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In May 2009, the FDA issued a Draft Guidance to Industry titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion". This presentation will highlight the salient points from the Draft Guidance and review some recent FDA enforcement actions against industry for violative promotional materials that, in FDA's view, do not adequately present risk information.

Click here to view the Draft Guidance document from the FDA website.

The meetup will consist of a 20-30 minute presentation followed by a Q&A period. The presenter for this meetup is:

David M. Jacobs
Bristol-Myers Squibb
Associate Counsel, US Pharmaceuticals Law & Promotion Compliance
JD, Brooklyn Law School, 2003
Masters in Biotechnology, Columbia University, 2009

PLEASE NOTE: You were asked to provide your full name when you signed up for this meetup. If you did not provide your full name (or don't remember whether you did), please contact Mariano DiFabio to confirm.

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This meetup, lead by Mariano DiFabio, will touch on the topic of Pharmacetuical companies and their presence in social media.

Many other industries have been quick to adopt the medium as an opportunity to connect with their customers and prospects in new ways. However, the pharmaceutical industry has merely dipped its toe into the waters. What is preventing it from diving in? Is it because the FDA hasn't sent a clear message about what's acceptable use for pharmaceuticals in social networks? Or is it that pharmaceuticals don't feel social networking is an effective way to reach people?

The presentation will lead to a discussion among the group about the true value of social media and whether it's a viable medium for the future.

This is a good meetup for people who understand the legal reasons behind the hesitation of the industry to adapt social media, for PR professionals who might want to discuss new ways to approach their clients on this subject, and for people who don't even know much about social media and want to use this meetup to learn more about it.

I look forward to seeing you there!

Mariano L. DiFabio
Avelient, Inc.

We're very excited to be welcoming our next speaker, Melinda Turner, at our April 29th meetup. She'll be speaking on "Streamlining Drug Development with Accelerator Mass Spectrometry."

There will be limited space for this meetup, so be sure to RSVP early, and if your plans change please be sure to update your stuats!

Synopsis:
Drug development statistics show that the number of molecules approved by the FDA is decreasing while the time and costs required to develop a drug continues to rise. In response to this crisis, many alternative strategies and technologies have been suggested to increase success rates of drug approval. One of these technologies is accelerator mass spectrometry (AMS), which can be used to de-risk early development programs and increase their value to investors and potential partners. Xceleron is a pioneer in accelerator mass spectrometry, having been the first commercial organization to apply this technology to biomedical research and helping to shape US and European regulatory agencies’ positions on the use of AMS within drug development. This presentation will provide an overview of the traditional early drug development strategy and introduce the AMS technology. We will review a few case studies demonstrating the practical application as well as the financial and scientific benefits of the use of AMS in early drug development.

Outline:
Overview of drug development
FDA’s critical path initiative
eIND guidance
MIST guidance
AMS technology
Applications of AMS (high-level)
Case studies (focus on financial benefits, de-risking, partnerships)

About Melinda Turner:
Melinda Turner works closely with pharmaceutical and biotech companies to provide solutions for early drug development. Throughout her career, Melinda has gained a firm knowledge of the drug development process from medicinal chemistry through early clinical development. Her practical understanding of drug metabolism and pharmacokinetics helps to guide potential partners and clients during the critical phases of selecting the appropriate clinical candidate.

After receiving her degree in biochemistry from Villanova University and completing some graduate coursework at the University of Pennsylvania, she began working in the preclinical drug development arena for Absorption Systems, a small contract services company. During her time at Absorption Systems, Melinda gained an understanding of early drug development and the driving factors of candidate selection and preclinical drug development. Melinda moved on to lead the US business development team at Cyprotex, a UK-based drug discovery company, where she developed partnerships with pharma and biotech to shape drug discovery efforts through lead optimization. She is continuing to expand her experience throughout the drug development paradigm while working with Xceleron, where she provides an opportunity for biotech and pharma to streamline late preclinical and early clinical development of drugs.

Prior to the meetup scheduled for February 25th, we'll all be briefly introduced to iambiotech.org, a new biotechnology blog which serves as a central site for people interested in exploring the promise of biotechnology. Our guest for this brief presentation will be Eva Barboni, current editor-in-chief of the blog.

The main event - Oligonucleotide therapeutics (ONT) are drugs designed to mimic snippets of DNA or RNA. Each ONT can be tailored to selectively interfere with a key biological process such as translation of a particular messenger RNA into protein, for example a protein whose overproduction underlies a certain disease.

ONT biotechnology emerged from academic research labs beginning in the 1980s. The aim was create magic bullets using different combinations of the same nucleotide building blocks to treat myriad diseases. Starting with the so-called antisense oligodeoxynucleotide class, the ONT field now includes RNAi-based siRNA compounds as well as the oligonucleotide immunoregulatory drugs. Currently, clinical trials are evaluating ONT compounds in each of the three classes, coming from several different companies. That said, the real strength of the ONT industry at the moment may lie in the tools it provides for target identification and validation, which speeds up the development of traditional types of chemical and biologic therapeutics. However, many in the ONT industry are optimistic that new ONT drugs will emerge soon, given all that has been learned in the last decade or so to improve the potency and delivery and to minimize the off-target adverse effects ONTs.

I have written about the ONT field since 1998, covering basic science as well as OTN drug development. Most of my writing on that topic has been meeting briefs from local and international conferences sponsored by the New York Academy of Sciences (NYAS). Links to introductory Overviews of these reports are on www.nasw.org/users/bschachter/writing.html; full reports appear on the NYAS Web (www.nyas.org), which requires membership.

My presentation to the NY PharmaBiotech Meetup will draw, in part, on what I learned at the 4th Annual Meeting of the Oligonucleotide Therapeutic Society in October 2008. (www.nyas.org/events/eventDetail.asp?eventID=10680&date=10/15/2008). I welcome questions before the Feb 25 Meetup so that I can try to deal with issues of interest to meetup attendees. Write to drbethie@rcn.com

About the speaker: Dr. Beth Schachter writes, edits, coaches and consults for the biomedical research communities in academia and industry. As a writer, she produces articles for audiences of biomedical scientists and science-savvy lay readers. Her feature articles, covering topics such as the biotechnology of biofilms, new academic programs in bioinformatics, and industry start-ups that focus on systems biology, have appeared in magazines and journals such as Nature Biotechnology, Bio-IT World, and Genomics & Proteomics. As an editor, she works directly with researchers who need help to produce clearer and more persuasive manuscripts and grant proposals. As a coach and consultant, she gives workshops to academic and corporate biomedical research groups, to help their members become better communicators of their findings, ideas and opinions.

Dr. Schachter brings to her clients the knowledge and expertise that she acquired “in the trenches”, having been a Principal Investigator on the faculty at Mount Sinai School of Medicine for many years, where she headed a molecular endocrinology research lab. She works as a sole contractor (Beth Schachter Consulting; see www.bethschachterconsulting.com) and as a partner in Still Point Coaching & Consulting (see www.stillpointcoaching.com).

Date change: October 6th was selected instead of October 8th in order to accommodate our members who celebrate Yom Kippur.
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Generic Competition in the Biopharmaceutical Industry: Implications of an Abbreviated Approval Pathway for Follow-on Biologics (FOBs).

Follow-on Biologics (FOB’s) are generic versions of innovator biologic therapeutics to include recombinant proteins and antibody therapeutics. An abbreviated scheme for their approval in the US is currently under intense discussion and meticulous review in Congress and heavy debate among innovator and generic manufacturers.

An accelerated approval process for FOBs is associated with complex scientific, commercial, financial, and legal implications when compared to small molecule (and biologic) generics approved under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA) . Congress has acknowledged these complexities as evidenced by their solicitation of the advice from both biopharmaceutical and generic manufacturers, in addition to regulatory bodies to include the US Food and Drug Administration, US Federal Trade Commission, Centers for Medicare and Medicaid, and the EMEA. Subsequently, innovator biopharmaceutical manufactures, which face potential generic challenge to their biologic annual revenues totaling billions of US dollars, are currently engaged in intense debate with generic manufactures regarding provisions for an ANDA for FOBs.

In this seminar, Carl D.Rios and Mitchell Wong will provide a top-level review of the heavily debated complexities and implications of an abbreviated pathway for Follow-on Biologics to include manufacturing and clinical challenges, financial impact of competition to manufacturer and consumers, potential changes to regulatory exclusivity and patent litigation.

Learning Objectives:

Consider molecular differences between generic versions of small molecule drugs and biologics and the challenges these differences present to FOB production.

Review current abbreviated approval pathway and regulatory exclusivities for small molecules generics (and some biologics) in the US and consider their applicability to FOBs in light of EMEA’s abbreviated pathway.

Understand the debate surrounding FOBs and impact of FOBs to biopharmaceutical and generic manufactures, regulatory agencies, payors and consumers.

Bios:
Mitchell M. Wong, Esq., is a patent litigator at Morrison & Foerster LLP, where he litigates and advises clients on biotechnology and Hatch-Waxman issues. Mitchell received his B.A. from Columbia College and his J.D. from the Cornell Law School. He then served as a law clerk to the Honorable Andrew J. Kleinfeld of the U.S. Court of Appeals for the Ninth Circuit.

Carl D. Rios, Ph.D., is a Medical Science Liaison at Amgen Inc. and supports the Nephrology Therapeutic Area scientific platforms aligned to three therapeutic franchises, as well as supports clinical-level post-marketing and pipeline development. Carl's educational background includes post-graduate studies at Weill-Cornell Medical College and New York University.