The FOBIP Alumni Network Executive Committee, in collaboration with NYUBA and the New York State Center for Biotechnology Present:

Regulatory Affairs Strategy:
Beyond the Formulaic Healthcare Product Development Plan

Abstract:
The biotechnology and pharmaceutical fields are heavily regulated industries requiring an average of 10-15 years of development to bring a new healthcare product to market. Due to the importance of governmental regulations in these industries, regulatory affairs professionals play critical roles in every stage of a products lifecycle.

Please join us for a panel discussion on Regulatory Affairs strategy for the health care industry. We have assembled a panel of leaders in the Regulatory Affairs industry with diverse backgrounds to share their insight about Regulatory Affairs strategy. The panel discussion will focus on global regulatory strategy, with an emphasis on changing strategies mid-stage in a products development and emerging trends in the regulatory affairs industry.

Panelists:
Glen Park, Sr. Director Regulatory Affairs, Target Health
Tom Ippolito, VP Regulatory Affairs, Chembio Diagnostics Systems, Inc.
Dr. Lian Lawrence He, Assistant Director of Global Regulatory Strategy, Bayer AG

Please check the FOBIP alumni site for updates on this event- http://fobip.org/alumni

Directions:

Schwartz Lecture Hall Entrance is on 30th street between 1st Avenue and FDR Drive. There will be signs for the NYU School of Medicine.  Walk down the stairs and show the guard your ID.

Schwartz E is on the left side of the lobby.

The FOBIP Alumni Network Executive Committee, New York State Center for Biotechnology, JPMorgan Chase & Co., and Connecticut Innovations Present:

Financing Biotech in 2021

Executive Summary

The goal of this event is to discuss some of the various sources of capital available to emerging pharma and biotech companies and the current trends affecting the market. We have established a panel of investors ranging from angels to investment bankers who will explain their role in financing companies in the healthcare sector. The panel discussion will touch on current technologies attracting investment, promising new sectors, selection mechanisms for targeting companies for investment, factors contributing to successful exits, and upcoming challenges facing the industry in the future. Click Here for Speaker’s Bios

Thank You to Our Sponsors and Supporters!

Social Media in Healthcare

Date: Monday, January 31st, 2011 at 6:30PM
Location: Mount Sinai School of Medicine, Icahn Medical Institute – 1425 Madison Avenue (@ 98th St.), 1st Floor Seminar room
Agenda: 6:30 pm – 8:00 pm Panel Discussion (networking reception to follow)

($10 suggested donation)

Abstract

Social media is emerging as an effective tool for attracting business opportunities. Healthcare providers and patients are building online communities to help manage disease and sort through medical information. In the quest to improve outcomes, hospitals and clinics are using online social networks to discuss their medical practices and for patient outreach. The FDA is considering guidelines for the drug industry’s use of social media for drug marketing.

Dr. Michelle Hoffmann, of Deloitte Research, will be presenting a summary of a recent industry study she co-authored on the practical applications of social networks in the Life Sciences industry. Results from the study are based on interviews with executives in pharmaceutical and biotechnology companies as well as experts in the social media community. Her presentation will be followed by a panel discussion. The panel, composed of individuals experienced in the use of social media and communications, will share their thoughts on the opportunities, challenges, best practices, and value of social media for healthcare.

• Presentation 

  “To friend or not? New insights about social networks in the life sciences industry”

  • Michelle Hoffmann, PhD, Senior Research Manager, Deloitte Research.
• Panelists 
  • Bradley Jobling, MBA, Social Media Consultant, Dept. of Surgery, Columbia University Medical Center.
  • Louise Clemens, JD, Consultant on Digital Strategy for the Healthcare Industry.
  • Sandra Holtzman, President and Founder, Holtzman Communications.
  • Diane Zuckerman, RPh, CEO, Evidence-Based Solutions.
• Moderator 
  • Sarah Webb, PhD, Journalist, Science Writer and Editor, Webb of Science.

Speaker’s Bios

Moderator

Sarah Webb, PhD, is a science writer and editor based in Brooklyn. Her work has appeared in Discover, Science News, ScientificAmerican.com, Science Careers, Nature Biotechnology, The Scientist, Weekly Reader’s Current Health titles, and many other publications. She has a B.S. in chemistry and a B.A. in German from Furman University (Greenville, SC). After a Fulbright fellowship studying organic chemistry in Gieβen, Germany, she completed a Ph.D. in bioorganic chemistry at Indiana University in Bloomington. Committed to communicating science to the public, she shifted her focus from laboratory research to writing, editing, and informal science education. In 2004, she launched her writing career in New York City with internships at Discover magazine and as an AAAS Mass Media Fellow at WNBC-TV. Learn more at webbofscience.com.

Guest Speakers

Michelle Hoffmann, PhD, is a Senior Research Manager in Deloitte Research specializing in the life sciences sector. As part of Deloitte Research, Michelle keeps abreast of emerging trends and drivers that impact the rapidly changing drug and device industry. Michelle recently co-authored an industry study on the practical applications of social networks in the Life Sciences industry. Results from the study are based on interviews with executives in pharmaceutical and biotechnology companies as well as experts in Health 2.0. Prior to joining Deloitte Research, Michelle was a consultant in the Strategic Advisory group at Leerink Swann, a boutique health care investment bank where she helped clients understand how to value and leverage new therapies and technologies. She led projects on a diverse range of topics that include cell therapy opportunities, the diagnostics landscape, oncology clinical strategies, next generation sequencing, as well as numerous opportunity assessments. Her clients included start ups as well as top 5 biopharma companies. Michelle holds a Ph.D. in molecular and cell biology from the University of California at Berkeley and a B.S. in biology from Cornell.

Bradley Jobling, MBA, created the social media program for the Columbia University Medical Center Department of Surgery. He has 15 years of experience on Internet strategy and online marketing projects. His work has involved the advertising, media and health care industries. Bradley’s additional interests include online video and entrepreneurial businesses.

Sandra Holtzman, President and Founder of Holtzman Communications, is an award-winning creative director and marketing strategist. She has over 20 years of expertise in all areas of pharmaceutical advertising (ethical, OTC, DTC), nanotech, biotech, and chemical as well as emerging and converging technologies. Her experience includes business-to-business, medical communications, and international marketing, as well as consumer marketing.

Diane Zuckerman, RPh, is the CEO of Evidence-Based Solutions, a company focused on making medical data actionable, by collecting, organizing, and turning medical information into useful solutions for healthcare providers, patients, systems and payers. Diane is an entrepreneur with 20+ years of experience building successful medical education and technology-driven companies, including PROmedica Communications and the Foundation for Better Healthcare.

Louise Clemens, JD, is currently working as a consultant on digital strategy for healthcare agencies, hospitals, non-profits, to create online community for healthcare constituents using social media platforms that provide metrics and ROI. With more than 20 years of experience in solution selling, Louise’s most recent experience was VP of Business Development for Within3, a company that builds and sustains secure online communities for formal and informal networks of healthcare professionals. Prior to joining Within3, Louise was with a medical publishing company, where she headed a multi-million dollar biomedical device magazine and quadrupled its revenue within a two-year span. In addition, to her extensive sales background, Louise has her JD from Cleveland-Marshall School of Law at Cleveland State University ensuring that the custom community solutions she develops with each customer meet the stringent regulatory and legal requirements necessary to be successful.

  ]]> http://fobip.org/alumni/social-media-healthcare-fobip-seminar/feed 1 http://fobip.org/alumni/mit-enterprise-biotech http://fobip.org/alumni/mit-enterprise-biotech#comments Tue, 26 Jan 2010 16:00:25 +0000 Matt http://fobip.org/alumni/?p=700

MIT Enterprise Forum of NYC Presents: The Changing Landscape of the Biotech Pharma Deal

REGISTER HERE

Join Biotech and Pharma industry experts as they converse on deal making trends. Learn how you can position your technology and/or company for success in the current environment.

Our seasoned panel will discuss the evolution of deal models in the life science industry from the 1980s to present day. Our panelist will touch upon issues relating to the size of the deals, valuations, early stage /late stage deals, and recent acquisition activity (Takeda/Millennium;AstraZeneca/MedImmune; Imclone/Lilly). A must attend for anyone interested in Biotech Pharma deal making.

Confirmed Moderator:
- Dr. Mark DeWyngaert – MD Huron Consulting Group

Confirmed Panelists:
- Ed Saltzman, President, DefinedHealth
- Tamar D. Howson, MS, MBA, JSB Partners
- Dr. Christine T. Fischette, President, Enzo Therapeutics, Inc.
- Mark J. Simon, President, Williver Group

Thanks to Kenyon & Kenyon LLP for hosting and sponsoring this event!

DATE: Thursday, January 28, 2010

TIME: 5:30pm – 6:00pm: Reception
6:00pm – 7:30pm: Panel Discussion
7:30pm – 8:30pm: Networking

PLACE: Kenyon & Kenyon LLP – MAP
One Broadway
New York, NY 10004

REGISTRATION:
Register here. Free to members of MIT Enterprise Forum, $50 non-members, $10 extra at door. All members and guests are welcome. If you can no longer attend this event, please open the event announcement from our Event List, click on the event registration link, select the Cancel registration for this event button and then hit Submit.

CLICK HERE FOR MORE INFORMATION AND SPEAKER’s BIOGRAPHIES

By Mathew A. Engel

Day 1 Summary: Venture Capital Financing, Intellectual Property Management, and Emerging Business Models

The 2009 Life Science Summit took place from September 23 to 24, 2009 at the Hyatt Regency Hotel in Happauge, NY. There were hundreds of attendees representing the biotech industry and academia from all over the state. The industry attendees showed a diverse segmentation with strong representation from university technology transfer offices, law firms, venture capital firms, medicine, privately held biotech companies, mid and large-cap pharmaceutical companies. As a graduate student and alumni of the Fundamentals of the Bioscience Industry Program, I spent most of my time talking with accomplished professionals from successful companies who had experience commercializing technology,  raising capital, or evaluating new ventures. Below I will summarize my findings from the most interesting sessions throughout the first day of the summit. Hopefully, in the near future I will publish a follow-up covering day 2.

What Does it Take to Build a Biotechnology Company in Today’s Environment

The opening plenary session was a great way to spark the crowd’s interest and attention. In the back of my mind, I am always thinking about starting a biotechnology company and therefore always eager to hear advice from seasoned industry veterans. These individuals, especially those who volunteer as panelists or speakers are often willing to share their knowledge and offer some deep insight to beginners. In this session the speakers focused on how to raise capital. Those who are evaluating your proposal will be thinking “where is the technology” and “where is the project”. It is suggested that you network and these connections will lead you to investors who can also guide you into small collaborations. Their role is to keep these smaller companies on track. Currently, most of the demand is for products in late stage clinical trials, in this space demand remains high. Pharma is limiting their investment to certain therapeutic areas. The days of massive deal for a new platform technology are behind us. The huge investment in genomics with no products to show for it was cited. Most deals come about because someone knew someone. It’s not just writing a business plan and patents (though that is still required!). Venture capital (VC) will only stay in for a very short time. Pharma will only jump in Phase II. VC largely invests in people they know. Mailing the best business plan in the world to VCs randomly will get you nothing. Your job is to meet and know people who may be interested in investing. For example, some of the people on the panels at the Summit are Angel investors. Remember to “pick your partners”. The entrepreneur better be prepared to invest. It is important to consider if there are there other options besides a start-up? Many of the panelists, knowing what they do now, would not have chosen to start their own company. You’ve “got to be ignorant to go do it” they claimed. Today, businesses are focusing on staying extremely lean – infrastructure is minimized, reducing the amount of money necessary to operate. However, a company can only “be so lean” and achieve its business goals. VC is not going to be the “sugar baby” that’s going to take the company all the way through. There are drug discovery and medical chemistry labs on campus for basic R&D work. A good university should have a funding pool designated for small companies coming out of academia. One of the panelists spent time describing the experience of his friend who was trying to raise capital. His friend took ‘no’ as just another opportunity to go back to the VC. However, it’s good to get someone with a lot of experience and put together a team of people. “Build a culture and your company”. Medical devices are a great area to get into now. Diagnostic tools are a “neat area to be going into”. Get management in – VC looks at the management team. Get help and advice from your VC. Donald L. Drakeman, Venture Partner at Advent Ventures previously ran a company and was now a VC. His motto is “management, management, management”. What makes great management someone asked? “Management that will step aside”.

Is the VC funding Model Broken?

Mary C. Tanner, Managing Director at Peter J. Solomon & Co. and Maggie Flanagan LeFlore, Managing Director at MedImmune Venture Inc. were two of the most outspoken panelists during this business workshop. The panel delivered an overview of the VC industry covering current trends and their investment strategies. VC’s are adaptable and clever. They are in the business of building private companies to be sold. Their goal is to reach a deal with your company, in which payments are made as milestones are met. LeFlore completed 18 deals in the last year (given as a benchmark). Private companies are easier to sell. Fewer and fewer big pharma are in the market for these types of investments. There has been a fundamentals shift in exit strategy. Survival has followed those most adaptable to change. There are many exit strategies available. How does one get the VCs interest, a participant asked? Early stage risk is notorious, your goal should be to find little pockets of money to move things forward. The faculty members on your team better be well known (i.e. published in Nature, Science, Cell..). One of the panelists, E. Jonathan Soderstrom, Managing Director of the Office of Cooperative Research at Yale University had brought a compound to the attention of Lily and they asked for a proof of concept in humans! He did not even have POC in animals. The message is that you cannot expect Lily or Genetech to fund your development costs when the product is highly experimental.

The Center for Biotechnology and NYC Bio invite you to the second session of “Nuts and Bolts of Biotechnology Entrepreneurship” series on October 7th 2009 from 6-8pm.

“Intellectual Property and Technology Licensing” feature panelists:

• Abram Goldfinger, Executive Director, Industrial Liasion/Technology Transfer, NYU
• Daryn A. Grossman, Partner and Co-Chair of the Technology, Media and Communications practice group, Proskauer Rose LLP
• Kathleen Denis, Ph.D., Associate Vice President, Technology Transfer, Rockefeller University

Venue:
Stony Brook Manhattan
401 Park Avenue South (between 27th and 28th Streets), 2nd Floor
New York, NY 10016

Registration
There is a fee of $10 for this session. All payments should be made through PayPal when you RSVP on the meetup website: http://biotech.meetup.com/40/calendar/11129215/

Note: If you are arriving before 7:00 pm, you can use the 401 Park Avenue South entrance (between 27th and 28th Streets) to come to the Main Hall on the second floor. After 7:00 pm, you need to use the 110 East 28th Street entrance.

Time: 6:30-8:00 PM on October 7th, 2009.

Networking Cocktail: 8.00-9.00 PM

By Adebanke Fagbemi

There is an ever-increasing shift towards personalized medicine in the fields of medicine and biotech. This is no surprise because, although it has long been known that individuals respond differently to drugs or treatment, it has only more recently come to light that subtle differences in our genetic make up may be responsible. The idea that our genetic profiles could be used to predict not just our susceptibility to disease, but also our response to treatment, holds obvious enticement to the biotech and healthcare industry. This is evident in two recent news stories. First, it recently came to light that the drug Erbitux® which is used to treat colo-rectal, head and neck cancers, is uneffective in colon cancer patients with mutations in the KRAS gene. As a result, the two companies that market Erbitux® (ImClone and Bristol-Myers Squibb), re-labeled it to discourage patients with these mutations from using it. The idea being to hopefully protect such patients from long, expensive, unnecessary treatments, and unpleasant side effects associated with treatment. It would also, truth be told, protect the companies from potential lawsuits that could result.

In a slightly different, though equally important vein, a New England Journal of Medicine article published in the July 9 issue, reports the results of a clinical trial showing that the new PARP inhibitor Olaparib, is effective in treating breast, ovarian, and prostate cancers in patients with mutations in BRCA1 and BRCA2 genes. This is an important finding, as this drug elicits significantly milder side effects than conventional chemotherapy, and its side effects were easily reversed by lowering dosage, as shown in the study. With the human genome sequenced, information from genetic profiles of individuals will ultimately aid healthcare professionals in patient treatment, allowing doctors to better prescribe drugs, and dose accordingly. The information provided on susceptibility to diseases such as cancer will allow patients along with their healthcare professionals to monitor disease status, and when possible, maybe even prevent it.

When discussing this issue, however, there is the other side of the story. Once all this genetic information becomes available and easily accessible, what are the disadvantages? I can think of a major one – health insurance. With all the recent talk of health insurance and health care, imagine what would happen if the insurance companies were to get a hold of genetic profiles of potential customers. This would provide them with good reasons for refusing coverage to patients with certain susceptibilities. Forget “pre-existing conditions” when “potential conditions” come into play! Any and everyone could become a victim.

All in all, there is a lot to be gained from personalized medicine, as long as genetic information is handled with care. If drugs and treatment are like the saying “one man’s meat is another man’s poison”, then isn’t it essential that doctors be provided information to prevent them from treating patient A with a drug that, although effective in patient B, could be deleterious to patient A?  Maybe my genetic profile could finally explain why Nyquil® keeps me wide awake at night, leaving me drowsy and groggy all of the next day, even though it’s marketed as giving you “the best sleep you ever got with a cold medicine”!

Great news for venture-minded Alumni!

The Center for Biotechnology has partnered with the non-profit organization NYC Bio and announced an upcoming seminar series/NYC Bio Meetup, entitled “The Nuts and Bolts of Biotechnology Entrepreneurship.” This four-part series is designed to educate innovators, academics, postdoctoral fellows, and graduate students on the practical, legal, and business aspects of commercializing their technology and transitioning their ideas into the bioscience industry.

All sessions will be held at the Stony Brook Manhattan Campus (401 Park Avenue South between 27th and 28th Streets, 2nd Floor, New York, NY 10016) at 6:30-8PM on their designated dates.

The first seminar entitled “Entrepreneurship in the Biotechnology Industry” will be held on Wednesday, September 2, 2009.

Featured panelists include:

• Alan Paau, Vice Provost for Technology Transfer and Economic Development at Weill Cornell   Medical College;

• Mark Wilson, President of Initiatives Consulting;

• Jeff Yablon, VP of Sales and Marketing at Sciformix Corp.;

• Jim Chinitz, CEO of Population Diagnostics; and

• Lorrence H. Green, President of Westbury Diagnostics.

Future seminars will run until December 2009 and are scheduled as follows:

“Intellectual Property and Technology Licensing,” on October 7th, 2009

“Business Plans 101: Making the Pitch,” on November 11th, 2009

“Crossing the Valley of Death: guides to transitional, pre-seed and seed funding,” on December 9th, 2009

There are only 63 slots for this series so registering early is HIGHLY recommended. The registration fee for each session is $10 (students/post docs) and $20 (everyone else) payable upon registration. And if you register for all four sessions at once, you even get a discount package ($30 for students/postdocs, and $60 for everyone else). Considering the caliber of the featured panelists and the networking opportunities at this event, I personally think that’s a steal.

To register, fee payments should be sent to the PayPal account: NYC.BIO.4U@gmail.com. Email your information to the same account and include: (1) your full name, (2) affiliated institution/company, (3) the session(s) you are interested in attending, (4) registration fee paid, and (5) the payment email address you used. NYC Bio will only confirm your registration upon receiving your payment.

For more details, see NYC Bio’s Meetup.

See you at the Series!