[Perryc]

Last week I participated on a panel for the 21st annual meeting of the New York Pharma Forum, which is an association of primarily Asian, mostly Japanese pharmaceutical companies that sell in the US. The program took place in the newly renovated Plaza Hotel, and one of the perks was a stay in the hotel.

It seems like nearly everyone in the business of finding cures has come around to understand the importance of the patients' perspective in the development of new therapies. As I was quoted in a 2006 Fortune Magazine feature article ("Deadly Caution", by Clifton Leaf) with a simple, almost self evident solution to many of the methodological and scientific challenges facing the FDA and industry, "The missing ingredient in the development of new therapies is the voice of the patient." This has been the motto of the Parkinson Pipeline Project, who along with PDF and in collaboration with FDA Office for Special Health Initiatives recruit, train, and keep informed highly qualified patient consultants to provide the missing ingredient.

Please contact me for further information.

Perry Cohen
www.pdpipeline.org

Below is a press release from the event:

New York Pharma Forum Explores Effects of
Patient Advocacy on the Drug Industry

December 7, 2010, New York—Patient advocacy groups have a growing influence on the drug approval process, according to representatives of the biopharmaceutical industry, the U.S. Food and Drug Administration (FDA), and patient groups themselves. Working with these groups builds positive long-term relationships, since many of their goals are aligned with the pharmaceutical industry’s. These were speakers’ key conclusions at New York Pharma Forum’s (NYPF) 21st Annual General Assembly in New York on December 3rd.

Speaking on “The Influence of Patient Groups on Drug Development,” were:

• Perry Cohen, Ph.D., founder and director, Parkinson’s Pipeline Project (PPP)
• Terri Cooper, Ph.D., principal and leader, National R&D Life Sciences Practice, Deloitte Consulting
• Christopher Collins, vice president and director of public policy, American Foundation for AIDS Research (amfAR)
• Kristin Reed, associate director, advocacy relations, Genentech, Inc.
• James Valentine, MHS, program analyst, Office of Special Health Issues, U.S. FDA

Dr. Cooper, panel moderator, noted that advocacy groups provide patients with many kinds of support, including fundraising for R&D; organizing patients to expedite clinical trials; lobbying government and payer organizations to create public awareness and build support for research funding, legislation and formulary access; backing research for “orphan” diseases; providing financial and legal support to patients; and developing patient disease state support systems.

“Drug developers face increased cost constraints, a growing need for real-world evidence and heavier regulatory scrutiny,” she concluded. “Patient groups can be valuable partners in dealing with these demands.”

Dr. Cohen, diagnosed with Parkinson’s Disease over 15 years ago, explained PPP’s activities, which seek to promote policies that accelerate the evaluation and approval of safe, effective and timely new treatments for Parkinson’s by providing patient perspectives to drug developers, investors, clinical scientists and regulatory agencies.

The patient has a different perspective than other stakeholders in drug development, he said. As an example, Dr. Cohen cited attitudes towards safety and efficacy. “Regulators and consumers see safety differently than patients,” he emphasized. “Patients are more willing to take risks when there are no other choices.” He said the U.S. is significantly behind Europe in moving towards a patient-centric model of medical science.

Mr. Valentine explained the FDA’s system for incorporating patient advocates’ input into decision-making and noted, “Patient advocates have a practical rather than purely scientific view of treatment.”

Mr. Collins explained the path from the early days of AIDS activism, when there were no treatments for AIDS, to amfAR’s current initiatives, which include articulating the needs of patients, informing the community, fundraising, lobbying for research support and fighting for AIDS victims’ rights.

According to Ms. Reed, Genentech learned from experience that it’s important to communicate company objectives to patient advocacy groups and respect their insight, even if they don’t always agree. “Sharing information and hearing their viewpoints on important decisions builds long-term relationships,” she stated. “We never underestimate these groups – they are extremely well-informed and sophisticated.”

Mr. Valentine added that working with patient advocacy groups is a win-win situation for both the FDA and drug companies, since their quest to speed up access to viable treatments supports the interests of the industry, and their input, informed by their experience, is valuable for both drug development and drug approval.

NYPF also held its annual meeting on Dec. 3rd to elect board members and officers. Sapan Shah, Ph.D., president and CEO of Shionogi, Inc., was elected president. Other officers elected were:
Vice Presidents:
• Seigo Kashii, president & CEO, Astellas Pharma U.S.
• Blaine McKee, Ph.D., senior vice president, Strategic Development, Oncology / Transplant / Multiple Sclerosis, Genzyme Corporation
Secretary:
• Mary Graves, Ph.D., Executive Director, Global Business Development and Virology Area Head, Roche Pharmaceuticals
Treasurer:
• Shigeru Nakayama, President, Taisho Pharmaceutical R&D, Inc.

About New York Pharma Forum
New York Pharma Forum Inc. is a non-profit organization intended to encourage dialogue among U.S., Japanese and other international biopharmaceutical executives and business and financial professionals on global issues of common interest. Members gain access to critical information on business, policy and technology issues important to the future of the global healthcare industry. For more information, go to http://www.nypharmaforum.org.

###

[paula_w]

You are a great advocate and i know it's getting harder. good on ya for representing us once again. hopefully there will be no policy or trial dev. meetings without patient representation. Much of this is because you have been a consistent voice in as many places as possible.. if award ceremonies were always objectively determined - you would have many. {m not big on awards but know you have done so very much goal setting and you are the one who sayss it first.) but it's not how much you do it's how useful it is and what it leads to. we have a new wpc video of pwp from canada, australia and europe. one man says, it's really about relationships. that determines much of what gets done. we have to work together as a team as patients if we expect to influence everyone else.perry you are a great team player. you act alone too and we didn't always agree with you, but we know it's from the heart and you are completely purpose driven, as so many of us are.

How far have we come? i remember talking to you on the phone and you asked me how we were going to communicate. I asked if you had ever used yahoo and you said no. So we taught you and several others how to set up our yahoo group and that yahoo email list still keeps me up to date from the college librarians access to articles and faithful emailing of them. We started in yahoo chat and ron hutton stayed up late for the meetings.

once again, thanks for dragging yourself out to speak. i did yesterday too and it isn't easy to ...well just multi-task; i was not dyskinetic tho and i'm going to post again about that tonight. i am convinced that we are taking the wrong drug combinations.

We have come very far and have much support now f or patient involvement, but we need to be sponsored more. Cure Parkinson's Trust and wpc were generous in helping patients get to the wpc, but without the patient advocacy it would be just another science/ medical conference and published in a journal two years later. Patients wouldn't see it at all. The world is different and doctors have got to recognze it and pwp should be granted expenses at all pd functions if they have something to offer; we are the ones who are poor and can't get to trials and symposiums so i agree with distribution of wealth in this regard.lol

for the ladies:
http://www.disruptivewomen.net/2008/...oining-the-we/

[pegleg]

I am so glad to be your friend, Perry. You always "do us proud." Thanks once again.
Peg

[Perryc]

Thank you, Paula and Peg. Just about 9 years ago, you 2 were my first supporters on the Parkinson Pipeline Project. Along with many others who post regularly on this forum we have made a difference as authentic voices for PWP in the process of development and approval of new therapies. Our efforts to establish collaborative relations with the FDA to train and inform patient consultants to the review staff of the agency is stilll a unique asset to provide input to the therapy approval process.

I am writng this not only to toot our horns, but also to inform the readers of this forum about how an authentic voice for patient interests can and has made a difference. Starting with you I want to honor all those PWP who have volunteered and contributed to our common goal for better therapies and better lives. I also want to pledge my intention to keep this forum more up to date with my recent experiences as a PWP representative in Europe and the USA on important ethical issues in clinical neuro-science

Perry Cohen
www.pdpipeline.org

Originally Posted by paula_w

You are a great advocate and i know it's getting harder. good on ya for representing us once again. hopefully there will be no policy or trial dev. meetings without patient representation. Much of this is because you have been a consistent voice in as many places as possible.. if award ceremonies were always objectively determined - you would have many. {m not big on awards but know you have done so very much goal setting and you are the one who sayss it first.) but it's not how much you do it's how useful it is and what it leads to. we have a new wpc video of pwp from canada, australia and europe. one man says, it's really about relationships. that determines much of what gets done. we have to work together as a team as patients if we expect to influence everyone else.perry you are a great team player. you act alone too and we didn't always agree with you, but we know it's from the heart and you are completely purpose driven, as so many of us are.

How far have we come? i remember talking to you on the phone and you asked me how we were going to communicate. I asked if you had ever used yahoo and you said no. So we taught you and several others how to set up our yahoo group and that yahoo email list still keeps me up to date from the college librarians access to articles and faithful emailing of them. We started in yahoo chat and ron hutton stayed up late for the meetings.

once again, thanks for dragging yourself out to speak. i did yesterday too and it isn't easy to ...well just multi-task; i was not dyskinetic tho and i'm going to post again about that tonight. i am convinced that we are taking the wrong drug combinations.

We have come very far and have much support now f or patient involvement, but we need to be sponsored more. Cure Parkinson's Trust and wpc were generous in helping patients get to the wpc, but without the patient advocacy it would be just another science/ medical conference and published in a journal two years later. Patients wouldn't see it at all. The world is different and doctors have got to recognze it and pwp should be granted expenses at all pd functions if they have something to offer; we are the ones who are poor and can't get to trials and symposiums so i agree with distribution of wealth in this regard.lol

for the ladies:
http://www.disruptivewomen.net/2008/...oining-the-we/