12/1: 2nd National Stakeholder Meeting. Review of Priorities in the National Vaccine Plan.

Managing Editor's Note: The meeting starts at 8am Pacific time on Monday, 12/1 (tomorrow.) The public is able to listen via webcase. Details within the post.

2nd National Stakeholder Meeting. Review of Priorities in the National Vaccine Plan

Event Date:   December 01, 2008 at 8:00am Pacific.

The workshop will focus on topics related to Goal 1 of the update to the National Vaccine Plan (Research and Development), and on draft portions of the update currently being developed by federal agencies with coordination by NVPO. The draft plan will be posted to the project website when it is given to the committee by NVPO (approximately two weeks before the meeting).

This meeting will be AUDIO WEBCAST in real-time. This link will be activated at 8 a.m. PST on December 1, 2008. Registration is not necessary to listen to the webcast--the Beckman
Center was able to provide unlimited access so anyone can join. The link
will be available on the project website at 8:00 a.m. PST on Monday
(http://www.iom.edu/?id=59440). The website is being updated right now
to clarify that registration is not needed to listen to the webcast.   

Those listening to the webcast may submit questions or comments during the meeting via email to vacineplan@nas.edu. The committee chair or IOM staff will read the questions/comments to the meeting participants. Due to time constraints questions most relevant to the days discussion (goal 4 of the draft national vaccine plan: research and development) will be addressed first.

The audio files from the meeting and available PowerPoint slides will be posted soon after the meeting. See below for a draft agenda of this meeting.

December 1, 2008: Second national stakeholder meeting, Irvine, CA
December 2, 2008: Closed committee meeting

REGISTRATION for this meeting is open until November 24th.  Registration ensures that we will have materials available for you, but is not required to attend.  Please direct any questions to vaccineplan@nas.edu.

For directions to the Beckman Center, click here.

Committee on Review of Priorities in the National Vaccine Plan
Second National Stakeholder Meeting

DRAFT AGENDA

December 1, 2008

National Academy of Sciences
Beckman Center[1] Huntington Room
100 Academy Way
Irvine, CA

Please note:
Panelists’ titles and affiliations are provided at the end of the agenda.
(*) denotes panelists who will give a formal presentation
(†) panelists who contributed to the draft National Vaccine Plan

8:30 am

Welcome and Committee Introductions

Claire V. Broome
Committee Chair

8:45 – 10:15 am

Panel 1: Encouraging scientific innovation (new vaccines, better vaccines)

Moderator: Milagritos Tapia (IOM committee member)

Panelists:
Philip Dormitzer (Novartis)
Kathryn Edwards (Vanderbilt University)
Harry Greenberg (Stanford University)
Diane Griffin (Johns Hopkins University)
Emil Gotschlich (Rockefeller University)
Ed Mocarski* (MedImmune)
Barbara Mulach† (NIH/NIAID)
Stanley Plotkin* (Sanofi)
Robin Robinson† (HHS/BARDA)
Rebecca Sheets† (NIH/NIAID) (via video)

10:15 – 10:30 pm

Break

10:30 – 11:15 am

Panel 1 continued

11:15 am – 12:30 pm

Panel 2: Financing vaccine research and development

Moderator: Claire V. Broome (IOM committee chair)

Panelists:
Harry B. Greenberg (Stanford University)
Karl D. Handelsman (CMEA Ventures)
David C. Kaslow (Merck)
Leighton Read* (Alloy Ventures)
Jeffrey Ulmer (Novartis)

12:30 – 1:30 pm

Lunch

1:30 – 3:00 pm

Panel 3: Addressing public needs and priorities

Moderator: Edgar Marcuse (IOM committee member)

Panelists:
Philip R. Dormitzer (Novartis)
Kathryn Edwards (Vanderbilt University)
David C. Kaslow (Merck)
Edward Mocarski (MedImmune)
Stanley A. Plotkin (Sanofi)
Robin Robinson† (HHS/BARDA)

3:00 – 3:15 pm

Break

3:15 – 4:30 pm

Panel 4: Regulatory and other issues in developing and licensing novel processes, new technologies, etc.

Moderator: Arthur Reingold (IOM committee member)

Panelists:
David C. Kaslow (Merck)
Karen Midthun (FDA/CBER)
Leighton Read (Alloy Ventures)
Rebecca Sheets† (NIH/NIAID) (via video)
Jeffrey Ulmer (Novartis)
Karl D. Handelsman (CMEA Ventures )

4:30 – 5:30 pm

Closing dialogue

Question to all stakeholders at the meeting
What criteria would you use to determine what objectives should receive the greatest level of attention in the national vaccine plan?

Final observations about the day’s discussions
All panelists and audience members

5:30 pm

Adjourn

PANELIST TITLES AND AFFILIATIONS

Philip Dormitzer
Senior Director and Senior Project Leader (viral vaccine research)
Novartis Vaccines and Diagnostics

Kathryn Edwards
Sarah Sell Professor of Pediatrics
Director, Division of Pediatric Clinical Research
Vanderbilt University School of Medicine

Harry B. Greenberg
Senior Associate Dean for Research and Training
Stanford University School of Medicine
Professor of Medicine (Gastroenterology & Hepatology) Microbiology and Immunology, and
Staff Physician VA Palo Alto Health Care System

Diane Griffin
Professor
Alfred and Jill Sommer Professor and Chair in Molecular Microbiology and Immunology
Johns Hopkins Bloomberg School of Public Health

Emil Gotschlich
R. Gwin Follis-Chevron Professor
Laboratory of Bacterial Pathogenesis and Immunology
Rockefeller University

Karl D. Handelsman
Managing Director
CMEA Ventures

David C. Kaslow
Vice President, Infectious Diseases and Vaccines Franchise
Merck Research Laboratories

Karen Midthun
Deputy Director, Center for Biologics Evaluation and Research
Food and Drug Administration

Edward S. Mocarski, Jr.*
Distinguished Fellow, MedImmune Vaccines
MedImmune, AstraZeneca
Professor Emeritus Stanford University
Robert W. Woodruff Professor in the Department of Microbiology and Immunology
Emory Vaccine Center, Emory University

Barbara Mulach†
Director, Office of Scientific Coordination and Program Operations
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health

Stanley Plotkin*
Executive Advisor to CEO, Sanofi Pasteur
Emeritus Professor of Pediatrics, University of Pennsylvania

Leighton Read*
General Partner
Alloy Ventures

Robin Robinson†
Director, Biomedical Advanced Research Development Authority
U.S. Department of Health and Human Services

CAPT Rebecca Sheets†
Vaccine Scientific and Regulatory Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health

Jeffrey Ulmer
Global Head, External Research
Novartis Vaccines and Diagnostics
    

[1] http://www7.nationalacademies.org/beckman/Beckman_Directions_Parking.html

Comments

[Tanners Dad]

Dear Committee,
I just want to thank you all for participating in the formulation of the vaccine plan. As a parent wrestling with the effects of Autism, many questions circulate in our community about vaccines.

I just hope in continuing discussions about the Risk, Benefit and values questions, I hope that the topic of public trust comes to the forefront. I would hope that the industry and government can come to a honest consensus to deal with those that have to deal with the downside of vaccines. Public trust will not be in place unless there is the perceived transparency and honesty in dealing with side effects and how vaccines effect different sub groups.
Regards,
Tim
Tim Welsh
Father of son with Autism

[Garbo]

So, my "takeaway" from this whole exercise is that it's designed as a forum for the manufacturers to lobby FDA and HHS to tear down regulatory obstacles and abdicate regulatory authority and scientific investigation to the pharma scientists because they know best and they're smarter. The big question of the day seems to be "how many ways can we expand our market and how can the government help us do that?" These people are so deep in the weeds of regulatory mumbo jumbo, they've lost the whole plot of making people healthy.

[Tanners Dad]

Final discussion about risk, benefit, and values. It is interesting how far they will go. 7:15 Central time "Trade Offs" "What is the risk is that is appropriate to assume."

Rebecca Sheets NIH/NIAID "the environment is shifting just to look at risks"

[Garbo]

Is "investment in the regulatory science" (4:20 PST) a euphemism for political payoffs? Because that's sure what it sounded like to me. Gee, avian retroviruses in flumist. Nope, nothing to see here, move along...

[Tanners Dad]

5 PM Central Time... Mark it on your calendar... talking about expanding the market to those over 65 and pregnant women without getting sued.

The more compelling we can spell out the effects of a disease the more likely to get buy in.

Start with... "What will the vaccine do for you"

Learn the terms "Burden of Disease" "Relative Value" "Orphan vaccines"

[Garbo]

Is there going to be a transcript of this available? Because I am really having a hard time listening without my head exploding every five seconds.

[Tanners Dad]

Companies are not interested in making a vaccine that they do not make $100,000,000 a year. 4:15 PM Central Time

Wow you would think in this multi billion dollar business they could afford to clean up their own collateral Damage?

[Tanners Dad]

I am sorry. I was dozing and awoke to that comment. It did not seem like something in their right mind would say. I still have a feeling that the government oversight bodies are much too cozy with the manufacturers.

[Jack]

Tanner's Dad,
I am a consultant for your company you just can't pay me. That is what the government pays me to do." 2:50 PM Central Time

I think this was meant in a more possible way than you took. Often a good auditor will help advise a small company in doing things the right way. Come in and say, "this is how people are doing it now."

That's not a negative connection between industry and pharma, but everyone trying to do it right.

That's how I took that line.

I got big problems with lots of other stuff though.

[Tanners Dad]

We need to formulate a few questions to send them. This group might answer them honestly? Any ideas, I would be happy to send a couple of good questions.

[Tanners Dad]

Holy cow... Did he just say that...

"I am a consultant for your company you just can't pay me. That is what the government pays me to do." 2:50 PM Central Time

Talk about no separation in the Pharmaceutical industry and Government. We need to figure out which gentleman Said that.

I was kind of falling asleep until I heard that.

[Kelli Ann Davis -- Sanofi Wants Legal Protection for Vaccinating Pregnant Women!!!!]

Just got this from Becky Estepp (who is at the meeting) regarding the statement about legal ramifications on vaccinating pregnant women and it seems Sanofi is making the rounds on Capitol Hill to get liability protection:

It was Stanley Plotkin from Sanofi. I'm @ the meeting.
Becky

[Tanners Dad]

I heard the thimerosal comment and was straining to listen when the mike went dead. Oh well...

I did like Kathy Edwards from Vanderbilt Universities comment

"We do have to engage the public"

"Extremes ... older people and babies... they are unique" talking about how they handle and are affected by disease and vaccines differently.

[Tanners Dad]

Even though the moderator has mentioned it a number of times to introduce themselves due to the webcast. I have not been able to get any names of the people speaking. Other than the first name references after people speak.

[Ginger Taylor]

My favorite part was when a man (all the men were pharma, so he must have been a Pharma rep) asked how they could eliminate regulatory hurdles and another man said that they were currently talking to US Senators about indemnification from liability so they could start vaccinating pregnant women for - was it for staff infections?

Lots of talk about more liability protection and how they are able to get around anti trust laws.

[nhokkanen]

Thanks again to the note-takers, Kelli and Tanners Dad, for posting meeting outquotes here.

[Kelli Ann Davis -- HEAD'S UP ON NEW ATTEMPT TO SHIELD VACCINE MANUFACTURES???...]

Tanner's Dad:

Did you catch the name of the guy that just spoke about this:

Legal issues of vaccinating while pregnancy….I talked to Senators regarding liability….important in keeping non-negligent issues out of tort system and is something to be addressed….don’t know how to be done but needs to be addressed considering what’s happening recently….risks/benefits and having a commission to determine this….assesment of benefits/risks….have to to decide….

[Kelli Ann Davis -- Skirting Anti-Trust Law???]

Robin Robinson†
Director, Biomedical Advanced Research Development Authority
U.S. Department of Health and Human Services

Pandemic influenza….requirements…did something different….specific question: could we use the adjuvant from one company to another cuz that's not how it's licensed….after a year, CDC/NIH/FDA/DOJ/FTC cuz anti trust issue here….(LINK WENT OUT FOR ABOUT 10 SECONDS)....anti trust abilities so we can waive that….pandemic occurred tomorrow what would we do….issue most formable was publication….companies don’t want to go that way….eventually published with commentary by HHS….going forward….this is real partnership….”if participate you get to see data and if don’t participate you don’t see data”….

[Kelli Ann Davis.... DID ANYONE ELSE HEAR THE PRIVATE CONVERSATION]

during the break before they realized the mic was still on and we could hear what was being discussed??

Woman: "spending a lot more on politics"

Man: "Dick….new vaccines...thimerosal"

Woman: "science will get there"

I was straining like heck to pick up more but it was tough. Then the link went down.

Meanwhile -- as you can see by the comments below -- whatever this IOM Committee decides in terms of the National Vaccine Plan, it will have a *TREMENDOUS* impact:

Stanley Plotkin* (Sanofi):

The point about immunology….until recently not interested in vaccines…..fortunately it’s changing…..could be promoted by old fashioned mechanism of putting your money where your mouth is…..2nd point want to hammer…..importance of recommendations…..most important external or nonscientific event is recommendation of previous IOM panel…..recommendation from committees like this really do get read….CMV….until recommendation came out, companies uninterested because didn’t think it was important….limited number of companies interested….once IOM recommendation came out…things changed…..numerous companies now interested in CMV experimental vaccines…..

[TannersDad]

Did anyone hear that 11:25 AM Central Time...

"We still don't understand how adjuvants work"

What the HE**!?

I thought it was interesting that they think there are only two directions (Issues) for a plan...

1. Vaccines for which there is a market...

2. Vaccines for which there is not a market...

[Kelli Ann Davis Novartis Comments]

Philip Dormitzer
Senior Director and Senior Project Leader(viral vaccine research)
Novartis Vaccines and Diagnostics:

“What would one want from national vaccine plan?”

“Vaccines for market – don’t need incentive it’s already there.”

“Predictable regulatory environment....while ensuring public safety one has confidnence that the vaccines makes it through.”

“Communication with public….not best advoctes because we have a financial incentive.”

“Government agencies are the advocates...”

[Kelli Ann Davis -- I'm Ready to Blow a Gasket]

Ed Mocarski* (MedImmune)

“Need adjuvants clear” yet he states “Don’t understand how they work”

Okay, I usually don’t swear but WTF???

So, following that logic, how is the vaccination program not considered a HUGE mass experiment???

I think I'm going to blow a gasket before the day is over.

[Kelli Ann Davis More Vaccines Whoopee....]

Stanley Plotkin*
Executive Advisor to CEO, Sanofi Pasteur
Emeritus Professor of Pediatrics, University of Pennsylvania

Many “vaccine targets left” and we “haven’t exhausted need for new vaccines”…..

First 30 seconds of his talk.

[Tanners Dad]

Just now able to log on...

I want to not give a play by play this week but I can not help myself. First salient point.

"We need to have a spirit of openness..." Of course he was saying this in the hopes of developing new vaccines. 11:18 Central Time

[Kelli Ann Davis For Tanner's Dad]

The link is working now:

http://www.iom.edu/?id=59440

Click on Audio Webcast. It just started.

[Kelli Ann Davis Question for IOM Committee]

Also, my first question for the Committee:

Why isn't there any Vaccine Safety Advocacy Group among the slated speakers?? Vaccine safety research is an integral part of the overall research agenda and Generation Rescue, as most of you know, is very interested in how federal funds are directed in terms of vaccine research. Please review for us the methods the IOM used to choose the participants in today's meeting.

Thank you,

Kelli Ann Davis
D.C. Political Liaison
Generation Rescue

[Tanners Dad]

Has anyone found or know a way to log on?

[Kelli Ann Davis IMPORTANT BACKGROUND ON THIS MEETING]

Just some quick background on this important meeting:

I received verbal notice for the first IOM Committee “Review of Priorities in the National Vaccine Plan” literally 2 hours before the meeting took place on March 3, 2008!!!

It’s in this meeting that I found out about the Vaccine Safety White Paper being developed by the NVAC Working Group. This Committee has been given "carte blanche" marching orders from the NVPO in regards to developing the National Vaccine Plan.

I was the only public individual in the room. The Hannah Poling ruling had just been made public and the press conference had not occurred. Geoffrey Evans, Director of the Vaccine Fund was in attendance and I mentioned the ruling during my public comment.

http://www.iom.edu/File.aspx?ID=53655

During my public comment, I stressed the need for more public involvement and transparency and of course, since I had no time to prepare a comment in advance, I spoke from my heart and commented on some of the day’s events.

Bottom Line: Please be aware that we can submit comments during the event today and it seems they will be read to the Committee at some point during the meeting:

"Those listening to the webcast may submit questions or comments during the meeting via email to vacineplan@nas.edu. The committee chair or IOM staff will read the questions/comments to the meeting participants. Due to time constraints questions most relevant to the days discussion (goal 4 of the draft national vaccine plan: research and development) will be addressed first."

This seems to be a first.