September 17-19, 2018
Ocean Place Resort, Long Branch, NJ

2017 Agenda

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Sunday, September 17, 2017

8:00pm - 11:45pm
Exhibitor Set Up
6:30pm - 8:30pm
Welcome Reception & Dinner (Dress Business Casual)
8:00pm - 10:00pm
After Hours Socializing at the Lobby Bar

Monday, September 18, 2017 - Day 1

Registration Opens 7:30am
8:00am - 6:00pm
Exhibit Halls Open
9:00am - 4:00pm
Exhibitor Presentations Track C
8:00am - 11:00am
Full Breakfast All Attendees, Exhibitors, Speakers in Exhibit Halls
8:00am - 8:00pm
16 Private Meetings Rooms Open (Use online portal to set up meetings)
12:00pm - 1:30pm
Full Luncheon
10:00am - 5:30pm
Snacks & Refreshments All Day in Exhibit Halls
Exhibit Hall A, 9:00 - 9:45 Exhibit Hall B, 9:00 - 9:45 Track C

Round Table One

Is It Really Important to Have Secondary RSM Suppliers and CMOs?

Why should you contract the services of a second CMO during Clinical Stage Drug Development? Several recent cases underscore the importance of the added expense.

Deborah Minor, Ph.D.
President
Drug Discovery Alliances
&
Tricia Scialla
Pharmaceutical Outsourcing Professional
(Formerly Bristol-Myers Squibb)

Round Table Two

Decision-Making in Early to Mid-Stage API Development

During early and mid-stage development, a balance must be struck between planning for success and managing attrition of drug candidates, in order to be adequately prepared to move forward (in the event of success) or to cut losses (in the event of attrition). How this is best done depends on many variables, including sponsor culture, budget, risk tolerance, and the science. This round table will discuss participants' experiences negotiating these competing but inevitable priorities.

Stuart G. Levy, Ph.D.
Principal
SGL Chemistry Consulting

Round Table One

Project Management: When Things Go Wrong
  1. How much power the PM has (strong vs. weak model)
  2. Why the PM's true value often comes out during crisis situations and during development there are going to be surprises.
  3. How much science do the PMs know. What is there manufacturing/analytical/business background
  4. Why PMs have to be able to go to the mat
  5. Why the PM tools are not going to make the PM

Sean Bradley
Head of Business Development US
Dottikon ES America, Inc.

Geoff Evans
President
Eurofins Alphora

Round Table Two

Current Topics in HPAPI

Categorization of HPAPI molecules and how it differs across the industry based on sponsor or CMO and the data available; How to best avoid cross contamination looking at facility design and equipment including considerations for risk assessment when determining where to manufacture.

Allison Vavala
Associate Director, Business Development
Helsinn

9:45am – 11:00am
Refreshment Break in Exhibit Halls
Exhibit Hall A, 11:00 - 11:45 Exhibit Hall B, 11:00 - 11:45 Track C

Round Table One

Transparent Pricing for CRO/CMOs

We all realize that pharmaceutical services cannot be itemized like a widget. However, in reality, there are many service offerings that clients want pricing on over and over again. In the current competitive pricing environment (Amazon, Trivago, etc...), the pharmaceutical service industry lags behind, only showing pricing after confidentiality agreements signed and when specifically asked for a quote. Let's discuss the pro's and con's of making pharmaceutical service pricing more transparent.

Bob Wenslow, Ph.D.
Vice President, Business Development
Crystal Pharmatech

Round Table Two

Applied Homogeneous Catalysis: Applications for Pharma and Biotech Company Development Projects

Catalysis is used very frequently in drug development. Ggram quantities of chiral ligands are sold to pharma for their screens. When a 'hit' occurs, they ask for 100g in a scale up, followed by 10 kg runs. For instance, a catalyst was developed or a customer a few years ago; it was eventually scaled to 750kg for the commercial production of Januvia (their diabetes drug). All big pharm and many biotechs use ligands and catalysts.

Johannes Schranck, Ph.D.
Leading Scientist Catalysis
Solvias AG

Round Table One

Current Topics in Continuous Flow Manufacturing

Continuous flow manufacturing has advantages over traditional batch production. It guarantees that the ideal "reactor" is available for each step in the process including the mixing of starting materials quickly, ensuring the correct stoichiometry everywhere, heating, cooling, addition of reagents, and removal of product. It also provides for the use of hazardous chemicals and extreme reaction conditions. Quality by Design (QbD) is built into the system as there is a high level of process control and reproducibility. Continuous processing using small-scale equipment results in improved energy and material use as well as increased capacity. What if you didn't have to "scale up" but could "number up"?

Brittany Hayes, Ph.D.
Business Management Director, API
Patheon

Round Table Two

Current Topics in Solid State Science

Solid State science is a corner stone of drug development that could significantly impact the vital physical properties such as solubility and dissolution rate as well as API and drug product processability. Furthermore, it could extend the lifetime of the drug through IP protection. When should we do the solid state studies and what kind of studies should we undertake?

Mahmoud Mirmehrabi, Ph.D, PEng
Director
Solid State Pharma Inc.

11:45am – 12:30pm
Refreshment Break in Exhibit Halls
12:30pm – 2:00pm
Luncheon
Exhibit Hall A, 2:00 - 2:45pm Exhibit Hall B, 2:00 - 2:45pm Track C

Round Table One

In-Sourcing Synthesis and Med Chem: Advantages, Risks, Costs for this Staffing Model

Modern pharma research rarely uses the go-it-alone approach. In-sourcing refers to the growing model where companies bring in scientists from an outside organization; they work side-by-side with the company’s internal team to enhance their project resourcing. We will share our experiences across multiple collaborations and seek open discussion among the participants.

  • Team management options: Should the insourced personnel operate as a sub-team or be fully integrated throughout the department’s scientists.
  • Scientific expectations from insourced vs internal employees? The same or different?
  • Coordination between organizations: What if the company wants to hire members of the insourced personnel?
  • Maintaining team cohesiveness between internal and insourced personnel: Challenges and successes in maintaining a harmonized team ethic.
  • IP Management: What risks may be introduced with "outside personnel"?
  • Typical costs of insourcing vs. internal or outsourcing

Jeffrey Albert, Ph.D.
Director
IntelliSynRD

Round Table Two

Regulatory Starting Materials and the Security of Our Supply Chain

Our supply chain is long, convoluted and globalized. Our drug discovery and development efforts depend on timely and predictable availability of starting materials and key intermediates. Just how secure is our supply chain and how can we make it ...more secure?

Stuart Silverman
Business Development
Albemarle

Round Table One

API Development for a Potentially Expedited FDA Review Program

The FDA now allows for several forms of expedited pathways for serious conditions. In many instances this forces Phase II to become the defacto Phase III. This often requires that the process and method employed during Phase II manufacture to be viable for validation or at the least validation readiness within a very short time frame. It also can force initial commercial supply to be manufactured with less than optimized processes and methods. There is development work that can be done early to be prepared for expedited review but this comes at a cost. An open discussion of experiences would be helpful to many involved in the development process to be aware of what has worked and what has not for those who have experience with expedited development programs.

Dan Torok
Director, API Process Development
DS InPharmatics

Round Table Two

Current Topics in API Crystallization in Drug Development

Jian Wang, Ph.D.
Director of Crystallization R&D
J-Star Research

2:45pm – 3:30pm
Refreshment Break in Exhibit Halls
Exhibit Hall A, 3:30 - 4:15pm Exhibit Hall B, 3:30 - 4:15pm Track C

Round Table One

Chirality Toolbox – Is this required or will Enzymes Suffice?

A lot of chemists have moved away from asymmetric hydrogenation and classical resolution to favour enzymes. In my view this is not always the best route to take and we should be looking for fit for purpose technology for early phase clinical projects and the best technology for commercial applications. A broad toolbox of technologies are required to cover these areas.

Ian Lennon, Ph.D.
Senior Vice President, Global Business Development
Chiral Quest

Ian Davies, Ph.D.
Principal
Ian W. Davies LLC

Round Table Two

Your API is Fluoro-Functionated: Let's Consider the Best Step to Introduce It

Let's go with the givens of adding fluorine to and API, i.e. different metabolism than the non-fluorinated analog, more lipophilic molecule with fluorine, longer acting API results. When is the optimal time to introduce it? Early vs late in a synthesis and why? Handling issues to consider with the choice of the timing. Means of introducing the fluorine such as actual distinct fluorination of the primary molecule or via a key part of the molecule added later. What purification advantages or disadvantages do we see with a fluorinated API? What formulation challenges arise with the fluorine in an API?

Nick Kosarych, Ph.D.
Head, Business Development North America
Zhejiang Hengdian Apeloa Pharmaceuticals

Round Table One

Current Topics in Stability Testing and Batch Release

Included in the complexity of manufacturing of API’s and finished products are a myriad of chemical, microbiological and physical testing requirements to ensure both compliance of the API/product with requisite specifications. Batch/Lot release testing and Stability science are two of these requirements. In this round table we will look the current regulations, consider ASAP for predictive stability testing and ask what Brexit could mean for EU release testing.

Dave Scott
Senior Director
Tepnel Pharma Services

Round Table Two

Small Molecule Analysis & Purification

Analytical, method development/validation, GMP Testing, quality control, control strategy.

Mickey Rego
Business Development
Neopharm Labs

4:15pm – 5:15pm
Refreshment Break in Exhibit Halls
5:30pm – 8:30pm
Casino Night Party of the Great Lawn with Gaming, Dinner, Karaoke, Open Bar
9:00pm - 11:00pm
After Hours Socializing at the Lobby Bar

Tuesday, September 19, 2017 - Day 2

7:00am - 6:00pm
Exhibit Halls Open
7:00am - 8:00pm
16 Private Meeting Rooms Open (Use online portal to set up meetings)
7:00am - 5:00pm
Networking & Snacks in Exhibit Halls
7:30am - 10:00am
Full Breakfast in Exhibitor Halls
9:00am - 3:00pm
Exhibitor Presentations Track C
Exhibit Hall A, 9:00 - 9:45pm Exhibit Hall B, 9:00 - 9:45pm Track C

Round Table One

CRO/CMO Supplier Selection by Pharma
  1. Phase Appropriate regulations for the development of the API's
    1. Potential difference between the US and Europe
  2. Difference between needs/wants of suppliers and innovators
    1. Process Development
    2. Analytical Development
    3. Stability Testing

Jim Bruno
Founder and Owner
Chemical and Pharmaceutical Solutions

Round Table Two

Tips for New ChemOutsourcing Outsourcing Managers

What are the top tips to keep in mind for beginning pharma managers sourcing services through CRO/CMOs? And what about the internal dynamics with colleagues at the pharmaceutical company? Very challenging. This discussion will focus on the lessons learned by the round table leaders and those who join the discussion.

Jeffrey Samuel
Director, Marketing
SK Life Science

Roger Hanselmann, Ph.D.
Director of Process Research & Development
Akebia Therapeutics

Round Table One

Outsourcing in Analytical Outsourcing

Release testing at CMO's vs CRO's for DS and DP... pros and cons of both. One stop shopping or specialized labs for certain testing? Big vs small analytical labs.

Jennifer Kolucki
Scientist, Analytical Development
Catabasis Pharmaceuticals, Inc.

Round Table Two

Bringing Pharmaceutical Manufacturing Back To The U.S.

What will it take to bring API manufacturing back to the United States? After years of offshoring the consensus on the value and cost has evolved. New environmental regulations in China are having an effect. What are the challenges to overcome in India? Is the FDA doing enough to make the US an attractive location to renew our manufacturing legacy culture? What other considerations should we bear in mind? Let’s get together to discuss this.

Stuart Silverman
Pharmaceutical Business Development
Albermarle

9:45am - 10:30am
Refreshments & Snacks in Exhibit Halls
Exhibit Hall A, 10:30 - 11:15am Exhibit Hall B, 10:30 - 11:15am Track C

Round Table One

Finding the Right CMO to Safely Handle Your Potent Drug

Robert Sussman, Ph.D.
Managing Director
SafeBridge Consultants, Inc.

Round Table Two

Biotech and Emerging Company Sourcing

The need for speed, pricing, timing, quality, and frequent personnel change on both the customer and supplier side make this an attractive and challenging job. These are the companies that are developing most of our new drugs.

Deborah Minor, Ph.D.
President
Drug Discovery Alliances

Round Table One

Both Sides of the Fence: Insights from People Who Have Worked for Both Suppliers and Pharma

David C. Zimmermann
Chief Executive Officer
Kalexsyn, Inc.

Round Table Two

CMC Readiness: Is Your Pharmaceutical Asset Ready to be Partnered Or Acquired?

Steve Baric
Director - North America
APC Ltd

11:15am - 12:00pm
Refreshments & Snacks in Exhibit Halls
12:00pm - 1:30pm
Luncheon
Speed Dating - Tracks A & B
Located in Ocean Port room on 2nd floor. Only access by stairs between Exhibit Halls, 1:30pm - 3:00pm
Track C
Participants, just show up. No sign up required, everyone may participate. Yes, there will be lines but you will meet 3-6 pharma buyers during the course of the speed dating event, now in its 6th consecutive year. Suppliers: No presentations, just business cards, and a 4 minute chat, then visit the next table that matches your service offerings.

Takeda Pharmaceuticals
Medicinal Chemistry/Discovery

Novartis Discovery & Pre-Clinical Development
Discovery & Pre-Clinical Development

Novartis Early-Mid Stage Clinical Development and Commercial
API (process development plus Clinical supply) and Formulation Development and Clinical Manufacture. For DP Clinical Manufacture (supply) EMA Certification is a must for Novartis.

Merck Table #1
Discovery/Medicinal Chemistry

Merck Table #2
Process Research & Development

AbbVie, Inc.
Large volume GMP production with Containment
Small Volume, Highly Potent GMP production
API Solids Processing
Regulatory Starting Materials

Newron Pharmaceuticals
CRO/CMOs for API, Drug Product, Analytical and
Clinical Supply Chain Management. On API,
Small Molecules and Biologics

Agios Pharmaceuticals
Process chemistry from Europe, Asia, North America; also, form screens, catalyst screens, and analytical services, DS/API, DP-oriented companies.

Celgene Corp
Process Development services

Abide Therapeutics
We are most interested in meeting GMP capable drug substance and drug product manufacturers with a good regulatory history.

Intercept Pharmaceuticals
MedChem services; general synthesis; large scale (kilo lab), nonGMP.

Lexicon Pharmaceuticals
Process Development, drug substance, raw materials, intermediates

Apeel Sciences
Looking for CMO's that can manufacture food ingredients. Also food grade materials such as Sodium Thiosulfate Anhydrous, Palmitic Stearics, Undecenoic and Undecanoic Acids, Ethanol, Tall Oil.

BD
Procurement Outsourcing services to support day-to-day chemical buying, including processing purchase orders and managing my small scale chemical spend. Looking for companies with chemical expertise that can aggregate volumes and leverage spend to gain savings and risk mitigation.

Gilead Sciences Discovery & Pre-Clinical Development
FFluorination process R&D, raws and intermediates, and small-molecule process R&D

Gilead Sciences Development
Commercial cGMP manufacturing, Bulk Contract Manufacturing API, GMP intermediates, Raw Materials High Potency APIs, Clinical phase Process development High hazard chemistry, Fluorination

Melinta Therapeutics
API Development and Raw Materials

CMC Turnkey Solutions
Looking for API manufacturing as well as CMOs for solid, parenteral, and aseptically-filled nasal products.

Genentech
Process development and Custom synthesis of SM staring material, intermediate and API including high potent API

Continuum Biosciences
We are a New Co looking at novel mito uncouplers for the treatment of various diseases. We are looking for a CRO that can make 2 kgs of our material (non GMP), which we expect to be rapidly done in a GMP fashion. This material will be used for animal studies and formulation development by another CRO.

3:00pm - 3:45pm
Refreshments & Snacks in Exhibit Halls
Exhibit Hall A, 3:45 - 4:30pm Exhibit Hall B, 3:45 - 4:30pm Track C

Round Table One

Trends in Late Stage Clinical and Commercial Scale API Manufacturing

Winston Wu, Ph.D.
Vice President, Chemical Development
Lexicon Pharmaceuticals

Round Table Two

Multinational Project Teams: Navigating Differences in Communication, Culture, Personality, Distance, Language

Stuart Needleman
Chief Commercial Officer
Piramal Pharma Solutions

4:30pm - 5:00pm
Refreshments & Snacks in the Exhibit Halls
5:15pm - 8:30pm
Annual Beach Party, BBQ, Open Bar
8:30pm - 11:00pm
After Hours Socializing at the Lobby Bar

Wednesday, September 20, 2017 - Day 3

7:30am - 6:00pm
Exhibit Halls Open
7:30am - 10:00am
Full Hot & Cold Breakfast in Exhibit Halls
7:00am - 5:00pm
16 Private Meeting Rooms Open (Use online portal to set up meetings)
Exhibit Hall A, 9:00 - 9:45am Exhibit Hall B, 9:00 - 9:45pm Track C

Round Table One

Route Scouting, Scale Up & Process Optimization

Michael Cannarsa, Ph.D.
Business Development Director - Sciences
Almac Group

Elena Bejan, Ph.D.
Vice President, Research & Development
Eurofins Alphora

Round Table One

How Is The M&A Rush is Shaking Up the CMO Industry?

An open question, which can lead to numerous discussions about the activity, the high valuation for the shareholders, the trends of such consolidation, what customers think about it, what employees thing about it?

Jean-Jacques (John) Mondoloni
Managing Partner
Wombat Capital

Round Table Two

Technical Packages for Contract Manufacturing: RFP’s Quotes, Contracts and Final Reports

TBA

10:00am – 12:30pm
Networking & Snacks in Exhibit Halls
12:30pm - 1:45pm
Luncheon in Main Restaurant
2:30pm - 3:30pm
Networking & Snacks in Exhibit Halls
4:00pm
Event Concludes

See you September 15-18, 2018 Here at Ocean Place Resort!