Drug Repurposing and Reformulation: At the Crossroads of IP, Clinical and Business Strategies

Thursday, July 18 2013
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

Discovering new uses for existing molecules is now a commonly explored strategy for both clinical development and business growth. Repurposing and reformulation create new markets for successful drugs; allows recouping investment on the failed ones; and may open up new, unexpected business opportunities. 

A panel of experts will address the following topics: 

•    The search for purpose: getting to the real value of a drug
•    Repurposing as a risk reduction strategy
•    Dumpster Diving: the waste that's more valuable than the output
•    FDA’s view on drug repurposing: recent trends
•    Pharma's and NIH’s efforts in drug repurposing: success or failure?
•    What are the prerequisites of a successful business case based on a repurposed drug?
•    Can a reformulation breathe a new life into an old drug?
•    What regulatory pathways are available?
•    How do IP and regulatory exclusivities factor in?
•    What are the contractual frameworks in drug repurposing collaborations?

Speakers:

  • Sara McKenzie, PhD, MBA, Principal, PharmaDirections
  • Mike Rea, CEO, IDEA Pharma
  • Yael Schwartz, PhD,  Founding CEO and President, Hygeia Therapeutics, Inc. and Canterbury Laboratories

Moderator:

  • Konstantin Linnik, Partner, Intellectual Property Department, Nutter McClennen & Fish LLP

 

Speaker Bios

Konstantin Linnik, Partner, Intellectual Property Department, Nutter McClennen & Fish LL

Konstantin Linnik is a partner in Nutter’s Intellectual Property Department and is  a co-chair of the Legal & Regulatory Working Group at MassBio. 

At Nutter, he works with biotech and pharma companies on various matters involving intellectual property, including IP strategy creation and execution, building and leveraging patent portfolios, competitive analysis, product design and development, licensing and negotiations, due diligence, IP audits, patent enforcement and litigation. Before joining Nutter in 2011, Konstantin was Senior Corporate Counsel at Pfizer, where he was lead patent counsel for Pfizer research units located in Cambridge, Massachusetts; Düsseldorf, Germany; and Ottawa, Canada. Prior to Pfizer, he had extensive experience representing other leading pharma and biotech companies as their external counsel.

Konstantin is currently chairs the Biotechnology Committee of the Boston Patent Law Association and is an adjunct professor at Suffolk University Law School, where teaches a course on drafting IP licenses. He earned his JD, cum laude, from Suffolk University Law School and PhD in Biophysics/Cell Biology from Boston University.

Sara McKenzie, PhD, MBA, Principal, PharmaDirections

Dr. McKenzie has over 25 years’ experience leading teams in the development of small molecule drugs and biologics for the treatment of a variety of indications.  As a Principal at PharmaDirections, she provides expert project and program leadership for preclinical and clinical stage development efforts.  She develops the strategies and detailed plans required for meeting goals, milestones, and deliverables together with multi-disciplinary project teams.  Dr. McKenzie has worked in numerous start-ups and virtual companies, employing a development model that minimizes fixed costs and maximizes flexibility.  Her past responsibilities have included the management of multiple drug development projects from the discovery stage through Phase III trials and NDA submissions.  Indications have ranged from oncology and heart disease to chronic obstructive pulmonary disease, erectile dysfunction, urinary incontinence, and asthma.   

Her career has also included work in medical devices and protein-therapeutics, vaccines and cancer diagnostics.   Her expertise spans the range of experimental design, data analysis, manufacturing, clinical operations, and the business of science.  Dr. McKenzie’s PhD is in biochemistry and her MBA is in General Management.

Mike Rea, CEO, IDEA Pharma

IDEA Pharma is a boutique consultancy firm that IDEA Pharma specialises in path-to-market strategy at Phase II, transforming the probability of commercial success for any molecule. Mike has worked in global pharma strategy for over 20 years, and has developed global marketing solutions for most of the world’s top ten pharmaceutical companies. Regarded as an industry leader, Mike’s principal point of interest is the incorporation of best practice into pharmaceutical strategy, and he has helped lead the strategic direction of over 50 pharmaceutical brands.

Yael Schwartz, PhD,  Founding CEO and President, Hygeia Therapeutics, Inc. and Canterbury Laboratories

Dr. Yael Schwartz is Founding CEO and President of both Hygeia Therapeutics, Inc. and its spin-out company, Canterbury Laboratories.

She has built and led several research and product development areas in women’s health, dermatology, CNS disorders and respiratory diseases.  During the course of her drug development career she worked on teams that delivered 5 new chemical entities into clinical practice; Lunesta® for the treatment of insomnia, Brovana® for Chronic Obstructive Pulmonary Disease management, Xopenex® for the treatment of bronchoconstriction in asthma, Carvedilol® for the treatment of mild to severe congestive heart failure, and Valstar® for the treatment of urinary bladder cancer.

In addition to her scientific expertise, Yael’s other core competencies include her ability to streamline product development, troubleshoot problematic areas in product development, build and manage both internal and external relationships, resolve conflicts, develop scientific talent, execute on product licensure, and lead organizations during times of change and fiscal uncertainty. 

For the past 6 years, Yael served on the Board of Trustees of Massachusetts Biomedical Initiatives.  Last year she co-founded and is currently Chair of the Board of a non-profit organization for executive women in the healthcare sector, the NEWISE Club, Boston, MA.

Yael received her Ph.D. with highest honors in Human Physiology from a joint program between the WPI Bio-Engineering Department, Worcester, MA and the University of Massachusetts Medical School, Department of Physiology, Worcester, MA.

 

 

 

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