and operational expertise to deliver clinical trial services of the highest quality for biopharmaceutical and medical device companies.

The recent Immunogenicity Testing: Clinical and Regulatory Strategy Conference that took place on October 12-13th at the Intercontinental Baltimore was Q1’s first conference focusing on the biopharmaceutical industry and relevant immunogenicity topics.   This meeting brought together thought leaders in regulatory affairs, clinical and pre-clinical development, assay development and other scientists.
The biotech industry has seen significant growth in large molecule discovery, especially in the past decade with nearly 3,00 compounds currently in development.

These products are highly complex derivatives that present extraordinary challenges in their discovery, testing and ultimately their clinical applications.  At the same time, these products also present outstanding opportunities and improvements in patient care and disease states; making the discovery and utilization of these products indispensable.

The goal of this conference program was to address the challenges companies face when integrating immunogenicity testing into their preclinical and clinical research.  Our audience represented members with little experience in immunogenicity testing while others had years of testing behind them and serious concerns and interest in new methods.  With continuing oversight on immunoresponse in patients over varying amounts of time, companies must plan their strategy for meeting their endpoints and standards from regulatory bodies. One speaker’s presentation which drew much attention was Dr. Daniela Verthelyi from Center for Drug Evaluation and Research (CDER).   In addition to addressing the possibility of future guidance from the agency; she focused mostly on risk assessment.

The two-day forum included eleven case study presentations and a robust panel discussion including Dr. Geoff Hale from BioAnaLabs, Dr. Lodge from Astarte Biologics and Dr. Afshin Safavi from BioAgilytix. Dr. Zhiyan Liang’s presentation made the case for preclinical testing and touched on study design and interpreting data.  Dr. Heather Myler’s Immunogenicity Risk Assessment presentation was extremely well-received and especially relevant to the conference audience.

A key area of discussion for the group in attendance was the use of statistics in data interpretation and cut points.  Robin Marsden from Ambrx demonstrated cut point estimation and assay design.  Preceding this discussion, Dr. Marsh from Adnexus detailed the opportunities of low immunogenic risk in Adnectin and PROfusion development.

Each presentation brought unique insight and attendees noted the quality of the speakers and audience members, the lively discussion and case study information as most valuable takeaways from the meeting.  At Q1 we are excited to expand our conference offering in the Biopharmaceutical area and will continue to develop meetings based on each industry’s largest challenges.

Comments on Participating Speakers:
“Great insight into FDA’s perspective.”

“Great questions and interaction during panel discussion”

“Very clear, well-organized presentations”

“Need more of this kind of subject matter”

Feedback from Market Research Questionnaires:

Of the following concerns, which is the greatest challenge that you feel your company currently faces?

Update: Our agenda is full for speakers for the 2010 event. If you would like to participate as an attendee please visit: http://www.q1productions.com/healthcarenewmedia

The first Health Care New Media Marketing Conference featured case study presentations from leading minds in the health care industry including: The Mayo Clinic, Duke University Health System, and the Cleveland Clinic.

The conference, which focused on the successful implementation of social media for health care professionals, also explored issues such as the future implications of electronic health records, as well as the value of content management systems.

Building upon the success of the last year’s conference, the 2010 event will address how new communication innovations and the recent social media boom have affected marketing strategies for health care professionals.

We are currently looking for health care executives who have successfully executed new media campaigns for their organization.

If you are interested in presenting a case study please submit your abstract to Emily Friedman at efriedman@q1productions.com

To see feedback from the 2009 conference Click Here

The recent Medical Device Intellectual Property and Strategy Conference that took place on July 9-10th at the San Mateo Marriott was an intimate meeting filled with valuable discussion, with forty attendees participating in the two day forum.  Throughout the program, discussions addressed a wide range of the challenges that device manufacturers currently face in prosecuting, litigating and generating IP assets for their companies.

Nearly every conference Q1 Productions has done or plans to have a legal aspect to it.  While there are legalities to nearly every aspect of medical device manufacturing, we decided to focus on an integral piece which is present from the very beginning and follows each product through to commercialization.  Many of our conferences have allowed us to gather feedback from the industry.  A topic that was brought up again and again at the M&A meeting was IP for medical device companies.  The two subjects are closely tied as many companies are bought for their IP.

Intellectual property is a company’s ideas, procedures and inventions which they legally “own” through patents.  IP is considered an asset and it typically used to protect inventions and procedures which companies use.  Most medical device entrepreneurs are somewhat knowledgeable regarding patent protection, however with landmark cases, new policy and globalization, the environment has changed significantly.

A key area of discussion for the group in attendance was the fundamental IP strategy of a company and how to go about filing patents for innovations coming from R&D.  Of great interest, was a perspective of one of our panelists, a former patent examiner at USPTO.  With companies facing extended lag times from filing to acceptance, higher filing costs and uncertainty to what protection patent prosecution affords; attendees were seeking advice on what measures and best practices to take in this vital area of IP.

Another key area which received a great deal of discussion during the conference was filing and litigating patents abroad.  For most manufacturers, large and small, testing and commercializing their products in foreign markets is a vital in competition for market share.  Legal protection warding off counterfeit products and patent infringement is an aspect device executives must be highly vigilant of their foreign patent strategy.

Overall, the conference provided attendees with an excellent opportunity to network amongst industry peers and prompt discussion during robust Q&A periods.  We will look forward to hosting this event again next year and thank all of our speakers, sponsors and attendees for their participation in the program.

Comments on Participating Speakers:

“Well thought out and to the point”

“Great useful information from Venture Capital and Intellectual Property perspectives”

“Excellent, real experts with good insights!”

“Good organization and content; Interesting summary of recent case law”

“Nice explanation of patent system in different countries.”

“Well balanced discussion. Great insight into workings of patent office, very informative.”

UPDATE: If you are interested in this event check out our 2nd Annual Intellectual Property Conference to be held in April 2010 in San Mateo

The recent Medical Device Coverage and Reimbursement Conference that took place on July 13-14th at the Westin River North Chicago was Q1’s third conference focusing on coding, coverage and reimbursement specifically for the device industry.   This year’s audience was the largest with ninety delegates, speakers and sponsors from industry taking part in educational sessions and constructive discussion.

The two-day forum included thirteen case study presentations and two robust panel discussions highlighting reimbursement experts and medical device executives from companies representing many therapeutic areas both small and large.  The response we have seen from our Reimbursement series both in the US and abroad, only continue to solidify the crucial nature of this topic.

As we continue to learn of new layers and perspectives involved with gaining and maintaining reimbursement for new medical technology it is vital to bring together a range of perspectives to give a rounded view of the current political and healthcare landscape. This year we heard from a private payor, a CMS contracted payor, several expert consultants, legal counsel, a venture capital representative, Technology Assessment director and many industry executives who shared their strategy and best practices with the audience.

Dr. Baer’s presentation on the LCD process and communicating with payors, hit the mark for an audiences facing coverage decisions on their products.  Mr. Rosendale, CEO at Cytomedix presented an extremely valuable case study using his company’s negative coverage decision as the prime example.  After providing a basic overview of the AMA CPT coding organization last year, John McInnis from Arnold & Porter, delved a bit deeper with strategy and advice for device executives on coding for their products.

A key area of discussion for the group in attendance was the definition and implication of comparative effectiveness for the industry.  Brent O’Connell, MD from Argenta Advisors moderated a panel discussion based on this subject however the topic continued to surface throughout the meeting.  Preceding this discussion, Naomi Aronson, PhD from BCBSA TEC spoke to the organization’s view of cost-effectiveness in relation to their assessments solidifying the idea that moving forward, these economic and effectiveness indicators will increase in importance for device manufacturers and industry decision-makers.

Overall, the conference attendees noted the quality of the speakers, discussions and networking opportunities as most valuable takeaways from the meeting.  At Q1 we are excited to expand our Coverage and Reimbursement series to specialize in Pharmaceutical and Diagnostic industries in addition to Medical Device.

Comments on Participating Speakers:

“Excellent examples.  Reimbursement is based on case studies and examples….GREAT”

“Very close to our company’s everyday issues.  Excellent!”

“Good insights and takeaways from practical aspects of the industry.”

“Great presentation from a small company perspective.”

“Great insight into medical directors perspective.”

“Well balanced discussion. Great insight into workings of private payors, very informative.”

The recent Partnerships in Personalized Medicine Conference, which took place July 27-28 in Munich was an interesting an informative conference for diagnostic companies currently working to establish partnerships with pharmaceutical companies to successfully commercialize new companion tests.  Throughout the program, which featured keynote presentations from companies including Qiagen, Lab21, Roche and DxS, and case studies from companies such as Curidium, Almac Diagnostics and Vivacta, speakers and the audience alike had much to say about their challenges, and ways of overcoming these issues.

One session that was of particular interest was a panel discussion that took place on Monday afternoon.  Moderated by Vivacta CEO, Neil Butler, this panel discussion focused on methods for approaching pharmaceutical companies when working to initiate partnerships.  For many diagnostic companies, making the initial approach is often the greatest challenge in the development of a companion diagnostic, and the discussion was lively and quite useful for many attendees.  Panelists Anne Bruinvels from Curidium, and Stephen Little of DxS, shared their experiences in approaching all areas of the pharmaceutical corporation, from scientific and clinical teams, through to marketing and commercialization departments.  Through a holistic approach to the partnership, creating value on all levels, diagnostic companies can truly engage their partners throughout the lifecycle of the product.  During the panel discussion, the panelists took many questions from the audience dealing from issues ranging from the scientific aspects through to marketing and branding questions.

Throughout the program, one of the comments that were continually circled back to related to the need for engaging the pharmaceutical industry, and really helping them to see the value of diagnostic tests.  Often times diagnostics are an after-thought, but through partnering with them from the outset of product development, manufacturers are able to create safer, more effective products.  There is a great need to hear from pharmaceutical companies, and the goal for the next series of personalized medicine conferences will be to shift the focus more evenly onto the pharmaceutical and diagnostic industries.

Overall, the conference was very well received, with one speaker summing up the program as, “A real success: great content, high quality attendees and good discussions.”  We hope to see everyone back at next year’s program!

We are currently working on a meeting to take place mid-January in Phoenix. This conference would have two-tracks and focus on both Reimbursement and Clinical Research challenges for the device industry.

We are looking for some specific feedback from both sides. If you could, please follow the applicable link(s) below; this survey should take no more than 5 minutes to complete.

As, always we appreciate your feedback.

Survey for Reimbursement Executives

Survey for Clinical Research Executives

Q1 Productions was recently mentioned in Health Leaders Magazine. The article entitled Marketing: Are Social Media’s Rewards Worth the Risks? discusses the pros an cons of implementing social media with various marketing and web professionals from major hospitals and health institutions including The Texas Hospital Association and the University of Maryland Medical Center (UMMC).

Marc Needham, director of Web technology at Scripps Health in San Diego, walked into the meeting with a stack of papers the size of a phone book. It contained printouts from all the Web sites where people were talking about Scripps—including reviews on sites such as Yelp.com, blog posts, videos, news stories, and reader comments about the four-hospital system.

“Here are some examples of the conversations that are happening,” he told the room. “And we need to be a part of it.” Read Full Article Here